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A Phase 1/2 Study of Bleximenib in Participants With Acute Leukemia (cAMeLot-1) (cAMeLot-1)
Study Contact - Participate-In-This-Study1@its.jnj.com
NCT04811560
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Inclusion Criteria:
Phase 1:
* Age 2 years and above (pediatric cohort only), all other cohorts 18 years and above
* Relapsed or refractory (R/R) acute leukemia and has exhausted, or is ineligible for, available therapeutic options
* Acute leukemia harboring histone-lysine N-methyltransferase 2A (KMT2A), nucleophosmin 1 gene (NPM1) or nucleoporin 98 gene or nucleoporin 214 gene (NUP98 or NUP214) alterations
Phase: 2
* Participants greater than 18 years are eligible
* Must have had an initial diagnosis of acute myeloid leukemia (AML) per the WHO 2022 classification criteria and have relapsed/refractory disease
* AML harboring KMT2A-r (gene rearrangement/translocation) or NPM1 mutations only
For Both Phase 1 and 2:
* Pretreatment clinical laboratory values meeting the following criteria: (a) Hematology: white blood cell (WBC) count less than or equal to (\<=) 20\*10\^9/liter (L) and (b) renal function; For adult participants, estimated or measured glomerular filtration rate greater than equal (\>=) 30 milliliter per minute (mL/min) per four variable MDRD equation. For pediatric participants an estimated or measured glomerular filtration rate \>50 mL/min per the CKiD (Chronic Kidney Disease in Children) Schwartz formula
* Eastern Cooperative Oncology Group (ECOG) performance status grade of 0, 1 or 2. Pediatric participants only: Performance status \>=70 by Lansky scale (for participants less than \[\<\]16 years of age) or \>=70 Karnofsky scale (for participants \>=16 years of age)
* A female of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin at screening and within 48 hours prior to the first dose of study treatment
* Participant must agree to all protocol required contraception requirements and avoid sperm or egg donations or freezing for future reproductive use while on study and for 90 days (males) or 6 months (females) after the last dose of study treatment
Exclusion Criteria:
* Acute promyelocytic leukemia, diagnosis of Down syndrome associated leukemia or juvenile myelomonocytic leukemia according to World Health Organization (WHO) 2016 criteria
* Active central nervous system (CNS) disease
* Prior solid organ transplantation
* QTc according to Fridericia's formula (QTcF) for males \>= 450 millisecond (msec) or for females \>= 470 msec. Participants with a family history of Long QT syndrome are excluded
* Exclusion criteria related to stem cell transplant: a. Received prior treatment with allogenic bone marrow or stem cell transplant \<=3 months before the first dose of study treatment; b. Has evidence of graft versus host disease; c. Received donor lymphocyte infusion \<=1 month before the first dose of study treatment; d. Requires immunosuppressant therapy (exception: daily doses \<=10 milligrams (mg) prednisone or equivalent are allowed for adrenal replacement)
* Prior cancer immunotherapy within 4 weeks prior to enrollment or blinatumomab within 2 weeks prior to enrollment. Additional prior cancer therapies must not be given within 4 weeks prior to enrollment or 5 half-lives of the agent (whichever is shorter) DRUG: Bleximenib
Acute Leukemias, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia
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Study Locations
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| Location | Contacts |
|---|---|
| Asan Medical Center Seoul, | |
| Baylor University Medical Center Dallas, Texas | |
| CHRU Nancy Brabois Vandœuvre-lès-Nancy, | |
| CHU Bretonneau Tours, | |
| CHU Lyon Sud Pierre-Bénite, | |
| CHU de Nantes hotel Dieu Nantes, | |
| Carmel Medical Center Haifa, | |
| Centre Hospitalier Universitaire (CHU) de Bordeaux Hopital HautLeveque Centre Francois Magendie Pessac, | |
| China Medical University Hospital Taichung, | |
| City of Hope Duarte, California | |
| City of Hope Phoenix Goodyear, Arizona | |
| Clinica Univ. de Navarra Pamplona, | |
| Dana Farber Cancer Institute Boston, Massachusetts | |
| First Affiliated Hospital Medical School of Zhejiang University Hangzhou, | |
| Fox Chase Cancer Center Philadelphia, Pennsylvania | |
| Fukushima Medical University Hospital Fukushima, | |
| Fundacao Antonio Prudente A C Camargo Cancer Center São Paulo, | |
| Fundacao Faculdade de Medicina Instituto do Cancer do Estado de Sao Paulo São Paulo, | |
| Gold Coast University Hospital Southport, | |
| Gunmaken Saiseikai Maebashi Hospital Maebashi, | |
| Gustave Roussy Villejuif, | |
| Guys and St Thomas NHS Foundation Trust London, | |
| Hadassah University Hospita Ein Kerem Jerusalem, | |
| Henan Cancer Hospital Zhengzhou, | |
| Hokkaido University Hospital Sapporo, | |
| Hopital Jean Minjoz Besançon, | |
| Hopital Maisonneuve Rosemont Montreal, Quebec | |
| Hopital Saint Louis Paris, Île-de-France Region | |
| Hopital trousseau- APHP Paris, | |
| Hosp Clinic de Barcelona Barcelona, | |
| Hosp Clinico Univ de Salamanca Salamanca, | |
| Hosp Univ Fund Jimenez Diaz Madrid, | |
| Hosp Univ Vall D Hebron Barcelona, | |
| Hosp. Clinico Univ. de Valencia Valencia, | |
| Hosp. Gral. Univ. Gregorio Marañon Madrid, | |
| Hosp. Virgen Del Rocio Seville, | |
| Houston Methodist Hospital Houston, Texas | |
| Institut Paoli Calmettes Marseille, | |
| Institut Universitaire du Cancer Toulouse Oncopole Toulouse, | |
| Institut de Cancerologie Strasbourg Europe ICANS Strasbourg, | |
| Institute of Hematology and Blood Diseases Hospital Tianjin, | |
| Instituto D Or de Pesquisa e Ensino São Paulo, | |
| Instituto D Or de Pesquisa e Ensino IDOR São Paulo, | |
| Kanazawa University Hospital Kanazawa, | |
| Karmanos Cancer Institute Detroit, Michigan | |
| Kobe City Medical Center General Hospital Hyōgo, | |
| Kyushu University Hospital Fukuoka, | |
| Leeds Teaching Hospitals NHS Trust Leeds, | |
| Liga Norte Riograndense Contra O Cancer Natal, Rio Grande do Norte | |
| MD Anderson Houston, Texas | |
| Maine Health Providence, Rhode Island | |
| Massachusetts General Hospital Boston, Massachusetts | |
| Medical College of WI at Froedtert Milwaukee, Wisconsin | |
| Ministerio da Saude Instituto Nacional do Cancer Rio de Janeiro, | |
| Monash Medical Centre Clayton, Victoria | |
| Montefiore Medical Center The Bronx, New York | |
| NTT Medical Center Tokyo Tokyo, | |
| NYU Langone Medical Center New York, New York | |
| Nagoya University Hospital Nagoya, | |
| Nanfang Hospital of Southern Medical Hospital Guangzhou, | |
| National Cancer Center Hospital East Kashiwa, Chiba | |
| National Cheng Kung University Hospital Tainan, | |
| National Taiwan University Hospital Taipei, | |
| Norton Cancer Institute Louisville, Kentucky | |
| Oregon Health and Science University Portland, Oregon | |
| Oxford University Hospitals NHS Trust Oxfordshire, | |
| Peking University First Hospital Beijing, | |
| Princess Margaret Cancer Centre University Health Network Toronto, Ontario | |
| Qilu Hospital of Shandong University Jinan, | |
| Roswell Park Comprehensive Cancer Center Buffalo, New York | |
| Royal Perth Hospital Perth, Western Australia | |
| START Midwest Grand Rapids, Michigan | |
| Samsung Medical Center Seoul, | |
| San Antonio Methodist TX Transplant Physicians Group San Antonio, Texas | |
| Seoul National University Hospital Seoul, | |
| Sheba Medical Center Ramat Gan, | |
| St Francis Hospital & Health Centers Indiana Blood and Marrow Transplantation Indianapolis, Indiana | |
| Swedish Cancer Institute Seattle, Washington | |
| Tel Aviv Sourasky Medical Center Tel Aviv, | |
| The Christie NHS Foundation Trust Manchester, | |
| The Clatterbridge Cancer Centre Liverpool, | |
| The First Affiliated Hospital of NanChang University Nanchang, | |
| The First Affiliated Hospital of Wenzhou Medical University Wenzhou, | |
| UCSF Benioff Children's Hospital San Francisco, California | |
| Union Hospital Tongji Medical College of Huazhong University of Science and Technology Wuhan, | |
| University College London Hospitals London, | |
| University Hospital of Wales Cardiff, | |
| University Hospitals Plymouth NHS Trust Plymouth, | |
| University of California Irvine Medical Center Orange, California | |
| University of California San Francisco San Francisco, California | |
| University of Chicago Chicago, Illinois | |
| University of Fukui Hospital Yoshida, | |
| University of New Mexico Albuquerque, New Mexico | |
| University of Tennessee Medical Center Knoxville, Tennessee | |
| Vancouver Coastal Health Vancouver, British Columbia | |
| Virginia Commonwealth University Richmond, Virginia | |
| West China Hospital Si Chuan University Chengdu, | |
| Yamagata University Hospital Yamagata, | |
| Zhongda Hospital Southeast University Nanjing, Jiangsu | |
| the First Hospital of Jilin University Changchun, |
Enhancing Oral Cancer Awareness
Tamas Gal, Ph.D - Tamas.Gal@vcuhealth.org
NCT06682494
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Inclusion Criteria:
* Identify as African American as defined by the US Census
* Participants must be able to read, speak, and write in English
Exclusion Criteria:
* Individuals who cannot physically or mentally participate in the research project will be excluded
* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Prisoners BEHAVIORAL: Traditional Education, BEHAVIORAL: AI-powered Chatbox
Oral Cancer, Chatbot, Patient Education, Prevention, Oral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity Cancer, Oropharyngeal Cancers
AI-powered Chatbox, Oral cancer prevention, Socio-economic barriers
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| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia | Tamas Gal, Ph.D - (Tamas.Gal@vcuhealth.org) |
A Study to Test Whether BI 1356225 Improves Impulsive Behavior in Men With Opioid Use Disorder Who Are Taking Buprenorphine
Boehringer Ingelheim - clintriage.rdg@boehringer-ingelheim.com
NCT06628622
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Inclusion Criteria:
• Male participants, 18 to 65 years of age, both inclusively, at the time of consent
• Meet current diagnostic and statistical manual of mental disorders, fifth edition (DSM-5) criteria for opioid use disorder, of at least moderate severity within the 12 months prior to screening
• Currently engaged in medications for opioid use disorder (MOUD) treatment with one of the following regimens:
• buprenorphine/naloxone sublingual film total daily dose ranging from 8 mg/2 mg to 24 mg/6 mg for at least 2 weeks at screening OR
• buprenorphine/naloxone sublingual tablet from 5.7 mg/1.4 mg to 17.1 mg/4.3 mg total daily dose for at least 2 weeks at screening OR
• buprenorphine sublingual tablet from 8 mg to 24 mg total daily dose for at least 2 weeks at screening OR
• on a stable dose of depot injectable buprenorphine for at least 5 weeks at screening, with at least 1 week since last depot buprenorphine injection
• Have a current MOUD prescription in accordance with inclusion criterion 4 and a positive urine drug screen for buprenorphine during screening and upon presenting for randomization to document buprenorphine use
• Willingness to abstain from using alcohol for 24 hours (h) and all other drugs of abuse for 72 h prior to Day 1 and through discharge from the trial site on Day 9
• Further inclusion criteria apply
Exclusion Criteria:
• Lifetime diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar I disorder, delusional disorder, or autism spectrum disorder as confirmed by the mini international neuropsychiatric interview (MINI) at the screening visit
• Moderate or severe substance use disorder other than opioid use disorder (OUD) within the 6 months prior to screening (excluding tobacco, caffeine, and moderate stimulant use)
• Severe stimulant use disorder within the 6 months prior to screening
• Any other psychiatric disorder that is not currently stable in symptoms and treatment. Stable is defined as having no significant changes in symptom acuity or treatment (medication or psychotherapy treatment) in the 8 weeks prior to randomization
• Score of ≥20 on the Montgomery-Åsberg Depression Rating Scale (MADRS)
• Positive results on a urine drug screen for ≥3 drugs (not counting buprenorphine or TCAs) at screening. In the case of a positive drug screen for 1 or 2 agents, if the participant does not meet the exclusion criteria regarding substance use disorder for these compounds, they may be included if the investigator determines that use will not be an impediment to trial participation or accurate data collection
• Any positive result on a urine drug screen (not counting buprenorphine, TCAs, or cannabis) at admission to the trial site on Day -1
• Intoxication at screening or randomization, as determined by clinical exam and breathalyzer
• Further exclusion criteria apply
DRUG: BI 1356225, DRUG: Placebo
Opioid Use Disorder
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| Location | Contacts |
|---|---|
| Collaborative Neuroscience Research, LLC, Los Alamitos Los Alamitos, California | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Hassman Research Institute-Marlton-66897 Marlton, New Jersey | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| University of California Los Angeles Los Angeles, California | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Virginia Commonwealth University Richmond, Virginia | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| iResearch Atlanta Decatur, Georgia | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003) (OMAHA-003)
Toll Free Number - Trialsites@msd.com
NCT06136624
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Inclusion Criteria:
* Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology.
* Has prostate cancer progression while on androgen deprivation therapy (or post bilateral orchiectomy) within 6 months before Screening
* Has current evidence of distant metastatic disease (M1 disease) documented by either bone lesions on bone scan and/or soft tissue disease by computed tomography/magnetic resonance imaging (CT/MRI).
* Has disease that progressed during or after treatment with 1 novel hormonal agent (NHA)
* Has received 1 but no more than 2 taxane-based chemotherapy regimens for metastatic castration-resistant prostate cancer (mCRPC) and has had progressive disease (PD) during or after treatment
* Has ongoing androgen deprivation with serum testosterone \<50 ng/dL (\<1.7 nM)
* Has provided tumor tissue from a fresh core or excisional biopsy from soft tissue not previously irradiated
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of randomization
* Has had prior treatment with PARPi or were deemed ineligible to receive treatment by the investigator or have refused PARPi treatment
* Has received prior 177Lu-PSMA-617 or were deemed ineligible to receive 177Lu-PSMA-617 treatment by the investigator or refused 177Lu-PSMA-617 treatment
* Participants who have not received cabazitaxel can be enrolled if they are ineligible for cabazitaxel treatment as determined by the investigator or have refused treatment
* If participant received first generation anti-androgen therapy before screening, the participant has evidence of disease progression \>4 weeks since the last flutamide treatment and \>6 weeks since the last bicalutamide or nilutamide treatment
* Participants receiving bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses for ≥ 4 weeks before the date of randomization
* Participants with human immunodeficiency virus (HIV) infection must have well controlled HIV on antiretroviral therapy (ART)
* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before randomization
* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at Screening.
* Participants who can produce sperm must agree to the following during the study treatment period and for at least 7 days after the last dose of opevesostat, for at least 30 days after the last dose of abiraterone acetate, and for at least 3 months after the last dose of enzalutamide: EITHER be abstinent OR must agree to use male condom
Exclusion Criteria:
* Has a gastrointestinal disorder that might affect absorption
* Has a history of pituitary dysfunction
* Has poorly controlled diabetes mellitus
* Has clinically significant abnormal serum potassium or sodium level
* Has a history of active or unstable cardio/cerebro-vascular disease, including thromboembolic events
* Has a history of seizure within 6 months of providing documented informed consent or any condition that may predispose to seizures within 12 months before the date of randomization
* Has a history of clinically significant ventricular arrhythmias
* Has received an anticancer monoclonal antibody (mAb) within 4 weeks before the date of randomization, or has not recovered from adverse events (AEs) due to mAbs administered more than 4 weeks before the date of randomization
* Has undergone major surgery, including local prostate intervention (except prostate biopsy), within 28 days before the date of randomization, and has not recovered from the toxicities and/or complications
* Participants who have not adequately recovered from major surgery or have ongoing surgical complications
* Has used herbal or medicinal products that may have hormonal anti-prostate cancer activity and/or are known to decrease prostate-specific Antigen (PSA) (eg, saw palmetto, megesterol acetate, citrus pectin polysaccharide) within 4 weeks before the date of randomization
* Has received radium-223 or lutetium-177 within 4 weeks before the date of randomization, or has not recovered to Grade ≤1 or baseline from AEs due to radium-223 or lutetium-177 administered more than 4 weeks before the date of randomization
* Has received treatment with 5-αreductase inhibitors (eg, finasteride or dutasteride), estrogens, or cyproterone within 4 weeks before the date of randomization
* Has received colony-stimulating factors within 28 days before the date of randomization
* Has received a whole blood transfusion in the last 120 days before the date of randomization. Packed red blood cells and platelet transfusions are acceptable if not given within 28 days of the date of randomization
* Has received prior targeted small molecule therapy or NHA treatment within 4 weeks before the first dose of study intervention as follows: enzalutamide or apalutamide within 3 weeks or abiraterone acetate + prednisone or darolutamide within 2 weeks
* Has a "superscan" bone scan
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
* Has an active autoimmune disease that has required systemic treatment in past 2 years
* Has an active infection requiring systemic therapy
* Has concurrent active HBV or known active HCV infection
* Has a history of long QTc syndrome
* Has any of the following at Screening Visit: hypotension (systolic BP \<110 mm Hg) or uncontrolled hypertension (systolic BP ≥160 mm Hg or diastolic BP ≥90 mm Hg, in 2 out of 3 recordings with optimized antihypertensive therapy)
* Is unable to swallow capsules/tablets
* Is currently being treated with cytochrome 450-inducing antiepileptic drugs for seizures
* Participants on an unstable dose of thyroid hormone therapy within 6 months before the start of the study intervention
* Received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention
* Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids
* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
* Systemic use of the following medications within 2 weeks before the first dose of study intervention: strong CYP3A4 inducers (eg, avasimibe, carbamazepine, lumacaftor, phenobarbital, rifampicin, rifapentine, or St John's Wort); P-gp inhibitors (eg, erythromycin, clarithromycin, rifampicin, ketoconazole, itraconazole, posaconazole, artesunate-pyronaridine, ritonavir, indinavir, nelfinavir, atazanavir, glecaprevir-pibrentasvir, simeprevir, ledipasvir-sofosbuvir, verapamil, diltiazem, dronedarone, propafenone, quinidine, cyclosporine, valspodar, or milk thistle \[Silybum marianum\])
* Use of aldosterone antagonist (eg, spironolactone, eplerenone) and phenytoin within 4 weeks before the start of the study intervention DRUG: Opevesostat, DRUG: Abiraterone acetate, DRUG: Enzalutamide, DRUG: Hydrocortisone, DRUG: Fludrocortisone acetate, DRUG: Prednisone, DRUG: Dexamethasone
Prostate Cancer Metastatic
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Study Locations
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| Location | Contacts |
|---|---|
| A. C. Camargo Cancer Center ( Site 0310) São Paulo, São Paulo | |
| AHN Allegheny General Hospital ( Site 0001) Pittsburgh, Pennsylvania | |
| Ad-Vance Medical Research-Research ( Site 1353) Ponce, | |
| Addenbrooke's Hospital ( Site 1605) Cambridge, Cambridgeshire | |
| Affiliated hospital of Jiangnan university ( Site 0434) Wuxi, Jiangsu | |
| Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1477) Uppsala, Uppsala County | |
| Akershus Universitetssykehus-Onkologisk avdeling ( Site 1227) Lørenskog, Akershus | |
| Akita University Hospital ( Site 0904) Akita, | |
| Aliada-Oncologìa ( Site 1257) Lima, | |
| Amsterdam UMC, locatie VUmc ( Site 1156) Amsterdam, North Holland | |
| Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1552) Ankara, | |
| Anschutz Cancer Pavilion ( Site 0046) Aurora, Colorado | |
| Asahikawa Medical University Hospital ( Site 0901) Asahikawa, Hokkaido | |
| Asan Medical Center-Oncology ( Site 1402) Songpagu, Seoul | |
| Asociación de Beneficencia Hospital Sirio Libanés ( Site 0205) Buenos Aires, Buenos Aires F.D. | |
| Atlantic Health System Morristown Medical Center ( Site 0115) Morristown, New Jersey | |
| Avera Cancer Institute - Pierre ( Site 0118) Pierre, South Dakota | |
| Avera Cancer Institute - Yankton ( Site 0117) Yankton, South Dakota | |
| Avera Cancer Institute- Research ( Site 0094) Sioux Falls, South Dakota | |
| Bacs-Kiskun Varmegyei Oktatokorhaz-Onkoradiologiai Kozpont ( Site 0752) Kecskemét, Bács-Kiskun county | |
| Baltimore Veterans Affairs Medical Center ( Site 0069) Baltimore, Maryland | |
| Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 1554) Adana, | |
| Beijing Cancer hospital-Urinary Surgery ( Site 0395) Beijing, Beijing Municipality | |
| Beijing Friendship Hospital Affiliate of Capital University ( Site 0396) Beijing, Beijing Municipality | |
| Bell Land General Hospital ( Site 0913) Sakai, Osaka | |
| Blue Ridge Cancer Care ( Site 0004) Roanoke, Virginia | |
| Bradford Hill Norte ( Site 0357) Antofagasta, | |
| Bradfordhill-Clinical Area ( Site 0351) Santiago, Region M. de Santiago | |
| Bruce W. Carter Veterans Affairs Medical Center ( Site 0082) Miami, Florida | |
| CIO - Centro de Inmuno-Oncología de Occidente ( Site 1103) Guadalajara, Jalisco | |
| Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 0632) Rennes, Ille-et-Vilaine | |
| Centre Hospitalier Universitaire de Nîmes - Institut de Cancérologie du Gard - Hôpital Universitaire ( Site 0630) Nîmes, Gard | |
| Centre Hospitalier de l'Université de Montréal ( Site 0326) Montreal, Quebec | |
| Centre Hospitalier de la Côte Basque ( Site 0633) Bayonne, Pyrenees-Atlantiques | |
| Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 0328) Greenfield Park, Quebec | |
| Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne ( Site 0629) Clermont-Ferrand, Puy-de-Dome | |
| Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0327) Québec, Quebec | |
| Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer ( Site 0329) Sherbrooke, Quebec | |
| Centro de Investigacion Clinica de Oaxaca ( Site 1109) Oaxaca City, | |
| Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1302) Bydgoszcz, Kuyavian-Pomeranian Voivodeship | |
| Chang Gung Medical Foundation-Linkou Branch-Medical Oncology ( Site 1504) Taoyuan District, | |
| Charing Cross Hospital-Oncology Research ( Site 1606) London, Hammersmith and Fulham | |
| Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0679) Berlin, | |
| China Medical University Hospital-Department of Urology ( Site 1503) Taichung, | |
| Chongqing Three Gorges Central Hospital's ( Site 0426) Chongqing, Chongqing Municipality | |
| Chongqing University Cancer Hospital ( Site 0416) Chongqing, Chongqing Municipality | |
| Chulalongkorn University ( Site 1530) Bangkok, Bangkok | |
| Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 0501) Bogotá, Bogota D.C. | |
| Clinica Universidad Catolica del Maule-Oncology ( Site 0355) Talca, Maule Region | |
| Clinical Research Chile SpA ( Site 0358) Valdivia, Los Ríos Region | |
| Clínica Imbanaco S.A.S ( Site 0509) Cali, Valle del Cauca Department | |
| Clínica Sánchez Ferrer ( Site 1261) Trujillo, La Libertad | |
| Clínica de Neoplasias Litoral ( Site 0305) Itajaí, Santa Catarina | |
| Colorado Clinical Research ( Site 0067) Lakewood, Colorado | |
| Complexo Hospitalario Universitario de Ourense ( Site 1426) Ourense, Orense | |
| Comprehensive Cancer Centers of Nevada ( Site 0010) Las Vegas, Nevada | |
| Cross Cancer Institute ( Site 0332) Edmonton, Alberta | |
| Debreceni Egyetem Klinikai Kozpont-Onkológiai Klinika ( Site 0758) Debrecen, | |
| Dubbo Hospital ( Site 0235) Dubbo, New South Wales | |
| Dunedin Hospital-Southern Blood and Cancers Service ( Site 1203) Dunedin, Otago | |
| ETZ Elisabeth-Internal Medicine ( Site 1160) Tilburg, North Brabant | |
| Ehime University Hospital ( Site 0918) Tōon, Ehime | |
| Emek Medical Center ( Site 0830) Afula, | |
| FALP ( Site 0353) Santiago, Region M. de Santiago | |
| Faculty of Medicine - Khon Kaen University ( Site 1526) Muang, Changwat Khon Kaen | |
| Faculty of Medicine Siriraj Hospital ( Site 1531) Bangkok, Bangkok | |
| Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 0555) Olomouc, Olomoucký kraj | |
| Fakultni nemocnice Ostrava-Klinika onkologicka ( Site 0554) Ostrava, Moravskoslezský kraj | |
| Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 0551) Prague, Praha 5 | |
| Filios Alta Medicina ( Site 1106) Monterrey, Nuevo León | |
| First Huai'an Hospital Affiliated to Nanjing Medical University ( Site 0436) Huaian, Jiangsu | |
| Florida Cancer Specialists - South ( Site 7003) Fort Myers, Florida | |
| Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0877) Milan, Lombardy | |
| Franciscus Gasthuis & Vlietland, Locatie Vlietland ( Site 1151) Schiedam, South Holland | |
| Fred Hutchinson Cancer Center ( Site 0013) Seattle, Washington | |
| Fudan University Shanghai Cancer Center-Urology department ( Site 0376) Shanghai, Shanghai Municipality | |
| Fukushima Medical University Hospital ( Site 0933) Fukushima, | |
| Fundacion Centro Oncologico de Integración Regional-Medical Oncology ( Site 0204) Mendoza, | |
| Fundación Cardiovascular de Colombia ( Site 0503) Piedecuesta, Santander Department | |
| Fundación Instituto Valenciano de Oncología-Oncologico ( Site 1430) Valencia, Valenciana, Comunitat | |
| Fundación Valle del Lili ( Site 0505) Cali, Valle del Cauca Department | |
| Gifu University Hospital ( Site 0910) Gifu, | |
| Greenebaum Comprehensive Cancer Center ( Site 0049) Baltimore, Maryland | |
| Gulhane Egitim Arastirma Hastanesi ( Site 1558) Ankara, | |
| Gustave Roussy ( Site 0626) Villejuif, Val-de-Marne | |
| HELIOS Kliniken Schwerin ( Site 0694) Schwerin, Mecklenburg-Vorpommern | |
| HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 1428) Seville, | |
| Hacettepe Universite Hastaneleri-oncology hospital ( Site 1551) Ankara, | |
| Hadassah Medical Center ( Site 0833) Jerusalem, | |
| Haga Ziekenhuis locatie Leyweg-Oncology ( Site 1164) The Hague, South Holland | |
| Henry Ford Hospital ( Site 0015) Detroit, Michigan | |
| Hiroshima University Hospital ( Site 0916) Hiroshima, | |
| Hokkaido University Hospital ( Site 0931) Sapporo, Hokkaido | |
| Hospital Aleman-Oncology ( Site 0207) Buenos Aires, | |
| Hospital Británico de Buenos Aires-Oncology ( Site 0202) Ciudad Autónoma de Buenos Aires, Buenos Aires | |
| Hospital Felicio Rocho ( Site 0317) Belo Horizonte, Minas Gerais | |
| Hospital Jerez de la Frontera ( Site 1427) Jerez de la Frontera, Cadiz | |
| Hospital Kuala Lumpur-Radiotherapy and Oncology ( Site 1078) Kuala Lumpur, | |
| Hospital Lucus Augusti-Oncology ( Site 1432) Lugo, | |
| Hospital Mario Penna ( Site 0309) Belo Horizonte, Minas Gerais | |
| Hospital Santa Rita de Cassia-Centro de Pesquisa Clínica ( Site 0320) Vitória, Espírito Santo | |
| Hospital Sultan Ismail ( Site 1081) Johor Bahru, Johor | |
| Hospital Universitario 12 de Octubre-Medical Oncology ( Site 1433) Madrid, Madrid, Comunidad de | |
| Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1431) Madrid, Madrid, Comunidad de | |
| Hospital Universitário Evangélico Mackenzie-Centro de Oncologia Mackenzie ( Site 0314) Curitiba, Paraná | |
| Hospital Universitário São Francisco de Assis - Bragança Paulista ( Site 0308) Bragança Paulista, São Paulo | |
| Hospital of the University of Occupational and Environmental Health, Japan ( Site 0921) Kitakyushu, Fukuoka | |
| Huadong Hospital Affiliated to Fudan University-Urology ( Site 0388) Shanghai, Shanghai Municipality | |
| Hubei Cancer Hospital-Urinary surgery ( Site 0406) Wuhan, Hubei | |
| Hunan Cancer Hospital ( Site 0405) Changsha, Hunan | |
| Hôpital Européen Georges Pompidou ( Site 0628) Paris, | |
| IC La Serena Research ( Site 0356) La Serena, Coquimbo Region | |
| IMAT S.A.S ( Site 0504) Montería, Departamento de Córdoba | |
| INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS-Medical Oncology ( Site 1256) Lima, | |
| IPOR Instituto Peruano de Oncología & Radioterapia-Centro de Investigación ( Site 1254) Lima, | |
| IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 0879) Meldola, Emilia-Romagna | |
| Institut de cancérologie Strasbourg Europe (ICANS) ( Site 0627) Strasbourg, Alsace | |
| Instituto Alexander Fleming-Alexander Fleming ( Site 0206) Buenos Aires, Buenos Aires F.D. | |
| Instituto Regional de Enfermedades Neoplasicas del Centro (IREN CENTRO) ( Site 1258) Concepción, Departamento de Junín | |
| Instituto de Investigaciones Clínicas Mar del Plata ( Site 0201) Mar del Plata, Buenos Aires | |
| Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 1555) Istanbul, | |
| James J. Peters VA Medical Center ( Site 0088) The Bronx, New York | |
| Jiangxi Cancer Hospital ( Site 0386) Nanchang, Jiangxi | |
| Kagawa University Hospital ( Site 0917) Kita, Kagawa-ken | |
| Kagoshima University Hospital ( Site 0929) Kagoshima, | |
| Kaiser Permanente Riverside Medical Center ( Site 0099) Riverside, California | |
| Kanazawa Medical University Hospital ( Site 0909) Mukai-awagasaki, Ishikawa-ken | |
| Kansai Medical University Hospital ( Site 0912) Hirakata, Osaka | |
| Karolinska Universitetssjukhuset Solna ( Site 1478) Stockholm, Stockholm County | |
| Klinikum Wels-Grieskirchen GmbH ( Site 0279) Wels, Upper Austria | |
| Kobe University Hospital ( Site 0914) Kobe, Hyōgo | |
| Kuopion Yliopistollinen Sairaala ( Site 0603) Kuopio, Northern Savonia | |
| Kurume University Hospital ( Site 0920) Kurume, Fukuoka | |
| Kyushu University Hospital ( Site 0919) Fukuoka, | |
| M Health Fairview Clinics and Surgery Center ( Site 0019) Minneapolis, Minnesota | |
| MEDICAL COLLEGE OF WISCONSIN ( Site 0020) Milwaukee, Wisconsin | |
| Macquarie University-MQ Health Clinical Trials Unit ( Site 0234) Macquarie University, New South Wales | |
| Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 0553) Brno, Brno-mesto | |
| Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1310) Siedlce, Masovian Voivodeship | |
| Meander Medisch Centrum ( Site 1157) Amersfoort, Utrecht | |
| Medical Care and Research SA de CV ( Site 1108) Mérida, Yucatán | |
| Medische Centrum Leeuwarden ( Site 1172) Leeuwarden, Provincie Friesland | |
| Medizinische Universität Graz-Innere Medizin Klin. Abt. Onkologie ( Site 0280) Graz, Styria | |
| Meir Medical Center. ( Site 0832) Kfar Saba, | |
| Memorial Ankara Hastanesi-Medical Oncology ( Site 1557) Ankara, | |
| Metro-Minnesota Community Clinical Oncology ( Site 0014) Saint Louis Park, Minnesota | |
| Miyazaki Prefectural Miyazaki Hospital ( Site 0927) Miyazaki, | |
| Nagano Municipal Hospital ( Site 0932) Nagano, | |
| Nanbu Tokushukai Hospital ( Site 0930) Shimajiri, Okinawa | |
| Nanchong Central Hospital-urology ( Site 0422) Nanchong, Sichuan | |
| Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( Site 0377) Nanjing, Jiangsu | |
| Nara Medical University Hospital ( Site 0915) Kashihara, Nara | |
| National Cancer Centre Singapore ( Site 1377) Singapore, Central Singapore | |
| National Cancer Institute ( Site 1079) Putrajaya, Putrajaya | |
| National Cheng Kung University Hospital-Urology ( Site 1502) Tainan, | |
| National Hospital Organization Kumamoto Medical Center ( Site 0924) Kumamoto, | |
| National Hospital Organization Nagasaki Medical Center ( Site 0923) Ōmura, Nagasaki | |
| National Hospital Organization Oita Medical Center ( Site 0925) Ōita, | |
| National Taiwan University Hospital-Urology ( Site 1506) Taipei, | |
| National University Hospital ( Site 1376) Singapore, Central Singapore | |
| Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 1153) Amsterdam, North Holland | |
| Nograd Varmegyei Szent Lazar Korhaz-Onkologia es Sugarterapias Osztaly ( Site 0761) Salgótarján, Nógrád megye | |
| Obras Sociais Irma Dulce ( Site 0302) Salvador, Estado de Bahia | |
| Ochsner Clinic Foundation ( Site 0108) New Orleans, Louisiana | |
| Odense Universitetshospital-Department of oncology ( Site 0579) Odense, Region Syddanmark | |
| Oncosalud-Clinical Research ( Site 1260) Lima, | |
| Ordensklinikum Linz GmbH Elisabethinen-Urologie ( Site 0276) Linz, Upper Austria | |
| Oregon Health and Science University ( Site 0028) Portland, Oregon | |
| Országos Onkológiai Intézet-Urogenitális Tumorok és Klinikai Farmakológiai Osztály ( Site 0756) Budapest, Pest County | |
| Ospedale San Raffaele-Oncologia Medica ( Site 0876) Milan, | |
| Pan American Center for Oncology Trials - Ciudadela ( Site 1351) San Juan, | |
| Peking University First Hospital-Urology ( Site 0390) Beijing, Beijing Municipality | |
| Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 0230) Melbourne, Victoria | |
| Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 0354) Santiago, Region M. de Santiago | |
| Prince of Wales Hospital ( Site 0730) Shatin, | |
| Princess Alexandra Hospital-Cancer Care Serices ( Site 0237) Brisbane, Queensland | |
| Princess Margaret Cancer Centre ( Site 0330) Toronto, Ontario | |
| Puerto Rico Medical Research Center LLC ( Site 1354) Hato Rey, | |
| Queen Mary Hospital ( Site 0727) Hong Kong, | |
| Quemex Medical and Research ( Site 1112) Mexico City, Mexico City | |
| Rabin Medical Center ( Site 0828) Petah Tikva, | |
| Radboudumc-Medical Oncology ( Site 1152) Nijmegen, Gelderland | |
| Ralph H. Johnson VA Health Care System (RHJVAHCS)-Urology ( Site 0083) Charleston, South Carolina | |
| Rambam Health Care Campus-Oncology Division ( Site 0826) Haifa, | |
| Regionalny Szpital Specjalistyczny im. dr. Władyslawa Biegańskiego ( Site 1316) Grudziądz, Kuyavian-Pomeranian Voivodeship | |
| Rigshospitalet ( Site 0576) Copenhagen, Capital Region | |
| Rutgers Cancer Institute of New Jersey ( Site 0033) New Brunswick, New Jersey | |
| SCRI Oncology Partners ( Site 7000) Nashville, Tennessee | |
| Saga-Ken Medical Centre Koseikan ( Site 0922) Saga, Saga-ken | |
| Sahlgrenska Universitetssjukhuset ( Site 1479) Gothenburg, Västra Götaland County | |
| Samsun Medical Park Hastanesi-medical oncology (1560) Samsun, | Dilek Erdem - (dilekgurgenyatagi@yahoo.com) |
| Samsung Medical Center ( Site 1405) Seoul, | |
| Sanatorio Parque ( Site 0208) Rosario, Santa Fe Province | |
| Sapporo Medical University Hospital ( Site 0902) Sapporo, Hokkaido | |
| Sarawak General Hospital-Radiotherapy Unit ( Site 1076) Kuching, Sarawak | |
| Second Affiliated hospital of Anhui Medical University-Urology ( Site 0408) Hefei, Anhui | |
| Seoul National University Hospital-Oncology ( Site 1401) Seoul, | |
| Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1404) Seoul, | |
| Sheba Medical Center ( Site 0827) Ramat Gan, | |
| Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0502) Valledupar, Cesar Department | |
| Songklanagarind hospital ( Site 1527) Hat Yai, Changwat Songkhla | |
| Southwest Hospital of Third Military Medical University ( Site 0420) Chongqing, Chongqing Municipality | |
| Spaarne Gasthuis - Hoofddorp-Oncology ( Site 1170) Hoofddorp, North Holland | |
| St. Olavs Hospital-Kreftklinikken ( Site 1231) Trondheim, Sor-Trondelag | |
| St. Vincent's University Hospital ( Site 0802) Dublin, Dublin | |
| Stanford Cancer Center ( Site 0036) Palo Alto, California | |
| Suining Central Hospital ( Site 0437) Suining, Sichuan | |
| Sun Yat-sen University Cancer Center-Internal medicine ( Site 0413) Guangzhou, Guangdong | |
| Sunnybrook Research Institute ( Site 0331) Toronto, Ontario | |
| Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Onkologii Klinicznej, Dzial Ch ( Site 1318) Kielce, Świętokrzyskie Voivodeship | |
| Sykehuset Østfold Kalnes ( Site 1228) Sarpsborg, Østfold fylke | |
| Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 1303) Koszalin, West Pomeranian Voivodeship | |
| TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1553) Istanbul, | |
| Taipei Veterans General Hospital ( Site 1505) Taipei, | |
| Tallaght University Hospital ( Site 0801) Dublin, | |
| Tampereen yliopistollinen sairaala ( Site 0604) Tampere, Pirkanmaa | |
| Tan Tock Seng Hospital-Medical Oncology ( Site 1378) Singapore, Central Singapore | |
| Tauranga Hospital-Bay of Plenty Clinical Trials Unit ( Site 1201) Tauranga, Bay of Plenty | |
| Texas Oncology - Central/South Texas ( Site 8003) Austin, Texas | |
| Texas Oncology - DFW ( Site 8001) Dallas, Texas | |
| Texas Oncology - Gulf Coast ( Site 8002) The Woodlands, Texas | |
| The Beatson West of Scotland Cancer Centre ( Site 1603) Glasgow, Glasgow City | |
| The Christie NHS Foundation Trust ( Site 1608) Manchester, | |
| The First Affiliated Hospital Of Fujian Medical University-Urology ( Site 0414) Fuzhou, Fujian | |
| The First Affiliated Hospital of Chongqing Medical University ( Site 0427) Chongqing, Chongqing Municipality | |
| The First Affiliated Hospital of Guangzhou Medical University ( Site 0412) Guangzhou, Guangdong | |
| The First Affiliated Hospital of Ningbo University ( Site 0383) Ningbo, Zhejiang | |
| The First Affiliated Hospital of Wenzhou Medical University-Urology Surgery ( Site 0379) Wenzhou, Zhejiang | |
| The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 0393) Xi'an, Shaanxi | |
| The First Affiliated hospital of Xiamen University-Urology ( Site 0415) Xiamen, Fujian | |
| The First Hospital of Jiaxing-urology ( Site 0380) Jiaxing, Zhejiang | |
| The Jikei University Hospital ( Site 0907) Minato, Tokyo | |
| The Ottawa Hospital - General Campus-The Ottawa Hospital Cancer Centre ( Site 0336) Ottawa, Ontario | |
| The Royal Cornwall Hospital ( Site 1610) Truro, England | |
| The Second Affiliated Hospital Of Kunming Medical University ( Site 0429) Kunming, Yunnan | |
| The Second Affiliated Hospital of Xi'an Jiaotong University ( Site 0394) Xi'an, Shaanxi | |
| The Second Hospital of Tianjin Medical University ( Site 0391) Tianjin, Tianjin Municipality | |
| The Third People's Hospital of Chengdu (CDTPH) ( Site 0428) Chengdu, Sichuan | |
| The University of Osaka Hospital ( Site 0911) Suita, Osaka | |
| Tianjin Medical University Cancer Institute & Hospital ( Site 0392) Tianjin, Tianjin Municipality | |
| Toho University Sakura Medical Center ( Site 0906) Sakura, Chiba | |
| Tongji Hospital Tongji Medical,Science & Technology ( Site 0407) Wuhan, Hubei | |
| Turku University Hospital-Department of Oncology ( Site 0601) Turku, Southwest Finland | |
| Universitaetsklinikum Hamburg-Eppendorf-Onkologisches Zentrum ( Site 0705) Hamburg, | |
| University College London Hospital ( Site 1612) London, London, City of | |
| University Hospitals Cleveland Medical Center ( Site 0043) Cleveland, Ohio | |
| University Malaya Medical Centre ( Site 1077) Lembah Pantai, Kuala Lumpur | |
| University Of Nebraska Medical Center-Oncology/Hematology ( Site 0095) Omaha, Nebraska | |
| University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0040) Orange, California | |
| University of Chicago Medical Center ( Site 0045) Chicago, Illinois | |
| University of Colorado Health - Highlands Ranch Hospital ( Site 0111) Highlands Ranch, Colorado | |
| University of Colorado Health - Lone Tree Medical Center ( Site 0112) Lone Tree, Colorado | |
| University of Illinois at Chicago ( Site 0105) Chicago, Illinois | |
| University of Iowa ( Site 0047) Iowa City, Iowa | |
| University of Kentucky Chandler Medical Center ( Site 0048) Lexington, Kentucky | |
| University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 0051) Miami, Florida | |
| University of Miyazaki Hospital ( Site 0926) Miyazaki, | |
| University of Virginia Health System ( Site 0054) Charlottesville, Virginia | |
| Universitätsklinikum Bonn-Klinik und Poliklinik für Urologie und Kinderurologie ( Site 0680) Bonn, North Rhine-Westphalia | |
| Universitätsklinikum Jena-Klinik und Poliklinik für Urologie ( Site 0682) Jena, Thuringia | |
| Universitätsklinikum Münster - Albert Schweitzer Campus-Klinik für Urologie ( Site 0678) Münster, North Rhine-Westphalia | |
| Universitätsklinikum Schleswig-Holstein-Klinik für Urologie ( Site 0691) Lübeck, Schleswig-Holstein | |
| VA Portland Health Care System ( Site 0058) Portland, Oregon | |
| VCU Health Adult Outpatient Pavillion ( Site 0061) Richmond, Virginia | |
| Vejle Sygehus ( Site 0578) Vejle, Region Syddanmark | |
| VieCuri Medisch Centrum ( Site 1173) Venlo, Limburg | |
| Washington University School of Medicine-Internal Medicine/Oncology ( Site 0062) St Louis, Missouri | |
| West China Hospital, Sichuan University-Urology Surgery ( Site 0417) Chengdu, Sichuan | |
| Westmead Hospital ( Site 0232) Westmead, New South Wales | |
| Wojewodzki Szpital Zespolony im Ludwika Rydygiera w Toruniu ( Site 1304) Torun, Kuyavian-Pomeranian Voivodeship | |
| Xinjiang Medical University Cancer Hospital - Urumqi-Urology ( Site 0419) Ürümqi, Xinjiang | |
| Yale-New Haven Hospital-Yale Cancer Center ( Site 0064) New Haven, Connecticut | |
| Yantai Yuhuangding Hospital ( Site 0397) Yantai, Shandong | |
| Yokohama City University Medical Center ( Site 0908) Yokohama, Kanagawa | |
| Yunnan Province Cancer Hospital ( Site 0418) Kunming, Yunnan | |
| Zachodniopomorskie Centrum Onkologii ( Site 1311) Szczecin, West Pomeranian Voivodeship | |
| Zhejiang Cancer Hospital ( Site 0435) Hangzhou, Zhejiang | |
| Zhejiang Provincial People's Hospital-Urology ( Site 0378) Hangzhou, Zhejiang | |
| Zhongshan Hospital of Fudan University (0430) Shanghai, Shangai | Jianming Guo - (guo.jianming@zs-hospital.sh.cn) |
| Zuyderland Medical Centre-Trialbureau Interne Geneeskunde ( Site 1163) Sittard-Geleen, Limburg | |
| klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Site 0696) Munich, Bavaria |
Chemotherapy Combined With Immunotherapy Versus Immunotherapy Alone for Older Adults With Stage IIIB-IV Lung Cancer, The ACHIEVE Trial
ctrrecruit@vcu.edu
NCT06096844
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Inclusion Criteria:
* STEP 1 REGISTRATION
* Patient must be ≥ 70 years of age
* Patient must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC) with PD-L1 Tumor Proportion Score (TPS) range of 1-49%
* Patient must have Stage IIIB, IIIC or IV disease and not be candidates for combined chemo-radiation. NOTE: Prior chemo-radiation therapy (RT) for stage III with recurrence is allowed
* Patient must have a tumor that is negative for EGFR mutation/ALK translocations or other actionable first line mutations in which patients would receive first-line oral tyrosine kinase inhibitors
* Patient must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 2
* Patient must agree not to father children while on study and for 6 months after the last dose of protocol treatment
* Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible
* Absolute neutrophil count (ANC) ≥ 1,500/uL (obtained within 14 days prior to Step 1 registration)
* Platelets ≥ 75,000/uL (obtained within 14 days prior to Step 1 registration)
* Hemoglobin (Hgb) ≥ 8.0 g/dL (obtained within 14 days prior to Step 1 registration)
* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (obtained within 14 days prior to Step 1 registration)
* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) ≤ 3.0 × institutional ULN (obtained within 14 days prior to Step 1 registration)
* Creatinine clearance (CrCL) ≥ 45 mL/min (estimated using Cockcroft-Gault method with actual body weight or measured) (obtained within 14 days prior to Step 1 registration)
* Human immunodeficiency virus (HIV)-infected patients on effective antiretroviral therapy with undetectable viral load within 6 months of Step 1 registration are eligible for this trial
* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have undetectable HCV viral
* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
* Patient must be English or Spanish speaking to be eligible for the QOL component of the study
* NOTE: Sites cannot translate the associated GA or QOL forms
* Patient must not have symptomatic central nervous system disease (CNS) metastases. Patients with a clinical history of CNS metastases or cord compression are eligible if they have been definitively treated and are clinically stable for at least 14 days prior to Step 1 registration and off all steroids for at least 24 hours prior to Step 1 registration. Patients with asymptomatic CNS metastases are eligible
* Patient must not have had any prior cytotoxic chemotherapy regimen for metastatic disease. Chemotherapy given in the setting of adjuvant therapy or locally advanced disease is allowed as long as treatment was completed, and they have fully recovered from treatment related adverse events prior to Step 1 registration
* Patient must not have had any prior immunotherapy for metastatic disease. Immunotherapy given in the setting of adjuvant therapy or locally advanced disease is allowed as long as treatment was completed greater than 6 months prior to Step 1 registration
* Patient must not have a history of uncontrolled autoimmune conditions with the following exceptions, which are allowed: alopecia, vitiligo, rheumatoid arthritis, psoriasis/psoriatic arthritis, Hashimoto's thyroiditis, lupus, inflammatory bowel disease
* Patient must not be on immunosuppressive medication, including steroids (if doses exceed the equivalent of prednisone 10 mg daily). Short courses of steroids which are discontinued prior to randomization are acceptable. Patients on inhaled, intranasal and/or topical steroids are eligible
* Patient must have baseline imaging done assessing all measurable or non-measurable sites of disease within 45 days prior to Step 1 registration
* Investigator must declare their intended chemotherapy regimen should their patient be randomized to Arm B (doublet versus\[vs\] singlet)
* STEP 2 RANDOMIZATION
* Patient must have completed the baseline Geriatric Assessment (GA) after Step 1 registration and prior to Step 2 randomization DRUG: Carboplatin, PROCEDURE: Computed Tomography, PROCEDURE: Magnetic Resonance Imaging, DRUG: Nab-paclitaxel, DRUG: Paclitaxel, BIOLOGICAL: Pembrolizumab, DRUG: Pemetrexed, PROCEDURE: Positron Emission Tomography, OTHER: Questionnaire Administration
Advanced Lung Non-Small Cell Carcinoma, Stage IIIB Lung Cancer AJCC v8, Stage IIIC Lung Cancer AJCC v8, Stage IV Lung Cancer AJCC v8
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Show 312 locations
Study Locations
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| Location | Contacts |
|---|---|
| AMG Crystal Lake - Oncology Crystal Lake, Illinois | Site Public Contact - (advocateresearch@advocate.com) |
| AMG Libertyville - Oncology Libertyville, Illinois | Site Public Contact - (advocateresearch@advocatehealth.com) |
| Abbott-Northwestern Hospital Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Adena Regional Medical Center Chillicothe, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Advocate Christ Medical Center Oak Lawn, Illinois | |
| Advocate Good Samaritan Hospital Downers Grove, Illinois | Site Public Contact - (Barbara.barhamand@advocatehealth.com) |
| Advocate Good Shepherd Hospital Barrington, Illinois | |
| Advocate Illinois Masonic Medical Center Chicago, Illinois | |
| Advocate Lutheran General Hospital Park Ridge, Illinois | |
| Advocate Sherman Hospital Elgin, Illinois | |
| Advocate South Suburban Hospital Hazel Crest, Illinois | |
| Aspirus Cancer Care - James Beck Cancer Center Rhinelander, Wisconsin | Site Public Contact - (Beth.Knetter@aspirus.org) |
| Aspirus Cancer Care - Stevens Point Stevens Point, Wisconsin | Site Public Contact - (Beth.Knetter@aspirus.org) |
| Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids, Wisconsin | |
| Aspirus Medford Hospital Medford, Wisconsin | Site Public Contact - (Beth.Knetter@aspirus.org) |
| Aspirus Regional Cancer Center Wausau, Wisconsin | |
| Asplundh Cancer Pavilion Willow Grove, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Atrium Medical Center-Middletown Regional Hospital Franklin, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Aultman Health Foundation Canton, Ohio | Site Public Contact - (ClinicalReserachDept@aultman.com) |
| Aurora Bay Area Medical Group-Marinette Marinette, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora BayCare Medical Center Green Bay, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Grafton Grafton, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Kenosha South Kenosha, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Milwaukee Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Milwaukee West Wauwatosa, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Racine Racine, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Southern Lakes VLCC Burlington, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Health Care Germantown Health Center Germantown, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Medical Center in Summit Summit, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Saint Luke's Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Saint Luke's South Shore Cudahy, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Sinai Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora West Allis Medical Center West Allis, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Bellin Memorial Hospital Green Bay, Wisconsin | |
| Benefis Sletten Cancer Institute Great Falls, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Billings Clinic Cancer Center Billings, Montana | Site Public Contact - (research@billingsclinic.org) |
| Bozeman Health Deaconess Hospital Bozeman, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Bronson Battle Creek Battle Creek, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Bronson Methodist Hospital Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Bryn Mawr Hospital Bryn Mawr, Pennsylvania | Site Public Contact - (turzoe@mlhs.org) |
| CTCA at Southeastern Regional Medical Center Newnan, Georgia | |
| Cancer Care Center of O'Fallon O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Care Specialists of Illinois - Decatur Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Hematology Centers - Flint Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores, Michigan | Site Public Contact - (connie.szczepanek@crcwm.org) |
| Carle Cancer Center Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Effingham Effingham, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Mattoon/Charleston Mattoon, Illinois | Site Public Contact - (Research@carle.com) |
| Carle at The Riverfront Danville, Illinois | Site Public Contact - (Research@Carle.com) |
| Case Western Reserve University Cleveland, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| Community Hospital of Anaconda Anaconda, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Toms River, New Jersey | Site Public Contact - (mccinfo@mtcancer.org) |
| Condell Memorial Hospital Libertyville, Illinois | Site Public Contact - (advocateresearch@advocatehealth.com) |
| Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Lakeland Hospitals - Niles Hospital Niles, Michigan | |
| Corewell Health Lakeland Hospitals - Saint Joseph Hospital Saint Joseph, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Reed City Hospital Reed City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Crossroads Cancer Center Effingham, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Dana Farber-Merrimack Valley Methuen, Massachusetts | |
| Dana-Farber Cancer Institute at Boston Medical Center - Brighton Brighton, Massachusetts | |
| Dana-Farber Cancer Institute at Foxborough Foxborough, Massachusetts | |
| Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Milford, Massachusetts | |
| Dana-Farber/Brigham and Women's Cancer Center at South Shore South Weymouth, Massachusetts | |
| Dartmouth Cancer Center - North Saint Johnsbury, Vermont | Site Public Contact - (cancer.research.nurse@hitchcock.org) |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire | Site Public Contact - (cancer.research.nurse@dartmouth.edu) |
| Decatur Memorial Hospital Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Duluth Clinic Ashland Ashland, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Durham VA Medical Center Durham, North Carolina | Site Public Contact - (VHADURcancertrials@va.gov) |
| ECOG-ACRIN Cancer Research Group Philadelphia, Pennsylvania | Megan A. Baumgart - (megan_baumgart@urmc.rochester.edu) |
| Edwards Comprehensive Cancer Center Huntington, West Virginia | Site Public Contact - (Christina.Cole@chhi.org) |
| Essentia Health - Deer River Clinic Deer River, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Cancer Center Duluth, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Hibbing Clinic Hibbing, Minnesota | |
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| Genesee Hematology Oncology PC Flint, Michigan | |
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| Genesys Hurley Cancer Institute Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
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| HaysMed Hays, Kansas | |
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Testing the Addition of an Individualized Vaccine to Durvalumab and Tremelimumab and Chemotherapy in Patients With Metastatic Triple Negative Breast Cancer
ctrrecruit@vcu.edu
NCT03606967
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Inclusion Criteria:
* Patients must have a histologically confirmed diagnosis of metastatic invasive triple negative breast cancer. Patients with clinical and/or radiologic suspicion of metastatic TNBC can be consented prior to this confirmation.
* Estrogen receptor (ER) and progesterone receptor (PR) less than Allred score of 3 OR less than 1% positive staining cells in the invasive component of the tumor.
* HER2 negative by fluorescence in situ hybridization (FISH) or immunohistochemistry (IHC) staining 0 or 1+.
* PD-L1 negative by a Clinical Laboratory Improvement Act (CLIA) approved laboratory using compatible assays appropriate for treatment decisions.
* Patients may have measurable or evaluable disease.
* Patients must be willing to undergo biopsy and have accessible lesions for a new biopsy, or they must have sufficient tissue available from a biopsy performed for standard of care (specifications below). If patient does not have enough archived tissue available, a new biopsy is required. A tumor specimen obtained from relapsed metastatic or locally advanced disease (if applicable) must be submitted. Acceptable samples include core needle biopsies for deep tumor tissue (minimum 4 cores) or excisional, incisional, punch, or forceps biopsies for cutaneous, subcutaneous, or mucosal lesions. Formalin-fixed, paraffin-embedded (FFPE) tumor specimens in paraffin blocks are preferred; FFPE tumor tissue sections on slides may be provided if sufficient material (15 x 10μ- unstained) is available. Fine-needle aspiration, brushing, cell pellet from pleural effusion, bone metastases, and lavage samples are not acceptable.
* No prior therapy for metastatic TNBC. Patients who have received taxane-based adjuvant therapy are required to have a disease-free interval of at least 12 months after completion of taxane therapy.
* Age \>= 18 years. Because no dosing or adverse event data are currently available on the use of durvalumab (MEDI4736) and tremelimumab in combination with neoantigen vaccine in patients \< 18 years of age, children are excluded from this study, but will be eligible for future pediatric trials
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 (Karnofsky \>= 60%).
* Body weight \> 30 kg.
* Must have a life expectancy of at least 12 weeks.
* Absolute neutrophil count \>= 1,500/mcL.
* Platelets \>= 100,000/mcL.
* Hemoglobin \>= 9.0 g/dL.
* Serum bilirubin =\< 1.5 x institutional upper limit of normal.
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) =\< 2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be =\< 5 x institutional upper limit of normal.
* Calculated creatinine clearance \> 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance.
* Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
* Women \< 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
* Women \>= 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \> 1 year ago, had chemotherapy-induced menopause with last menses \> 1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
* The effects of durvalumab (MEDI4736) and tremelimumab and neoantigen vaccine on the developing human fetus are unknown. For this reason and because these agents may be teratogenic, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and through 180 days after completion of durvalumab (MEDI4736) and tremelimumab. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
* Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
* Human immunodeficiency virus (HIV)-positive patients are eligible provided they have a negative viral load, CD4 count \> 250, and are on a stable antiretroviral regimen.
* Ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity who have a close caregiver or legal guardian are also eligible with the consent of the caregiver/guardian.
Exclusion Criteria:
* Patients who are not considered to be candidates for carboplatin + gemcitabine for first line therapy of their metastatic triple negative breast cancer are not eligible.
* Patients who have had chemotherapy, radiotherapy (to more than 30% of the bone marrow), or biologic therapy within 30 days (42 days for nitrosoureas or mitomycin C) prior to entering the study.
* Patients who have received prior immunotherapy for metastatic disease.
* Patients who have not recovered from grade \>= 2 adverse events due to prior anti-cancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria.
* Patients with grade \>= 2 neuropathy will be evaluated on a case-by-case basis after consultation with the study physician.
* Patients with stable endocrinological adverse events (AEs), (e.g., hypothyroidism, adrenal insufficiency, hypopituitarism, or diabetes mellitus), must have been on a stable dose of supplemental therapy for at least 2 weeks before screening to be eligible for this study.
* Patients who are receiving any other investigational agents or who have received an investigational agent within the last 30 days.
* Receipt of live attenuated vaccination within 6 months prior to study entry or within 30 days of receiving durvalumab (MEDI4736) and tremelimumab.
* Note: Patients, if enrolled, should not receive live vaccine whilst receiving study treatment and up to 30 days after the last dose of study treatment.
* Major surgical procedure within 28 days prior to the first dose of durvalumab (MEDI4736) and tremelimumab. Local surgery of isolated lesions for palliative intent is acceptable.
* Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab (MEDI4736) or tremelimumab. The following are exceptions to this criterion:
* Intranasal, inhaled, topical steroids or local steroid injections (e.g. intra-articular injection)
* Systemic corticosteroids at physiological doses which are not to exceed 10 mg/day of prednisone or an equivalent corticosteroid
* Steroids as premedication for hypersensitivity reactions (e.g. CT scan premedication).
* Known central nervous system (CNS) disease, except for treated asymptomatic CNS metastases. Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to durvalumab (MEDI4736) and tremelimumab. Known allergy, or history of serious adverse reaction to vaccines, such as anaphylaxis, hives or respiratory difficulty.
* Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) \>= 470 ms calculated from 3 electrocardiograms (ECGs) (within 15 minutes at 5 minutes apart).
