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Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)

Contact(s):

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com - Clinical.Trials@bms.com

Principal Investigator:

System ID: NCT07100080

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Interventions: DRUG: Iza-bren, DRUG: Carboplatin, DRUG: Cisplatin, DRUG: Pemetrexed

Conditions: Non-small Cell Lung Cancer

Keywords: Epidermal Growth Factor Receptor, Tyrosine Kinase Inhibitors, Osimertinib, Standard of Care, Lung Neoplasms, Antineoplastic Agents, Izalontamab brengitecan, Iza-bren, BL-B01D1, Carboplatin, Cisplatin, Pemetrexed

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Study Locations

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Location	Contacts
Arthur J. E. Child Comprehensive Cancer Centre Calgary, Alberta
Cantonal Hospital St.Gallen Sankt Gallen, Canton of St. Gallen
Dana-Farber Cancer Institute Boston, Massachusetts
E-DA Hospital Kaohsiung City,
Fujian Cancer Hospital Fuzhou,
Hospital of the University of Pennsylvania Philadelphia, Pennsylvania
Jiangmen Center Hospital Jiangmen, Guangdong
John B Amos Cancer Center Columbus, Georgia
Kantonsspital Baden Baden,
Local Institution - 0004 ABB, Buenos Aires F.D.
Local Institution - 0005 Leeds,
Local Institution - 0006 Thessaloniki, Kentrikí Makedonía
Local Institution - 0007 Santiago, Santiago Metropolitan
Local Institution - 0008 Ciudad Autónoma de Buenos Aires, Buenos Aires
Local Institution - 0010 Kfar Saba, Central District
Local Institution - 0011 Milan, Lombardy
Local Institution - 0012 Marseille,
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Local Institution - 0015 Paris,
Local Institution - 0017 Jerusalem, Jerusalem
Local Institution - 0018 La Tronche, Isère
Local Institution - 0019 Villejuif, Val-de-Marne
Local Institution - 0022 Yvoir, Namur
Local Institution - 0023 Ghent, Oost-Vlaanderen
Local Institution - 0024 Boston, Massachusetts
Local Institution - 0025 Houston, Texas
Local Institution - 0028 Cleveland, Ohio
Local Institution - 0029 Philadelphia, Pennsylvania
Local Institution - 0031 Orbassano, Piedmont
Local Institution - 0032 Pittsburgh, Pennsylvania
Local Institution - 0034 Chicago, Illinois
Local Institution - 0036 Aviano, Friuli Venezia Giulia
Local Institution - 0042 Seoul, Seoul-teukbyeolsi [Seoul]
Local Institution - 0043 Goyang-si, Kyǒnggi-do
Local Institution - 0044 London, Greater London
Local Institution - 0045 Seoul, Seoul-teukbyeolsi [Seoul]
Local Institution - 0046 Suwon, Kyǒnggi-do
Local Institution - 0054 Athens, Attikí
Local Institution - 0056 Thessaloniki, Kentrikí Makedonía
Local Institution - 0060 Chaïdári, Attikí
Local Institution - 0061 Créteil,
Local Institution - 0062 Thessaloniki, Thessaloníki
Local Institution - 0069 Hangzhou, Zhejiang
Local Institution - 0070 New Delhi, National Capital Territory of Delhi
Local Institution - 0071 Mumbai, Maharashtra
Local Institution - 0072 Hefei, Anhui
Local Institution - 0073 Ahmedabad, Gujarat
Local Institution - 0077 Fortaleza, Ceará
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Local Institution - 0083 Ahmedabad, Gujarat
Local Institution - 0085 Gainesville, Florida
Local Institution - 0089 Cheongju-si, Chungcheongbuk-do [Chungbuk]
Local Institution - 0092 Seoul, Seoul-teukbyeolsi [Seoul]
Local Institution - 0094 Córdoba, Córdoba Province
Local Institution - 0095 Seoul, Seoul-teukbyeolsi [Seoul]
Local Institution - 0097 Nagpur, Maharashtra
Local Institution - 0103 Drammen, Buskerud
Local Institution - 0105 Oslo,
Local Institution - 0106 Harbin, Heilongjiang
Local Institution - 0110 Glasgow, Glasgow City
Local Institution - 0115 Bucharest,
Local Institution - 0119 Iași,
Local Institution - 0120 Bucharest, Bucharest
Local Institution - 0123 Bucharest, Bucharest
Local Institution - 0124 Iași,
Local Institution - 0130 Craiova, Dolj
Local Institution - 0132 Florești, Cluj
Local Institution - 0133 Cluj-Napoca,
Local Institution - 0137 Avellino,
Local Institution - 0140 London, London, City of
Local Institution - 0142 Pembroke Pines, Florida
Local Institution - 0161 Auderghem, Bruxelles-Capitale, Région de
Local Institution - 0162 Bron, Rhône
Local Institution - 0163 Cleveland, Ohio
Local Institution - 0164 Amsterdam, North Holland
Local Institution - 0170 Saint-Herblain, Loire-Atlantique
Local Institution - 0173 San Antonio, Texas
Local Institution - 0175 Madrid, Madrid, Comunidad de
Local Institution - 0176 Madrid, Madrid, Comunidad de
Local Institution - 0177 Barcelona, Catalunya [Cataluña]
Local Institution - 0178 Málaga,
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Local Institution - 0185 Montreal, Quebec
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Local Institution - 0202 München, Bavaria
Local Institution - 0203 Tōon, Ehime
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Local Institution - 0207 Esslingen am Neckar, Baden-Wurttemberg
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Local Institution - 0209 Oldenburg, Lower Saxony
Local Institution - 0210 Heidelberg,
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Local Institution - 0213 Créteil, Val-de-Marne
Local Institution - 0215 Saint-Herblain, Loire-Atlantique
Local Institution - 0216 Amsterdam, North Holland
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Local Institution - 0219 Bydgoszcz,
Local Institution - 0220 Montpellier, Hérault
Local Institution - 0222 Chihuahua City,
Local Institution - 0223 Mexico City,
Local Institution - 0224 Oaxaca City, Oaxaca
Local Institution - 0225 Yvoir, Namur
Local Institution - 0226 Cali, Valle del Cauca Department
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Local Institution - 0229 Valledupar, Cesar Department
Local Institution - 0231 Gdynia, Pomeranian Voivodeship
Local Institution - 0236 Kashiwa, Chiba
Local Institution - 0238 Yokohama, Kanagawa
Local Institution - 0239 Kassel,
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Local Institution - 0242 Ube, Yamaguchi
Local Institution - 0244 Beijing, Beijing Municipality
Local Institution - 0246 Fukuoka,
Local Institution - 0247 Kobe, Hyōgo
Local Institution - 0248 Hospitalet, Barcelona [Barcelona]
Local Institution - 0249 Shanghai, Shanghai Municipality
Local Institution - 0250 Shanghai, Shanghai Municipality
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Local Institution - 0255 Valencia,
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Local Institution - 0257 Kawasaki, Kanagawa
Local Institution - 0259 Krakow, Lesser Poland Voivodeship
Local Institution - 0260 Nanning,
Local Institution - 0261 Warsaw, Masovian Voivodeship
Local Institution - 0262 Singapore,
Local Institution - 0263 Bangalore, Karnataka
Local Institution - 0264 Varanasi, Uttar Pradesh
Local Institution - 0265 Hyderabad, Telangana
Local Institution - 0266 Mumbai, Maharashtra
Local Institution - 0267 New Delhi, National Capital Territory of Delhi
Local Institution - 0268 Chattanooga, Tennessee
Local Institution - 0271 Anyang, Henan
Local Institution - 0272 Mueng, Changwat Khon Kaen
Local Institution - 0274 Kiel, Schleswig-Holstein
Local Institution - 0277 Candiolo, Torino
Local Institution - 0278 Nantes,
Local Institution - 0280 Wilrijk, Antwerpen
Local Institution - 0281 Shenzhen, Guangdong
Local Institution - 0284 Shenyang, Liaoning
NYU Langone Health New York, New York
National Cheng Kung University Hospital Tainan,
National Taiwan University Hospital Taipei,
Oregon Health and Science University Portland, Oregon
Perlmutter Cancer Center at NYU Langone Hospital - Long Island Mineola, New York
Piedmont Healthcare Atlanta, Georgia
Princess Margaret Cancer Centre Toronto, Ontario
Providence Cancer Institute Franz Clinic Portland, Oregon
Providence St. Vincent Medical Center Portland, Oregon
Renown Regional Medical Center Reno, Nevada
Rochester General Hospital Infectious Disease Rochester, New York
Rush University Medical Center Chicago, Illinois
Shanxi Cancer Hospital Taiyuan, Shanxi
Shaw Cancer Center Edwards, Colorado
Taichung Veterans General Hospital Taichung,
Taipei Medical University Hospital Taipei,
Taipei Veterans General Hospital Taipei,
Tennessee Oncology Nashville, Tennessee
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology Wuhan, Hubei
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care building Irvine, California
University Hospitals Cleveland Medical Center Cleveland, Ohio
University of California, Irvine (UCI) Health - UC Irvine Medical Center Orange, California
University of Virginia Health System Charlottesville, Virginia
Virginia Commonwealth University (VCU) Richmond, Virginia
Washington University School of Medicine St Louis, Missouri
Weill Cornell Medical College New York, New York
West Penn Allegheny Health Pittsburgh, Pennsylvania

Testing the Addition of Docetaxel (Chemotherapy) to the Usual Treatment (Hormonal Therapy and Apalutamide) for Metastatic Prostate Cancer, ASPIRE Trial

Contact(s):

Shiva Baghaie, MPH - GUprotocols@alliancenctn.org

Principal Investigator:

System ID: NCT06931340

Show full eligibility criteria

Inclusion Criteria:

* Documentation of disease: \* Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology * Must have had evidence of metastatic disease (American Joint Committee on Cancer \[AJCC\] metastasis \[M\]1 disease) based on conventional CT/MRI and/or bone scan. This will be defined as: * Bone metastases detected by CT, radionuclide technetium-99 (99Tc)- methylene bisphosphonate bone scan, or MRI as defined by PCWG3 criteria; OR * Non-pelvic lymph node metastases (measurable lymph nodes above the aortic bifurcation; lymph nodes are measurable if the short axis diameter is ≥ 15 mm) detected on CT or MRI as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Subjects with regional lymph node metastases only (nodes \[N\]1, below the aortic bifurcation) will not be eligible for the study; OR * Visceral or soft tissue metastases detected on CT or MRI as defined by RECIST version 1.1. Soft tissue/visceral lesions are measurable if the long axis diameter is ≥ 10 mm * Evidence of metastatic disease by PSMA-PET only and not visible by CT, radionuclide bone scan, or MRI will not satisfy eligibility criteria * No metachronous low-volume disease (defined as recurrent metastatic disease after definitive treatment of prostate primary) and with ≤ 4 bone metastasis and no visceral metastasis on conventional imaging by CT, radionuclide 99Tc-biphosphonate bone scan, or MRI) * Next generation sequencing (NGS) results from any tissue based Clinical Laboratory Improvement Act (CLIA) test must be available at the time of registration. NGS from soft tissue or visceral lesion if available is preferred. NGS from bone or primary prostate will be accepted. Patients with failed NGS testing are not eligible * Prior treatment * ADT (luteinizing hormone-releasing hormone \[LHRH\] agonist/antagonist or orchiectomy) with or without first generation anti-androgen, or second-generation androgen receptor signaling inhibitor (ARSI) within 120 days of registration is permitted. No washout period will be needed for the first generation- androgen or ARSI prior to registration. Anti-androgen treatment is only permitted if used within 120 days of registration * No prior chemotherapy for prostate cancer * Age ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 * Absolute neutrophil count (ANC) ≥ 1,500/mm\^3 * Hemoglobin ≥ 9.0 g/dL * Platelet count ≥ 100,000/mm\^3 * Total bilirubin ≤ 1 x upper limit of normal (ULN) (Note: In subjects with Gilbert's syndrome, if total bilirubin is \> 1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤ 1 × ULN, subject may be eligible) * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate transaminase \[SGT\]) ≤ 1.5 x upper limit of normal (ULN) * Calculated (Calc.) creatinine clearance \> 30 mL/min * Serum potassium ≥ 3.5 mmol/L * Comorbid conditions * 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 * Leptomeningeal metastases: Patients with treated leptomeningeal metastases are eligible if follow-up brain imaging 30 days after central nervous system (CNS)-directed therapy shows no evidence of progression * HIV: Patients with known HIV infection on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial * Hepatitis B: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated * Hepatitis C: 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 * No seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1 year to randomization, brain arteriovenous malformation or condition requiring CNS surgery or radiation therapy) * 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 II or better. Any condition that in the opinion of the investigator, would preclude participation in this study. Patients with stable asymptomatic deep venous thromboembolism on stable anti-coagulation will be eligible * Hypertension: Subjects with uncontrolled hypertension as indicated by a resting systolic blood pressure (BP) \>= 160 mmHg or diastolic BP \>= 100 mmHg despite medical management are not permitted to register * Allergies: Subjects with known hypersensitivity to any of the study drugs, or excipients in the formulation of the study drugs are not permitted to register * Concomitant medications * Chronic concomitant treatment with strong inhibitors of cytochrome P450 3A4 (CYP3A4) is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug prior to registration on the study. See Section 8.1.9 for more information * Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment * Medications known to lower the seizure threshold must be discontinued or substituted prior to study entry. See Section 8.1.9 for more information * Patient agrees to use a condom (even men with vasectomies) and another effective method of birth control if having sex with a woman of childbearing potential or agrees to use a condom if having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug. Must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug

Interventions: DRUG: Androgen Therapy, DRUG: Apalutamide, DRUG: Docetaxel, PROCEDURE: Computed Tomography, PROCEDURE: Magnetic Resonance Imaging, PROCEDURE: Bone Scan, PROCEDURE: PSMA PET Scan, PROCEDURE: Biospecimen Collection, OTHER: Questionnaire Administration

Conditions: Castration-Sensitive Prostate Carcinoma, Metastatic Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8

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Study Locations

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Location	Contacts
Allegheny General Hospital Pittsburgh, Pennsylvania
Allegheny Valley Hospital Natrona Heights, Pennsylvania	Site Public Contact - (Dawnmarie.DeFazio@ahn.org)
Ascension All Saints Hospital-Spring Street-Racine Racine, Wisconsin	Site Public Contact - (AWRI.Inquiry@Ascension.org)
Ascension Calumet Hospital-Chilton Chilton, Wisconsin	Site Public Contact - (AWRI.inquiry@ascension.org)
Ascension Columbia Saint Mary's Hospital-Milwaukee Campus Milwaukee, Wisconsin	Site Public Contact - (AWRI.Inquiry@Ascension.org)
Ascension Columbia Saint Mary's Hospital-Ozaukee Campus-Mequon Mequon, Wisconsin	Site Public Contact - (AWRI.Inquiry@Ascension.org)
Ascension Northeast Wisconsin-Mercy Hospital-Oshkosh Oshkosh, Wisconsin	Site Public Contact - (AWRI.inquiry@ascension.org)
Ascension Northeast Wisconsin-Saint Elizabeth Cancer Center-Appleton Appleton, Wisconsin	Site Public Contact - (AWRI.inquiry@ascension.org)
Ascension Southeast Wisconsin Hospital-Elmbrook Campus-Brookfield Brookfield, Wisconsin	Site Public Contact - (AWRI.Inquiry@Ascension.org)
Ascension Southeast Wisconsin Hospital-Mayfair Road-Wauwatosa Wauwatosa, Wisconsin	Site Public Contact - (AWRI.Inquiry@Ascension.org)
Asplundh Cancer Pavilion Willow Grove, Pennsylvania	Site Public Contact - (ONCTrialNow@jefferson.edu)
Banner University Medical Center - Tucson Tucson, Arizona	Site Public Contact - (UACC-IIT@uacc.arizona.edu)
Bayhealth Hospital Kent Campus Dover, Delaware
Bayhealth Hospital Sussex Campus Milford, Delaware
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)
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)
Central Vermont Medical Center/National Life Cancer Treatment Berlin Corners, Vermont
Centralia Oncology Clinic Centralia, Illinois	Site Public Contact - (morganthaler.jodi@mhsil.com)
Coborn Cancer Center at Saint Cloud Hospital Saint Cloud, Minnesota	Site Public Contact - (coborncancercenter@centracare.com)
Community Hospital of Anaconda Anaconda, Montana	Site Public Contact - (mccinfo@mtcancer.org)
Community Medical Center Missoula, Montana	Site Public Contact - (mccinfo@mtcancer.org)
Crossroads Cancer Center Effingham, Illinois	Site Public Contact - (morganthaler.jodi@mhsil.com)
Decatur Memorial Hospital Decatur, Illinois	Site Public Contact - (morganthaler.jodi@mhsil.com)
Drexel Town Square Health Center Oak Creek, Wisconsin
Duke University Medical Center Durham, North Carolina
Durham VA Medical Center Durham, North Carolina	Site Public Contact - (VHADURcancertrials@va.gov)
Eisenhower Medical Center Rancho Mirage, California
FirstHealth of the Carolinas-Moore Regional Hospital Pinehurst, North Carolina	Site Public Contact - (jcwilliams@firsthealth.org)
Forbes Hospital Monroeville, Pennsylvania
Froedtert Menomonee Falls Hospital Menomonee Falls, Wisconsin
Froedtert West Bend Hospital/Kraemer Cancer Center West Bend, Wisconsin
Froedtert and MCW Moorland Reserve Health Center New Berlin, Wisconsin
Genesys Hurley Cancer Institute Flint, Michigan	Site Public Contact - (wstrong@ghci.org)
Guthrie Cortland Memorial Hospital Cortland, New York
Guthrie Medical Group PC-Robert Packer Hospital Sayre, Pennsylvania
HSHS Saint Elizabeth's Hospital O'Fallon, Illinois	Site Public Contact - (morganthaler.jodi@mhsil.com)
HaysMed Hays, Kansas
Hematology Oncology Associates of Fredericksburg Inc Fredericksburg, Virginia	Site Public Contact - (cvaughn@hoafredericksburg.com)
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)
Intermountain Medical Center Murray, Utah	Site Public Contact - (officeofresearch@imail.org)
Jefferson Cherry Hill Hospital Cherry Hill, New Jersey	Site Public Contact - (ONCTrialNow@jefferson.edu)
Jefferson Hospital Jefferson Hills, Pennsylvania	Site Public Contact - (ddefazio@wpahs.org)
Jefferson Methodist Hospital Philadelphia, Pennsylvania
Jefferson Torresdale Hospital Philadelphia, Pennsylvania	Site Public Contact - (ONCTrialNow@jefferson.edu)
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- Modesto MOB II Modesto, California
Kaiser Permanente-Franklin Denver, Colorado	Site Public Contact - (KPCOIHRClinicalResearch@kp.org)
Kaiser Permanente-Fremont Fremont, California	Site Public Contact - (Kpoct@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-Rock Creek Lafayette, Colorado	Site Public Contact - (KPCOIHRClinicalResearch@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)
LDS Hospital Salt Lake City, Utah	Site Public Contact - (officeofresearch@imail.org)
Lawrence Memorial Hospital Lawrence, Kansas	Site Public Contact - (Stephanie.Norris@LMH.ORG)
Logan Health Medical Center Kalispell, Montana	Site Public Contact - (mccinfo@mtcancer.org)
Malcom Randall Veterans Administration Medical Center Gainesville, Florida	Site Public Contact - (trials@cancer.ufl.edu)
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
MedStar Georgetown University Hospital Washington D.C., District of Columbia
Medical College of Wisconsin Milwaukee, Wisconsin
Medstar Washington Hospital Center Washington D.C., District of Columbia
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
Memorial Sloan Kettering Nassau Uniondale, New York
Memorial Sloan Kettering Westchester Harrison, New York
Mercy Hospital Coon Rapids, Minnesota
Mercy Hospital Saint Louis St Louis, Missouri
Mercy Hospital South St Louis, Missouri	Site Public Contact - (Danielle.Werle@mercy.net)
Mount Sinai Hospital New York, New York	Site Public Contact - (CCTO@mssm.edu)
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)
Oncology Associates at Mercy Medical Center Cedar Rapids, Iowa
ProMedica Flower Hospital Sylvania, Ohio	Site Public Contact - (PCIOncResearch@promedica.org)
Rapid City Regional Hospital Rapid City, South Dakota	Site Public Contact - (research@monument.health)
Reiman Cancer Center-Ascension Wisconsin Health Center-Rawson Franklin, Wisconsin	Site Public Contact - (AWRI.Inquiry@Ascension.org)
Roswell Park Cancer Institute Buffalo, New York	Site Public Contact - (askroswell@roswellpark.org)
Rush MD Anderson Cancer Center Chicago, Illinois	Site Public Contact - (Cancer_Studies@rush.edu)
Saint Francis Cancer Center Greenville, South Carolina	Site Public Contact - (Heather_Rich@bshsi.org)
Saint Francis Hospital Federal Way, Washington	Site Public Contact - (Heather_Rich@bshsi.org)
Saint Francis Medical Center Cape Girardeau, Missouri	Site Public Contact - (sfmc@sfmc.net)
Saint George Regional Medical Center St. George, Utah	Site Public Contact - (officeofresearch@imail.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 Mary's Hospital and Regional Medical Center Grand Junction, Colorado	Site Public Contact - (ccrp@co-cancerresearch.org)
Saint Vincent Frontier Cancer Center Billings, Montana
Saint Vincent Hospital Erie, Pennsylvania
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)
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)
Self Regional Healthcare Greenwood, South Carolina	Site Public Contact - (nmcgaha@selfregional.org)
Sheboygan Physicians Group Sheboygan, Wisconsin	Site Public Contact - (wi_research_admin@hshs.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)
Stony Brook University Medical Center Stony Brook, New York
The University of Kansas Cancer Center - Olathe Olathe, Kansas	Site Public Contact - (OlatheCCResearch@kumc.edu)
ThedaCare Regional Cancer Center Appleton, Wisconsin	Site Public Contact - (ResearchDept@thedacare.org)
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 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 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)
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)
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)
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 Illinois Chicago, Illinois
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-Westwood Cancer Center Westwood, Kansas	Site Public Contact - (KUCC_Navigation@kumc.edu)
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 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)
VCU Health Tappahannock Hospital Tappahannock, Virginia	Site Public Contact - (klcampbell@vcu.edu)
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)
Washington University School of Medicine St Louis, Missouri	Site Public Contact - (info@siteman.wustl.edu)
West Penn Hospital Pittsburgh, Pennsylvania
West Virginia University Charleston Division Charleston, West Virginia
Wexford Health and Wellness Pavilion Wexford, Pennsylvania	Site Public Contact - (Dawnmarie.DeFazio@ahn.org)
William S Middleton VA Medical Center Madison, Wisconsin

Symbiotic-Lung-20: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Different Anticancer Agents in Advanced Cancers

Contact(s):

Pfizer CT.gov Call Center - ClinicalTrials.gov_Inquiries@pfizer.com

Principal Investigator:

System ID: NCT07227298

Show full eligibility criteria

Interventions: BIOLOGICAL: PF-08634404, BIOLOGICAL: Sigvotatug Vedotin, BIOLOGICAL: Combination Agent 1

Conditions: Advanced/Metastatic Non-Small Cell Lung Cancer, Carcinoma, Non-Small Cell Lung, Non-small Cell Lung Cancer

Keywords: non-small cell lung cancer, NSCLC, advanced solid tumors, metastatic non-small cell lung cancer, locally advanced non-small cell lung cancer, squamous non-small cell lung cancer, non-squamous non-small cell lung cancer

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Study Locations

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Location	Contacts
Azienda Sanitaria Territoriale Pesaro Urbino (AST PU) Fano, Pesaro AND Urbino
BRCR Global - Tamarac Tamarac, Florida
BRCR Global Puerto Rico - Hato Rey San Juan,
BRCR Medical Center Inc. Coral Springs, Florida
Beijing Cancer Hospital Beijing, Beijing Municipality
Centre Georges Francois Leclerc Dijon, CÔTE D'OR
Chang Gung Memorial Hospital at Kaohsiung Kaohsiung City,
Dallas Cancer Specialists Garland, Texas
Highlands Oncology Group, PA Springdale, Arkansas
Highlands Oncology Group, PA Springdale, Arkansas
Highlands Oncology Group, PA Springdale, Arkansas
Hospital Clinico San Carlos Madrid,
Hospital De La Santa Creu I Sant Pau Barcelona, Catalunya [cataluña]
Hospital Nuestra Señora del Rosario Madrid, Madrid, Comunidad de
Hospital Universitario 12 de Octubre Madrid,
Hospital Universitario San Cecilio Granada,
Hospital Universitario Virgen Macarena Seville,
IRCCS Istituto Nazionale dei Tumori Regina Elena Roma, ROME
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest Bordeaux, Aquitaine
Institut Paoli-Calmettes Marseille, Provence-Alpes-Côte d'Azur Region
Kansai Medical University Hospital Hirakata, Osaka
Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung City,
Lumi Research Houston, Texas
Mackay Memorial Hospital Taipei,
Marien Hospital Dusseldorf Düsseldorf, North Rhine-Westphalia
Massey Cancer Center Clinical & Translational Research Lab Richmond, Virginia
Montefiore Medical Center- Montefiore Medical Park The Bronx, New York
National Cheng Kung University Hospital Tainan,
National Taiwan University Hospital Taipei,
Oncology Associates of Oregon, P.C. Eugene, Oregon
Orlando Health Ambulatory Care Center Orlando, Florida
Orlando Health Cancer Institute Orlando, Florida
Orlando Health Orlando Regional Medical Center Orlando, Florida
Ospedale Isola Tiberina - Gemelli Isola Roma, ROME
Pan American Center for Oncology Trials, LLC Rio Piedras,
Providence Medical Foundation Fullerton, California
Providence St. Jude Medical Center Fullerton, California
Providence St. Jude Medical Center - Virginia K. Crosson Cancer Center and Infusion Center Fullerton, California
Rocky Mountain Cancer Centers, LLP Lone Tree, Colorado
Shanghai Chest Hospital Shanghai,
Shizuoka Cancer Center Nagaizumi-cho, Shizuoka
Southwest Oncology Associates Houston, Texas
Taipei Veterans General Hospital Taipei,
Taizhou Hospital of Zhejiang Province Taizhou, Zhejiang
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology Wuhan, Hubei
US Oncology Investigational Products Center (IPC) Irving, Texas
VCU Health Community Memorial Hospital South Hill, Virginia
VCU Health Stony Point Richmond, Virginia
VCU Health Tappahannock Hospital Tappahannock, Virginia
VCU Medical Center Gateway Building Richmond, Virginia
VIVO Capuchinos Seville,
Virginia Commonwealth University Richmond, Virginia
Virginia Commonwealth University Richmond, Virginia
Voyage Clinical Sugar Land, Texas
mid Florida hematology and Oncology Center Orange City, Florida

Ketamine add-on Therapy for Established Status Epilepticus Treatment Trial (KESETT) (KESETT)

Contact(s):

Megan Wardius - mew5j@virginia.edu

Principal Investigator:

System ID: NCT06907173

Show full eligibility criteria

Interventions: DRUG: Levetiracetam (LEV) (60 mg/Kg) + 1 mg/kg Ketamine (KET), DRUG: Levetiracetam (LEV) (60 mg/Kg) + 3 mg/kg Ketamine (KET), DRUG: Levetiracetam (LEV) (60 mg/Kg)

Conditions: Status Epilepticus

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Study Locations

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Location	Contacts
Arthur M. Blank Hospital Atlanta, Georgia	Claudia Morris, MD - (claudia.r.morris@emory.edu)
Banner University Medical Center - Tucson Campus Tucson, Arizona	Aaron Leetch, MD - (aleetch@arizona.edu)
Children's Hospital Los Angeles Los Angeles, California	Ara Festekjian, MD - (afestekjian@chla.usc.edu)
Children's Hospital of Wisconsin Milwaukee, Wisconsin	Keli Coleman, MD - (kcoleman@mcw.edu)
Children's Medical Center Dallas Dallas, Texas	Pamela Okada, MD - (pamela.okada@utsouthwestern.edu)
Children's National Medical Center Washington D.C., District of Columbia	James Chamberlain, MD - (jchamber@childrensnational.org)
Christiana Hospital Newark, Delaware	Jason Nomura, MD - (jnomura@christianacare.org)
Comer Children's Hospital Chicago, Illinois	David Beiser, MD - (dbeiser@medicine.bsd.uchicago.edu)
Detroit Receiving Hospital Detroit, Michigan	Wazim Mohamed, MD - (wmohamed@med.wayne.edu)
Duke Regional Hospital Durham, North Carolina	Alexander Limkakeng, MD - (alexander.limkakeng@duke.edu)
Duke University Hospital Durham, North Carolina	Alexander Limkakeng, MD - (alexander.limkakeng@duke.edu)
Froedtert Hospital Milwaukee, Wisconsin	Jamie Jasti, MD - (jjasti@mcw.edu)
Grady Memorial Hospital Delaware, Ohio	Jonathan Ratcliff, MD, MPH - (jonathan.ratcliff@emoryhealthcare.org)
Harborview Medical Center Seattle, Washington	Vasisht Srinivasan, MD - (vasishts@uw.edu)
Hennepin County Medical Center Minneapolis, Minnesota	Brian Driver, MD - (brian.driver@hcmed.org)
Henry Ford Hospital Detroit, Michigan	Joseph Miller, MD - (jmiller6@hfhs.org)
Hospital of the University of Pennsylvania Philadelphia, Pennsylvania	John Greenwood, MD - (john.greenwood@pennmedicine.upenn.edu)
IU Health Methodist Hospital Indianapolis, Indiana	Daniel Udrea, MD - (dudrea@iu.edu)
Jefferson Einstein Philadelphia Hospital Philadelphia, Pennsylvania	Joseph Herres, DO - (Joseph.herres@jefferson.edu)
Massachusetts General Hospital Boston, Massachusetts	Michael Filbin, MD - (mfilbin@mgh.harvard.edu)
Memorial Hermann Texas Medical Center Houston, Texas	Kayleigh Fischer, MD - (Kayleigh.A.Fischer@uth.tmc.edu)
Nationwide Children's Hospital Columbus, Ohio	Aarti Gaglani Aarti Gaglani, MD - (kesett@nationwidechildrens.org)
Nemours Children's Hospital Orlando, Florida	Amy Thompson, MD - (amy.thompson@nemours.org)
Northwestern Memorial Hospital Chicago, Illinois	Peter Pruitt, MD - (peter.pruitt@nm.org)
OSU Wexner Medical Center Columbus, Ohio	Kirstin Acus, MD - (kirstin.acus@osumc.edu)
Oregon Health & Science University Hospital Portland, Oregon	Bory Kea, MD - (kea@ohsu.edu)
Orlando Regional Medical Center Orlando, Florida	Dipali Nemade, MD - (Dipali.Nemade@orlandohealth.com)
Penn Presbyterian Medical Center Philadelphia, Pennsylvania	John Greenwood, MD - (john.greenwood@pennmedicine.upenn.edu)
Primary Children's Hospital Salt Lake City, Utah	Maija Holsti, MD, MPH - (Maija.Holsti@hsc.utah.edu)
Reading Hospital West Reading, Pennsylvania	Adam Sigal, MD - (adam.sigal@towerhealth.org)
Riley Hospital for Children Indianapolis, Indiana	Benjamin Nti, MD - (bnti@iu.edu)
Ronald Reagan UCLA Medical Center Los Angeles, California	Richelle Cooper, MD - (rcooper@mednet.ucla.edu)
SUNY Upstate Medical University Syracuse, New York	Lindsay Nausin, DO - (nausinl@upstate.edu)
San Francisco General Hospital San Francisco, California	Debbie Madhok, MD - (Debbie.madhok@ucsf.edu)
Sinai-Grace Hospital Detroit, Michigan	Arun Sherma, MD - (arun@sherma.org)
Stanford University Medical Center Palo Alto, California	Alexandra June Gordon, MD - (ajgordon@stanford.edu)
Temple University Hospital Philadelphia, Pennsylvania	Derek Isenberg, MD - (derek.isenberg@tuhs.temple.edu)
UC Davis Medical Center Sacramento, California	Daniel Nishijima, MD - (dnishijima@ucdavis.edu)
UCSF Medical Center San Francisco, California	Debbie Madhok, MD - (Debbie.madhok@ucsf.edu)
UPMC Children's Hospital of Pittsburgh Pittsburgh, Pennsylvania	Robert Hickey, MD - (robert.hickey@chp.edu)
UPMC Presbyterian Hospital Pittsburgh, Pennsylvania	Adam Frisch, MD - (frischan@upmc.edu)
University of Chicago Medical Center Chicago, Illinois	David Beiser, MD - (dbeiser@medicine.bsd.uchicago.edu)
University of Cincinnati Medical Center Cincinnati, Ohio	Jason McMullan, MD - (jason.mcmullan@uc.edu)
University of Iowa Medical Center Iowa City, Iowa	Brett Faine, MD - (brett-faine@uiowa.edu)
University of Maryland Medical Center Baltimore, Maryland	Jennifer Hopp, MD - (jhopp@som.umaryland.edu)
University of Michigan University Hospital Ann Arbor, Michigan	Mariama Runcie, MD - (runciema@med.umich.edu)
University of Minnesota Masonic Children's Hospital Minneapolis, Minnesota	James Miner, MD - (miner015@umn.edu)
University of Minnesota Medical Center Minneapolis, Minnesota	James Miner, MD - (miner015@umn.edu)
University of Utah Healthcare Salt Lake City, Utah	Scott Youngquist, MD - (scott.youngquist@utah.edu)
University of Virginia Medical Center Charlottesville, Virginia	Thomas Hartka, MD - (trh6u@uvahealth.org)
VCU Medical Center Richmond, Virginia	Lisa Merck, MD, MPH, MHA - (Lisa.Merck@vcuhealth.org)
Yale New Haven Hospital New Haven, Connecticut	Charles Wira, MD - (charles.wira@yale.edu)

Evaluating the Safety and Efficacy of dNerva Lung Denervation System in Patients With COPD (AIRFLOW-4)

Contact(s):

John Carline - jcarline@nuvaira.com

Principal Investigator:

System ID: NCT07051707

Show full eligibility criteria

Inclusion Criteria:

* ≥ 40 and ≤ 80 years of age at the time of consent. * Women of childbearing potential must not be pregnant, evidenced by a negative pregnancy test (blood or urine) pre-treatment, or lactating and agree not to become pregnant for the duration of the study. * Smoking history of at least 10 pack years. * Not smoking or using any other inhaled substance (e.g. cigarettes, vaping, cannabis, pipes) for a minimum of 2 months prior to consent and agrees to not start for the duration of the study. * Resting SpO2 ≥ 89% on room air. * MMRC ≥ 2; CAT score ≥ 10. * Diagnosis of moderate to severe COPD as defined by FEV1/FVC \< 70% (post-bronchodilator), 25% ≤ FEV1 ≤ 70% predicted, and PaCO2 \< 50 (if FEV1 \< 30%). * RV ≥ 175% of predicted and RV/TLC \> 55% (post-bronchodilator). * Participant is on standard medical care, defined as a minimum of therapy with LABA/ICS, LAMA/LABA, or LAMA/LABA/ICS for at least 2 months prior to consent. * If subject has participated in a formal pulmonary rehabilitation program recently, program completion must have occurred ≥3 months prior to consent; if in a maintenance program, subject agrees to continue their current program through their 12-month follow-up visit; NOTE: Prior participation in a pulmonary rehabilitation program is not required for inclusion in the study. * Participant is a candidate for bronchoscopy in the opinion of the investigator or per hospital guidelines and is able to discontinue blood thinning medication peri-procedurally. * Participant is able and agrees to complete all protocol required baseline and follow up tests and assessments including taking certain medications (e.g., azithromycin, prednisolone/prednisone).