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, evidence of any acute or chronic viral illness or disease, or psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant women are excluded from this study because durvalumab (MEDI4736) and tremelimumab has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with durvalumab (MEDI4736) and tremelimumab, breastfeeding should be discontinued if the mother is treated with durvalumab (MEDI4736) and tremelimumab. These potential risks may also apply to other agents used in this study. A negative serum pregnancy test is required no more than 7 days before study entry.
* Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
* History of pneumonitis or interstitial lung disease.
* History of active primary immunodeficiency.
* Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination, and radiographic findings, and tuberculosis \[TB\] testing in line with local practice), hepatitis B (known positive hepatitis B virus \[HBV\] surface antigen \[HBsAg\] result), or hepatitis C. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \[anti-HBc\] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA).
* The patient with a previous history of non-breast malignancy is eligible for this study only if the patient meets the following criteria for a cancer survivor. A cancer survivor is eligible provided the following criteria are met:
* Patient has undergone potentially curative therapy for all prior malignancies.
* Patients have been considered disease free for at least 1 year (with the exception of basal cell or squamous cell carcinoma of the skin or carcinoma-in-situ of the cervix).
* Patients with a strong likelihood of non-adherence (such as difficulties in adhering to follow-up schedule due to geographic distance from the treatment facility) should not be knowingly registered.
* History of allogeneic organ transplantation. PROCEDURE: Biopsy Procedure, PROCEDURE: Biospecimen Collection, DRUG: Carboplatin, PROCEDURE: Computed Tomography, BIOLOGICAL: Durvalumab, DRUG: Gemcitabine Hydrochloride, PROCEDURE: Magnetic Resonance Imaging, DRUG: Nab-paclitaxel, BIOLOGICAL: Personalized Synthetic Long Peptide Vaccine, DRUG: Poly ICLC, BIOLOGICAL: Sacituzumab Govitecan, BIOLOGICAL: Tremelimumab
Anatomic Stage IV Breast Cancer AJCC v8, Invasive Breast Carcinoma, Metastatic Triple-Negative Breast Carcinoma
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Study Locations
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| Location | Contacts |
|---|---|
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire | |
| Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland | Site Public Contact - (jhcccro@jhmi.edu) |
| Moffitt Cancer Center Tampa, Florida | Site Public Contact - (ClinicalTrials@moffitt.org) |
| Moffitt Cancer Center - McKinley Campus Tampa, Florida | Site Public Contact - (ClinicalTrials@moffitt.org) |
| Moffitt Cancer Center at Wesley Chapel Wesley Chapel, Florida | Site Public Contact - (ClinicalTrials@moffitt.org) |
| Moffitt Cancer Center-International Plaza Tampa, Florida | Site Public Contact - (ClinicalTrials@moffitt.org) |
| NYP/Weill Cornell Medical Center New York, New York | |
| Ohio State University Comprehensive Cancer Center Columbus, Ohio | Site Public Contact - (Jamesline@osumc.edu) |
| Siteman Cancer Center at Christian Hospital St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center at Saint Peters Hospital City of Saint Peters, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center at West County Hospital Creve Coeur, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center-South County St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Smilow Cancer Hospital Care Center at Saint Francis Hartford, Connecticut | |
| UC Irvine Health/Chao Family Comprehensive Cancer Center Orange, California | |
| UCHealth University of Colorado Hospital Aurora, Colorado | |
| UM Sylvester Comprehensive Cancer Center at Aventura Aventura, Florida | |
| UM Sylvester Comprehensive Cancer Center at Coral Gables Coral Gables, Florida | |
| UM Sylvester Comprehensive Cancer Center at Deerfield Beach Deerfield Beach, Florida | |
| UM Sylvester Comprehensive Cancer Center at Kendall Miami, Florida | |
| UM Sylvester Comprehensive Cancer Center at Plantation Plantation, Florida | |
| University of California Davis Comprehensive Cancer Center Sacramento, California | |
| University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida | |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | |
| University of Pittsburgh Cancer Institute (UPCI) Pittsburgh, Pennsylvania | |
| University of Texas Medical Branch Galveston, Texas | Site Public Contact - (clinical.research@utmb.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Wake Forest University Health Sciences Winston-Salem, North Carolina | |
| Wake Forest University at Clemmons Clemmons, North Carolina | |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Yale University New Haven, Connecticut |
A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiopathic Pulmonary Fibrosis
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com - Clinical.Trials@bms.com
NCT06003426
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Inclusion Criteria
* Subjects with IPF aged ≥ 40 years at the time of signing the informed consent.
* Diagnosis of IPF within 7 years prior to screening that is supported by centrally read chest high-resolution computed tomography (HRCT) obtained at screening and verification of usual interstitial pneumonia.
* If on pirfenidone or nintedanib, participants must have been on a stable dose for at least 90 days prior to screening.
* If not currently on pirfenidone or nintedanib, participants must not have received either of these medications within 28 days prior to screening.
* Women who are of childbearing potential must have a highly effective form of contraception and must provide a negative urine/serum pregnancy test.
* Men who are sexually active with women of childbearing potential agree to use male barrier contraception.
Exclusion Criteria
* History of stroke or transient ischemic attack within 3 months prior to screening.
* Participants who exhibit symptoms of heart failure at rest.
* Participants who have a current malignancy or a previous malignancy with less than 2 years free of recurrence or a biopsy that is suspicious for malignancy and the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory, or other diagnostic evaluations.
* Other protocol-defined Inclusion/Exclusion criteria apply.
DRUG: BMS-986278, DRUG: BMS-986278 Placebo
Idiopathic Pulmonary Fibrosis
BMS-986278, LPA1 antagonist, IPF, Pulmonary fibrosis
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Study Locations
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| Location | Contacts |
|---|---|
| "Corfu General Hospital ""St. IRINI""" Corfu, | |
| "General Hospital of Thessaloniki ""G. Papanikolaou""" Pylaia-Chortiatis, B | |
| "Ospedale ""Gian Battista Morgagni - Luigi Pierantoni"" di Forli" Forlì, | |
| ACE Hospital & Research Center Pune, Maharashtra | |
| AORN - Ospedali dei Colli Ospedale V. Monaldi Napoli, | |
| Aarhus University Hospital Aarhus N, | |
| Accellacare US Inc. of Wilmington Wilmington, North Carolina | |
| Ajou University Hospital Suwon, | |
| All India Institute of Medical Sciences (AIIMS) - New Delhi New Delhi, National Capital Territory of Delhi | |
| Alliance Pulmonary Group Guaynabo, PR | |
| Amsterdam UMC - Locatie VUMC - Pulmonale Hypertensie (PH) Kenniscentrum Amsterdam, | |
| AnMed Health Oglesby Center - AnMed Health Pulmonary and Sleep Medicine Anderson, South Carolina | |
| Anhui Medical University - Anhui Chest Hospital Hefei, AH | |
| Anhui Medical University - The Second Hospital - Hematological Research Center Hefei, Anhui | |
| Anhui Provincial Hospital Hefei, Anhui | |
| Ankara Universitesi Tip Fakultesi Hastaneleri - Cebeci Hastanesi Ankara, | |
| Asan Medical Center (AMC) Songpa-gu, Seoul | |
| Aso Iizuka Hospital Iizuka-shi, | |
| Assistance Publique Hopitaux de Marseille - Hopital Nord Marseille, | |
| Asst Papa Giovanni XXIII Bergamo, Lombardy | |
| Asthma Bhawan Jaipur, Rajasthan | |
| Athens Medical Center Marousi, Attica | |
| Avanza Medical Research Center Pensacola, Florida | |
| Azienda Ospedaliera San Paolo Milan, | |
| Azienda Ospedaliera Universitaria - Universita di Sassari Sassari, | |
| Azienda Ospedaliero - Universitaria di Modena Policlinico Modena, Emilia-Romagna | |
| Azienda Ospedaliero Universitaria Pisana Pisa, | |
| Azienda Ospedaliero Universitaria delle Marche Ancona, | |
| Azienda Ospedaliero-Universitaria Careggi Florence, | |
| Baylor College of Medicine Medical Center - Pulmonary, Critical Care, and Sleep Medicine Houston, Texas | |
| Baylor University Medical Center at Dallas Dallas, Texas | |
| Beijing Chaoyang Hospital, Capital Medical University Beijing, Beijing Municipality | |
| Beijing Friendship Hospital, Capital Medical University Beijing, | |
| Bioreuma Concepción, Bio Bio | |
| Brightshores Health System Owen Sound, Ontario | |
| Burlington Lung Clinic Burlington, Ontario | |
| C.I.C. Joliette Saint-Charles-Borromée, Quebec | |
| C.I.C. Mauricie Inc. Trois-Rivières, Quebec | |
| CEC Centros Estudios Clinicos Santiago, RM | |
| CEMEC - Centro Multidisciplinar de Estudos Clínicos São Bernardo do Campo, São Paulo | |
| CENRESIN - Centro Respiratorio Integral Quillota, Región de Valparaíso | |
| CHRU de Tours - Hôpital Bretonneau Tours, | |
| CHU Dijon - Hôpital François Mitterrand Dijon, | |
| CHU Hopitaux de Bordeaux - Hopital Haut-Leveque Pessac, | |
| CHU UCL Namur - Mont-Godinne Yvoir, Namur | |
| CHU de Brest - Hôpital Cavale Blanche Brest, | |
| CHU de Nantes - Hôpital Nord Laennec Nantes, Pays de la Loire Region | |
| Carmel Medical Center Haifa, | |
| Center Hospital of the National Center for Global Health and Medicine Shinjyu-Ku, | |
| Centre Hospitalier Universitaire Grenoble Alpes (CHU Grenoble Alpes) Grenoble, Auvergne-Rhône-Alpes | |
| Centre Hospitalier Universitaire d'Angers Angers, Maine-et-Loire | |
| Centre Hospitalier Universitaire de Liege - Sart Tilman Liège, | |
| Centre Hospitalier de L'Universite de Montreal (CHUM) Montreal, Quebec | |
| Centro Medico Santa Maria Barra Mansa, Rio de Janeiro | |
| Centro Medico de Enfermedades Respiratorias Florida, B | |
| Centro Respiratorio Quilmes Quilmes, Provincia de Buenos Aires, B | |
| Centro de Estudos de Pneumologia da Faculdade de Medicina do ABC (CEPFMABC) Santo André, São Paulo | |
| Centro de Investigacion Clinica de Oaxaca (CICLO) Oaxaca City, Oaxaca | |
| Centro de Investigacion Curico Curicó, Maule Region | |
| Centro de Investigaciones Metabólicas (CINME) Buenos Aires, | |
| Centro de Investigación Clínica Chapultepec S.A. de C.V. Morelia, Michoacán | |
| Centro de Investigación del Maule Talca, | |
| Centrum Medycyny Oddechowej Bialystok, Podlaskie Voivodeship | |
| Chang Gung Medical Foundation - Kaohsiung Branch Kaohsiung City, Kao-Hsiung | |
| Changhua Christian Hospital Changhua County, | |
| Chiba University Hospital Chiba, Chiba, | |
| China Medical University Hospital Taichung, | |
| Christiana Care Pulmonary Associates - Newark Newark, Delaware | |
| Clinica 25 de Mayo Mar del Plata, B | |
| Clinica Providencia San Miguel, LIM | |
| Clinica Universidad de Navarra Madrid, | |
| Clinica Universidad de los Andes Santiago, RM | |
| Clinical Research Specialists, LLC - Kissimmee Kissimmee, Florida | |
| Cliniques Universitaires Saint-Luc Brussels, | |
| Clínica Universidad de Navarra -Madrid Madrid, | |
| Clínica de día Jockey Salud Lima, LIM | |
| Coastal Pulmonary & Critical Care, P.L.C. St. Petersburg, Florida | |
| Connolly Hospital Blanchardstown Dublin, | |
| Consultorios Médicos del Buen Ayre Capital Federal, | |
| David Geffen School of Medicine at UCLA Los Angeles, California | |
| Diex Recherche - Trois-Rivieres Trois-Rivières, Quebec | |
| Dokuz Eylul Universitesi Tip Fakultesi Pasaport, | |
| Duke University Medical Center Durham, North Carolina | |
| Ege Universitesi Tip Fakultesi Hastanesi (Ege University Medical Faculty Hospital) Izmir, | |
| Erasmus MC - Centrum voor Interstitiele Longziekten Rotterdam, South Holland | |
| Erciyes University School of Medicine Kayseri, | |
| Escola Paulista de Medicina São Paulo, | |
| Fachkrankenhaus Coswig GmbH Coswig, | |
| Far Eastern Memorial Hospital Taipei, | |
| Fiona Stanley Hospital Murdoch, | |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milan, Lombardy | |
| Fondazione IRCCS Policlinico San Matteo Pavia, | |
| Fondazione IRCCS San Gerardo dei Tintori Monza, | |
| Fondazione Policlinico Universitario Agostino Gemelli Roma, | |
| Fortis Hospital Mohali Mohali, Punjab | |
| Fundacion Enfisema - Instituto Ave Pulmo Mar del Plata, Buenos Aires | |
| Fundacion Respirar Buenos Aires, | |
| Fundacion Santa Fe de Bogota Bogotá, | |
| Fundacion Scherbovsky Mendoza, M | |
| Gachon University - Gil Medical Center Incheon, | |
| Gallipoli Medical Research Centre - Clinical Trials Unit (CTU) Greenslopes, Queensland | |
| Gentofte Hospital Hellerup, | |
| Getwell Hospital and Research Institute - Lungs Care Nagpur, Maharashtra | |
| Giromed Institute, SLP Barcelona, | |
| Grant Medical Foundation - Ruby Hall Clinic Pune, | |
| Green City Hospital Bhopal, Madhya Pradesh | |
| Guy's and St Thomas' NHS Foundation Trust - Royal Brompton Hospital London, Greater London | |
| Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz Győr, | |
| HELIOS Klinikum Emil von Behring Berlin, State of Berlin | |
| Hadassah Medical Center (HMC) - Hadassah University Hospital (HUH) - Ein Kerem Jerusalem, | |
| Hamamatsu University Hospital Shizuoka, Hamamatsu, | |
| Hangzhou First People's Hospital Hangzhou, | |
| Harmony Medical Research Institute, Inc Hialeah, Florida | |
| Health SURA Calle 100 Bogotá, DC | |
| Health SURA Chipichape Santiago de Cali, VAC | |
| Helsinki University Hospital Heart and Lung Center Helsinki, Etelae-Suomen Laeaeni | |
| Henan provincial people's hospital Zhengzhou, HA | |
| Hiroshima Prefectural Hospital Hiroshima, Hirohima-ken | |
| Hopital Avicenne Bobigny, | |
| Hopitaux Universitaires de Geneve (HUG) Geneva, Canton of Geneva | |
| Hospices Civils de Lyon Bron, Auvergne-Rhône-Alpes | |
| Hospital Alemao Oswaldo Cruz (HAOC) - Centro de Oncologia (Oncology Center) São Paulo, | |
| Hospital CUF Tejo Lisbon, | |
| Hospital Clinic de Barcelona Barcelona, | |
| Hospital Clinico San Carlos Madrid, | |
| Hospital Clinico Universitario Madrid, | |
| Hospital Dia do Pulmão Blumenau, Santa Catarina | |
| Hospital Ernesto Dornelles (HED) Porto Alegre, Rio Grande do Sul | |
| Hospital Madre Teresa Belo Horizonte, Minas Gerais | |
| Hospital Nacional Cayetano Heredia Lima, | |
| Hospital Universitari de Bellvitge (IDIBELL) Barcelona, | |
| Hospital Universitario Central de Asturias Oviedo, | |
| Hospital Universitario Fundacion Jimenez Diaz Madrid, | |
| Hospital Universitario La Paz Madrid, | |
| Hospital Universitario Marqués de Valdecilla Santander, | |
| Hospital Universitario Puerta De Hierro - Majadahonda Majadahonda, M | |
| Hospital Universitario de La Princesa Madrid, | |
| Hospital das Clínicas da Universidade Federal de Minas Gerais (UFMG) Belo Horizonte, Minas Gerais | |
| Hospital de Santa Marta Lisbon, | |
| Huadong Hospital Affiliated to Fudan University Shanghai, | |
| Hull and East Yorkshire Hospitals NHS Trust - Castle Hill Hospital Cottingham, Yorkshire and the Humber | |
| Hôpital Bichat - Claude-Bernard Paris, | |
| Hôpital Larrey Toulouse, | |
| Ibamedica Santa Fe, | |
| Inje University Busan Paik Hospital BusanjinGu, Busan Gwang'yeogsi | |
| Inje University Haeundae Paik Hospital Busan, | |
| Inje University Ilsan Paik Hospital Goyang-si, | |
| Inselspital - Universitaetsklinik Bern für Pneumologie Bern, Canton of Bern | |
| Inspiration Research Toronto, Ontario | |
| Institute for Respiratory Health Nedlands, Western Australia | |
| Institute of Science Tokyo Hospital Tokyo, Bunkyo-ku, | |
| Instituto De Enfermedades Respiratorias E Investigacion Medica (IERIM) San Juan Bautista, Buenos Aires | |
| Instituto Medico DAMIC Córdoba, Córdoba Province | |
| Instituto Medico INSARES SA Mendoza, M | |
| Instituto Medico de la Fundacion de Estudios Clínicos Rosario, S | |
| Instituto Neumologico del Oriente Floridablanca, Santander Department | |
| Instituto de Seguridad Social del Estado de Mexico y Municipios (ISSEMYM) - Centro Medico Toluca Metepec, Edo De Mexico | |
| Investigaciones en Patologias Respiratorias San Miguel de Tucuman, Tucumán, T | |
| Istanbul Universitesi - Istanbul Tip Fakultesi (ITF) Hastanesi Topkapı, | |
| Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione (ISMETT) Palermo, | |
| Jehangir Clinical Development Center Pune, Maharashtra | |
| Jichi Medical University Hospital Shimotsuke, | |
| Jizankai Medical Foundation Tsuboi Cancer Center Hospital Koriyama-shi, Fukushima | |
| Juntendo University Hospital Bunkyo-ku, Tokyo | |
| K.L.E.S. Dr. Prabhakar Kore Hospital & Medical Research Centre Belagavi, Karnataka | |
| Kameda Medical Center - Kameda Clinic Kamogawa-shi, Chiba | |
| Kanagawa Cardiovascular and Respiratory Center Kanagawa, Yokohama, | |
| Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung City, | |
| Kaplan Medical Center Rehovot, | |
| Kepler Universitatsklinikum Linz, Upper Austria | |
| Kindai University Hospital Ōsaka-sayama, | |
| King George's Medical University Lucknow, Uttar Pradesh | |
| Klinikum der Universitat Munchen Munich, Bavaria | |
| Kobe City Medical Center General Hospital Hyōgo, | |
| Krankenhaus Hietzing Vienna, | |
| Krankenhaus der Augustinerinnen- Klinik fuer Pneumologie, Allergologie, Schlaf- und Beatmungsmedizin Cologne, Northwest | |
| Kurume University Hospital Kurume-shi, Fukuoka | |
| Kyorin University Hospital Mitaka-shi, Tokyo | |
| Kyushu University Hospital Fukuoka, | |
| Lankenau Medical Center Wynnewood, Pennsylvania | |
| Layrek Clinical Research Tulsa, Oklahoma | |
| Leeds Teaching Hospitals NHS Trust Leeds, | |
| Local Institution - 0001 Lenexa, Kansas | |
| Local Institution - 0006 São Paulo, | |
| Local Institution - 0008 Munster, Northwest | |
| Local Institution - 0014 Salt Lake City, Utah | |
| Local Institution - 0016 Lima, LIM | |
| Local Institution - 0020 Badalona, Barcelona | |
| Local Institution - 0032 Pittsburgh, Pennsylvania | |
| Local Institution - 0043 Changchun, Jilin | |
| Local Institution - 0055 Lima, | |
| Local Institution - 0060 Gainesville, Florida | |
| Local Institution - 0063 Brno, JM | |
| Local Institution - 0070 Seoul, Seoul-teukbyeolsi [Seoul] | |
| Local Institution - 0071 L'Hospitalet Del Llobregat, Barcelona [Barcelona] | |
| Local Institution - 0076 Villejuif, Val-de-Marne | |
| Local Institution - 0078 Monterrey, Nuevo León | |
| Local Institution - 0080 Iowa City, Iowa | |
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| Local Institution - 0094 Evanston, Illinois | |
| Local Institution - 0100 Seoul, Seoul-teukbyeolsi [Seoul] | |
| Local Institution - 0104 Atlanta, Georgia | |
| Local Institution - 0112 Buenos Aires, | |
| Local Institution - 0115 Busan, Pusan-Kwangyǒkshi | |
| Local Institution - 0116 Deagu, Taegu-Kwangyǒkshi | |
| Local Institution - 0133 Milano, MI | |
| Local Institution - 0136 Buenos Aires, | |
| Local Institution - 0141 Aguascalientes, AGU | |
| Local Institution - 0148 Katowice, | |
| Local Institution - 0156 Piura, PIU | |
| Local Institution - 0157 Valencia, Comunidad Valencia | |
| Local Institution - 0162 Monterrey, Nuevo Leon | |
| Local Institution - 0163 Córdoba, VER | |
| Local Institution - 0179 Jasper, Alabama | |
| Local Institution - 0182 Chicago, Illinois | |
| Local Institution - 0190 Buffalo, New York | |
| Local Institution - 0192 Milwaukee, Wisconsin | |
| Local Institution - 0195 Springfield, Massachusetts | |
| Local Institution - 0203 Exeter, South West | |
| Local Institution - 0208 Edmonton, Alberta | |
| Local Institution - 0212 Talcahuano, BI | |
| Local Institution - 0217 Sherbrooke, Quebec | |
| Local Institution - 0219 Exeter, South West | |
| Local Institution - 0223 La Tronche, Isère | |
| Local Institution - 0234 Mérida, YUC | |
| Local Institution - 0245 Nagpur, Maharashtra | |
| Local Institution - 0248 Guadalajara, JAL | |
| Local Institution - 0253 Melbourne, Victoria | |
| Local Institution - 0277 Uppsala, Uppsala Län [se-03] | |
| Local Institution - 0280 Helsinki, | |
| Local Institution - 0281 Oulu, North Ostrobothnia | |
| Local Institution - 0293 Darlinghurst, New South Wales | |
| Local Institution - 0296 Zhengzhou Shi, Henan | |
| Local Institution - 0303 Murdoch, Western Australia | |
| Local Institution - 0308 Paris, | |
| Local Institution - 0310 Milano, MI | |
| Local Institution - 0311 Lille CEDEX, | |
| Local Institution - 0312 Incheon, | |
| Local Institution - 0315 Caen, | |
| Local Institution - 0316 Deogyang-Gu, Goyang-Si, | |
| Local Institution - 0317 Kitakyushu-shi, Fukuoka-Ken | |
| Local Institution - 0327 Sapporo, Hokkaido | |
| Local Institution - 0329 Okayama, | |
| Local Institution - 0340 Olomouc, | |
| Local Institution - 0357 Gosford, New South Wales | |
| Local Institution - 0376 Yinchuan, | |
| Local Institution - 0381 London, LND | |
| Local Institution - 0384 Koblenz, Rhineland-Palatinate | |
| Local Institution - 0387 Linz, | |
| Local Institution - 0390 Zagreb, City of Zagreb | |
| Local Institution - 0392 Sofia, | |
| Local Institution - 0397 Chaïdári, Attikí | |
| Local Institution - 0399 Athens, Attikí | |
| Local Institution - 0401 Miami, Florida | |
| Local Institution - 0412 A Coruña, A Coruña [La Coruña] | |
| Local Institution - 0413 Guadalajara, | |
| Local Institution - 0422 Ankara, | |
| Local Institution - 0423 Kitakyushu-shi, Fukuoka | |
| Local Institution - 0427 Singapore, Central Singapore | |
| Local Institution - 0432 George Town, Pulau Pinang | |
| Local Institution - 0435 Louisville, Kentucky | |
| Local Institution - 0439 Dammam, Eastern Province | |
| Local Institution - 0443 Box Hill, Victoria | |
| Local Institution - 0444 Hermosillo, Sonora | |
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| Local Institution - 0452 Atlanta, Georgia | |
| Local Institution - 0453 Lembah Pantai, Kuala Lumpur | |
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| Local Institution - 0455 Seongnam, | |
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| Local Institution - 0465 Tacoma, Washington | |
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| Local Institution - 0467 Darlinghurst, New South Wales | |
| Local Institution - 0468 Santiago, | |
| Local Institution - 0469 Rock Hill, South Carolina | |
| Local Institution - 0471 Coimbatore, Tamil Nadu | |
| Local Institution - 0474 Chermside, Queensland | |
| Local Institution - 0475 Eiheiji-cho,Yoshida-gun, Fukui | |
| Local Institution - 0476 Engenho Velho da Federação, Salvador | |
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| Local Institution - 0500 Leiden, South Holland | |
| Local Institution - 0501 Newport Beach, California | |
| Local Institution - 0504 Halle, Saxony-Anhalt | |
| Loyola University Health System Maywood, Illinois | |
| Lungenfachklinik Immenhausen Immenhausen, | |
| MICS Centrum Medyczne Bydgoszcz Bydgoszcz, Kuyavian-Pomeranian Voivodeship | |
| Marengo CIMS Hospital Ahmedabad, Gujarat | |
| Massachusetts General Hospital Boston, Massachusetts | |
| Mater Misericordiae Limited South Brisbane, Queensland | |
| Matsusaka Municipal Hospital Matsusaka-shi, Mie-ken | |
| Max Super Specialty Hospital, Saket - West Block - A Unit of Max Healthcare Institute Limited New Delhi, National Capital Territory of Delhi | |
| McGovern Medical School - UT Physicians - Pulmonary Medicine - Texas Medical Center Location Houston, Texas | |
| MedStar Georgetown University Hospital Washington D.C., District of Columbia | |
| Medical University of South Carolina- College of Medicine Charleston, South Carolina | |
| Medicos Internistas de Caldas Manizales, CL | |
| Mercy St. Vincent Medical Center Toledo, Ohio | |
| Meris Clinical Research Brandon, Florida | |
| Metroplex Pulmonary and Sleep Center McKinney, Texas | |
| Midland Healthcare & Research Center Lucknow, | |
| Monteregie Centre de Recherche Greenfield Park, Quebec | |
| Myongji Hospital Goyang-si, Gyeonggi-do | |
| NHS Lothian - Royal Infirmary of Edinburgh Edinburgh, EDH | |
| NHS Tayside Dundee, DND | |
| NZOZ Przychodnia Vitamed Bydgoszcz, Kuyavian-Pomeranian Voivodeship | |
| Nagasaki University Hospital Nagasaki, Nagasaki | |
| Nagoya University Hospital Nagoya, | |
| Nanfang Hospital of Southern Medical University Guangzhou, Guangdong | |
| Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School Nanjing, JS | |
| National Hospital Organization - Okinawa National Hospital Ginowan-Shi, Okinawa | |
| National Hospital Organization Himeji Medical Center Himeji, Hyōgo | |
| National Hospital Organization Ibarakihigashi National Hospital Naka-gun, Gunma | |
| National Hospital Organization Kinki-Chuo Chest Medical Center Osaka, Sakai, | |
| National Hospital Organization Kyushu Medical Center Fukuoka, | |
| National Jewish Health Denver, Colorado | |
| National Taiwan University Hospital - The National Center of Excellence for Clinical Trial Taipei, | |
| National Taiwan University Hospital Yun-Lin Branch Yunlin County, | |
| Nilratan Sircar (NRS) Medical College & Hospital Kolkata, West Bengal | |
| Nippon Medical School Hospital Bunkyo-ku, Tokyo | |
| North Bristol NHS Trust - Southmead Hospital Bristol Bristol, BST | |
| Northern Westchester Hospital Mount Kisco, New York | |
| Northwestern Memorial Hospital Evanston, Illinois | |
| Norton Pulmonary Specialists Louisville, Kentucky | |
| OSF Saint Francis Medical Center Peoria, Illinois | |
| OU Health Sciences Center - OU Health Physicians - Cardiology, Pulmonary & Vascular Medicine Clinic Oklahoma City, Oklahoma | |
| Ocala Lung & Critical Care Ocala, Florida | |
| Odense Universitetshospital - Svendborg Sygehus Odense C, Region Syddanmark | |
| Omega Research Consultants LLC DeBary, Florida | |
| Oregon Health & Science University - Pulmonary Clinic Portland, Oregon | |
| Ospedale Colonnello D'Avanzo Foggia Foggia, | |
| Ospedale Policlinico di Siena Siena, | |
| Our Lady of Lourdes Hospital - Drogheda Drogheda, LH | |
| Oxford University Hospitals NHS Trust - Churchill Hospital Oxford, Oxfordshire | |
| Papworth Hospital NHS Foundation Trust Cambridge, Cambridgeshire | |
| Peking Union Medical College Hospital Beijing, | |
| Peking University Shenzhen Hospital Shenzhen, | |
| Peninsula Health - Frankston Hospital Frankston, Victoria | |
| Penn Medicine - Perelman Center for Advanced Medicine Philadelphia, Pennsylvania | |
| Penn State Milton S. Hershey Medical Center Hershey, Pennsylvania | |
| Peterborough City Hospital Peterborough, | |
| Policlínica Piquet Carneiro, Universidade do Estado do Rio de Janeiro Rio de Janeiro, Rio de Janeiro | |
| Praxis fur Pneumologie Marburg, HE | |
| Pulmonary Group of Central Florida, LLC - Leesburg Leesburg, Florida | |
| Pulmonary Specialists of the Palm Beaches Loxahatchee Groves, Florida | |
| Pulmonology, Sleep, Asthma & Allergy Center of Dublin Dublin, Georgia | |
| Qilu Hospital of Shandong University Jinan, | |
| Quebec Heart and Lung Institute Quebec, | |
| Rabin Medical Center - Hasharon Hospital Petah Tikva, | |
| Rambam Health Care Campus - Pulmonology Haifa, | |
| Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine - South Branch Shanghai, SH | |
| Renmin Hospital of Wuhan University Wuhan, | |
| Respira Salud Clinica Integral Godoy Cruz, M | |
| Royal Adelaide Hospital Adelaide, | |
| Royal Prince Alfred Hospital Sydney, New South Wales | |
| Rush University Medical Center - Rush Pulmonary and Critical Care Medicine - Professional Building Chicago, Illinois | |
| SALK - Universitatsklinik Fur Pneumologie/ Lungenheilkunde Landeskrankenhaus Salzburg, Salzburger Land | |
| Saiseikai Kumamoto Hospital Kumamoto, | |
| Santa Casa de Misericórdia de Porto Alegre - Hospital Sao Jose Porto Alegre, Rio Grande do Sul | |
| Santiago Clinic Hospital (Hospital Clínico Universitario de Santiago -CHUS) Santiago de Compostela, Galicia | |
| Sapporo Medical University Hospital Sapporo, Hokkaid | |
| Scripps Clinic Torrey Pines La Jolla, California | |
| Semmelweis Egyetem Pulmonologiai Klinika Budapest, | |
| Seoul National University Bundang Hospital Seongnam-si, | |
| Seoul National University Hospital Seoul, | |
| Servicios de Salud IPS Suramericana S.A.S - IPS Sura Industriales Medellín Medellín, ANT | |
| Shanghai Jiao Tong University - Shanghai Chest Hospital Shanghai, SH | |
| Shanghai Jiaotong University Affiliated Sixth People's Hospital Shanghai, | |
| Shanghai Pulmonary Hospital Shanghai, | |
| Shengjing Hospital of China Medical University Shengyang, | |
| Shenyang Chest Hospital Shenyang, Liaoning | |
| Shenzhen People's Hospital Shenzhen, | |
| Shimane University Hospital Izumo-Shi, | |
| Shree Hospital and Critical Care Centre Nagpur, MH | |
| Shri Guru Ram Rai (SGRR) Institute of Medical and Health Sciences - Shri Mahant Indiresh Hospital Dehradun, Uttarakhand | |
| Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital Chengdu, | |
| SoonChunHyang University Bucheon Hospital Bucheon-si, | |
| SoonChunHyang University Seoul Hospital Yongsan-gu, Seoul | |
| South Texas Veterans Health Care System - Audie L. Murphy VA Hospital San Antonio, Texas | |
| Southeastern Research Center Winston-Salem, North Carolina | |
| St Francis Sleep Allergy & Lung Institute Clearwater, Florida | |
| St. Antonius Ziekenhuis Nieuwegein, | |
| St. John's Medical College Bangalore, | |
| St. Joseph's Healthcare Hamilton Hamilton, Ontario | |
| St. Joseph's Hospital and Medical Center Phoenix, Arizona | |
| St. Paul's Hospital Vancouver, British Columbia | |
| St. Vincent's University Hospital Dublin, | |
| Stanford University School of Medicine Stanford, California | |
| Steward St. Elizabeth Medical Center Boston, Massachusetts | |
| Synergy Respiratory & Cardiac Care Sherwood Park, Alberta | |
| T.C.S.B. Süreyyapasa Gögüs Hastaliklari Egitim Ve Arastirma Hastanesi Maltepe, | |
| TC Saglik Bakanlig -Izmir Dr.Suat Seren Gogus Hastaliklari Ve Cerrahisi Egitim Arastirma Hastanesi Izmir, | |
| Taichung Veterans General Hospital Taichung, | |
| Taipei Veterans General Hospital Taipei, | |
| Tel Aviv Sourasky Medical Center Tel Aviv, | |
| Temple University Hospital (TUH) - Temple Lung Center (TLC) Philadelphia, Pennsylvania | |
| Tenri Hospital Tenri, | |
| The Affiliated Hospital of Inner Mongolia Medical University Hohhot, Inner Mongolia | |
| The Affiliated Hospital of Xuzhou Medical University Xuzhou, | |
| The Catholic University of Korea, Bucheon St. Mary's Hospital Bucheon-si, Gyeonggi-do | |
| The First Affiliated Hospital of Guangzhou Medical University Guangzhou, | |
| The First Affiliated Hospital of Nanchang University - Xianghu District Nanchang, JX | |
| The First Affiliated Hospital of Ningbo University Ningbo, | |
| The First Affiliated Hospital of Soochow University Suzhou, | |
| The First Affiliated Hospital of Zhengzhou University Zhengzhou, | |
| The First Affiliated Hospital, Sun Yat-sen University Guangzhou, Guangdong | |
| The First Hospital of China Medical University Shenyang, Liaoning | |
| The Jikei University Hospital Tokyo, | |
| The Lung Centre Vancouver, British Columbia | |
| The Lung Research Center Chesterfield, Missouri | |
| The Ohio State University Wexner Medical Center Columbus, Ohio | |
| The Prince Charles Hospital Chermside, Queensland | |
| The Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou, Zhejiang | |
| The Second Hospital of Hebei Medical University Shijiazhuang, Hebei | |
| The Second Xiangya Hospital of Central South University Changsha, | |
| The Third Hospital of Hebei Medical University Shijiazhuang, | |
| The University of Alabama at Birmingham Birmingham, Alabama | |
| The University of Chicago Medicine Chicago, Illinois | |
| Thomas Jefferson University Hospital - Jane and Leonard Korman Lung Center Philadelphia, Pennsylvania | |
| Thoraxklinik-Heidelberg gGmbH Heidelberg, | |
| Thoraxzentrum Bezirk Unterfranken Münnerstadt, Bavaria | |
| Tianjin Chest Hospital Tianjin, Tianjin Municipality | |
| Tianjin Medical University General Hospital Tianjin, | |
| Toho University - Omori Medical Center Tokyo, | |
| Tokyo Medical University Hospital Shinjuku-Ku, Tokyo | |
| Toranomon Hospital Tokyo, Minato-ku, | |
| Tosei General Hospital Aichi, Seto, | |
| Turun Yliopistollinen Keskussairaala (TYKS) Turku, Laensi-Suomen Laeaeni | |
| UC Irvine Medical Center Orange, California | |
| UPMC - Dorothy P. and Richard P. Simmons Center for Interstitial Lung Diseases (ILD) Pittsburgh, Pennsylvania | |
| UZ Leuven Leuven, | |
| Ulsan University Hospital (UUH) Dong-gu, Ulsan | |
| Uludag Universitesi Tip Fakultesi (Uludag University Faculty of Medicine) Bursa, | |
| Unidade Local de Saude de Gaia/Espinho, EPE Vila Nova de Gaia, | |
| Unidade Local de Saude de Loures - Odivelas, E. P. E. Loures, | |
| Unidade Local de Saude de Santa Maria, EPE - Hospital Pulido Valente Lisbon, | |
| Unidade Local de Saude de Santo Antonio, E.P.E. Porto, | |
| Unidade Local de Saude de Sao Joao, EPE - Hospital de Sao Joao Porto, | |
| Unidade Local de Saúde do Algarve, EPE Faro, | |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan, Hubei | |
| Unity Hospital Fridley, Minnesota | |
| Universitaetsklinikum Essen - Ruhrlandklinik Essen, North Rhine-Westphalia | |
| Universitaetsklinikum Freiburg - Klinik fuer Pneumologie Freiburg I. Breisgau, Baden-Wurttemberg | |
| Universitaetsklinikum Leipzig - Klinik und Poliklinik fuer Pneumologie Leipzig, | |
| University General Hospital Attikon Athens, | |
| University Hospitals Birmingham NHS Foundation Trust - Heartlands Hospital Birmingham, BIR | |
| University Hospitals Birmingham NHS Foundation Trust - New Queen Elizabeth Hospital Birmingham Birmingham, | |
| University of California UC Davis Medical Center Sacramento, California | |
| University of California, San Francisco Medical Center- Pulmonary Practice San Francisco, California | |
| University of Cincinnati College of Medicine Cincinnati, Ohio | |
| University of Colorado Anschutz Medical Campus - Department of Family Medicine Aurora, Colorado | |
| University of Florida (UF) Health Shands Hospital Gainesville, Florida | |
| University of Fukui Hospital Yoshida, | |
| University of Iowa Hospitals and Clinics Iowa City, Iowa | |
| University of Kansas Medical Center (KUMC) Kansas City, Kansas | |
| University of Maryland - Marlene and Stewart Greenebaum Cancer Center Baltimore, Maryland | |
| University of Michigan Ann Arbor, Michigan | |
| University of Patras - Rio Regional University Hospital Rio, | |
| University of South Florida Tampa, Florida | |
| University of Southern California (USC) - Keck School of Medicine (KSOM) - Transplant Clinic Los Angeles, California | |
| University of Texas Southwestern Medical Center - Pulmonary Specialty Clinic Dallas, Texas | |
| University of Thessaly- General University Hospital of Larissa Larissa, | |
| University of Ulsan College of Medicine - Ulsan University Hospital (UUH) Dong-Gu, | |
| University of Utah, University Hospital Salt Lake City, Utah | |
| University of Washington Medical Center Seattle, Washington | |
| Universitätsklinikum Hamburg-Eppendorf (UKE) Hamburg, | |
| Universitätsmedizin der Johannes Gutenberg-Universität Mainz Mainz, | |
| Universitätsspital Basel Basel, | |
| Uniwersytecki Szpital Kliniczny Nr. 1 im. Norberta Barlickiego Lodz, | |
| Uniwersyteckie Centrum Kliniczne Gdansk, | |
| VCU Medical Center Richmond, Virginia | |
| Vanderbilt Lung Institute - One Hundred Oaks Nashville, Tennessee | |
| Velocity Clinical Research Germany GmbH Ahrensburg, | |
| Vivantes Klinikum Neukolln Berlin, | |
| Vzw Az Groeninge Kortrijk, | |
| WM Clinica Pneumologica Sociedade Simples LTDA Porto Alegre, Rio Grande do Sul | |
| Warminsko-Mazurskie Centrum Chorób Pluc w Olsztynie Olsztyn, Warmian-Masurian Voivodeship | |
| Washington University School of Medicine in St. Louis St Louis, Missouri | |
| West China Hospital, Sichuan University Chengdu, Sichuan | |
| Western Washington Medical Group (WWMG) - Everett - Silver Lake Medical Center Location Everett, Washington | |
| Westmead Hospital Westmead, New South Wales | |
| Wiener Gesundheitsverbund - Klinik Floridsdorf Vienna, | |
| Wonkwang University Hospital Iksansi, | |
| Wuxi People's Hospital Wuxi, | |
| Xi'an International Medical Center Hospital Xi'an, | |
| Yale New Haven Hospital New Haven, Connecticut | |
| Yichang Central People's Hospital - Xiling Campus Yichang Shi, HE | |
| Yonsei University Health System, Severance Hospital Seoul, | |
| Zuyderland Medisch Centrum, Sittard-Geleen Heerlen, | |
| hospital Italiano de Buenos Aires CABA, |
Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma.
Iovance Biotherapeutics https://www.tilvance-301.com - Clinical.Inquiries@iovance.com
NCT05727904
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Inclusion Criteria:
• Participant has a histologically or pathologically confirmed diagnosis of Stage IIIC, IIID, or IV unresectable or metastatic melanoma.
• In the investigator's assessment, the participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and an estimated life expectancy of \> 6 months.
• Participant is assessed as having at least one resectable lesion (or aggregate lesions) for lifileucel generation.
• Participant must have at least one measurable disease as defined by RECIST 1.1 following tumor resection.
• Participants must have adequate organ function.
• Participants of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control.
• Participants who are \> 70 years of age may be allowed to enroll after the investigator discusses with the medical monitor.
Exclusion Criteria:
• Participant has melanoma of uveal/ocular origin.
• Participant has symptomatic untreated brain metastases.
• Participant received more than 1 prior line of therapy.
• Participant received prior therapy for metastatic disease
• Participants with a BRAF V600 mutation-positive tumor received prior adjuvant/neoadjuvant ICI therapy only
• Participant has an active medical illness(es) that, in the opinion of the investigator, would pose increased risks for study participation, such as systemic infections; seizure disorders; coagulation disorders; or other active major medical illnesses of the cardiovascular, respiratory, or immune systems.
• Participant has any form of primary or acquired immunodeficiency (eg, SCID or AIDS).
• Participant had another primary malignancy within the previous 3 years (except for those that do not require treatment or were curatively treated \>1 year ago, and in the judgment of the investigator do not pose a significant risk of recurrence.)
• Participant has a history of allogeneic cell or organ transplant. Other protocol defined inclusion/exclusion criteria could apply.
BIOLOGICAL: Lifileucel plus Pembrolizumab, BIOLOGICAL: Pembrolizumab with Optional Crossover Period
Metastatic Melanoma, Unresectable Melanoma, Melanoma
Tumor Infiltrating Lymphocytes, TIL, Metastatic Melanoma, Unresectable Melanoma, Cell Therapy, Cellular Immuno-therapy, IL-2, Non-myeloablative lymphodepletion (NMALD), Check point inhibitor, Melanoma, Lifileucel, Stage III Melanoma, Stage IV Melanoma, Skin cancer, Skin cancer types, Malignant melanoma, Autologous Adoptive Cell Therapy, Autologous Adoptive Cell Transfer, LN-144, Pembrolizumab, Pembro, Adjuvant/Neo-adjuvant, BRAF/MEK, ICI, BRAF v600, Immune checkpoint inhibitor, Tumor infiltrating T-cells, TILVANCE, TILVANCE-301
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Show 72 locations
Study Locations
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| Location | Contacts |
|---|---|
| Allegheny Health Network Pittsburgh, Pennsylvania | |
| Azienda Ospedaliera Universitaria Senese Siena, Si | |
| Azienda Ospedaliero Universitaria Pisana Pisa, | |
| Baptist Cancer Center Memphis, Tennessee | |
| Barbara Ann Karmanos Cancer Hospital dba Karmanos Cancer Center Detroit, Michigan | |
| Beaston West of Scotland Canter Centre Glasgow, | |
| Bundang Medical Center - CHA University Seongnam-si, Gyeonggi-do | |
| California Pacific Medical Center San Francisco, California | |
| Centre Hospitalier Universitaire Vaudois Lausanne Lausanne, Canton of Vaud | |
| Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hotel-Dieu Nantes, | |
| Centre Hospitalier de l'Université de Montréal Montreal, | |
| Centro di Riferimento Oncologico IRCCS Aviano, Friuli-Venezia Giulia | |
| City of Hope Duarte, California | |
| Clinica Universitaria de Navarra Pamplona, | |
| Consorcio Hospital General Universitario de Valencia Valencia, | |
| Dartmouth-Hitchcock Medical Center (DHMC) - Norris Cotton Cancer Center Lebanon, New Hampshire | |
| Fiona Stanley Hospital Murdoch, | |
| Flinders Medical Centre Bedford Park, | |
| Freeman Hospital Newcastle upon Tyne, | |
| Greenslopes Private Hospital Greenslopes, Queensland | |
| Guy's Hospital London, | |
| Hadassah Medical Center Jerusalem, | |
| Henry Ford Health Detroit, Michigan | |
| Hopital Saint Louis Paris, Île-de-France Region | |
| Hospital 12 de Octubre Madrid, | |
| Hospital Clinic de Barcelona Barcelona, | |
| Hospital General Universitario Gregorio Marañon Madrid, | |
| Hospital Regional Universitario de Malaga - Hospital General Malaga, Málaga | |
| Hospital Universitari Vall dHebron Barcelona, | |
| Hospital Universitario Madrid Sanchinarro - CIOCC Madrid, | |
| Hospital Universitario Marqués de Valdecilla Santander, | |
| Hospital Universitario Quironsalud Madrid Pozuelo de Alarcón, | |
| Hospital Universitario Ramon y Cajal Madrid, | |
| Hospital Universitario Virgen Macarena Seville, | |
| ICO l'Hospitalet - Hospital Duran i Reynals Barcelona, | |
| Institut Paoli Calmettes Marseille, | |
| Instituto Oncologico Rosell Barcelona, | |
| Istituto Europeo Di Oncologia Milan, | |
| Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale Napoli, | |
| Istituto Romagnolo per lo Studio dei Tumori Meldola, Forli Cesena | |
| Klinikum rechts der Isar der Technischen Universitat Munchen München, Bavaria | |
| MD Anderson Cancer Center at Cooper Camden, New Jersey | |
| National Cancer Institute Bangkok, | |
| Nederlands Kanker Instituut Amsterdam, | |
| Ohio State University Colombus, Ohio | |
| Oncology Hematology Care Cincinnati, Ohio | |
| Orlando Health Cancer Institute Orlando, Florida | |
| Peter MacCallum Cancer Centre Melbourne, Victoria | |
| Princess Margaret Cancer Centre Toronto, Ontario | |
| Queen Elizabeth Hospital Birmingham Birmingham, | |
| Royal Marsden Hospital London, | |
| SCRI Oncology Partners Nashville, Tennessee | |
| Sahlgrenska Universitetssjukhuset Gasteborg, | |
| Sarah Cannon Research Institute UK London, | |
| Seoul National University Hospital Seoul, | |
| Severance Hospital, Yonsei University Health System Seoul, | |
| Sheba Medical Center Ramat Gan, | |
| St. Luke's Cancer Center - Anderson Easton, Pennsylvania | |
| Swedish Cancer Institute Seattle, Washington | |
| Tel Aviv Sourasky Medical Center Tel Aviv, | |
| USC Norris Comprehensive Cancer Center Los Angeles, California | |
| Universitair Ziekenhuis Brussel - Oncologisch Centrum Jette, | |
| Universitatsklinikum Hamburg-Eppendorf Hamburg, | |
| University of Alabama at Birmingham: The Kirklin Clinic Birmingham, Alabama | |
| University of Colorado Cancer Center Aurora, Colorado | |
| University of Illinois Hospital & Health Sciences System Chicago, Illinois | |
| University of Kansas Kansas City, Kansas | |
| University of Louisville - James Graham Brown Cancer Center Louisville, Kentucky | |
| Universitätsklinikum Carl Gustav Carus Dresden, | |
| Universitätsklinikum Schleswig-Holstein - Campus Lübeck Lübeck, Schleswig-Holstein | |
| Virginia Commonwealth University Richmond, Virginia | |
| Westmead Hospital Westmead, New South Wales |
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
ctrrecruit@vcu.edu
NCT05987241
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Inclusion Criteria:
* PRE-REGISTRATION: Histologically confirmed muscle-invasive urothelial carcinoma of the urethra, bladder, ureter or renal pelvis
* PRE-REGISTRATION: Variant histology, including neuroendocrine differentiation, sarcomatoid, micropapillary, glandular, trophoblastic, Mullerian, is allowed if urothelial cancer is predominant histology (any amount of squamous differentiation is allowed provided the tumor is not a pure squamous cell cancer)
* PRE-REGISTRATION: Patient must have had radical surgery (i.e., cystectomy and lymph node dissection or nephroureterectomy or ureterectomy) ≥ 3 weeks, but ≤ 12 weeks prior to pre-registration. Patients who have had a partial cystectomy as definitive therapy are not eligible
* PRE-REGISTRATION: No gross cancer at the surgical margins. Microscopic invasive urothelial carcinoma at the surgical margins (i.e., "positive margins") are allowed. Carcinoma in situ (CIS) at margins is considered negative margins
* PRE-REGISTRATION: No evidence of residual cancer or metastasis after radical cystectomy or nephroureterectomy or ureterectomy (imaging is not required prior to pre-registration but is required prior to registration)
* PRE-REGISTRATION: Have undergone a radical cystectomy nephroureterectomy, or ureterectomy with pathological evidence of urothelial carcinoma at high risk of recurrence as described in one of the two scenarios below (i or ii). The 7th edition of American Joint Committee on Cancer (AJCC) staging will be utilized.:
* (i) Patients who have not received neoadjuvant systemic therapy: pT3-pT4\* or pT0/x-pT4/N+ on radical surgery (i.e., cystectomy, nephroureterectomy, or ureterectomy) and are not eligible for adjuvant cisplatin chemotherapy
* (i) Patients ineligible for cisplatin due to at least one of the following criteria and reason for ineligibility should be documented:
* (i) Creatinine Clearance (using Cockcroft-Gault): \< 60 mL/min
* (i) Common Terminology Criteria for Adverse Events (CTCAE) version 5, grade \>= 2 audiometric hearing loss
* (i) CTCAE version 5, grade \>= 2 or above peripheral neuropathy
* New York Heart Association Class III heart failure
* (i) Eastern Cooperative Oncology Group (ECOG) performance status = 2
* (i) Patients who are eligible for cisplatin may be candidates if they refuse adjuvant cisplatin-based chemotherapy, despite being informed by the investigator about the treatment options. The patient's refusal must be documented.
* (i) Patients with pT2N0 urothelial cancer on radical surgery specimen (without prior neoadjuvant systemic therapy) with ctDNA(+) Signatera results based on an assay performed post-radical surgery as part of routine care outside of the study may proceed with pre-registration but require confirmation of ctDNA(+) Signatera testing on repeat "central testing" in the context of A032103 testing. Patients with pT2N0 with central testing not confirming ctDNA(+) will not be eligible for A032103 (Note: this is distinct from patients with ypT2N0 who are eligible based on ii).
* (ii) Patients who received neoadjuvant systemic therapy: ypT2-T4a and/or ypN+ on radical surgery (i.e., cystectomy. , nephroureterectomy, or ureterectomy) pathology specimen. Neoadjuvant systemic therapy may have included cisplatin-based chemotherapy, cisplatin-based chemotherapy plus PD-1/PD-L1 blockade, or enfortumab vedotin plus PD-1/PD-L1 blockade
* PRE-REGISTRATION: Available tumor tissue for central Signatera testing to be submitted at pre-registration. Central testing is defined as testing performed as part of the A032103 study prior to registration and is provided by the study and not routine standard commercial testing. Patients who have already had local Signatera testing performed as part of routine care will require repeat central testing as part of the A032103 study to be eligible for registration/randomization. Tumor tissue from the radical surgery specimen is preferred over tissue from prior diagnostic biopsy specimen (e.g., transurethral resection of bladder tumor specimen)
* PRE-REGISTRATION: Age \>= 18 years
* PRE-REGISTRATION: ECOG Performance Status 0-2
* PRE-REGISTRATION: Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects
* PRE-REGISTRATION: No postoperative/adjuvant systemic therapy after radical surgery
* PRE-REGISTRATION: No adjuvant radiation after radical surgery
* PRE-REGISTRATION: No treatment with any other type of investigational agent =\< 4 weeks before pre-registration
* PRE-REGISTRATION: Not have ever received prior treatment with LAG-3 blockade
* PRE-REGISTRATION: Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
* PRE-REGISTRATION: Absolute Neutrophil Count (ANC) \>= 1,200/mm\^3
* PRE-REGISTRATION: Platelet count \>= 100,000/mm\^3
* PRE-REGISTRATION: Hemoglobin \>= 8 g/dL
* PRE-REGISTRATION: Creatinine =\< 1.5 x upper limit of normal (ULN) or calculated (calc.) creatinine clearance \> 30 mL/min (using either Cockcroft-Gault formula or Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
* PRE-REGISTRATION: Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 3 x ULN
* PRE-REGISTRATION: Total bilirubin =\< 1.5 x upper limit of normal (ULN) (except in patients with Gilbert Syndrome, who can have total bilirubin \< 3.0 mg/dL)
* PRE-REGISTRATION: For women of childbearing potential only: A negative urine or serum pregnancy test done =\< 14 days prior to pre-registration is required
* PRE-REGISTRATION: Not currently requiring hemodialysis
* PRE-REGISTRATION: No current or prior history of myocarditis
* PRE-REGISTRATION: No grade ≥ 3 immune related adverse event with prior PD-1/PD-L1 blockade
* PRE-REGISTRATION: No active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids. These include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens- Johnson syndrome, or phospholipid syndrome because of the risk of recurrence or exacerbation of disease.
* PRE-REGISTRATION: Patients with vitiligo, endocrine deficiencies including type I diabetes mellitus, thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible.
* PRE-REGISTRATION: Patients with rheumatoid arthritis and other arthropathies, Sjögren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible.
* PRE-REGISTRATION: No current pneumonitis or prior history of non-infectious pneumonitis that required steroids within the previous 5 years.
* PRE-REGISTRATION: No known active hepatitis B (e.g., hepatitis B surface antigen \[HBsAg\] reactive) or hepatitis C (e.g., hepatitis C virus \[HCV\] ribonucleic acid \[RNA\] \[qualitative\] is detected).
* PRE-REGISTRATION: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
* PRE-REGISTRATION: Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible.
* PRE-REGISTRATION: No concurrent antineoplastic therapy.
* PRE-REGISTRATION: No current immunosuppressive agents (with the exception of corticosteroids as described below).
* PRE-REGISTRATION: No condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of pre-registration (with the exception of steroid pre-medications for contrast allergies). Inhaled or topical steroids and adrenal replacement doses \< 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
* REGISTRATION: Patient must have had radical cystectomy and lymph node dissection or nephroureterectomy or ureterectomy =\< 18 weeks prior to registration.
* REGISTRATION: Must have evaluable ctDNA Signatera assay result (i.e., ctDNA\[+\]or ctDNA\[-\]) based on test performed as part of central testing at pre-registration to A032103. Central testing is defined as testing performed as part of the A032103. Local/commercial testing results may not be used for registration to A032103
* Cisplatin-ineligible (or cisplatin-declining) patients with a pT2N0 urothelial cancer on cystectomy or nephroureterectomy or ureterectomy who were pre-registered based on routine standard care ctDNA(+) Signatera testing must have confirmed ctDNA(+) Signatera testing on central testing. If central Signatera testing yields a ctDNA(-) result, these patients are ineligible. NOTE: This is a distinct consideration from patients with ypT2-4 and/or ypN+ urothelial cancer (i.e., patients who had received neoadjuvant cisplatin-based chemotherapy) who are eligible with either ctDNA(+) or ctDNA(-) central Signatera testing
* REGISTRATION: All patients must have confirmed disease-free status defined as no measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, or definitive non-measurable radiographic metastatic disease, within 60 days prior to registration. Patients with equivocal nodes less than 15 mm in short axis, or \< 10 mm in long axis for non-lymph node lesions, not considered by the investigator to represent malignant disease will be eligible. Attempts should be made to resolve the etiology of equivocal lesions with complementary imaging (e.g., PET scan) or biopsy.
* REGISTRATION: No major surgery =\< 3 weeks before registration.
* REGISTRATION: No live vaccine within 30 days prior to registration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette- Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist \[registered trademark\]) are live attenuated vaccines and are not allowed. Coronavirus disease 2019 (COVID-19) vaccines are not live vaccines and are allowed
* REGISTRATION: No change since registration in clinical condition and/or laboratory tests that would impact the safety of nivolumab +/- relatlimab administration in the opinion of the treating investigator
* COHORT B, ARM 4 PATIENTS INITIATING NIVOLUMAB AFTER CONVERSION OF ctDNA ASSAY FROM ctDNA(-) to ctDNA (+):
* Patient must have converted to ctDNA(+) during serial monitoring performed centrally in the setting of the A032103 study
* COHORT B, ARM 4 PATIENTS INITIATING NIVOLUMAB AFTER CONVERSION OF ctDNA ASSAY FROM ctDNA(-) to ctDNA (+):
* No evidence of metastatic disease on the most recent scheduled imaging assessment as outlined in the study calendar (no repeat imaging is necessary specifically at the time of the conversion from ctDNA\[-\] to ctDNA\[+\]).