Exclusion Criteria:

* Body Mass Index (BMI) \<18 or \>32. * Participant has an implantable electronic device and has not received appropriate medical clearance. * Uncontrolled diabetes in the opinion of the investigator. * 4 or more respiratory related hospitalizations within 1 year of consent. * Malignancy treated with radiation or chemotherapy within 1 year of consent. * Participant diagnosed with a dominant non-COPD lung disease, or condition affecting the lungs, which is the main driver of the participant's clinical symptoms (e.g., cystic fibrosis, paradoxical vocal cord motion, eosinophilic granulomatosis with polyangiitis (EGPA), allergic bronchopulmonary aspergillosis, interstitial lung disease or active tuberculosis or Asthma) or has a documented medical history of pneumothorax within 1 year of consent. * Clinically relevant bronchiectasis, defined as \> 1/3 cup mucous expectoration daily. * Pre-existing diagnosis of pulmonary hypertension, clinical evidence of pulmonary hypertension (e.g., cardiovascular function impairment including peripheral edema) and mPAP ≥25 mmHg at rest by right heart catheterization (or estimated right ventricular systolic pressure \>50 mmHg by echocardiogram if no previous right heart catheterization). * Myocardial infarction within last 6 months, evidence of life-threatening arrhythmias or acute ischemia, pre-existing documented evidence of a LVEF \< 40%, stage C or D (ACC/AHA) or Class III or IV (NYHA) congestive heart failure. * Surgical procedure(s) on the stomach, esophagus or pancreas performed ≤2 years of consent, or ongoing related symptoms within the past year. * Symptomatic gastric motility disorder(s) (e.g., gastroparesis) as evidenced by GCSI score ≥18.0, severe uncontrolled GERD (e.g., refractory heartburn, endoscopic esophagitis) or severe dysphagia (e.g., esophageal stricture, achalasia, esophageal spasm). NOTE: Participants with a hiatal hernia are allowed if Participant meets all other enrollment criteria. * Any disease or condition that might interfere with completion of a procedure or this study (e.g., structural esophageal disorder, life expectancy \<3 years). * Prior lung or chest procedure (e.g., BLVR explant procedure, median sternotomy, bullectomy, lobectomy, segmentectomy or other interventional lung or chest procedure) performed ≤1 year of consent? Participants with lung transplant, BLVR valves, LVRS, metal stents within 5cm of the anticipated treatment location; presence of lung volume reduction valves, coils or other lung implants. * Daily use of \>20 mg of prednisone or its equivalent at the time of consent. * Known contraindication or allergy to medications required for bronchoscopy or general anesthesia (e.g., lidocaine, atropine, propofol, sevoflurane) that cannot be medically controlled. * Baseline chest CT scan reveals bronchial anatomy cannot be treated with available catheter sizes; presence of whole lung emphysema \>20% (-950 HU), single lung emphysema \>26% (-950 HU), severe bullous disease (\>1/3 hemithorax) or discovery of a mass that requires treatment. * Participant is currently enrolled in another drug or interventional clinical trial that has not completed follow-up.

Interventions: DEVICE: Targeted Lung Denervation (TLD)

Conditions: COPD, Chronic Obstructive Pulmonary Disease

Keywords: Optimal Medical Care, Device: dNerva Lung Denervation System, Device: Targeted Lung Denervation (TLD)

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Location	Contacts
Henry Ford Hospital - Lung and Pulmonary Care Detroit, Michigan	Saira Saif - (ssaif1@hfhs.org) Deepti Naidu - (dnaidu1@hfhs.org)
Mayo Clinic Jacksonville Jacksonville, Florida	John Hazimouratides - (hatzimouratidesjr.john@mayo.edu) Maria Caruso - (Caruso.maria@mayo.edu)
Medical College of Wisconsin Milwaukee, Wisconsin	Isabel Gilbert - (igilbert@mcw.edu) Samantha Servi - (sservi@mcw.edu)
Ohio State University Medical Center - Ohio State Lung Center Columbus, Ohio	Amy Miller - (Amy.Miller2@osumc.edu) Michael Woods - (michael.woods@osumc.edu)
Penn Highlands - Lung Innovations/Clinical Research Associates DuBois, Pennsylvania	Rebecca Taylor - (rebecca@clinicalresearchassoc.com) Levi Miller - (levi@clinicalresearchassoc.com)
Temple University - Temple Lung Center Philadelphia, Pennsylvania	Helga Criner - (Lii-Yoong.Criner@tuhs.temple.edu) Priya Walia - (priya.walia@tuhs.temple.edu)
University of Alabama-Birmingham Hospital - UAB Lung Health Center Birmingham, Alabama	Daniel Baugh - (dbaugh@uabmc.edu) Abbey West - (amwest@uabmc.edu)
University of Pittsburgh Medical Center - UMPC Comprehensive Lung Center Pittsburgh, Pennsylvania	Paula Consolaro - (consolarpj@upmc.edu) Tiffany Ditter - (ditterdl2@upmc.edu)
Virginia Commonwealth University Health System Richmond, Virginia	Robin Toft - (robin.toft@vcuhealth.org)
Wake Forest School of Medicine Salem, North Carolina	Anna Pippins - (anna.pippins@advocatehealth.org)

A Research Study to Look at How Well NNC0487-0111 Works Compared to Placebo in People With Heart Failure and Obesity (HF-POLARIS)

Contact(s):

Novo Nordisk - clinicaltrials@novonordisk.com

Principal Investigator:

System ID: NCT07567001

Show full eligibility criteria

Inclusion Criteria:

* Body Mass Index (BMI) greater than or equal to (\>=) 30 kilograms per square metre (kg/m\^2) at screening. * Diagnosis of HF with New York Heart Association (NYHA) class II-IV and in stable condition at screening, at the discretion of the investigator. For participants with Type 2 Diabetes (T2D) at screening: \- Diagnosed with T2D \>= 30 days before screening.

Exclusion Criteria:

* MI, stroke, unstable angina pectoris or worsening HF leading to either hospitalization or intravenous loop diuretics within 30 days prior to the day of screening and until randomization. * HF due to infiltrative cardiomyopathy (e.g., sarcoid, amyloid), arrhythmogenic right ventricular cardiomyopathy, Takutsubo cardiomyopathy, Chagas cardiomyopathy, genetic hypertrophic cardiomyopathy or obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, or uncorrected primary valve disease of moderate or severe degree. * Severe pulmonary disease including primary pulmonary hypertension, chronic pulmonary embolism, or severe chronic obstructive pulmonary disease (COPD) defined as: * requiring home oxygen; or - ongoing oral corticosteroid therapy; or - hospital for COPD Exacerbation within 12 months prior to screening. * Any other condition judged by the investigator to be the cause of HF symptoms (e.g., anaemia, hypothyroidism). Glycaemia-related: * History of type 1 diabetes. * Participant with diabetic retinopathy or maculopathy who received treatment with retinal photocoagulation, vitrectomy or anti-Vascular Endothelial Growth Factor (anti-VEGF) within 180 days before screening or who, at the time of screening, are expected to require treatment within 180 days after screening. Diabetic retinopathy or maculopathy must be verified by an eye examination performed within 90 days before screening or in the period between screening and randomization. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination. * Glycated haemoglobin (HbA1c) greater than (\>) 10 percent (%) (86 \[millimoles per mole\] mmol/mol) as measured by local or central laboratory at screening.

Interventions: DRUG: NNC0487-0111, DRUG: Placebo

Conditions: Obesity, Heart Failure

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Study Locations

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Location	Contacts
"AHEPA" University General Hospital of Thessaloniki Thessaloniki,
"Hygeia" General Hospital of Athens Athens,
'G. Gennimatas' General Hospital of Athens - Cardiology Department Athens,
'Ippokrateio' General Hospital of Thessaloniki Thessaloniki,
251 Air Force General Hospital - Department of Endocrinology & Diabetes Athens,
4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu Wroclaw, Lower Silesian Voivodeship
AHEPA General University Hospital Thessaloniki,
AIPSCMC - Dr. Nikolay Iliev EOOD Pleven,
AIPSMCIDC - Dr. Georgi Nedyalkov EOOD Plovdiv,
AOU Bologna - Malpighi - Dipartimento Medicina Interna Bologna, Emilia-Romagna
AOU Federico II Di Napoli - DAI di Medicina Interna e della Complessità Clinica Naples, Campania
AOU Perugia - Santa Maria della Misericordia - S. C. Medicina Interna Perugia, Umbria
AOU Sassari - UOC Cardiologica Clinica ed Interventistica Sassari,
APHP - HOPITAL BICETRE_Service de Cardiologie Le Kremlin-Bicêtre,
ASSL Sette Laghi - Ospedale Galmarini di Tradate Varese, Lombardy
ASST Papa Giovanni XXIII - Cardiologia 1 Bergamo, Lombardy
Accellacare Wilmington Wilmington, North Carolina
Acibadem City Clinic UMHAT EOOD, Cardiology Sofia,
Adana Şehir Eğitim ve Araştırma Hastanesi Adana,
Adana Şehir Eğitim ve Araştırma Hastanesi-Dahiliye Yuregir/Adana,
Adrian Costa Clinical Trials Centre Geelong, Victoria
Advanced Cardiology LLC - Hackettstown Hackettstown, New Jersey
Advanced Cardiovascular, LLC Alexander City, Alabama
Advanced Medical Research Maumee, Ohio
Advara HeartCare Joondalup Joondalup, Western Australia
Advara HeartCare Leabrook Leabrook, South Australia
Advara HeartCare Mulgrave Mulgrave, Victoria
Adventist Healthcare Shady Grove Medical Center Rockville, Maryland
Aesculap Ambulance s.r.o. Dolní Břežany,
Afyonkarahisar Sağlık Bilimleri Üniversitesi Sağlık Uygulama Ve Araştırma Merkezi- Kardiyoloji Afyonkarahisar,
Aintree University Hospital Liverpool,
Ajou University Hospital_Cardiology Suwon, Gyeonggi-do
Akdeniz Üniversitesi Hastanesi-Kardiyoloji Antalya,
Al-Zoebi Wermsdorf,
Alexandra General Hospital, Therapeutic Clinic Athens, Attica
All India Institute of Medical Sciences (AIIMS) Jodhpur, Rajasthan
All India Institute of Medical Sciences (AIIMS), Bhubaneswar Bhubaneswar, Odisha
All India Institute of Medical Sciences (AIIMS), Nagpur Nagpur, Maharashtra
Alrijne Leiderdorp - Cardiologie Leiderdorp,
American Clinical Trials, LLC Acworth, Georgia
American Heart of Poland S.A. Zgierz, Łódź Voivodeship
American Heart of Poland S.A. Zgierz, Łódź Voivodeship
American Heart of Poland S.A. Zgierz, Łódź Voivodeship
Amicis Centers of Clinical Research St Louis, Missouri
Amicis Research Center Northridge, California
Amicis Research Center Northridge, California
Amphia Ziekenhuis Breda,
Amrita Institute of Medical Sciences Kochi, Kerala
AmsterdamUMC AMC Amsterdam,
Anderson Medical Group Ft. Washington, Maryland
AngioCor Blumenau Blumenau, Santa Catarina
Ankara Bilkent Şehir Hastanesi-Dahiliye Ankara,
Ankara Bilkent Şehir Hastanesi-Kardiyoloji Ankara,
Ankara Etlik Şehir Hastanesi- Kardiyoloji Yenimahalle/Ankara,
Antalya Eğitim ve Araştırma Hastanesi- Kardiyoloji Muratpasa/ Antalya,
Arcispedale S. Maria Nuova - U.O.C. Cardiologia Reggio Emilia, Emilia-Romagna
Arcispedale Sant'Anna (Cona) - Dipartimento Interaziendale Cardio-toraco-vascolare Ferrara, Emilia-Romagna
Arizona Research Center Phoenix, Arizona
Arkansas Health Group Little Rock, Arkansas
Arneja Heart & Multispeciality Hospital Nagpur, Maharashtra
Arrow Clinical Trials Daytona Beach, Florida
Asan Medical Center_Cardiology Seoul,
Ascension Saint Agnes Heart Ca Baltimore, Maryland
Asha Clinical Rsch-Munster, LLC Hammond, Indiana
Asklepieion General Hospital - Cardiology Clinic Athens/Voula,
Asklepios Klinik Langen - Medizinische Klinik I Langen,
Associacao Beneficente Siria - HCOR São Paulo, São Paulo
Associação Lar São Francisco de Assis na Providência de Deus - Bragança Paulista Bragança Paulista, São Paulo
Assuta Ashdod MC - The Institute of Cardiology Ashdod,
Aster Medcity Kochi, Kerala
Atatürk Üniversitesi Araştırma Hastanesi-Kardiyoloji Yakutiye / Erzurum,
Athens Medical Center S.A (Iatriko Athinon) - Cardiology Clinic Athens,
Athens Medical Center S.A. (Iatriko Peristeriou) - Diabetes, obesity and cardiometabolic diseases department Peristeri,
Athens Medical Center S.A., European Interbalkan Medical Center - Department of Internal Medicine Thessaloniki,
Atlanta Center for Clinical Research_Atlanta Atlanta, Georgia
Atlanta Heart Specialists, LLC Tucker, Georgia
AtlantiCare Regional Medical Center Pomona, New Jersey
Augustinerinnen KHs - Cellitinnen KH Köln Cologne,
Aultman Hospital Canton, Ohio
Aurora St. Luke's Medi Ctr Milwaukee, Wisconsin
Austin Heart Austin, Texas
Austin Heart Austin, Texas
Azienda Ospedaliera Padova - UOC Clinica Medica 3 Padova, Veneto
Azienda Ospedaliera Policlinico Universitario Tor Vergata - UOC Cardiologia Rome, Lazio
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone - U.O. Cardiologia Palermo, Sicily
Azienda Ospedaliero - Universitaria Sant'Andrea - UOC Medicina interna Rome, Lazio
Azienda Ospedaliero Universitaria Pisana - U.O. Medicina 1 Pisa, Tuscany
Azienda Ospedaliero-Universitaria Senese - Dipartimento Cardio-toraco-vascolare Siena, Tuscany
Baker-HeartWest - Hoppers Crossing Hoppers Crossing, Victoria
Balad Hlth Sys-Welmont CardCVA Greeneville, Tennessee
Balticmed Świnoujście Sp. z o. o. Świnoujście,
Baotou City Central Hospital-Cardiology Baotou, Inner Mongolia
Barnet Hospital - Cardiology Department Barnet,
Batra Hospital and Medical Research Center New Delhi, National Capital Territory of Delhi
BayCare Health System Tampa, Florida
Baylor Scott & White Health Temple, Texas
Baylor Scott & White Health Temple, Texas
Baylor Scott & White Health Temple, Texas
Baylor Scott & White Res Inst Plano, Texas
Bella Vita Clinical Research Cape Town, Western Cape
Biopharma Informatic, LLC McAllen, Texas
Blue Coast Research Center Vista, California
Bnai Zion MC - Department of Cardiology Haifa,
Bravis Zkh Roosendaal Roosendaal,
Broward Research Ctr. Miami Beach, Florida
Broward Research Ctr. Miami Beach, Florida
Bryan Heart Lincoln, Nebraska
Bursa Yüksek İhtisas Eğitim ve Araştırma Merkezi-Kardiyoloji Bursa,
C.I.C. Joliette Saint-Charles-Borromée, Quebec
CAICI Rosario,
CAPED - Centro Avançado de Pesquisa, Estudos e Diagnósticos Ribeirão Preto, São Paulo
CC LIFE s.r.o. Brno,
CCECB _Cabinet de Cardiologie ALDAPA Bayonne,
CCIH-Consultoria em Controle de Infecção Hospitalar Ltda Belo Horizonte, Minas Gerais
CEDIC Centro de Investigación Clínica CABA,
CEDIR - Centro de diagnóstico y rehabilitación Santa Fe Santa Fe,
CEMEDIC CABA,
CENTRE HOSPITALIER DE CHOLET_Service de Cardiologie Cholet,
CENTRE HOSPITALIER DE VERSAILLES-HOPITAL ANDRE MIGNOT_Service de Cardiologie Le Chesnay,
CH LA ROCHELLE - Service de Cardiologie La Rochelle,
CHI Franciscan Research Center Tacoma, Washington
CHI TOULON - HOPITAL SAINTE MUSSE_Service de Cardiologie Toulon,
CHRU BREST - HOPITAL DE LA CAVALE BLANCHE_Service de cardiologie Brest,
CHRU NANCY - HOPITAL BRABOIS_Service de Cardiologie Vandœuvre-lès-Nancy,
CHRU TOURS - HOPITAL TROUSSEAU - Service de Cardiologie Chambray-lès-Tours,
CHU NANTES - HOPITAL NORD LAENNEC_Service d'Endocrinologie-Diabétologie-Nutrition Saint-Herblain,
CHU NIMES - HOPITAL CAREMEAU_Service de Cardiologie Nîmes,
CHU de Quebec-Uni Laval-Hotel Québec,
CHUM-Hosp de Univ Montreal Montreal, Quebec
CIMAB SA de CV Torreón, Coahuila
CIPES - Centro Internacional de Pesquisa Clínica LTDA São José dos Campos, São Paulo
CISSS BAS ST-LAURENT, HOPITAL regional DE RIMOUSKI Rimouski, Quebec
CIUSSS du Saguenay-Lac-St-Jean Chicoutimi, Quebec
CLINIQUE DU MILLENAIRE_Service de Cardiologie Interventionelle Montpellier,
CMC Cardiología Sociedad Simple San Miguel de Tucumán,
CPQuali Pesquisa Clinica Ltda São Paulo, São Paulo
CPS Research Waterloo, Ontario
California Heart Specialist Huntington Beach, California
Canberra Hospital - Clinical Trials Unit Canberra, Australian Capital Territory
Capital Cardiology Associates_Albany Albany, New York
Card Specialists of Willowbrook Houston, Texas
CardiaMet Ciudad Autonoma de Buenos Aires, Buenos Aires
Cardiac Clinical Research Unit, University of Cape Town Cape Town, Western Cape
Cardiac Institute for Research at Queen's - CIRQ Kingston, Ontario
Cardiac Vascular Sentral Kuala Lumpur Kuala Lumpur, Kuala Lumpur
Cardio Health Clinical Trials Hamilton, Ontario
Cardio Innovation & Resch Ctr Long Beach, California
Cardio Metabolic Institute Somerset, New Jersey
Cardio Research & Education Foundation Wausau, Wisconsin
Cardio Research of S. Cal Beverly Hills, California
Cardio Research s.r.o. Zlín,
Cardio and Vascular Assoc-CAVA Bloomfield Hills, Michigan
CardioConsil GmbH Rostock,
Cardiologicum Dresden und Pirna - MVZ "Am Felsenkeller" (Dresden) Dresden,
Cardiología Hospital J. M. Ramos Mejia Buenos Aires,
Cardiología Palermo City of Buenos Aires, Buenos Aires
Cardiovascular Consultants of South Georgia Thomasville, Georgia
Cardiovascular Institute of Orlando Orlando, Florida
Cardiovascular Institute of the South Opelousas, Louisiana
Cardiovascular Institute of the South Opelousas, Louisiana
Care Access Research Rapid City, South Dakota
Care United Research, LLC Forney, Texas
Carient Heart and Vascular Manassas, Virginia
Catharina Zkh Eindhoven - Cardiologie Eindhoven,
Cbk Med Clinic Sp. z o.o. Płock, Masovian Voivodeship
Centro Cardiovascular Salta Salta,
Centro Medico Capital La Plata, Buenos Aires,
Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli Buenos Aires,
Centro Médico CIMEL Lanús Este, Buenos Aires
Centro Médico Luquez Córdoba,
Centro de Atención al Diabético Actopan (CAD) Actopan, Hidalgo
Centro de Atención e Investigación Cardiovascular del Potosi (CICAP) San Luis Potosí City,
Centro de Investigaciones Clinica Baigorria Santa Fe, Santa Fe Province
Centro de Investigaciones Clinicas del Litoral Santa Fe,
Centro de Investigaciones Metabólicas Capital Federal, Buenos Aires
Centro de Investigación Integral MEDIVEST Chihuahua City,
Centro de Investigación y Control Metabólico S. C. San Nicolás de los Garza, Nuevo León
Centro de Pesquisa Silvestre Santé Rio Branco, Acre
Centro de Pesquisas Clínicas Dr. Marco Mota LTDA Maceió, Alagoa
Centrum Medyczne "Hipokrates" s.c. Elżbieta i Grzegorz Grześk Bydgoszcz,
Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j. Bydgoszcz,
Centrum Medyczne Komorniki Sp. z o.o. Komorniki,
Centrum Medyczne MBB-MED Marta Blach-Burek Libiąż,
Centrum Medyczne MBB-MED Marta Blach-Burek Libiąż,
Centrum Medyczne Ogrodowa Sp. z o.o. Lowicz,
Chambersburg Hospital Chambersburg, Pennsylvania
Chang Gung Memorial Hospital - Kaohsiung Branch Kaohsiung City,
Chang Gung Memorial Hospital, Linkou Taoyuan County,
Changsha Central Hospital-Cardiovascular Medicine Changsha, Hunan
Changzhou No.2 People's Hospital-Cardiology Changzhou, Jiangsu
Charité - Campus Virchow-Klinikum - Kardiologie, Angiologie und Intensivmedizin (CRU) Berlin,
Chesterfield Royal Hospital Chesterfield,
Chicago Clinical Research Institute INC Orland Park, Illinois
Chicago Clinical Research Institute INC Orland Park, Illinois
Chicago Medical Research LLC Hazel Crest, Illinois
China-Japan Union Hospital of Jilin University-Cardiology Changchun, Jilin
Chonnam National University Hospital_Cardiology Gwangju,
Chungnam National University Hospital_Cardiology Daejeon,
Circulate Cardiac and Vascular Centre Burlington, Ontario
Clalit HMO Holon - Heart Institute Holon,
Clearwater Cardiovascular Consultants Safety Harbor, Florida
Clindove Research Brooklyn, New York
Clinical Medical Research Sp. z o.o. Katowice,
Clinical Research Consultants, JCCT Co Kansas City, Missouri
Clinical Research Institute of South Africa KwaDukuza, KwaZulu-Natal
Clinical Trial Systems (CTC) Pretoria, Gauteng
Clinical Trials Network Helderberg (Pty) Ltd Somerset West, Western Cape
Clinique Saint Augustin Bordeaux,
Clinresco Centres (Pty) Ltd Kempton Park, Gauteng
Clinstile S.A. de C.V. Col Roma Norte, Mexico City
Clínica Privada Velez Sarsfield Córdoba,
Colorado Heart and Vascular PC Golden, Colorado
Columbia University Medical Center_New York New York, New York
Complejo Hospitalario Universitario A Coruna A Coruña,
Conquest Research Winter Park, Florida
Consultorio 1020 Hospital Angeles Xalapa Xalapa, Veracruz
Consultorio Dr. Eduardo Chuquiure Tlalpan, Mexico City
Consultorio Privado Dr Gabriel Arturo Ramos Guadalajara, Jalisco
Consultorio Privado Dr. Francisco Padilla Guadalajara, Jalisco
Corcare Cardiovascular Research Scarborough Village, Ontario
Core Research Group Brisbane,
Corewell Health Grand Rapids, Michigan
Craigavon Area Hospital - Cardiovascular Research Unit Craigavon,
Crescent Hospital And Heart Centre Nagpur, Maharashtra
Curnew Medicine Professional Corporation Hamilton, Ontario
DAI Scienze Mediche - UOC Medicina Interna Angiologia e Malattie Aterosclerotiche Messina, Sicily
DBC Research - Pembroke Pines Pembroke Pines, Florida
DCC 1 - Lom EOOD Lom,
DCC Aleksandrovska EOOD Sofia,
DCC Convex EOOD Sofia,
Dallas Heart and Vascular Duncanville, Texas
David Turbay, MD, PLLC El Paso, Texas
Dayanand Medical College & Hospital Ludhiana, Punjab
Deenanath Mangeshkar Hospital & Research Centre Pune,
Derriford Hospital Plymouth,
Desert Oasis Healthcare Palm Springs, California
Diabetes Heart Research Centre Toronto, Ontario
Diakonessenhuis Utrecht - Cardiologie Utrecht,
Diex Recherche Sherbrooke Sherbrooke, Quebec
Diex Recherche Trois-Rivieres Trois-Rivières, Quebec
Dokuz Eylül Üniversitesi Araştırma Uygulama Hastanesi-Kardiyoloji Izmir,
Dorset County Hospital Dorchester, Dorset
Doylestown Heath cardiology Doylestown, Pennsylvania
Dr A Jacovides and Partners Inc Midrand, Gauteng
Dr Hendrik Snyman's Practice Mossel Bay, Western Cape
Dr IO Ebrahim Inc Pretoria, Gauteng
Dr MT Makhomisane Inc Polokwane,
Dr Pillay's Rooms Durban, KwaZulu-Natal
Dr. Siyami Ersek Göğüs Kalp ve Damar Cerrahisi EAH- Kardiyoloji Istanbul,
Duke University Durham, North Carolina
EKAMED sp. z o.o. Lublin, Lublin Voivodeship
Eagle Clinical Research Chicago, Illinois
East Atlanta Cardiology Conyers, Georgia
East Rand Physicians Clinical Research Division (Pty) Ltd Benoni, Gauteng
East Texas Cardiology PA Houston, Texas
Eastbourne Distirct General Hospital - Cardiology Eastbourne,
Eastern Shore Rsrch Inst, LLC Fairhope, Alabama
Edumed s.r.o. Náchod,
Edumed s.r.o. Náchod,
Elkerliek Ziekenhuis - Cardiologie Helmond,
Empire Clin. Research Pomona, California
Endolife Specialty Hospitals Guntur, Andhra Pradesh
Erciyes Üniversitesi Hastanesi- Kardiyoloji Kayseri,
Eskişehir Osmangazi Üniversitesi Hastanesi- Kardiyoloji Eskişehir,
Eskişehir Şehir Hastanesi- Kardiyoloji Eskişehir,
Eurolatino Medical Research Center Uberlândia, Minas Gerais
FOMAT Medical Research Oxnard, California
Facharztzentrum Dresden Betriebsgesellschaft mbH Dresden,
Fakultni nemocnice Brno Brno,
Fakultni nemocnice Olomouc Olomouc,
Fakultni nemocnice u sv. Anny v Brne Brno,
Flinders Medical Centre - Cardiology Department Bedford Park, South Australia
Flourish Research Bowie Bowie, Maryland
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Dipartimento di Scienze Cardiovascolari Rome, Lazio
Forschungszentrum Ruhr KliFoCenter GmbH, Kahrmann Witten,
Fortis Hospital, Mohali Mohali,
Fortis Memorial Research Institute _Gurgaon Gurugram, Haryana
Franciscus Gasthuis en Vlietland - Cardiologie Rotterdam,
Frederiksberg Hospital - Hjertemedicinsk afdeling Y Frederiksberg,
Fukuoka Wajiro Hospital_Cardiology Fukuoka-shi, Fukuoka,
Fukuokaken Saiseikai Futsukaichi Hospital_Cardiovascular Medicine Chikushino-shi, Fukuoka,
Fundacion Respirar Buenos Aires,
Fundação Faculdade Regional de Medicina de São José do Rio Preto São José do Rio Preto,
Future Life Clinical Trials Miami, Florida
Futuremeds Sp. z o.o. Olsztyn,
Fırat Üniversitesi Hastanesi- Kardiyoloji Merkez/elaziğ,
G B Pant Institute of Postgraduate Medical Education and Research New Delhi, National Capital Territory of Delhi
G&J Research San Diego, California
G.A. Research Associates Ltd. Moncton, New Brunswick
Gachon University Gil Medical Center_Cardiology Incheon,
Galaxy Life Care Services Pvt. Ltd Varanasi, Uttar Pradesh
Gangnam Severance Hospital_Cardiology Seoul,
Gelderse Vallei - Cardiologie Ede,
Gemeinschaftspraxis Faghih-Friedrichs-Zühlke Essen,
Gemeinschaftspraxis Melcherstätte - Dr. L. Pohlmeier, T. Drescher Stuhr,
General Hospital Venizeleio-Pananeio - Cardiology department Heraklion,
General Hospital of Athens "Elpis" - Cardiology Department Ampelokipoi/Athens,
General Hospital of Athens "Laiko" Athens, Attikí
General Hospital of Chalkida - Cardiology department Chalcis,
General Hospital of Chios "Skilitsio" - Cardiology Clinic Chios,
General Hospital of Kalamata - Cardiology Department Kalamata,
General Hospital of Thessaloniki "G.Papanikolaou" Thessaloniki,
George Eliot Hospital Nuneaton, Warwickshire
Gesundheitscentrum Mainz (Regner / Schmitt) Mainz,
Glan Clwyd Hospital - North Wales Cardiac Centre Rhyl, Denbighshire
Glenfield Hospital - Cardiovascular Research Leicester,
Glenny Corp. S.A CABA,
Government Siddhartha Medical College & Government General Hospital, Vijayawada Vijayawada, Andhra Pradesh
Grace Research, LLC Bossier City, Louisiana
Grace Research, LLC_Shreveport Shreveport, Louisiana
Groene Hart Zkh Gouda - Cardiologie Gouda,
Guangdong Provincial People's Hospital-Cardiovascular Guangzhou, Guangdong
Guardian Research Org LLC Winter Park, Florida
Gunma University Hospital_Cardiovascular Medicine Maebashi-shi, Gunma,
Gyncentrum Sp. z o. o. Katowice,
Gülhane Eğitim ve Araştırma Hastanesi- Kardiyoloji Keçiören/Ankara,
H Virgen del Camino_Sanlúcar_Medicina Interna Sanlúcar de Barrameda,
H. Fundación Alcorcón_Cardiología Alcorcón,
H.Sant Joan Despí_Dto. Cardiología Sant Joan Despí, Catalonia
HCL-HOPITAL LYON SUD_Service d'Endocrinologie-Diabète-Nutrition Pierre-Bénite,
Hadassah Ein Karam MC - Cardio Department Jerusalem,
Haemek MC - Research Unit of Internal Medicine C Afula,
Hallym University Sacred Heart Hospital_Cardiology Anyang-si, Gyeonggi-do
Halton Healthcare Oakville, Ontario
Hanyang university seoul hospital_Cardiology Seoul,
Hawthorne Health Diamondhead, Mississippi
Hawthorne Health NC Concord, North Carolina
Hayama Heart Center_Cardiology Miura-gun, Kanagawa,
Healthworld hospitals Durgapur, West Bengal
Heart House - Sewell Sewell, New Jersey
Heart House - Vineland Elmer, New Jersey
Heart of Australia Chelmer, Queensland
Helderberg Research Institute Cape Town, Western Cape
Henry Ford Health System Detroit, Michigan
Herlev Hospital - Afdeling for Hjertesygdomme, Forskning 1 Herlev, Capital Region
Herz- und Diabeteszentrum NRW - Bad Oeynhausen Bad Oeynhausen,
Herz-Kreislauf-Zentrum Klinikum Hersfeld-Rotenburg GmbH - Zentrum für Klinische Forschung Rotenburg A. D. Fulda,
Herz-Lungen-Zentrum Weyhe-Leeste Weyhe,
Higashi Takarazuka Satoh Hospital_Cardiology Hyōgo,
Higashiosaka City Medical Center_Cardiovascular Medicine Higashiosaka-shi, Osaka,
High Desert Heart and Vascular PLLC Meridian, Idaho
Hillel Yaffe MC - Cardiology Department Hadera,
Holbæk Sygehus - Forskningsenheden, Medicinsk Afdeling, afs. 44-4 Holbæk,
Honor Health Phoenix, Arizona
Hope Clin Res & Wellness Conyers, Georgia
Hope Research Network Virginia Gardens, Florida
Horizon Research Group of Opelousas, LLC Eunice, Louisiana
Hosp. Comarcal de Antequera_Medicina Interna Antequera,
Hosp. U Gran Canaria Dr. Negrín_Cardiologia Las Palmas de Gran Canaria,
Hosp. Univ. de Jaén_Cardiología Jaén,
Hosp. Virgen de las Montañas_Medicina Interna Villamartín,
Hospital 12 de Octubre Madrid,
Hospital Alemão Oswaldo Cruz São Paulo,
Hospital Canselor Tuanku Muhriz UKM Cheras, Kuala Lumpur
Hospital Clinico Universitario de Valencia Valencia,
Hospital De La Santa Creu I Sant Pau Barcelona, Catalunya [cataluña]
Hospital Espanol De Mendoza Mendoza,
Hospital General de Mexico (HGM) Cuauhtémoc, Mexico City
Hospital Germans Trias I Pujol Badalona, Barcelona [barcelona]
Hospital Kuala Lumpur Kuala Lumpur,
Hospital Miri Miri, Sarawak
Hospital Pakar Sultanah Fatimah Muar town, Johor
Hospital Ramón.y Cajal_Med. Interna Madrid,
Hospital Serdang Kajang,
Hospital Sultanah Aminah Johor Bahru, Johor
Hospital Sultanah Bahiyah Alor Setar, Kedah,
Hospital Taiping Taiping, Perak
Hospital Tengku Ampuan Afzan Kuantan, Pahang
Hospital Tuanku Fauziah Kangar, Perlis,
Hospital Univ. La Luz_Cardiología Madrid,
Hospital Univ. Virgen de la Arrixaca El Palmar,
Hospital Univ. de Gerona Doctor Josep Trueta Girona,
Hospital Universitario Austral - Instituto de Cardiologia Pilar, Buenos Aires
Hospital Universitario Dr. José Eleuterio González_Monterrey Monterrey, Nuevo León
Hospital Universitario La Paz Madrid,
Hospital Universitario Lucus Augusti Lugo,
Hospital Universitario Puerta de Hierro Majadahonda Madrid,
Hospital Universitario Virgen de Valme Seville,
Hospital Universitario Virgen de las Nieves Granada,
Hospital Universitario Virgen del Rocio Seville,
Hospital Universitario y Politécnico La Fe Valencia,
Hospital Universiti Sains Malaysia Kota Bharu,
Hospital Vall d'Hebron Barcelona,
Hospital Zambrano Hellion TecSalud Monterrey, Nuevo León
Hospital de Basurto Bilbao,
Hospital de Clínicas da Universidade Federal de Goiânia Goiânia/GO,
Hospital de Clínicas de Porto Alegre Porto AlegreRS,
Hospital de Manises Manises,
Hvidovre Hospital Hjertemedicinsk Hvidovre,
Hyogo Prefectural HarimaHimeji General Medical Center_Cardiology Himeji-shi, Hyogo,
IAPES Pesquisa Clínica - Rede AME Saúde Recife, Pernambuco
ICM - Instituto do Coração de Marília Marília/SP,
ICOT Istituto Marco Pasquali - UOC Cardiologia Latina, Lazio
IMA Research Mount Airy, North Carolina
INECO Neurociencias Oroño Rosario,
IRCCS Humanitas - UOC Cardiologia Rozzano, Milano
IRCCS Ospedale Policlinico San Martino - U.O. Clinica di Malattie dell'Apparato Cardiovascolare e UTIC Genoa, Liguria
IRCCS Policlinico San Matteo - S.C. Cardiologia Pavia, Lombardy
IRCCS San Raffaele - Dipartimento area Cardiorespiratoria Rome, Lazio
IUCPQ - Universite Laval Québec,
Iaso Thessalia General Clinic Private Obstetrics S.A. - Cardiology Clinic Larissa,
Iatros International Bloemfontein,
Ind. Prak. Lek. w dziedz. Kardiologii lek. med. K. Cymerman Gdynia, Pomeranian Voivodeship
Indiana University Health Methodist Hospital Indianapolis, Indiana
Infinite Clinical Research Miami, Florida
Inha University Hospital_Cardiology Incheon,
Innera s.r.o. Benešov,
InnoMed Clinical Trial Centre Cape Town, Western Cape
Inpatient Research Clinic LLC Miami Lakes, Florida
Inpatient Research Clinic LLC Miami Lakes, Florida
Institut klinicke a experimentalni mediciny Prague,
Instituto Cardiovascular de León S.C. León, Guanajuato
Instituto Dante Pazzanese de Cardiologia São Paulo, São Paulo
Instituto Especialidades de la Salud Rosario Rosario, Santa Fe Province
Instituto Medico Quirurgico San Rafael A Coruña,
Instituto de Investigaciones Clinicas San Nicolas San Nicolás,
Instituto de Investigaciones Clínicas Córdoba Córdoba,
Instituto de Investigaciones Clínicas Rosario Rosario,
Instituto de Investigaciones de Patologías Respiratorias San Miguel de Tucumán,