* COHORT B, ARM 4 PATIENTS INITIATING NIVOLUMAB AFTER CONVERSION OF ctDNA ASSAY FROM ctDNA(-) to ctDNA (+):
* No change in clinical condition and/or laboratory tests that would impact the safety of nivolumab administration in the opinion of the treating investigator
* COHORT B, ARM 4 PATIENTS INITIATING NIVOLUMAB AFTER CONVERSION OF ctDNA ASSAY FROM ctDNA(-) to ctDNA (+):
* =\< 6 weeks from reporting of ctDNA(+) result to site (not from the date sample was drawn). PROCEDURE: Biospecimen Collection, OTHER: cfDNA or ctDNA Measurement, PROCEDURE: Computed Tomography, PROCEDURE: Cystoscopy, PROCEDURE: Magnetic Resonance Imaging, BIOLOGICAL: Nivolumab, OTHER: Questionnaire Administration, BIOLOGICAL: Relatlimab
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma, Muscle Invasive Ureter Urothelial Carcinoma, Muscle Invasive Urethral Urothelial Carcinoma, Stage II Bladder Urothelial Carcinoma AJCC v6 and v7, Stage III Bladder Urothelial Carcinoma AJCC v6 and v7, Stage IV Bladder Urothelial Carcinoma AJCC v7
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Study Locations
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| Location | Contacts |
|---|---|
| AMG Crystal Lake - Oncology Crystal Lake, Illinois | Site Public Contact - (advocateresearch@advocate.com) |
| AMG Libertyville - Oncology Libertyville, Illinois | Site Public Contact - (advocateresearch@advocatehealth.com) |
| Abbott-Northwestern Hospital Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Addison Gilbert Hospital Gloucester, Massachusetts | |
| AdventHealth Orlando Orlando, Florida | Site Public Contact - (FH.Cancer.Research@flhosp.org) |
| Advocate Christ Medical Center Oak Lawn, Illinois | |
| Advocate Good Samaritan Hospital Downers Grove, Illinois | Site Public Contact - (Barbara.barhamand@advocatehealth.com) |
| Advocate Good Shepherd Hospital Barrington, Illinois | |
| Advocate Illinois Masonic Medical Center Chicago, Illinois | |
| Advocate Lutheran General Hospital Park Ridge, Illinois | |
| Advocate Sherman Hospital Elgin, Illinois | |
| Allegiance Health Jackson, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| AnMed Health Cancer Center Anderson, South Carolina | Site Public Contact - (rhonda.ballew@anmedhealth.org) |
| Arthur J E Child Comprehensive Cancer Centre Calgary, Alberta | Site Public Contact - (ctsucontact@westat.com) |
| Asplundh Cancer Pavilion Willow Grove, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Atrium Health Cleveland/LCI-Cleveland Shelby, North Carolina | |
| Atrium Health Lincoln/LCI-Lincolnton Lincolnton, North Carolina | |
| Atrium Health Pineville/LCI-Pineville Charlotte, North Carolina | |
| Atrium Health Stanly/LCI-Albemarle Albemarle, North Carolina | |
| Atrium Health Union/LCI-Union Monroe, North Carolina | |
| Atrium Health University City/LCI-University Charlotte, North Carolina | |
| Aurora Bay Area Medical Group-Marinette Marinette, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora BayCare Medical Center Green Bay, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Grafton Grafton, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Milwaukee West Wauwatosa, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Medical Center in Summit Summit, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Saint Luke's Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Saint Luke's South Shore Cudahy, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Sinai Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora West Allis Medical Center West Allis, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| BCCA-Vancouver Cancer Centre Vancouver, British Columbia | |
| BJC Outpatient Center at Sunset Hills Sunset Hills, Missouri | |
| Banner University Medical Center - Tucson Tucson, Arizona | Site Public Contact - (UACC-IIT@uacc.arizona.edu) |
| Baptist Health Louisville Louisville, Kentucky | Site Public Contact - (Cbcresearch@bhsi.com) |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas | Site Public Contact - (burton@bcm.edu) |
| Ben Taub General Hospital Houston, Texas | |
| Benefis Sletten Cancer Institute Great Falls, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Beth Israel Deaconess Medical Center Boston, Massachusetts | |
| Beth Israel Deaconess Medical Center/Winchester Center for Cancer Care Winchester, Massachusetts | |
| Beverly Hospital Beverly, Massachusetts | |
| Billings Clinic Cancer Center Billings, Montana | Site Public Contact - (research@billingsclinic.org) |
| Bon Secours Memorial Regional Medical Center Mechanicsville, Virginia | |
| Bon Secours Richmond Community Hospital Richmond, Virginia | |
| Bon Secours Saint Francis Medical Center Midlothian, Virginia | |
| Bon Secours Saint Mary's Hospital Richmond, Virginia | |
| Bozeman Health Deaconess Hospital Bozeman, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Bronson Battle Creek Battle Creek, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Bronson Methodist Hospital Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Cancer Care Center of O'Fallon O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Care Specialists of Illinois - Decatur Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Care and Hematology-Fort Collins Fort Collins, Colorado | Site Public Contact - (protocols@AllianceNCTN.org) |
| Cancer Center at Saint Joseph's Phoenix, Arizona | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Cancer Centers of Southwest Oklahoma Research Lawton, Oklahoma | |
| Cancer Hematology Centers - Flint Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores, Michigan | Site Public Contact - (connie.szczepanek@crcwm.org) |
| Carle Cancer Center Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Effingham Effingham, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Mattoon/Charleston Mattoon, Illinois | Site Public Contact - (Research@carle.com) |
| Carle at The Riverfront Danville, Illinois | Site Public Contact - (Research@Carle.com) |
| Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina | |
| Central Vermont Medical Center/National Life Cancer Treatment Berlin Corners, Vermont | |
| Coborn Cancer Center at Saint Cloud Hospital Saint Cloud, Minnesota | Site Public Contact - (coborncancercenter@centracare.com) |
| Columbus Oncology and Hematology Associates Dublin, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Columbus Oncology and Hematology Associates Inc Columbus, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Community Hospital of Anaconda Anaconda, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Toms River, New Jersey | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Toms River, New Jersey | Site Public Contact - (Lennette.Gonzales@rwjbh.org) |
| Condell Memorial Hospital Libertyville, Illinois | Site Public Contact - (advocateresearch@advocatehealth.com) |
| Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Lakeland Hospitals - Niles Hospital Niles, Michigan | |
| Corewell Health Lakeland Hospitals - Saint Joseph Hospital Saint Joseph, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Reed City Hospital Reed City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Cross Cancer Institute Edmonton, Alberta | |
| Crossroads Cancer Center Effingham, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Dana-Farber Cancer Institute Boston, Massachusetts | |
| Dana-Farber Cancer Institute at Boston Medical Center - Brighton Brighton, Massachusetts | |
| Dana-Farber Cancer Institute at Foxborough Foxborough, Massachusetts | |
| Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Milford, Massachusetts | |
| Dana-Farber/Brigham and Women's Cancer Center at South Shore South Weymouth, Massachusetts | |
| Decatur Memorial Hospital Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Delaware Health Center-Grady Cancer Center Delaware, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Doctors Hospital Columbus, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Dublin Methodist Hospital Dublin, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Duke Cancer Center Cary Cary, North Carolina | Site Public Contact - (NCTNStudyTeam@dm.duke.edu) |
| Duke Cancer Center Raleigh Raleigh, North Carolina | Site Public Contact - (NCTNStudyTeam@dm.duke.edu) |
| Duke University Medical Center Durham, North Carolina | |
| Edward Hospital/Cancer Center Naperville, Illinois | |
| Edward Hospital/Cancer Center?Plainfield Plainfield, Illinois | Site Public Contact - (Cancerresearch@edward.org) |
| Elmhurst Memorial Hospital Elmhurst, Illinois | Site Public Contact - (Jrohde@emhc.org) |
| Emory Johns Creek Hospital Johns Creek, Georgia | Site Public Contact - (m.lisa.hwang@emory.edu) |
| Emory Saint Joseph's Hospital Atlanta, Georgia | |
| Emory University Hospital Midtown Atlanta, Georgia | |
| Emory University Hospital/Winship Cancer Institute Atlanta, Georgia | |
| Fairview Southdale Hospital Edina, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| FirstHealth of the Carolinas-Moore Regional Hospital Pinehurst, North Carolina | Site Public Contact - (jcwilliams@firsthealth.org) |
| Genesee Hematology Oncology PC Flint, Michigan | |
| Genesys Hurley Cancer Institute Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| George Washington University Medical Center Washington D.C., District of Columbia | |
| Glens Falls Hospital Glens Falls, New York | |
| Grady Health System Atlanta, Georgia | |
| Grady Memorial Hospital Delaware, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Grant Medical Center Columbus, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Hackensack University Medical Center Hackensack, New Jersey | |
| Hartford HealthCare - Saint Vincent's Medical Center Bridgeport, Connecticut | |
| Hartford Healthcare - Fairfield Fairfield, Connecticut | Site Public Contact - (CancerResearchSupport@hhchealth.org) |
| Hartford Hospital Hartford, Connecticut | |
| HaysMed Hays, Kansas | |
| Helen F Graham Cancer Center Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Hennepin County Medical Center Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Henry Ford Hospital Detroit, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford Macomb Hospital-Clinton Township Clinton Township, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford Medical Center-Columbus Novi, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford West Bloomfield Hospital West Bloomfield, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Highlands Oncology Group Springdale, Arkansas | Site Public Contact - (research@hogonc.com) |
| Highlands Oncology Group - Fayetteville Fayetteville, Arkansas | Site Public Contact - (research@hogonc.com) |
| Highlands Oncology Group - Rogers Rogers, Arkansas | Site Public Contact - (research@hogonc.com) |
| Huntsman Cancer Institute/University of Utah Salt Lake City, Utah | Site Public Contact - (cancerinfo@hci.utah.edu) |
| Hurley Medical Center Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Illinois CancerCare - Washington Washington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Bloomington Bloomington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Canton Canton, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Carthage Carthage, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Dixon Dixon, Illinois | |
| Illinois CancerCare-Eureka Eureka, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Galesburg Galesburg, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Kewanee Clinic Kewanee, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Macomb Macomb, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Ottawa Clinic Ottawa, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Pekin Pekin, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Peoria Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Peru Peru, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Princeton Princeton, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Indiana University/Melvin and Bren Simon Cancer Center Indianapolis, Indiana | Site Public Contact - (iutrials@iu.edu) |
| Ingalls Memorial Hospital Harvey, Illinois | Site Public Contact - (clinicaltrials@ingalls.org) |
| Iowa Methodist Medical Center Des Moines, Iowa | |
| Jefferson Cherry Hill Hospital Cherry Hill, New Jersey | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Jefferson Torresdale Hospital Philadelphia, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland | Site Public Contact - (jhcccro@jhmi.edu) |
| Kaiser Permanente - Panorama City Panorama City, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente Downtown Commons Sacramento, California | Site Public Contact - (kpoct@kp.org) |
| Kaiser Permanente Dublin Dublin, California | |
| Kaiser Permanente Fresno Orchard Plaza Fresno, California | |
| Kaiser Permanente Los Angeles Medical Center Los Angeles, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente Medical Center - Santa Clara Santa Clara, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente Moanalua Medical Center Honolulu, Hawaii | Site Public Contact - (shelley.a.clark@kp.org) |
| Kaiser Permanente San Leandro San Leandro, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente South Bay Harbor City, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente West Los Angeles Los Angeles, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Anaheim Anaheim, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Baldwin Park Baldwin Park, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Bellflower Bellflower, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Fontana Fontana, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Franklin Denver, Colorado | Site Public Contact - (KPCOIHRClinicalResearch@kp.org) |
| Kaiser Permanente-Fremont Fremont, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Fresno Fresno, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Irvine Irvine, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Lone Tree Lone Tree, Colorado | Site Public Contact - (KPCOIHRClinicalResearch@kp.org) |
| Kaiser Permanente-Modesto Modesto, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Oakland Oakland, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Ontario Ontario, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Riverside Riverside, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Rock Creek Lafayette, Colorado | Site Public Contact - (KPCOIHRClinicalResearch@kp.org) |
| Kaiser Permanente-Roseville Roseville, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-San Diego Zion San Diego, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-San Francisco San Francisco, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-San Marcos San Marcos, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Santa Rosa Santa Rosa, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Santa Teresa-San Jose San Jose, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-South Sacramento Sacramento, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-South San Francisco South San Francisco, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Vallejo Vallejo, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Walnut Creek Walnut Creek, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Woodland Hills Woodland Hills, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser San Rafael-Gallinas San Rafael, California | Site Public Contact - (Kpoct@kp.org) |
| Kansas City Veterans Affairs Medical Center Kansas City, Missouri | |
| Karmanos Cancer Institute at McLaren Greater Lansing Lansing, Michigan | Site Public Contact - (ctoadmin@karmanos.org) |
| Keck Medicine of USC Koreatown Los Angeles, California | |
| Kootenai Clinic Cancer Services - Post Falls Post Falls, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Clinic Cancer Services - Sandpoint Sandpoint, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Health - Coeur d'Alene Coeur d'Alene, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Lafayette Family Cancer Center-EMMC Brewer, Maine | |
| Lahey Hospital and Medical Center Burlington, Massachusetts | Site Public Contact - (lhmc-cancer-clinical-trials@lahey.org) |
| Lahey Medical Center-Peabody Peabody, Massachusetts | Site Public Contact - (lhmc-cancer-clinical-trials@lahey.org) |
| Lancaster General Ann B Barshinger Cancer Institute Lancaster, Pennsylvania | Site Public Contact - (nctn@pennmedicine.upenn.edu) |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York | Site Public Contact - (CancerTrials@nyulangone.org) |
| Lawrence Memorial Hospital Lawrence, Kansas | Site Public Contact - (Stephanie.Norris@LMH.ORG) |
| Lehigh Valley Hospital - Muhlenberg Bethlehem, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Levine Cancer Institute - Huntersville Huntersville, North Carolina | |
| Levine Cancer Institute - Rutherford Forest City, North Carolina | |
| Levine Cancer Institute - Union West Matthews, North Carolina | |
| Levine Cancer Institute-Ballantyne Charlotte, North Carolina | |
| Levine Cancer Institute-Gaston Gastonia, North Carolina | |
| Levine Cancer Institute-Rock Hill Rock Hill, South Carolina | |
| Levine Cancer Institute-SouthPark Charlotte, North Carolina | |
| Logan Health Medical Center Kalispell, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| London Regional Cancer Program London, Ontario | |
| Los Angeles General Medical Center Los Angeles, California | |
| Louisiana Hematology Oncology Associates LLC Baton Rouge, Louisiana | Site Public Contact - (clinicalresearch@marybird.com) |
| Lyndon Baines Johnson General Hospital Houston, Texas | |
| MU Health - University Hospital/Ellis Fischel Cancer Center Columbia, Missouri | |
| MU Health Care Goldschmidt Cancer Center Jefferson City, Missouri | |
| Maimonides Medical Center Brooklyn, New York | |
| Malcom Randall Veterans Administration Medical Center Gainesville, Florida | Site Public Contact - (trials@cancer.ufl.edu) |
| Marshfield Medical Center - Weston Weston, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center-EC Cancer Center Eau Claire, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center-River Region at Stevens Point Stevens Point, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Mary Bird Perkins Cancer Center - Metairie Metairie, Louisiana | |
| Mary Greeley Medical Center Ames, Iowa | |
| McFarland Clinic - Ames Ames, Iowa | Site Public Contact - (ksoder@mcfarlandclinic.com) |
| McFarland Clinic - Boone Boone, Iowa | |
| McFarland Clinic - Jefferson Jefferson, Iowa | |
| McFarland Clinic - Marshalltown Marshalltown, Iowa | |
| McFarland Clinic - Trinity Cancer Center Fort Dodge, Iowa | |
| McLaren Cancer Institute-Bay City Bay City, Michigan | Site Public Contact - (ctoadmin@karmanos.org) |
| McLaren Cancer Institute-Northern Michigan Petoskey, Michigan | Site Public Contact - (ctoadmin@karmanos.org) |
| MedStar Georgetown University Hospital Washington D.C., District of Columbia | |
| Medical Center of the Rockies Loveland, Colorado | |
| Medical College of Wisconsin Milwaukee, Wisconsin | |
| Medical Oncology Hematology Consultants PA Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Medical University of South Carolina Charleston, South Carolina | Site Public Contact - (hcc-clinical-trials@musc.edu) |
| Medstar Washington Hospital Center Washington D.C., District of Columbia | |
| Memorial Hospital East Shiloh, Illinois | Site Public Contact - (dschwab@wustl.edu) |
| Memorial Hospital West Pembroke Pines, Florida | |
| Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood, Florida | Site Public Contact - (OHR@mhs.net) |
| Memorial Sloan Kettering Basking Ridge Basking Ridge, New Jersey | |
| Memorial Sloan Kettering Bergen Montvale, New Jersey | |
| Memorial Sloan Kettering Cancer Center New York, New York | |
| Memorial Sloan Kettering Commack Commack, New York | |
| Memorial Sloan Kettering Monmouth Middletown, New Jersey | |
| Memorial Sloan Kettering Nassau Uniondale, New York | |
| Memorial Sloan Kettering Westchester Harrison, New York | |
| Mercy Hospital Coon Rapids, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Mercy Hospital Saint Louis St Louis, Missouri | |
| Mercy Hospital South St Louis, Missouri | Site Public Contact - (Danielle.Werle@mercy.net) |
| Mercy Hospital Springfield Springfield, Missouri | |
| Mercy Medical Center - Des Moines Des Moines, Iowa | Site Public Contact - (cancerresearch@mercydesmoines.org) |
| Miami Cancer Institute Miami, Florida | |
| Michael E DeBakey VA Medical Center Houston, Texas | |
| Midstate Medical Center Meriden, Connecticut | |
| Missouri Baptist Medical Center St Louis, Missouri | |
| Missouri Baptist Sullivan Hospital Sullivan, Missouri | |
| Monmouth Medical Center Long Branch, New Jersey | Site Public Contact - (mary.danish@rwjbh.org) |
| Monmouth Medical Center Southern Campus Lakewood, New Jersey | Site Public Contact - (mary.danish@rwjbh.org) |
| Montefiore Medical Center-Einstein Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Mount Sinai Chelsea New York, New York | Site Public Contact - (CCTO@mssm.edu) |
| Mount Sinai Comprehensive Cancer Center at Aventura Aventura, Florida | |
| Mount Sinai Hospital New York, New York | Site Public Contact - (CCTO@mssm.edu) |
| Mount Sinai Medical Center Miami Beach, Florida | |
| Munson Medical Center Traverse City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| MyMichigan Medical Center Saginaw Saginaw, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| MyMichigan Medical Center Tawas Tawas City, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| NYP/Weill Cornell Medical Center New York, New York | |
| NYU Langone Hospital - Long Island Mineola, New York | |
| Nebraska Medicine-Bellevue Bellevue, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| Nebraska Medicine-Village Pointe Omaha, Nebraska | |
| New Hampshire Oncology Hematology PA-Concord Concord, New Hampshire | |
| NorthShore University HealthSystem-Evanston Hospital Evanston, Illinois | |
| NorthShore University HealthSystem-Glenbrook Hospital Glenview, Illinois | |
| NorthShore University HealthSystem-Highland Park Hospital Highland Park, Illinois | |
| Northside Hospital Atlanta, Georgia | Site Public Contact - (ClinicalTrials@northside.com) |
| Northside Hospital - Duluth Duluth, Georgia | Site Public Contact - (Clinical.trials@northside.com) |
| Northside Hospital - Gwinnett Lawrenceville, Georgia | Site Public Contact - (Clinical.trials@northside.com) |
| Northwestern Medicine Cancer Center Delnor Geneva, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Cancer Center Kishwaukee DeKalb, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Cancer Center Warrenville Warrenville, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Glenview Outpatient Center Glenview, Illinois | |
| Northwestern Medicine Grayslake Outpatient Center Grayslake, Illinois | |
| Northwestern Medicine Lake Forest Hospital Lake Forest, Illinois | Site Public Contact - (cancertrials@northwestern.edu) |
| Northwestern Medicine Oak Brook Oak Brook, Illinois | Site Public Contact - (nctnprogram_rhlccc@northwestern.edu) |
| Northwestern Medicine Orland Park Orland Park, Illinois | Site Public Contact - (nctnprogram_rhlccc@northwestern.edu) |
| Northwestern University Chicago, Illinois | Site Public Contact - (cancer@northwestern.edu) |
| OSF Saint Francis Hospital and Medical Group Escanaba, Michigan | Site Public Contact - (WI_research_admin@hshs.org) |
| Ochsner Medical Center Jefferson New Orleans, Louisiana | Site Public Contact - (Elisemarie.curry@ochsner.org) |
| Odette Cancer Centre- Sunnybrook Health Sciences Centre Toronto, Ontario | |
| Ohio State University Comprehensive Cancer Center Columbus, Ohio | Site Public Contact - (Jamesline@osumc.edu) |
| OhioHealth Mansfield Hospital Mansfield, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| OhioHealth Marion General Hospital Marion, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| OhioHealth O'Bleness Hospital Athens, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| OhioHealth Pickerington Methodist Hospital Pickerington, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| OhioHealth Westerville Medical Campus/Westerville Cancer Center Westerville, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Oklahoma Cancer Specialists and Research Institute-Tulsa Tulsa, Oklahoma | |
| Oncology Hematology Associates of Saginaw Valley PC Saginaw, Michigan | |
| OptumCare Cancer Care at Charleston Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at Fort Apache Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at Seven Hills Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Oregon Health and Science University Portland, Oregon | Site Public Contact - (trials@ohsu.edu) |
| Ottawa Hospital and Cancer Center-General Campus Ottawa, Ontario | |
| Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Parkland Health Center - Farmington Farmington, Missouri | |
| Pocono Medical Center East Stroudsburg, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Poudre Valley Hospital Fort Collins, Colorado | |
| Presbyterian Kaseman Hospital Albuquerque, New Mexico | Site Public Contact - (WBurman@phs.org) |
| Presbyterian Rust Medical Center/Jorgensen Cancer Center Rio Rancho, New Mexico | Site Public Contact - (WBurman@phs.org) |
| Prisma Health Cancer Institute - Butternut Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Easley Easley, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Eastside Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Faris Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Greer Greer, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Seneca Seneca, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Spartanburg Boiling Springs, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Greenville Memorial Hospital Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| ProHealth D N Greenwald Center Mukwonago, Wisconsin | Site Public Contact - (research.institute@phci.org) |
| ProHealth Oconomowoc Memorial Hospital Oconomowoc, Wisconsin | |
| ProHealth Waukesha Memorial Hospital Waukesha, Wisconsin | |
| ProMedica Flower Hospital Sylvania, Ohio | Site Public Contact - (PCIOncResearch@promedica.org) |
| Providence Portland Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Saint Vincent Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Willamette Falls Medical Center Oregon City, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Reading Hospital West Reading, Pennsylvania | |
| Regions Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Riverside Methodist Hospital Columbus, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Robert Wood Johnson University Hospital Somerset Somerville, New Jersey | Site Public Contact - (Siby.Varughese@rwjbh.org) |
| Rochester General Hospital Rochester, New York | Site Public Contact - (tia.derosa@rochestergeneral.org) |
| Roswell Park Cancer Institute Buffalo, New York | Site Public Contact - (askroswell@roswellpark.org) |
| Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey | |
| Saint Alphonsus Cancer Care Center-Boise Boise, Idaho | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Saint Alphonsus Cancer Care Center-Caldwell Caldwell, Idaho | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Saint Alphonsus Cancer Care Center-Nampa Nampa, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Saint Alphonsus Cancer Care Center-Ontario Ontario, Oregon | Site Public Contact - (mccinfo@mtcancer.org) |
| Saint Francis Medical Center Cape Girardeau, Missouri | Site Public Contact - (sfmc@sfmc.net) |
| Saint John's Cancer Institute Santa Monica, California | |
| Saint Mary's Oncology/Hematology Associates of West Branch West Branch, Michigan | |
| Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Sheboygan Sheboygan, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Sainte Genevieve County Memorial Hospital Sainte Genevieve, Missouri | |
| Salina Regional Health Center Salina, Kansas | Site Public Contact - (mleepers@srhc.com) |
| Sanford Bismarck Medical Center Bismarck, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Broadway Medical Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Cancer Center Oncology Clinic Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicTrialsSF@sanfordhealth.org) |
| Sanford Joe Lueken Cancer Center Bemidji, Minnesota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Roger Maris Cancer Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org) |
| Sibley Memorial Hospital Washington D.C., District of Columbia | Site Public Contact - (jquiver1@jhmi.edu) |
| Sidney Kimmel Cancer Center Washington Township Sewell, New Jersey | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Siteman Cancer Center at Christian Hospital St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center at Saint Peters Hospital City of Saint Peters, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center at West County Hospital Creve Coeur, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center-South County St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Smilow Cancer Hospital Care Center - Guilford Guilford, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center - Waterford Waterford, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center - Westerly Westerly, Rhode Island | Site Public Contact - (canceranswers@yale.edu) |
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| Smilow Cancer Hospital Care Center at Long Ridge Stamford, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center at Saint Francis Hartford, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center-Fairfield Fairfield, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center-Trumbull Trumbull, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital-Derby Care Center Derby, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital-Torrington Care Center Torrington, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital-Waterbury Care Center Waterbury, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Solinsky Center for Cancer Care Manchester, New Hampshire | |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| Southern Ocean County Medical Center Manahawkin, New Jersey | |
| Springfield Clinic Springfield, Illinois | |
| Springfield Memorial Hospital Springfield, Illinois | Site Public Contact - (pallante.beth@mhsil.com) |
| Stanford Cancer Institute Palo Alto Palo Alto, California | Site Public Contact - (ccto-office@stanford.edu) |
| Swedish Covenant Hospital Chicago, Illinois | |
| The Hospital of Central Connecticut New Britain, Connecticut | |
| The James Graham Brown Cancer Center at University of Louisville Louisville, Kentucky | |
| The New York Hospital Medical Center of Queens Flushing, New York | Site Public Contact - (ctsucontact@westat.com) |
| The University of Kansas Cancer Center - Olathe Olathe, Kansas | Site Public Contact - (OlatheCCResearch@kumc.edu) |
| The West Clinic - Wolf River Germantown, Tennessee | |
| Thomas Jefferson University Hospital Philadelphia, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Trinity Health Grand Rapids Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Canton Canton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Muskegon Hospital Muskegon, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Trinity Health Saint Joseph Mercy Hospital Ann Arbor Ann Arbor, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Joseph Mercy Oakland Hospital Pontiac, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Mary Mercy Livonia Hospital Livonia, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| UC Comprehensive Cancer Center at Silver Cross New Lenox, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| UC San Diego Moores Cancer Center La Jolla, California | Site Public Contact - (cancercto@ucsd.edu) |
| UCHealth Greeley Hospital Greeley, Colorado | Site Public Contact - (protocols@AllianceNCTN.org) |
| UCHealth Highlands Ranch Hospital Highlands Ranch, Colorado | |
| UCHealth Lone Tree Health Center Lone Tree, Colorado | Site Public Contact - (protocols@AllianceNCTN.org) |
| UCHealth University of Colorado Hospital Aurora, Colorado | |
| UCLA / Jonsson Comprehensive Cancer Center Los Angeles, California | |
| UF Health Cancer Institute - Gainesville Gainesville, Florida | Site Public Contact - (cancer-center@ufl.edu) |
| UI Health Care Mission Cancer and Blood - Ankeny Clinic Ankeny, Iowa | |
| UI Health Care Mission Cancer and Blood - Des Moines Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - Laurel Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - Waukee Clinic Waukee, Iowa | |
| UI Health Care Mission Cancer and Blood - West Des Moines Clinic Clive, Iowa | |
| UM Sylvester Comprehensive Cancer Center at Aventura Aventura, Florida | |
| UM Sylvester Comprehensive Cancer Center at Coral Gables Coral Gables, Florida | |
| UM Sylvester Comprehensive Cancer Center at Deerfield Beach Deerfield Beach, Florida | |
| UM Sylvester Comprehensive Cancer Center at Kendall Miami, Florida | |
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| UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina | Site Public Contact - (cancerclinicaltrials@med.unc.edu) |
| UPMC Altoona Altoona, Pennsylvania | Site Public Contact - (protocols@AllianceNCTN.org) |
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| UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion Mechanicsburg, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
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| UT Southwestern Clinical Center at Richardson/Plano Richardson, Texas | Site Public Contact - (Suzanne.cole@utsouthwestern.edu) |
| UT Southwestern Simmons Cancer Center - RedBird Dallas, Texas | Site Public Contact - (canceranswerline@utsouthwestern.edu) |
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| United Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Unity Park Ridge Campus Rochester, New York | Site Public Contact - (protocols@AllianceNCTN.org) |
| University Health Network-Princess Margaret Hospital Toronto, Ontario | Site Public Contact - (clinical.trials@uhn.on.ca) |
| University Health Truman Medical Center Kansas City, Missouri | |
| University of Arizona Cancer Center-North Campus Tucson, Arizona | Site Public Contact - (UACC-IIT@uacc.arizona.edu) |
| University of Arizona Cancer Center-Orange Grove Campus Tucson, Arizona | |
| University of California Davis Comprehensive Cancer Center Sacramento, California | |
| University of Chicago Comprehensive Cancer Center Chicago, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| University of Chicago Medicine-Orland Park Orland Park, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| University of Cincinnati Cancer Center-UC Medical Center Cincinnati, Ohio | Site Public Contact - (cancer@uchealth.com) |
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| University of Kansas Cancer Center - North Kansas City, Missouri | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Cancer Center at North Kansas City Hospital North Kansas City, Missouri | |
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| University of Kansas Hospital-Westwood Cancer Center Westwood, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kentucky/Markey Cancer Center Lexington, Kentucky | |
| University of Maryland/Greenebaum Cancer Center Baltimore, Maryland | |
| University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida | |
| University of Michigan - Brighton Center for Specialty Care Brighton, Michigan | |
| University of Michigan Health - Sparrow Lansing Lansing, Michigan | Site Public Contact - (harsha.trivedi@umhsparrow.org) |
| University of Michigan Health - West Wyoming, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| University of Michigan Rogel Cancer Center Ann Arbor, Michigan | Site Public Contact - (CancerAnswerLine@med.umich.edu) |
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| University of Nebraska Medical Center Omaha, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| University of New Mexico Cancer Center Albuquerque, New Mexico | |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Pennsylvania/Abramson Cancer Center Philadelphia, Pennsylvania | Site Public Contact - (PMCancerResearch@pennmedicine.upenn.edu) |
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| University of Rochester Rochester, New York | |
| University of Vermont Medical Center Burlington, Vermont | Site Public Contact - (rpo@uvm.edu) |
| University of Vermont and State Agricultural College Burlington, Vermont | Site Public Contact - (rpo@uvm.edu) |
| University of Virginia Cancer Center Charlottesville, Virginia | Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu) |
| University of Wisconsin Carbone Cancer Center - Eastpark Medical Center Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| University of Wisconsin Carbone Cancer Center - University Hospital Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| UofL Health Medical Center Northeast Louisville, Kentucky | Site Public Contact - (ctoinfo@louisville.edu) |
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| VCU Massey Cancer Center at Stony Point Richmond, Virginia | Site Public Contact - (ctoclinops@vcu.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Vanderbilt University/Ingram Cancer Center Nashville, Tennessee | |
| Veteran's Affairs Medical Center - Saint Louis St Louis, Missouri | Site Public Contact - (protocols@AllianceNCTN.org) |
| Vince Lombardi Cancer Clinic - Oshkosh Oshkosh, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
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| Vince Lombardi Cancer Clinic-Two Rivers Two Rivers, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Virginia Mason Medical Center Seattle, Washington | Site Public Contact - (cancerresearch@virginiamason.org) |
| Wake Forest University Health Sciences Winston-Salem, North Carolina | |
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| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Waterloo Regional Health Network Kitchener, Ontario | Site Public Contact - (research@wrhn.ca) |
| Wayne State University/Karmanos Cancer Institute Detroit, Michigan | Site Public Contact - (ctoadmin@karmanos.org) |
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| West Michigan Cancer Center Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| West Virginia University Charleston Division Charleston, West Virginia | |
| Wilmot Cancer Institute at Webster Webster, New York | Site Public Contact - (WCICTOresearch@urmc.rochester.edu) |
| Yale University New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Yale-New Haven Hospital North Haven Medical Center North Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
Venetoclax and HMA Treatment of Older and Unfit Adults With FLT3 Mutated Acute Myeloid Leukemia (AML) (A MyeloMATCH Treatment Trial)
ctrrecruit@vcu.edu
NCT06317649
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Inclusion Criteria:
* Patient must be ≥ 60 years of age or adults ˂ 60 who in the opinion of the treating physician are better served by azanucleoside-based therapy rather than intensive, cytarabine-based induction based on clinical status (i.e., performance status, age \> 75 years), organ dysfunction, or disease biology
* Patient must have a morphologically confirmed diagnosis of AML according to the World Health Organization (WHO) 2016 classification excluding acute promyelocytic leukemia (APL) with PML-RARA, AML with RUNX1-RUNX1T1, or AML with CBFB-MYH11
* Patient must have no prior therapy for AML with the exception of hydroxyurea and all-trans retinoic acid (ATRA), or leukapheresis. Patients with cytarabine-based emergency therapy prior to the start of therapy on this trial are eligible
* Patient must have no prior therapy with hypomethylating agents or FLT3 inhibitors
* Patient must have the FLT3-ITD or D835 mutation based on MyeloMATCH Master Screening and Reassessment Protocol (MSRP)
* Patient must be assigned to this protocol by the myeloMATCH MSRP
* Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used.
* All patients of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy.
* A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
* Patient of childbearing potential and/or sexually active patients must not expect to conceive or father children by using an accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study. Contraception measures must continue for 30 days after the last dose of venetoclax for all patients and for 6 months after the last dose of gilteritinib for patients of childbearing potential and for 4 months after the last dose of gilteritinib for male patients with partners of childbearing potential. Patient must not breastfeed during treatment and for 2 months after treatment ends
* Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible
* Total bilirubin 2X ≤ institutional upper limit of normal (ULN) (unless thought to be elevated due to disease involvement or Gilbert's syndrome)
* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3.0 x institutional ULN
* Either measured or estimated by Cockcroft-Gault equation
* Creatinine clearance of ≥ 30 mL/min/1.73m\^2
* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration/randomization are eligible for this trial
* Patients must not have a baseline corrected QT interval ≥ 480 msec using Fredericia correction (QTcF).
NOTE: Since older patients are at risk for prolonged QTc and many will require supportive care with agents that affect the QTc, an ECG is recommended if clinically indicated. If the QTc is prolonged, they should be treated on tier advancement process (TAP) instead of EA02
* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
* Patient must not have the medical necessity for ongoing treatment with a strong CYP3A4 inducing drug
* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
* Patients must not have an active or uncontrolled infection DRUG: Azacitidine, PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Bone Marrow Biopsy, DRUG: Gilteritinib, DRUG: Venetoclax
Acute Myeloid Leukemia
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| Location | Contacts |
|---|---|
| Abbott-Northwestern Hospital Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Allegiance Health Jackson, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Alta Bates Summit Medical Center-Herrick Campus Berkeley, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Augusta University Medical Center Augusta, Georgia | Site Public Contact - (ga_cares@augusta.edu) |
| Banner University Medical Center - Tucson Tucson, Arizona | Site Public Contact - (UACC-IIT@uacc.arizona.edu) |
| Baptist Cancer Center-Grenada Grenada, Mississippi | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baptist Memorial Hospital and Cancer Center-Collierville Collierville, Tennessee | |
| Baptist Memorial Hospital and Cancer Center-Desoto Southhaven, Mississippi | |
| Baptist Memorial Hospital and Cancer Center-Golden Triangle Columbus, Mississippi | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baptist Memorial Hospital and Cancer Center-Memphis Memphis, Tennessee | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baptist Memorial Hospital and Cancer Center-Oxford Oxford, Mississippi | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baptist Memorial Hospital and Cancer Center-Union County New Albany, Mississippi | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas | Site Public Contact - (burton@bcm.edu) |
| Ben Taub General Hospital Houston, Texas | |
| Benefis Sletten Cancer Institute Great Falls, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Billings Clinic Cancer Center Billings, Montana | Site Public Contact - (research@billingsclinic.org) |
| Bozeman Health Deaconess Hospital Bozeman, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Cancer Care Center of O'Fallon O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Care Specialists of Illinois - Decatur Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Hematology Centers - Flint Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Carle Cancer Center Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Effingham Effingham, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Mattoon/Charleston Mattoon, Illinois | Site Public Contact - (Research@carle.com) |
| Carle at The Riverfront Danville, Illinois | Site Public Contact - (Research@Carle.com) |
| Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina | |
| Case Western Reserve University Cleveland, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| Cedars Sinai Medical Center Los Angeles, California | |
| Centro Comprensivo de Cancer de UPR San Juan, | Site Public Contact - (ecog.rss@jimmy.harvard.edu) |
| Community Hospital of Anaconda Anaconda, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Toms River, New Jersey | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Toms River, New Jersey | Site Public Contact - (Lennette.Gonzales@rwjbh.org) |
| Cotton O'Neil Cancer Center / Stormont Vail Health Topeka, Kansas | |
| Crossroads Cancer Center Effingham, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Dana-Farber Cancer Institute Boston, Massachusetts | |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire | Site Public Contact - (cancer.research.nurse@dartmouth.edu) |
| Decatur Memorial Hospital Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Duke University Medical Center Durham, North Carolina | |
| Duluth Clinic Ashland Ashland, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Edward Hines Jr VA Hospital Hines, Illinois | |
| Essentia Health - Deer River Clinic Deer River, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Cancer Center Duluth, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Hibbing Clinic Hibbing, Minnesota | |
| Essentia Health Sandstone Sandstone, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Virginia Clinic Virginia, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Fairview Southdale Hospital Edina, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Fred Hutchinson Cancer Center Seattle, Washington | |
| Geisinger Medical Center Danville, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Genesee Hematology Oncology PC Flint, Michigan | |
| Genesys Hurley Cancer Institute Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| George E Wahlen Department of Veterans Affairs Medical Center Salt Lake City, Utah | |
| Gundersen Lutheran Medical Center La Crosse, Wisconsin | Site Public Contact - (cancerctr@gundersenhealth.org) |
| Hawaii Cancer Care - Westridge ‘Aiea, Hawaii | Site Public Contact - (info@hawaiicancercare.com) |
| Hawaii Cancer Care Inc - Waterfront Plaza Honolulu, Hawaii | Site Public Contact - (i.webster@hawaiicancercare.com) |
| Henry Ford Hospital Detroit, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford Macomb Hospital-Clinton Township Clinton Township, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford Medical Center-Columbus Novi, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford West Bloomfield Hospital West Bloomfield, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Huntsman Cancer Institute/University of Utah Salt Lake City, Utah | Site Public Contact - (cancerinfo@hci.utah.edu) |
| Hurley Medical Center Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Kaiser Permanente Downtown Commons Sacramento, California | Site Public Contact - (kpoct@kp.org) |
| Kaiser Permanente Dublin Dublin, California | |
| Kaiser Permanente Fresno Orchard Plaza Fresno, California | |
| Kaiser Permanente Medical Center - Santa Clara Santa Clara, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente Moanalua Medical Center Honolulu, Hawaii | Site Public Contact - (shelley.a.clark@kp.org) |
| Kaiser Permanente San Leandro San Leandro, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Fremont Fremont, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Fresno Fresno, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Modesto Modesto, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Oakland Oakland, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Roseville Roseville, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-San Francisco San Francisco, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Santa Rosa Santa Rosa, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Santa Teresa-San Jose San Jose, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-South Sacramento Sacramento, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-South San Francisco South San Francisco, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Vallejo Vallejo, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Walnut Creek Walnut Creek, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser San Rafael-Gallinas San Rafael, California | Site Public Contact - (Kpoct@kp.org) |
| Kootenai Clinic Cancer Services - Post Falls Post Falls, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Clinic Cancer Services - Sandpoint Sandpoint, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Health - Coeur d'Alene Coeur d'Alene, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| LSU Health Baton Rouge-North Clinic Baton Rouge, Louisiana | |
| Lahey Hospital and Medical Center Burlington, Massachusetts | Site Public Contact - (lhmc-cancer-clinical-trials@lahey.org) |
| Lahey Medical Center-Peabody Peabody, Massachusetts | Site Public Contact - (lhmc-cancer-clinical-trials@lahey.org) |
| Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Logan Health Medical Center Kalispell, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Loyola University Medical Center Maywood, Illinois | |
| MaineHealth Cancer Care and IV Therapy - Brunswick Brunswick, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| MaineHealth Cancer Care and IV Therapy - South Portland South Portland, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| MaineHealth Maine Medical Center - Portland Portland, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| Marshfield Medical Center - Weston Weston, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center-River Region at Stevens Point Stevens Point, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Medical College of Wisconsin Milwaukee, Wisconsin | |
| Medical University of South Carolina Charleston, South Carolina | Site Public Contact - (hcc-clinical-trials@musc.edu) |
| Memorial Hospital East Shiloh, Illinois | Site Public Contact - (dschwab@wustl.edu) |
| Memorial Sloan Kettering Basking Ridge Basking Ridge, New Jersey | |
| Memorial Sloan Kettering Bergen Montvale, New Jersey | |
| Memorial Sloan Kettering Cancer Center New York, New York | |
| Memorial Sloan Kettering Commack Commack, New York | |
| Memorial Sloan Kettering Monmouth Middletown, New Jersey | |
| Mercy Hospital Coon Rapids, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Mid Coast Hospital Brunswick, Maine | Site Public Contact - (ctsucontact@westat.com) |
| Mills Health Center San Mateo, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Monmouth Medical Center Long Branch, New Jersey | Site Public Contact - (mary.danish@rwjbh.org) |
| North Shore University Hospital Manhasset, New York | |
| NorthShore University HealthSystem-Evanston Hospital Evanston, Illinois | |
| NorthShore University HealthSystem-Glenbrook Hospital Glenview, Illinois | |
| NorthShore University HealthSystem-Highland Park Hospital Highland Park, Illinois | |
| Northwell Health/Center for Advanced Medicine Lake Success, New York | |
| Northwestern Medicine Cancer Center Delnor Geneva, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Cancer Center Kishwaukee DeKalb, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Cancer Center Warrenville Warrenville, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Glenview Outpatient Center Glenview, Illinois | |
| Northwestern Medicine Grayslake Outpatient Center Grayslake, Illinois | |
| Northwestern Medicine Lake Forest Hospital Lake Forest, Illinois | Site Public Contact - (cancertrials@northwestern.edu) |
| Northwestern Medicine Orland Park Orland Park, Illinois | Site Public Contact - (nctnprogram_rhlccc@northwestern.edu) |
| Northwestern University Chicago, Illinois | Site Public Contact - (cancer@northwestern.edu) |
| OptumCare Cancer Care at Charleston Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at Fort Apache Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at Seven Hills Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Our Lady of The Lake Baton Rouge, Louisiana | |
| Our Lady of the Lake Physician Group Baton Rouge, Louisiana | Site Public Contact - (research@ololrmc.com) |
| Pali Momi Medical Center ‘Aiea, Hawaii | |
| Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Penn State Milton S Hershey Medical Center Hershey, Pennsylvania | Site Public Contact - (CTO@hmc.psu.edu) |
| Phoebe Putney Memorial Hospital Albany, Georgia | Site Public Contact - (ga_cares@augusta.edu) |
| Prisma Health Cancer Institute - Butternut Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Easley Easley, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Eastside Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Faris Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Greer Greer, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Seneca Seneca, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Spartanburg Boiling Springs, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Providence Newberg Medical Center Newberg, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Portland Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Saint Vincent Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Willamette Falls Medical Center Oregon City, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Reading Hospital West Reading, Pennsylvania | |
| Regions Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Rhode Island Hospital Providence, Rhode Island | |
| Roswell Park Cancer Institute Buffalo, New York | Site Public Contact - (askroswell@roswellpark.org) |
| Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey | |
| Saint Alphonsus Cancer Care Center-Boise Boise, Idaho | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Saint Alphonsus Cancer Care Center-Caldwell Caldwell, Idaho | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Saint Alphonsus Cancer Care Center-Nampa Nampa, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Saint Alphonsus Cancer Care Center-Ontario Ontario, Oregon | Site Public Contact - (mccinfo@mtcancer.org) |
| Saint Barnabas Medical Center Livingston, New Jersey | Site Public Contact - (joanne.loeb@rwjbh.org) |
| Saint Luke's Cancer Institute - Boise Boise, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Fruitland Fruitland, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Meridian Meridian, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Nampa Nampa, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Sheboygan Sheboygan, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| San Juan City Hospital San Juan, | |
| Siteman Cancer Center at Christian Hospital St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center at Saint Peters Hospital City of Saint Peters, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center at West County Hospital Creve Coeur, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center-South County St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| Springfield Clinic Springfield, Illinois | |
| Springfield Memorial Hospital Springfield, Illinois | Site Public Contact - (pallante.beth@mhsil.com) |
| State University of New York Upstate Medical University Syracuse, New York | |
| Straub Clinic and Hospital Honolulu, Hawaii | |
| Swedish Cancer Institute-Edmonds Edmonds, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Swedish Cancer Institute-Issaquah Issaquah, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Swedish Medical Center-First Hill Seattle, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| The James Graham Brown Cancer Center at University of Louisville Louisville, Kentucky | |
| The Valley Hospital - Luckow Pavilion Paramus, New Jersey | Site Public Contact - (clinicaltrialsresearch@valleyhealth.com) |
| ThedaCare Regional Cancer Center Appleton, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Canton Canton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Mary Mercy Livonia Hospital Livonia, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Tufts Medical Center Boston, Massachusetts | Site Public Contact - (ContactUsCancerCenter@TuftsMedicalCenter.org) |
| UCSF Medical Center-Parnassus San Francisco, California | |
| UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina | Site Public Contact - (cancerclinicaltrials@med.unc.edu) |
| United Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| University of Arizona Cancer Center-North Campus Tucson, Arizona | Site Public Contact - (UACC-IIT@uacc.arizona.edu) |
| University of Arkansas for Medical Sciences Little Rock, Arkansas | |
| University of California Davis Comprehensive Cancer Center Sacramento, California | |
| University of Illinois Chicago, Illinois | |
| University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa | |
| University of Kansas Cancer Center Kansas City, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Clinical Research Center Fairway, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Hospital-Indian Creek Campus Overland Park, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Hospital-Westwood Cancer Center Westwood, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kentucky/Markey Cancer Center Lexington, Kentucky | |
| University of New Mexico Cancer Center Albuquerque, New Mexico | Site Public Contact - (HSC-ClinicalTrialInfo@salud.unm.edu) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Pennsylvania/Abramson Cancer Center Philadelphia, Pennsylvania | Site Public Contact - (PMCancerResearch@pennmedicine.upenn.edu) |
| University of Pittsburgh Cancer Institute (UPCI) Pittsburgh, Pennsylvania | |
| University of Rochester Rochester, New York | |
| University of Tennessee - Knoxville Knoxville, Tennessee | |
| University of Vermont Medical Center Burlington, Vermont | Site Public Contact - (rpo@uvm.edu) |
| University of Vermont and State Agricultural College Burlington, Vermont | Site Public Contact - (rpo@uvm.edu) |
| University of Virginia Cancer Center Charlottesville, Virginia | Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu) |
| University of Washington Medical Center - Montlake Seattle, Washington | |
| University of Wisconsin Carbone Cancer Center - Eastpark Medical Center Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| University of Wisconsin Carbone Cancer Center - University Hospital Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| UofL Health Medical Center Northeast Louisville, Kentucky | Site Public Contact - (ctoinfo@louisville.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Valley Health System Ridgewood Campus Ridgewood, New Jersey | Site Public Contact - (clinicaltrialsresearch@valleyhealth.com) |
| Veterans Affairs Connecticut Healthcare System-West Haven Campus West Haven, Connecticut | |
| Wake Forest University Health Sciences Winston-Salem, North Carolina | |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| William S Middleton VA Medical Center Madison, Wisconsin | |
| Yale University New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas
ctrrecruit@vcu.edu
NCT06422806
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Inclusion Criteria:
* Patient must be \>= 18 years of age
* Patient must have a confirmed histopathologic diagnosis of dedifferentiated liposarcoma (DDLPS), undifferentiated pleomorphic sarcoma (UPS) or a related poorly differentiated sarcoma. Because UPS can sometimes exist in a spectrum among related diagnoses, the following additional diagnostic will be allowed, but not limited to:
* Pleomorphic sarcoma with inflammation or with limited areas of differentiation
* Pleomorphic sarcoma with giant cells
* Malignant fibrous histiocytoma (including storiform-pleomorphic and inflammatory subtypes)
* Myxofibrosarcoma
* Poorly differentiated sarcoma not otherwise specified (NOS)
* Undifferentiated spindle cell sarcoma
* Poorly differentiated spindle cell sarcoma NOS Any of these subtypes may have areas of focal myogenic differentiation
* Patient must have metastatic or unresectable sarcoma
* Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy. A patient of childbearing potential is defined as anyone, regardless of whether they have undergone tubal ligation, who meets the following criteria:
* Has achieved menarche at some point
* Has not undergone a hysterectomy or bilateral oophorectomy; or
* Has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
* Patient must not expect to conceive or father children by using an accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study. Contraception measures must continue for 6 months after the last dose of doxorubicin for patients of child bearing potential and for 3 months after the last dose of doxorubicin for male patients with partners of child bearing potential. Males with pregnant partners should use condoms during doxorubicin treatment and for at least 10 days after the last dose of doxorubicin. Contraception measures must also continue for 4 months after the last dose of pembrolizumab for patients of child bearing potential
* Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible
* Patient must have a left ventricular ejection fraction (LVEF) \> 50% by either MUGA scan or echocardiogram obtained within 28 days prior to randomization
* Absolute neutrophil count (ANC) ≥ 1,500 cells/uL (must be obtained ≤ 7 days prior to protocol randomization)
* Platelets ≥ 75,000 cells/uL (must be obtained ≤ 7 days prior to protocol randomization)
* Total bilirubin \< 1.2 mg/dL (must be obtained ≤ 7 days prior to protocol randomization)
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3.0 × institutional upper limit of normal (ULN) (must be obtained ≤ 7 days prior to protocol randomization)
* Creatinine clearance ≥ 30 mL/min according to the Cockcroft-Gault formula (must be obtained ≤ 7 days prior to protocol randomization)
* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial
* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression
* Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy
* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
* Patient must not have a history of or active interstitial lung disease
* Patient must have measurable disease. Baseline imaging must include a chest computed tomography (CT). Imaging should be inclusive of all measurable and non-measurable disease and must be obtained within 28 days prior to randomization. Imaging must be available for uploading to Transfer of Images and Data (TRIAD)
* NOTE: CT with (w/) contrast preferred, chest CT without contrast is acceptable, CT portion of positron emission tomography (PET) may be acceptable. Magnetic resonance imaging (MRI) is acceptable for measuring other sites of disease
* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Patient must not have had prior treatment with an anthracycline
* Patient must not have a diagnosis of clinically significant immunodeficiency or an autoimmune disorder requiring the patient to use systemic steroid chronically, or systemic steroids within 7 days prior to randomization
* Patient must not have a known history of active TB (Bacillus Tuberculosis)
* Patient must not have a known hypersensitivity to doxorubicin or pembrolizumab or any of their excipients
* Patients who have received prior chemotherapy, targeted small molecule therapy or radiation therapy must have recovered from the prior therapy at the time of randomization
* Patient must have recovered adequately from any prior major surgery prior to randomization
* Patient must not have had prior pericardial or mediastinal radiation
* Patient must not have received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 or anti-CTLA4 agent
* Patient must not have an autoimmune or other disease that requires the use of daily corticosteroids of \> 10 mg of prednisone (or equivalent). Patients who are on an active steroid taper at the time of randomization must finish prior to beginning study treatment. Patients who require inhaled or topical steroids are eligible PROCEDURE: Biospecimen Collection, PROCEDURE: Diagnostic Imaging Testing, DRUG: Doxorubicin, PROCEDURE: Echocardiography Test, PROCEDURE: Multigated Acquisition Scan, BIOLOGICAL: Pembrolizumab
Metastatic Dedifferentiated Liposarcoma, Metastatic Undifferentiated Pleomorphic Sarcoma, Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8, Stage IV Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8, Unresectable Dedifferentiated Liposarcoma, Unresectable Undifferentiated Pleomorphic Sarcoma
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Show 232 locations
Study Locations
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| Location | Contacts |
|---|---|
| AMG Crystal Lake - Oncology Crystal Lake, Illinois | Site Public Contact - (advocateresearch@advocate.com) |
| AMG Libertyville - Oncology Libertyville, Illinois | Site Public Contact - (advocateresearch@advocatehealth.com) |
| Advocate Christ Medical Center Oak Lawn, Illinois | |
| Advocate Good Samaritan Hospital Downers Grove, Illinois | Site Public Contact - (Barbara.barhamand@advocatehealth.com) |
| Advocate Good Shepherd Hospital Barrington, Illinois | |
| Advocate Illinois Masonic Medical Center Chicago, Illinois | |
| Advocate Lutheran General Hospital Park Ridge, Illinois | |
| Advocate Outpatient Center - Aurora Aurora, Illinois | Site Public Contact - (ncorp@aah.org) |
| Advocate Sherman Hospital Elgin, Illinois | |
| Advocate South Suburban Hospital Hazel Crest, Illinois | |
| Allegheny General Hospital Pittsburgh, Pennsylvania | |
| Allegiance Health Jackson, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Arthur J E Child Comprehensive Cancer Centre Calgary, Alberta | Site Public Contact - (ctsucontact@westat.com) |
| Atrium Medical Center-Middletown Regional Hospital Franklin, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Aurora Bay Area Medical Group-Marinette Marinette, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora BayCare Medical Center Green Bay, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Grafton Grafton, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Kenosha South Kenosha, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Milwaukee Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Milwaukee West Wauwatosa, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Racine Racine, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Southern Lakes VLCC Burlington, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Health Care Germantown Health Center Germantown, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Medical Center in Summit Summit, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Saint Luke's Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Saint Luke's South Shore Cudahy, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Sinai Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora West Allis Medical Center West Allis, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Banner University Medical Center - Tucson Tucson, Arizona | Site Public Contact - (UACC-IIT@uacc.arizona.edu) |
| Beebe Health Campus Rehoboth Beach, Delaware | Site Public Contact - (research@beebehealthcare.org) |
| Beebe South Coastal Health Campus Millville, Delaware | Site Public Contact - (research@beebehealthcare.org) |
| Benefis Sletten Cancer Institute Great Falls, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Billings Clinic Cancer Center Billings, Montana | Site Public Contact - (research@billingsclinic.org) |
| Bozeman Health Deaconess Hospital Bozeman, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Broadlawns Medical Center Des Moines, Iowa | |
| Cancer Care Center of O'Fallon O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Care Specialists of Illinois - Decatur Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Care and Hematology-Fort Collins Fort Collins, Colorado | Site Public Contact - (ecog.rss@jimmy.harvard.edu) |
| CancerCare Manitoba Winnipeg, Manitoba | Site Public Contact - (ctu_web@cancercare.mb.ca) |
| Carle Cancer Center Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Effingham Effingham, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Mattoon/Charleston Mattoon, Illinois | Site Public Contact - (Research@carle.com) |
| Carle at The Riverfront Danville, Illinois | Site Public Contact - (Research@Carle.com) |
| Case Western Reserve University Cleveland, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| Cedars Sinai Medical Center Los Angeles, California | |
| Centralia Oncology Clinic Centralia, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cleveland Clinic Foundation Cleveland, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Community Hospital of Anaconda Anaconda, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Toms River, New Jersey | Site Public Contact - (mccinfo@mtcancer.org) |
| Condell Memorial Hospital Libertyville, Illinois | Site Public Contact - (advocateresearch@advocatehealth.com) |
| Cross Cancer Institute Edmonton, Alberta | |
| Crossroads Cancer Center Effingham, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Dana-Farber Cancer Institute Boston, Massachusetts | |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire | Site Public Contact - (cancer.research.nurse@dartmouth.edu) |
| Decatur Memorial Hospital Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Duke University Medical Center Durham, North Carolina | |
| Duluth Clinic Ashland Ashland, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Edward Hospital/Cancer Center Naperville, Illinois | |
| Edward Hospital/Cancer Center?Plainfield Plainfield, Illinois | Site Public Contact - (Cancerresearch@edward.org) |
| Elmhurst Memorial Hospital Elmhurst, Illinois | Site Public Contact - (Jrohde@emhc.org) |
| Emory University Hospital Midtown Atlanta, Georgia | |
| Essentia Health - Deer River Clinic Deer River, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Cancer Center Duluth, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Hibbing Clinic Hibbing, Minnesota | |
| Essentia Health Sandstone Sandstone, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Virginia Clinic Virginia, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Fox Chase Cancer Center Philadelphia, Pennsylvania | |
| Helen F Graham Cancer Center Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Henry Ford Hospital Detroit, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford Macomb Hospital-Clinton Township Clinton Township, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford Medical Center-Columbus Novi, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford West Bloomfield Hospital West Bloomfield, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Illinois CancerCare - Washington Washington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Bloomington Bloomington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Canton Canton, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Carthage Carthage, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Dixon Dixon, Illinois | |
| Illinois CancerCare-Eureka Eureka, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Galesburg Galesburg, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Kewanee Clinic Kewanee, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Macomb Macomb, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Ottawa Clinic Ottawa, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Pekin Pekin, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Peoria Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Peru Peru, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Princeton Princeton, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Indiana University/Melvin and Bren Simon Cancer Center Indianapolis, Indiana | |
| Ingalls Memorial Hospital Harvey, Illinois | Site Public Contact - (clinicaltrials@ingalls.org) |
| Juravinski Cancer Centre at Hamilton Health Sciences Hamilton, Ontario | |
| Kaiser Permanente Downtown Commons Sacramento, California | Site Public Contact - (kpoct@kp.org) |
| Kaiser Permanente Dublin Dublin, California | |
| Kaiser Permanente Fresno Orchard Plaza Fresno, California | |
| Kaiser Permanente Medical Center - Santa Clara Santa Clara, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente Moanalua Medical Center Honolulu, Hawaii | Site Public Contact - (shelley.a.clark@kp.org) |
| Kaiser Permanente San Leandro San Leandro, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Fremont Fremont, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Fresno Fresno, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Modesto Modesto, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Oakland Oakland, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Roseville Roseville, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-San Francisco San Francisco, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Santa Rosa Santa Rosa, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Santa Teresa-San Jose San Jose, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-South Sacramento Sacramento, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-South San Francisco South San Francisco, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Vallejo Vallejo, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Walnut Creek Walnut Creek, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser San Rafael-Gallinas San Rafael, California | Site Public Contact - (Kpoct@kp.org) |
| Keck Medicine of USC Koreatown Los Angeles, California | |
| Kootenai Clinic Cancer Services - Post Falls Post Falls, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Clinic Cancer Services - Sandpoint Sandpoint, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Health - Coeur d'Alene Coeur d'Alene, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Logan Health Medical Center Kalispell, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Los Angeles General Medical Center Los Angeles, California | Site Public Contact - (uscnorrisinfo@med.usc.edu) |
| Louisiana Hematology Oncology Associates LLC Baton Rouge, Louisiana | Site Public Contact - (clinicalresearch@marybird.com) |
| Marshfield Medical Center - Weston Weston, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center-EC Cancer Center Eau Claire, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center-River Region at Stevens Point Stevens Point, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Mayo Clinic Hospital in Arizona Phoenix, Arizona | |
| Mayo Clinic in Florida Jacksonville, Florida | |
| Mayo Clinic in Rochester Rochester, Minnesota | |
| Medical Center of the Rockies Loveland, Colorado | |
| Medical College of Wisconsin Milwaukee, Wisconsin | |
| Medical Oncology Hematology Consultants PA Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Medical University of South Carolina Charleston, South Carolina | Site Public Contact - (hcc-clinical-trials@musc.edu) |
| Memorial Sloan Kettering Basking Ridge Basking Ridge, New Jersey | |
| Memorial Sloan Kettering Bergen Montvale, New Jersey | |
| Memorial Sloan Kettering Cancer Center New York, New York | |
| Memorial Sloan Kettering Nassau Uniondale, New York | |
| Miami Valley Cancer Care and Infusion Greenville, Ohio | |
| Miami Valley Hospital Dayton, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Miami Valley Hospital North Dayton, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Miami Valley Hospital South Centerville, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Montefiore Medical Center - Moses Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Montefiore Medical Center-Einstein Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Nebraska Medicine-Bellevue Bellevue, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| Nebraska Medicine-Village Pointe Omaha, Nebraska | |
| Northwell Health/Center for Advanced Medicine Lake Success, New York | |
| Northwestern Medicine Cancer Center Delnor Geneva, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Cancer Center Kishwaukee DeKalb, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Cancer Center Warrenville Warrenville, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Glenview Outpatient Center Glenview, Illinois | |
| Northwestern Medicine Grayslake Outpatient Center Grayslake, Illinois | |
| Northwestern Medicine Lake Forest Hospital Lake Forest, Illinois | Site Public Contact - (cancertrials@northwestern.edu) |
| Northwestern Medicine Orland Park Orland Park, Illinois | Site Public Contact - (nctnprogram_rhlccc@northwestern.edu) |
| Northwestern University Chicago, Illinois | Site Public Contact - (cancer@northwestern.edu) |
| Ohio State University Comprehensive Cancer Center Columbus, Ohio | Site Public Contact - (Jamesline@osumc.edu) |
| Oregon Health and Science University Portland, Oregon | Site Public Contact - (trials@ohsu.edu) |
| Ottawa Hospital and Cancer Center-General Campus Ottawa, Ontario | |
| Pan American Center for Oncology Trials LLC San Juan, | |
| Pennsylvania Hospital Philadelphia, Pennsylvania | Site Public Contact - (PennCancerTrials@careboxhealth.com) |
| Poudre Valley Hospital Fort Collins, Colorado | |
| Premier Blood and Cancer Center Dayton, Ohio | |
| ProHealth D N Greenwald Center Mukwonago, Wisconsin | Site Public Contact - (research.institute@phci.org) |
| ProHealth Oconomowoc Memorial Hospital Oconomowoc, Wisconsin | |
| ProHealth Waukesha Memorial Hospital Waukesha, Wisconsin | |
| Roswell Park Cancer Institute Buffalo, New York | Site Public Contact - (askroswell@roswellpark.org) |
| Saint Alphonsus Cancer Care Center-Boise Boise, Idaho | |
| Saint Alphonsus Cancer Care Center-Caldwell Caldwell, Idaho | |
| Saint Alphonsus Cancer Care Center-Nampa Nampa, Idaho | |
| Saint Alphonsus Cancer Care Center-Ontario Ontario, Oregon | |
| Saint Anthony Regional Hospital Carroll, Iowa | Site Public Contact - (sbenson@iora.org) |
| Sanford Bismarck Medical Center Bismarck, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Broadway Medical Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Cancer Center Oncology Clinic Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicTrialsSF@sanfordhealth.org) |
| Sanford Joe Lueken Cancer Center Bemidji, Minnesota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Roger Maris Cancer Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org) |
| Sidney and Lois Eskenazi Hospital Indianapolis, Indiana | |
| Siteman Cancer Center-South County St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Smilow Cancer Hospital Care Center - Guilford Guilford, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center - Waterford Waterford, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center at Greenwich Greenwich, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center at Long Ridge Stamford, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center-Fairfield Fairfield, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center-Trumbull Trumbull, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital-Derby Care Center Derby, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital-Torrington Care Center Torrington, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital-Waterbury Care Center Waterbury, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| Springfield Clinic Springfield, Illinois | |
| Springfield Memorial Hospital Springfield, Illinois | Site Public Contact - (pallante.beth@mhsil.com) |
| Stanford Cancer Institute Palo Alto Palo Alto, California | Site Public Contact - (ccto-office@stanford.edu) |
| The James Graham Brown Cancer Center at University of Louisville Louisville, Kentucky | |
| Thomas Jefferson University Hospital Philadelphia, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| UC Comprehensive Cancer Center at Silver Cross New Lenox, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| UCHealth Greeley Hospital Greeley, Colorado | Site Public Contact - (ecog.rss@jimmy.harvard.edu) |
| UCHealth University of Colorado Hospital Aurora, Colorado | |
| UCSF Medical Center-Mission Bay San Francisco, California | Site Public Contact - (cancertrials@ucsf.edu) |
| UChicago Medicine Northwest Indiana Crown Point, Indiana | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| UF Health Cancer Institute - Gainesville Gainesville, Florida | Site Public Contact - (cancer-center@ufl.edu) |
| UH Seidman Cancer Center at UH Avon Health Center Avon, Ohio | |
| UHHS-Chagrin Highlands Medical Center Beachwood, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| UI Health Care Mission Cancer and Blood - Ankeny Clinic Ankeny, Iowa | |
| UI Health Care Mission Cancer and Blood - Des Moines Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - Laurel Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - Waukee Clinic Waukee, Iowa | |
| UI Health Care Mission Cancer and Blood - West Des Moines Clinic Clive, Iowa | |
| UI Healthcare Mission Cancer and Blood - Fort Dodge Fort Dodge, Iowa | Site Public Contact - (trials@missioncancer.com) |
| UM Sylvester Comprehensive Cancer Center at Coral Gables Coral Gables, Florida | |
| UM Sylvester Comprehensive Cancer Center at Coral Springs Coral Springs, Florida | |
| UM Sylvester Comprehensive Cancer Center at Deerfield Beach Deerfield Beach, Florida | |
| UM Sylvester Comprehensive Cancer Center at Hollywood Hollywood, Florida | |
| UM Sylvester Comprehensive Cancer Center at Kendall Miami, Florida | |
| UM Sylvester Comprehensive Cancer Center at Plantation Plantation, Florida | |
| USC / Norris Comprehensive Cancer Center Los Angeles, California | |
| USC Norris Oncology/Hematology-Newport Beach Newport Beach, California | |
| UW Cancer Center at ProHealth Care Waukesha, Wisconsin | Site Public Contact - (Chanda.miller@phci.org) |
| University Health Network-Princess Margaret Hospital Toronto, Ontario | Site Public Contact - (clinical.trials@uhn.on.ca) |
| University of Arizona Cancer Center-North Campus Tucson, Arizona | Site Public Contact - (UACC-IIT@uacc.arizona.edu) |
| University of Chicago Comprehensive Cancer Center Chicago, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| University of Chicago Medicine-Orland Park Orland Park, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| University of Illinois Chicago, Illinois | |
| University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa | |
| University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida | |
| University of Miami Sylvester Comprehensive Cancer Center at Sole Mia North Miami, Florida | Site Public Contact - (kginnity@med.miami.edu) |
| University of Michigan Rogel Cancer Center Ann Arbor, Michigan | Site Public Contact - (CancerAnswerLine@med.umich.edu) |
| University of Nebraska Medical Center Omaha, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| University of New Mexico Cancer Center Albuquerque, New Mexico | Site Public Contact - (HSC-ClinicalTrialInfo@salud.unm.edu) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | |
| University of Pittsburgh Cancer Institute (UPCI) Pittsburgh, Pennsylvania | |
| University of Virginia Cancer Center Charlottesville, Virginia | Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu) |
| UofL Health Medical Center Northeast Louisville, Kentucky | Site Public Contact - (ctoinfo@louisville.edu) |
| Upper Valley Medical Center Troy, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| VA Palo Alto Health Care System Palo Alto, California | |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Vanderbilt University/Ingram Cancer Center Nashville, Tennessee | |
| Vince Lombardi Cancer Clinic - Oshkosh Oshkosh, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Vince Lombardi Cancer Clinic-Sheboygan Sheboygan, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Vince Lombardi Cancer Clinic-Two Rivers Two Rivers, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Yale University New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)
Reference Study ID Number: CO44657 https://forpatients.roche.com/ - global-roche-genentech-trials@gene.com
NCT06065748
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Inclusion Criteria:
* Locally advanced or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent
* Documented estrogen receptor-positive (ER+), HER2-negative (HER2-) tumor assessed locally on the most recent tumor biopsy (or an archived tumor sample if a recent tumor sample is not available for testing)
* Confirmed ESR1 mutation status (ESR1m versus ESR1nmd) in baseline circulating tumor DNA (ctDNA) through central laboratory testing
* Resistance to prior adjuvant endocrine therapy (ET), which is defined as having relapsed with prior standard adjuvant ET, on-treatment after \>/=12 months or off-treatment within 12 months of completion. Prior use of adjuvant CDK4/6i is allowed (if relapse occurred \>/=12 months since completion).