Instituto de Moléstias Cardiovasculares de Tatuí Ltda Tatuí, São Paulo
Instituto de Pesquisa Clinica de Campinas Campinas, São Paulo
Instituto do Coração - HCFMUSP São Paulo, São Paulo
Intercard Spolka z ograniczona odpowiedzialnoscia Krosno,
Intercoastal Medical Group Sarasota, Florida
Intermountain Heart & Vascular Denver, Colorado
Intermountain Medical Center Murray, Utah
Internal Medicine Clin Trials Monterrey, Nuevo León
Interventional Cardiology Medical Group West Hills, California
InvivoCure Van Nuys, California
InvivoCure -2 Denver, Colorado
Iwate Prefectural Central Hospital_Cardiology Morioka-shi, Iwate,
JA Shizuoka Kohseiren Enshu Hospital_Internal Medicine Hamamatsu-shi, Shizuoka,
JPJ Research Northridge, California
JSS Hospital, Mysore Mysuru, Karnataka
Jacksonville Ctr for Clin Res Jacksonville, Florida
Jantar Sp. z o.o. Ostrów Wielkopolski,
Japanese Red Cross Wakayama Medical Center_Department of Cardiology Wakayama-shi, Wakayama,
Javara Inc. / Privia Medical Group Gulf Coast PLLC Conroe, Texas
Jawaharlal Nehru Medical College and Hospital Aligarh, Uttar Pradesh
Jeroen Bosch Zkh 's-Hertogenbosch,
Jersey City Medical Center Jersey City, New Jersey
Jinan Central Hospital-Cardiovascular Jinan, Shandong
Jmf Clínica Do Coração Ltda Aracaju,
Joe C.Wen & Fam CTR for Adv Care Irvine, California
John Muir Physicians Network Concord, California
Jongaie Research Pretoria West, Gauteng
K&R Research Llc Marion, Ohio
K2 Medical Research Orlando, Florida
KARDIA - Dr. Hashemi Berlin,
KG Hospital and PG Medical Institute & Research Centre Coimbatore, Tamil Nadu
KLES Dr. Prabhakar Kore Hospital & Medical Research Centre Belagavi, Karnataka
Kagawa Prefectural Central Hospital_Cardiovascular Medicine Takamatsu-shi, Kagawa,
Kaiser Permanente Northern California San Francisco, California
Kaohsiung Medical University Chung-Ho Memorial Hospital_Dept of Internal medicine Kaohsiung City,
Kardio Elbl s.r.o. Brno - Sever,
Kardio Life - Tomasz Borkowski Włocławek, Kuyavian-Pomeranian Voivodeship
Kardiologicka ambulance Brno s.r.o. Brno,
Kardiologie - Ústí nad Labem s.r.o. Ústí nad Labem,
Kardiologie MUDr. Libor Nechvátal s.r.o. Brno,
Kardiologie a Angiologie Praha s.r.o. Prague,
Kardiologie im Spreebogen Berlin,
Kardiologische Gemeinschaftspraxis Papenburg Papenburg,
Kardiologische Praxis Ludwigshafen Ludwigshafen am Rhein,
Kardiopraxis Schirmer Kaiserslautern,
Karnataka Medical College and Research Institute Hubbali, Karnataka
Kasugai Municipal Hospital_Cardiovascular Medicine Kasugai-shi, Aichi,
Kath. Hospitalvereinigung Thüringen gGmbH - KKH St. Johann Nepomuk - Innere Med. II Erfurt,
Kath. Klinikum Bochum gGmbH - St. Josef-Hospital Kardiologie Bochum,
Kawartha Cardiology Clinical Trials Peterborough, Ontario
Kayseri Şehir Hastanesi-Kardiyoloji Kayseri,
Keimyung University Dongsan Hospital_Cardiology Daegu,
King George's Medical University (KGMU) Lucknow, Uttar Pradesh
King's College Hospital - Cardiology London,
Klinika Dr. Pírka s.r.o. Mladá Boleslav,
Kliniken Südostbayern AG - Klinikum Traunstein Traunstein,
Kocaeli Üniversitesi Hastanesi- Kardiyoloji Kocaeli,
Konstantopouleio G.H. of Athens, "Agia Olga" Athens,
Korea University Anam Hospital_Cardiology Seoul,
Korea University Guro Hospital_Cardiology Seoul,
Krishna Vishwa Vidyapeeth Karad, Maharashtra
Kütahya Şehir Hastanesi-Kardiyoloji Kütahya,
LES HOPITAUX DE CHARTRES_HOPITAL LOUIS PASTEUR_Service de Cardiologie Le Coudray,
Laurelton Heart Specialist PC Rosedale, New York
Life Care Hospital and Research Centre Bangalore, Karnataka
Life Clinical Research Ipswich, Queensland
Lincoln County Hospital Lincoln,
Lindner Center,Christ Hospital Cincinnati, Ohio
Lisie Hospital Kochi, Kerala
Lister Hospital Stevenage,
Louis Stokes Clvlnd VA Med Ctr Cleveland, Ohio
Lps Institute of Cardiology, Gsvm Medical College Kanpur, Uttar Pradesh
Lyell McEwin Hospital - Clinical Trials Unit Elizabeth Vale, South Australia
MBAL Trakia EOOD Stara Zagora,
MC Diamedical - 2013 OOD, Dimitrovgrad Dimitrovgrad,
MC Diamedical - 2013 OOD, Sofia Sofia,
MC Hera EOOD - Sofia Sofia,
MC Nevromedics EOOD, Cardiology Veliko Tarnovo,
MEDICUS SERVICES s.r.o. Brandýs nad Labem,
MHAT - City Clinic - Sveti Georgi EOOD Montana,
MHAT - Dobrich AD, Cardiology Dobrich,
MHAT - Ivan Skenderov EOOD Gotse Delchev,
MHAT Heart and Brain EAD - Burgas, Cardiology Burgas,
MHAT Heart and Brain EAD - Pleven, Cardiology Pleven,
MHAT Sveta Sofia EOOD Sofia,
MIT Medicina, Investigación y tratamiento Santa Rosa, La Pampa,
MVZ CCB Frankfurt Und Main-Taunus GbR Frankfurt,
MVZ im Altstadt-Carree Fulda GmbH - Zentrum für klinische Studien Fulda,
Maasstad Ziekenhuis - Cardiologie Rotterdam,
Main Heart Clinic Houston, Texas
MaineHealth Cardiology - Biddeford Biddeford, Maine
Malla Reddy Narayana Multispeciality Hospital Hyderabad, Telangana
Marienhaus Klinikum Mainz GmbH - Innere Medizin I Mainz,
Marmara Üniversitesi Pendik EAH- Kardiyoloji Istanbul,
Marshfield Clinic Marshfield, Wisconsin
Maxima MC Veldhoven - Cardiologie Veldhoven,
Med Trust Research, Inc. Courtice, Ontario
Med. Uni. of SC Ashley River T Charleston, South Carolina
Medanta - The Medicity Multi-Speciality Hospital, Gurugram Gurugram, Haryana
Medical Care and Research S. A de C.V Mérida, Yucatán
Medical Center Cardiohelp EOOD, Cardiology Consulting room Sofia,
Medical Center Medconsult Pleven OOD Pleven,
Medical Center Medica Plus Ltd. Veliko Tarnovo,
Medical Center Nov Rehabilitatsionen center EOOD Stara Zagora,
Medical center ISUL - Tsaritsa Yoanna EOOD Sofia,
Medical center Kalimat EOOD Sofia,
Medical center Medconsult Burgas OOD Burgas,
Medical centre Zdrave 1 OOD Kozloduy,
Meditrial Clinical Research Centre Pietermaritzburg, KwaZulu-Natal
Medizentrum Essen-Borbeck Essen,
Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR Berlin,
Medon Clinical Research Sp. z o.o. Warsaw,
Medrasa Clinical Research Wylie, Texas
Mehmet Akif Ersoy Göğüs Kalp ve Damar Cerrahisi EAH Istanbul,
Mercy Gilbert Medical Center Gilbert, Arizona
Mercy Medical Center, GI Research Baltimore, Maryland
Mersin Üniversitesi Hastanesi- Kardiyoloji Mersin,
Metabolica Sp. z o.o. Tarnów,
Metropolitan General Hospital Healthcare Facilities Operation And Management Single Member S.A. - Cardiology Clinic Athens,
Michal Tomaszewski Indywidualna Praktyka Lekarska Lublin,
Midwest Cardiovascu Rsrch Foundation Elkhart, Indiana
Mission Cardiovascular Research Institute Fremont, California
Mita Clinic of Internal Medicine and Cardiology_Cardiology Sapporo-shi, Hokkaido,
Mobile Heart USA Health Cardiology Clinic Mobile, Alabama
Mohak Bariatrics and Robotics Indore, Madhya Pradesh
Monument Health Clinical Rsrch Rapid City, South Dakota
Mount Sinai Hosp at NYC New York, New York
Musgrove Park Hospital - Cardiology Taunton,
NIPPON MEDICAL SCHOOL HOSPITAL_Cardiovascular medicine Bunkyo-ku, Tokyo,
NSC Research, Inc Johns Creek, Georgia
NYU Langone Med Assoc Chelsea New York, New York
NYU Langone Orthopedic Center New York, New York
NZOZ "Twoje Zdrowie EL" Sp. z o.o. Elblag,
NZOZ SALUSMED Jan Zbigniew Peruga PPHU SALUS Lodz,
Nagasaki Harbor Medical Center_Cardiovascular medicine Nagasaki,
Nanjing Jiangning Hospital-Cardiovascular Nanjing, Jiangsu
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy Warsaw,
National Center for Global Health and Medicine_Cardiology Shinjuku-ku, Tokyo,
National Heart Institute Beverly Hills, California
National Heart Institute,India New Delhi,
National Hospital Organization Chiba Medical Center_Cardiovascular Medicine Chiba-shi,Chiba,
National Hospital Organization Kyoto Medical Center_Cardiology Kyoto-shi, Kyoto,
National Hospital Organization Mito Medical Center_Cardiovascular medicine Ibaraki,
Nature Coast Clinical Research Crystal River, Florida
Nemocnice Jihlava, p.o. Jihlava,
Niels-Stensen-Kliniken Marienhospital Osnabrück - Klinik für Innere Medizin, Kardiologie und Intensivmedizin Osnabrück,
Nightingale Research Adelaide, South Australia
Nightingale Research Victoria Frankston, Victoria
Ninewells Hospital Dundee,
Nkpsims & Rc , Lata Mangeshkar Hospital , Hingna Nagpur, Maharashtra
Norfolk and Norwich University Hospital - Clinical Research Facility Norwich, Norfolk
North Texas Research Associates McKinney, Texas
North Tyneside General Hospital North Shields,
North York Diagn & Cardiac Ctr North York, Ontario
NorthBay Clinical Research Santa Rosa, California
Northeast Georgia Medical Ctr Gainesville, Georgia
Northwick Park Hospital - Cardiac Research Dept Harrow,
Nova Scotia Health Halifax, Nova Scotia
OCIPSMCC - Dr. Aleksandar Nosikov Sofia,
Oaxaca Site Management Organization (OSMO) Oaxaca City, Oaxaca
Ocala Cardiovascular Research Ocala, Florida
Ordu Üniversitesi Eğitim ve Araştırma Hastanesi- Kardiyoloji Altınordu/Ordu,
Oregon Health & Science University Portland, Oregon
Ormond Beach Clinical Research Ormond Beach, Florida
Osaka General Medical Center_Cardiology Osaka,
Osaka Metropolitan University Hospital_Cardiovascular Medicine Osaka-Shi, Osaka,
Osmania General Hospital Hyderabad, Telangana
Ospedale Bellaria Carlo Alberto Pizzardi - UO Cardiologia e Unità coronarica Bologna, Emilia-Romagna
Ospedale Ca' Foncello - U.O.C. Medicina Generale 1 Treviso, Veneto
Ospedale Cremona - U.O. Cardiologia Cremona, Lombardy
Ospedale Misericordia Grosseto - UOC Cardiologia Grosseto, Tuscany
Ospedale S. Maria della Misericordia - Clinica Medica Udine Udine, Friuli Venezia Giulia
Ospedale SS. Annunziata di Chieti - U.O. Clinica medica Medicina generale 1 Chieti, Abruzzo
Ospedale San Raffaele S.r.l. - Unità Clinica Anestesia, Rianimazione e Terapia Intensiva Cardio-Toraco-Vascolare Milan, Lombardy
Ospedale Santissima Annunziata - Dipartimento Cardio Toraco Vascolare Cosenza, Calabria
Ospedale di Bentivoglio - UOC Cardiologia Bentivoglio, Emilia-Romagna
Osrodek Badan Klinicznych LabMed Sp. z o.o. Szczecin, West Pomeranian Voivodeship
Ota Memorial Hospital_Cardiology Ota-shi, Gunma,
PHC Accelacare Statesville, North Carolina
PUCCAMP - Hospital e Maternidade Celso Pierro Campinas, São Paulo
Pacific Clinical Studies Los Alamitos, California
Palm Research Center Inc-Vegas Las Vegas, Nevada
Panamerican Clinical Research Mexico S. A de C.V Querétaro City, Querétaro
Peachtree Cardiology Peachtree, Georgia
Peak Clinical Trials Apex, North Carolina
Penn Med. Lancaster Gen Hospital Lancaster, Pennsylvania
Penn State Hlth Holy Spirit Med Ctr Camp Hill, Pennsylvania
PharmaTex Research, LLC Amarillo, Texas
Physicians East Endocrinology Greenville, North Carolina
Piedmont Research Partners, LLC Fort Mill, South Carolina
Pinderfields Hospital - Clinical Research & Innovation Wakefield,
Pol. Uni. Campus Biomedico - UOC Cardiologia Rome, Lazio
Policlinico San Donato di Milano S.p.A - UO Cardiologia Universitaria Perioperatoria e Riabilitativa San Donato Milanese, Lombardy
Policum Berlin Studien GmbH - Friedenau Berlin,
Pratia Prague, s.r.o Prague,
Praxis Dr. med. Jens Taggeselle Markkleeberg,
Praxis Joachim Heisters Kamp-Lintfort,
Praxis für Innere Medizin, Kardiologie, Pneumologie - Köln Cologne,
Princess of Wales Hospital Bridgend,
Pro Familia Altera Sp. z o.o. Katowice, Silesian Voivodeship
Proactive El Paso LLC El Paso, Texas
Providence Health Partners Ctr Dayton, Ohio
Prywatna Praktyka Lekarska Anna Chudoba Żyrardów,
Pusan National University Yangsan Hospital_Cardiology Yangsan, Gyeongsangnam-do
Raigmore Hospital Inverness,
Rambam MC - Heart Failure Unit Haifa,
Regionshospital Nordjylland, Hjørring - Afdelingen for hjerte- og hormonsygdomme Hjørring,
Renal Disease Research Institute Dallas, Texas
Research Integrity Global, LLC Owensboro, Kentucky
Rhythm Heart Institute Vadodara, Gujarat
Rigshospitalet - Kardiologisk Forskningsenhed København Ø,
Robert-Bosch-Krankenhaus Stuttgart - Behandlungsexzellenz Bosch Health Campus Stuttgart,
Rode Kruis Zkh Beverwijk - Cardiologie Beverwijk,
Royal Cornwall Hospital (Treliske) Truro, Cornwall
Royal Hobart Hospital - Cardiology Department Hobart, Tasmania
Royal Victoria Infirmary Newcastle upon Tyne,
Ruppiner Kliniken - Universitätsklinikum Ruppin-Brandenburg Neuruppin,
SAKAKIBARA HEART INSTITUTE_Cardiology Fuchu-shi,Tokyo,
SEC Clinical Research Pensacola, Florida
SHATC - Cardiolife OOD - Varna Varna,
SIYODE S.A. de C.V. Unimeden Ciudad Madero, Tamaulipas
SLK-Klinken Heilbronn - Klinikum am Plattenwald Bad Friedrichshall Bad Friedrichshall,
SMC Heart Institute and IVF Research Centre Raipur, Chhattisgarh
SPIMED, s.r.o. Česká Třebová,
STAT Research Ohio Vandalia, Ohio
Sakarya Eğitim ve Araştırma Hastanesi- Dahiliye Adapazarı/Sakarya,
Samodzielny Publiczny Specjalistyczny Szpital Zachodni Im.Sw.Jana Pawla II Grodzisk Mazowiecki, Masovian Voivodeship
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych i Administracji w Rzeszowie Rzeszów,
Samsun Şehir Hastanesi-Kardiyoloji Canik/Samsun,
Samsung Medical Center_Cardiology Seoul,
San Diego Veterans Affairs San Diego, California
San Francisco V.A. Medical Center San Francisco, California
Sana Kliniken Oberfranken Coburg GmbH - II. Med. Klinik, Kardiologie Coburg,
Sanatorio Esperanza Esperanza, Santa Fe,
Sanjay Gandhi Postgraduate Institute of Medical Sciences Lucknow, Uttar Pradesh
Sarawak General Hospital Kuching,
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH Villingen-Schwenningen,
Scientia Investigación Clínica S. C. Col. Zona Comercial Plaza Del Sol, Chihuahua
Scripps Hospital Chula Vista, California
Scripps Memorial Hospital La Jolla La Jolla, California
Sekino Hospital_Internal Medicine Toshima-ku,Tokyo,
Selma Medical Associates Winchester, Virginia
Sengupta Hospital and Research Institute Nagpur, Maharashtra
Sentara Health Research Center Norfolk, Virginia
Seoul National University Bundang Hospital_Cardiology Seongnam-si, Gyeonggi-do
Seoul National University Hospital_Cardiology Seoul,
Serce Sp. z o.o. Leszno, Greater Poland Voivodeship
Seth GS Medical College & KEM Hospital Mumbai, Maharashtra
Severance Hospital, Yonsei University Health System_Cardiology Seoul,
Shaanxi Provincial People's Hospital-Cardiology Xi'an, Shaanxi
Shamir MC - Cardiology Department Beer Yaakov,
Sherman Clinical Research Sherman, Texas
Shinshu University Hospital__Department of Cardiology Matsumoto-shi, Nagano,
Shri Mahant Indiresh Hospital Dehradun, Uttarakhand
Siping Central People's Hospital-Cardiology Siping, Jilin
Sir Ganga Ram Hospital New Delhi,
Sismanogleio General Hospital - Amalia Fleming Hospital, Cardiology Department Athens,
Slaskie Centrum Chorob Serca w Zabrzu Zabrze, Silesian Voivodeship
Soroka MC - Department of Cardiology Beersheba,
South Texas Clinical Research Corpus Christi, Texas
Southmead Hospital - Cardiology Research Bristol,
Southwest Family Medicine_Dallas Dallas, Texas
Spaarne Gasthuis Haarlem Haarlem,
Specjalistyczny Szpital Im. E. Szczeklika W Tarnowie Tarnów, Lesser Poland Voivodeship
Spedali Civili Brescia - U.O. Medicina Generale 2 Brescia, Lombardy
Sri Ramachandra Medical Centre Chennai, Tamil Nadu
St Bartholomew's Hospital London,
St George's Hospital - Cardiology Tooting, London
St Joseph's Hospital Foundation Tampa, Florida
St Pauls Hospital Vancouver, British Columbia
St. Antonius Zkh Nieuwegein - Cardiologie Nieuwegein,
St. Boniface Hospital Winnipeg, Manitoba
St. Joseph's Heath Centre Toronto, Ontario
St. Joseph's Medical Center Stockton, California
St. Luke's Idaho Cardiology Associates Meridian, Idaho
St. Richard's Hospital_Cardiology Chichester, West Sussex
Sun City Clinical Research Glendale, Arizona
Suncoast Clinical Research, Inc. New Port Richey, Florida
Sunderland Royal Hospital Sunderland,
Svendborg Sygehus - Kardiologisk Svendborg, Region South
Swedish Medical Center_Seattle Seattle, Washington
Sydney Cardiometabolic Centre Liverpool, New South Wales
Sygehus Sønderjylland, Aabenraa - Afdeling for Hjertesygdomme Aabenraa,
Synapta Clinical Research Centre Durban, KwaZulu-Natal
Synergy Biomed Research Institute East London, Eastern Cape
Synvia Laboratorios E Toxicologia Ltda Campinas, São Paulo
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o.o. Krakow,
TPMG Clinical Research Newport News, Virginia
Taipei Mackay Memorial Hospital Taipei,
Taipei Medical University Hospital Taipei,
Tampa Cardiovascular Interventions and Research Tampa, Florida
Texama Medical Center Denison, Texas
Texas Health Heart and Vascular Specialists Dallas, Texas
The Affiliated Hospital of Jining Medical University-Cardiology Jining, Shandong
The Affiliated Hospital of Xuzhou Medical University-Cardiology Xuzhou, Jiangsu
The Catholic University of Korea, Seoul ST. Mary's Hospital_Cardiology Seoul,
The Catholic University of Korea. Uijeongbu St. Mary's Hospital_Cardiology Uijeongbu-si, Gyeonggi-do
The First Affiliated Hospital of Harbin Medical University-Cardiovascular Harbin, Heilongjiang
The First Affiliated Hospital of Jinan University-Cardiovascular Guangzhou, Guangdong
The First Affiliated Hospital of Soochow University-Cardiology Suzhou, Jiangsu
The First Hospital of Hebei Medical University-Cardiovascular Shijiazhuang, Hebei
The First People's Hospital of Changzhou-Cardiology Changzhou, Jiangsu
The GW Medical Faculty Associates Washington D.C., District of Columbia
The Heart House Haddon Heights Haddon Heights, New Jersey
The Jackson Clinic, PA Jackson, Tennessee
The James Cook University Hospital - Cardiology Middlesbrough,
The Medicity Super Speciality Hospital, Udham Singh Nagar, Uttarakhand
The People's Hospital of Liaoning Province-Cardiology Shenyang, Liaoning
The Prince Charles Hospital - Cardiology Clinical Research Centre Chermside, Queensland
The Queen's Medical Center Honolulu, Hawaii
The Research Group of Lexington LLC Lexington, Kentucky
The Royal Oldham Hospital Oldham,
The Third People's Hospital of Hubei Province (Qiaokou Campus)-Cardiology Wuhan, Wuhan
The Valley Hospital Paramus Paramus, New Jersey
Thomas Jefferson University Philadelphia, Pennsylvania
Thoracic General Hospital Of Athens I Sotiria - Cardiology Department Athens,
Tianjin People's Hospital-Cardiology Tianjin, Tianjin Municipality
Tickerdoc Research (Pty) LTD Johannesburg, Gauteng
Tiervlei Trial Centre Cape Town, Western Cape
Tokyo-Eki Center-building Clinic_Internal Medicine Tokyo,
Tomakomai City Hospital_Cardiology Tomakomai-Shi, Hokkaido,
Torbay Hospital Torquay,
Torre De Plaza Las Americas San Juan,
Total Research Group LLC Miami, Florida
Tread Research (Pty)Ltd Cape Town, Western Cape
Trinity Health Michigan Heart Ypsilanti, Michigan
Tsuchiura Kyodo General Hospital_Internal Medicine Ibaraki,
Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o. Szczecin,
U.G.H of Athens "Attikon" Chaidari, Athens,
UCSD NAFLD Research Center La Jolla, California
UMC Groningen - Cardiologie Groningen,
UMC of Southern Nevada Las Vegas, Nevada
UMHAT - Dr. Georgi Stranski EAD Pleven,
UMHAT - EUROHOSPITAL PLOVDIV OOD, Department of Internal Diseases Plovdiv,
UMHAT Aleksandrovska EAD, Clinic of Cardiology Sofia,
UMHAT Sofiamed EAD Sofia,
UMHAT Sveta Marina EAD, Second Clinic of Cardiology Varna,
UMHAT Sveti Georgi EAD, Plovdiv, Clinic of Cardiology Plovdiv,
UMHATEM N.I. Pirogov EAD, Cardiology department Sofia,
UTD SW Medical Center-Dallas Dallas, Texas
Ulster Hospital Belfast,
UniCardia & UniMedica & UniEstetica Krakow,
Uniklinik Aachen - Med. Klinik I Aachen,
Uniklinik Schleswig-Holstein - Med. Klinik III Kardiologie und Internist. Intensivmedizin Kiel,
Uniklinik TU Dresden - Herzzentrum Dresden GmbH Dresden,
UnityPoint Health-Diabetes Care Center Peoria, Illinois
Univ Gen Hospital Larisa, Cardiology Medicine Clinic Larissa,
Univ of Alabama Birmingham Birmingham, Alabama
Univ of Colorado at Denver Aurora, Colorado
Univ of Mississippi Med Center Jackson, Mississippi
Univer Of Illinois at Chicago Chicago, Illinois
Universidade Municipal de São Caetano do Sul (USCS) São Caetano Do Sul / SP, São Paulo
Universitatsklinikum Würzburg - Zentrum für Herzinsuffizienz Würzburg,
University Hospital Cleveland, Ohio
University Hospital Coventry - Cardiology Research PRI Suite Coventry,
University Hospital Monklands - Cardiology Research Airdrie, Lanarkshire
University Malaya Medical Centre Kuala Lumpur,
University Technology MARA (UiTM) - Sg Buloh Sungai Buloh, Selangor
University of Calgary Calgary, Alberta
University of Iowa Iowa City, Iowa
University of Michigan Ann Arbor, Michigan
University of Rochester Rochester, New York
University of Virginia Hospital Charlottesville, Virginia
Universitätsklinikum Frankfurt aM - Kardiologie Frankfurt am Main,
Universitätsklinikum Freiburg - Medical Center Freiburg im Breisgau,
Universitätsklinikum Münster - Klinik für Kardiologie I Münster,
Uniwersytecki Szpital Kliniczny Nr 2 Uniwersytetu Medycznego w Lodzi Lodz, Łódź Voivodeship
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu Wroclaw,
Uniwersytecki Szpital Kliniczny nr 4 w Lublinie Lublin,
Uniwersytecki Szpital Kliniczny w Bialymstoku Bialystok,
Uniwersyteckie Centrum Medycyny Morskiej i Tropikalnej Gdynia,
UofL Health Care Outpatient Louisville, Kentucky
Uwajima City Hospital_Cardiology Uwajima-shi, Ehime
VA Eastern Colorado Health Care System Aurora, Colorado
VAGrtrLosAngelesHlthcareSystem Los Angeles, California
VMMC & Safdarjung Hospital New Dehli, New Delhi
Valiance Clinical Research Tarzana, California
Valiance Clinical Research Tarzana, California
Valley Clinical Trials Covina, California
Valley Clinical Trials Covina, California
Van Weel-Bethesda Zkh - Cardiologie Dirksland,
Velocity Clinical Research Lincoln Lincoln, Nebraska
Velocity Nova Sp. z o.o. Zamość,
Velocity Nova Sp. z o.o. Zamość,
Viborg Sygehus Viborg,
Victoria Hospital Kirkcaldy,
Victorium Clinical Research Houston, Texas
VieCuri - Cardiologie Venlo,
Vijan Hospital & Research Centre Nashik, Maharashtra
Virginia Commonwealth University Richmond, Virginia
WMF's Villoo Poonawalla Memorial Hospital Pune,
WVU Medicine Morgantown, West Virginia
WakeMed_Cardiology Raleigh, North Carolina
Washington University St Louis, Missouri
West Houston Area Clinical Trial Consultants Wichita, Kansas
West Middlesex University Hospital Isleworth, Middlesex
Westchester Medical Center Valhalla, New York
Westside Medical Associates Los Angeles Beverly Hills, California
Winchester Dist Memorial Hosp Winchester, Ontario
Wits Bara Clinical Trial Site Johannesburg, Gauteng
Wits Clinical Research Johannesburg, Gauteng
Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu Przemyśl,
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika Lodz,
Women's College Hospital Toronto, Ontario
Wonju Severance Christian Hospital_Cardiology Wŏnju, Gangwon-do
Worcestershire Royal Hospital_Cardiology Worcester,
Yamanashi Prefectural Central Hospital_Cardiology Kofu-shi, Yamanashi,
Yokohama City University Hospital_Cardiovascular Medicine Yokohama-shi，Kanagawa,
Yokohama City University Medical Center_Cardiovascular Center Kanagawa,
Zentrum für klinische Studien Südbrandenburg GmbH Elsterwerda,
Zhongshan Hospital, Fudan University-Cardiology Shanghai, Shanghai Municipality
Ziv MC - Cardiology Department Safed,
Zuyderland ziekenhuis - Cardiologie Heerlen,
cardiologicum Hamburg - Studienzentrum Hamburg,
Çanakkale Onsekiz Mart Üniversitesi Sağlık Araştırma ve Uygulama Hastanesi- Kardiyoloji Çanakkale/Türkiye,
İnönü Üniversitesi Turgut Özal Tıp Merkezi - Kardiyoloji Malatya,
İstanbul Üniversitesi-Cerrahpaşa Kardiyoloji Enstitüsü Istanbul,
İzmir Atatürk Eğitim Ve Araştırma Hastanesi- Kardiyoloji Izmir,
İzmir Şehir Hastanesi- Kardiyoloji Bayraklı/İzmir,

A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease (PARAISO)

Contact(s):

Reference Study ID Number: BN44715 https://forpatients.roche.com/ No attachments to email below. - global-roche-genentech-trials@gene.com

Principal Investigator:

System ID: NCT07174310

Show full eligibility criteria

Interventions: DRUG: Prasinezumab, DRUG: Placebo

Conditions: Parkinson's Disease

I'm interested

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Show 174 locations

Study Locations

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Location	Contacts
A.O. Universitaria Pisana Pisa, Tuscany
APHP - Hopital Henri Mondor Créteil,
APHP - Hopital de la Pitie Salpetriere Paris,
Aarhus Universitetshospital Skejby Aarhus N,
Allegheny General Hospital Pittsburgh, Pennsylvania
Asan Medical Center SongpaGu, Seoul Teugbyeolsi
Asheville Neurology Asheville, North Carolina
Avera Medical Group Sioux Falls, South Dakota
Az. Osp. OO.RR. S. Giovanni di Dio e Ruggi D' Aragona Salerno, Campania
Azienda Ospedaliera Spedali Civili Brescia, Lombardy
Baptist Hospital of Miami Miami, Florida
Barrow Neurological Institute Phoenix, Arizona
Beijing Friendship Hospital Affiliated of Capital University of Medical Science Beijing,
Beijing Hospital of Ministry of Health Beijing,
Beijing Tian Tan Hospital,Capital Medical University Beijing,
Bispebjerg Hospital;Neurologisk Afdeling København NV,
Boramae Medical Center Dongjak-gu,
CHU de Clermont-Ferrand - Site Gabriel-Montpied Clermont-Ferrand,
CHU de Grenoble - Hôpital André Michallon La Tronche,
CHU de Limoges - Hopital Dupuytren Limoges,
CHU de Montpellier - Hôpital Gui de Chauliac Montpellier,
CHU de Nice Hopital Pasteur Nice,
CHUM Montreal, Quebec
CNS - Campus Neurológico Torres Vedras,
Campus for Ageing and Vitality Newcastle,
Central Texas Neurology Consultants Round Rock, Texas
Centro Parkinson e Parkinsonismi Milan, Lombardy
Centro de Pesquisas Clinicas São Paulo, São Paulo
Changhua Christian Hospital Changhua,
Charing Cross Hospital London, Greater London
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin Berlin,
Charite Universitätsmed. Berlin Berlin,
Charter Research - Winter Park/Orlando Orlando, Florida
China Medical University Hospital Taichung,
Cleveland Clinic Cleveland, Ohio
Cleveland Clinic Lou Ruvo Las Vegas, Nevada
Complejo Hospitalario Universitario A Coruna A Coruña,
Dent Neurological Institute Amherst, New York
Faculdade de Medicina de Ribeirão Preto - Universidade de Sao Paulo Ribeirão Preto, São Paulo
Faculdade de Medicina de Sao Jose do Rio Preto - FAMERPX São José do Rio Preto, São Paulo
First Affiliated Hospital of Medical College of Xi'an Jiaotong University Xi'an,
Fujian Medical University Union Hospital Fuzhou, Fujian
Georgetown University Washington D.C., District of Columbia
Guangdong Provincial People's Hospital Guangzhou,
Hackensack University Medical Center;Department of Neurology, Neuroscience Institute Paramus, New Jersey
Hawaii Pacific Neuroscience Honolulu, Hawaii
Heinrich-Heine Universitätsklinik Düsseldorf Düsseldorf,
Hospices Civils de Lyon - Hôpital Pierre Wertheimer Bron, Rhône
Hospital Clinic Barcelona Barcelona,
Hospital Dr. Nélio Mendonça;Serviço de Neurologia Funchal,
Hospital General Universitario de Elche Elche, Alicante
Hospital General de Catalunya Sant Cugat del Vallès, Barcelona
Hospital General de Mexico Mexico City, Mexico CITY (federal District)
Hospital Pedro Hispano Matosinhos Municipality,
Hospital Quiron de Madrid Pozuelo de Alarcón, Madrid
Hospital Regional Universitario de Malaga ? Hospital General Málaga,
Hospital Ruber Juan Bravo Madrid,
Hospital Univ 12 de Octubre Madrid,
Hospital Universitari Vall d Hebron Barcelona,
Hospital Universitario Fundacion Alcorcon Alcorcón, Madrid
Hospital Universitario Virgen del Rocio Seville,
Hospital Universitario de La Princesa Madrid,
Hospital da Luz Coimbra Coimbra,
Hospital da Senhora da Oliveira-Guimarães Guimarães,
Hospital das Clinicas - UFMG Belo Horizonte, Minas Gerais
Hospital de Braga Braga,
Hospital de Santa Maria Lisbon,
Huashan Hospital, Fudan University Shanghai, Shanghai Municipality
IRCCS Istituto Neurologico Carlo Besta Milan, Lombardy
IRCCS Ospedale San Raffaele Milan, Lombardy
IRCCS San Raffaele;Clinical Trial Center Rome, Lazio
Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak. Lublin,
Institute for Neurodegenerative Disorders New Haven, Connecticut
Instituto Nacional de Neurologia y Neurocirugia Mexico City, Mexico CITY (federal District)
Instituto de Neurologia de Curitiba Curitiba, Paraná
Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. Sp. k. Oświęcim,
Irccs A.O.U.San Martino Ist Genoa, Liguria
JEM Research LLC Atlantis, Florida
K2 - Villages Lady Lake, Florida
K2 Medical Research-Maitland Maitland, Florida
Keck School of Medicine of USC Los Angeles, California
Kepler Universitätsklinikum GmbH - Neuromed Campus Linz,
Klinik Ottakring Vienna,
Kliniken Beelitz GmbH Beelitz,
Klinikum rechts der Isar der TU Munchen Munich,
Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K Krakow,
L2 Ip Instituto de Pesquisas Clinicas Ltda ME Brasília, Federal District
Massachusetts General Hospital Boston, Massachusetts
Mazowiecki Szpital Bródnowski w Warszawie Sp. z o.o. Warsaw,
Medizinische Hochschule Hannover, Klinik für Neurologie Hanover,
Medizinische Universität Graz Graz,
Medizinische Universität Wien Vienna,
Monash Health Clayton, Victoria
Montreal Neurological Institute and Hospital Montreal, Quebec
NEURO-CARE Sp. z o.o. Sp. Komandytowa Katowice,
NZOZ Vitamed Bydgoszcz,
Nanjing Brain Hospital Nanjing,
National Cheng Kung University Hospital Tainan,
National Taiwan University Hospital Taipei,
NeuroCare Center Canton, Ohio
NeuroProtect Warsaw,
Neurology Center of North Orange County Fullerton, California
Ninewells Hospital, Dundee- Scotland Dundee,
Nmedis sp. z o.o. Rzeszów,
Northwestern University Feinberg School of Medicine Chicago, Illinois
Núcleo de Pesquisa do Rio Grande do Sul Porto Alegre, Rio Grande do Sul
Ospedale Bellaria Bologna, Emilia-Romagna
Oxford University Hospitals NHS Foundation Trust Oxford,
Paracelsus Elena Klinik Kassel Kassel,
Parkinson's Disease and Movement Disorders Center of Boca Raton Boca Raton, Florida
Parkinson's Research Centers of America - Long Island Commack, New York
Parkinson?s Research Centers of America ? Palo Alto Palo Alto, California
Perron Institute for Neurological and Translational Science Nedlands, Western Australia
Plymouth Hospitals NHS Trust - Derriford Hospital Plymouth,Devon,
Podlaskie Centrum Psychogeriatrii Bia?ystok,
Policlinica Guipuzcoa Donostia / San Sebastian, Guipuzcoa
Policlinico Universitario Agostino Gemelli Rome, Lazio
Profound Research LLC at The Neurology Center of Southern California Pasadena, California
QUEST Research Institute Farmington Hills, Michigan
Renown Health Reno, Nevada
Rocky Mountain Movement Disorders Englewood, Colorado
Royal Devon and Exeter Hospital (Wonford) Exeter,
Royal London Hospital London,
Royal Melbourne Hospital Parkville, Victoria
Ruijin Hospital Shanghai Jiaotong University School of Medicine Shanghai,
Samsung Medical Center GangnamGu, Seoul Teugbyeolsi
San Raffaele Cassino Cassino, Lazio
Seoul National University Hospital Seoul, Seoul Teugbyeolsi
Severance Hospital, Yonsei University Health System Seoul,
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University Hangzhou,
Southern Neurology Kogarah, New South Wales
St. Josef-Hospital, Klinik für Neurologie Bochum,
Szpital Sw. Wojciecha Gda?sk,
Taipei Veterans General Hospital Taipei,
Texas Neurology PA Dallas, Texas
The Affiliated Hospital of Xuzhou Medical University Xuzhou, Jiangsu
The Alfred Hospital Melbourne, Victoria
The First Affiliated Hospital of Guangzhou Medical University Guangzhou,
The First Affiliated Hospital of Sun Yat-sen University Guangzhou,
The First Affiliated Hospital, Chongqing Medical University Chongqing,
The Movement Disorder Clinic of Oklahoma Tulsa, Oklahoma
The Second Affiliated Hospital of Soochow University Suzhou,
The Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou,
Tianjin Medical University General Hospital Tianjin,
UC San Diego La Jolla, California
UCLA Neurology Outpatient Clinic Los Angeles, California
UCSF Weill Institute for Neurosciences San Francisco, California
Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck Innsbruck,
Universitaettsklinikum Tübingen Tübingen,
University Health Network Toronto, Ontario
University Pennsylvania Hospital Philadelphia, Pennsylvania
University of Alabama at Birmingham Birmingham, Alabama
University of Kansas Medical Center Kansas City, Kansas
University of New Mexico Albuquerque, New Mexico
University of Vermont Medical Center Burlington, Vermont
University of Virginia Health System Charlottesville, Virginia
Università degli Studi della Campania Luigi Vanvitelli Naples, Campania
Universität Des Saarlandes Homburg,
Universitätsklinikum "Carl Gustav Carus" Dresden,
Universitätsklinikum Erlangen, Abteilung Molekulare Neurologie Erlangen,
Universitätsklinikum Freiburg, Klinik für Neurologie und Neurophysiologie Freiburg im Breisgau,
Universitätsklinikum Heidelberg, Neurologische Klinik, Abteilung für Neuroradiologie Heidelberg,
Universitätsklinikum Münster Münster,
Universitätsklinikum Würzburg, Neurologische Klinik und Poliklinik Würzburg,
VCU Health North Hospital Richmond, Virginia
Vanderbilt University Medical Center Nashville, Tennessee
Veracity Neuroscience Memphis, Tennessee
Washington Uni School of Medicine St Louis, Missouri
Weill Cornell Medical College New York, New York
West China Hospital of Sichuan University Chengdu,
West Virginia University Morgantown, West Virginia
Westmead Hospital Westmead, New South Wales
Xuanwu Hospital, Capital Medical University Beijing,
the First Hospital of Jilin University Changchun, Jilin