* No prior systemic anti-cancer therapy for advanced disease
* Measurable disease as defined per RECIST v.1.1 or non-measurable (including bone-only) disease
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1
* For pre/perimenopausal women and for men: willing to undergo and maintain treatment with approved LHRH agonist therapy (as per local guidelines) for the duration of study treatment
Exclusion Criteria:
* Prior systemic therapy (e.g., prior chemotherapy, immunotherapy, or biologic therapy) for locally advanced unresectable or metastatic breast cancer
* Prior treatment with another SERD (e.g., fulvestrant, oral SERDs) or novel ER-targeting agents
* Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term
* Active cardiac disease or history of cardiac dysfunction
* Clinically significant history of liver disease DRUG: Giredestrant, DRUG: Fulvestrant, DRUG: Abemaciclib, DRUG: Palbociclib, DRUG: Ribociclib, DRUG: LHRH Agonist, DIAGNOSTIC_TEST: FoundationOne Liquid CDx Assay (F1LCDx)
Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer
oral Selective Estrogen Receptor Degrader (SERD), CDK4/6 inhibitor (CDK4/6i), ESR1 mutation
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Show 351 locations
Study Locations
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| Location | Contacts |
|---|---|
| ?wi?tokrzyskie Centrum Onkologii Kielce, | |
| A.O. Universitaria Di Parma Parma, Emilia-Romagna | |
| A.O. Universitaria S. Maria Della Misericordia Di Udine Udine, Friuli Venezia Giulia | |
| A.O.U. Maggiore della Carità Novara, Piedmont | |
| ASST degli Spedali Civili di Brescia Brescia, Lombardy | |
| AZ St Maarten Campus Leopoldstr Mechelen, | |
| Abramson Cancer Center; Univ of Pennsylvania; Clinical Research Unit Philadelphia, Pennsylvania | |
| AdventHealth Altamonte Altamonte Springs, Florida | |
| Advocate Lutheran General Hospital Park Ridge, Illinois | |
| Allan Blair Cancer Centre Regina, Saskatchewan | |
| Alliance Cancer Specialists Bensalem, Pennsylvania | |
| Amethyst Cluj Cluj County, | |
| Ankara City Hospital Ankara, | |
| Ann B. Barshinger Cancer Institute Lancaster, Pennsylvania | |
| Anticancer Hospital Ag. Savas Athens, | |
| Aretaieio Hospital of Athens Athens, | |
| Asan Medical Center Seoul, | |
| Asante Rogue Regional Medical Center Medford, Oregon | |
| Asst Di Cremona Cremona, Lombardy | |
| Asst Papa Giovanni XXIII Bergamo, Lombardy | |
| Astera Cancer Care East Brunswick East Brunswick, New Jersey | |
| Aurora BayCare Medical Center Green Bay, Wisconsin | |
| Aurora St Lukes Medical Center Milwaukee, Wisconsin | |
| Avera Cancer Institute Sioux Falls, South Dakota | |
| Avera Cancer Institute - Aberdeen Aberdeen, South Dakota | |
| Azienda Ospedaliera Universitaria Careggi Florence, Tuscany | |
| Azienda Ospedaliera Universitaria Federico II Napoli, Campania | |
| Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialita San Giuseppe Moscati Avellino, Campania | |
| B-A-Z Vármegyei Központi Kórház és Egyetemi Oktatókórház Miskolc, | |
| Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji Bakirkoy / Istanbul, | |
| Baptist Health Hamburg Lexington, Kentucky | |
| Baptist Health Lexington Lexington, Kentucky | |
| Baptist Health Louisville Louisville, Kentucky | |
| Barwon Health Geelong, Victoria | |
| Beijing Cancer Hospital Beijing, | |
| Brown University Health Providence, Rhode Island | |
| Brustzentrum Rhein-Ruhr Servicegesellschaft mbH Mönchengladbach, | |
| Bács-Kiskun Vármegyei Oktatókórház Kecskemét, | |
| CEDOES - Diagnóstico e Pesquisa Vitória, Espírito Santo | |
| CENEIT Oncologicos Mexico City, | |
| CHU de Liège (Sart Tilman) Liège, | |
| CHU de Quebec - Hopital du Saint-Sacrement Québec, Quebec | |
| CHVNG/E_Unidade 1 Vila Nova de Gaia, | |
| CISSS Chaudière-Appalaches Lévis, Quebec | |
| CIUSSS du Saguenay Lac-Saint-Jean, Chicoutimi Hospital Chicoutimi, Quebec | |
| Cancer Care Center of O'Fallon O'Fallon, Illinois | |
| Cancer Center, Sun Yat-sen University of Medical Sciences Guangzhou, | |
| Cancer Research SA Adelaide, South Australia | |
| Cancer Specialists of North Florida Jacksonville, Florida | |
| Cancercare Port Elizabeth, | |
| Cancercare Rondebosch Oncology Cape Town, | |
| Capital Health Regional Medical Center Pennington, New Jersey | |
| Celan S.A. Guatemala City, | |
| Centre Cancerologie Grand Montpellier Montpellier, | |
| Centre Eugene Marquis Rennes, | |
| Centre Francois Baclesse Caen, | |
| Centre Hospitalier Regional de Trois-Rivieres Trois-Rivières, Quebec | |
| Centre Hospitalier Saint Louis La Rochelle, | |
| Centre Hospitalier de L'Universite de Montreal (CHUM) Montreal, Quebec | |
| Centre Jean Perrin Clermont-Ferrand, | |
| Centre Leon Berard Lyon, | |
| Centre Oscar Lambret Lille, | |
| Centro De Cancer Universidad Catolica Santiago, | |
| Centro Medico Integral de Cancerologia CEMIC Salcajá, | |
| Centro Medico monte Carmelo Arequipa, | |
| Centro Oncologico MD Anderson Internacional Madrid, | |
| Centro Oncologico Riojano Integral (CORI) La Rioja, | |
| Centro Oncológico Korben Ciudad Autonoma Buenos Aires, | |
| Centro Oncológico de Excelencia San Juan, | |
| Centro de Atencion Oncologica Viva S de RL de CV Mexico City, Mexico CITY (federal District) | |
| Centro de Investigacion Clinica de Oaxaca Oaxaca City, Oaxaca | |
| Centro de Investigaciones Médicas y Desarrollo LC S.R.L Buenos Aires, | |
| Centro de Oncología de Precisión Las Condes, | |
| Centrul de Oncologie Oncohelp Timișoara, | |
| Centrul de Oncologie Sfantul Nectarie Craiova, | |
| Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli Lublin, | |
| Centrum Onkologii im. Prof. Franciszka ?ukaszczyka Bydgoszcz, | |
| China Medical University Hospital Taichung, | |
| Christchurch Hospital Christchurch, | |
| Chulabhorn Hospital Lak Si, | |
| Chulalongkorn Hospital Bangkok, | |
| Clinica Alivia sucursal Coyoacan Mexico City, | |
| Clinica CIMCA San José, | |
| Clinica Colsanitas S.A. sede Clinica Universitaria Colombia Bogotá D.C., | |
| Clinica Internacional, Sede San Borja Lima, | |
| Clinica Peruana Americana Trujillo, | |
| Clinica San Antonio;Investigaciones Trujillo S.A.C. Trujillo, | |
| Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda São Paulo, São Paulo | |
| Clinique Ste-Elisabeth Namur, | |
| Cliniques Universitaires St-Luc Brussels, | |
| Clínica Puerto Montt Port Montt, | |
| Clínica Santa Beatriz Lima, | |
| Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico Jaén, | |
| Comprehensive Hematology Oncology St. Petersburg, Florida | |
| Credit Valley Hospital/Carlo Fidani Peel Regional Cancer Centre Mississauga, Ontario | |
| Crio - Centro Regional Integrado de Oncologia Fortaleza, Ceará | |
| Cross Cancer Institute Edmonton, Alberta | |
| DONAU ISAR Klinikum Deggendorf Deggendorf, | |
| Dana Farber Cancer Institute Boston, Massachusetts | |
| Duke Women Cancer Care Raleigh, North Carolina | |
| European Interbalkan Medical Center Thessaloniki, | |
| Ewha Womans University Mokdong Hospital Seoul, | |
| Florida Cancer Specialists - Broadway Fort Myers, Florida | |
| Florida Cancer Specialists - EAST - SCRI - PPDS West Palm Beach, Florida | |
| Florida Cancer Specialists - Tampa Tampa, Florida | |
| Frederick Health Hospital Frederick, Maryland | |
| Fudan University Shanghai Cancer Center Shanghai, | |
| Fujian Medical University Union Hospital Fuzhou, | |
| Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo Bogota, D.C., | |
| GHdC Site Les Viviers Charleroi, | |
| Gangnam Severance Hospital Seoul, | |
| Georgetown University Medical Center Washington D.C., District of Columbia | |
| Goztepe Prof.Dr. Suleyman Yalcin City Hospital Kadiköy, | |
| Grady Health System Atlanta, Georgia | |
| Grant Medical Foundation, Ruby Hall Clinic Pune, Maharashtra | |
| Grupo Angeles Guatemala City, | |
| Guangxi Cancer Hospital of Guangxi Medical University Nanning, | |
| Gustave Roussy Villejuif, | |
| Gynonco Düsseldorf, MVZ Medical Center GmbH Düsseldorf, | |
| HCA Midwest Division Kansas City, Missouri | |
| Hacettepe Uni Medical Faculty Hospital Sihhiye/Ankara, | |
| Hadassah Ein Karem Hospital Jerusalem, | |
| Harbin Medical University Cancer Hospital Harbin, | |
| HealthCare Global Enterprises Limited Banglore, Karnataka | |
| Henry Ford Hospital Detroit, Michigan | |
| Hopital Jean Minjoz Besançon, | |
| Hopital regional de saint jerome Saint-Jérôme, Quebec | |
| Hospital A. C. Camargo São Paulo, São Paulo | |
| Hospital Aleman Recoleta, | |
| Hospital Amaral Carvalho Jaú, São Paulo | |
| Hospital Araujo Jorge Goiânia, Goiás | |
| Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia Valencia, | |
| Hospital Goyeneche Arequipa, | |
| Hospital Juan Ramon Jimenez Huelva, | |
| Hospital Moinhos de Vento Porto Alegre, Rio Grande do Sul | |
| Hospital Nacional Arzobispo Loayza Lima, | |
| Hospital Nossa Senhora da Conceicao Porto Alegre, Rio Grande do Sul | |
| Hospital Provincial del Centenario Rosario, | |
| Hospital Quiron de Madrid Pozuelo de Alarcón, Madrid | |
| Hospital Sao Domingos São Luís, Maranhão | |
| Hospital Sao Lucas - PUCRS Porto Alegre, Rio Grande do Sul | |
| Hospital Sírio-Libanês São Paulo, São Paulo | |
| Hospital Sírio-Libanês São Paulo, São Paulo | |
| Hospital Universitari Dexeus - Grupo Quironsalud Barcelona, | |
| Hospital Universitari Vall d'Hebron Barcelona, | |
| Hospital Universitario Virgen Macarena Seville, | |
| Hospital Universitario Virgen de la Arrixaca EL Palmar (EL Palmar), Murcia | |
| Hospital Universitario Virgen del Rocio Seville, | |
| Hospital Zambrano Hellion TecSalud Monterrey, Nuevo León | |
| Hospital da Luz Lisbon, | |
| Hospital de Cancer de Barretos Barretos, São Paulo | |
| Hospital de Jerez de la Frontera Jerez de la Frontera, Cadiz | |
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| Hubei Cancer Hospital Wuhan, | |
| Humanitas Centro Catanese Di Oncologia Misterbianco (CT), Sicily | |
| Hunan Cancer Hospital Changsha, | |
| I.R.S.T Srl IRCCS Meldola, Emilia-Romagna | |
| ICIMED Instituto de Investigación en Ciencias Médicas San José, | |
| ICO Paul Papin Angers, | |
| INTEGRA Cancer Institute Guatemala City, | |
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| IPO de Coimbra Coimbra, | |
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| Inst. de Oncologia Angel H. Roffo Buenos Aires, | |
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| Katip Celebi University Ataturk Training and Research Hospital Izmir, | |
| Kliniken Essen-Mitte Essen, | |
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| Korea University Anam Hospital Seoul, | |
| Kuopio Uni Hospital Kuopio, | |
| Kyungpook National University Chilgok Hospital Daegu, | |
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| La Hematology Oncology Medical Group Glendale, California | |
| Lakeridge Health Oshawa Oshawa, Ontario | |
| MVR Cancer Centre and Research Institute Kozhikode, Kerala | |
| Maharaj Nakorn Chiang Mai Hospital;Depart of Radiology Muang Chiang MAI Delivery Branch 3, | |
| Marin Cancer Care Inc Greenbrae, California | |
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| Mater Misericordiae Limited South Brisbane, Queensland | |
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| Orszagos Onkologiai Intezet Budapest, | |
| Ospedale Di Macerata Macerata, The Marches | |
| Palmerston North Hospital Palmerston North, | |
| Pamela Youde Nethersole Eastern Hospital Hong Kong, | |
| PanAmerican Clinical Research, Querétaro Queréaro, Querétaro | |
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| Zhejiang Cancer Hospital Zhejiang, | |
| Zhongshan Hospital Fudan University Shanghai, | |
| the First Hospital of Jilin University Changchun, |
Study to Compare the Effectiveness and Safety of Golcadomide Plus R-CHOP vs Placebo Plus R-CHOP in Participants With Previously Untreated High-risk Large B-cell Lymphoma (GOLSEEK-1)
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com - Clinical.Trials@bms.com
NCT06356129
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Inclusion Criteria
\- Histologically confirmed (per local evaluation) diagnosis of de novo, previously untreated large B-cell lymphoma (LBCL) according to 2022 world health organization (WHO) classification including:
i) Diffuse large B-cell lymphoma (DLBCL), not otherwise specified \[including germinal center B-cell (GCB) and activated B-cell (ABC) types\]
ii) High-grade B-cell lymphoma, with MYC and BCL2 rearrangements (HGBL-MYC/BCL2 double-hit lymphomas)
iii) High-grade B-cell lymphoma, not otherwise specified
iv) T-cell/histiocyte/rich large B-cell lymphoma (THRLBCL)
v) Epstein-Barr virus + DLBCL
* International Prognostic Index (IPI) score 1 or 2 with lactate dehydrogenase (LDH) \> 1.3 x upper limit of normal (ULN) and/or bulky disease defined as single lesion of ≥ 7 cm OR IPI ≥ 3.
* Measurable disease defined by at least 1 fluorodeoxyglucose (FDG)-avid lesion for FDG-avid subtype and 1 bi-dimensionally measurable (\> 1.5 cm in longest diameter) disease by computed tomography (CT) or magnetic resonance imaging (MRI), as defined by the Lugano classification.
* Must have Ann Arbor Stage II-IV disease.
Exclusion Criteria
* Any significant medical condition, active infection, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study.
* Any other subtype of lymphoma. Cases of primary mediastinal (thymic) large B-cell lymphoma (PMBCL), primary cutaneous DLBCL-leg type, Grade 3b FL, indolent lymphoma transformed to large B-cell lymphoma (LBCL), Anaplastic lymphoma kinase (ALK) positive large B-cell lymphoma, primary effusion lymphoma, and Burkitt lymphoma.
* Documented or suspected central nervous system (CNS) involvement by lymphoma.
* Other protocol-defined Inclusion/Exclusion criteria apply.
DRUG: Golcadomide, DRUG: Placebo, DRUG: Rituximab, DRUG: Cyclophosphamide, DRUG: Doxorubicin, DRUG: Vincristine, DRUG: Prednisone
Large B-cell Lymphoma
Lymphoma, Large B-Cell, Lymphoma, BMS-986369, CC-99282, DLBCL
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Study Locations
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| Location | Contacts |
|---|---|
| A. C. Camargo Cancer Center São Paulo, São Paulo | |
| Affidea Fundeni Bucharest, | |
| Aidport Skórzewo, Greater Poland Voivodeship | |
| Alaska Oncology and Hematology Anchorage, Alaska | |
| All India Institute of Medical Sciences New Delhi, National Capital Territory of Delhi | |
| Allina Health Cancer Institute - Abbott Northwestern Hospital Minneapolis, Minnesota | |
| Ankara University Health Practice and Research Hospitals Ankara, | |
| Aster Medcity Kochi, Kerala | |
| Astera Cancer Care East Brunswick, New Jersey | |
| Atlantic Health System Morristown Medical Center Morristown, New Jersey | |
| Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO Palermo, Sicily | |
| Brooke Army Medical Center Fort Sam Houston, Texas | |
| CHN - Complexo Hospitalar de Niterói Niterói, Rio de Janeiro | |
| Cancer Care Specialists Reno, Nevada | |
| Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa Porto Alegre, Rio Grande do Sul | |
| Centro de Investigacion Clinica Chapultepec Morelia, Michoacán | |
| Centro de Investigacion Clinica de Oaxaca Oaxaca City, Oaxaca | |
| Centrum Onkologii Ziemi Lubelskiej Lublin, Lublin Voivodeship | |
| Chang Gung Medical Foundation-LinKou Branch Taoyuan District, | |
| Chang Gung Memorial Hospital at Kaohsiung Kaohsiung City, | |
| Chang Gung Memorial Hospital- Chiayi Chiayi City, Chiayi | |
| Chi Mei Medical Center Tainan, Tainan | |
| China Medical University Hospital Taichung, | |
| Chongqing University Cancer Hospital Chongqing, Chongqing Municipality | |
| Cleveland Clinic Florida Stuart, Florida | |
| Clínica Supera Chapecó, Santa Catarina | |
| Debreceni Egyetem Klinikai Kozpont Debrecen, Hajdú-Bihar | |
| Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi Ankara, | |
| Ege Universitesi Hastanesi Izmir, | |
| Emory University School of Medicine- Grady Campus Atlanta, Georgia | |
| Faculty of Medicine Siriraj Hospital Bangkok, Bangkok | |
| Fakultni nemocnice Hradec Kralove Hradec Králové, | |
| Fakultni nemocnice Kralovske Vinohrady Prague, | |
| Fakultni nemocnice Olomouc Olomouc, | |
| Fakultni nemocnice Plzen Pilsen, | |
| Fakultní nemocnice Brno Bohunice Brno, Brno-město | |
| Florida Cancer Specialists - East West Palm Beach, Florida | |
| Florida Cancer Specialists - North St. Petersburg, Florida | |
| Florida Cancer Specialists - South Fort Myers, Florida | |
| Fudan University Shanghai Cancer Center Shanghai, | |
| Fujian Cancer Hospital Fuzhou, Fujian | |
| Fundacion Ctic Centro de Tratamiento E Investigacion Sobre Cancer Luis Carlos Sarmiento Angulo Bogotá, Bogota D.C. | |
| Fundação Faculdade Regional de Medicina de São José do Rio Preto Sao Jose Rio Preto, | |
| Fundação Pio XII - Hospital de Câncer de Barretos Barretos, São Paulo | |
| Fundeni Clinical Institute Bucharest, București | |
| Gazi University Health Research and Application Center Gazi Hospital Ankara, | |
| Guangxi Medical University Affiliated Tumor Hospital Nanning, Guangxi | |
| Harbin Medical University Cancer Hospital Harbin, | |
| Health Pharma Professional Research S.A. de C.V: Mexico City, DIF | |
| Hematology-Oncology Associates of Central New York, PC East Syracuse, New York | |
| Henan Cancer Hospital Zhengzhou, | |
| Hospital 9 De Julho São Paulo, | |
| Hospital Alemão Oswaldo Cruz São Paulo, | |
| Hospital Amaral Carvalho Jaú, São Paulo | |
| Hospital Brasilia Lago Sul, Federal District | |
| Hospital Erasto Gaertner Curitiba, | |
| Hospital São Lucas de Copacabana Rio de Janeiro, | |
| Hospital Universitario "Dr. Jose Eleuterio Gonzalez" Monterrey, Nuevo León | |
| Hospital das Clinicas FMUSP São Paulo, | |
| Hunan Cancer Hospital Changsha, | |
| Icahn School of Medicine at Mount Sinai New York, New York | |
| Instituto D'Or de Pesquisa e Ensino (IDOR) São Paulo, | |
| Instituto Joinvilense De Hematologia e Oncologia Joinville, Santa Catarina | |
| Instituto Nacional De Cancerologia Bogota, Cundinamarca | |
| Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Mexico City, DIF | |
| Institutul Oncologic Cluj Cluj-Napoca, | |
| Institutul Regional de Oncologie Iași, | |
| Jiangxi Provincial Cancer Hospital Nanchang, Jiangxi | |
| KLES Dr. Prabhakar Kore Hospital & M.R.C Belagavi, Karnataka | |
| Karadeniz Teknik Universitesi Tip Fakultesi Trabzon, | |
| Koo Foundation Sun Yat-Sen Cancer Center Taipei, | |
| Liga Norte Riograndense Contra O Cancer Natal, Rio Grande do Norte | |
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| Local Institution - 0395 Ioannina, Ípeiros | |
| Local Institution - 0396 Athens, Attikí | |
| Local Institution - 0397 Chaïdári, Attikí | |
| Local Institution - 0398 Alexandroupoli, Anatolikí Makedonía Kai Thráki | |
| Local Institution - 0399 Athens, Attikí | |
| Local Institution - 0409 El Palmar, Murcia, Murcia, Región de | |
| Local Institution - 0412 A Coruña, A Coruña [La Coruña] | |
| Local Institution - 0415 Margate, Florida | |
| Local Institution - 0416 Riyadh, | |
| Local Institution - 0421 Buenos Aires, Buenos Aires F.D. | |
| Local Institution - 0422 Ankara, | |
| Local Institution - 0427 Singapore, Central Singapore | |
| Local Institution - 0429 Srinagar, Jammu and Kashmir | |
| Local Institution - 0431 Kuching, Sarawak | |
| Local Institution - 0432 George Town, Pulau Pinang | |
| Local Institution - 0434 Bangkok, Bangkok | |
| Local Institution - 0436 Edgewood, Kentucky | |
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| Local Institution - 0438 Jeddah, | |
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| Local Institution - 0448 Guadalajara, Jalisco | |
| Local Institution - 0449 Ampang, Selangor | |
| Local Institution - 0450 Tulsa, Oklahoma | |
| Local Institution - 0453 Lembah Pantai, Kuala Lumpur | |
| Local Institution - 0455 Seongnam, | |
| Local Institution - 0456 Seongnam, Kyǒnggi-do | |
| Local Institution - 0459 Santiago, Santiago Metropolitan | |
| Local Institution - 0462 Auckland, | |
| Local Institution - 0463 Hermosillo, Sonora | |
| Local Institution - 0465 Tacoma, Washington | |
| Local Institution - 0475 Eiheiji-cho,Yoshida-gun, Fukui | |
| Local Institution - 0480 Hackensack, New Jersey | |
| Local Institution - 0484 New York, New York | |
| Local Institution - 0486 Besançon, Doubs | |
| Local Institution - 0487 Solna, Stockholms Län [se-01] | |
| Local Institution - 0488 Madrid, | |
| Local Institution - 0489 Seville, | |
| Local Institution - 0490 Madrid, | |
| Local Institution - 0491 Badalona, Barcelona [Barcelona] | |
| Local Institution - 0492 Edmonton, Alberta | |
| Local Institution - 0493 Rome, Lazio | |
| Local Institution - 0495 Ravenna, Emilia-Romagna | |
| Local Institution - 0496 Novara, | |
| Local Institution - 0499 Groningen, | |
| Local Institution - 0500 Leiden, South Holland | |
| Local Institution - 0503 Cottbus, | |
| Local Institution - 0504 Halle, Saxony-Anhalt | |
| Local Institution - 0505 Erlangen, Bavaria | |
| Local Institution - 0506 Lübeck, Schleswig-Holstein | |
| Local Institution - 0507 Langen, Hesse | |
| Local Institution - 0508 Berlin, | |
| Local Institution - 0510 Dresden, | |
| Local Institution - 0511 Ulm, Baden-Wurttemberg | |
| Local Institution - 0512 Bayreuth, Bavaria | |
| Local Institution - 0513 Hanover, Lower Saxony | |
| Local Institution - 0516 Houston, Texas | |
| Maharaj Nakorn Chiang Mai Hospital Chiang Mai, | |
| Markusovszky Egyetemi Oktatokorhaz Szombathely, Vas County | |
| Mary Bird Perkins Cancer Center Baton Rouge Baton Rouge, Louisiana | |
| Mayo Clinic in Arizona - Phoenix Phoenix, Arizona | |
| Mayo Clinic in Florida Jacksonville, Florida | |
| Mayo Clinic in Rochester, Minnesota Rochester, Minnesota | |
| Memorial Hermann Hospital - Texas Medical Center Houston, Texas | |
| Mission Cancer + Blood Waukee, Iowa | |
| Moffitt Cancer Center Tampa, Florida | |
| Mount Sinai Cancer Center Miami Beach, Florida | |
| Narayana Superspecialty Hospital Howrah, West Bengal | |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie Warsaw, Masovian Voivodeship | |
| National Taiwan University Hospital Taipei, | |
| Núcleo de Oncologia e Hematologia do Ceará Fortaleza, Ceará | |
| Ondokuz Mayıs Universitesi Samsun, | |
| Orchard Healthcare Research Inc. Skokie, Illinois | |
| Oregon Health and Science University Portland, Oregon | |
| Orszagos Onkologiai Intezet Budapest, | |
| Pan American Center for Oncology Trials - Ciudadela San Juan, | |
| Peking University Third Hospital Beijing, | |
| Pratia MCM Kraków Krakow, Lesser Poland Voivodeship | |
| Qilu Hospital of Shandong University Jinan, | |
| Rajiv Gandhi Cancer Institute And Research Centre New Delhi, National Capital Territory of Delhi | |
| Ramathibodi Hospital Bangkok, Bangkok | |
| Ruijin Hospital Shanghai Jiaotong University School of Medicine Shanghai, Shanghai Municipality | |
| Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey | |
| Sacred Heart Medical Oncology Group Pensacola, Florida | |
| Sc Onco Card Srl Brasov, | |
| Semmelweis Egyetem Budapest, | |
| Shandong Cancer Hospital Jinan, | |
| Shanxi Bethune Hospital Taiyuan, Shanxi | |
| Shengjing Hospital of China Medical University Shengyang, | |
| Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein São Paulo, | |
| Somogy Varmegyei Kaposi Mor Oktato Korhaz Kaposvár, Somogy County | |
| Southern Medical University Nanfang Hospital Guangzhou, Guangdong | |
| Spital Clinic Judetean de Urgenta Tg.Mures Tg.Mures, Mureș County | |
| Spitalul Clinic Coltea Bucharest, | |
| Spitalul Clinic Coltea Bucharest, | |
| Spitalul Clinic Județean de Urgență Sibiu Sibiu, | |
| Spitalul Universitar de Urgenta Bucuresti Bucharest, | |
| Sun Yat-sen University Cancer Center Guangzhou, Guangdong | |
| Szabolcs Szatmár Bereg Vármegyei Oktatókórház Nyíregyháza, Szabolcs-Szatmár-Bereg | |
| Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy Bydgoszcz, Kuyavian-Pomeranian Voivodeship | |
| Taichung Veterans General Hospital Taichung, | |
| Taipei Veterans General Hospital Taipei, | |
| Tata Medical Center New Town, West Bengal | |
| Tata Memorial Hospital Mumbai, Maharashtra | |
| The First Affiliated Hospital of Chongqing Medical University Chongqing, | |
| The First Affiliated Hospital of NanChang University Nanchang, | |
| The First Affiliated Hospital of Soochow University Suzhou, | |
| The First Affiliated Hospital of Wenzhou Medical University Wenzhou, | |
| The First Affiliated Hospital of Xiamen University Xiamen, Fujian | |
| The First Affiliated Hospital, Zhejiang University School of Medicine Hangzhou, Zhejiang | |
| The First Hospital of China Medical University Shenyang, Liaoning | |
| The Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou, Zhejiang | |
| The University of Kansas Cancer Center - Westwood Westwood, Kansas | |
| Tianjin Medical University Cancer Institute & Hospital Tianjin, Tianjin Municipality | |
| Tongji Hospital Tongji Medical,Science & Technology Wuhan, Hubei | |
| UMHAT 'Sveti Ivan Rilsky' Sofia, | |
| USA Mitchell Cancer Institute Mobile, Alabama | |
| Unidad Médica Onco-Hematológica Puebla City, | |
| Union Hospital Tongji Medical College Huazhong University of Science and Technology Wuhan, | |
| Universidade Federal de Goias Goiânia, Goiás | |
| University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD Plovdiv, | |
| University of Michigan Ann Arbor, Michigan | |
| University of Texas MD Anderson Cancer Center Houston, Texas | |
| VM Medical Park Mersin Hastanesi Mersin, | |
| Virginia Commonwealth University (VCU) Medical Center Richmond, Virginia | |
| Vseobecna Fakultni Nemocnice v Praze Prague, | |
| WellSpan Oncology Research York, Pennsylvania | |
| West China Hospital, Sichuan University Chengdu, Sichuan | |
| Winship Cancer Institute, Emory University Atlanta, Georgia | |
| Xinjiang Medical University Cancer Hospital - Urumqi Ürümqi, Xinjiang | |
| the First Hospital of Jilin University Changchun, |
Studying the Effect of Levocarnitine in Protecting the Liver From Chemotherapy for Leukemia or Lymphoma
ctrrecruit@vcu.edu
NCT05602194
Show full eligibility criteria
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Inclusion Criteria:
* \>= 15 and \< 40 years at time of diagnosis
* Newly diagnosed B-ALL, T-ALL, lymphoblastic lymphoma (LLy), or mixed-phenotype acute leukemia/lymphoma (MPAL)
* Note: Philadelphia chromosome (PH)+ and PH-like acute leukemia are eligible (use of tyrosine kinase inhibitors \[TKI\] or CRLF2- targeted concomitant medication must be documented, if used)
* Conjugated bilirubin =\< 1.5 x upper limit of normal (ULN) for age, regardless of baseline bilirubin (within 7 days prior to enrollment), and
* Serum glutamate pyruvate transaminase (SGPT) (ALT) =\< 225 U/L (=\< 5x ULN) (within 7 days prior to enrollment), and
* Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L and serum glutamic oxaloacetic transaminase (SGOT) (AST) to 50 U/L regardless of baseline
* SGOT (AST) =\< 250 U/L (=\< 5x ULN) (within 7 days prior to enrollment)
* Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L and SGOT (AST) to 50 U/L regardless of baseline
* For patients receiving ursodiol prior to enrollment, laboratory values must meet above criteria off ursodiol for 7 days
* PEDIATRIC PATIENTS (AGE 15-17 years):
* A 24-hour urine creatinine clearance \>= 30 mL/min/1.73 m\^2 (within 7 days prior to enrollment) OR
* A glomerular filtration rate (GFR) \>= 30 mL/min/1.73 m\^2. GFR must be performed using one of the following methods (within 7 days prior to enrollment):
* 1\. Estimated GFR (eGFR) \>= 30 mL/min/1.73 m\^2.
* An online calculator is available through the National Kidney Foundation at https://www.kidney.org/professionals/kdoqi/gfr\_calculatorped
* 2\. Measured GFR \>= 30 mL/min/1.73 m\^2 (any age). If measured GFR is used, it must be performed using direct measurement with a nuclear blood sampling method or small molecule clearance method (iothalamate or other molecule per institutional standard).
* ADULT PATIENTS (AGE 18 YEARS OR OLDER): Creatinine clearance \>= 30 mL/min, as estimated by the Cockcroft and Gault formula or a 24-hour urine collection (within 7 days prior to enrollment). Estimated creatinine clearance is based on actual body weight
* An online calculator is available through the National Kidney Foundation at https://www.kidney.org/professionals/kdoqi/gfr\_calculatorcoc
* Berlin-Frankfurt-Munich (BFM), Children's Oncology Group (COG), or C10403-based Induction regimen and must be inclusive of \>= 1 dose of pegaspargase or calaspargase pegol, and
* First dose of asparaginase must be planned within the first week of induction therapy, and
* Dose of pegaspargase or calaspargase pegol must be \>= 1,000 IU/ m\^2 (dose-capping permitted per primary regimen)
* Note: Co-enrollment on a therapeutic consortia trial is not required
* All patients and/or their parents or legal guardians must sign a written informed consent
* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria:
* Down syndrome
* Known inherited or autoimmune liver disease impacting conjugated bilirubin (e.g., Alagille syndrome, primary sclerosing cholangitis, other)
* Known biopsy (or imaging) proven severe liver fibrosis (Batts-Ludwig \>= stage 3)
* Unable to tolerate oral formulation of study drug at enrollment
* Patients who received chemotherapy or treatment for a prior malignancy are not eligible
* The following are permitted: steroid prophase, hydroxyurea, or other cytoreduction prior to initiation of Induction chemotherapy (must be documented) and chemotherapy for current diagnosis (i.e. initiation of Induction therapy within enrollment window). Chemotherapy prior to enrollment for treatment of a non-malignancy (e.g., steroid or methotrexate for autoimmune disease) is also permitted and must be documented
* Female patients who are pregnant since fetal toxicities and teratogenic effects in humans are unknown for study drug. A pregnancy test is required for female patients of childbearing potential
* Lactating females who plan to breastfeed their infants
* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation PROCEDURE: Biospecimen Collection, DRUG: Calaspargase Pegol, DIETARY_SUPPLEMENT: Levocarnitine, DRUG: Pegaspargase, OTHER: Quality-of-Life Assessment
B Acute Lymphoblastic Leukemia, B Acute Lymphoblastic Leukemia With t(9,22)(q34.1,q11.2), BCR-ABL1, B Acute Lymphoblastic Leukemia, BCR-ABL1-Like, Lymphoblastic Lymphoma, Mixed Phenotype Acute Leukemia, T Acute Lymphoblastic Leukemia
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Show 223 locations
Study Locations
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| Location | Contacts |
|---|---|
| AdventHealth Orlando Orlando, Florida | Site Public Contact - (FH.Cancer.Research@flhosp.org) |
| Advocate Children's Hospital-Oak Lawn Oak Lawn, Illinois | |
| Advocate Children's Hospital-Park Ridge Park Ridge, Illinois | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Albany Medical Center Albany, New York | |
| Alfred I duPont Hospital for Children Wilmington, Delaware | Site Public Contact - (Allison.bruce@nemours.org) |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Ann M Wierman MD LTD Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Arkansas Children's Hospital Little Rock, Arkansas | |
| Ascension Saint Vincent Indianapolis Hospital Indianapolis, Indiana | Site Public Contact - (research@stvincent.org) |
| Aurora Bay Area Medical Group-Marinette Marinette, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora BayCare Medical Center Green Bay, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Grafton Grafton, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Kenosha South Kenosha, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Milwaukee Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Milwaukee West Wauwatosa, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Racine Racine, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Southern Lakes VLCC Burlington, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Health Care Germantown Health Center Germantown, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Medical Center in Summit Summit, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Saint Luke's Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Saint Luke's South Shore Cudahy, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Sinai Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora West Allis Medical Center West Allis, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| BI-LO Charities Children's Cancer Center Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Banner University Medical Center - Tucson Tucson, Arizona | Site Public Contact - (UACC-IIT@uacc.arizona.edu) |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas | Site Public Contact - (burton@bcm.edu) |
| Beacon Kalamazoo Kalamazoo, Michigan | |
| Beacon Kalamazoo Cancer Center Kalamazoo, Michigan | |
| Blank Children's Hospital Des Moines, Iowa | Site Public Contact - (samantha.mallory@unitypoint.org) |
| Bronson Battle Creek Battle Creek, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Bronson Methodist Hospital Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| C S Mott Children's Hospital Ann Arbor, Michigan | |
| Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores, Michigan | Site Public Contact - (connie.szczepanek@crcwm.org) |
| Carilion Children's Roanoke, Virginia | Site Public Contact - (wpmccarty@carilionclinic.org) |
| Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina | |
| Carson Tahoe Regional Medical Center Carson City, Nevada | Site Public Contact - (research@sncrf.org) |
| Children's Healthcare of Atlanta - Arthur M Blank Hospital Atlanta, Georgia | Site Public Contact - (Olivia.Floyd@choa.org) |
| Children's Hospital London, Ontario | |
| Children's Hospital Colorado Aurora, Colorado | Site Public Contact - (josh.b.gordon@nsmtp.kp.org) |
| Children's Hospital Los Angeles Los Angeles, California | |
| Children's Hospital Medical Center Of Akron Akron, Ohio | |
| Children's Hospital New Orleans New Orleans, Louisiana | |
| Children's Hospital and Medical Center of Omaha Omaha, Nebraska | |
| Children's Hospital at Montefiore The Bronx, New York | Site Public Contact - (aaraiza@montefiore.org) |
| Children's Hospital of Alabama Birmingham, Alabama | Site Public Contact - (oncologyresearch@peds.uab.edu) |
| Children's Hospital of Michigan Detroit, Michigan | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital of Philadelphia Philadelphia, Pennsylvania | Site Public Contact - (CancerTrials@email.chop.edu) |
| Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania | Site Public Contact - (jean.tersak@chp.edu) |
| Children's Hospital of San Antonio San Antonio, Texas | Site Public Contact - (bridget.medina@christushealth.org) |
| Children's Hospital of Wisconsin Milwaukee, Wisconsin | Site Public Contact - (MACCCTO@mcw.edu) |
| Children's Hospital of the King's Daughters Norfolk, Virginia | Site Public Contact - (CCBDCresearch@chkd.org) |
| Children's Mercy Hospitals and Clinics Kansas City, Missouri | Site Public Contact - (COGResearchGroup@cmh.edu) |
| Children's National Medical Center Washington D.C., District of Columbia | Site Public Contact - (OncCRC_OnCall@childrensnational.org) |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | Site Public Contact - (cancer@cchmc.org) |
| City of Hope Comprehensive Cancer Center Duarte, California | Site Public Contact - (becomingapatient@coh.org) |
| Cleveland Clinic Foundation Cleveland, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Comprehensive Cancer Centers of Nevada Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Henderson Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Northwest Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Town Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada-Horizon Ridge Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada-Southeast Henderson Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada-Summerlin Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Cook Children's Medical Center Fort Worth, Texas | Site Public Contact - (CookChildrensResearch@cookchildrens.org) |
| Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Lakeland Hospitals - Niles Hospital Niles, Michigan | |
| Corewell Health Lakeland Hospitals - Saint Joseph Hospital Saint Joseph, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Reed City Hospital Reed City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Covenant Children's Hospital Lubbock, Texas | Site Public Contact - (mbisbee@providence.org) |
| Dayton Children's Hospital Dayton, Ohio | |
| Dell Children's Medical Center of Central Texas Austin, Texas | Site Public Contact - (TXAUS-DL-SFCHemonc.research@ascension.org) |
| Driscoll Children's Hospital Corpus Christi, Texas | Site Public Contact - (Crystal.DeLosSantos@dchstx.org) |
| East Tennessee Childrens Hospital Knoxville, Tennessee | |
| El Paso Children's Hospital El Paso, Texas | Site Public Contact - (ranjan.bista@ttuhsc.edu) |
| Geisinger Medical Center Danville, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Golisano Children's Hospital of Southwest Florida Fort Myers, Florida | Site Public Contact - (molly.arnstrom@leehealth.org) |
| Hackensack University Medical Center Hackensack, New Jersey | |
| Hope Cancer Care of Nevada Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Hope Cancer Care of Nevada-Pahrump Pahrump, Nevada | Site Public Contact - (research@sncrf.org) |
| Hospital for Sick Children Toronto, Ontario | |
| IWK Health Centre Halifax, Nova Scotia | Site Public Contact - (Research@iwk.nshealth.ca) |
| Inova Fairfax Hospital Falls Church, Virginia | Site Public Contact - (Stephanie.VanBebber@inova.org) |
| Jersey Shore Medical Center Neptune City, New Jersey | |
| Johns Hopkins All Children's Hospital St. Petersburg, Florida | Site Public Contact - (Ashley.Repp@jhmi.edu) |
| Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland | Site Public Contact - (jhcccro@jhmi.edu) |
| Kaiser Permanente Downey Medical Center Downey, California | |
| Kaiser Permanente Los Angeles Medical Center Los Angeles, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Anaheim Anaheim, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Bellflower Bellflower, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Fontana Fontana, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-San Diego Mission San Diego, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-San Diego Zion San Diego, California | Site Public Contact - (clinical.trials@kp.org) |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | |
| Kingman Regional Medical Center Kingman, Arizona | Site Public Contact - (research@sncrf.org) |
| Las Vegas Urology - Cathedral Rock Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Las Vegas Urology - Green Valley Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Las Vegas Urology - Pebble Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Las Vegas Urology - Pecos Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Las Vegas Urology - Smoke Ranch Las Vegas, Nevada | Site Public Contact - (research@smcrf.org) |
| Las Vegas Urology - Sunset Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Loma Linda University Medical Center Loma Linda, California | |
| Lucile Packard Children's Hospital Stanford University Palo Alto, California | Site Public Contact - (ccto-office@stanford.edu) |
| M D Anderson Cancer Center Houston, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| Madigan Army Medical Center Tacoma, Washington | Site Public Contact - (melissa.a.forouhar.mil@health.mil) |
| Maine Children's Cancer Program Scarborough, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| Marshfield Medical Center-Marshfield Marshfield, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Mary Bridge Children's Hospital and Health Center Tacoma, Washington | Site Public Contact - (research@multicare.org) |
| Mayo Clinic in Rochester Rochester, Minnesota | |
| Medical City Dallas Hospital Dallas, Texas | |
| Memorial Health University Medical Center Savannah, Georgia | Site Public Contact - (Lorraine.OHara@hcahealthcare.com) |
| Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood, Florida | Site Public Contact - (OHR@mhs.net) |
| Mercy Hospital Saint Louis St Louis, Missouri | |
| Methodist Children's Hospital of South Texas San Antonio, Texas | Site Public Contact - (Vinod.GidvaniDiaz@hcahealthcare.com) |
| Miami Cancer Institute Miami, Florida | |
| Michigan State University East Lansing, Michigan | |
| Miller Children's and Women's Hospital Long Beach Long Beach, California | |
| Montefiore Medical Center - Moses Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Montefiore Medical Center-Einstein Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Montefiore Medical Center-Weiler Hospital The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Munson Medical Center Traverse City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| NYP/Weill Cornell Medical Center New York, New York | |
| NYU Langone Hospital - Long Island Mineola, New York | Site Public Contact - (cancertrials@nyulangone.org) |
| Natalie Warren Bryant Cancer Center at Saint Francis Tulsa, Oklahoma | |
| Nationwide Children's Hospital Columbus, Ohio | Site Public Contact - (Melinda.Triplet@nationwidechildrens.org) |
| Nemours Children's Clinic - Pensacola Pensacola, Florida | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Nemours Children's Clinic-Jacksonville Jacksonville, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| Nemours Children's Hospital Orlando, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| New York Medical College Valhalla, New York | |
| Newark Beth Israel Medical Center Newark, New Jersey | Site Public Contact - (Christine.Kosmides@rwjbh.org) |
| Nicklaus Children's Hospital Miami, Florida | |
| North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima, Washington | Site Public Contact - (Memorial-ClinicalTrials@yvmh.org) |
| Northwestern University Chicago, Illinois | Site Public Contact - (cancer@northwestern.edu) |
| Norton Children's Hospital Louisville, Kentucky | Site Public Contact - (CancerResource@nortonhealthcare.org) |
| Ochsner Medical Center Jefferson New Orleans, Louisiana | Site Public Contact - (Elisemarie.curry@ochsner.org) |
| Oncology Las Vegas - Henderson Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Oncology Las Vegas - Tenaya Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at Charleston Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at Fort Apache Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at MountainView Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at Seven Hills Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Oregon Health and Science University Portland, Oregon | Site Public Contact - (trials@ohsu.edu) |
| PCR Oncology Arroyo Grande, California | Site Public Contact - (research@sncrf.org) |
| Penn State Children's Hospital Hershey, Pennsylvania | |
| Phoenix Childrens Hospital Phoenix, Arizona | |
| Presbyterian Hospital Albuquerque, New Mexico | Site Public Contact - (wburman@phs.org) |
| Prisma Health Cancer Institute - Eastside Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Greenville Memorial Hospital Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo, Ohio | Site Public Contact - (PCIOncResearch@promedica.org) |
| Providence Alaska Medical Center Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Providence Sacred Heart Medical Center and Children's Hospital Spokane, Washington | Site Public Contact - (HopeBeginsHere@providence.org) |
| Radiation Oncology Associates Reno, Nevada | Site Public Contact - (research@sncrf.org) |
| Radiation Oncology Centers of Nevada Central Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Radiation Oncology Centers of Nevada Southeast Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Rainbow Babies and Childrens Hospital Cleveland, Ohio | |
| Renown Regional Medical Center Reno, Nevada | Site Public Contact - (research@sncrf.org) |
| Riley Hospital for Children Indianapolis, Indiana | |
| Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver, Colorado | Site Public Contact - (PSGResearchSharedMailbox@HCAHealthcare.com) |
| Sacred Heart Hospital Pensacola, Florida | |
| Saint Francis Cancer Center Greenville, South Carolina | Site Public Contact - (Heather_Rich@bshsi.org) |
| Saint Francis Hospital Greenville, South Carolina | Site Public Contact - (Heather_Rich@bshsi.org) |
| Saint Joseph's Hospital/Children's Hospital-Tampa Tampa, Florida | Site Public Contact - (jennifer.manns@baycare.org) |
| Saint Joseph's Regional Medical Center Paterson, New Jersey | Site Public Contact - (HallL@sjhmc.org) |
| Saint Luke's Cancer Institute - Boise Boise, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Fruitland Fruitland, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Meridian Meridian, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Nampa Nampa, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Twin Falls Twin Falls, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Mary's Regional Medical Center Reno, Nevada | Site Public Contact - (research@sncrf.org) |
| Sanford Broadway Medical Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org) |
| Seattle Children's Hospital Seattle, Washington | |
| Sinai Hospital of Baltimore Baltimore, Maryland | |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| Stanford Cancer Institute Palo Alto Palo Alto, California | Site Public Contact - (ccto-office@stanford.edu) |
| Stony Brook University Medical Center Stony Brook, New York | |
| Summerlin Hospital Medical Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Sunrise Hospital and Medical Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Sutter Medical Center Sacramento Sacramento, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Tampa General Hospital Tampa, Florida | Site Public Contact - (syapchanyk@tgh.org) |
| The Children's Hospital at TriStar Centennial Nashville, Tennessee | |
| The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park, New York | |
| Trinity Health Grand Rapids Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Trinity Health Muskegon Hospital Muskegon, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| UCSF Benioff Children's Hospital Oakland Oakland, California | Site Public Contact - (PedOncRschOAK@ucsf.edu) |
| UCSF Medical Center-Mission Bay San Francisco, California | Site Public Contact - (cancertrials@ucsf.edu) |
| UF Health Cancer Institute - Gainesville Gainesville, Florida | Site Public Contact - (cancer-center@ufl.edu) |
| UMC Cancer Center / UMC Health System Lubbock, Texas | |
| UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina | Site Public Contact - (cancerclinicaltrials@med.unc.edu) |
| UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| University Medical Center of Southern Nevada Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| University of California Davis Comprehensive Cancer Center Sacramento, California | |
| University of Chicago Comprehensive Cancer Center Chicago, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| University of Illinois Chicago, Illinois | |
| University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa | |
| University of Kansas Cancer Center Kansas City, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Hospital-Westwood Cancer Center Westwood, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kentucky/Markey Cancer Center Lexington, Kentucky | |
| University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan | Site Public Contact - (slusserb@med.umich.edu) |
| University of Michigan Health - West Wyoming, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| University of Mississippi Medical Center Jackson, Mississippi | |
| University of Nebraska Medical Center Omaha, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| University of New Mexico Cancer Center Albuquerque, New Mexico | Site Public Contact - (HSC-ClinicalTrialInfo@salud.unm.edu) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Texas Health Science Center at San Antonio San Antonio, Texas | Site Public Contact - (phoresearchoffice@uthscsa.edu) |
| University of Virginia Cancer Center Charlottesville, Virginia | Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu) |
| University of Wisconsin Carbone Cancer Center - Eastpark Medical Center Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| University of Wisconsin Carbone Cancer Center - University Hospital Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| Urology Specialists of Nevada - Central Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Urology Specialists of Nevada - Green Valley Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Urology Specialists of Nevada - Northwest Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Urology Specialists of Nevada - Southwest Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Valley Children's Hospital Madera, California | Site Public Contact - (Research@valleychildrens.org) |
| Valley Medical Center Renton, Washington | Site Public Contact - (research@valleymed.org) |
| Vanderbilt University/Ingram Cancer Center Nashville, Tennessee | |
| Vince Lombardi Cancer Clinic - Oshkosh Oshkosh, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Vince Lombardi Cancer Clinic-Sheboygan Sheboygan, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Vince Lombardi Cancer Clinic-Two Rivers Two Rivers, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Wake Forest University Health Sciences Winston-Salem, North Carolina | |
| West Michigan Cancer Center Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
Evaluation of the Safety and Effectiveness of the CereVasc® eShunt® System in Normal Pressure Hydrocephalus (STRIDE)
Ona Whelove - clinicaltrials@cerevasc.com
NCT06498960
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Inclusion Criteria:
Each subject must meet the following criteria:
• Patients ≥60 years old on the day of study informed consent
• Patient or legally authorized representative is able and willing to provide written informed consent
• History or evidence of gait impairment with a duration ≥3 months
• Clinical presentation consistent with NPH including two or more of the clinical triad (i.e., history of gait disturbance, progressive mental deterioration, and urinary urgency or incontinence), together with all of the following:
• Brain MRI signs of ventricular enlargement disproportionate to cerebral atrophy (Evans' Index \>0.3) and the absence of severe hippocampal atrophy,
• Pre-procedure spinal tap test or lumbar drain with subsequent gait disturbance improvement (Timed Up and Go Test) of at least 20%,
• CSF opening pressure ≥8 cmH2O,
• Baseline cognitive evaluation assessed by Montreal Cognitive Assessment (MoCA) test score ≥12
• Patient is willing and able to attend all scheduled visits and comply with study procedures.
• Confirmation of anatomy suitable for the eShunt procedure, as determined by evaluation of pre-procedure imaging (CT and MRI) and approved by an independent anatomical screening committee.
Exclusion Criteria:
Each subject may not:
• Be unable to walk 10 meters (33 feet) with or without an assistive device
• Be diagnosed with obstructive hydrocephalus
• Have an active systemic infection or infection detected in CSF
• Have had prior or existing shunts, endoscopic third ventriculostomy, or any previous surgical intervention for hydrocephalus
• Demonstrate hypersensitivity or contraindication to heparin or radiographic contrast agents against which the subject cannot be adequately pre-medicated, desensitized or where no alternative is available
• Have occlusion or stenosis of the internal jugular vein which would prohibit access to the IPS
• Present with venous distension in the neck on physical exam
• Have medical conditions associated with prolonged elevation of jugular venous pressure, including jugular vein stenosis or stricture, right sided heart failure, cirrhosis of the liver, arteriovenous fistulas in the arm for dialysis purposes, or an arterial venous fistula or malformation in the neck or brain
• Have history of bleeding diatheses, coagulopathy or refuse to consent for blood transfusion in cases of emergency
• Have had an ischemic stroke or transient ischemic attack within 180 days of eShunt procedure
• Have documented evidence of a deep vein thrombosis superior to the popliteal vein
• Have intrinsic blood clotting disorder
• Have medical conditions requiring anticoagulation which is unable to be managed to allow for surgical procedure
• Have presence of a posterior fossa tumor or mass
• Have a life expectancy \<1 year
• Be currently participating in another interventional (drug, device, etc.) research project that may confound the results of this study.