Targeted Treatment for Advanced Non-Small Cell Lung Cancer That Has Increased Copies of the MET Gene (An Expanded Lung-MAP Treatment Trial)

Contact(s):

ctrrecruit@vcu.edu

Principal Investigator:

System ID: NCT06116682

Show full eligibility criteria

Inclusion Criteria:

* Participants must have been assigned to S1900J by the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC). Assignment to S1900J is determined by the LUNGMAP protocol * Participants must have documentation of NSCLC with MET amplification determined by FMI tissue-based next generation sequencing (NGS) assay * Participants must have measurable disease documented by CT or MRI. The CT from a combined positron emission tomography (PET)/CT may be used to document measurable disease ONLY if it is of diagnostic quality: otherwise, it may be used to document non-measurable disease only. Measurable disease must be assessed within 28 days prior to sub-study registration. Pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease. Non-measurable disease must be assessed within 42 days prior to sub-study registration. All known sites of disease must be assessed and documented on the Baseline Tumor Assessment Form. Participants whose only measurable disease is within a previous radiation therapy port must demonstrate clearly progressive disease (in the opinion of the treating investigator) prior to sub-study registration to be considered measurable * Participants must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to sub-study registration * Participants with asymptomatic CNS metastasis (brain metastases or leptomeningeal disease) must be clinically stable and asymptomatic for at least 14 days prior to sub-study registration * NOTE: Participants can be on a low-dose corticosteroid treatment (≤ 10 mg prednisone or equivalent) for at least 14 days prior to study treatment * Participants must not have other known actionable oncogenic alterations, such as (but not limited to) EGFR sensitizing mutations, EGFR T790M mutation, MET Exon-14 skipping mutant NSCLC, ALK gene fusion, ROS1 gene rearrangement, RET gene rearrangement, NTRK rearrangement, HER2 mutation, KRAS activating mutations, and BRAF V600E mutation * Participants must have progressed (in the opinion of the treating physician) following the most recent line of therapy * Participants must have received at least one line of systemic treatment for Stage IV or recurrent NSCLC * Participants must have recovered (≤ Grade 1) from any side effects of prior therapy. The exception is if a side effect from a prior treatment is known to be permanent without expected further recovery or resolution (i.e., endocrinopathy from immunotherapy or cisplatin neurotoxicity) * Participants must not have been previously treated for any cancer with MET tyrosine kinase inhibitors (TKIs) such as tepotinib, capmatinib, and crizotinib * Participants must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 21 days prior to sub-study registration * Participants must not have a prior treatment with anti-PD-1 or anti-PD-L1 antibody within 6 weeks of sub-study registration * Participants must not have received any radiation therapy within 14 days prior to sub-study registration * Participants must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment while receiving treatment on this study * Participants must not have had major surgery excluding placement of vascular access or tumor biopsy, or had significant traumatic injury within 28 days prior to sub-study registration, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study * NOTE: Participants with planned surgical procedures to be conducted under local anesthesia may participate * Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen * Absolute neutrophil count ≥ 1.5 x 10\^3/uL (within 28 days prior to sub-study registration) * Hemoglobin \>= 10.0 g/dL (within 28 days prior to sub-study registration) * Platelets ≥ 75 x 10\^3/uL (within 28 days prior to sub-study registration) * Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN (within 28 days prior to sub-study registration) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × institutional ULN. Participants with history of liver metastasis must have AST and ALT ≤ 5 x ULN (within 28 days prior to sub-study registration) * Participants must have a serum creatinine ≤ the institutional upper limit of normal (IULN) or calculated creatinine clearance ≥ 45 mL/min using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to sub-study registration. For creatinine clearance formula see the tools on the CRA Workbench * Participants' most recent Zubrod performance status must be 0-2 and be documented within 28 days prior to sub-study registration * Participants must have a completed medical history and physical exam within 28 days prior to sub-study registration * Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2B or better * Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy and have undetectable viral load test on the most recent test results obtained within 6 months prior to sub-study registration * Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to sub-study registration * Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to sub-study registration * Participants with known diabetes as determined by the treating investigator must show evidence of controlled disease within 14 days prior to sub-study registration * Participants of reproductive potential must have a negative serum pregnancy test within 7 days prior to sub-study registration * Participants must not have other clinically active infectious liver disease * Participants must not have clinically significant hypertension within 28 days prior to sub-study registration as determined by the treating investigator * Participants must not have a history of pneumonitis that required drug therapy or an active symptomatic interstitial lung disease (ILD)/pneumonitis, including drug-induced or radiation ILD/pneumonitis * Participants must not have ongoing or active infection or be diagnosed or suspected viral infection as determined by the treating investigator. NOTE: Participants that have an infection requiring antimicrobial therapy will be required to complete antibiotics 1 week prior to starting treatment * Participants must not have active bleeding diathesis as determined by the treating investigator * Participants must not have impaired oxygenation requiring continuous oxygen supplementation as determined by the treating investigator * Participants must not have psychiatric illness, social situation, or any other circumstances that would limit compliance with study requirements as determined by the treating investigator * Participants must not have any ophthalmologic condition that is unstable in the opinion of the treating investigator * Participants must not be pregnant or breastfeeding (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen * Participants must agree to have blood specimens submitted for circulating tumor DNA (ctDNA) * Participants must also be offered participation in specimen banking. With participant consent, specimens must be collected and submitted via the SWOG Specimen Tracking System * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines * NOTE: Participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations

Interventions: BIOLOGICAL: Amivantamab, PROCEDURE: Biospecimen Collection, PROCEDURE: Computed Tomography, PROCEDURE: Magnetic Resonance Imaging

Conditions: Lung Non-Small Cell Carcinoma

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Show 248 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)
Adams Cancer Center Gettysburg, Pennsylvania
Addison Gilbert Hospital Gloucester, Massachusetts
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 - Aurora Aurora, Illinois	Site Public Contact - (ncorp@aah.org)
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
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)
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)
BJC Outpatient Center at Sunset Hills Sunset Hills, Missouri
Baptist Cancer Center-Grenada Grenada, Mississippi	Site Public Contact - (BCCclintrials@bmhcc.org)
Baptist Memorial Hospital and Cancer Center-Collierville Collierville, Tennessee	Site Public Contact - (BCCclintrials@bmhcc.org)
Baptist Memorial Hospital and Cancer Center-Desoto Southhaven, Mississippi	Site Public Contact - (BCCclintrials@bmhcc.org)
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)
Bayhealth Hospital Kent Campus Dover, Delaware	Site Public Contact - (clinical_trials@bayhealth.org)
Bayhealth Hospital Sussex Campus Milford, Delaware	Site Public Contact - (clinical_trials@bayhealth.org)
Baystate Medical Center Springfield, Massachusetts	Site Public Contact - (tamara.wrenn@baystatehealth.org)
Benefis Sletten Cancer Institute Great Falls, Montana	Site Public Contact - (mccinfo@mtcancer.org)
Beverly Hospital Beverly, Massachusetts
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)
California Pacific Medical Center-Pacific Campus San Francisco, California	Site Public Contact - (clinicalresearch@sutterhealth.org)
Cancer Care Associates of York York, Pennsylvania
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@swog.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)
Community Hospital of Anaconda Anaconda, Montana	Site Public Contact - (mccinfo@mtcancer.org)
Community Medical Center Missoula, Montana	Site Public Contact - (mccinfo@mtcancer.org)
Community Medical Center Missoula, Montana	Site Public Contact - (HemonCCTrials@geisinger.edu)
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 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)
Decatur Memorial Hospital Decatur, Illinois	Site Public Contact - (morganthaler.jodi@mhsil.com)
Duluth Clinic Ashland Ashland, Wisconsin	Site Public Contact - (CancerTrials@EssentiaHealth.org)
Edward Hines Jr VA Hospital Hines, Illinois
Edwards Comprehensive Cancer Center Huntington, West Virginia	Site Public Contact - (Christina.Cole@chhi.org)
Eisenhower Medical Center Rancho Mirage, California
Ephrata Cancer Center Ephrata, Pennsylvania
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)
Geisinger Cancer Center Dickson City Dickson City, Pennsylvania	Site Public Contact - (hemoncctrials@geisinger.edu)
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)
Genesee Hematology Oncology PC Flint, Michigan
Genesys Hurley Cancer Institute Flint, Michigan	Site Public Contact - (wstrong@ghci.org)
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)
HaysMed Hays, Kansas
Henry Ford Cancer Institute-Downriver Brownstown, Michigan	Site Public Contact - (CTOResearch@hfhs.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 Medical Center-Fairlane Dearborn, Michigan	Site Public Contact - (CTOResearch@hfhs.org)
Henry Ford West Bloomfield Hospital West Bloomfield, Michigan	Site Public Contact - (CTOResearch@hfhs.org)
Henry Ford Wyandotte Hospital Wyandotte, Michigan	Site Public Contact - (nhay@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)
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)
Kaiser Permanente Northwest Portland, Oregon	Site Public Contact - (information@kpchr.org)
Kapiolani Medical Center for Women and Children Honolulu, Hawaii
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)
Lawrence Memorial Hospital Lawrence, Kansas	Site Public Contact - (Stephanie.Norris@LMH.ORG)
Logan Health Medical Center Kalispell, Montana	Site Public Contact - (mccinfo@mtcancer.org)
Loma Linda University Medical Center Loma Linda, California
Loyola University Medical Center Maywood, Illinois
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-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
Memorial Hospital North Colorado Springs, Colorado
Memorial Medical Center Modesto, California	Site Public Contact - (clinicalresearch@sutterhealth.org)
Mercy Hospital South St Louis, Missouri	Site Public Contact - (Danielle.Werle@mercy.net)
Mills Health Center San Mateo, California	Site Public Contact - (clinicalresearch@sutterhealth.org)
Missouri Baptist Medical Center St Louis, Missouri
Missouri Baptist Sullivan Hospital Sullivan, Missouri
Munson Medical Center Traverse City, Michigan	Site Public Contact - (crcwm-regulatory@crcwm.org)
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro Jonesboro, Arkansas	Site Public Contact - (Emily.Carvell@bmhcc.org)
New Hampshire Oncology Hematology PA-Concord Concord, New Hampshire
Northeast Georgia Medical Center-Gainesville Gainesville, Georgia	Site Public Contact - (cancerpatient.navigator@nghs.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)
Ohio State University Comprehensive Cancer Center Columbus, Ohio	Site Public Contact - (Jamesline@osumc.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)
Oregon Health and Science University Portland, Oregon	Site Public Contact - (trials@ohsu.edu)
Pali Momi Medical Center ‘Aiea, Hawaii
Palo Alto Medical Foundation Health Care Palo Alto, California
Palo Alto Medical Foundation-Fremont Fremont, California	Site Public Contact - (clinicalresearch@sutterhealth.org)
Palo Alto Medical Foundation-Sunnyvale Sunnyvale, California	Site Public Contact - (clinicalresearch@sutterhealth.org)
Parkland Health Center - Farmington Farmington, Missouri
Poudre Valley Hospital Fort Collins, Colorado
ProMedica Flower Hospital Sylvania, Ohio	Site Public Contact - (PCIOncResearch@promedica.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 Medical Center Honolulu, Hawaii
Ralph H Johnson VA Medical Center Charleston, South Carolina	Site Public Contact - (ashley.salvo@va.gov)
Rocky Mountain Regional VA Medical Center Aurora, Colorado
SSM Health Good Samaritan Mount Vernon, Illinois
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)
Sainte Genevieve County Memorial Hospital Sainte Genevieve, Missouri
Salina Regional Health Center Salina, Kansas	Site Public Contact - (mleepers@srhc.com)
Sechler Family Cancer Center Lebanon, Pennsylvania	Site Public Contact - (doxenberg@wellspan.org)
Smilow Cancer Hospital Care Center - Guilford Guilford, 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-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
Springfield Clinic Springfield, Illinois
Springfield Memorial Hospital Springfield, Illinois	Site Public Contact - (pallante.beth@mhsil.com)
Straub Clinic and Hospital Honolulu, Hawaii
Sutter Auburn Faith Hospital Auburn, California	Site Public Contact - (clinicalresearch@sutterhealth.org)
Sutter Medical Center Sacramento Sacramento, California	Site Public Contact - (clinicalresearch@sutterhealth.org)
Sutter Pacific Medical Foundation Santa Rosa, California	Site Public Contact - (clinicalresearch@sutterhealth.org)
Sutter Roseville Medical Center Roseville, California	Site Public Contact - (clinicalresearch@sutterhealth.org)
Sutter Solano Medical Center/Cancer Center Vallejo, California	Site Public Contact - (clinicalresearch@sutterhealth.org)
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 Queen's Medical Center - West Oahu ‘Ewa Beach, Hawaii	Site Public Contact - (rohta@queens.org)
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 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 San Diego Moores Cancer Center La Jolla, California	Site Public Contact - (cancercto@ucsd.edu)
UCHealth Greeley Hospital Greeley, Colorado	Site Public Contact - (protocols@swog.org)
UCHealth Memorial Hospital Central Colorado Springs, Colorado
UMass Memorial Medical Center - University Campus Worcester, Massachusetts	Site Public Contact - (cancer.research@umassmed.edu)
University Health Truman Medical Center Kansas City, Missouri
University of Arkansas for Medical Sciences Little Rock, Arkansas
University of California Davis Comprehensive Cancer Center Sacramento, California
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 Clinical Research Center Fairway, 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 Kentucky/Markey Cancer Center Lexington, Kentucky
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 Oklahoma Health Sciences Center Oklahoma City, Oklahoma	Site Public Contact - (ou-clinical-trials@ouhsc.edu)
University of Virginia Cancer Center Charlottesville, Virginia	Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu)
VCU Community Memorial Health Center South Hill, Virginia	Site Public Contact - (nemer.elmouallem@vcuhealth.org)
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)
Virginia Cancer Institute Richmond, Virginia	Site Public Contact - (smoore@vacancer.com)
Virtua Samson Cancer Center Moorestown, New Jersey	Site Public Contact - (nctn@pennmedicine.upenn.edu)
Virtua Voorhees Voorhees Township, New Jersey	Site Public Contact - (nctn@pennmedicine.upenn.edu)
WellSpan Health-York Cancer Center York, Pennsylvania
WellSpan Medical Oncology and Hematology Hanover, Pennsylvania
West Michigan Cancer Center Kalamazoo, Michigan	Site Public Contact - (crcwm-regulatory@crcwm.org)
West Virginia University Healthcare Morgantown, West Virginia	Site Public Contact - (cancertrialsinfo@hsc.wvu.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)