• Have established diagnosis of neurodegenerative diseases such as Parkinson's disease, Alzheimer's disease, or Lewy body dementia
• Be diagnosed with schizophrenia or any psychiatric diagnosis (including depression) that may complicate outcome evaluation
• Need an intracranial neurosurgical procedure within 180 days of study index procedure
• Be unwilling or unable to comply with follow-up requirements
• Have mRS of 0, 5, or 6
DEVICE: CereVasc eShunt System, DEVICE: VP Shunt
Normal Pressure Hydrocephalus
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Study Locations
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| Location | Contacts |
|---|---|
| Advocate Lutheran General Hospital Park Ridge, Illinois | Gina Littlejohn, BSN, RN, CCRC - (Gina.Littlejohn@aah.org) |
| Albany Medical Center Albany, New York | Julia Zajaceskowski - (zajacej@amc.edu) |
| Baptist Medical Center - Jacksonville Jacksonville, Florida | Jefferson Atillo, RN, BSN - (jefferson.atillo@bmcjax.com) |
| Beth Israel Deaconess Medical Center Boston, Massachusetts | Mark Rotondo, MS - (mrotondo@bidmc.harvard.edu) |
| Brigham and Women's Hospital Boston, Massachusetts | Odysseas Nikas - (onikas@bwh.harvard.edu) |
| Cleveland Clinic Cleveland, Ohio | Joyce Barmen - (BARMENJ2@ccf.org) |
| Clinica La Sagrada Familia Buenos Aires, | Carlos Toranzo - (ctoranzo@lylyk.com.ar) |
| Cooper Neurological Institute Camden, New Jersey | Sean Behnke - (Behnke-sean@cooperhealth.edu) |
| Henry Ford Health Detroit, Michigan | Rehnuma Newaz - (rnewaz1@hfhs.org) |
| Icahn School of Medicine at Mount Sinai New York, New York | Kevin Buttet - (kevin.buttet@mountsinai.org) |
| Indiana University Indianapolis, Indiana | Caliel Hines - (calhines@iu.edu) |
| Lenox Hill Hospital New York, New York | Sara Massimo - (smassimo@northwell.edu) |
| Massachusetts General Hospital Boston, Massachusetts | Shayna Hollander - (sdhollander@mgh.harvard.edu) |
| Montefiore Medical Center The Bronx, New York | Lyanna Gomez, MD - (lygomez@montefiore.org) |
| NYU Langone Health New York, New York | Michelle Sclafani - (michelle.sclafani@nyulangone.org) |
| Northwell Health New Hyde Park, New York | Ajith Vellat - (avellat1@northwell.edu) |
| Northwestern University Chicago, Illinois | Pouya Nazari - (pouya.nazari@northwestern.edu) |
| Rhode Island Hospital Providence, Rhode Island | Wendy Smith, BS, RTRCV, CCRP - (wsmith@brownhealth.org) |
| St. Michael's Hospital Toronto, Ontario | Eileen Liu - (Eileen.liu@unityhealth.to) |
| Thomas Jefferson University Philadelphia, Pennsylvania | Sha'Mere Herder - (shamere.herder@jefferson.edu) |
| University at Buffalo Neurosurgery Buffalo, New York | Ellen Carl - (ecarl@ubns.com) |
| University of Kansas Medical Center Kansas City, Kansas | Max Hardenbrook - (mhardenbrook@kumc.edu) |
| University of Kentucky Research Foundation Lexington, Kentucky | Rachel Norris - (rachel.norris@uky.edu) |
| University of Rochester Medical Center Rochester, New York | Tilor Hallquist - (Tilor_Hallquist@URMC.Rochester.edu) |
| University of South Florida Tampa, Florida | Shalini Nampally - (snampally@tgh.org) |
| University of Southern California Newport Beach, California | Kelly Hu - (kelly.hu@med.usc.edu) |
| Virginia Commonwealth University Richmond, Virginia | Amy Erickson - (amy.e.stout@vcuhealth.org) |
| Yale University New Haven, Connecticut | Lindsey Fraczkiewicz - (lindsey.fraczkiewicz@yale.edu) |
A Study to Evaluate the Safety and Tolerability of Efgartigimod PH20 SC Given by Prefilled Syringe in Kidney Transplant Recipients With Antibody-Mediated Rejection (AMR) (Shamrock)
Sabine Coppieters, MD - clinicaltrials@argenx.com
NCT06503731
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Inclusion Criteria:
* The participant is within the ages of 18 and 80 years old
* The participant had a kidney transplant (living or deceased donor) at least 6 months before the study
* The participant has received a diagnosis of active or chronic active antibody-mediated rejection (AMR) with detectable donor-specific antibodies at time of the study
* A participant may be allowed into the study if they receive the following medications:
• Received mycophenolate mofetil for at least 20 weeks before the study
• Has remained on a stable dose of mycophenolate mofetil and tacrolimus for at least 4 weeks before being allowed to participate in the study
• Has remained on tacrolimus doses between 5 to 10 ng/mL at least 4 weeks before being allowed to participate in the study
• Steroid dose was between 0 to 10 mg per day of prednisone (or dose equivalent) for at least 4 weeks before being allowed to participate in the study
Exclusion Criteria:
* Confirmed T-cell or mixed rejection at time of the study
* Recent change in immunosuppressive therapy agents
* Any other medical condition that, in the investigator's opinion, would interfere with the results of the study or put the participant at undue risk
* Pregnant or lactating state or intention to become pregnant during the study
The complete list of criteria can be found in the protocol COMBINATION_PRODUCT: Efgartigimod PH20 SC - prefilled syringe, OTHER: Placebo PH20 SC - prefilled syringe
Antibody-mediated Rejection
Active AMR, Chronic active AMR, Late AMR
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| Location | Contacts |
|---|---|
| Allgemeines Krankenhaus der Stadt Wien (AKH Wien) - Medizinischer Universitätscampus Vienna, | Georg A. Boehmig, MD - (clinicaltrials@argenx.com) |
| Cedars-Sinai Medical Center Los Angeles, California | Stanley Jordan, MD - (clinicaltrials@argenx.com) |
| Centre Hospitalier Universitaire (CHU) de Bordeaux - Hôpital Pellegrin Bordeaux, | Lionel Couzi, MD - (clinicaltrials@argenx.com) |
| Centre Hospitalier Universitaire (CHU) de Grenoble Alpes - Hôpital Michallon La Tronche, | Paolo Malvezzi, MD - (clinicaltrials@argenx.com) |
| Centre Hospitalier Universitaire (CHU) de Toulouse - Hôpital de Rangueil Toulouse, | Nassim Kamar, MD - (clinicaltrials@argenx.com) |
| Charite - Universitatsmedizin Berlin Berlin, | Eva Schrezenmeier, MD - (clinicaltrials@argenx.com) |
| Duke University Hospital Durham, North Carolina | Goni Katz-Greenberg, MD - (clinicaltrials@argenx.com) |
| Hospital Del Mar Barcelona, Catalonia | Marta Crespo, MD - (clinicaltrials@argenx.com) |
| Hospital Universitario Miguel Servet Zaragoza, | Alex Gutierrez-Dalmau, MD - (clinicaltrials@argenx.com) |
| Hospital Universitario Vall d'Hebron Barcelona, | Francesc Moreso, MD - (clinicaltrials@argenx.com) |
| Hospital Universitario de Bellvitge L'Hospitalet de Llobregat, | Edoardo Melilli, MD - (clinicaltrials@argenx.com) |
| Institut klinicke a experimentalni mediciny (IKEM) Prague, | Ondrej Viklický, MD - (clinicaltrials@argenx.com) |
| London Health Sciences Centre London, | Lakshman Gunaratnam, MD - (clinicaltrials@argenx.com) |
| The Ohio State University Wexner Medical Center Columbus, Ohio | Todd Pesavento, MD - (clinicaltrials@argenx.com) |
| Universitaetsklinikum Carl Gustav Carus Dresden Dresden, | Christian Hugo, MD - (clinicaltrials@argenx.com) |
| Universitair Ziekenhuis (UZ) Gent Ghent, | Steven Van Laecke, MD - (clinicaltrials@argenx.com) |
| Universitair Ziekenhuis Leuven (UZ Leuven) - Campus Gasthuisberg Leuven, | Dirk Kuypers, MD - (clinicaltrials@argenx.com) |
| Universitatsklinikum Hamburg-Eppendorf Hamburg, | Florian Grahammer, MD - (clinicaltrials@argenx.com) |
| University of Alabama at Birmingham (UAB) Hospital Birmingham, Alabama | Navya Eleti, MD - (clinicaltrials@argenx.com) |
| University of Nebraska Medical Center Omaha, Nebraska | Eric Langewisch, MD - (clinicaltrials@argenx.com) |
| University of Washington Medical Center Seattle, Washington | Nicolae Leca, MD - (clinicaltrials@argenx.com) |
| Virginia Commonwealth University (VCU) Medical Center Hume-Lee Transplant Center Richmond, Virginia | Gaurav Gupta, MD - (clinicaltrials@argenx.com) |
Safety and Tolerability Study of GIM-122 in Subjects With Advanced Solid Malignancies
LumaBridge CRO - contact@lumabridge.com
NCT06028074
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Inclusion Criteria:
General
* Written informed consent
* ECOG performance status 0-1.
* Laboratory assessment 28 days prior to enrollment for assessment of acceptable cardiac, renal and hepatic functions
* Recommended Double methods of contraception 90-days post treatment Cancer Specific
* Histologically or cytologically confirmed locally advanced/unresectable or metastatic solid tumor
* Received FDA approved treatment of PD-1 inhibitor or PD-L1 inhibitor for advance malignant tumors and have progressed/relapsed, are refractory, or intolerant
* Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1
* Had prior therapy with PD-1/PD-L1 inhibitors. Other checkpoint inhibitors (ie, CTLA4, LAG3) are permitted if they did not lead to treatment discontinuation
* No other lines of therapy that are available
Exclusion Criteria:
General
* Enrolled in any other interventional clinical trial, starting within 4 weeks of the first dose of GIM-122 and throughout the duration of the study, or is receiving other therapy directed at their malignancy
* Women who are pregnant or breastfeeding
* History of cardiac issues, pulmonary embolism, active and clinically significant bacterial, fungal, or viral infection ≤ 6 months prior to dosing
* Contraindications to the imaging assessments or other study procedures that subjects will undergo or any medical or social condition that, in the opinion of the investigator, might place a subject at an increased risk, affect compliance, or confound safety or other clinical study data interpretation Cancer Specific
* Current second malignancy at other sites
* Leptomeningeal disease
* Spinal cord compression
* Symptomatic or new or enlarging central nervous system (CNS) metastases
Treatment-specific Exclusion Criteria
* Ongoing toxicity \> Grade 1 from prior therapy according to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0
* Has undergone a major surgery \< 1 month prior to administration of GIM-122
* Has received radiation therapy within 2 weeks prior to administration of GIM-122
* Has undergone or is anticipated to undergo organ transplantation including allogeneic or autologous stem cell transplantation at any time
* Has received systemic anti-cancer therapy within 2 weeks and cytotoxic agents that have a major delayed toxicity within 4 weeks, of the first dose of GIM-122
* Prior treatment with other immune modulating agents within \< 4 weeks prior to the first dose of GIM-122.
* Has a diagnosis of immunodeficiency, either primary or acquired
* Has received treatment with systemic steroids or any form of immunosuppressive therapy within 14 days prior to administration of GIM-122
* Has active or prior history of autoimmune disease, including ulcerative colitis and Crohn's disease, or any condition that requires systemic steroids.
* Has a known severe intolerance to or hypersensitivity reactions to monoclonal antibodies, Fc-bearing proteins, or IV immunoglobulin preparations; prior history of human anti-human antibody response; known allergy to any of the study medications, or excipients in the various formulations of any agent.
* Has received live vaccines within 30 days of study initiation (inactivated vaccines are allowed; seasonal vaccines should be up to date \> 30 days prior to administration of GIM-122). DRUG: GIM122
Advanced Solid Malignancies
solid tumor, advanced malignancies, GIM-122
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Study Locations
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| Location | Contacts |
|---|---|
| Florida Cancer Specialists West Palm Beach, Florida | |
| NEXT Oncology Dallas Irving, Texas | |
| Norton Cancer Institute Louisville, Kentucky | Juanita Dwingelo, MS, PhD, ACRP-CP - (juanita.vondwingelo@nortonhealthcare.org) |
| Rutgers Cancer Institute of Nj New Brunswick, New Jersey | Taryn Bollaro - (tb509@cinj.rutgers.edu) |
| Tennessee Oncology, PLLC Nashville, Tennessee | Amber Hilyard - (ahilyard@tnonc.com) |
| Texas Oncology - Baylor Sammons Cancer Center Dallas, Texas | |
| The Angeles Clinic and Research Institute Los Angeles, California | |
| UCLA Hematology/Oncology Los Angeles, California | Thu Ly - (tply@mednet.ucla.edu) |
| UCSF Helen Diller Family Comprehensive Cancer Center San Francisco, California | Markee Micu - (markee.micu@ucsf.edu) |
| USC/Norris Comprehensive Cancer Center Los Angeles, California | Thomas Won - (thomas.won@med.usc.edu) |
| Virginia Commonwealth University Richmond, Virginia | Faith McFadden - (mcfaddenfr@vcu.edu) |
EXercise Cardiac Magnetic Resonance Assessment of Left Atrial Mechanics Following Ablation (EXCLAMATORY)
Pamela Grizzard - pamela.grizzard@vcuhealth.org
NCT06212791
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Inclusion Criteria:
* Age ≥18 years
* Diagnosis of paroxysmal AF
* Left ventricular ejection fraction ≥50%
* Scheduled for catheter ablation
* Able to speak, hear, and read English
* Willing and able to provide informed consent
Exclusion Criteria:
* Persistent or permanent AF
* Prior ablation (catheter based or surgical) for AF
* Significant sinus node dysfunction
* Implanted pacemaker or defibrillator
* Contraindication to or inability to complete cardiovascular magnetic resonance study
* Contraindication to or inability to complete exercise testing
* Chronic kidney disease with estimated glomerular filtration rate \<30 mL/min/1.73m2
* Severe left ventricular hypertrophy
* Unrelated cardiomyopathy that is expected to limit exercise capacity, including but not limited to:
* Hypertrophic cardiomyopathy
* Cardiac amyloidosis
* Constrictive pericarditis
* Pulmonary arterial hypertension
* Prior cardiac surgery
* Active pregnancy BEHAVIORAL: Self- Report Evaluation-Duke Activity Status Index, BEHAVIORAL: Self- Report Evaluation Atrial Fibrillation Effect on Quality of Life Questionnaire, DIAGNOSTIC_TEST: Cardiopulmonary exercise test (CPET), DIAGNOSTIC_TEST: Transthoracic echocardiogram, DIAGNOSTIC_TEST: Ambulatory cardiac rhythm assessment, DIAGNOSTIC_TEST: Cardiovascular magnetic resonance (CMR)
Paroxysmal Atrial Fibrillation
Catheter ablation, Exercise capacity
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| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia | Pamela Grizzard - (pamela.grizzard@vcuhealth.org) Melissa Sears - (melissa.sears@vcuhealth.org) |
Targeting Trimethylamine N-Oxide for Cardiovascular Health In Liver Transplant Recipients
Patrice Wiecek - wiecekpj@vcu.edu
NCT06043531
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Inclusion Criteria:
* Aged \> 18 years
* Speak and understand English
* Have received and LT
Exclusion Criteria:
* Acute cellular or chronic rejection within 3 months
* Post-LT liver or non-liver related malignancy
* Active viral hepatitis (B or C) or autoimmune hepatitis
* Untreated biliary strictures or vascular complications (e.g. hepatic artery thrombosis)
* Poorly controlled diabetes (HbA1c \>8.5%)
* Relapse of alcohol use after LT
* Follow a vegetarian or vegan diet
* Current pregnancy
* Unable to provide informed consent OTHER: Experimental: EVOO
Liver Transplant
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| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia | Danielle Kirkman - (dlkirkman@vcu.edu) Patrice Wiecek - (wiecekpj@vcu.edu) |
Effect of Clear Aligner Attachment Size on Extrusion of Maxillary Lateral Incisors
Alexis Catalano - catalanoam2@vcu.edu
NCT06814262
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Inclusion Criteria:
* Patients treated with either Comprehensive Invisalign or Invisalign Teen treatment
* The maxillary arch has less than 6 mm of crowding or spacing
* Maxillary lateral incisors have a minimum of 0.3 mm of extrusion prescribed in the Tooth Movement Table on the Invisalign ClinCheck for the first set of aligners
* Maxillary lateral incisors within a normal range of bucco-lingual inclination
* Patients 12 years of age or older and either the patient or legal guardian are able to give consent
* Patients confirm good compliance throughout the study period
Exclusion Criteria:
* Patients do not complete all aligners in the first phase as prescribed
* Poor compliance recorded for aligner wear
* Restorations placed or oral surgery completed prior to final scan
* Midcourse intervention to improve tracking such as a bootstrap
* Maxillary lateral incisors not tracking and noted by minimum of 1 mm of aligner material incisally displaced when aligner fully seated
* Treatment plans include surgery or extractions
* Maxillary lateral incisors with pathology and restorations
* Missing teeth other than third molars
* Patients with anterior crossbite DEVICE: Corresponding treatment order in the prescription with Align Technology, DEVICE: Superimposition of final and initial positions of lateral incisors: Predicted model, DEVICE: Superimposition of final and initial positions of lateral incisors: Gingivally beveled 1x1x3mm aligners, DEVICE: Superimposition of final and initial positions of lateral incisors: Gingivally beveled 1x1x4mm aligners, DEVICE: Superimposition of final and initial positions of lateral incisors: Gingivally beveled 1x1x5mm aligners
Orthodontic Appliance Complication
Extrusion of Maxillary Lateral Incisors, Clear Aligner Attachment
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| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia | Alexis Catalano - (catalanoam2@vcu.edu) Steven Lindauer - (sjlindau@vcu.edu) |
LOTUS-CC: An Observational Research Study to Uncover Subtypes of Cancer Cachexia (LOTUS)
Ashley Mack, MS - URCC_22063@urmc.rochester.edu
NCT06073431
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Inclusion Criteria:
* Have a primary diagnosis of unresectable or stage IV 1) non-small cell lung cancer (NSCLC), 2) pancreatic adenocarcinoma, or 3) colorectal cancer
* Note: Patients do not need to have cachexia to be eligible
* Plan to start first-line systemic anti-cancer therapy (chemotherapy, immunotherapy, targeted therapy, interventional clinical trial) in the next 6 weeks or has started first-line systemic therapy in the previous 6 weeks.
* NOTE: Patients who received systemic anti-cancer therapy previously as part of adjuvant or neoadjuvant treatment and have since recurred are still eligible if such treatment ended \> 6 months prior to enrollment. Patients receiving concurrent radiation with systemic therapy or received local therapy alone (surgery, radiation therapy \[RT\]) prior to first line therapy remain eligible. Patients receiving maintenance treatment after first line therapy are not eligible
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
* Be able to understand, speak and read English
* Be 18 years of age or older
Exclusion Criteria:
* Have contraindications to physical function assessments (30-second arm curl, Timed-Up-And-Go test, or 30-second chair-stand test) per the treating provider or their designee
* Have any planned major surgeries within the next 3 months
* Have received chemotherapy or surgery for separate primary cancer within the past 3 years other than early local staged non-melanoma skin cancer
* Be pregnant PROCEDURE: Biospecimen Collection, PROCEDURE: Computed Tomography, OTHER: Electronic Health Record Review, OTHER: Medical Device Usage and Evaluation, OTHER: Physical Performance Testing, PROCEDURE: Positron Emission Tomography, OTHER: Survey Administration
Advanced Colorectal Carcinoma, Advanced Lung Non-Small Cell Carcinoma, Advanced Pancreatic Adenocarcinoma, Stage IV Colorectal Cancer AJCC v8, Stage IV Lung Cancer AJCC v8, Stage IV Pancreatic Cancer AJCC v8, Unresectable Colorectal Carcinoma, Unresectable Lung Non-Small Cell Carcinoma, Unresectable Pancreatic Adenocarcinoma
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| Location | Contacts |
|---|---|
| AMG Crystal Lake - Oncology Crystal Lake, Illinois | Site Public Contact - (advocateresearch@advocate.com) |
| AMG Libertyville - Oncology Libertyville, Illinois | Site Public Contact - (advocateresearch@advocatehealth.com) |
| Abbott-Northwestern Hospital Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Advocate Christ Medical Center Oak Lawn, Illinois | |
| Advocate Good Samaritan Hospital Downers Grove, Illinois | Site Public Contact - (Barbara.barhamand@advocatehealth.com) |
| Advocate Good Shepherd Hospital Barrington, Illinois | |
| Advocate Illinois Masonic Medical Center Chicago, Illinois | |
| Advocate Lutheran General Hospital Park Ridge, Illinois | |
| Advocate Outpatient Center - Oak Lawn Oak Lawn, Illinois | Site Public Contact - (ncorp@aah.org) |
| Advocate Sherman Hospital Elgin, Illinois | |
| Advocate South Suburban Hospital Hazel Crest, Illinois | |
| AnMed Health Cancer Center Anderson, South Carolina | Site Public Contact - (rhonda.ballew@anmedhealth.org) |
| Armes Family Cancer Center Findlay, Ohio | |
| Ascension All Saints Hospital Racine, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Ascension Calumet Hospital Chilton, Wisconsin | Site Public Contact - (AWRI.inquiry@ascension.org) |
| Ascension Columbia Saint Mary's Hospital - Milwaukee Milwaukee, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Ascension Columbia Saint Mary's Hospital Ozaukee Mequon, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Ascension Medical Group Southeast Wisconsin - Mayfair Road Wauwatosa, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Ascension Mercy Hospital Oshkosh, Wisconsin | Site Public Contact - (AWRI.inquiry@ascension.org) |
| Ascension Saint Elizabeth Hospital Appleton, Wisconsin | Site Public Contact - (AWRI.inquiry@ascension.org) |
| Ascension Saint Francis - Reiman Cancer Center Franklin, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Ascension Southeast Wisconsin Hospital - Elmbrook Campus Brookfield, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Aurora Bay Area Medical Group-Marinette Marinette, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora BayCare Medical Center Green Bay, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Grafton Grafton, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Kenosha South Kenosha, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Milwaukee Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Milwaukee West Wauwatosa, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Racine Racine, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Southern Lakes VLCC Burlington, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Health Care Germantown Health Center Germantown, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Health Center - Greenfield Greenfield, Wisconsin | Site Public Contact - (ncorp@aah.org) |
| Aurora Medical Center in Summit Summit, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Saint Luke's Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Saint Luke's South Shore Cudahy, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Sinai Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora West Allis Medical Center West Allis, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| BJC Outpatient Center at Sunset Hills Sunset Hills, Missouri | |
| Beebe Health Campus Rehoboth Beach, Delaware | Site Public Contact - (research@beebehealthcare.org) |
| Beebe South Coastal Health Campus Millville, Delaware | Site Public Contact - (research@beebehealthcare.org) |
| Blanchard Valley Hospital Findlay, Ohio | |
| Boulder Community Foothills Hospital Boulder, Colorado | |
| Bronson Methodist Hospital Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Cancer Care Center of O'Fallon O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Care Specialists of Illinois - Decatur Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Center of Western Wisconsin New Richmond, Wisconsin | Site Public Contact - (mmcorc@healthpartners.com) |
| Carle BroMenn Medical Center Normal, Illinois | Site Public Contact - (Research@Carle.com) |
| Carle Cancer Center Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Cancer Institute Normal Normal, Illinois | Site Public Contact - (Research@Carle.com) |
| Carle at The Riverfront Danville, Illinois | Site Public Contact - (Research@Carle.com) |
| Carson Tahoe Regional Medical Center Carson City, Nevada | Site Public Contact - (research@sncrf.org) |
| Centralia Oncology Clinic Centralia, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Christiana Care - Union Hospital Elkton, Maryland | Site Public Contact - (frank.crum@christianacare.org) |
| Christiana Care Health System-Christiana Hospital Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Christiana Care Health System-Wilmington Hospital Wilmington, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Colorado Blood Cancer Institute Denver, Colorado | |
| Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Henderson Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Northwest Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Town Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada-Southeast Henderson Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada-Summerlin Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Condell Memorial Hospital Libertyville, Illinois | Site Public Contact - (advocateresearch@advocatehealth.com) |
| Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Crossroads Cancer Center Effingham, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Dayton Physician LLC - Englewood Dayton, Ohio | |
| Dayton Physicians LLC - Troy Troy, Ohio | |
| Dayton Physicians LLC-Atrium Franklin, Ohio | |
| Decatur Memorial Hospital Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Dickinson County Healthcare System Iron Mountain, Michigan | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Fairview Clinics and Surgery Center Maple Grove Maple Grove, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Fairview Lakes Medical Center Wyoming, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Fairview Northland Medical Center Princeton, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Fairview Southdale Hospital Edina, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Geisinger Medical Center Danville, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Geisinger Medical Oncology-Lewisburg Lewisburg, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Gibbs Cancer Center-Gaffney Gaffney, South Carolina | Site Public Contact - (kmertz-rivera@gibbscc.org) |
| Gibbs Cancer Center-Pelham Greer, South Carolina | Site Public Contact - (kmertz-rivera@gibbscc.org) |
| Greater Dayton Cancer Center Kettering, Ohio | |
| HSHS Sacred Heart Hospital Eau Claire, Wisconsin | |
| HSHS Saint Elizabeth's Hospital O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Hawaii Cancer Care - Westridge ‘Aiea, Hawaii | Site Public Contact - (info@hawaiicancercare.com) |
| Hawaii Cancer Care Inc - Waterfront Plaza Honolulu, Hawaii | Site Public Contact - (i.webster@hawaiicancercare.com) |
| Helen F Graham Cancer Center Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Hennepin County Medical Center Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Highland Hospital Rochester, New York | |
| Illinois CancerCare - Washington Washington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Bloomington Bloomington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Canton Canton, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Carthage Carthage, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Dixon Dixon, Illinois | |
| Illinois CancerCare-Eureka Eureka, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Galesburg Galesburg, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Kewanee Clinic Kewanee, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Macomb Macomb, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Ottawa Clinic Ottawa, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Pekin Pekin, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Peoria Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Peru Peru, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Princeton Princeton, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Indu and Raj Soin Medical Center Beavercreek, Ohio | |
| John B Amos Cancer Center Columbus, Georgia | Site Public Contact - (cdean@iacthealth.com) |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | |
| Kettering Medical Center Kettering, Ohio | |
| Lake Regional Hospital Osage Beach, Missouri | Site Public Contact - (clinicaltrials@lakeregional.com) |
| Lakeview Hospital Stillwater, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Lenox Hill Hospital New York, New York | |
| Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah, Georgia | Site Public Contact - (underberga@sjchs.org) |
| Manhattan Eye Ear and Throat Hospital New York, New York | |
| Marietta Memorial Hospital Marietta, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Marshfield Medical Center - Minocqua Minocqua, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center - Weston Weston, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center-EC Cancer Center Eau Claire, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center-Marshfield Marshfield, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center-Rice Lake Rice Lake, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center-River Region at Stevens Point Stevens Point, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| MedStar Georgetown University Hospital Washington D.C., District of Columbia | |
| Medical Oncology Hematology Consultants PA Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Memorial Health University Medical Center Savannah, Georgia | Site Public Contact - (Lorraine.OHara@hcahealthcare.com) |
| Memorial Hospital of Carbondale Carbondale, Illinois | Site Public Contact - (clinical.research@sih.net) |
| Mercy Hospital Coon Rapids, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Mercy Hospital Fort Smith Fort Smith, Arkansas | |
| Mercy Hospital South St Louis, Missouri | Site Public Contact - (Danielle.Werle@mercy.net) |
| Mercy Hospital Springfield Springfield, Missouri | |
| Methodist Medical Center of Illinois Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Minnesota Oncology - Burnsville Burnsville, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Minnesota Oncology Hematology PA-Maplewood Maplewood, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Minnesota Oncology Hematology PA-Woodbury Woodbury, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Missouri Baptist Medical Center St Louis, Missouri | |
| Missouri Baptist Sullivan Hospital Sullivan, Missouri | |
| Monticello Cancer Center Monticello, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| New Ulm Medical Center New Ulm, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| North Memorial Medical Health Center Robbinsdale, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Northeast Georgia Medical Center Braselton Braselton, Georgia | Site Public Contact - (cancerpatient.navigator@nghs.com) |
| Northeast Georgia Medical Center-Gainesville Gainesville, Georgia | Site Public Contact - (cancerpatient.navigator@nghs.com) |
| Northside Hospital Atlanta, Georgia | Site Public Contact - (ClinicalTrials@northside.com) |
| Northside Hospital - Duluth Duluth, Georgia | Site Public Contact - (Clinical.trials@northside.com) |
| Northside Hospital - Gwinnett Lawrenceville, Georgia | Site Public Contact - (Clinical.trials@northside.com) |
| Northwell Health/Center for Advanced Medicine Lake Success, New York | |
| Noyes Memorial Hospital/Myers Cancer Center Dansville, New York | Site Public Contact - (WCICTOresearch@urmc.rochester.edu) |
| OSF Saint Anthony's Health Center Alton, Illinois | |
| Ochsner Medical Center Jefferson New Orleans, Louisiana | Site Public Contact - (Elisemarie.curry@ochsner.org) |
| Oncology Hematology Care Inc-Kenwood Cincinnati, Ohio | |
| OptumCare Cancer Care at Charleston Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at Fort Apache Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at MountainView Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at Seven Hills Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Pali Momi Medical Center ‘Aiea, Hawaii | |
| Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Parkland Health Center - Farmington Farmington, Missouri | |
| PeaceHealth Saint John Medical Center Longview, Washington | Site Public Contact - (kmakin-bond@peacehealth.org) |
| PeaceHealth Saint Joseph Medical Center Bellingham, Washington | |
| PeaceHealth Southwest Medical Center Vancouver, Washington | Site Public Contact - (kmakin-bond@peacehealth.org) |
| Pluta Cancer Center Rochester, New York | Site Public Contact - (ctsucontact@westat.com) |
| Prisma Health Cancer Institute - Butternut Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Eastside Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Faris Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Providence Newberg Medical Center Newberg, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Portland Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Saint Vincent Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Willamette Falls Medical Center Oregon City, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Queen's Cancer Cenrer - POB I Honolulu, Hawaii | |
| Queen's Cancer Center - Kuakini Honolulu, Hawaii | |
| Queen's Cancer Center - Pearlridge ‘Aiea, Hawaii | |
| Queen's Medical Center Honolulu, Hawaii | |
| Regions Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Reid Health Richmond, Indiana | |
| Renown Regional Medical Center Reno, Nevada | Site Public Contact - (research@sncrf.org) |
| Rice Memorial Hospital Willmar, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Ridgeview Medical Center Waconia, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Rocky Mountain Cancer Centers - Centennial Centennial, Colorado | |
| Rocky Mountain Cancer Centers - Swedish Englewood, Colorado | |
| Rocky Mountain Cancer Centers-Aurora Aurora, Colorado | |
| Rocky Mountain Cancer Centers-Boulder Boulder, Colorado | |
| Rocky Mountain Cancer Centers-Lakewood Lakewood, Colorado | |
| Rocky Mountain Cancer Centers-Littleton Littleton, Colorado | |
| Rocky Mountain Cancer Centers-Midtown Denver, Colorado | |
| Rocky Mountain Cancer Centers-Rose Denver, Colorado | |
| Rocky Mountain Cancer Centers-Sky Ridge Lone Tree, Colorado | |
| Rocky Mountain Cancer Centers-Thornton Thornton, Colorado | |
| SIH Cancer Institute Carterville, Illinois | Site Public Contact - (clinical.research@sih.net) |
| SMC Center for Hematology Oncology Union Union, South Carolina | Site Public Contact - (kmertz-rivera@gibbscc.org) |
| Saint Elizabeth Boardman Hospital Boardman, Ohio | |
| Saint Elizabeth Youngstown Hospital Youngstown, Ohio | |
| Saint Francis Regional Medical Center Shakopee, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Saint John's Hospital - Healtheast Maplewood, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Saint Joseph Warren Hospital Warren, Ohio | |
| Saint Joseph's/Candler - Bluffton Campus Bluffton, South Carolina | Site Public Contact - (underberga@sjchs.org) |
| Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Sainte Genevieve County Memorial Hospital Sainte Genevieve, Missouri | |
| Shenandoah Oncology PC Winchester, Virginia | Site Public Contact - (William.Houck@usoncology.com) |
| South Carolina Cancer Specialists PC Hilton Head Island, South Carolina | Site Public Contact - (underberga@sjchs.org) |
| South Georgia Medical Center/Pearlman Cancer Center Valdosta, Georgia | Site Public Contact - (maryann.heddon@sgmc.org) |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| Spartanburg Medical Center Spartanburg, South Carolina | Site Public Contact - (kmertz-rivera@gibbscc.org) |
| Springfield Clinic Springfield, Illinois | |
| Springfield Memorial Hospital Springfield, Illinois | Site Public Contact - (pallante.beth@mhsil.com) |
| Straub Clinic and Hospital Honolulu, Hawaii | |
| Strecker Cancer Center-Belpre Belpre, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Summerlin Hospital Medical Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| The Longstreet Clinic - Gainesville Gainesville, Georgia | |
| The Melanoma and Skin Cancer Institute Englewood, Colorado | |
| The Queen's Medical Center - West Oahu ‘Ewa Beach, Hawaii | Site Public Contact - (rohta@queens.org) |
| The Women's Imaging Center Denver, Colorado | |
| ThedaCare Regional Cancer Center Appleton, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| Tift Regional Medical Center Tifton, Georgia | |
| Trinity Health Grand Rapids Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| United Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| University of Rochester Rochester, New York | |
| Urology Specialists of Nevada - Green Valley Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Urology Specialists of Nevada - Northwest Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Urology Specialists of Nevada - Southwest Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| VCU Community Memorial Health Center South Hill, Virginia | Site Public Contact - (nemer.elmouallem@vcuhealth.org) |
| Valley Medical Center Renton, Washington | Site Public Contact - (research@valleymed.org) |
| Valley Radiation Oncology Peru, Illinois | |
| Vince Lombardi Cancer Clinic - Oshkosh Oshkosh, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Vince Lombardi Cancer Clinic-Sheboygan Sheboygan, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Vince Lombardi Cancer Clinic-Two Rivers Two Rivers, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Wayne Hospital Greenville, Ohio | |
| West Michigan Cancer Center Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Wilmot Cancer Institute Radiation Oncology at Greece Rochester, New York | |
| Wilmot Cancer Institute at Webster Webster, New York | Site Public Contact - (WCICTOresearch@urmc.rochester.edu) |
Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587/KEYNOTE-587)
Toll Free Number - Trialsites@msd.com
NCT03486873
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Inclusion Criteria:
* Treated on the parent pembrolizumab studies established by the Sponsor as MK-3475-587 ready.
* Currently receiving pembrolizumab, pembrolizumab based combinations or lenvatinib from parent studies or in a follow-up phase.
Additional eligibility criteria for participants who enter Second Course Phase once they are enrolled on MK-3475-587:
* Has not received any anticancer systemic treatment since the last dose of pembrolizumab or a pembrolizumab-based combination in First Course Phase.
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Demonstrates adequate organ function.
* Have resolution of any toxic effect(s) of First Course Phase trial treatment with pembrolizumab or a pembrolizumab-based combination to Grade 1 or less (except alopecia) before trial treatment in Second Course Phase is started. If participant received major surgery or radiation therapy of \>30 Gray (Gy), they must have recovered from the toxicity and/or complications of the intervention.
* A female participant is eligible to enroll if she is not pregnant, not breastfeeding, and ≥1 of the following conditions applies: A woman of childbearing potential (WOCBP) who agrees to use contraception during the study treatment period and for ≥120 days (corresponding to time needed to eliminate any study combination treatment(s) plus 30 days (a menstruation cycle) for study treatments with risk of genotoxicity.
Additional eligibility criteria for participants who enter dosing with Lenvatinib:
* Adequately controlled blood pressure (BP) to \<150/90 mmHg, with or without antihypertensive medications.
* For male agrees to be abstinent from penile-vaginal intercourse OR agrees to use a highly effective contraceptive method while receiving study drug and for 7 days after the last dose of lenvatinib.
* Is female and not pregnant/breastfeeding and at least one of the following applies during the study and for ≥4 days after: is not a woman of childbearing potential (WOCBP), is a WOCBP and uses highly effective contraception (low user dependency method OR a user dependent hormonal method in combination with a barrier method) or is a WOCBP who is abstinent from heterosexual intercourse.
Exclusion Criteria:
-There are no exclusion criteria to participate in MK-3475-587.
Participants are excluded from entering Second Course trial treatment once they are enrolled on MK-3475-587 if any of the following criteria applies:
* Has severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients.
* Has received a live vaccine within 30 days prior to the first dose of Second Course Phase trial treatment.
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the Cycle 1 Day 1 of Second Course Phase.
* Has a known additional malignancy that is progressing or requires active treatment. Exceptions include early stage cancers (carcinoma in situ or Stage 1) treated with curative intent, melanoma (non-ulcerated, thin primary), basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, or in situ breast cancer that has undergone potentially curative therapy.
* Has known active central nervous system metastases and/or carcinomatous meningitis.
* Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
* Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. Note: Participants that experienced pneumonitis during First Course that did not meet the criteria for permanent discontinuation are eligible.
* Non-small cell lung cancer (NSCLC) participants only: Has interstitial lung disease.
* Has an active infection requiring systemic therapy.
* Has a known history of human immunodeficiency virus (HIV) infection.
* Has a known history of or is positive for hepatitis B or hepatitis C. For parent studies where inclusion of participants with hepatitis was permitted, MK-3475-587 will follow the parent study eligibility criteria for hepatitis.
* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the Second Course Phase eligibility Visit through 120 days after the last dose of study treatment.
* Has severe cardiovascular disease, i.e., arrhythmias, requiring chronic treatment, congestive heart failure (New York Heart Association Class III or IV) or symptomatic ischemic heart disease.
* Has hepatic decompensation (Child-Pugh score \>6 \[class B and C\]).
* Has uncontrolled thyroid dysfunction.
* Has uncontrolled diabetes mellitus.
* Has had an allogeneic tissue/solid organ transplant.
* Has a known history of active tuberculosis (TB; Bacillus tuberculosis).
Additional exclusion criteria for participants who enter dosing with Lenvatinib:
* Has had major surgery within 3 weeks prior to first dose of study intervention(s).
* Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula.
* Has urine protein ≥1 g/24 hours.
* Has LVEF below the institutional (or local laboratory) normal range, as determined by multigated acquisition scan (MUGA) or echocardiogram (ECHO).
* Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation.
* Prolongation of QT intervals corrected for heart rate using Fridericia's (cube root) correction (QTcF) interval to \>480 ms.
* Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability.
* Gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib.
* Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug.
* Has a history of any contraindication or has a severe hypersensitivity to any components of lenvatinib. DRUG: Pembrolizumab, DRUG: Standard of Care (SOC), DRUG: Lenvatinib, DRUG: Olaparib, DRUG: MK-4280, BIOLOGICAL: MK-4280A
Solid Tumors, Hematologic Malignancies
PD1, PD-1, PDL1, PD-L1
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Show 752 locations
Study Locations
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| Location | Contacts |
|---|---|
| A. C. Camargo Cancer Center ( Site 1002) São Paulo, | |
| AO Santa Maria della Misericordia-Oncology Department ( Site 1971) Perugia, Umbria | |
| AZ Maria Middelares ( Site 2908) Ghent, Oost-Vlaanderen | |
| AZ Sint-Maarten ( Site 2904) Mechelen, Antwerpen | |
| Aberdeen Royal Infirmary-Department of Oncology ( Site 0521) Aberdeen, Aberdeen City | |
| Acibadem Adana Hospital-Pediatric Hematology-Oncology ( Site 1312) Adana, | |
| Acibadem Altunizade Hospital-Oncology ( Site 1317) Üsküdar /Istanbul, Istanbul | |
| Acibadem Universitesi Atakent Hastanesi ( Site 1319) Istanbul, | |
| Acıbadem Maslak Hastanesi-Medical Oncology ( Site 1321) Istanbul, | |
| Ad-Vance Medical Research-Research ( Site 1151) Ponce, | |
| Adana Sehir Egitim ve Arastirma Hastanesi ( Site 1324) Adana, | |
| Addenbrookes Hospital ( Site 0522) Cambridge, Cambridgeshire | |
| Administradora Country S.A. ( Site 2701) Bogotá, Bogota D.C. | |
| Aichi Cancer Center ( Site 3101) Nagoya, Aichi-ken | |
| Ajou University Hospital ( Site 0969) Suwon, Kyonggi-do | |
| Akdeniz Universitesi Hastanesi-Medical Onkology ( Site 1318) Antalya, | |
| Almazov National Medical Research Centre ( Site 1233) Saint Petersburg, Sankt-Peterburg | |
| Altai Regional Clinical Oncology Center ( Site 1229) Barnaul, Altayskiy Kray | |
| Ambroise Pare Hopital ( Site 2503) Boulogne, Hauts-de-Seine | |
| Amsterdam UMC, locatie VUmc ( Site 1555) Amsterdam, North Holland | |
| Andreas Syggros Hospital ( Site 1853) Athens, Attica | |
| Anhui Provincial Hospital-Cancer Chemotherapy Department ( Site 3480) Hefei, Anhui | |
| Anhui Provincil Hospital South District-Respiratory Medicine Dept ( Site 3487) Hefei, Anhui | |
| Ankara City Hospital-Medical Oncology ( Site 1311) Ankara, | |
| Ankara University Health Practice and Research Hospitals ( Site 1331) Ankara, | |
| Ankara University Hospital Cebeci ( Site 1306) Ankara, | |
| Antoni van Leeuwenhoek Ziekenhuis ( Site 1551) Amsterdam, North Holland | |
| Arizona Cancer Center at UMC North ( Site 0018) Tucson, Arizona | |
| Army Medical Center of People's Liberation Army-Oncology Department ( Site 3477) Chongqing, Chongqing Municipality | |
| Arthur J.E. Child Comprehensive Cancer Centre ( Site 2815) Calgary, Alberta | |
| Asan Medical Center ( Site 0952) Songpagu, Seoul | |
| Asklepion Medical Center ( Site 3667) Khodosovka, Kyivska Oblast | |
| Atatürk Üniversitesi ( Site 1333) Erzurum, | |
| Auckland City Hospital ( Site 1503) Auckland, | |
| Augusta University ( Site 0077) Augusta, Georgia | |
| Austin Health-Austin Hospital ( Site 3004) Heidelberg, Victoria | |
| Avix Investigación Clinica, S.C.-Oncology ( Site 1104) Monterrey, Nuevo León | |
| Azienda Ospedaliera San Camillo Forlanini ( Site 1958) Roma, | |
| Azienda Ospedaliera San Gerardo ( Site 1980) Monza, Lombardy | |
| Azienda Ospedaliera Santa Maria ( Site 1962) Terni, | |
| Azienda Ospedaliera Spedali Civili di Brescia-Oncology ( Site 1972) Brescia, | |
| Azienda Ospedaliero Universitaria di Parma-UO Oncologia Medica ( Site 1964) Parma, | |
| Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino ( Site 1974) Torino, | |
| Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII-UOC Oncologia ( Site 1967) Bergamo, | |
| BP - A Beneficencia Portuguesa de São Paulo-Medical Oncology ( Site 1030) São Paulo, | |
| Bacs-Kiskun Varmegyei Oktatokorhaz-Onkoradiologiai Kozpont ( Site 1419) Kecskemét, Bács-Kiskun county | |
| Ballarat Oncology & Haematology Services ( Site 3022) Wendouree, Victoria | |
| Baptist MD Anderson Cancer Center ( Site 0083) Jacksonville, Florida | |
| Barts Health NHS Trust ( Site 0512) London, London, City of | |
| Bashkir State Medical University ( Site 1221) Ufa, Baskortostan, Respublika | |
| Baskent Universitesi Ankara Hastanesi ( Site 1303) Ankara, | |
| Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 1307) Adana, | |
| Beijing Cancer Hospital ( Site 3451) Beijing, Beijing Municipality | |
| Beijing Cancer Hospital ( Site 3499) Beijing, Beijing Municipality | |
| Beijing Cancer Hospital ( Site 3500) Beijing, Beijing Municipality | |
| Beijing Cancer hospital-Thoracic Cancer Department A ( Site 3454) Beijing, Beijing Municipality | |
| Belfast City Hospital ( Site 0508) Belfast, Northern Ireland | |
| Belgorod Oncology Dispensary ( Site 1213) Belgorod, Belgorod Oblast | |
| Bezmialem Vakf Üniversitesi-Oncology ( Site 1308) Istanbul, | |
| Bialostockie Centrum Onkologii ( Site 1610) Bialystok, Podlaskie Voivodeship | |
| Biocenter ( Site 2763) Concepción, Región del Biobío | |
| Blod och Tumorssjukdomar. Akademiska sjukhuset ( Site 0801) Uppsala, Uppsala County | |
| Blue Ridge Cancer Care ( Site 0067) Roanoke, Virginia | |
| Bnai Zion Medical Center ( Site 2060) Haifa, | |
| Bon Secours St. Francis Medical Center-Oncology Research ( Site 0075) Midlothian, Virginia | |
| Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház ( Site 1409) Miskolc, Borsod-Abauj Zemplen county | |
| Bradfordhill-Clinical Area ( Site 2756) Santiago, Region M. de Santiago | |
| Békés Megyei Központi Kórház Pándy Kálmán Tagkórház-Megyei Onkológiai Centrum ( Site 1405) Gyula, Bekes County | |
| C.H.U. Pontchaillou ( Site 2511) Pierre-Bénite, Rhone | |
| C.H.U. de Tours - Hopital Bretonneau ( Site 2515) Tours, Indre-et-Loire | |
| CELAN,S.A ( Site 3405) Guatemala City, | |
| CEPEN - Centro de Pesquisa e Ensino em Oncologia de Santa Catarina ( Site 1034) Florianópolis, Santa Catarina | |
| CEPON ( Site 1012) Florianópolis, Santa Catarina | |
| CH Lyon Sud Hospices Civils de Lyon ( Site 2521) Pierre-Bénite, Auvergne-Rhône-Alpes | |
| CHA Bundang Medical Center CHA University ( Site 0957) Seongnam-si, Kyonggi-do | |
| CHRU Brest - Hopital Cavale Blanche ( Site 2504) Brest, Finistere | |
| CHRU Lille Hospital Claude Huriez ( Site 2506) Lille, Nord | |
| CHU Bordeaux Haut-Leveque ( Site 2534) Pessac, Aquitaine | |
| CHU Hopital Saint Antoine ( Site 2517) Paris, | |
| CHU Jean Minjoz ( Site 2520) Besançon, Doubs | |
| CHU La Timone ( Site 2508) Marseille, Bouches-du-Rhone | |
| CHU Montpellier. ( Site 2556) Montpellier, Herault | |
| CHU Toulouse - Hopital Rangueil ( Site 2518) Toulouse, Haute-Garonne | |
| CHU de Toulouse - Hopital Larrey-service de pneumologie ( Site 2526) Toulouse, Haute-Garonne | |
| CHU-Jean Minjoz ( Site 2550) Besançon, Doubs | |
| CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 0876) Santiago de Compostela, La Coruna | |
| CIDO SpA ( Site 2765) Temuco, Región de la Araucanía | |
| CIMCA ( Site 3900) San José, | |
| COMMUNAL NONPROFIT ENTERPRISE "CLINICAL CENTER OF ONCOLOGY, HEMATOLOGY, TRANSPLANTOLOGY AND PALLIATI ( Site 3671) Cherkasy, Cherkasy Oblast | |
| CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA-Pesquisa Clínica ( Site 1024) Fortaleza, Ceará | |
| Cabinet Medical Oncomed ( Site 3554) Timișoara, Timiș County | |
| California Cancer Associates for Research & Excellence ( Site 0016) Fresno, California | |
| Calvary Mater Newcastle ( Site 3005) Waratah, New South Wales | |
| Cancer Institute Hospital of JFCR ( Site 3108) Tokyo, | |
| Cancer Institute Hospital of JFCR ( Site 3146) Koto, Tokyo | |
| Cancer Institute Hospital of JFCR ( Site 3164) Koto, Tokyo | |
| Cancer Institute of New Jersey ( Site 0025) New Brunswick, New Jersey | |
| CancerCare Manitoba ( Site 2814) Winnipeg, Manitoba | |
| Canterbury Regional Cancer & Blood Service ( Site 1500) Christchurch, Canterbury | |
| Cape Town Oncology Trials ( Site 2007) Cape Town, Western Cape | |
| Capital & Coast District Health Board - Wellington Hospital ( Site 1501) Wellington, | |
| Cardiomed SRL Cluj-Napoca ( Site 3555) Cluj-Napoca, Cluj | |
| Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 2525) Rennes, Ille-et-Vilaine | |
| Centre Francois Baclesse ( Site 2558) Caen, Calvados | |
| Centre Georges François Leclerc-Centre de recherche clinique ( Site 2536) Dijon, Cote-d Or | |
| Centre Henri Becquerel ( Site 2547) Rouen, Seine-Maritime | |
| Centre Hopitalar Leon-Berard ( Site 2519) Lyon, Auvergne | |
| Centre Hopitalier Intercommunal Creteil ( Site 2514) Créteil, Val-de-Marne | |
| Centre Hospitalier Annecy Genevois ( Site 2554) Epagny Metz Tessy, Haute-Savoie | |
| Centre Hospitalier Universitaire de Nice - Hôpital l'Archet-Dermatology Department ( Site 2539) Nice, Alpes-Maritimes | |
| Centre Hospitalier Universitaire de Poitiers-Dermatologie ( Site 2544) Poitiers, Vienne | |
| Centre Hospitalier de l Universite de Montreal - CHUM ( Site 2807) Montreal, Quebec | |
| Centre Hospitalier du Mans-Pneumologie ( Site 2527) Le Mans, Sarthe | |
| Centre Intégré de Santé et de Services Sociaux (CISSS) de La-Centre intégré de cancérologie de Lava ( Site 2810) Laval, Quebec | |
| Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre-Oncology ( Site 2809) Greenfield Park, Quebec | |
| Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne-ONCOLOGY ( Site 2542) Clermont-Ferrand, Puy-de-Dome | |
| Centre Oscar Lambret ( Site 2551) Lille, Hauts-de-France | |
| Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-centre-du-quebec ( Site 2816) Trois-Rivières, Quebec | |
| Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 2805) Québec, Quebec | |
| Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer ( Site 2812) Sherbrooke, Quebec | |
| Centro Hospitalar de Sao Joao - Hospital de Sao Joao ( Site 1752) Porto, | |
| Centro Integral Oncologico Clara Campal-Hospital HM Universitario Sanchinarro-START Madrid, ( Site 0869) Madrid, | |
| Centro Medico Privado CEMAIC ( Site 1371) Córdoba, | |
| Centro Medico San Roque-Oncology ( Site 1352) San Miguel de Tucumán, | |
| Centro Oncologico Norte. ( Site 1370) Santiago del Estero, | |
| Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) ( Site 1368) Buenos Aires., Buenos Aires | |
| Centro de Investigaciones ( Site 2755) Viña del Mar, Región de Valparaíso | |
| Centro de Oncología e Investigación de Buenos Aires ( Site 1357) Berazategui, Buenos Aires | |
| Centro de Pesquisa Clínica do Instituto do Câncer do Ceará ( Site 1016) Fortaleza, Ceará | |
| Centro de Urologa Avanzada del Noreste ( Site 1110) San Pedro Garza García, Nuevo León | |
| Centrul de Oncologie "Sfântul Nectarie" ( Site 3552) Craiova, Dolj | |
| Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1612) Bydgoszcz, Kuyavian-Pomeranian Voivodeship | |
| Chaim Sheba Medical Center ( Site 2055) Ramat Gan, | |
| Chaim Sheba Medical Center. ( Site 2052) Ramat Gan, | |
| Champalimaud Foundation ( Site 1751) Lisbon, Lisbon District | |
| Chang Gung Medical Foundation-Linkou Branch ( Site 3206) Taoyuan District, | |
| Changhua Christian Hospital ( Site 3210) Changhua, | |
| Chelyabinsk Regional Clinical Oncology Dispensary ( Site 1253) Chelyabinsk, Chelyabinsk Oblast | |
| Chiba Cancer Center ( Site 3117) Chiba, | |
| China Medical University Hospital ( Site 3204) Taichung, | |
| Chinese Academy of medical science, Peking Union Medical College Hospital(Dongdan) ( Site 3466) Beijing, Beijing Municipality | |
| Chonnam National University Hwasun Hospital-Hemato-Oncology ( Site 0959) Hwasun, Jeonranamdo | |
| Chris OBrien Lifehouse ( Site 3003) Camperdown, New South Wales | |
| Chulalongkorn University ( Site 2363) Bangkok, Bangkok | |
| Chungbuk National University Hospital ( Site 0961) Cheongju-si, North Chungcheong | |
| Chungnam national university hospital-Department of Internal Medicine ( Site 0958) Daejeon, Taejon-Kwangyokshi | |
| City Clinical Oncology Center ( Site 1237) Saint Petersburg, Sankt-Peterburg | |
| Clinica Universitaria de Navarra ( Site 0855) Madrid, | |
| Clinica Viedma ( Site 1353) Viedma, Río Negro Province | |
| Clinica Viver ( Site 1021) Santa Maria, Rio Grande do Sul | |
| Clinica de la Costa S.A.S. ( Site 2705) Barranquilla, Atlántico | |
| Clinical Research Center of specialized types medical care-Oncology ( Site 1205) Saint Petersburg, Sankt-Peterburg | |
| Clinique de L'Europe ( Site 2548) Amiens, Somme | |
| Cliniques Universitaires de Bruxelles - CUB - Hopital Erasme ( Site 2905) Brussels, Bruxelles-Capitale, Region de | |
| Cliniques universitaires Saint-Luc-Medical Oncology ( Site 2911) Brussels, Bruxelles-Capitale, Region de | |
| Clínica Imbanaco S.A.S ( Site 2708) Cali, Valle del Cauca Department | |
| Clínica Inmunocel ( Site 2762) Santiago, Region M. de Santiago | |
| Clínica de Pesquisa e Centro de Estudos em Ginecologia Oncológica e Mamária LTDA ( Site 1017) São Paulo, São Paulo | |
| Communal Non-Commercial Enterprise "Prykarpatski Clinical Oncological Center" of Ivano-Frankivsk Reg ( Site 3663) Ivano-Frankivsk, Ivano-Frankivsk Oblast | |
| Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council" ( Site 3662) Vinnytsia, Vinnytsia Oblast | |
| Complejo Hospitalario de Jaén-Servicio de Oncología Médica ( Site 0879) Jaén, | |
| Comprehensive Blood & Cancer Center [Bakersfield, CA] ( Site 0054) Bakersfield, California | |
| Comprehensive Cancer Centers of Nevada ( Site 0043) Las Vegas, Nevada | |
| Cross Cancer Institute ( Site 2804) Edmonton, Alberta | |
| Cuidados Oncologicos. ( Site 1118) Querétaro, | |
| Dana-Farber Cancer Institute ( Site 0006) Boston, Massachusetts | |
| Debreceni Egyetem Klinikai Kozpont-Belgyógyászati Klinika (Haematologia) ( Site 1415) Debrecen, | |
| Debreceni Egyetem Klinikai Kozpont-Onkológiai Klinika ( Site 1412) Debrecen, | |
| Derma Internacional SA ( Site 1372) CABA, Buenos Aires | |
| Dokkyo Medical University Saitama Medical Center ( Site 3152) Koshigaya, Saitama | |
| Dokuz Eylul Universitesi Hastanesi ( Site 1323) Izmir, | |
| Duke Cancer Center ( Site 0028) Durham, North Carolina | |
| Ege Universitesi Tip Fakultesi Hastanesi ( Site 1300) Izmir, | |
| Ehime University Hospital ( Site 3158) Tōon, Ehime | |
| Elbe Klinikum Buxtehude ( Site 2400) Buxtehude, Lower Saxony | |
| Emory School of Medicine ( Site 0013) Atlanta, Georgia | |
| Erasmus MC ( Site 1553) Rotterdam, South Holland | |
| EuroCityClinic ( Site 1230) Saint Petersburg, Sankt-Peterburg | |
| European Interbalkan Medical Center ( Site 1855) Thessaloniki, | |
| FDI Clinical Research ( Site 1152) San Juan, | |
| FSAI Treatment and Rehabilitation Centre of the MoH and SD of RF ( Site 1208) Moscow, Moscow | |
| FSBI-FRCC of Special Types Med. Care and Technologies FMBA of Russia ( Site 1234) Moscow, Moscow | |
| Facharztzentrum Eppendorf ( Site 2415) Hamburg, | |
| Faculty of Medicine - Khon Kaen University ( Site 2366) Muang, Changwat Khon Kaen | |
| Faculty of Medicine Siriraj Hospital ( Site 2365) Bangkok, Bangkok | |
| Fakultni Thomayerova nemocnice-Onkologicka klinika 1. LF UK ( Site 0702) Prague, Praha 4 | |
| Fakultni nemocnice Olomouc ( Site 0701) Olomouc, | |
| Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 0704) Olomouc, Olomoucký kraj | |
| Fakultni nemocnice v Motole ( Site 0700) Prague, | |
| Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 0705) Prague, Praha 5 | |
| Farkasgyepui Tudogyogyintezet-Pulmonologia ( Site 1414) Farkasgyepű, Veszprém megye | |
| Fejér Megyei Szent György Egyetemi Oktató Kórház-l.Pulmonologia ( Site 1407) Székesfehérvár, Fejér | |
| Fiona Stanley Hospital ( Site 3029) Murdock, Western Australia | |
| First Moscow State Medical University n.a. I.M.Sechenov ( Site 1245) Moscow, Moscow | |
| First Pavlov State Medical University of Saint Petersburg ( Site 1232) Saint Petersburg, Sankt-Peterburg | |
| Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1977) Milan, Lombardy | |
| Fondazione IRCCS Policlinico San Matteo ( Site 1982) Pavia, | |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 1975) Rome, Lazio | |
| Fox Chase Cancer Center ( Site 0042) Philadelphia, Pennsylvania | |
| Fred Hutchinson Cancer Center ( Site 0024) Seattle, Washington | |
| Fudan University Shanghai Cancer Center ( Site 3467) Shanghai, Shanghai Municipality | |
| Fujian Provincial Cancer Hospital ( Site 3461) Fuzhou, Fujian | |
| Fundacion Arturo Lopez Perez FALP ( Site 2750) Santiago, Region M. de Santiago | |
| Fundacion Colombiana de Cancerología Clinica Vida ( Site 2707) Medellín, Antioquia | |
| Fundacion Estudios Clinicos ( Site 1369) Rosario, Santa Fe Province | |
| Fundacion Favaloro ( Site 1367) CABA, Buenos Aires | |
| Fundación CORI para la Investigación y Prevención del Cáncer ( Site 1358) La Rioja, | |
| Fundación Valle del Lili ( Site 2700) Cali, Valle del Cauca Department | |
| Fundação Faculdade Regional de Medicina de São José do Rio Preto-Centro Integrado de Pesquisa ( Site 1003) São José do Rio Preto, São Paulo | |
| Fundação Pio XII - Hospital de Câncer de Barretos ( Site 1010) Barretos, São Paulo | |
| GBUZ LOKB ( Site 1218) Saint-Petersburg, Leningradskaya Oblast' | |
| GBUZ LOKB-Oncology department #1 ( Site 1222) Saint-Petersburg, Leningradskaya Oblast' | |
| GBUZ SK Pyatigorsk Interdistrict Oncology dispensary ( Site 1223) Pyatigorsk, Stavropol Kray | |
| GVI Oncology ( Site 2008) George, Western Cape | |
| Gachon University Gil Medical Center ( Site 0967) Inceon, Incheon | |
| Gallipoli Medical Research Ltd ( Site 3011) Brisbane, Queensland | |
| Gangnam Severance Hospital, Yonsei University Health System ( Site 0966) Gangnam-gu, Seoul | |
| Gazi University Health Research and Application Center Gazi Hospital ( Site 1325) Ankara, | |
| General Hospital of Athens "Laiko"-Hematology Department ( Site 1851) Athens, Attica | |
| Georgetown University Medical Center ( Site 0023) Washington D.C., District of Columbia | |
| Gifu University Hospital ( Site 3161) Gifu, | |
| Gleneagles Penang ( Site 0625) George Town, Pulau Pinang | |
| Gold Coast University Hospital ( Site 3028) Southport, Queensland | |
| Groupe Hospitalier Diaconesses Croix Saint Simon ( Site 2545) Paris, | |
| Groupe hospitalier Paris saint Joseph-Service de Pneumologie-Allergologie -Oncologie Thoracique ( Site 2533) Paris, Île-de-France Region | |
| Grupo Medico Angeles ( Site 3402) Guatemala City, | |
| Guangdong Provincial People's Hospital-Cancer Center ( Site 3462) Guangzhou, Guangdong | |
| H. Marques de Valdecilla ( Site 0865) Santander, Cantabria | |
| H.R.U Malaga - Hospital General ( Site 0884) Málaga, Malaga | |
| H.U. Vall de Hebron ( Site 0850) Barcelona, | |
| HENRI MONDOR HOSPITAL ( Site 2561) Créteil, Val-de-Marne | |
| HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 0872) Seville, | |
| Hacettepe Universitesi-oncology hospital ( Site 1304) Ankara, | |
| Hadassah Ein Kerem Medical Center ( Site 2051) Jerusalem, | |
| Hamilton Health Sciences-Juravinski Cancer Centre ( Site 2801) Hamilton, Ontario | |
| Hangzhou Cancer Hospital-Medical Oncology ( Site 3468) Hangzhou, Zhejiang | |
| Hanoi Oncology Hospital ( Site 3780) Hanoi, Hanoi | |
| Harbin Medical University Cancer Hospital ( Site 3506) Harbin, Heilongjiang | |
| Harbin Medical University Cancer Hospital-Harbin Medical University Cancer Hospital ( Site 3475) Harbin, Heilongjiang | |
| Helios Klinikum Emil von Behring Berlin-Zehlendorf-Lungenklinik Heckeshorn ( Site 2418) Berlin, | |
| Helse Bergen Haukeland universitetssykehus ( Site 1451) Bergen, Vestfold | |
| Henan Cancer Hospital ( Site 3488) Zhengzhou, Henan | |
| Hiroshima City Hiroshima Citizens Hospital ( Site 3119) Hiroshima, | |
| Hiroshima University Hospital ( Site 3154) Hiroshima, | |
| Hokkaido University Hospital ( Site 3165) Sapporo, Hokkaido | |
| Holy Cross Hospital, Michael & Dianne Bienes Comp Cancer Ctr ( Site 0022) Fort Lauderdale, Florida | |
| Hopital Cochin ( Site 2509) Paris, | |
| Hopital Nord ( Site 2516) Marseille, Bouches-du-Rhone | |
| Hopital Saint Louis ( Site 2510) Paris, | |
| Hopital Trousseau ( Site 2512) Chambray-lès-Tours, Indre-et-Loire | |
| Hospital Aleman-Oncology ( Site 1351) Buenos Aires, | |
| Hospital Amaral Carvalho ( Site 1023) Jaú, São Paulo | |
| Hospital Arnau de Vilanova ( Site 0866) Valencia, Valenciana, Comunitat | |
| Hospital Cayetano Heredia-Oncology ( Site 0675) Lima, | |
| Hospital Clinic de Barcelona ( Site 0852) Barcelona, Catalonia | |
| Hospital Clinico San Carlos ( Site 0857) Madrid, | |
| Hospital Clinico Universitario Lozano Blesa ( Site 0859) Zaragoza, | |
| Hospital Clinico de Valencia ( Site 0858) Valencia, Valenciana, Comunitat | |
| Hospital Erasto Gaertner ( Site 1036) Curitiba, Paraná | |
| Hospital General Universitario 12 de Octubre ( Site 0856) Madrid, | |
| Hospital General Universitario de Alicante-Oncologia ( Site 0881) Alicante, | |
| Hospital General Universitario de Valencia ( Site 0854) Valencia, Valenciana, Comunitat | |
| Hospital Metropolitano - Sede Lindora ( Site 3901) Santa Ana, Provincia de San José | |
| Hospital Nossa Senhora da Conceição ( Site 1011) Porto Alegre, Rio Grande do Sul | |
| Hospital Paulistano ( Site 1033) São Paulo, | |
| Hospital Privado Universitario de Córdoba ( Site 1354) Córdoba, | |
| Hospital Provincial del Centenario ( Site 1359) Rosario, Santa Fe Province | |
| Hospital Son Llatzer ( Site 0886) Palma de Mallorca, Balearic Islands | |
| Hospital São Carlos-Oncocentro Ce ( Site 1029) Fortaleza, Ceará | |
| Hospital São Lucas da PUCRS-Centro de Pesquisa em Oncologia ( Site 1006) Porto Alegre, Rio Grande do Sul | |
| Hospital Tacchini ( Site 1040) Bento Gonçalves, Rio Grande do Sul | |
| Hospital Tengku Ampuan Afzan ( Site 0627) Kuantan, Pahang | |
| Hospital Universitari Sant Joan de Reus-Oncology ( Site 0874) Reus, Tarragona | |
| Hospital Universitari Son Espases-Oncologia ( Site 0883) Palma, Balearic Islands | |
| Hospital Universitari i Politecnic La Fe ( Site 0875) Valencia, Valencia | |
| Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Hematologia and Oncologia ( Site 1113) Monterrey, Nuevo León | |
| Hospital Universitario Central de Asturias-Medical Oncology ( Site 0870) Oviedo, Principality of Asturias | |
| Hospital Universitario Fundación Jiménez Díaz-Oncology & Hematology ( Site 0871) Madrid, | |
| Hospital Universitario Gregorio Maranon ( Site 0864) Madrid, | |
| Hospital Universitario Insular de Gran Canaria ( Site 0867) Las Palmas de Gran Canaria, Las Palmas | |
| Hospital Universitario La Paz ( Site 0853) Madrid, | |
| Hospital Universitario Puerta de Hierro-Majadahonda ( Site 0861) Majadahonda, Madrid | |
| Hospital Universitario Quiron Madrid ( Site 0868) Pozuelo de Alarcón, Madrid | |
| Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 0877) Madrid, Madrid, Comunidad de | |
| Hospital Universitario Reina Sofia ( Site 0885) Córdoba, | |
| Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 0880) Seville, | |
| Hospital Universitario Virgen de Valme-Departamento de Oncologia ( Site 0882) Seville, | |
| Hospital Universitario Virgen de la Victoria ( Site 0878) Málaga, Andalusia | |
| Hospital Universitario de Donostia ( Site 0890) San Sebastian- Donostia, Basque Country | |
| Hospital de Clinicas de Porto Alegre ( Site 1000) Porto Alegre, Rio Grande do Sul | |
| Hospital de Clínicas de Passo Fundo ( Site 1025) Passo Fundo, Rio Grande do Sul | |
| Hospital de la Santa Creu i Sant Pau-Oncología Médica ( Site 0862) Barcelona, Catalonia | |
| Humanitas Gavazzeni ( Site 1954) Bergamo, | |
| Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1968) Rozzano, Milano | |
| Hunan Cancer Hospital ( Site 3485) Changsha, Hunan | |
| Hunan Cancer Hospital ( Site 3501) Changsha, Hunan | |
| Hyogo Cancer Center ( Site 3131) Akashi, Hyōgo | |
| Hyogo Medical University Hospital ( Site 3100) Nishinomiya, Hyōgo | |
| Hôpital Avicenne-Dermatologie ( Site 2538) Bobigny, Seine-Saint-Denis | |
| Hôpital Beaujon ( Site 2524) Clichy, Île-de-France Region | |
| Hôpital Foch ( Site 2543) Suresnes, Hauts-de-Seine | |
| Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes-lung oncology ( Site 2546) Saint-Herblain, Loire-Atlantique | |
| Hôpital Privé Clairval ( Site 2549) Marseille, Bouches-du-Rhone | |
| Hôpital Tenon ( Site 2530) Paris, | |
| Hôpital Universitaire Paul Brousse ( Site 2541) Villejuif, Val-de-Marne | |
| Hôpitaux Universitaires de Genève (HUG) ( Site 0753) Geneva, Canton of Geneva | |
| I.E.U. Medical Point Hastanesi-Oncology ( Site 1310) Izmir, | |
| IC La Serena Research ( Site 2766) La Serena, Coquimbo Region | |
| IDIM - Instituto de Investigaciones Metabólicas ( Site 1362) Ciudad de Buenos Aires, Buenos Aires | |
| IMAT S.A.S ( Site 2703) Montería, Departamento de Córdoba | |
| INSTITUTO NACIONAL DE CANCEROLOGIA ( Site 1102) Mexico City, Mexico City | |
| INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS ( Site 0681) Lima, | |
| IPOR Instituto Peruano de Oncología & Radioterapia ( Site 0678) Lima, | |
| IRCCS A.O.U. San Martino - IST ( Site 1961) Genova, | |
| IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 1978) Bologna, Emilia-Romagna | |
| IRCCS CRO Aviano, Hematology/Oncology ( Site 1957) Aviano, Pordenone | |
| Ibaraki Prefectural Central Hospital ( Site 3180) Kasama, Ibaraki | |
| Inonu Universitesi ( Site 1309) Malatya, | |
| Institut Bergonie ( Site 2502) Bordeaux, Gironde | |
| Institut Catala d Oncologia Hospital Germans Trias i Pujol ( Site 0851) Badalona, Catalonia | |
| Institut Gustave Roussy ( Site 2513) Villejuif, Île-de-France Region | |
| Institut Jules Bordet ( Site 2903) Anderlecht, Bruxelles-Capitale, Region de | |
| Institut Sainte Catherine ( Site 2557) Avignon, Vaucluse | |
| Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE ( Site 2560) Toulouse, Haute-Garonne | |
| Institut de Cancérologie de Lorraine Alexis Vautrin ( Site 2532) Vandœuvre-lès-Nancy, Lorraine | |
| Institut de Cancérologie de l'Ouest-Oncologie Médicale ( Site 2522) Saint-Herblain, Loire-Atlantique | |
| Institute of Science Tokyo Hospital ( Site 3149) Bunkyō, Tokyo | |
| Instituto Alexander Fleming ( Site 1364) Ciudad Autónoma de Buenos Aires, Buenos Aires | |
| Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 0860) L'Hospitalet de Llobregat, Barcelona | |
| Instituto Médico Río Cuarto ( Site 1375) Río Cuarto, Córdoba Province | |
| Instituto Nacional De Cancerologia-Oncología Clínica ( Site 2706) Bogota, Cundinamarca | |
| Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA ( Site 1020) Rio de Janeiro, | |
| Instituto Nacional del Cancer-CR Investigación ( Site 2753) Santiago, Region M. de Santiago | |
| Instituto Português de Oncologia do Porto Francisco Gentil, EPE-Oncologia Médica ( Site 1753) Porto, | |
| Instituto San Marcos ( Site 1366) San Juan, | |
| Instituto Valenciano de Oncologia - IVO ( Site 0863) Valencia, Valenciana, Comunitat | |
| Instituto de Cancerología-Oncology ( Site 2702) Medellín, Antioquia | |
| Instituto de Investigaciones Clínicas Mar del Plata ( Site 1363) Mar del Plata, Buenos Aires | |
| Instituto de Oncologia Saint Gallen ( Site 1039) Ssanta Cruz Do Sul, Rio Grande do Sul | |
| Instituto de Oncologia de Rosario ( Site 1350) Rosario, Santa Fe Province | |
| Instituto de de Educação, pesquisa e Gestão em Saúde ( Site 1014) Rio de Janeiro, | |
| Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 1001) São Paulo, | |
| Institutul Oncologic "Prof. Dr. Ioan Chiricuta" ( Site 3551) Cluj-Napoca, | |
| Instytut Centrum Zdrowia Matki Polki-Klinika Onkologii ( Site 1609) Lodz, Łódź Voivodeship | |
| Investigación Oncofarmacéutica-Investigación clínica ( Site 1114) La Paz, Baja California Sur | |
| Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 1035) Porto Alegree, Rio Grande do Sul | |
| Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 1302) Istanbul, | |
| Istanbul University Capa Campus ( Site 1314) Istanbul, | |
| Istittuto Nazionale dei Tumori Regina Elena IRCCS - IFO ( Site 1963) Rome, Lazio | |
| Istituto Europeo di Oncologia ( Site 1952) Milan, | |
| Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1955) Napoli, | |
| Istituto Oncologico Veneto IRCCS ( Site 1976) Padua, Veneto | |
| Istituto di Candiolo - IRCCS ( Site 1960) Candiolo, Torino | |
| Iwate Medical University Hospital ( Site 3157) Shiwa-gun, Iwate | |
| James Graham Brown Cancer Center ( Site 0058) Louisville, Kentucky | |
| James Lind Centro de Investigacion del Cancer ( Site 2757) Temuco, Región de la Araucanía | |
| Jewish General Hospital ( Site 2800) Montreal, Quebec | |
| Jiangsu Cancer Hospital-Medical Oncotherapy ( Site 3469) Nanjing, Jiangsu | |
| Jichi Medical University Hospital ( Site 3141) Shimotsuke, Tochigi | |
| Jilin Province Tumor Hospital ( Site 3484) Changchun, Jilin | |
| John Theurer Cancer Center at Hackensack University Medical Center ( Site 0038) Hackensack, New Jersey | |
| Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 1401) Szolnok, Jász-Nagykun-Szolnok | |
| K Hospital - National Cancer Hospital ( Site 3783) Hanoi, Hanoi | |
| Kagawa University Hospital ( Site 3171) Kita, Kagawa-ken | |
| Kaiser Permanente Moanalua Medical Center ( Site 0063) Honolulu, Hawaii | |
| Kanagawa Cancer Center ( Site 3137) Yokohama, Kanagawa | |
| Kanazawa University Hospital ( Site 3140) Kanazawa, Ishikawa-ken | |
| Kansai Medical University Hospital ( Site 3126) Hirakata, Osaka | |
| Kaohsiung Chang Gung Memorial Hospital ( Site 3203) Kaohsiung City, | |
| Karmanos Cancer Institute ( Site 0047) Detroit, Michigan | |
| Karolinska Universitetssjukhuset Solna ( Site 0802) Stockholm, Stockholm County | |
| Keimyung University Dongsan Hospital CRC room 1 ( Site 0960) Daegu, Taegu-Kwangyokshi | |
| Keio University Hospital ( Site 3127) Tokyo, | |
| Kepler Universitätsklinikum ( Site 2955) Linz, Upper Austria | |
| Kindai University Hospital ( Site 3102) Sakai, Osaka | |
| Kindai University Hospital ( Site 3135) Sakai, Osaka | |
| Kindai University Hospital ( Site 3166) Sakai, Osaka | |
| Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 2808) Kingston, Ontario | |
| Kitasato University Hospital ( Site 3142) Sagamihara, Kanagawa | |
| Klaipeda University Hospital-Oncology chemotherapy ( Site 3302) Klaipėda, Klaipedos Miestas | |
| Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 2954) Vienna, | |
| Kobe City Medical Center General Hospital ( Site 3144) Kobe, Hyōgo | |
| Kocaeli Üniversitesi ( Site 1313) Kocaeli, | |
| Kochi Health Sciences Center ( Site 3145) Kochi, | |
| Koo Foundation Sun Yat-Sen Cancer Center-Gynecology, Obstetrics, and women's health ( Site 3207) Taipei, | |
| Korea University Anam Hospital ( Site 0956) Seoul, | |
| Korea University Guro Hospital ( Site 0963) Seoul, | |
| Krankenhaus Nordwest ( Site 2409) Frankfurt am Main, Hesse | |
| Kumamoto University Hospital ( Site 3179) Kumamoto, | |
| Kurashiki Central Hospital ( Site 3132) Kurashiki, Okayama-ken | |
| Kurume University Hospital ( Site 3105) Kurume, Fukuoka | |
| Kyorin University Hospital ( Site 3103) Mitaka, Tokyo | |
| Kyorin University Hospital ( Site 3147) Mitaka-shi, Tokyo | |
| Kyoto University Hospital ( Site 3181) Kyoto, | |
| Kyungpook National University Chilgok Hospital ( Site 0964) Deagu, Taegu-Kwangyokshi | |
| Kyushu University Hospital ( Site 3143) Fukuoka, | |
| Kyushu University Hospital ( Site 3185) Fukuoka, | |
| LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 2005) Pretoria, Gauteng | |
| LLC Clinic Verum Expert ( Site 3669) Kyiv, Kyivska Oblast | |
| Lacks - Oncologia E Hematologia ( Site 1026) Pelotas, Rio Grande do Sul | |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0032) New York, New York | |
| Levine Cancer Institute ( Site 0034) Charlotte, North Carolina | |
| Liepjas reionl slimnca ( Site 3851) Liepāja, | |
| LinYi Cancer Hospital ( Site 3511) Linyi, Shandong | |
| Liv Hospital Ankara ( Site 1330) Ankara, | |
| Liverpool Hospital-Medical Oncology ( Site 3021) Liverpool, New South Wales | |
| London Regional Cancer Program - LHSC ( Site 2806) London, Ontario | |
| Lung Center of the Philippines ( Site 1705) Quezon City, National Capital Region | |
| LungenClinic Grosshansdorf GmbH ( Site 2412) Großhansdorf, Schleswig-Holstein | |
| Luxmed Onkologia sp. z o. o. ( Site 1621) Warsaw, Masovian Voivodeship | |
| ME І.І. Mechnykov Dnipro Regional Clinical Hospital ( Site 3668) Dnipro, Dnipropetrovsk Oblast | |
| MEDI-K ( Site 3403) Guatemala City, | |
| MEMORIAL HEALTHCARE INTERNATIONAL S.R.L ( Site 3553) Bucharest, București | |
| MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional-Chemotherapy department ( Site 3657) Kryvyi Rih, Dnipropetrovsk Oblast | |
| MNPE Regional Center of Oncology ( Site 3665) Kharkiv, Kharkivs’ka Oblast’ | |
| Mackay Memorial Hospital ( Site 3205) Taipei, | |
| Macquarie University ( Site 3010) Macquarie University, New South Wales | |
| Makati Medical Center ( Site 1702) Makati City, National Capital Region | |
| Markusovszky Egyetemi Oktatokorhaz-Onkológiai Osztály ( Site 1410) Szombathely, Vas County | |
| Marmara Universitesi Pendik Egitim Arastirma Hastanesi-Medical Oncology ( Site 1305) Istanbul, | |
| Maryland Oncology Hematology (MOH) ( Site 8000) Columbia, Maryland | |
| Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 0703) Brno, Brno-mesto | |
| Massachusetts General Hospital ( Site 0041) Boston, Massachusetts | |
| Mater Hospital Sydney ( Site 3007) North Sydney, New South Wales | |
| Mater Misercordiae University Hospital ( Site 1800) Dublin, Leinster | |
| Mater Misericordiae Limited-Medical Oncology ( Site 3019) Brisbane, Queensland | |
| Mayo Clinic in Rochester, Minnesota ( Site 0002) Rochester, Minnesota | |
| McGill University Health Centre ( Site 2818) Montreal, Quebec | |
| Med-Polonia Sp. z o. o. ( Site 1605) Poznan, Greater Poland Voivodeship | |
| MedStar Franklin Square Medical Center ( Site 0046) Baltimore, Maryland | |
| Medical Care and Research SA de CV ( Site 1103) Mérida, Yucatán | |
| Medical University of Graz ( Site 2952) Graz, Styria | |
| Medipol Mega Universite Hastanesi ( Site 1326) Istanbul, | |
| Medizinische Hochschule Hannover ( Site 2402) Hanover, Lower Saxony | |
| Medizinische Universitaet Innsbruck ( Site 2951) Innsbruck, Tyrol | |
| Medizinische Universität Wien ( Site 2953) Vienna, | |
| Melanoma Institute Australia ( Site 3001) Wollstonecraft, New South Wales | |
| Memorial Antalya Hospital-Oncology ( Site 1315) Antalya, | |
| Memorial Sloan Kettering Cancer Center ( Site 0012) New York, New York | |
| Mercy Health-Paducah Cancer Center ( Site 0084) Paducah, Kentucky | |
| Mid Essex Hospitals Service Trust. Broomfield Hospital ( Site 0503) Broomfield, Essex | |
| Miyagi Cancer Center ( Site 3122) Natori-shi, Miyagi | |
| Moffitt Cancer Center ( Site 0011) Tampa, Florida | |
| Monash Health ( Site 3015) Clayton, Victoria | |
| Mount Sinai Hospital ( Site 2811) Toronto, Ontario | |
| Mount Sinai Medical Center Comprehensive Cancer Center ( Site 0031) Miami Beach, Florida | |
| Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council ( Site 3650) Dnipro, Dnipropetrovsk Oblast | |
| Municipal institution of Lviv regional council Lviv Oncology-Chemotherapy ( Site 3653) Lviv, Lviv Oblast | |
| Municipal non-profit enterprise "Kyiv City Clinical Oncology Center" of executive body of Kyiv City ( Site 3651) Kyiv, Kyivska Oblast | |
| Municipal non-profit enterprise "Zaporizhzhia regional clinical hospital" of Zaporizhzhia regional c ( Site 3664) Zaporizhzhia, Zaporizhzhia Oblast | |
| Mátrai Gyógyintézet ( Site 1417) Gyöngyös, Heves County | |
| N.N. Blokhin NMRCO ( Site 1209) Moscow, Moscow | |
| N.N.Petrov Research Institute of Oncology-Department of Preclinical and Clinical Research ( Site 1211) Saint Petersburg, Sankt-Peterburg | |
| Nagoya University Hospital ( Site 3151) Nagoya, Aichi-ken | |
| Nara Medical University Hospital ( Site 3110) Kashihara, Nara | |
| Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1620) Gliwice, Silesian Voivodeship | |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Oddzial w Krakowie ( Site 1608) Krakow, Lesser Poland Voivodeship | |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 1604) Warsaw, Masovian Voivodeship | |
| National Cancer Center ( Site 0955) Goyang-si, Kyonggi-do | |
| National Cancer Center Hospital ( Site 3130) Tokyo, | |
| National Cancer Center Hospital East ( Site 3121) Kashiwa, Chiba | |
| National Cancer Centre Singapore ( Site 2200) Singapore, Central Singapore | |
| National Cancer Institute-Department of Minimally Invasive and Endoscopic Surgery, Interventional R ( Site 3658) Kyiv, Kyivska Oblast | |
| National Cheng Kung University Hospital ( Site 3201) Tainan, | |
| National Defense Medical College Hospital ( Site 3177) Tokorozawa, Saitama | |
| National Hospital Organization Himeji Medical Center ( Site 3111) Himeji, Hyōgo | |
| National Hospital Organization Hokkaido Cancer Center ( Site 3160) Sapporo, Hokkaido | |
| National Hospital Organization Kyushu Cancer Center ( Site 3169) Fukuoka, | |
| National Hospital Organization Kyushu Medical Center ( Site 3136) Fukuoka, | |
| National Hospital Organization Nagoya Medical Center ( Site 3109) Nagoya, Aichi-ken | |
| National Hospital Organization Osaka National Hospital ( Site 3162) Osaka, | |
| National Hospital Organization Shikoku Cancer Center ( Site 3116) Matsuyama, Ehime | |
| National Hospital Organization Yamaguchi Ube Medical Center ( Site 3123) Ube, Yamaguchi | |
| National Lung Hospital ( Site 3781) Hanoi, Hanoi | |
| National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 1210) Saint Petersburg, Sankt-Peterburg | |
| National Taiwan University Hospital ( Site 3200) Taipei, | |
| National Taiwan University Hospital - Hsinchu branch ( Site 3208) Hsinchu, | |
| National University Hospital-Haematology -Oncology Research Group ( Site 2201) Singapore, South West | |
| New Cross Hospital-Department of Oncology ( Site 0517) Wolverhampton, | |
| Niigata Cancer Center Hospital ( Site 3173) Niigata, Niigata | |
| Niigata University Medical & Dental Hospital ( Site 3174) Niigata, | |
| Nippon Medical School Hospital ( Site 3139) Tokyo, | |
| Nippon Medical School Musashi Kosugi Hospital ( Site 3178) Kawasaki, Kanagawa | |
| Norrlands Universitetssjukhus ( Site 0800) Umeå, Västerbotten County | |
| Northern Jiangsu People's Hospital-General Surgery Department ( Site 3474) Yangzhou, Jiangsu | |
| Northwest Georgia Oncology Centers PC ( Site 0061) Marietta, Georgia | |
| Nottingham University Hospitals NHS Trust ( Site 0510) Nottingham, Nottinghamshire | |
| Nouvel Hôpital Civil (NHC) ( Site 2529) Strasbourg, Alsace | |
| ONCOCENTRO APYS-ACEREY ( Site 2758) Viña del Mar, Región de Valparaíso | |
| ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 1008) Ijuí, Rio Grande do Sul | |
| Oaxaca Site Management Organization ( Site 1106) Oaxaca City, Oaxaca | |
| Obstetrics & Gynecology Hospital of Fudan University ( Site 3494) Shanghai, Shanghai Municipality | |
| Odense Universitetshospital ( Site 0650) Odense, Region Syddanmark | |
| Odessa Regional Oncology Center ( Site 3655) Odesa, Odesa Oblast | |
| Ogarev Mordovia State University ( Site 1206) Saransk, Mordoviya, Respublika | |
| Okayama University Hospital ( Site 3107) Okayama, | |
| Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0082) Tulsa, Oklahoma | |
| Oncare Viaducto Napoles ( Site 1107) Mexico City, | |
| Oncological Dispensary #2 of Ministry of Health of Krasnodar region ( Site 1244) Sochi, Krasnodarskiy Kray | |
| Oncologos del Occidente ( Site 2709) Pereira, Risaralda Department | |
| Oncomedica ( Site 3401) Guatemala City, | |
| Oncovida ( Site 2759) Santiago, Region M. de Santiago | |
| Opolskie Centrum Onkologii w Opolu im. prof. Tadeusza Kosza-Klinika Onkologii z Odcinkiem Dziennym ( Site 1616) Opole, Opole Voivodeship | |
| Orange Hospital-Clinical Trials Unit ( Site 3027) Orange, New South Wales | |
| Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 2957) Linz, Upper Austria | |
| Orlandi Oncologia-Oncology ( Site 2752) Santiago, Region M. de Santiago | |
| Orszagos Koranyi Pulmonologiai Intezet ( Site 1403) Budapest, | |
| Országos Onkológiai Intézet-Urogenitális Tumorok és Klinikai Farmakológiai Osztály ( Site 1411) Budapest, Pest County | |
| Osaka City General Hospital ( Site 3125) Osaka, | |
| Osaka General Medical Center ( Site 3184) Osaka, | |
| Osaka Habikino Medical Center ( Site 3138) Habikino, Osaka | |
| Osaka Medical and Pharmaceutical University Hospital ( Site 3167) Takatsuki, Osaka | |
| Osaka Medical and Pharmaceutical University Hospital ( Site 3187) Takatsuki, Osaka | |
| Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 3129) Osaka, | |
| Osaka Rosai Hospital ( Site 3148) Sakai, Osaka | |
| Oslo Universitetssykehus Radiumhospitalet ( Site 1450) Oslo, | |
| Oslo universitetssykehus, Radiumhospitalet ( Site 1452) Oslo, | |
| Ospedale Cannizzaro ( Site 1981) Catania, Sicily | |
| Ospedale San Luigi Gonzaga ( Site 1956) Orbassano, Torino | |
| Ospedale San Raffaele. ( Site 1979) Milan, | |
| P. A. Hertsen Moscow Oncology Research Center ( Site 1214) Moscow, Moscow | |
| P. A. Hertsen Moscow Oncology Research Center ( Site 1247) Moscow, Moscow | |
| Palmerston North Hospital, MidCentral DHB ( Site 1504) Palmerston North, Manawatu-Wanganui | |
| Pantai Hospital Kuala Lumpur ( Site 0628) Kuala Lumpur, | |
| Parc de Salut Mar - Hospital del Mar-Oncologia ( Site 0873) Barcelona, | |
| Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 3008) Melbourne, Victoria | |
| Policlinico Universitario Agostino Gemelli ( Site 1965) Roma, | |
| Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 2751) Santiago, Region M. de Santiago | |
| Port Macquarie - Mid North Coast Cancer Institute-Medical Oncology ( Site 3020) Port Macquarie, New South Wales | |
| Powiatowe Centrum Zdrowia w Brzezinach Sp. z o. o. Oddział Dziennej Chemioterapii ( Site 1611) Brzeziny, Łódź Voivodeship | |
| Princess Alexandra Hospital ( Site 3002) Woolloongabba, Queensland | |
| Princess Margaret Cancer Centre ( Site 2803) Toronto, Ontario | |
| Princess Margaret Hospital ( Site 1903) Hong Kong, | |
| Private Enterprise Private Manufacturing Company Acinus-Medical and Diagnostic Centre ( Site 3656) Kropyvnytskyi, Kirovohrad Oblast | |
| Providence Medical Foundation ( Site 0087) Fullerton, California | |
| Providence Portland Medical Center ( Site 0051) Portland, Oregon | |
| Providence Saint John's Health Center ( Site 0059) Santa Monica, California | |
| Przychodnia Lekarska KOMED ( Site 1603) Konin, Greater Poland Voivodeship | |
| Queen Mary Hospital ( Site 1902) Hksar, | |
| Queen Mary Hospital-Department of Medicine (Respiratory) ( Site 1900) Hksar, | |
| RIGA EAST UNIVERSITY HOSPITAL ,Oncology Centre of Latvia-Out-patient and Day patient facility of Ch ( Site 3850) Riga, | |
| Rabin Medical Center ( Site 2059) Petah Tikva, | |
| Radboud University Medical Center ( Site 1554) Nijmegen, Gelderland | |
| Ramathibodi Hospital. ( Site 2364) Bangkok, Bangkok | |
| Rambam Health Care Campus-Oncology Division ( Site 2053) Haifa, | |
| Regional Budgetary Healthcare Institution 'Ivanovo Regional Oncology Dispensary'-Urology ( Site 1219) Ivanovo, Ivanovo Oblast | |
| Republican Clinical Oncology Dispensary ( Site 1228) Kazan', Tatarstan, Respublika | |
| Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1204) Ufa, Baskortostan, Respublika | |
| Republican Clinical Oncology Dispensary of Tatarstan MoH named after professor M.Z. Sigal ( Site 1203) Kazan', Tatarstan, Respublika | |
| Royal Adelaide Hospital ( Site 3014) Adelaide, South Australia | |
| Royal Brisbane and Women's Hospital ( Site 3009) Herston, Queensland | |
| Royal Free Hospital ( Site 0507) London, London, City of | |
| Royal Marsden Hospital ( Site 0505) London, London, City of | |
| Royal North Shore Hospital-Medical Oncology Clinical Trials ( Site 3025) St Leonards, New South Wales | |
| Royal Preston Hospital ( Site 0518) Preston, Lancashire | |
| Royal Prince Alfred Hospital-A.W. Morrow Gastroenterology and Liver Centre ( Site 3016) Camperdown, New South Wales | |
| Russian Oncological Research Center n.a. N.N.Blokhin of MoH ( Site 1201) Moscow, Moscow | |
| Russian Scientific Center of Roentgenoradiology ( Site 1215) Moscow, Moscow | |
| Russian Scientific Research Institute of Hematology and Blood Transfusion-Hematology ( Site 1224) Saint Petersburg, Sankt-Peterburg | |
| SAIH of the Tyumen region, Multidisciplinary Clinical Medical Center "Medical town" ( Site 1220) Tyumen, Tyumen Oblast | |
| SO"Grigoriev Inst for Med Radiolgy and Oncology of NAMS of Ukraine" ( Site 3666) Kharlkiv, Kharkivs’ka Oblast’ | |
| SRH Wald-Klinikum Gera GmbH ( Site 2403) Gera, Thuringia | |
| SUN YAT-SEN UNIVERSITY CANCER CENTRE-Internal Medicine ( Site 3452) Guangzhou, Guangdong | |
| Sahlgrenska Universitetssjukhuset-Department of Oncology CTU Clinical Trial Unit ( Site 0803) Gothenburg, Västra Götaland County | |
| Saint Francis Health System ( Site 0089) Greenville, South Carolina | |
| Saitama Medical University International Medical Center ( Site 3118) Hidaka, Saitama | |
| Saitama Prefectural Cancer Center ( Site 3112) Kitaadachi-gun, Saitama | |
| Sakarya University School of Medicine ( Site 1332) Sakarya, | |
| Samsun Medical Park Hastanesi ( Site 1328) Samsun, | |
| Samsung Medical Center ( Site 0950) Seoul, | |
| Samsung Medical Center ( Site 0970) Seoul, | |
| Samsung Medical Center ( Site 0971) Seoul, | |
| Sanatorio Parque ( Site 1355) Rosario, Santa Fe Province | |
| Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 2004) Sandton, Gauteng | |
| Sanford Cancer Center ( Site 0066) Sioux Falls, South Dakota | |
| Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0065) Fargo, North Dakota | |
| Sapporo Kosei General Hospital ( Site 3172) Sapporo, Hokkaido | |
| Sapporo Medical University Hospital ( Site 3113) Sapporo, Hokkaido | |
| Sarah Cannon Research UK ( Site 0504) London, London, City of | |
| Semmelweis University-Belgyógyászati és Hematológiai Klinika ( Site 1406) Budapest, | |
| Sendai Kousei Hospital ( Site 3115) Sendai, Miyagi | |
| Seoul National University Bundang Hospital ( Site 0951) Seongnam-si, Kyonggi-do | |
| Seoul National University Hospital ( Site 0953) Seoul, | |
| Severance Hospital ( Site 0954) Seoul, | |
| Severance Hospital, Yonsei University Health System ( Site 0962) Seoul, | |
| Shaare Zedek Medical Center ( Site 2068) Jerusalem, | |
| Shamir Medical Center Assaf Harofeh ( Site 2058) Ẕerifin, | |
| Shandong Cancer Hospital ( Site 3517) Jinan, Shandong | |
| Shanghai Pulmonary Hospital ( Site 3470) Shanghai, Shanghai Municipality | |
| Sheba Medical Center ( Site 2062) Ramat Gan, | |
| Sheba Medical Center ( Site 2065) Ramat Gan, | |
| Shizuoka Cancer Center ( Site 3128) Nakatogari, Shizuoka | |
| Sichuan Cancer hospital. ( Site 3515) Chengdu, Sichuan | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 0056) Baltimore, Maryland | |
| Sir Charles Gairdner Hospital ( Site 3006) Nedlands, Western Australia | |
| Sir Run Run Shaw Hospital ( Site 3505) Hangzhou, Zhejiang | |
| Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 2704) Valledupar, Cesar Department | |
| Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 1402) Kaposvár, | |
| Songklanagarind Hospital ( Site 2367) Hat Yai, Changwat Songkhla | |
| Sotiria Regional Chest Diseases Hospital of Athens ( Site 1850) Athens, Attica | |
| Sourasky Medical Center ( Site 2054) Tel Aviv, | |
| South Texas Accelerated Research Therapeutics, LLC (START) ( Site 0001) San Antonio, Texas | |
| Southern medical university Nangfang Hospital ( Site 3490) Guanghzou, Guangdong | |
| Spitalul Județean Sfântul Ioan cel Nou Suceava-Oncology ( Site 3550) Suceava, | |
| St James University Hospital ( Site 0509) Leeds, | |
| St John of God Subiaco Hospital ( Site 3013) Subiaco, Western Australia | |
| St Vincent's Hospital-Oncology Clinical Trials ( Site 3018) Melbourne, Victoria | |
| St. James s Hospital ( Site 1801) Dublin, | |
| St. Luke s Medical Center ( Site 1700) Quezon City, National Capital Region | |
| St. Luke's University Health Network ( Site 0017) Bethlehem, Pennsylvania | |
| St. Marianna University Hospital ( Site 3182) Kawasaki, Kanagawa | |
| St. Marys Hospital Center ( Site 2820) Montreal, Quebec | |
| St. Petersburg Clinical Hospital of Russian Academy Of Sciences ( Site 1235) Saint Petersburg, Sankt-Peterburg | |
| St.Luke's International Hospital ( Site 3120) Tokyo, | |
| Stanford Cancer Center ( Site 0086) Palo Alto, California | |
| Sumy regional clinical oncological dispensary-Oncothoracic department ( Site 3661) Sumy, Sumska Oblast | |
| Sun Yat-sen University Cancer Center-melanoma ( Site 3482) Guangzhou, Guangdong | |
| Sunnybrook Research Institute ( Site 2802) Toronto, Ontario | |
| Sunshine Coast University Private Hospital-Coastal Cancer Care ( Site 3032) Sunshine Coast, Queensland | |
| Szpital Kliniczny im. Przemienienia Panskiego Uniwersytetu Medycznego im. K. Marcinkowskiego w Pozna ( Site 1601) Poznan, Greater Poland Voivodeship | |
| Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 1625) Gdynia, Pomeranian Voivodeship | |
| Szpital Rejonowy im. dr. J. Rostka w Raciborzu ( Site 1624) Racibórz, Silesian Voivodeship | |
| Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie-Oncology Department ( Site 1618) Krakow, Lesser Poland Voivodeship | |
| Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie ( Site 1614) Koszalin, West Pomeranian Voivodeship | |
| TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1316) Istanbul, | |
| Taipei Medical University Hospital ( Site 3211) Taipei, | |
| Taipei Veterans General Hospital ( Site 3202) Taipei, | |
| Tallaght University Hospital ( Site 1803) Dublin, | |
| Tampere University Hospital [Tampere Finland] ( Site 0600) Tampere, Pirkanmaa | |
| Tangdu Hospital of Fourth Military Medical University of Chi-department of radiotherapy ( Site 3455) Xi'an, Shaanxi | |
| Tartu University Hospital-Radiotherapy and oncology ( Site 3800) Tartu, Tartu | |
| Tasman Oncology Research Pty Ltd ( Site 3012) Southport, Queensland | |
| Teikyo University Hospital ( Site 3104) Tokyo, | |
| Texas Oncology - Central/South Texas ( Site 8001) Austin, Texas | |
| Texas Oncology-Baylor Sammons Cancer Center ( Site 0062) Dallas, Texas | |
| The Affiliated Cancer Hospital of Guizhou Medical University ( Site 3498) Guiyang, Guizhou | |
| The Affiliated Cancer Hospital of Xinjiang Medical University ( Site 3502) Ürümqi, Xinjiang | |
| The Angeles Clinic and Research Institute ( Site 0005) Los Angeles, California | |
| The Beatson West of Scotland Cancer Centre ( Site 0506) Glasgow, Glasgow City | |
| The Catholic University Of Korea St. Vincent's Hospital ( Site 0968) Suwon, Kyonggi-do | |
| The Christie ( Site 0516) Manchester, England | |
| The Fifth Medical Center Of The Chinese PLA General Hospital (South) ( Site 3465) Beijing, Beijing Municipality | |
| The First Affiliated Hospital of Guangzhou Medical University-thoracic surgery department ( Site 3460) Guangzhou, Guangdong | |
| The First Affiliated Hospital of Nanchang University ( Site 3513) Nanchang, Jiangxi | |
| The First Affiliated Hospital of Xi an Jiaotong University ( Site 3489) XiAn, Shanxi | |
| The First Affiliated Hospital of Xiamen University ( Site 3514) Xiamen, Fujian | |
| The First Affiliated Hospital, Sun Yat-sen University-pneumology department ( Site 3459) Guangzhou, Guangdong | |
| The First Hospital of Jilin University-Oncology ( Site 3464) Changchun, Jilin | |
| The Jikei University Hospital ( Site 3156) Tokyo, | |
| The National Medico-Surgical Center N.I. Pirogov ( Site 1225) Moscow, Moscow | |
| The Oncology Centre ( Site 2000) Durban, KwaZulu-Natal | |
| The Ottawa Hospital - General Campus ( Site 2813) Ottawa, Ontario | |
| The Queen Elizabeth Hospital ( Site 3026) Woodville, South Australia | |
| The Royal Marsden NHS Foundation Trust. ( Site 0513) Sutton, | |
| The Second People's Hospital of Yibin ( Site 3516) Yibin, Sichuan | |
| The Sixth Affiliated Hospital of Sun Yat-sen University ( Site 3491) Guangzhou, Guangdong | |
| The Townsville Hospital ( Site 3017) Townsville, Queensland | |
| The University of Chicago ( Site 0020) Chicago, Illinois | |
| The University of Osaka Hospital ( Site 3168) Suita, Osaka | |
| Tianjin Medical University Cancer Institute and Hospital ( Site 3456) Tianjin, Tianjin Municipality | |
| Tohoku University Hospital ( Site 3175) Sendai, Miyagi | |
| Tokyo Medical University Hospital ( Site 3170) Shinjuku-ku, Tokyo | |
| Tokyo Metropolitan Komagome Hospital ( Site 3133) Tokyo, | |
| Tomsk Scientific Research Institute of Oncology ( Site 1227) Tomsk, Tomsk Oblast | |
| Tongji Hospital Tongji Medical,Science & Technology-oncology ( Site 3476) Wuhan, Hubei | |
| Toranomon Hospital ( Site 3134) Minato-ku, Tokyo | |
| Toranomon Hospital ( Site 3153) Minato-ku, Tokyo | |
| Toyama Prefectural Central Hospital ( Site 3183) Toyama, | |
| Trakya Universitesi Tip Fakultesi ( Site 1301) Edirne, | |
| Transcarpathian Regional Clinical Oncology Center-Chemotherapy dept. ( Site 3652) Uzhhorod, Zakarpattia Oblast | |
| Turku University Hospital ( Site 0601) Turku, Southwest Finland | |
| UCLA Hematology/Oncology - Westwood (Building 100) ( Site 0009) Los Angeles, California | |
| UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0004) San Francisco, California | |
| UNIVERSIDAD CATÓLICA DEL MAULE ( Site 2768) Talca, Maule Region | |
| UPMC Hillman Cancer Center ( Site 0008) Pittsburgh, Pennsylvania | |
| UPR Comprehensive Cancer Center ( Site 1150) San Juan, | |
| UZ Brussel ( Site 2900) Brussels, Bruxelles-Capitale, Region de | |
| UZ Leuven ( Site 2901) Leuven, Vlaams-Brabant | |
| UZ Leuven - Campus Gasthuisberg ( Site 2906) Leuven, Vlaams-Brabant | |
| UZ Leuven Gasthuisberg, Gynaecologie-Verloskunde ( Site 2907) Leuven, Vlaams-Brabant | |
| Udmurtian Republican Clinical Oncology Center ( Site 1212) Izhevsk, Udmurtiya Republic | |
| Umraniye Training and Research Hospital ( Site 1329) Istanbul, | |
| Unidade Local de Saude de Santa Maria - Hospital Pulido Valente ( Site 1750) Lisbon, | |
| Uniklinikum Salzburg ( Site 2956) Salzburg, | |
| Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 3492) Wuhan, Hubei | |
| Universitaetsklinik Muenchen ( Site 2406) Munich, Bavaria | |
| Universitaetsklinikum Essen ( Site 2404) Essen, North Rhine-Westphalia | |
| Universitaetsklinikum Tuebingen ( Site 2405) Tübingen, Baden-Wurttemberg | |
| Universitaetsklinikum des Saarlandes-Klinik für Innere Medizin V-Pneumologie, Allergologie, Beatmun ( Site 2411) Homburg, Saarland | |
| Universitaetsspital Zuerich ( Site 0750) Zürich-Flughafen, Canton of Zurich | |
| Universitair Medisch Centrum Groningen ( Site 1550) Groningen, | |
| Universitatsklinikum Carl Gustav Carus ( Site 2407) Dresden, Saxony | |
| University College London Hospital-Cancer Clinical Trials Unit ( Site 0520) London, London, City of | |
| University Hospital Basel ( Site 0752) Basel, Canton of Basel-City | |
| University Hospital Coventry & Warwickshire ( Site 0524) Coventry, | |
| University Hospitals ( Site 0044) Cleveland, Ohio | |
| University Malaya Medical Centre ( Site 0626) Kuala Lumpur, | |
| University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0076) Orange, California | |
| University of Colorado Cancer Center ( Site 0021) Aurora, Colorado | |
| University of Iowa Hospital and Clinics ( Site 0026) Iowa City, Iowa | |
| University of North Carolina at Chapel Hill ( Site 0040) Chapel Hill, North Carolina | |
| University of Pennsylvania ( Site 0010) Philadelphia, Pennsylvania | |
| University of Texas MD Anderson Cancer Center ( Site 0007) Houston, Texas | |
| University of Tsukuba Hospital ( Site 3176) Tsukuba, Ibaraki | |
| University of Virginia Health System ( Site 0035) Charlottesville, Virginia | |
| University of the Ryukyus Hospital ( Site 3155) Ginowan, Okinawa | |
| Universitätsklinikum Erlangen ( Site 2408) Erlangen, Bavaria | |
| Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godi ( Site 2909) Namur, | |
| Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 1607) Poznan, Greater Poland Voivodeship | |
| Uniwersyteckie Centrum Kliniczne-Klinika Chirurgii Onkologicznej, Transplantacyjnej i Ogólnej ( Site 1622) Gdansk, Pomeranian Voivodeship | |
| Uzhhorod City Multidisciplinary Clinical Hospital ( Site 3672) Uzhhorod, Zakarpattia Oblast | |
| Uzsoki Utcai Kórház-Onkoradiológiai Osztály ( Site 1413) Budapest, | |
| VCU Health Adult Outpatient Pavillion ( Site 0080) Richmond, Virginia | |
| Vanderbilt Health One Hundred Oaks Diagnostic ( Site 0060) Nashville, Tennessee | |
| Vanderbilt Ingram Cancer Center ( Site 0015) Nashville, Tennessee | |
| Vejle Sygehus ( Site 0653) Vejle, Region Syddanmark | |
| Vilniaus Universiteto Ligonine Santaros Klinikos ( Site 3300) Vilnius, | |
| Vilnius University Hospital Santaros Clinics Affiliate - National Cancer Center ( Site 3301) Vilnius, | |
| Volga District Medical Center Federal Medical and Biological Agency ( Site 1242) Nizhny Novgorod, Nizhny Novgorod Oblast | |
| WCR Office ( Site 2002) Johannesburg, Gauteng | |
| Waikato Hospital ( Site 1502) Hamilton, Waikato Region | |
| Wakayama Medical University Hospital ( Site 3124) Wakayama, | |
| WakeMed Cancer Care - Waverly Hematology & Medical Oncology ( Site 0074) Cary, North Carolina | |
| West Cancer Center and Research Institute ( Site 0055) Germantown, Tennessee | |
| West China Hospital Sichuan University-respiratory ( Site 3473) Chengdu, Sichuan | |
| Western General Hospital ( Site 0502) Edinburgh, Edinburgh, City of | |
| Western Health-Sunshine & Footscray Hospitals ( Site 3023) St Albans, Victoria | |
| Westmead Hospital ( Site 3000) Westmead, New South Wales | |
| Weston Park Hospital ( Site 0519) Sheffield, England | |
| White Plains Hospital-Center for Cancer Care ( Site 0069) White Plains, New York | |
| Wielkopolskie Centrum Onkologii im.M.Sklodowskiej-Curie ( Site 1619) Poznan, Greater Poland Voivodeship | |
| Wilgers Oncology Centre ( Site 2006) Pretoria, Gauteng | |
| Wojskowy Instytut Medyczny-Klinika Onkologii ( Site 1606) Warsaw, Masovian Voivodeship | |
| Women s Hospital School of Medicine Zhejiang University ( Site 3493) Hangzhou, Zhejiang | |
| Women's Cancer Care ( Site 0088) Covington, Louisiana | |
| Xiangya Hospital Central South University ( Site 3508) Changsha, Hunan | |
| Xiangya Hospital Central South University-Gynecology ( Site 3497) Changsha, Hunan | |
| Xiangya Hospital Central South University-Respiratory ( Site 3479) Changsha, Hunan | |
| Xinjiang Medical University Cancer Hospital - Urumqi-galactophore department ( Site 3486) Ürümqi, Xinjiang | |
| Yale Cancer Center ( Site 0014) New Haven, Connecticut | |
| Yamaguchi University Hospital ( Site 3114) Ube, Yamaguchi | |
| Yancheng First People s Hospital ( Site 3504) Yancheng, Jiangsu | |
| Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 1243) Yaroslavl, Yaroslavl Oblast | |
| Yokohama City University Hospital ( Site 3163) Yokohama, Kanagawa | |
| Yokosuka Kyosai Hospital ( Site 3150) Yokosuka, Kanagawa | |
| ZIV Medical Center-Hematology Institute ( Site 2061) Safed, | |
| Zala Megyei Szent Rafael Korhaz ( Site 1400) Zalaegerszeg, | |
| Zhejiang Cancer Hospital ( Site 3481) Hangzhou, Zhejiang | |
| Zhejiang Cancer Hospital ( Site 3495) Hangzhou, Zhejiang | |
| Zhongshan Hospital of Fudan University ( Site 3503) Shanghai, Shanghai Municipality | |
| Zhytomyr Regional Oncology Center ( Site 3670) Zhytomyr, Zhytomyr Oblast | |
| ospedale le scotte-U.O.C. Immunoterapia Oncologica ( Site 1969) Siena, |
Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors (A ComboMATCH Treatment Trial)
ctrrecruit@vcu.edu
NCT06126276
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Inclusion Criteria:
* Patient must have enrolled onto EAY191 and must have been given a treatment assignment to ComboMATCH to EAY191-N5 based on the presence of an actionable mutation as defined in EAY191
* Patients must have a HER2 amplified solid tumor except breast cancer. Patient's cancer must have HER2 amplification as defined with ≥ 7 copies by next generation sequencing (NGS) testing
* Patients must have recurrent or persistent disease
* No known evidence of RB1 loss or deletion including copy number loss or deleterious mutation
* Patients must have disease that can be safely biopsied and agree to a pre-treatment biopsy or, if disease cannot be safely biopsied, have archival tissue available from within 12 months prior to the date of registration on the ComboMATCH Registration Trial (EAY191)
* Patients must have measurable disease based on RECIST 1.1. A second measurable lesion outside of the biopsiable lesion is required
* Patients with treated brain metastases are eligible if follow up brain imaging after central nervous system (CNS) directed therapy shows no evidence of progression for 3 months or more and patient is not on steroids and is asymptomatic
* No known leptomeningeal disease
* Patients may have received up to 5 prior lines of systemic therapy
* Prior therapy with trastuzumab or pertuzumab, either alone or in combination, antibody drug conjugates (ADC) such as DS8201a or T-DM1 is allowed
* Prior therapy with tyrosine kinase inhibitors (TKI) such as neratinib or tucatinib is not allowed
* No prior therapy with CDK4/6 inhibition
* No cancer directed therapy within 3 weeks prior to registration. For oral therapy, the washout can be reduced to greater than or equal to 5 half lives of the drug. No HER2 targeting ADCs within 30 days prior to registration
* Age ≥ 18
* Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2
* Not pregnant and not nursing
* Absolute neutrophil count (ANC) ≥ 1,500 cells/mm\^3
* Platelets ≥ 100,000 cells/mm\^3
* Hemoglobin ≥ 9 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin (Hgb) ≥ 9 g/dl is acceptable)
* Creatinine clearance (CrCL) of ≥ 30 mL/min by the Cockcroft-Gault formula
* Total bilirubin level ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x institutional ULN may be enrolled)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x institutional upper limit of normal (ULN)
* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
* No active infection requiring parenteral antibiotics
* No current evidence of intra-abdominal abscess, abdominal/pelvic fistula (not diverted), gastrointestinal perforation, gastrointestinal (GI) obstruction, and/or need for drainage nasogastric or gastrostomy tube
* No current evidence of malabsorption or chronic diarrhea or any other significant gastro-intestinal disease (e.g gastrectomy, ileal bypass, Crohn's disease, gastroparesis), associated with moderate to severe diarrhea (grade 2 or more) or inability to tolerate oral therapy
* No lung disease causing dyspnea at rest
* No interstitial lung disease with ongoing signs and symptoms at the time of registration
* No history of allergic reaction to the study agents, compound of similar chemical or biologic composition of the study agents or any of their excipients PROCEDURE: Biopsy Procedure, PROCEDURE: Biospecimen Collection, PROCEDURE: Computed Tomography, PROCEDURE: Echocardiography Test, PROCEDURE: Magnetic Resonance Imaging, PROCEDURE: Multigated Acquisition Scan, DRUG: Neratinib Maleate, DRUG: Palbociclib
Malignant Female Reproductive System Neoplasm, Malignant Solid Neoplasm, Recurrent Malignant Female Reproductive System Neoplasm, Recurrent Malignant Solid Neoplasm
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Show 175 locations
Study Locations
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| Location | Contacts |
|---|---|
| Alaska Women's Cancer Care Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Asplundh Cancer Pavilion Willow Grove, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Atrium Medical Center-Middletown Regional Hospital Franklin, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Ballad Health Cancer Care - Bristol Bristol, Virginia | Site Public Contact - (charles.mays@balladhealth.org) |
| Ballad Health Cancer Care - Kingsport Kingsport, Tennessee | Site Public Contact - (charles.mays@balladhealth.org) |
| Benefis Sletten Cancer Institute Great Falls, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Billings Clinic Cancer Center Billings, Montana | Site Public Contact - (research@billingsclinic.org) |
| Bozeman Health Deaconess Hospital Bozeman, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Bristol Regional Medical Center Bristol, Tennessee | Site Public Contact - (charles.mays@balladhealth.org) |
| Cancer Care Center of O'Fallon O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Care Specialists of Illinois - Decatur Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Hematology Centers - Flint Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Carle BroMenn Medical Center Normal, Illinois | Site Public Contact - (Research@Carle.com) |
| Carle Cancer Center Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Cancer Institute Normal Normal, Illinois | Site Public Contact - (Research@Carle.com) |
| Carle Physician Group-Effingham Effingham, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Mattoon/Charleston Mattoon, Illinois | Site Public Contact - (Research@carle.com) |
| Carle at The Riverfront Danville, Illinois | Site Public Contact - (Research@Carle.com) |
| Cedars Sinai Medical Center Los Angeles, California | |
| Columbus Oncology and Hematology Associates Dublin, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Columbus Oncology and Hematology Associates Inc Columbus, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Community Hospital of Anaconda Anaconda, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Toms River, New Jersey | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Toms River, New Jersey | Site Public Contact - (Lennette.Gonzales@rwjbh.org) |
| Corewell Health Beaumont Troy Hospital Troy, Michigan | |
| Corewell Health Dearborn Hospital Dearborn, Michigan | |
| Corewell Health Farmington Hills Hospital Farmington Hills, Michigan | |
| Corewell Health William Beaumont University Hospital Royal Oak, Michigan | |
| Crossroads Cancer Center Effingham, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Dayton Physician LLC - Englewood Dayton, Ohio | |
| Decatur Memorial Hospital Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Delaware Health Center-Grady Cancer Center Delaware, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Doctors Hospital Columbus, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Dublin Methodist Hospital Dublin, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Duke University Medical Center Durham, North Carolina | |
| Duke Women's Cancer Care Raleigh Raleigh, North Carolina | |
| Duluth Clinic Ashland Ashland, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health - Deer River Clinic Deer River, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Cancer Center Duluth, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Hibbing Clinic Hibbing, Minnesota | |
| Essentia Health Sandstone Sandstone, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Virginia Clinic Virginia, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Genesee Hematology Oncology PC Flint, Michigan | |
| Genesys Hurley Cancer Institute Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Grady Memorial Hospital Delaware, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Grant Medical Center Columbus, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Gundersen Lutheran Medical Center La Crosse, Wisconsin | Site Public Contact - (cancerctr@gundersenhealth.org) |
| Harold Alfond Center for Cancer Care Augusta, Maine | |
| Hurley Medical Center Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Inova Fairfax Hospital Falls Church, Virginia | Site Public Contact - (Stephanie.VanBebber@inova.org) |
| Inova Schar Cancer Institute Fairfax, Virginia | Site Public Contact - (Stephanie.VanBebber@inova.org) |
| Jersey City Medical Center Jersey City, New Jersey | Site Public Contact - (Roster@nrgoncology.org) |
| John H Stroger Jr Hospital of Cook County Chicago, Illinois | |
| Kettering Medical Center Kettering, Ohio | |
| Kootenai Clinic Cancer Services - Post Falls Post Falls, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Clinic Cancer Services - Sandpoint Sandpoint, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Health - Coeur d'Alene Coeur d'Alene, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Lafayette Family Cancer Center-EMMC Brewer, Maine | |
| Logan Health Medical Center Kalispell, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| M D Anderson Cancer Center Houston, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| MaineHealth Maine Medical Center- Scarborough Scarborough, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| Marshfield Medical Center - Minocqua Minocqua, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center - Weston Weston, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center-EC Cancer Center Eau Claire, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center-Marshfield Marshfield, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center-Rice Lake Rice Lake, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center-River Region at Stevens Point Stevens Point, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Mayo Clinic in Rochester Rochester, Minnesota | |
| Mercyhealth Cancer Institute - Rockford Rockford, Illinois | Site Public Contact - (oncologyclinicaltrials@mhemail.org) |
| Miami Valley Cancer Care and Infusion Greenville, Ohio | |
| Miami Valley Hospital Dayton, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Miami Valley Hospital North Dayton, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Miami Valley Hospital South Centerville, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Monmouth Medical Center Long Branch, New Jersey | Site Public Contact - (mary.danish@rwjbh.org) |
| Monmouth Medical Center Southern Campus Lakewood, New Jersey | Site Public Contact - (mary.danish@rwjbh.org) |
| National Institutes of Health Clinical Center Bethesda, Maryland | |
| NorthShore University HealthSystem-Evanston Hospital Evanston, Illinois | |
| NorthShore University HealthSystem-Glenbrook Hospital Glenview, Illinois | |
| NorthShore University HealthSystem-Highland Park Hospital Highland Park, Illinois | |
| OSF Saint Francis Hospital and Medical Group Escanaba, Michigan | Site Public Contact - (WI_research_admin@hshs.org) |
| Ohio State University Comprehensive Cancer Center Columbus, Ohio | Site Public Contact - (Jamesline@osumc.edu) |
| OhioHealth Mansfield Hospital Mansfield, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| OhioHealth Marion General Hospital Marion, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| OhioHealth O'Bleness Hospital Athens, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| OhioHealth Pickerington Methodist Hospital Pickerington, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| OhioHealth Westerville Medical Campus/Westerville Cancer Center Westerville, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| OptumCare Cancer Care at Charleston Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at Fort Apache Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at Seven Hills Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Premier Blood and Cancer Center Dayton, Ohio | |
| Providence Portland Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Saint Vincent Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Regional Cancer Center at Johnson City Medical Center Johnson City, Tennessee | Site Public Contact - (charles.mays@balladhealth.org) |
| Riverside Methodist Hospital Columbus, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Roswell Park Cancer Institute Buffalo, New York | Site Public Contact - (askroswell@roswellpark.org) |
| Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey | |
| SIH Cancer Institute Carterville, Illinois | Site Public Contact - (clinical.research@sih.net) |
| Saint Alphonsus Cancer Care Center-Boise Boise, Idaho | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Saint Alphonsus Cancer Care Center-Caldwell Caldwell, Idaho | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Saint Alphonsus Cancer Care Center-Nampa Nampa, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Saint Alphonsus Cancer Care Center-Ontario Ontario, Oregon | Site Public Contact - (mccinfo@mtcancer.org) |
| Saint Francis Medical Center Cape Girardeau, Missouri | Site Public Contact - (sfmc@sfmc.net) |
| Saint John's Hospital - Healtheast Maplewood, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Saint Joseph Hospital East Lexington, Kentucky | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Luke's Cancer Institute - Boise Boise, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Fruitland Fruitland, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Meridian Meridian, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Nampa Nampa, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Sheboygan Sheboygan, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Sanford Bismarck Medical Center Bismarck, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Broadway Medical Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Cancer Center Oncology Clinic Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicTrialsSF@sanfordhealth.org) |
| Sanford Joe Lueken Cancer Center Bemidji, Minnesota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Roger Maris Cancer Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org) |
| Southeastern Medical Oncology Center-Clinton Clinton, North Carolina | Site Public Contact - (jfields@cancersmoc.com) |
| Southeastern Medical Oncology Center-Goldsboro Goldsboro, North Carolina | Site Public Contact - (jfields@cancersmoc.com) |
| Southeastern Medical Oncology Center-Jacksonville Jacksonville, North Carolina | Site Public Contact - (jfields@cancersmoc.com) |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| Springfield Clinic Springfield, Illinois | |
| Springfield Memorial Hospital Springfield, Illinois | Site Public Contact - (pallante.beth@mhsil.com) |
| State University of New York Upstate Medical University Syracuse, New York | |
| Swedish Medical Center-First Hill Seattle, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| The Angeles Clinic and Research Institute - West Los Angeles Office Los Angeles, California | Site Public Contact - (ctsucontact@westat.com) |
| Thomas Jefferson University Hospital Philadelphia, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Canton Canton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Joseph Mercy Hospital Ann Arbor Ann Arbor, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Joseph Mercy Oakland Hospital Pontiac, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Mary Mercy Livonia Hospital Livonia, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| UC San Diego Health System - Encinitas Encinitas, California | |
| UC San Diego Medical Center - Hillcrest San Diego, California | Site Public Contact - (rhabbaba@health.ucsd.edu) |
| UC San Diego Moores Cancer Center La Jolla, California | Site Public Contact - (cancercto@ucsd.edu) |
| UI Health Care Mission Cancer and Blood - Ankeny Clinic Ankeny, Iowa | |
| UI Health Care Mission Cancer and Blood - Des Moines Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - Laurel Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - Waukee Clinic Waukee, Iowa | |
| UM Sylvester Comprehensive Cancer Center at Aventura Aventura, Florida | |
| UM Sylvester Comprehensive Cancer Center at Coral Gables Coral Gables, Florida | |
| UM Sylvester Comprehensive Cancer Center at Coral Springs Coral Springs, Florida | |
| UM Sylvester Comprehensive Cancer Center at Deerfield Beach Deerfield Beach, Florida | |
| UM Sylvester Comprehensive Cancer Center at Kendall Miami, Florida | |
| UM Sylvester Comprehensive Cancer Center at Plantation Plantation, Florida | |
| UPMC Altoona Altoona, Pennsylvania | Site Public Contact - (Roster@nrgoncology.org) |
| UPMC Cancer Centers - Arnold Palmer Pavilion Greensburg, Pennsylvania | |
| UPMC Hillman Cancer Center - Monroeville Monroeville, Pennsylvania | Site Public Contact - (ClinicalResearchServices@upmc.edu) |
| UPMC Hillman Cancer Center Erie Erie, Pennsylvania | Site Public Contact - (ClinicalResearchServices@upmc.edu) |
| UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion Mechanicsburg, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC Western Maryland Cumberland, Maryland | |
| UPMC-Magee Womens Hospital Pittsburgh, Pennsylvania | |
| UPMC-Passavant Hospital Pittsburgh, Pennsylvania | |
| UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| University of Alabama at Birmingham Cancer Center Birmingham, Alabama | Site Public Contact - (gingerreeves@uabmc.edu) |
| University of Illinois Chicago, Illinois | |
| University of Kentucky/Markey Cancer Center Lexington, Kentucky | |
| University of Maryland/Greenebaum Cancer Center Baltimore, Maryland | |
| University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida | |
| University of Michigan Health - Sparrow Lansing Lansing, Michigan | Site Public Contact - (harsha.trivedi@umhsparrow.org) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Pittsburgh Cancer Institute (UPCI) Pittsburgh, Pennsylvania | |
| University of South Alabama Mitchell Cancer Institute Mobile, Alabama | Site Public Contact - (pfrancisco@usouthal.edu) |
| University of Virginia Cancer Center Charlottesville, Virginia | Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu) |
| Upper Valley Medical Center Troy, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Vanderbilt University/Ingram Cancer Center Nashville, Tennessee | |
| Walter Reed National Military Medical Center Bethesda, Maryland | |
| Wellmont Holston Valley Hospital and Medical Center Kingsport, Tennessee | Site Public Contact - (charles.mays@balladhealth.org) |
| West Virginia University Healthcare Morgantown, West Virginia | Site Public Contact - (cancertrialsinfo@hsc.wvu.edu) |
| Woodland Cancer Care Center Michigan City, Indiana |
Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment
ctrrecruit@vcu.edu
NCT06589804
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Inclusion Criteria:
* Histologically confirmed diagnosis head and neck squamous cell carcinomas (HNSCC).
* Previously untreated for recurrent and/or metastatic disease incurable by local therapies.
* Primary tumor location of oral cavity, oropharynx, larynx, or hypopharynx.
* Note: Other primary tumor sites of HNSCC, including nasopharynx primary tumor are not eligible. Unknown primary tumors may be eligible and can be enrolled at the discretion of the treatment team with approval by the study chair.
* Measurable disease.
* Must have platinum-refractory disease defined as disease progression during or ≤ 29 weeks after completion of definitive therapy (chemoradiation therapy) or adjuvant (post-operative) therapy.
* Patient must have a combined positive score PD-L1 positive (CPS \>/= 1) tumor.
* Any radiation therapy must be completed \>= 10 days prior to registration.
* Patients should not have received any prior treatment in the recurrent or metastatic setting.
* Prior therapy with neoadjuvant or induction anti PD-1/PD-L1 monoclonal antibody or cetuximab in the curative setting is allowed if last treatment dose was \>= 26 weeks prior to registration without evidence of disease progression during that treatment period.
* Patient has not received a live vaccine within 30 days prior to registration.
* Patient does not have a history of any contraindication or has a severe hypersensitivity to any component of pembrolizumab or cetuximab (≥ grade 3).
* Patient has not received chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to registration.
* Patient with oropharyngeal cancer only must have negative results from testing of human papillomavirus (HPV) status defined as p16 immunohistochemistry (IHC) and/or HPV in situ hybridization (ISH).
* Note: A Clinical Laboratory Improvement Act (CLIA) certified circulating tumor HPV deoxyribonucleic acid (ctHPVDNA) assay can be used if tissue sample is not available.
* Age ≥ 18 years.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
* Absolute neutrophil count (ANC) ≥ 1,500/mm\^3.
* Platelet count ≥ 100,000/mm\^3.
* Hemoglobin (Hgb) ≥ 9 g/dL (if \< 9 g/dL, then transfusions are acceptable to increase hemoglobin above 9 g/dL).
* Creatinine ≤ 1.5 x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance ≥ 30 mL/min using the Cockcroft-Gault formula for participant with creatinine levels \> 1.5 x institutional ULN.
* Total bilirubin ≤ 1.5 x ULN OR direct bilirubin \< ULN for participant with total bilirubin \> 1.5 x institutional ULN.
* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase \[SGPT\]) ≤ 3.0 x ULN unless liver metastases are present in which case \< 5.0 x ULN.
* Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic, and teratogenic effects.
* Therefore, for women of childbearing potential only, a negative pregnancy test done ≤ 7 days prior to registration is required.
* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen should be included.
* For treated/stable brain metastases: Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.
* Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy.
* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial.
* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.
* Patients does not have a history of active myocarditis.
* Patients does not have a history of any form of pneumonitis or diffuse idiopathic or immune mediated interstitial pulmonary disease.
* Patient does not have a history of solid organ transplantation. PROCEDURE: Biospecimen Collection, BIOLOGICAL: Cetuximab, PROCEDURE: Computed Tomography, PROCEDURE: Magnetic Resonance Imaging, BIOLOGICAL: Pembrolizumab, PROCEDURE: Positron Emission Tomography
Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Hypopharyngeal Squamous Cell Carcinoma, Metastatic Laryngeal Squamous Cell Carcinoma, Metastatic Oral Cavity Squamous Cell Carcinoma, Metastatic Oropharyngeal Squamous Cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma, Recurrent Hypopharyngeal Squamous Cell Carcinoma, Recurrent Laryngeal Squamous Cell Carcinoma, Recurrent Neck Squamous Cell Carcinoma of Unknown Primary, Recurrent Oral Cavity Squamous Cell Carcinoma, Recurrent Oropharyngeal Squamous Cell Carcinoma, Refractory Head and Neck Squamous Cell Carcinoma, Refractory Hypopharyngeal Squamous Cell Carcinoma, Refractory Laryngeal Squamous Cell Carcinoma, Refractory Oral Cavity Squamous Cell Carcinoma, Refractory Oropharyngeal Squamous Cell Carcinoma, Stage IV Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8, Stage IV Hypopharyngeal Carcinoma AJCC v8, Stage IV Laryngeal Cancer AJCC v8, Stage IV Lip and Oral Cavity Cancer AJCC v8, Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8
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Show 171 locations
Study Locations
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| Location | Contacts |
|---|---|
| AMG Crystal Lake - Oncology Crystal Lake, Illinois | Site Public Contact - (advocateresearch@advocate.com) |
| AMG Libertyville - Oncology Libertyville, Illinois | Site Public Contact - (advocateresearch@advocatehealth.com) |
| Abbott-Northwestern Hospital Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Advocate Christ Medical Center Oak Lawn, Illinois | |
| Advocate Good Samaritan Hospital Downers Grove, Illinois | Site Public Contact - (Barbara.barhamand@advocatehealth.com) |
| Advocate Good Shepherd Hospital Barrington, Illinois | |
| Advocate High Tech Medical Park Palos Heights, Illinois | Site Public Contact - (ncorp@aah.org) |
| Advocate Illinois Masonic Medical Center Chicago, Illinois | |
| Advocate Lutheran General Hospital Park Ridge, Illinois | |
| Advocate Outpatient Center - Oak Lawn Oak Lawn, Illinois | Site Public Contact - (ncorp@aah.org) |
| Advocate Sherman Hospital Elgin, Illinois | |
| Advocate South Suburban Hospital Hazel Crest, Illinois | |
| Atrium Medical Center-Middletown Regional Hospital Franklin, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Aurora Bay Area Medical Group-Marinette Marinette, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora BayCare Medical Center Green Bay, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Grafton Grafton, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Kenosha South Kenosha, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Milwaukee Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Milwaukee West Wauwatosa, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Racine Racine, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Southern Lakes VLCC Burlington, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Health Care Germantown Health Center Germantown, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Medical Center in Summit Summit, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Saint Luke's Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Saint Luke's South Shore Cudahy, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Sinai Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora West Allis Medical Center West Allis, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Avera Cancer Institute Sioux Falls, South Dakota | Site Public Contact - (OncRegulatory@avera.org) |
| Avera Cancer Institute - Mitchell Mitchell, South Dakota | Site Public Contact - (OncRegulatory@avera.org) |
| Avera Cancer Institute at Pierre Pierre, South Dakota | Site Public Contact - (OncRegulatory@avera.org) |
| Avera Cancer Institute at Yankton Yankton, South Dakota | Site Public Contact - (OncRegulatory@avera.org) |
| Benefis Sletten Cancer Institute Great Falls, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Billings Clinic Cancer Center Billings, Montana | Site Public Contact - (research@billingsclinic.org) |
| Bozeman Health Deaconess Hospital Bozeman, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Cancer Care Center of O'Fallon O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Care Specialists of Illinois - Decatur Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Care and Hematology-Fort Collins Fort Collins, Colorado | Site Public Contact - (protocols@AllianceNCTN.org) |
| Cancer Centers of Southwest Oklahoma Research Lawton, Oklahoma | |
| Cancer Hematology Centers - Flint Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Community Hospital of Anaconda Anaconda, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Toms River, New Jersey | Site Public Contact - (mccinfo@mtcancer.org) |
| Condell Memorial Hospital Libertyville, Illinois | Site Public Contact - (advocateresearch@advocatehealth.com) |
| Crossroads Cancer Center Effingham, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Decatur Memorial Hospital Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Fairview Southdale Hospital Edina, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| FirstHealth of the Carolinas-Moore Regional Hospital Pinehurst, North Carolina | Site Public Contact - (jcwilliams@firsthealth.org) |
| Fremont - Rideout Cancer Center Marysville, California | |
| Genesee Hematology Oncology PC Flint, Michigan | |
| Genesys Hurley Cancer Institute Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Glens Falls Hospital Glens Falls, New York | |
| Gundersen Lutheran Medical Center La Crosse, Wisconsin | Site Public Contact - (cancerctr@gundersenhealth.org) |
| HaysMed Hays, Kansas | |
| Hurley Medical Center Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Illinois CancerCare-Macomb Macomb, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Peoria Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Jefferson Cherry Hill Hospital Cherry Hill, New Jersey | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Jefferson Torresdale Hospital Philadelphia, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Kootenai Clinic Cancer Services - Post Falls Post Falls, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Clinic Cancer Services - Sandpoint Sandpoint, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Health - Coeur d'Alene Coeur d'Alene, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Lake Regional Hospital Osage Beach, Missouri | Site Public Contact - (clinicaltrials@lakeregional.com) |
| Lawrence Memorial Hospital Lawrence, Kansas | Site Public Contact - (Stephanie.Norris@LMH.ORG) |
| Lehigh Valley Hospital - Muhlenberg Bethlehem, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Logan Health Medical Center Kalispell, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Lutheran Hospital - Cancer Centers of Colorado Golden, Colorado | Site Public Contact - (peaksresearch@imail.org) |
| Margaret R Pardee Memorial Hospital Hendersonville, North Carolina | Site Public Contact - (pardeecancerresearch@unchealth.unc.edu) |
| Marshfield Medical Center - Weston Weston, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center-EC Cancer Center Eau Claire, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center-River Region at Stevens Point Stevens Point, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Mary Greeley Medical Center Ames, Iowa | |
| McFarland Clinic - Ames Ames, Iowa | Site Public Contact - (ksoder@mcfarlandclinic.com) |
| McFarland Clinic - Boone Boone, Iowa | |
| McFarland Clinic - Jefferson Jefferson, Iowa | |
| McFarland Clinic - Marshalltown Marshalltown, Iowa | |
| McFarland Clinic - Trinity Cancer Center Fort Dodge, Iowa | |
| Medical Center of the Rockies Loveland, Colorado | |
| Medical University of South Carolina Charleston, South Carolina | Site Public Contact - (hcc-clinical-trials@musc.edu) |
| Memorial Hospital East Shiloh, Illinois | Site Public Contact - (dschwab@wustl.edu) |
| Memorial Hospital North Colorado Springs, Colorado | |
| Memorial Sloan Kettering Basking Ridge Basking Ridge, New Jersey | |
| Memorial Sloan Kettering Bergen Montvale, New Jersey | |
| Memorial Sloan Kettering Cancer Center New York, New York | |
| Memorial Sloan Kettering Commack Commack, New York | |
| Memorial Sloan Kettering Monmouth Middletown, New Jersey | |
| Memorial Sloan Kettering Nassau Uniondale, New York | |
| Memorial Sloan Kettering Westchester Harrison, New York | |
| Mercy Hospital Coon Rapids, Minnesota | |
| Mercy Hospital Coon Rapids, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Mercy Hospital South St Louis, Missouri | Site Public Contact - (Danielle.Werle@mercy.net) |
| Miami Valley Cancer Care and Infusion Greenville, Ohio | |
| Miami Valley Hospital Dayton, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Miami Valley Hospital North Dayton, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Miami Valley Hospital South Centerville, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Mount Sinai Medical Center Miami Beach, Florida | |
| Oncology Associates at Mercy Medical Center Cedar Rapids, Iowa | |
| Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Pocono Medical Center East Stroudsburg, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Poudre Valley Hospital Fort Collins, Colorado | |
| ProHealth D N Greenwald Center Mukwonago, Wisconsin | Site Public Contact - (research.institute@phci.org) |
| ProHealth Oconomowoc Memorial Hospital Oconomowoc, Wisconsin | |
| ProHealth Waukesha Memorial Hospital Waukesha, Wisconsin | |
| ProMedica Flower Hospital Sylvania, Ohio | Site Public Contact - (PCIOncResearch@promedica.org) |
| Providence Portland Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Saint Vincent Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Willamette Falls Medical Center Oregon City, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Regions Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| SUNY Upstate Medical Center-Community Campus Syracuse, New York | |
| Saint Alphonsus Cancer Care Center-Boise Boise, Idaho | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Saint Alphonsus Cancer Care Center-Caldwell Caldwell, Idaho | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Saint Alphonsus Cancer Care Center-Nampa Nampa, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Saint Alphonsus Cancer Care Center-Ontario Ontario, Oregon | Site Public Contact - (mccinfo@mtcancer.org) |
| Saint Francis Medical Center Cape Girardeau, Missouri | Site Public Contact - (sfmc@sfmc.net) |
| Saint John's Hospital - Healtheast Maplewood, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Salina Regional Health Center Salina, Kansas | Site Public Contact - (mleepers@srhc.com) |
| Sanford Bismarck Medical Center Bismarck, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Broadway Medical Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Cancer Center Oncology Clinic Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicTrialsSF@sanfordhealth.org) |
| Sanford Joe Lueken Cancer Center Bemidji, Minnesota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Roger Maris Cancer Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org) |
| Sidney Kimmel Cancer Center Washington Township Sewell, New Jersey | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Siteman Cancer Center at Christian Hospital St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center at Saint Peters Hospital City of Saint Peters, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center at West County Hospital Creve Coeur, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center-South County St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| Springfield Clinic Springfield, Illinois | |
| Springfield Memorial Hospital Springfield, Illinois | Site Public Contact - (pallante.beth@mhsil.com) |
| State University of New York Upstate Medical University Syracuse, New York | |
| The University of Kansas Cancer Center - Olathe Olathe, Kansas | Site Public Contact - (OlatheCCResearch@kumc.edu) |
| Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Canton Canton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Joseph Mercy Hospital Ann Arbor Ann Arbor, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Joseph Mercy Oakland Hospital Pontiac, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Mary Mercy Livonia Hospital Livonia, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| UC Comprehensive Cancer Center at Silver Cross New Lenox, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| UCHealth Greeley Hospital Greeley, Colorado | Site Public Contact - (protocols@AllianceNCTN.org) |
| UCHealth Memorial Hospital Central Colorado Springs, Colorado | |
| UChicago Medicine Northwest Indiana Crown Point, Indiana | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina | Site Public Contact - (cancerclinicaltrials@med.unc.edu) |
| UW Cancer Center at ProHealth Care Waukesha, Wisconsin | Site Public Contact - (Chanda.miller@phci.org) |
| UW Health Carbone Cancer Center Rockford Rockford, Illinois | Site Public Contact - (lkline@uwhealth.org) |
| United Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| University Health Truman Medical Center Kansas City, Missouri | |
| University of Arkansas for Medical Sciences Little Rock, Arkansas | |
| University of Chicago Comprehensive Cancer Center Chicago, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| University of Chicago Medicine-Orland Park Orland Park, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| University of Kansas Cancer Center Kansas City, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Cancer Center - Briarcliff Kansas City, Missouri | |
| University of Kansas Cancer Center - Lee's Summit Lee's Summit, Missouri | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Cancer Center - North Kansas City, Missouri | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Cancer Center-Overland Park Overland Park, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Health System Saint Francis Campus Topeka, Kansas | |
| University of Kansas Hospital-Indian Creek Campus Overland Park, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Hospital-Westwood Cancer Center Westwood, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Maryland/Greenebaum Cancer Center Baltimore, Maryland | |
| University of Michigan Health - Sparrow Lansing Lansing, Michigan | Site Public Contact - (harsha.trivedi@umhsparrow.org) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| Upper Valley Medical Center Troy, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Upstate Cancer Center at Verona Verona, New York | Site Public Contact - (McDowelE@upstate.edu) |
| VA Palo Alto Health Care System Palo Alto, California | |
| VCU Massey Cancer Center at Stony Point Richmond, Virginia | Site Public Contact - (ctoclinops@vcu.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Vince Lombardi Cancer Clinic - Oshkosh Oshkosh, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Vince Lombardi Cancer Clinic-Sheboygan Sheboygan, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Vince Lombardi Cancer Clinic-Two Rivers Two Rivers, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| West Virginia University Charleston Division Charleston, West Virginia |
A Study With Tovorafenib (DAY101) as a Treatment Option for Progressive, Relapsed, or Refractory Langerhans Cell Histiocytosis
ctrrecruit@vcu.edu
NCT05828069
Show full eligibility criteria
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Inclusion Criteria:
* 180 days- \< 22 years (at time of study enrollment)
* Patient must have a body surface area of ≥ 0.3 m\^2
* Patients with progressive, relapsed, or recurrent LCH with measurable disease at study entry
* Patients must have had histologic verification of LCH (from either original diagnosis or relapse/progression) at the time of study entry
* Tissue confirmation of relapse is recommended but not required.
* Pathology report must be submitted for central confirmation of diagnosis within 7 days of enrollment.
* Formalin-fixed paraffin-embedded (FFPE) blocks or unstained slides (initial diagnosis and/or subsequent biopsies) will be required for retrospective central confirmation of diagnosis and molecular studies
* Patients with mixed histiocytic disorders (e.g. LCH with juvenile xanthogranuloma) may be included
* Patients must have measurable disease
* Patients must have progressive or refractory disease or experience relapse after at least one previous systemic treatment strategy
* Pathogenic somatic mutation detected in genes encoding tyrosine kinase receptors (CSFR1, ERBB3 or ALK), RAS or RAF (may be from original or subsequent biopsy or peripheral blood/bone marrow aspirate). Clinical mutation reports may include quantitative polymerase chain reaction (PCR) (e.g. BRAFV600E) and/or Sanger or next generation sequencing. Immunohistochemistry (e.g. VE1 antibody for BRAFV600E) alone is not sufficient
* Participant must be able to take an enteral dose and formulation of medication. Study medication is only available as an oral suspension or tablet, which may be taken by mouth or other enteral route such as nasogastric, jejunostomy, or gastric tube
* Karnofsky \>= 50% for patients \> 16 years of age and Lansky \>= 50% for patients =\< 16 years of age
* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients \> 16 years of age and Lansky for patients =\< 16 years of age
* Myelosuppressive chemotherapy: Patients must not have received within 14 days of entry onto this study
* Investigational agent or any other anticancer therapy not defined above: Patients must not have received any investigational agent or any other anticancer therapy (including MAPK pathway inhibitor) for at least 14 days prior to planned start of tovorafenib (DAY101)
* Radiation therapy (RT): Patient must not have received RT within 2 weeks after the last dose fraction of RT
* Patients must have fully recovered from any prior surgery
* Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, targeted inhibitor, and/or radiotherapy with toxicities reduced to grade 1 or less (Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0)
* Steroids: =\< 0.5 mg/kg/day of prednisone equivalent (maximum 20 mg/day) averaged during the month prior to study enrollment is permissible
* Strong inducers or inhibitors of CYP2C8 are prohibited for 14 days before the first dose of tovorafenib (DAY101) and from planned administration for the duration of study participation
* Medications that are breast cancer resistant protein (BCRP) substrates that have a narrow therapeutic index are prohibited for 14 days before the first dose of tovorafenib (DAY101) and for the duration of study participation
* Peripheral absolute neutrophil count (ANC) \>= 750/uL unless secondary to bone marrow involvement, in such cases bone marrow involvement must be documented (must be performed within 7 days prior to enrollment, must be repeated prior to the start of protocol therapy if \> 7 days have elapsed from their most recent prior assessment)
* Platelet count \>= 75,000/uL (unsupported/without transfusion within the past 7 days) (must be performed within 7 days prior to enrollment, must be repeated prior to the start of protocol therapy if \> 7 days have elapsed from their most recent prior assessment)
* Patients with marrow disease must have platelet count of \>= 75,000/uL (transfusion support allowed) and must not be refractory to platelet transfusions. Bone marrow involvement must be documented
* Hemoglobin \>= 8 g/dL (unsupported/without transfusion within the past 7 days). Patients with marrow disease must have hemoglobin \>= 8 g/dL (transfusion support allowed). Bone marrow involvement must be documented
* Hematopoietic growth factors: At least 14 days after the last dose of a long-acting growth factor (e.g., Neulasta \[registered trademark\]) or 7 days for short-acting growth factor
* A serum creatinine based on age/sex as follows (must be performed within 7 days prior to enrollment, must be repeated prior to the start of protocol therapy if \> 7 days have elapsed from their most recent prior assessment)
* Age: 6 months to \< 1 year; Maximum Serum Creatinine (mg/dL):= 0.5 mg/dl (male and female)
* Age: 1 to \< 2 years; Maximum Serum Creatinine (mg/dL): = 0.6 mg/dl (male and female)
* Age: 2 to \< 6 years; Maximum Serum Creatinine (mg/dL): = 0.8 mg/dl (male and female)
* Age: 6 to \< 10 years; Maximum Serum Creatinine (mg/dL): = 1.0 mg/dl (male and female)
* Age: 10 to \< 13 years; Maximum Serum Creatinine (mg/dL): = 1.2 mg/dl (male and female)
* Age: 13 to \< 16 years; Maximum Serum Creatinine (mg/dL): = 1.5 mg/dl (male) and 1.4 mg/dl (female)
* Age: \>= 16 years; Maximum Serum Creatinine (mg/dL): = 1.7 mg/dl (male) and 1.4 mg/dl (female)
* OR- a 24 hour urine creatinine clearance \>= 50 mL/min/1.73 m\^2
* OR- a glomerular filtration rate (GFR) \>= 50 mL/min/1.73 m\^2. GFR must be performed using direct measurement with a nuclear blood sampling method OR direct small molecule clearance method (iothalamate or other molecule per institutional standard)
* Note: Estimated GFR (eGFR) from serum creatinine, cystatin C or other estimates are not acceptable for determining eligibility
* Bilirubin (sum of conjugated + unconjugated) =\< 1.5 x upper limit of normal (ULN) for age (must be performed within 7 days prior to enrollment, must be repeated prior to the start of protocol therapy if \> 7 days have elapsed from their most recent prior assessment)
* Alanine aminotransferase (ALT) =\< 3 x ULN for age (must be performed within 7 days prior to enrollment, must be repeated prior to the start of protocol therapy if \> 7 days have elapsed from their most recent prior assessment)
* Serum albumin \>= 2 g/dl must be performed within 7 days prior to enrollment, must be repeated prior to the start of protocol therapy if \> 7 days have elapsed from their most recent prior assessment)
* For patients with liver disease caused by their histiocytic disorder (as evaluated on radiographic imaging or biopsy): patients may be enrolled with abnormal bilirubin, aspartate aminotransferase (AST), ALT and albumin with documentation of histiocytic liver disease
* Fractional shortening (FS) of \>= 25% or ejection fraction of \>= 50%, as determined by echocardiography or multigated acquisition scan (MUGA) within 28 days prior to study enrollment. Depending on institutional standard, either FS or left ventricular ejection fraction (LVEF) is adequate for enrollment if only one value is measured; if both values are measured, then both values must meet criteria above (must be obtained within 28 days prior to enrollment and start of protocol therapy) (repeat if necessary)
* No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry \> 94% if there is clinical indication for determination; unless it is due to underlying pulmonary LCH
* Central Nervous System Function Defined As:
* Patients with seizure disorder may be enrolled if well controlled
* Central nervous system (CNS) toxicity =\< Grade 2
* Human immunodeficiency virus (HIV) infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial unless antiretroviral therapy interacts with the metabolism of tovorafenib (DAY101) and cannot safely be changed to antivirals that do not interact with study medication
* All patients and/or their parent(s) or legal guardians must sign a written informed consent
* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.
Exclusion Criteria:
* LCH arising along with other hematologic malignancy (e.g. mixed LCH with acute lymphoblastic leukemia) or any history of non-histiocytic malignancy
* Disease scenarios as below will be excluded
* Skin-limited disease
* Gastrointestinal (GI) tract involvement only (those that have disease that can be determined by endoscopic biopsies only)
* LCH-associated neurodegeneration (LCH-ND) without parenchymal lesions or other systemic lesions
* Patients with activating mutations in MAP2K1 are not eligible for this study due to drug target specificity. Mutation status will be submitted to study team within 7 days of enrollment
* Refractory nausea and vomiting, malabsorption, or external biliary shunt that would preclude adequate absorption of tovorafenib (DAY101)
* Uncontrolled systemic bacterial, viral, or fungal infection
* Major surgical procedure or significant traumatic injury within 14 days prior to study enrollment, or anticipation of need for major surgical procedure during the course of the study. Placement of a vascular access device or minor surgery is permitted within fourteen (14) days of study enrollment (provided that the wound has healed)
* History of significant bowel resection that would preclude adequate absorption or other significant malabsorptive disease
* Ophthalmologic considerations: Patients with known significant ophthalmologic conditions or known risk factors for retinal vein occlusion (RVO) or central serous retinopathy (CSR) are not eligible
* History of solid organ or hematopoietic bone marrow transplantation
* Clinically significant active cardiovascular disease, or history of myocardial infarction, or deep vein thrombosis/pulmonary embolism within 6 months prior to enrollment, ongoing cardiomyopathy, or current prolonged QT interval \> 440 ms based on triplicate electrocardiogram (ECG) average
* History of Grade \>= 2 CNS hemorrhage or history of any CNS hemorrhage within 28 days of study entry
* History of any drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome or Stevens Johnsons syndrome (SJS) or who are allergic to tovorafenib (DAY101) or any of its components
* CTCAE version (V.) 5.0 Grade 3 symptomatic creatinine kinase (CPK) elevation (\> 5 x ULN)
* Female patients who are pregnant are ineligible. A pregnancy test is required for female patients of childbearing potential
* Lactating females who plan to breastfeed their infants are ineligible
* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation are ineligible. Women of childbearing potential must use non-hormonal contraception during tovorafenib treatment and for at least 28 days after the last dose. Men should use effective contraception and must not father a child while taking tovorafenib and for 14 days after the last dose PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Bone Marrow Biopsy, PROCEDURE: Computed Tomography, PROCEDURE: Echocardiography Test, PROCEDURE: FDG-Positron Emission Tomography and Computed Tomography Scan, PROCEDURE: Lumbar Puncture, PROCEDURE: Multigated Acquisition Scan, DRUG: Tovorafenib
Recurrent Langerhans Cell Histiocytosis, Refractory Langerhans Cell Histiocytosis
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Study Locations
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| Location | Contacts |
|---|---|
| Albany Medical Center Albany, New York | |
| Alfred I duPont Hospital for Children Wilmington, Delaware | Site Public Contact - (Allison.bruce@nemours.org) |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Arkansas Children's Hospital Little Rock, Arkansas | |
| Arnold Palmer Hospital for Children Orlando, Florida | Site Public Contact - (Jennifer.spinelli@orlandohealth.com) |
| BI-LO Charities Children's Cancer Center Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas | Site Public Contact - (burton@bcm.edu) |
| Blank Children's Hospital Des Moines, Iowa | Site Public Contact - (samantha.mallory@unitypoint.org) |
| British Columbia Children's Hospital Vancouver, British Columbia | |
| Bronson Methodist Hospital Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL) Québec, | Site Public Contact - (rechclinique@crchudequebec.ulaval.ca) |
| Cardinal Glennon Children's Medical Center St Louis, Missouri | |
| Centre Hospitalier Universitaire Sainte-Justine Montreal, Quebec | Site Public Contact - (yvan.samson@umontreal.ca) |
| Centre Hospitalier Universitaire de Sherbrooke-Fleurimont Sherbrooke, Quebec | Site Public Contact - (crcinformation.chus@ssss.gouv.qc.ca) |
| Children's Healthcare of Atlanta - Arthur M Blank Hospital Atlanta, Georgia | Site Public Contact - (Olivia.Floyd@choa.org) |
| Children's Hospital London, Ontario | |
| Children's Hospital Colorado Aurora, Colorado | Site Public Contact - (josh.b.gordon@nsmtp.kp.org) |
| Children's Hospital Los Angeles Los Angeles, California | |
| Children's Hospital New Orleans New Orleans, Louisiana | |
| Children's Hospital and Medical Center of Omaha Omaha, Nebraska | |
| Children's Hospital of Alabama Birmingham, Alabama | Site Public Contact - (oncologyresearch@peds.uab.edu) |
| Children's Hospital of Orange County Orange, California | Site Public Contact - (oncresearch@choc.org) |
| Children's Hospital of Philadelphia Philadelphia, Pennsylvania | Site Public Contact - (CancerTrials@email.chop.edu) |
| Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania | Site Public Contact - (jean.tersak@chp.edu) |
| Children's Hospital of San Antonio San Antonio, Texas | Site Public Contact - (bridget.medina@christushealth.org) |
| Children's Hospital of Wisconsin Milwaukee, Wisconsin | Site Public Contact - (MACCCTO@mcw.edu) |
| Children's Hospital of the King's Daughters Norfolk, Virginia | Site Public Contact - (CCBDCresearch@chkd.org) |
| Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis, Minnesota | Site Public Contact - (pauline.mitby@childrensmn.org) |
| Children's National Medical Center Washington D.C., District of Columbia | Site Public Contact - (OncCRC_OnCall@childrensnational.org) |
| Connecticut Children's Medical Center Hartford, Connecticut | |
| Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Dayton Children's Hospital Dayton, Ohio | |
| Dell Children's Medical Center of Central Texas Austin, Texas | Site Public Contact - (TXAUS-DL-SFCHemonc.research@ascension.org) |
| Duke University Medical Center Durham, North Carolina | |
| East Carolina University Greenville, North Carolina | Site Public Contact - (eubankss@ecu.edu) |
| East Tennessee Childrens Hospital Knoxville, Tennessee | |
| El Paso Children's Hospital El Paso, Texas | Site Public Contact - (ranjan.bista@ttuhsc.edu) |
| Geisinger Medical Center Danville, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Golisano Children's Hospital of Southwest Florida Fort Myers, Florida | Site Public Contact - (molly.arnstrom@leehealth.org) |
| Hackensack University Medical Center Hackensack, New Jersey | |
| Hospital for Sick Children Toronto, Ontario | Site Public Contact - (ask.CRS@sickkids.ca) |
| IWK Health Centre Halifax, Nova Scotia | Site Public Contact - (Research@iwk.nshealth.ca) |
| Kaiser Permanente Downey Medical Center Downey, California | |
| Kaiser Permanente-Oakland Oakland, California | Site Public Contact - (Kpoct@kp.org) |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York | Site Public Contact - (CancerTrials@nyulangone.org) |
| Loma Linda University Medical Center Loma Linda, California | |
| Lucile Packard Children's Hospital Stanford University Palo Alto, California | Site Public Contact - (ccto-office@stanford.edu) |
| Lurie Children's Hospital-Chicago Chicago, Illinois | |
| M D Anderson Cancer Center Houston, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| Maimonides Medical Center Brooklyn, New York | |
| McMaster Children's Hospital at Hamilton Health Sciences Hamilton, Ontario | |
| Memorial Health University Medical Center Savannah, Georgia | Site Public Contact - (Lorraine.OHara@hcahealthcare.com) |
| Memorial Sloan Kettering Cancer Center New York, New York | |
| Mercy Hospital Saint Louis St Louis, Missouri | |
| Methodist Children's Hospital of South Texas San Antonio, Texas | Site Public Contact - (Vinod.GidvaniDiaz@hcahealthcare.com) |
| Michigan State University East Lansing, Michigan | |
| Mission Hospital Asheville, North Carolina | Site Public Contact - (NCDV.ResearchRegulatory@HCAHealthcare.com) |
| Montefiore Medical Center - Moses Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York | Site Public Contact - (cancerclinicaltrials@cumc.columbia.edu) |
| NYP/Weill Cornell Medical Center New York, New York | |
| Nationwide Children's Hospital Columbus, Ohio | Site Public Contact - (Melinda.Triplet@nationwidechildrens.org) |
| Nemours Children's Clinic - Pensacola Pensacola, Florida | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Nemours Children's Clinic-Jacksonville Jacksonville, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| Nemours Children's Hospital Orlando, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| New York Medical College Valhalla, New York | |
| Nicklaus Children's Hospital Miami, Florida | |
| Ochsner Medical Center Jefferson New Orleans, Louisiana | Site Public Contact - (Elisemarie.curry@ochsner.org) |
| Oregon Health and Science University Portland, Oregon | Site Public Contact - (trials@ohsu.edu) |
| Perth Children's Hospital Perth, Western Australia | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Primary Children's Hospital Salt Lake City, Utah | |
| Prisma Health Richland Hospital Columbia, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Providence Sacred Heart Medical Center and Children's Hospital Spokane, Washington | Site Public Contact - (HopeBeginsHere@providence.org) |
| Queensland Children's Hospital South Brisbane, Queensland | |
| Rainbow Babies and Childrens Hospital Cleveland, Ohio | |
| Riley Hospital for Children Indianapolis, Indiana | |
| Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver, Colorado | Site Public Contact - (PSGResearchSharedMailbox@HCAHealthcare.com) |
| Royal Children's Hospital Parkville, Victoria | Site Public Contact - (Jordan.Hansford@rch.org.au) |
| Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick, New Jersey | |
| Saint Christopher's Hospital for Children Philadelphia, Pennsylvania | |
| Saint Joseph's Hospital/Children's Hospital-Tampa Tampa, Florida | Site Public Contact - (jennifer.manns@baycare.org) |
| Saint Joseph's Regional Medical Center Paterson, New Jersey | Site Public Contact - (HallL@sjhmc.org) |
| Saint Jude Midwest Affiliate Peoria, Illinois | |
| Scott and White Memorial Hospital Temple, Texas | |
| Seattle Children's Hospital Seattle, Washington | |
| Sinai Hospital of Baltimore Baltimore, Maryland | |
| State University of New York Upstate Medical University Syracuse, New York | |
| Summerlin Hospital Medical Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Sydney Children's Hospital Randwick, New South Wales | |
| The Children's Hospital at TriStar Centennial Nashville, Tennessee | |
| The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park, New York | |
| UCSF Benioff Children's Hospital Oakland Oakland, California | Site Public Contact - (PedOncRschOAK@ucsf.edu) |
| UCSF Medical Center-Mission Bay San Francisco, California | Site Public Contact - (cancertrials@ucsf.edu) |
| UF Health Cancer Institute - Gainesville Gainesville, Florida | Site Public Contact - (cancer-center@ufl.edu) |
| UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| University of Alberta Hospital Edmonton, Alberta | Site Public Contact - (pedsoncologyresearch@ahs.ca) |
| University of Chicago Comprehensive Cancer Center Chicago, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa | |
| University of Kentucky/Markey Cancer Center Lexington, Kentucky | |
| University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida | |
| University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota | |
| University of Mississippi Medical Center Jackson, Mississippi | |
| University of Nebraska Medical Center Omaha, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Texas Health Science Center at San Antonio San Antonio, Texas | Site Public Contact - (phoresearchoffice@uthscsa.edu) |
| University of Virginia Cancer Center Charlottesville, Virginia | Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Valley Children's Hospital Madera, California | Site Public Contact - (Research@valleychildrens.org) |
| Vanderbilt University/Ingram Cancer Center Nashville, Tennessee | |
| Wake Forest University Health Sciences Winston-Salem, North Carolina | |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| West Virginia University Charleston Division Charleston, West Virginia | |
| Yale University New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
Testing Nivolumab With or Without Ipilimumab in Deficient Mismatch Repair System (dMMR) Recurrent Endometrial Carcinoma
ctrrecruit@vcu.edu
NCT05112601
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Inclusion Criteria:
* Patients with measurable or non-measurable (detectable) recurrent endometrial cancer
* Measurable disease will be defined and monitored by RECIST v 1.1. Measurable disease is defined per RECIST 1.1 criteria as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be \>= 10 mm when measured by computed tomography (CT) or magnetic resonance imaging (MRI). Lymph nodes must be \>= 15 mm in short axis when measured by CT or MRI
* Non-measurable (detectable) disease in a patient is defined in this protocol per RECIST 1.1 criteria as one who does not have measurable disease but has at least one of the following conditions:
* All other lesions (or sites of disease), including small lesions (longest diameter \<10 mm or pathological lymph nodes with \>= 10 to \< 15 mm short axis), are considered non-measurable disease
* Ascites and/or pleural effusion attributed to tumor
* Solid and/or cystic abnormalities on radiographic imaging that do not meet RECIST 1.1 definitions for target lesions
* Patients must have endometrial cancer with deficient mismatch repair system. All patients must have institutional immunohistochemistry (IHC) and/or microsatellite instability (MSI) testing to determine mismatch repair (MMR) status. MMR deficiency is defined as lack of expression of one or more mismatch repair proteins (MLH1, PMS2, MSH2, MSH6, EPCAM) by immunohistochemistry and/or presence of microsatellite instability high using the National Cancer Institute (NCI)-5plex and Promega v1.2 assays, or institutional standards (e.g. next-generation sequencing \[NGS\] panel)
* Method(s) of detection of MMR deficiency will be recorded for each patient. An institutional pathology report, and additional reports if available, documenting these results must be submitted. Patients with "equivocal" results on MMR testing by immunohistochemistry may be eligible if they have documented evidence of microsatellite instability by MSI testing or by next generation sequencing assays. MMR testing by IHC may be used to resolve equivocal/indeterminate MSI results
* Histologic confirmation of the original primary tumor is required (submission of pathology report(s) is required). Patients with the following histologic types are eligible: Endometrioid adenocarcinoma, mucinous adenocarcinoma, dedifferentiated/undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.)
* Patients may have received 1-2 prior lines of systemic therapy:
* Prior anti-PD1/PD-L1 therapy is allowed if given in combination with chemotherapy or radiation therapy in adjuvant or primary metastatic/recurrent settings. Patients must have had a complete response and have disease progression/relapse with treatment-free interval of 12 months or more from last dose of therapy with immune check inhibition
* Patients may have received prior radiation therapy for treatment of endometrial cancer. Prior radiation therapy may have included pelvic radiation therapy, extended field pelvic/para aortic radiation therapy, intravaginal brachytherapy, and/or palliative radiation therapy. All radiation therapy must be completed at least 4 weeks prior to registration
* Patients may have received prior hormonal therapy for treatment of endometrial cancer. All hormonal therapy must be discontinued at least three weeks prior to registration
* Any other prior therapy directed at the malignant tumor including chemotherapy, targeted agents, biologic agents, immunologic agents, and any investigational agents, must be discontinued at least 4 weeks prior to registration (6 weeks for nitrosoureas or mitomycin C)
* Age \>= 18
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
* Platelets \>= 100,000/mcl
* Absolute neutrophil count (ANC) \>= 1,500/mcl
* Creatinine =\< 1.5 x institutional/laboratory upper limit of normal (ULN)
* Total serum bilirubin level =\< 1.5 x ULN (patients with known Gilbert's disease who have bilirubin level =\<3 x ULN may be enrolled)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3 x ULN
* Adequate oxygen saturation via pulse oximeter (CTCAE v.5.0 hypoxia \< grade 2 within 28 days prior to registration)
* Thyroid-stimulating hormone (TSH) within normal limits (TSH \< ULN allowed in euthyroid patients on thyroid replacement therapy). TSH testing is only required if clinically indicated
* Patients must have recovered from effects of recent surgery, radiotherapy or chemotherapy. At least 4 weeks must have elapsed since major surgery
* As clinically indicated, patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better and have a corrected QT (QTc) interval \< 450 msec
* The effects of nivolumab, and ipilimumab on the developing human fetus are unknown. For this reason and because nivolumab and ipilimumab are known to be teratogenic, women of child-bearing potential (WOCBP) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for 5 months after the last dose of investigational drug. Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin \[HCG\]) within 24 hours prior to the start of nivolumab. Women must not be breastfeeding. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) do not require contraception
* WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL
* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial
* Patients with evidence of chronic hepatitis B virus (HBV) infection must have an undetectable HBV viral load on suppressive therapy, if indicated
* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression and the patient is stable off steroids for at least one month
* The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information
* Patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible
* Patients with rheumatoid arthritis and other arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible
Exclusion Criteria:
* Patients with a diagnosis of endometrial serous carcinoma or carcinosarcoma
* Patients who received prior anti-PD1/PD-L1 therapy and had grade 3-4 or recurring grade 2 immune-related toxicities that led to dose delay or discontinuation of immunotherapy due to those toxicities
* Patients who received anti-CTLA-4 therapy or other immunotherapeutic agents
* Patients on chronic steroid therapy except those on replacement therapy at a daily dose of 10mg or less prednisone or equivalent
* Patients on immunosuppressive therapy, with the exception of:
* Intra-nasal, inhaled, topical or local steroid injections
* Premedication for hypersensitivity reaction
* Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded. These include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded because of the risk of recurrence or exacerbation of disease
* Patients with known immune impairment who may be unable to respond to anti-CTLA-4 antibody
* Patients with uncontrolled intercurrent illness including, but not limited to: ongoing or active infection (except for uncomplicated urinary tract infection), interstitial lung disease or active, non-infectious pneumonitis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Women who are pregnant or unwilling to discontinue nursing
* Prior therapy with CTLA-4 inhibitors, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab, and/or ipilimumab including severe hypersensitivity reactions to any monoclonal antibody PROCEDURE: Biospecimen Collection, PROCEDURE: Computed Tomography, BIOLOGICAL: Ipilimumab, PROCEDURE: Magnetic Resonance Imaging, BIOLOGICAL: Nivolumab
Endometrial Adenocarcinoma, Endometrial Clear Cell Adenocarcinoma, Endometrial Dedifferentiated Carcinoma, Endometrial Endometrioid Adenocarcinoma, Endometrial Mixed Cell Adenocarcinoma, Endometrial Mucinous Adenocarcinoma, Endometrial Undifferentiated Carcinoma, Endometrioid Adenocarcinoma, Recurrent Endometrial Carcinoma
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Study Locations
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| Location | Contacts |
|---|---|
| Abbott-Northwestern Hospital Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Arnold Palmer Cancer Center Medical Oncology Norwin N. Huntingdon, Pennsylvania | Site Public Contact - (ClinicalResearchServices@upmc.edu) |
| Augusta University Medical Center Augusta, Georgia | Site Public Contact - (ga_cares@augusta.edu) |
| Benefis Sletten Cancer Institute Great Falls, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Billings Clinic Cancer Center Billings, Montana | Site Public Contact - (research@billingsclinic.org) |
| Bozeman Health Deaconess Hospital Bozeman, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Carle BroMenn Medical Center Normal, Illinois | Site Public Contact - (Research@Carle.com) |
| Carle Cancer Center Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Cancer Institute Normal Normal, Illinois | Site Public Contact - (Research@Carle.com) |
| Carle Physician Group-Effingham Effingham, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Mattoon/Charleston Mattoon, Illinois | Site Public Contact - (Research@carle.com) |
| Carle at The Riverfront Danville, Illinois | Site Public Contact - (Research@Carle.com) |
| Case Western Reserve University Cleveland, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| Cleveland Clinic Cancer Center/Fairview Hospital Cleveland, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Cleveland Clinic Foundation Cleveland, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Community Hospital of Anaconda Anaconda, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Toms River, New Jersey | Site Public Contact - (mccinfo@mtcancer.org) |
| Duke University Medical Center Durham, North Carolina | |
| Duke Women's Cancer Care Raleigh Raleigh, North Carolina | |
| Duluth Clinic Ashland Ashland, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health - Deer River Clinic Deer River, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Cancer Center Duluth, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Cancer Center-South University Clinic Fargo, North Dakota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Hibbing Clinic Hibbing, Minnesota | |
| Essentia Health Sandstone Sandstone, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Virginia Clinic Virginia, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Fairview Southdale Hospital Edina, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Fred Hutchinson Cancer Center Seattle, Washington | |
| Geauga Hospital Chardon, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| Good Samaritan Hospital - Cincinnati Cincinnati, Ohio | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
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| IRMC Cancer Center Indiana, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| IU Health North Hospital Carmel, Indiana | Site Public Contact - (iutrials@iu.edu) |
| Indiana University/Melvin and Bren Simon Cancer Center Indianapolis, Indiana | Site Public Contact - (iutrials@iu.edu) |
| Intermountain Health West End Clinic Billings, Montana | |
| Kootenai Clinic Cancer Services - Post Falls Post Falls, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Clinic Cancer Services - Sandpoint Sandpoint, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Health - Coeur d'Alene Coeur d'Alene, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Logan Health Medical Center Kalispell, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Mercy Hospital Coon Rapids, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Miami Valley Hospital South Centerville, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Miller-Dwan Hospital Duluth, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Nebraska Methodist Hospital Omaha, Nebraska | |
| Northwest Cancer Center - Hobart Hobart, Indiana | |
| Northwest Cancer Center - Main Campus Crown Point, Indiana | |
| Northwest Cancer Center - Valparaiso Valparaiso, Indiana | Site Public Contact - (CancerResearch@COMHS.org) |
| Northwest Oncology LLC Dyer, Indiana | |
| Northwest Wisconsin Cancer Center Ashland, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Ohio State University Comprehensive Cancer Center Columbus, Ohio | Site Public Contact - (Jamesline@osumc.edu) |
| Oklahoma Cancer Specialists and Research Institute-Tulsa Tulsa, Oklahoma | |
| Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Parkland Memorial Hospital Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| Providence Portland Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Saint Vincent Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Regions Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Roswell Park Cancer Institute Buffalo, New York | |
| Saint Alphonsus Cancer Care Center-Boise Boise, Idaho | |
| Saint Alphonsus Cancer Care Center-Caldwell Caldwell, Idaho | |
| Saint Alphonsus Cancer Care Center-Nampa Nampa, Idaho | |
| Saint Alphonsus Cancer Care Center-Ontario Ontario, Oregon | |
| Saint Catherine Hospital Indianapolis, Indiana | Site Public Contact - (Roster@nrgoncology.org) |
| Saint Francis Regional Medical Center Shakopee, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Saint Luke's Cancer Institute - Boise Boise, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Fruitland Fruitland, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Meridian Meridian, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Nampa Nampa, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Mary Medical Center Hobart, Indiana | Site Public Contact - (CancerResearch@COMHS.org) |
| Saint Vincent Frontier Cancer Center Billings, Montana | |
| State University of New York Upstate Medical University Syracuse, New York | |
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| The Community Hospital Munster, Indiana | |
| The James Graham Brown Cancer Center at University of Louisville Louisville, Kentucky | |
| UH Seidman Cancer Center at Lake Health Mentor Campus Mentor, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| UH Seidman Cancer Center at Saint John Medical Center Westlake, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| UHHS-Chagrin Highlands Medical Center Beachwood, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| UPMC Cancer Center at UPMC Horizon Farrell, Pennsylvania | Site Public Contact - (Roster@nrgoncology.org) |
| UPMC Cancer Center at UPMC McKeesport McKeesport, Pennsylvania | |
| UPMC Cancer Center at UPMC Northwest Seneca, Pennsylvania | |
| UPMC Cancer Center-Natrona Heights Natrona Heights, Pennsylvania | |
| UPMC Cancer Center-Washington Washington, Pennsylvania | Site Public Contact - (Roster@nrgoncology.org) |
| UPMC Cancer Centers - Arnold Palmer Pavilion Greensburg, Pennsylvania | |
| UPMC Hillman Cancer Center - Monroeville Monroeville, Pennsylvania | Site Public Contact - (ClinicalResearchServices@upmc.edu) |
| UPMC Hillman Cancer Center - New Castle New Castle, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC Hillman Cancer Center - Part of Frick Hospital Mount Pleasant, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC Hillman Cancer Center - Passavant - Cranberry Cranberry Township, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC Hillman Cancer Center Erie Erie, Pennsylvania | Site Public Contact - (ClinicalResearchServices@upmc.edu) |
| UPMC Hillman Cancer Center at Butler Health System Butler, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion Mechanicsburg, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC Hillman Cancer Center in Coraopolis Moon Township, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC West Mifflin-Cancer Center Jefferson West Mifflin, Pennsylvania | |
| UPMC-Heritage Valley Health System Beaver Beaver, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC-Johnstown/John P. Murtha Regional Cancer Center Johnstown, Pennsylvania | |
| UPMC-Magee Womens Hospital Pittsburgh, Pennsylvania | |
| UPMC-Mercy Hospital Pittsburgh, Pennsylvania | |
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| UPMC-Saint Clair Hospital Cancer Center Pittsburgh, Pennsylvania | |
| UPMC-Saint Margaret Pittsburgh, Pennsylvania | |
| UT Southwestern Clinical Center at Richardson/Plano Richardson, Texas | Site Public Contact - (Suzanne.cole@utsouthwestern.edu) |
| UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| UT Southwestern/Simmons Cancer Center-Fort Worth Fort Worth, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| United Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| University Cancer and Blood Center LLC Athens, Georgia | Site Public Contact - (research@universitycancer.com) |
| University of Alabama at Birmingham Cancer Center Birmingham, Alabama | Site Public Contact - (gingerreeves@uabmc.edu) |
| University of Illinois Chicago, Illinois | |
| University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa | |
| University of New Mexico Cancer Center Albuquerque, New Mexico | Site Public Contact - (HSC-ClinicalTrialInfo@salud.unm.edu) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Pittsburgh Cancer Institute (UPCI) Pittsburgh, Pennsylvania | |
| University of Rochester Rochester, New York | |
| University of Virginia Cancer Center Charlottesville, Virginia | Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu) |
| UofL Health Medical Center Northeast Louisville, Kentucky | Site Public Contact - (ctoinfo@louisville.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Wilmot Cancer Institute at Webster Webster, New York | Site Public Contact - (WCICTOresearch@urmc.rochester.edu) |
| Women and Infants Hospital Providence, Rhode Island | |
| Women's Cancer Center of Nevada Las Vegas, Nevada | |
| Women's Diagnostic Center - Munster Munster, Indiana | Site Public Contact - (mnicholson@comhs.org) |
A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab
ctrrecruit@vcu.edu
NCT05675410
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Inclusion Criteria:
* Patients must be 5 to 60 years of age at the time of enrollment
* Patients with newly diagnosed untreated histologically confirmed classic Hodgkin lymphoma (cHL) (nodular sclerosis, mixed cellularity, lymphocyte-rich, or lymphocyte-depleted, or not otherwise specified \[NOS\]) with stage I or II disease
* Patients must have bidimensionally measurable disease (at least one lesion with longest diameter \>= 1.5 cm)
* Patients must have a whole body or limited whole body PET scan performed within 42 days prior to enrollment. PET-CT is strongly preferred. PET-MRI allowed if intravenous contrast enhanced CT is also obtained
* Pediatric patients (age 5-17 years) with known or suspected mediastinal disease must have an upright posteroanterior (PA) chest X-ray (CXR) for assessment of bulky mediastinal disease.
* Note: Pediatric patients who have received both a CT chest and upright PA CXR may meet the definition of bulk through either modality.
* Patients \>= 18 years must have a performance status corresponding to Zubrod scores of 0, 1 or 2
* Patients =\< 17 years of age must have a Lansky performance score of \>= 50
* Pediatric patients (age 5-17 years): A serum creatinine based on age/sex as follows (within 28 days prior to enrollment):
* 2 to \< 6 years (age): 0.8 mg/dL (male), 0.8 mg/dL (female)
* 6 to \< 10 years (age): 1 mg/dL (male), 1 mg/dL (female)
* 10 to \< 13 years (age): 1.2 mg/dL (male), 1.2 mg/dL (female)
* 13 to \< 16 years (age): 1.5 mg/dL (male), 1.4 mg/dL (female)
* \>= 16 years (age): 1.7 mg/dL (male), 1.4 mg/dL (female) OR a 24 hour urine creatinine clearance \>= 50 mL/min/1.73 m\^2 (within 28 days prior to enrollment) OR a glomerular filtration rate (GFR) \>= 50 mL/min/1.73 m\^2 (within 28 days prior to enrollment). GFR must be performed using direct measurement with a nuclear blood sampling method OR direct small molecule clearance method (iothalamate or other molecule per institutional standard)
* Note: Estimated GFR (eGFR) from serum or plasma creatinine, cystatin C or other estimates are not acceptable for determining eligibility
* For adult patients (age 18 years or older) (within 28 days prior to enrollment): Creatinine clearance \>= 30 mL/min, as estimated by the Cockcroft and Gault formula or a 24-hour urine collection. The creatinine value used in the calculation must have been obtained within 28 days prior to registration. Estimated creatinine clearance is based on actual body weight
* Total bilirubin =\< 2 x upper limit of normal (ULN) (within 28 days prior to enrollment)
* Unless due to Gilbert's disease, lymphomatous involvement of liver or vanishing bile duct syndrome
* Aspartate aminotransferase (AST) =\< 3 x ULN (within 28 days prior to enrollment)
* Unless due to Gilbert's disease, lymphomatous involvement of liver or vanishing bile duct syndrome
* Alanine aminotransferase (ALT) =\< 3 x ULN (within 28 days prior to enrollment)
* Unless due to Gilbert's disease, lymphomatous involvement of liver or vanishing bile duct syndrome
* Shortening fraction of \>= 27% by echocardiogram (ECHO), multigated acquisition scan (MUGA), or functional cardiac imaging scan (within 28 days prior to enrollment) or ejection fraction of \>= 50% by radionuclide angiogram, ECHO, MUGA, or cardiac imaging scan (within 28 days prior to enrollment)
* Diffusion capacity of the lung for carbon monoxide (DLCO) \>= 50% of predicted value as corrected for hemoglobin by pulmonary function test (PFT) (within 28 days prior to enrollment). If unable to obtain PFTs, the criterion is: a pulse oximetry reading of \> 92% on room air
* Known human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
Exclusion Criteria:
* Patients with nodular lymphocyte predominant Hodgkin lymphoma
* Patients with a history of active interstitial pneumonitis or interstitial lung disease
* Patients with a diagnosis of inherited or acquired immunodeficiency that is poorly controlled or requiring active medications, such as primary immunodeficiency syndromes or organ transplant recipients
* Patients with any known uncontrolled intercurrent illness that would jeopardize the patient's safety such as infection, autoimmune conditions, cardiac arrhythmias, angina pectoris, and gastrointestinal disorders affecting swallowing and/or absorption of pills
* Patients with a condition requiring systemic treatment with either corticosteroids (defined as equivalent to \> 10 mg daily predniSONE for patients \>= 18 years or \> 0.5 mg/kg \[up to 10 mg/day\] for patients \< 18 years) or other immunosuppressive medications within 14 days prior to enrollment
* Note: Replacement therapy such as thyroxine, insulin, or physiologic corticosteroid for adrenal or pituitary insufficiency is not considered a form of systemic treatment. Inhaled or topical steroids, and adrenal replacement doses (=\< 10 mg daily for patients \>= 18 years or =\< 0.5 mg/kg \[up to 10 mg/day\] predniSONE equivalents) are permitted in the absence of active autoimmune disease
* Note: Steroid use for the control of Hodgkin lymphoma symptoms is allowable, but must be discontinued by cycle 1, day 1
* Short term use of corticosteroids for premedication or treatment of an allergy or hypersensitivity is considered an acceptable use of corticosteroids.
* Patients with peripheral neuropathy \> grade 1 at the time of enrollment or patients with known Charcot-Marie-Tooth syndrome
* Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen
* Administration of prior chemotherapy, radiation, or antibody-based treatment for cHL
* Prior solid organ transplant
* Prior allogeneic stem cell transplantation
* Live vaccine within 30 days prior to planned day 1 of protocol therapy (e.g., measles, mumps, rubella, varicella, yellow fever, rabies, bacillus Calmette Guerin \[BCG\], oral polio vaccine, and oral typhoid). Administration of messenger ribonucleic acid (mRNA) vaccines are permitted
* Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test within 28 days prior to enrollment is required for female patients of childbearing potential
* Lactating females who plan to breastfeed their infants starting with the first dose of study therapy and for at least 6 months after the last treatment
* Sexually active patients of reproductive potential who have not agreed to use a highly effective contraceptive method for the duration of their study drug therapy. Following therapy, patients will be advised to use contraception as per institutional practice or as listed below for investigational agents, whichever is longer
* Men and women of childbearing potential (WOCBP) must use effective contraception during the study and for 2 months for WOCBP and 4 months for men, after last dose of brentuximab vedotin
* WOCBP must continue contraception for a period of at least 5 months after the last dose of nivolumab
* All patients and/or their parents or legal guardians must sign a written informed consent
* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met PROCEDURE: Biospecimen Collection, BIOLOGICAL: Bleomycin Sulfate, DRUG: Brentuximab Vedotin, PROCEDURE: Computed Tomography, DRUG: Cyclophosphamide, DRUG: Dacarbazine, DRUG: Doxorubicin Hydrochloride, DRUG: Etoposide, DRUG: Etoposide Phosphate, OTHER: Fludeoxyglucose F-18, RADIATION: Involved-site Radiation Therapy, PROCEDURE: Magnetic Resonance Imaging, BIOLOGICAL: Nivolumab, PROCEDURE: Positron Emission Tomography, DRUG: Prednisolone, DRUG: Prednisone, DRUG: Procarbazine Hydrochloride, OTHER: Questionnaire Administration, DRUG: Vinblastine Sulfate, DRUG: Vincristine Sulfate
Lugano Classification Limited Stage Hodgkin Lymphoma AJCC v8
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Show 385 locations
Study Locations
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| Location | Contacts |
|---|---|
| AMG Crystal Lake - Oncology Crystal Lake, Illinois | Site Public Contact - (advocateresearch@advocate.com) |
| AMG Libertyville - Oncology Libertyville, Illinois | Site Public Contact - (advocateresearch@advocatehealth.com) |
| Abbott-Northwestern Hospital Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| AdventHealth Orlando Orlando, Florida | Site Public Contact - (FH.Cancer.Research@flhosp.org) |
| Advocate Children's Hospital-Oak Lawn Oak Lawn, Illinois | |
| Advocate Children's Hospital-Park Ridge Park Ridge, Illinois | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Advocate Christ Medical Center Oak Lawn, Illinois | |
| Advocate Good Samaritan Hospital Downers Grove, Illinois | Site Public Contact - (Barbara.barhamand@advocatehealth.com) |
| Advocate Good Shepherd Hospital Barrington, Illinois | |
| Advocate Illinois Masonic Medical Center Chicago, Illinois | |
| Advocate Lutheran General Hospital Park Ridge, Illinois | |
| Advocate Sherman Hospital Elgin, Illinois | |
| Advocate South Suburban Hospital Hazel Crest, Illinois | |
| Albany Medical Center Albany, New York | |
| Alberta Children's Hospital Calgary, Alberta | Site Public Contact - (research4kids@ucalgary.ca) |
| Alfred I duPont Hospital for Children Wilmington, Delaware | Site Public Contact - (Allison.bruce@nemours.org) |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Arkansas Children's Hospital Little Rock, Arkansas | |
| Arnold Palmer Hospital for Children Orlando, Florida | Site Public Contact - (Jennifer.spinelli@orlandohealth.com) |
| Ascension Saint Vincent Indianapolis Hospital Indianapolis, Indiana | Site Public Contact - (research@stvincent.org) |
| Atrium Health Navicent Macon, Georgia | Site Public Contact - (andrew.weatherall@atriumhealth.org) |
| Augusta University Medical Center Augusta, Georgia | Site Public Contact - (ga_cares@augusta.edu) |
| Aurora Bay Area Medical Group-Marinette Marinette, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora BayCare Medical Center Green Bay, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Grafton Grafton, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Kenosha South Kenosha, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Milwaukee Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Milwaukee West Wauwatosa, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Racine Racine, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Southern Lakes VLCC Burlington, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Health Care Germantown Health Center Germantown, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Medical Center in Summit Summit, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Saint Luke's Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Saint Luke's South Shore Cudahy, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Sinai Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora West Allis Medical Center West Allis, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| BI-LO Charities Children's Cancer Center Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas | Site Public Contact - (burton@bcm.edu) |
| Beacon Kalamazoo Cancer Center Kalamazoo, Michigan | |
| Blank Children's Hospital Des Moines, Iowa | Site Public Contact - (samantha.mallory@unitypoint.org) |
| Bronson Battle Creek Battle Creek, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Bronson Methodist Hospital Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Broward Health Medical Center Fort Lauderdale, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| C S Mott Children's Hospital Ann Arbor, Michigan | |
| CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL) Québec, | Site Public Contact - (rechclinique@crchudequebec.ulaval.ca) |
| CTCA at Western Regional Medical Center Goodyear, Arizona | |
| Cancer Care and Hematology-Fort Collins Fort Collins, Colorado | Site Public Contact - (ctsucontact@westat.com) |
| Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores, Michigan | Site Public Contact - (connie.szczepanek@crcwm.org) |
| CancerCare Manitoba Winnipeg, Manitoba | Site Public Contact - (ctu_web@cancercare.mb.ca) |
| Cardinal Glennon Children's Medical Center St Louis, Missouri | |
| Carilion Children's Roanoke, Virginia | Site Public Contact - (wpmccarty@carilionclinic.org) |
| Carle Cancer Center Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Effingham Effingham, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Mattoon/Charleston Mattoon, Illinois | Site Public Contact - (Research@carle.com) |
| Carle at The Riverfront Danville, Illinois | Site Public Contact - (Research@Carle.com) |
| Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina | |
| Cedars Sinai Medical Center Los Angeles, California | |
| Centre Hospitalier Universitaire Sainte-Justine Montreal, Quebec | Site Public Contact - (yvan.samson@umontreal.ca) |
| Centre Hospitalier Universitaire de Sherbrooke-Fleurimont Sherbrooke, Quebec | Site Public Contact - (crcinformation.chus@ssss.gouv.qc.ca) |
| Children's Healthcare of Atlanta - Arthur M Blank Hospital Atlanta, Georgia | Site Public Contact - (Olivia.Floyd@choa.org) |
| Children's Hospital London, Ontario | |
| Children's Hospital Colorado Aurora, Colorado | Site Public Contact - (josh.b.gordon@nsmtp.kp.org) |
| Children's Hospital Los Angeles Los Angeles, California | |
| Children's Hospital Medical Center Of Akron Akron, Ohio | |
| Children's Hospital New Orleans New Orleans, Louisiana | |
| Children's Hospital Of Eastern Ontario Ottawa, Ontario | |
| Children's Hospital and Medical Center of Omaha Omaha, Nebraska | |
| Children's Hospital of Alabama Birmingham, Alabama | Site Public Contact - (oncologyresearch@peds.uab.edu) |
| Children's Hospital of Michigan Detroit, Michigan | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital of Orange County Orange, California | Site Public Contact - (oncresearch@choc.org) |
| Children's Hospital of Philadelphia Philadelphia, Pennsylvania | Site Public Contact - (CancerTrials@email.chop.edu) |
| Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania | Site Public Contact - (jean.tersak@chp.edu) |
| Children's Hospital of San Antonio San Antonio, Texas | Site Public Contact - (bridget.medina@christushealth.org) |
| Children's Hospital of Wisconsin Milwaukee, Wisconsin | Site Public Contact - (MACCCTO@mcw.edu) |
| Children's Hospital of the King's Daughters Norfolk, Virginia | Site Public Contact - (CCBDCresearch@chkd.org) |
| Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis, Minnesota | Site Public Contact - (pauline.mitby@childrensmn.org) |
| Children's Mercy Hospitals and Clinics Kansas City, Missouri | Site Public Contact - (COGResearchGroup@cmh.edu) |
| Children's National Medical Center Washington D.C., District of Columbia | Site Public Contact - (OncCRC_OnCall@childrensnational.org) |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | Site Public Contact - (cancer@cchmc.org) |
| City of Hope Antelope Valley Lancaster, California | Site Public Contact - (becomingapatient@coh.org) |
| City of Hope Comprehensive Cancer Center Duarte, California | Site Public Contact - (becomingapatient@coh.org) |
| City of Hope Corona Corona, California | Site Public Contact - (becomingapatient@coh.org) |
| City of Hope Newport Beach Newport Beach, California | |
| City of Hope Seacliff Huntington Beach, California | |
| City of Hope South Bay Torrance, California | |
| City of Hope South Pasadena South Pasadena, California | Site Public Contact - (becomingapatient@coh.org) |
| City of Hope Upland Upland, California | Site Public Contact - (becomingapatient@coh.org) |
| City of Hope at Irvine Lennar Irvine, California | |
| City of Hope at Long Beach Elm Long Beach, California | |
| Cleveland Clinic Foundation Cleveland, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Community Medical Center Toms River, New Jersey | Site Public Contact - (Lennette.Gonzales@rwjbh.org) |
| Condell Memorial Hospital Libertyville, Illinois | Site Public Contact - (advocateresearch@advocatehealth.com) |
| Connecticut Children's Medical Center Hartford, Connecticut | |
| Cook Children's Medical Center Fort Worth, Texas | Site Public Contact - (CookChildrensResearch@cookchildrens.org) |
| Cooper Hospital University Medical Center Camden, New Jersey | |
| Corewell Health Beaumont Troy Hospital Troy, Michigan | |
| Corewell Health Children's Royal Oak, Michigan | |
| Corewell Health Dearborn Hospital Dearborn, Michigan | |
| Corewell Health Farmington Hills Hospital Farmington Hills, Michigan | |
| Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Reed City Hospital Reed City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health William Beaumont University Hospital Royal Oak, Michigan | |
| Covenant Children's Hospital Lubbock, Texas | Site Public Contact - (mbisbee@providence.org) |
| Crossroads Cancer Center Effingham, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Dana-Farber Cancer Institute Boston, Massachusetts | |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire | Site Public Contact - (cancer.research.nurse@dartmouth.edu) |
| Dayton Children's Hospital Dayton, Ohio | |
| Decatur Memorial Hospital Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Dell Children's Medical Center of Central Texas Austin, Texas | Site Public Contact - (TXAUS-DL-SFCHemonc.research@ascension.org) |
| Driscoll Children's Hospital Corpus Christi, Texas | Site Public Contact - (Crystal.DeLosSantos@dchstx.org) |
| Duke University Medical Center Durham, North Carolina | |
| East Carolina University Greenville, North Carolina | Site Public Contact - (eubankss@ecu.edu) |
| East Tennessee Childrens Hospital Knoxville, Tennessee | |
| Eastern Maine Medical Center Bangor, Maine | |
| Edward Hospital/Cancer Center Naperville, Illinois | |
| Edward Hospital/Cancer Center?Plainfield Plainfield, Illinois | Site Public Contact - (Cancerresearch@edward.org) |
| Edwards Comprehensive Cancer Center Huntington, West Virginia | Site Public Contact - (Christina.Cole@chhi.org) |
| El Paso Children's Hospital El Paso, Texas | Site Public Contact - (ranjan.bista@ttuhsc.edu) |
| Elmhurst Memorial Hospital Elmhurst, Illinois | Site Public Contact - (Jrohde@emhc.org) |
| Emory Proton Therapy Center Atlanta, Georgia | Site Public Contact - (allyson.anderson@emory.edu) |
| Emory Saint Joseph's Hospital Atlanta, Georgia | |
| Emory University Hospital Midtown Atlanta, Georgia | |
| Emory University Hospital/Winship Cancer Institute Atlanta, Georgia | |
| Fairview Southdale Hospital Edina, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Geisinger Medical Center Danville, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Glens Falls Hospital Glens Falls, New York | |
| Golisano Children's Hospital of Southwest Florida Fort Myers, Florida | Site Public Contact - (molly.arnstrom@leehealth.org) |
| Grady Health System Atlanta, Georgia | |
| Gundersen Lutheran Medical Center La Crosse, Wisconsin | Site Public Contact - (cancerctr@gundersenhealth.org) |
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| Yale University New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Yale-New Haven Hospital North Haven Medical Center North Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
A Study of Bomedemstat (IMG-7289/MK-3543) Compared to Best Available Therapy (BAT) in Participants With Essential Thrombocythemia and an Inadequate Response or Intolerance of Hydroxyurea (MK-3543-006)
Toll Free Number - Trialsites@msd.com
NCT06079879
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Inclusion Criteria:
* Has a diagnosis of ET per WHO 2016 diagnostic criteria for myeloproliferative neoplasms (confirmed by a central pathologist)
* Has a centrally assessed bone marrow fibrosis score of Grade 0 or Grade 1, as per a modified version of the European Consensus Criteria for Grading Myelofibrosis
* Has a history of inadequate response to or intolerance of hydroxyurea based on modified European LeukemiaNet (ELN) criteria for hydroxyurea resistance or intolerance
* Has an inadequate or loss of response to their most recent prior ET therapy, requiring a change of cytoreductive therapy
* Has a platelet count \> 450 × 10\^9/L (450k /μL) assessed up to 72 hours before first dose of study intervention
* Has an absolute neutrophil count (ANC) ≥0.75 × 10\^9/L assessed up to 72 hours before first dose of study intervention
* Participants may have received up to 3 prior ET-directed cytoreductive agents including hydroxyurea
Exclusion Criteria:
* Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to bomedemstat or lysine demethylase or monoamine oxidase inhibitor (LSDi or MAOi) or the chosen best available therapy (including anagrelide, interferon alfa/pegylated interferon, ruxolitinib, or busulfan) that contraindicates participation
* History of any illness/impairment of GI function that might interfere with drug absorption (eg, chronic diarrhea or history of gastric bypass surgical procedure), confound the study results or pose an additional risk to the individual by participation in the study
* Evidence at the time of Screening of increased risk of bleeding
* History of a malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years. Note: The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder
* Human immunodeficiency virus (HIV)-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease DRUG: Bomedemstat, DRUG: Anagrelide, DRUG: Busulfan, DRUG: Interferon alfa/pegylated interferon alfa 2a/pegylated interferon alfa 2b, DRUG: Ruxolitinib
Essential Thrombocythemia
essential thrombocythemia, ET, bomedemstat, IMG-7289
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Show 159 locations
Study Locations
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| Location | Contacts |
|---|---|
| Addenbrooke's Hospital ( Site 3303) Cambridge, Cambridgeshire | |
| Affiliated Hospital of Nantong University ( Site 3527) Nantong, Jiangsu | |
| Albert Schweitzer Ziekenhuis, locatie Dordwijk-Internal Medicine ( Site 2302) Dordrecht, South Holland | |
| Anhui Provincial Hospital ( Site 3513) Hefei, Anhui | |
| Ankara Bilkent Şehir Hastanesi ( Site 3201) Ankara, | |
| Ankara UTF Cebeci Arastırma ve Uygulama Hastanesi ( Site 3210) Ankara, | |
| Antalya Egitim ve Arastırma Hastanesi ( Site 3207) Antalya, | |
| Aotearoa Clinical Trials ( Site 0050) Auckland, | |
| Arcispedale Santa Maria Nuova ( Site 0301) Reggio Emilia, | |
| Asan Medical Center ( Site 0603) Seoul, | |
| Azienda Ospedaliera Universitaria Careggi ( Site 0030) Florence, Tuscany | |
| Azienda Ospedaliero Universitaria Pisana-UO Ematologia UNIV ( Site 0309) Pisa, Tuscany | |
| Azienda Ospedaliero Universitaria delle Marche ( Site 0302) Ancona, | |
| Azienda Ospedaliero Universitaria di Ferrara ( Site 0304) Cona, Ferrara | |
| Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo ( Site 0034) Alessandria, Ancona | |
| Boston Pilgrim Hospital ( Site 3301) Boston, Lincolnshire | |
| C.I.C.E. 9 de Julio ( Site 1001) San Miguel de Tucumán, Tucumán Province | |
| CHUS - Hospital Clinico Universitario ( Site 0421) Santiago de Compostela, La Coruna | |
| Calvary Mater Newcastle ( Site 0505) Waratah, New South Wales | |
| Carmel Hospital ( Site 0906) Haifa, | |
| Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois-HEMATOLOGY ( Site 0407) Vandœuvre-lès-Nancy, Lorraine | |
| Centre Hospitalier Régional Universitaire de Tours - Hôpital-Hématologie et Thérapie Cellulaire ( Site 0413) Tours, Indre-et-Loire | |
| Centre Hospitalier Universitaire de Limoges - Hôpital Dupuyt-Hématologie Clinique et Thérapie Cellu ( Site 1701) Limoges, Limousin | |
| Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou ( Site 0417) Rennes, Ille-et-Vilaine | |
| Centre Hospitalier de Roubaix ( Site 1703) Roubaix, Nord | |
| Chang Gung Medical Foundation-Linkou Branch ( Site 3103) Taoyuan District, | |
| Chang Gung Memorial Hospital at Kaohsiung-Division of Hematology and Oncology ( Site 3104) Kaohsiung City, | |
| Chang Gung Memorial Hospital- Chiayi ( Site 3102) Chiayi City, Chiayi | |
| Debreceni Egyetem Klinikai Kozpont-Belgyógyászati Klinika (Haematologia) ( Site 0707) Debrecen, | |
| Duke University Health System (DUHS) ( Site 0016) Durham, North Carolina | |
| Ege Universitesi Hastanesi ( Site 3202) Izmir, | |
| Ehime University Hospital ( Site 3612) Tōon, Ehime | |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 2201) Milan, Lombardy | |
| Fujita Health University Hospital ( Site 3613) Toyoake, Aichi-ken | |
| Fukushima Medical University Hospital ( Site 3616) Fukushima, | |
| Fundacion Colombiana de Cancerología Clinica Vida ( Site 1403) Medellín, Antioquia | |
| GenesisCare - Windsor ( Site 3309) Windsor, Windsor And Maidenhead | |
| Gloucestershire Royal Hospital ( Site 3302) Gloucester, Gloucestershire | |
| Guy's & St Thomas' NHS Foundation Trust ( Site 3305) London, London, City of | |
| HOSPITAL CLÍNIC DE BARCELONA ( Site 2800) Barcelona, Catalonia | |
| Hacettepe Universite Hastaneleri-Department of Hematology ( Site 3204) Ankara, | |
| Hadassah Medical Center ( Site 0904) Jerusalem, | |
| Henan Cancer Hospital-hematology department ( Site 3504) Zhengzhou, Henan | |
| Henry Ford Hospital ( Site 3413) Detroit, Michigan | |
| Hokkaido University Hospital ( Site 3601) Sapporo, Hokkaido | |
| Hospital Costa del Sol-Hematology Service ( Site 0412) Marbella, Malaga | |
| Hospital General Universitario de Albacete ( Site 0408) Albacete, | |
| Hospital Germans Trias i Pujol-Instituto Catalán de Oncología de Badalona ( Site 0409) Badalona, Barcelona | |
| Hospital Italiano de Buenos Aires ( Site 0105) ABB, Buenos Aires F.D. | |
| Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0404) Barcelona, | |
| Hospital Universitario 12 de Octubre ( Site 2806) Madrid, | |
| Hospital Universitario Austral ( Site 0104) Pilar, Buenos Aires | |
| Hospital Universitario Doctor Peset ( Site 0411) Valencia, | |
| Hospital Universitario Ramón y Cajal-Hematology ( Site 2803) Madrid, Madrid, Comunidad de | |
| Hospital Universitario Virgen de la Victoria ( Site 0418) Málaga, | |
| Hospital Universitario de Salamanca - Complejo Asistencial U-Servicio de Hematologia ( Site 0419) Salamanca, | |
| Hospital del Mar ( Site 2807) Barcelona, Catalonia | |
| Huashan Hospital, Fudan University ( Site 3529) Shanghai, Shanghai Municipality | |
| Hôpital Saint Antoine-Service d'Hématologie et de Thérapie Cellulaire ( Site 1702) Paris, Île-de-France Region | |
| Hôpital Saint-Louis-Centre d'Investigations Cliniques ( Site 0405) Paris, | |
| IMAT S.A.S ( Site 1401) Montería, Departamento de Córdoba | |
| IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 0308) Meldola, Forli-Cesena | |
| Institut Català d'Oncologia - L'Hospitalet-Haematology Department ( Site 2801) L'Hospitalet Del Llobregat, Barcelona | |
| Institute of hematology&blood disease hospital ( Site 3501) Tianjin, Tianjin Municipality | |
| Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 0414) Porto, | |
| Istituto Oncologico Veneto IRCCS-Oncoematologia ( Site 0306) Castelfranco Veneto, Veneto | |
| Jiangsu Province Hospital ( Site 3507) Nanjing, Jiangsu | |
| Jinan Central Hospital ( Site 3523) Jinan, Shandong | |
| Juntendo University Hospital ( Site 3611) Bunkyo-ku, Tokyo | |
| Kanazawa University Hospital ( Site 3614) Kanazawa, Ishikawa-ken | |
| Kansai Medical University Hospital ( Site 3607) Hirakata, Osaka | |
| Karolinska Universitetssjukhuset Huddinge ( Site 2900) Huddinge, Stockholm County | |
| Kindai University Hospital ( Site 3600) Sakai, Osaka | |
| King's College Hospital ( Site 3308) London, London, City of | |
| Kobe City Medical Center General Hospital ( Site 3603) Kobe, Hyōgo | |
| Kocaeli Üniversitesi-Hematology ( Site 3205) Kocaeli, | |
| Korea University Anam Hospital ( Site 0604) Seoul, | |
| Kyushu University Hospital ( Site 3605) Fukuoka, | |
| Lincoln County Hospital ( Site 3310) Lincoln, Great Britain | |
| Liverpool Hospital-Haematology ( Site 0501) Liverpool, New South Wales | |
| Los Angeles Cancer Network ( Site 3491) Glendale, California | |
| Los Cobos Medical Center ( Site 1404) Bogotá, Bogota D.C. | |
| Martini Ziekenhuis ( Site 2300) Groningen, | |
| Medical University of South Carolina-Hollings Cancer Center ( Site 3426) Charleston, South Carolina | |
| Medipol Mega Universite Hastanesi-oncology ( Site 3203) Istanbul, | |
| Mie University Hospital ( Site 3615) Tsu, Mie-ken | |
| Monash Health-Haematology Research ( Site 0006) Clayton, Victoria | |
| National Cancer Center Hospital East ( Site 3610) Kashiwa, Chiba | |
| National Cheng Kung University Hospital-Clinical Trial Center ( Site 3105) Tainan, | |
| National Hospital Organization Sendai Medical Center ( Site 3617) Sendai, Miyagi | |
| National Taiwan University Hospital ( Site 3101) Taipei, | |
| Nippon Medical School Hospital ( Site 3608) Bunkyo-ku, Tokyo | |
| North Shore Hospital-Department of Haematology ( Site 0051) Auckland, | |
| Okayama University Hospital ( Site 3604) Okayama, | |
| Ondokuz Mayıs Universitesi-hematology ( Site 3206) Samsun, | |
| Ospedale Mauriziano ( Site 0305) Torino, | |
| Ospedale di Circolo e Fondazione Macchi Varese ( Site 2200) Varese, | |
| Peking Union Medical College Hospital ( Site 3531) Beijing, Beijing Municipality | |
| Peking University Third Hospital-Hematology ( Site 3502) Beijing, Beijing Municipality | |
| Petz Aladar Egyetemi Oktato Korhaz ( Site 2000) Győr, Győr-Moson-Sopron | |
| Pratia Onkologia Katowice ( Site 0702) Katowice, Silesian Voivodeship | |
| Queen Mary Hospital ( Site 1901) Hksar, | |
| Rabin Medical Center ( Site 0905) Petah Tikva, | |
| Rambam Health Care Campus ( Site 2102) Haifa, | |
| Roswell Park Cancer Institute ( Site 3421) Buffalo, New York | |
| Royal Adelaide Hospital-Haematology Clinical Trials Unit ( Site 0001) Adelaide, South Australia | |
| Royal Gwent Hospital ( Site 3304) Gwent, Newport | |
| Royal North Shore Hospital ( Site 0003) St Leonards, New South Wales | |
| Royal Perth Hospital-Haematology ( Site 0504) Perth, Western Australia | |
| Royal Prince Alfred Hospital ( Site 1100) Camperdown, New South Wales | |
| Semmelweis Egyetem-Belgyógyászati és Hematológiai Klinika ( Site 0708) Budapest, | |
| Seoul National University Bundang Hospital-Hematology ( Site 0605) Seongnam, Kyonggi-do | |
| Shaanxi provincial people's hospital ( Site 3516) Xi'an, Shaanxi | |
| Sheba Medical Center ( Site 2101) Ramat Gan, | |
| Soroka Medical Center ( Site 2100) Beersheba, | |
| Sourasky Medical Center ( Site 0902) Tel Aviv, | |
| Southern Medical University Nanfang Hospital-Department of Hematopathology ( Site 3511) Guangzhou, Guangdong | |
| Spaarne Gasthuis - Hoofddorp-Oncology ( Site 2301) Hoofddorp, North Holland | |
| Stanford Cancer Institute ( Site 0107) Stanford, California | |
| Sun Yat-sen Memorial Hospital of Sun Yat-sen University ( Site 3524) Guangzhou, Guangdong | |
| Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Hematologii i Transplantacji S ( Site 2504) Kielce, Świętokrzyskie Voivodeship | |
| Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór-Haematológia osztály ( Site 0706) Nyíregyháza, Szabolcs-Szatmár-Bereg | |
| The Catholic Univ. of Korea Seoul St. Mary's Hospital ( Site 0606) Seoul, | |
| The Christie NHS Foundation Trust ( Site 3307) Manchester, | |
| The First Affiliated hospital of Xiamen University ( Site 3515) Xiamen, Fujian | |
| The First Afflilated Hospital of Bengbu Medical College ( Site 3509) Bengbu, Anhui | |
| The First Hospital of Hebei Medical University ( Site 3510) Shijiazhuang, Hebei | |
| The First Hospital of Jilin University-Hematology ( Site 3526) Changchun, Jilin | |
| The First affiliated hospital of Nanchang University (Xianghu campus) ( Site 3505) Nanchang, Jiangxi | |
| The Lundquist Institute ( Site 3423) Torrance, California | |
| The Moncton Hospital-Oncology ( Site 1500) Moncton, New Brunswick | |
| The Second Affiliated Hospital Of Fujian Medical University ( Site 3525) Quanzhou, Fujian | |
| The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 3508) Hangzhou, Zhejiang | |
| Trakya University Medical Faculty Hospital-Hematology ( Site 3200) Edirne, | |
| Tufts Medical Center ( Site 3408) Boston, Massachusetts | |
| Unidade Local de Saude Lisboa Ocidental - Hospital de São Francisco Xavier ( Site 2600) Lisbon, | |
| Unidade Local de Saude de Braga - Hospital de Braga ( Site 0415) Braga, | |
| Universitaetsklinikum Carl Gustav Carus Dresden-Medical Dept I - Medical Oncology ( Site 0402) Dresden, Saxony | |
| Universitetssjukhuset Örebro ( Site 0403) Örebro, Örebro County | |
| University College London Hospital ( Site 3300) London, London, City of | |
| University Medical Center Groningen ( Site 2304) Groningen, | |
| University of Colorado Anschutz Medical Campus ( Site 3425) Aurora, Colorado | |
| University of Michigan ( Site 0008) Ann Arbor, Michigan | |
| University of Miyazaki Hospital ( Site 3609) Miyazaki, | |
| University of Virginia ( Site 3422) Charlottesville, Virginia | |
| University of Yamanashi Hospital ( Site 3606) Chūō, Yamanashi | |
| Universitätsklinikum Aachen ( Site 1801) Aachen, North Rhine-Westphalia | |
| Universitätsklinikum Halle ( Site 0401) Halle, Saxony-Anhalt | |
| VCU Health Adult Outpatient Pavillion ( Site 3416) Richmond, Virginia | |
| VM Medical Park Mersin Hastanesi ( Site 3208) Mersin, | |
| Wake Forest Baptist Health-Internal Medicine, Section on Hematology & Oncology ( Site 3400) Winston-Salem, North Carolina | |
| West China Hospital, Sichuan University ( Site 3518) Chengdu, Sichuan | |
| Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 0502) Melbourne, Victoria | |
| Wuhan Union Hospital ( Site 3500) Wuhan, Hubei | |
| Yitzhak Shamir Medical Center. ( Site 0901) Ẕerifin, | |
| ZAS Cadix ( Site 1200) Antwerp, | |
| Zhejiang University School of Medicine-The Fourth Affiliated Hospital ( Site 3517) Yiwu, Zhejiang | |
| Zhongshan Hospital,Fudan University-Hematology ( Site 3530) Shanghai, Shanghai Municipality | |
| centre hospitalier lyon sud ( Site 0406) Pierre-Bénite, Rhone |
Study Assessing Activity of Intravenous (IV) Etentamig Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refractory Multiple Myeloma (CERVINO)
ABBVIE CALL CENTER - abbvieclinicaltrials@abbvie.com
NCT06158841
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Inclusion Criteria:
* Eastern Cooperative Oncology Group (ECOG) performance of \<= 2.
* Diagnosis of relapsed/refractory (R/R) multiple myeloma (MM) during or after the participant's last treatment as stated in the protocol.
* Must have measurable disease with at least 1 of the following assessed within 28 days of enrollment:
* Serum M-protein \>= 0.5 g/dL (\>= 5 g/L).
* Urine M-protein \>= 200 mg/24 hours.
* In participants without measurable serum or urine M protein, serum free light chain (FLC) \>= 100 mg/L (10 mg/dL) (involved light chain)and an abnormal serum kappa lambda ratio.
* Must have received at least 2 or more lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory imide (IMiD), and an anti-CD38 monoclonal antibody (mAb).
* Must be eligible to receive the Investigator's choice standard available therapy (SAT) based on approved prescribing information, previous MM treatment history, and institutional guidelines.
Exclusion Criteria:
* Clinically significant (per Investigator's judgment) drug or alcohol abuse within the last 6 months.
* Clinically significant conditions such as but not limited to the following: neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular, pulmonary, or hepatic disease within the last 6 months that would adversely affect the participant's participation in the study.
* Central nervous system involvement of MM.
* Has received B-cell maturation antigen (BCMA)-targeted therapy. DRUG: Etentamig, DRUG: Carfilzomib, DRUG: Pomalidomide, DRUG: Elotuzumab, DRUG: Selinexor, DRUG: Bortezomib, DRUG: Dexamethasone
Multiple Myeloma
Cervino, Multiple Myeloma, Etentamig, Carfilzomib, Pomalidomide, Elotuzumab, Selinexor, Bortezomib, Dexamethasone
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Show 165 locations
Study Locations
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| Location | Contacts |
|---|---|
| A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 256808 Turin, Piedmont | |
| AOU Policlinico G. Rodolico - San Marco /ID# 256814 Catania, | |
| ASST Ovest Milanese /ID# 256813 Legnano, Milano | |
| AZ Sint-Jan Brugge /ID# 245345 Bruges, West-Vlaanderen | |
| Addenbrookes Hospital /ID# 261104 Cambridge, Cambridgeshire | |
| Alberts Cellular Therapy /ID# 245725 Pretoria, Gauteng | |
| Alexandra General Hospital /ID# 240591 Athens, Attica | |
| Algemeen Ziekenhuis klina /ID# 260856 Brasschaat, Antwerpen | |
| Alta Bates Summit Medical Center for Research /ID# 261438 Berkeley, California | |
| Anjo Kosei Hospital /ID# 263434 Anjo, Aichi-ken | |
| Antalya Egitim Ve Arastirma Hastanesi /ID# 261674 Antalya, | |
| Atrium Health Levine Cancer Institute /ID# 246199 Charlotte, North Carolina | |
| Auxilio Mutuo Cancer Center /ID# 272565 San Juan, | |
| Azienda Ospedaliero Universitaria delle Marche /ID# 256812 Ancona, | |
| Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 256810 Rome, Roma | |
| Baptist Memorial Hospital /ID# 270910 Memphis, Tennessee | |
| Barbara Ann Karmanos Cancer Institute - McLaren Greater Lansing /ID# 259891 Lansing, Michigan | |
| Beijing Chaoyang Hospital,Capital Medical University /ID# 245533 Beijing, Beijing Municipality | |
| Beth Israel Deaconess Medical Center /ID# 271535 Boston, Massachusetts | |
| Box Hill Hospital /ID# 262784 Melbourne, Victoria | |
| CH Henri Duffaut /ID# 261844 Avignon, Vaucluse | |
| Calvary Mater Newcastle /ID# 261804 Waratah, New South Wales | |
| Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 246230 Jacksonville, Florida | |
| Cedars-Sinai Medical Center /ID# 261008 Los Angeles, California | |
| Center for Cancer and Blood Disorders-American Oncology Partners of Maryland /ID# 263637 Bethesda, Maryland | |
| Centre Hospitalier Régional d'Orléans - Hôpital de la Source /ID# 261854 Orléans, | |
| Centre Hospitalier du Mans /ID# 261852 Le Mans, Sarthe | |
| Centrum fuer Haematologie und Onkologie Bethanien /ID# 271982 Frankfurt am Main, | |
| Ch Saint Quentin /Id# 261856 Saint-Quentin, Aisne | |
| Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 260689 Berlin, | |
| Chiba University Hospital /ID# 262006 Chiba, Chiba | |
| China Medical University Hospital /ID# 245483 Taichung, | |
| Chugoku Central Hospital /ID# 263431 Fukuyama, Hiroshima | |
| Cleveland Clinic Main Campus /ID# 246183 Cleveland, Ohio | |
| Complejo Hospitalario Universitario Ourense /ID# 246400 Ourense, Ourense | |
| Constantiaberg Haematology /ID# 261320 Cape Town, Western Cape | |
| Dana-Farber Cancer Institute /ID# 261554 Boston, Massachusetts | |
| Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 261646 Budapest, | |
| Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi /ID# 261672 Ankara, | |
| Duke University Medical Center /ID# 259694 Durham, North Carolina | |
| Dup_Guys and St Thomas NHS Foundation Trust - Guy's Hospital /ID# 262488 London, Greater London | |
| Eastchester Center for Cancer Care /ID# 262952 The Bronx, New York | |
| Fakultni Nemocnice Ostrava /ID# 245686 Ostrava, Ostrava-mesto | |
| Fakultní Nemocnice Brno - Jihlavská /ID# 245689 Brno, Brno-mesto | |
| Fakultní nemocnice Hradec Králové - Sokolská /ID# 245690 Hradec Králové, Hradec Kralove | |
| Falu Lasarett /ID# 262231 Falun, | |
| First Affiliated Hospital of China Medical University /ID# 245547 Shenyang, Liaoning | |
| Fujian Medical University Union Hospital /ID# 245558 Fuzhou, Fujian | |
| Fundacao Champalimaud /ID# 246258 Lisbon, Lisbon District | |
| General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 240596 Athens, | |
| General University Hospital of Thessaloniki AXEPA /ID# 240595 Thessaloniki, | |
| Gifu Municipal Hospital /ID# 263321 Gifu, Gifu | |
| Gunma University Hospital /ID# 262580 Maebashi, Gunma | |
| Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz /ID# 261648 Győr, Győr-Moson-Sopron | |
| Haemalife Inc. /ID# 245724 Kuils River, Western Cape | |
| Helsingborgs Lasarett /ID# 262513 Helsingborg, Skåne County | |
| Hematology And Oncology Institute /ID# 272531 Manatí, | |
| Henan Cancer Hospital /ID# 245536 Zhengzhou, Henan | |
| Henry Ford Hospital /ID# 262704 Detroit, Michigan | |
| Hospital General Universitario Gregorio Maranon /ID# 246401 Madrid, | |
| Hospital Universitario de Salamanca /ID# 262218 Salamanca, | |
| Hospital Universitario y Politecnico La Fe /ID# 261625 Valencia, | |
| Hospital de Leon /ID# 261624 León, | |
| Hyogo Prefectural Amagasaki General Medical Center /ID# 265696 Amagasaki, Hyōgo | |
| Institute of Hematology and Blood Diseases Hospital /ID# 265702 Tianjin, Tianjin Municipality | |
| Instituto Catalan de Oncologia (ICO) Badalona /ID# 246398 Badalona, Barcelona | |
| Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE /ID# 246257 Porto, | |
| Istanbul Florence Nightingale Hospital /ID# 271543 Şişli, | |
| Japanese Red Cross Medical Center /ID# 261717 Shibuya-ku, Tokyo | |
| Karmanos Cancer Institute - Detroit /ID# 266298 Detroit, Michigan | |
| Klinik Ottakring /ID# 245829 Vienna, Vienna | |
| Klinikum Chemnitz - Flemmingstraße /ID# 273108 Chemnitz, Saxony | |
| Kyushu University Hospital /ID# 264704 Fukuoka, Fukuoka | |
| Leeds Teaching Hospitals NHS Trust /ID# 261101 Leeds, West Yorkshire | |
| Liverpool Hospital /ID# 262159 Liverpool, New South Wales | |
| Mayo Clinic - Rochester /ID# 246228 Rochester, Minnesota | |
| Mayo Clinic Hospital - Phoenix /ID# 263326 Phoenix, Arizona | |
| Mayo Clinic Hospital Jacksonville /ID# 263324 Jacksonville, Florida | |
| Medical University of South Carolina /ID# 259692 Charleston, South Carolina | |
| Medizinische Universitaet Graz /ID# 261908 Graz, Styria | |
| Miyagi Cancer Center /ID# 265094 Natori-shi, Miyagi | |
| Monash Health - Monash Medical Centre /ID# 262158 Clayton, Victoria | |
| Nagoya City University Hospital /ID# 263320 Nagoya, Aichi-ken | |
| Naha City Hospital /ID# 263972 Naha, Okinawa | |
| Nancy W. Knowles Cancer Center /ID# 271361 Elmhurst, Illinois | |
| National Taiwan University Hospital /ID# 245482 Taipei City, Taipei | |
| Nebraska Cancer Specialists - Omaha - Wright Street /ID# 276772 Omaha, Nebraska | |
| New York Cancer & Blood Specialists - Bay Shore /ID# 261524 Bay Shore, New York | |
| New York Cancer & Blood Specialists - Lake Success Medical Oncology /ID# 262953 New Hyde Park, New York | |
| New York Cancer and Blood Specialists - New York /ID# 262951 New York, New York | |
| Northwest Medical Specialties Tacoma /ID# 276281 Tacoma, Washington | |
| Nottingham City Hospital /ID# 261105 Nottingham, Nottinghamshire | |
| Odense University Hospital /ID# 260924 Odense, Region Syddanmark | |
| Ordensklinikum Linz GmbH Elisabethinen /ID# 245609 Linz, Upper Austria | |
| Oregon Medical Research Center /ID# 262335 Portland, Oregon | |
| Our Lady Of The Lake Regional Medical Center /ID# 272780 Baton Rouge, Louisiana | |
| Peking Union Medical College Hospital (East) - Dongdan Campus /ID# 245545 Beijing, Beijing Municipality | |
| People's Hospital of Henan Province /ID# 260918 Zhengzhou, Henan | |
| Princess Alexandra Hospital /ID# 261810 Woolloongabba, Queensland | |
| Providence - St. Jude Medical Center /ID# 262031 Fullerton, California | |
| Rabin Medical Center. /ID# 245498 Petah Tikva, | |
| Regents of the University of Michigan /ID# 261577 Ann Arbor, Michigan | |
| Rocky Mountain Cancer Centers - Lone Tree /ID# 278320 Lone Tree, Colorado | |
| Rush University Medical Center /ID# 265690 Chicago, Illinois | |
| Saitama Prefectural Cancer Center /ID# 262586 Kitaadachi-gun, Saitama | |
| Samsung Medical Center /ID# 245492 Seoul, Seoul Teugbyeolsi | |
| Second Affiliated Hospital of Xian Jiaotong University /ID# 261255 Xi'an, Shaanxi | |
| Semmelweis Egyetem /ID# 261647 Budapest, | |
| Seoul National University Hospital /ID# 245491 Seoul, Seoul Teugbyeolsi | |
| Shaare Zedek Medical Center /ID# 245681 Jerusalem, Jerusalem | |
| Shanghai Tongji Hospital /ID# 245539 Shanghai, Shanghai Municipality | |
| Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 260882 Hangzhou, Zhejiang | |
| Springfield Clinic - First /ID# 262266 Springfield, Illinois | |
| St George Hospital /ID# 261806 Kogarah, New South Wales | |
| St Vincent's Hospital Melbourne /ID# 261808 Fitzroy Melbourne, Victoria | |
| Staedtisches Klinikum Karlsruhe /ID# 272377 Karlsruhe, Baden-Wurttemberg | |
| Sun Yat-Sen University Cancer Center /ID# 245542 Guangzhou, Guangdong | |
| Taichung Veterans General Hospital /ID# 261142 Taichung, | |
| Tel Aviv Sourasky Medical Center /ID# 245495 Tel Aviv, Tel Aviv | |
| Texas Oncology - Northeast Texas /ID# 278304 Tyler, Texas | |
| The Catholic University of Korea, Seoul St. Marys Hospital /ID# 245493 Seoul, Seoul Teugbyeolsi | |
| The Chaim Sheba Medical Center /ID# 245497 Ramat Gan, Tel Aviv | |
| The Christie Hospital /ID# 261102 Manchester, | |
| The First Affiliated Hospital of Nanchang University /ID# 245537 Nanchang, Jiangxi | |
| The First Affiliated Hospital of Soochow University /ID# 245544 Suzhou, Jiangsu | |
| The First Affiliated Hospital of Wenzhou Medical University /ID# 245550 Wenzhou, Zhejiang | |
| The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 260883 Hangzhou, Zhejiang | |
| The Royal Marsden NHS Foundation Trust /ID# 262470 London, | |
| The University of Osaka Hospital /ID# 263974 Suita-shi, Osaka | |
| The West Clinic /ID# 262444 Memphis, Tennessee | |
| Tianjin Medical University General Hospital /ID# 260851 Tianjin, Tianjin Municipality | |
| Tokyo Metropolitan Komagome Hospital /ID# 277567 Bunkyo Ku, Tokyo | |
| Trakya University Medical Facu /ID# 261673 Edirne, Istanbul, | |
| Uddevalla sjukhus /ID# 262034 Uddevalla, Västra Götaland County | |
| Ulsan University Hospital /ID# 245490 Ulsan, Ulsan Gwang Yeogsi | |
| Unidade Local de Saude de Santa Maria, EPE /ID# 246255 Lisbon, | |
| Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 245549 Wuhan, Hubei | |
| Universitaetsklinikum Freiburg /ID# 262147 Freiburg im Breisgau, Baden-Wurttemberg | |
| Universitaetsklinikum Hamburg-Eppendorf /ID# 260651 Hamburg, | |
| Universitaetsklinikum Krems /ID# 261509 Krems, Lower Austria | |
| University General Hospital Attikon /ID# 240592 Athens, Attica | |
| University Health Network_Princess Margaret Cancer Centre /ID# 261566 Toronto, Ontario | |
| University Hospital Kyoto Prefectural University of Medicine /ID# 262585 Kyoto, Kyoto | |
| University Of Cincinnati Medical Center /ID# 246415 Cincinnati, Ohio | |
| University of Alabama at Birmingham - Main /ID# 261434 Birmingham, Alabama | |
| University of Fukui Hospital /ID# 264222 Yoshida-gun, Fukui | |
| University of Illinois Hospital and Health Sciences System /ID# 246349 Chicago, Illinois | |
| University of Missouri Hospital /ID# 261553 Columbia, Missouri | |
| University of North Carolina /ID# 259854 Chapel Hill, North Carolina | |
| University of Tennessee Health Science Center /ID# 261622 Memphis, Tennessee | |
| University of Yamanashi Hospital /ID# 262912 Chuo-shi, Yamanashi | |
| Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie /ID# 260168 Lublin, Lublin Voivodeship | |
| Uniwersytecki Szpital Kliniczny We Wroclawiu /ID# 260172 Wroclaw, Lower Silesian Voivodeship | |
| Uniwersyteckie Centrum Kliniczne /ID# 260169 Gdansk, Pomeranian Voivodeship | |
| VA Loma Linda Healthcare System /ID# 261015 Loma Linda, California | |
| VCU Massey Cancer Center: Dalton Oncology Clinic /ID# 261944 Richmond, Virginia | |
| Vanderbilt University Medical Center /ID# 261621 Nashville, Tennessee | |
| Vejle Sygehus /ID# 260923 Vejle, Region Syddanmark | |
| Virginia Cancer Specialists - Fairfax /ID# 262792 Fairfax, Virginia | |
| Virginia Oncology Associates - Norfolk (Lake Wright) /ID# 278314 Norfolk, Virginia | |
| Vseobecna fakultni nemocnice v Praze /ID# 245691 Prague, Praha 17 | |
| Western General Hospital - NHS Lothian /ID# 261106 Edinburgh, Edinburgh, City of | |
| Winship Cancer Institute of Emory University /ID# 262525 Atlanta, Georgia | |
| Yonsei University Health System Severance Hospital /ID# 245489 Seoul, | |
| Zhongda Hospital Southeast University /ID# 245563 Nanjing, Jiangsu |
A Study to Investigate the Efficacy and Safety of Sonrotoclax Plus Zanubrutinib Compared With Placebo Plus Zanubrutinib in Adults With Relapsed/Refractory Mantle Cell Lymphoma (CELESTIAL-RRMCL)
Study Director - clinicaltrials@beonemed.com
NCT06742996
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Inclusion Criteria:
* Histologically locally confirmed diagnosis of MCL based on the World Health Organization 2022 classification of Haematolymphoid Tumors (WHO-HAEM5), or based on International Consensus Classification (ICC)
* Ability to provide archival or fresh tumor tissue for retrospective central confirmation of MCL diagnosis
* Received 1 to 5 prior lines of systemic therapy including an anti-CD20 monoclonal antibody (mAb)-based immunotherapy or chemoimmunotherapy and requiring treatment in the opinion of the investigator
* Relapsed or refractory disease after the last line of therapy
* Measurable disease defined as ≥ 1 nodal lesion that is \> 1.5 cm in longest diameter, or ≥ 1 extranodal lesion that is \> 1 cm in longest diameter
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
* Adequate organ function
Exclusion Criteria:
* Prior therapy with B-cell lymphoma-2 inhibitor (BCL2i)
* Prior therapy with BTK degraders
* Prior therapy with covalent or non-covalent Bruton tyrosine kinase inhibitor (BTKi) unless the participant was intolerant of non-zanubrutinib covalent or non-covalent BTKi. Participants with refractory disease to BTKi therapy or relapse attributed to failure of BTKi therapy are ineligible.
* Prior autologous stem cell transplantation or chimeric antigen receptor T-cell therapy within 3 months before first dose of study drug
* Prior allogeneic stem cell transplant within 6 months of the first dose of the study drug
* Known central nervous system involvement by lymphoma
* Clinically significant cardiovascular disease
* History of stroke or intracranial hemorrhage within 6 months before first dose of study drug
Note: Other protocol defined Inclusion/Exclusion criteria may apply. DRUG: Sonrotoclax, DRUG: Zanubrutinib, DRUG: Placebo
Mantle Cell Lymphoma, B Cell Lymphoma
mantle cell lymphoma, MCL, relapsed/refractory mantle cell lymphoma, sonrotoclax, BGB-11417
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Study Locations
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| Location | Contacts |
|---|---|
| Aichi Cancer Center Hospital Clinical Oncology Nagoya, Aichi-ken | |
| Aidport Sp Z O O Skorzewo, | |
| Antalya Memorial Hospital Dokuma, | |
| Asan Medical Center Seoul, | |
| Atrium Health Levine Cancer Institute (Lci) Charlotte, North Carolina | |
| Atrium Health Wake Forest Baptist Charlotte, North Carolina | |
| Auxilio Mutuo Cancer Center San Juan, | |
| Azienda Sanitaria Universitaria Giuliano Isontina Trieste, | |
| Beatson West of Scotland Cancer Centre Glasgow, | |
| Beijing Cancer Hospital Beijing, | |
| Beijing Hospital Beijing, Beijing Municipality | |
| Box Hill Hospital Box Hill, | |
| Centre Hospitalier Universitaire Nantes Hotel Dieu Nantes, | |
| Centroricerche Cliniche Di Verona Srl Verona, | |
| Chiba Cancer Center Chiba, Chiba | |
| Christchurch Hospital Christchurch, | |
| Chu Hopital Lyon Sud PierreBenite, | |
| Chu Montpellier Hopital Saint Eloi Montpellier, | |
| Chu Tours Hopital Bretonneau Tours, | |
| Churchill Hospital Oxford University Hospital Nhs Trust Headington, | |
| Clatterbridge Cancer Centre Metropolitan Borough of Wirral, | |
| Cleveland Clinic Florida Stuart, Florida | |
| Cleveland Clinic Foundation Cleveland, Ohio | |
| Concord Repatriation General Hospital Concord, New South Wales | |
| Dana Farber Cancer Institute Longwood Medical Center Boston, Massachusetts | |
| Dept of Medicine Iii, University Hospitallmu München, | |
| Derriford Hospital Plymouth, | |
| Dokkyo Medical University Saitama Medical Center Koshigaya, Saitama | |
| Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii Wroclaw, | |
| Duke University Durham, North Carolina | |
| Dunedin Hospital Dunedin, | |
| Etlik City Hospital Ankara, | |
| FUNDALEU Caba, | |
| Fort Wayne Medical Oncology and Hematology Fort Wayne, Indiana | |
| Fudan University Shanghai Cancer Center Shanghai, | |
| Fujian Medical University Union Hospital Fuzhou, | |
| Fundacao Pio Xii Hospital de Amor de Barretos Barretos, | |
| Fundacao Universidade de Caxias Do Sul Instituto de Pesquisas Em Saude Petrópolis, | |
| GenesisCare North Shore St Leonards, New South Wales | |
| H Puerta de Hierro Majadahonda Majadahonda, | |
| Harbin Medical University Cancer Hospital Harbin, | |
| Hattiesburg Hematology and Oncology Clinic Hattiesburg, Mississippi | |
| Hcfmusp Servico de Hematologia, Hemoterapia E Terapia Celular São Paulo, | |
| Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital Hiroshima, Hiroshima | |
| Hokkaido University Hospital Sapporo, | |
| Hospital Aleman Recoleta, | |
| Hospital Clinic de Barcelona Barcelona, | |
| Hospital Do Cancer de Pernambuco Recife, | |
| Hospital Erasto Gaertner Curitiba, | |
| Hospital Felício Rocho Belo Horizonte, | |
| Hospital Santa Rita de Cassia Afecc Vitória, | |
| Hospital Universitario Fundacion Jimenez Diaz Madrid, | |
| Hospital Universitario de Cordoba Córdoba, | |
| Hospital de Clínicas de Porto Alegre Porto Alegre, Rio Grande do Sul | |
| Ico H Duran I Reynals Barcelona, | |
| Institute of Science Tokyo Hospital Tokyo, Bunkyo-ku, | |
| Instituto Joinvilense De Hematologia e Oncologia Joinville, Santa Catarina | |
| Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst Meldola, | |
| Jiangsu Province Hospital Nanjing, Jiangsu | |
| Jiangxi Province Cancer Hospital Nanchang, Jiangxi | |
| Kagoshima University Hospital Kagoshima, Kagoshima, | |
| Kanagawa Cancer Center Yokohama, | |
| Klinikum Chemnitz gGmbH Chemnitz, | |
| Kobe City Medical Center General Hospital Hyōgo, | |
| Kocaeli Universitesi Tip Fakultesi Kocaeli, | |
| Kurashiki Central Hospital Okayama, Kurashiki, | |
| Liaoning Cancer Hospital and Institute Shenyang, Liaoning | |
| Linear Clinical Research Nedlands, Western Australia | |
| Linyi Cancer Hospital Linyi, Shandong | |
| MD Anderson Cancer Center Houston, Texas | |
| Matsuyama Red Cross Hospital Matsuyama, | |
| Mayo Clinic Phoenix Phoenix, Arizona | |
| Mayo Clinic Rochester Rochester, Minnesota | |
| McGlinn Cancer Institute West Reading, Pennsylvania | |
| Medical University Vienna Oncology Vienna, | |
| Memorial Cancer Institute, Memorial Healthcare System Pembroke Pines, Florida | |
| Mission Cancer and Blood Waukee, Iowa | |
| Monash Health Clayton, Victoria | |
| Nanfang Hospital of Southern Medical University Guangzhou, Guangdong | |
| National Hospital Organization Okayama Medical Center Okayama, | |
| Nebraska Cancer Specialists Omaha, Nebraska | |
| Nebraska Cancer Specialists St Francis Grand Island Grand Island, Nebraska | |
| North Shore Hospital Auckland, | |
| Northwest Cancer Specialist, Pc(Us Oncology Research) Vancouver, Washington | |
| Ogaki Municipal Hospital Ōgaki, Gifu | |
| Ohio Health Research Institute Columbus, Ohio | |
| Ohio State University Comprehensive Cancer Center Columbus, Ohio | |
| One Clinical Research Nedlands, Western Australia | |
| Ordensklinikum Linz GmbH Elisabethinen Linz, | |
| Osaka Metropolitan University Hospital Osaka, | |
| Osaka Red Cross Hospital Osakashi, Osaka | |
| Ospedale Vito Fazzi, Asl Lecce Leece, | |
| Penn State Milton S Hershey Medical Center Hershey, Pennsylvania | |
| Perth Blood Institute West Perth, Western Australia | |
| Policlinico Sorsola Malpighi, Aou Di Bologna Bologna, | |
| Pratia MCM Kraków Krakow, Lesser Poland Voivodeship | |
| Pusan National University Hospital Seogu, Busan Gwang'yeogsi | |
| Rockingham Hospital Cooloongup, Western Australia | |
| Rush University Medical Center Chicago, Illinois | |
| Samsung Medical Center Seoul, | |
| Seoul National University Bundang Hospital Seongnam-si, | |
| Seoul National University Hospital Seoul, | |
| Severance Hospital Yonsei University Health System SeodaemunGu, Seoul Teugbyeolsi | |
| Shaanxi Provincial Peoples Hospital Xi'an, Shaanxi | |
| Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital Chengdu, Sichuan | |
| Stauferklinikum Schwabisch Gmund Kliniken Ostalb Mutlangen, | |
| Sun Yat Sen University Cancer Center Guangzhou, Guangdong | |
| Sunshine Coast Hospital and Health Service Birtinya, Queensland | |
| Tauranga Hospital Tauranga, | |
| Tennesse Oncology Chattanooga Downtown Chattanooga, Tennessee | |
| Tennessee Oncology Nashville, Tennessee | |
| Texas Oncology Austin Midtown Round Rock, Texas | |
| The Affiliated Hospital of Qingdao University Branch West Coast Qingdao, Shandong | |
| The Affiliated Hospital of Xuzhou Medical University Xuzhou, | |
| The Cancer and Hematology Centers Grand Rapids, Michigan | |
| The Catholic University of Korea, Seoul St Marys Hospital SeochoGu, Seoul Teugbyeolsi | |
| The Catholic University of Korea, Yeouido St Marys Hospital Yeongdeungpo-gu, Seoul Teugbyeolsi | |
| The First Affiliated Hospital of Chongqing Medical University Chongqing, | |
| The First Affiliated Hospital of Wenzhou Medical University Wenzhou, | |
| The First Affiliated Hospital of Zhengzhou University Zhengzhou, | |
| The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan Hangzhou, Zhejiang | |
| The Royal Bournemouth and Christchurch Hospitals Nhs Foundation Bournemouth, | |
| The Valley Hospital, Inc Paramus, New Jersey | |
| Tohoku University Hospital Miyagi, | |
| Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology Wuhan, Hubei | |
| Toyohashi Municipal Hospital Toyohashishi, Aichi-ken | |
| Uk St Poelten Sankt Pölten, | |
| Union Hospital of Tongji Medical College, Huazhong University of Science and Technology Wuhan, Hubei | |
| Universidade de Campinas Centro de Hematologia E Hemoterapia Campinas, | |
| Universitatsklinik Fur Innere Medizin Iii Universitatsklinikum Der Pmu Landeskrankenhaus Salzburg Salzburg, | |
| University College Hospital London, | |
| University Hospitals Cleveland, Ohio | |
| University of Alabama at Birmingham Hospital Birmingham, Alabama | |
| University of Maryland Greenebaum Comprehensive Cancer Center Baltimore, Maryland | |
| University of Michigan Ann Arbor, Michigan | |
| University of Virginia Charlottesville, Virginia | |
| Universitätsklinikum Halle Halle, | |
| Universitätsklinikum Hamburg Eppendorf Hamburg, | |
| Uniwersytecki Szpital Kliniczny Nr W Lublinie Lublin, | |
| VCU Massey Cancer Center Richmond, Virginia | |
| Virgina Cancer Specialists Gainesville, Virginia | |
| Washington University School of Medicine St Louis, Missouri | |
| Wellington Regional Hospital (Ccdhb) Wellington, | |
| Westmead Hospital Westmead, New South Wales | |
| Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi Lodz, | |
| Yale University, Yale Cancer Center New Haven, Connecticut | |
| Yokohama Municipal Citizens Hospital Yokohama, | |
| hospital Italiano de Buenos Aires CABA, |