Studying the PAGODA Algorithm for Chemotherapy Dose Changes to Prevent Unplanned Treatment Delays

Contact(s):

Lilli Johnson - cancercontrolprotocols@allinancenctn.org

Principal Investigator:

System ID: NCT07283939

Show full eligibility criteria

Inclusion Criteria:

* \* REGISTRATION ELIGIBILITY CRITERIA (STEP 1) * Histologic confirmation of invasive cancer that is confirmed or suspected to arise from the gastrointestinal (GI) tract * Any stage for which FOLFOX-based chemotherapy is a clinically-indicated, standard-of-care treatment (adjuvant, neoadjuvant, or first-line chemotherapy) * Eligible primary tumor sites include the esophagus, gastroesophageal junction, stomach, small intestine, ampulla of Vater, appendix, colon, rectum, and cancers of unknown primary with suspected GI origin * Prior systemic therapy for GI cancer (other than cycle 1 of FOLFOX-based chemotherapy) is not allowed. Prior radiation-sensitizing chemotherapy is permitted * The planned duration of FOLFOX-based chemotherapy must be at least four cycles (1 cycle = 14 days) * Cycle 1, day 1 of FOLFOX-based chemotherapy must be completed 1 to 8 days prior to registration * Cycle 1, day 1 of FOLFOX-based chemotherapy must include minimum ordered doses of oxaliplatin (≥ 65 mg/m\^2) and infusional 5-FU (2400 mg/m\^2/46 hours). Use of the 5-FU bolus is at the discretion of the treating physician * Patients who require primary prophylactic white blood cell growth factor with cycle 1 of FOLFOX chemotherapy due to high risk for fever and neutropenia are not eligible * History of hypersensitivity reaction to oxaliplatin or other platinum-based drugs, to fluorouracil, or to leucovorin, and the excipients in their formulations are not eligible * Age ≥ 18 years * ECOG performance status ≤ 2 * Absolute neutrophil count (ANC) ≥ 1,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Total bilirubin ≤ 3 x upper limit of normal (ULN) * AST (SGOT)/ALT (SGPT) ≤ 5 x upper limit of normal (ULN) * Calc. creatinine clearance ≥ 30 mL/min * Not pregnant and not nursing, because this study involves agents that have known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test done ≤ 30 days prior to registration is required * Patients with treated brain metastases are eligible if follow-up brain imaging after CNS-directed therapy shows no evidence of progression * Patients with known HIV infection are eligible if receiving effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration * Patients with known chronic hepatitis B virus (HBV) infection are eligible if HBV DNA is undetectable when measured within 6 months prior to registration * Patients with a known history of hepatitis C virus (HCV) infection are eligible if HCV RNA is undetectable when measured at least 12 weeks after completion of antiviral therapy * Patients with known history or current symptoms of cardiac disease are eligible if the New York Heart Association Functional Classification is class I or II * Patients with a known history of congenital long QT syndrome are ineligible * Patients with known DPD deficiency are ineligible * \* NON-PATIENT (ONCOLOGY PHYSICIAN OR ONCOLOGY ADVANCED PRACTICE PROVIDER ELIGIBILITY: * The non-patient provider participant is a medical oncologist or oncology advanced practice provider with responsibility for signing and making necessary modifications to chemotherapy orders for a subject assigned to the intervention arm (Arm B). Non-patient participants may not be enrolled more than once over the course of the study * The non-patient participant must be proficient in the English language * The non-patient participant must be age 21 years or older

Interventions: OTHER: PAGODA algorithm, DRUG: Oxaliplatin, DRUG: Folinic Acid, DRUG: Fluorouracil

Conditions: Ampulla of Vater Carcinoma, Appendix Carcinoma, Carcinoma of Unknown Primary With Gastrointestinal Profile, Colon Carcinoma, Esophageal Carcinoma, Gastric Carcinoma, Gastroesophageal Junction Carcinoma, Malignant Digestive System Neoplasm, Rectal Carcinoma, Small Intestinal Carcinoma

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Show 344 locations

Study Locations

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Location	Contacts
Abbott-Northwestern Hospital Minneapolis, Minnesota	Site Public Contact - (mmcorc@healthpartners.com)
Alegent Health Bergan Mercy Medical Center Omaha, Nebraska	Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Alegent Health Immanuel Medical Center Omaha, Nebraska	Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Alegent Health Lakeside Hospital Omaha, Nebraska	Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Ascension All Saints Hospital-Spring Street-Racine Racine, Wisconsin	Site Public Contact - (AWRI.Inquiry@Ascension.org)
Ascension Calumet Hospital-Chilton Chilton, Wisconsin	Site Public Contact - (AWRI.inquiry@ascension.org)
Ascension Columbia Saint Mary's Hospital-Milwaukee Campus Milwaukee, Wisconsin	Site Public Contact - (AWRI.Inquiry@Ascension.org)
Ascension Columbia Saint Mary's Hospital-Ozaukee Campus-Mequon Mequon, Wisconsin	Site Public Contact - (AWRI.Inquiry@Ascension.org)
Ascension Northeast Wisconsin-Mercy Hospital-Oshkosh Oshkosh, Wisconsin	Site Public Contact - (AWRI.inquiry@ascension.org)
Ascension Northeast Wisconsin-Saint Elizabeth Cancer Center-Appleton Appleton, Wisconsin	Site Public Contact - (AWRI.inquiry@ascension.org)
Ascension Saint Francis Hospital-Milwaukee Milwaukee, Wisconsin	Site Public Contact - (AWRI.Inquiry@Ascension.org)
Ascension Southeast Wisconsin Hospital - Franklin Franklin, Wisconsin	Site Public Contact - (AWRI.Inquiry@Ascension.org)
Ascension Southeast Wisconsin Hospital-Elmbrook Campus-Brookfield Brookfield, Wisconsin	Site Public Contact - (AWRI.Inquiry@Ascension.org)
Ascension Southeast Wisconsin Hospital-Mayfair Road-Wauwatosa Wauwatosa, Wisconsin	Site Public Contact - (AWRI.Inquiry@Ascension.org)
Ascension Southeast Wisconsin Hospital-Saint Joseph-Milwaukee Milwaukee, Wisconsin	Site Public Contact - (AWRI.Inquiry@Ascension.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 Cancer Care-Antigo-Volm Cancer Center Antigo, Wisconsin	Site Public Contact - (Juli.Alford@aspirus.org)
Aspirus Cancer Care-Rhinelander-James Beck Cancer Center Rhinelander, Wisconsin	Site Public Contact - (Beth.Knetter@aspirus.org)
Aspirus Cancer Care-Wausau Wausau, Wisconsin
Aspirus Medford Hospital Medford, Wisconsin	Site Public Contact - (Beth.Knetter@aspirus.org)
BJC Outpatient Center at Sunset Hills Sunset Hills, Missouri
Baptist Cancer Center-Grenada Grenada, Mississippi	Site Public Contact - (BCCclintrials@bmhcc.org)
Baptist Memorial Hospital and Cancer Center-Collierville Collierville, Tennessee	Site Public Contact - (BCCclintrials@bmhcc.org)
Baptist Memorial Hospital and Cancer Center-Desoto Southhaven, Mississippi	Site Public Contact - (BCCclintrials@bmhcc.org)
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)
Beacon Kalamazoo Kalamazoo, Michigan
Beacon Kalamazoo Cancer Center Kalamazoo, Michigan
Beebe Health Campus Rehoboth Beach, Delaware	Site Public Contact - (research@beebehealthcare.org)
Beebe Medical Center Lewes, Delaware	Site Public Contact - (research@beebehealthcare.org)
Beebe South Coastal Health Campus Millville, Delaware	Site Public Contact - (research@beebehealthcare.org)
Benefis Helena Specialty Center Helena, Montana	Site Public Contact - (mccinfo@mtcancer.org)
Benefis Sletten Cancer Institute Great Falls, Montana	Site Public Contact - (mccinfo@mtcancer.org)
Bethesda North Hospital Cincinnati, Ohio	Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Billings Clinic Cancer Center Billings, Montana	Site Public Contact - (research@billingsclinic.org)
Billings Clinic-Cody Cody, Wyoming	Site Public Contact - (research@billingsclinic.org)
Bozeman Health Deaconess Hospital Bozeman, Montana	Site Public Contact - (mccinfo@mtcancer.org)
Broadlawns Medical Center Des Moines, Iowa
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)
CARTI Cancer center Little Rock, Arkansas	Site Public Contact - (Research@CARTI.com)
CHI Health Good Samaritan Kearney, Nebraska	Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
CHI Health Saint Francis Grand Island, Nebraska	Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.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 at Saint Joseph's Phoenix, Arizona	Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Cancer Center of Western Wisconsin New Richmond, Wisconsin	Site Public Contact - (mmcorc@healthpartners.com)
Cancer Center-Metro Medical Center Bayamon Bayamón,
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 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)
Central Care Cancer Center - Bolivar Bolivar, Missouri	Site Public Contact - (aroland@kccop.org)
Central Care Cancer Center - Garden City Garden City, Kansas	Site Public Contact - (aroland@kccop.org)
Central Care Cancer Center - Great Bend Great Bend, Kansas	Site Public Contact - (aroland@kccop.org)
Centralia Oncology Clinic Centralia, Illinois	Site Public Contact - (morganthaler.jodi@mhsil.com)
Centro Comprensivo de Cancer de UPR San Juan,	Site Public Contact - (ctsucontact@westat.com)
Chelsea Hospital Chelsea, Michigan	Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
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-Concord Health Center Chadds Ford, Pennsylvania	Site Public Contact - (lbarone@christianacare.org)
Christiana Care Health System-Wilmington Hospital Wilmington, Delaware	Site Public Contact - (lbarone@christianacare.org)
CommonSpirit Cancer Center Mercy Durango, Colorado	Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
CommonSpirit Saint Anthony Hospital Cancer Center Lakewood, Colorado	Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
CommonSpirit Saint Joseph Hospital - Bardstown Bardstown, Kentucky	Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
CommonSpirit Saint Joseph Hospital - Lexington Lexington, Kentucky	Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
CommonSpirit Saint Joseph Hospital London London, Kentucky	Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
CommonSpirit Saint Joseph Hospital Mount Sterling Mount Sterling, Kentucky	Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
CommonSpirit Saint Joseph Medical Center - East Lexington Lexington, Kentucky	Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Commonwealth Cancer Center-Corbin Corbin, Kentucky	Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Community Hospital of Anaconda Anaconda, Montana	Site Public Contact - (mccinfo@mtcancer.org)
Community Medical Center Missoula, Montana	Site Public Contact - (mccinfo@mtcancer.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)
Cox Cancer Center Branson Branson, Missouri
CoxHealth South Hospital Springfield, Missouri
Crossroads Cancer Center Effingham, Illinois	Site Public Contact - (morganthaler.jodi@mhsil.com)
Decatur Memorial Hospital Decatur, Illinois	Site Public Contact - (morganthaler.jodi@mhsil.com)
Doctors Cancer Center Manati,
Duluth Clinic Ashland Ashland, Wisconsin	Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health - Baxter Clinic Baxter, Minnesota
Essentia Health - Deer River Clinic Deer River, Minnesota	Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health - Ely Clinic Ely, Minnesota
Essentia Health - Fosston Fosston, Minnesota	Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health - International Falls Clinic International Falls, Minnesota
Essentia Health - Jamestown Clinic Jamestown, North Dakota	Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health - Moose Lake Clinic Moose Lake, Minnesota
Essentia Health - Park Rapids Park Rapids, Minnesota	Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health - Saint Joseph's Crosslake Clinic Crosslake, Minnesota
Essentia Health - Saint Joseph's Pequot Lakes Clinic Pequot Lakes, Minnesota
Essentia Health - Saint Joseph's Pine River Clinic Pine River, Minnesota
Essentia Health - Saint Joseph's Staples Clinic Staples, Minnesota
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 Saint Joseph's Medical Center Brainerd, Minnesota	Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Saint Mary's - Detroit Lakes Clinic Detroit Lakes, Minnesota	Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Saint Mary's Hospital - Superior Superior, Wisconsin
Essentia Health Saint Mary's Medical Center Duluth, Minnesota	Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Sandstone Sandstone, Minnesota	Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Virginia Clinic Virginia, Minnesota	Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health-Hayward Clinic Hayward, Wisconsin	Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health-Spooner Clinic Spooner, Wisconsin	Site Public Contact - (CancerTrials@EssentiaHealth.org)
FHP Health Center-Guam Tamuning,
Fairbanks Memorial Hospital Fairbanks, Alaska	Site Public Contact - (Veronica.Stevenson@foundationhealth.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)
FirstHealth of the Carolinas-Moore Regional Hospital Pinehurst, North Carolina	Site Public Contact - (jcwilliams@firsthealth.org)
Freeman Health System Joplin, Missouri	Site Public Contact - (LJCrockett@freemanhealth.com)
Genesee Hematology Oncology PC Flint, Michigan	Site Public Contact - (wstrong@ghci.org)
Genesys Hurley Cancer Institute Flint, Michigan	Site Public Contact - (wstrong@ghci.org)
Good Samaritan Hospital - Cincinnati Cincinnati, Ohio	Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Great Falls Clinic Great Falls, Montana	Site Public Contact - (mccinfo@mtcancer.org)
Greater Regional Medical Center Creston, Iowa
Gundersen Lutheran Medical Center La Crosse, Wisconsin	Site Public Contact - (cancerctr@gundersenhealth.org)
HSHS Saint Elizabeth's Hospital O'Fallon, Illinois	Site Public Contact - (morganthaler.jodi@mhsil.com)
Heartland Regional Medical Center Saint Joseph, Missouri	Site Public Contact - (Trisha.England2@mymlc.com)
Helen F Graham Cancer Center Newark, Delaware	Site Public Contact - (lbarone@christianacare.org)
Hematology Oncology Consultants-Clarkston Clarkston, Michigan	Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Hennepin County Medical Center Minneapolis, Minnesota	Site Public Contact - (mmcorc@healthpartners.com)
Henry Ford Health Saint John Hospital Detroit, Michigan	Site Public Contact - (Kkeenan1@hfhs.org)
Henry Ford Health Warren Hospital Warren, Michigan	Site Public Contact - (kforman1@hfhs.org)
Henry Ford Madison Heights Hospital - Breast Warren, Michigan	Site Public Contact - (kforman1@hfhs.org)
Henry Ford River District Hospital East China Township, Michigan	Site Public Contact - (kforman1@hfhs.org)
Henry Ford Saint John Hospital - Academic Grosse Pointe Woods, Michigan	Site Public Contact - (kforman1@hfhs.org)
Henry Ford Saint John Hospital - Breast Grosse Pointe Woods, Michigan	Site Public Contact - (karen.forman@ascension.org)
Henry Ford Saint John Hospital - Macomb Medical Macomb, Michigan	Site Public Contact - (kforman1@hfhs.org)
Henry Ford Saint John Hospital - Van Elslander Grosse Pointe Woods, Michigan	Site Public Contact - (kforman1@hfhs.org)
Henry Ford Warren Hospital - Breast Macomb Macomb, Michigan	Site Public Contact - (kforman1@hfhs.org)
Henry Ford Warren Hospital - GLCMS Warren, Michigan	Site Public Contact - (kforman1@hfhs.org)
Hi-Line Sletten Cancer Center Havre, Montana	Site Public Contact - (protocols@AllianceNCTN.org)
Holy Cross Hospital Fort Lauderdale, Florida	Site Public Contact - (eileen.georgi@holy-cross.com)
Hope Cancer Center Pontiac, Michigan	Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Hurley Medical Center Flint, Michigan	Site Public Contact - (wstrong@ghci.org)
Huron Gastroenterology PC Ypsilanti, Michigan	Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Idaho Urologic Institute-Meridian Meridian, Idaho	Site Public Contact - (stephanie.couch@stjoeshealth.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)
Iowa Methodist Medical Center Des Moines, Iowa
James J Peters VA Medical Center The Bronx, New York	Site Public Contact - (kl2965@cumc.columbia.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)
Lakeview Hospital Stillwater, Minnesota	Site Public Contact - (mmcorc@healthpartners.com)
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)
Lehigh Valley Hospital-Hazleton Hazleton, Pennsylvania	Site Public Contact - (Morgan_M.Horton@lvhn.org)
Logan Health Medical Center Kalispell, Montana	Site Public Contact - (mccinfo@mtcancer.org)
Longmont United Hospital Longmont, Colorado	Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
MaineHealth Cancer Care Center of York County Sanford, Maine
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- Scarborough Scarborough, Maine	Site Public Contact - (clinicalresearch@mainehealth.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 Oncology Hematology Consultants PA Newark, Delaware	Site Public Contact - (lbarone@christianacare.org)
Memorial Hospital of Carbondale Carbondale, Illinois	Site Public Contact - (clinical.research@sih.net)
Memorial Hospital of Laramie County Cheyenne, Wyoming	Site Public Contact - (protocols@AllianceNCTN.org)
Mercy Cancer Center Merced, California	Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Mercy Cancer Center - Cape Girardeau Cape Girardeau, Missouri
Mercy Cancer Center - Carmichael Carmichael, California	Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Mercy Cancer Center - Elk Grove Elk Grove, California	Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Mercy Cancer Center - Rocklin Rocklin, California	Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Mercy Cancer Center - Sacramento Sacramento, California	Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Mercy Cancer Center-West Lakes Clive, Iowa
Mercy Clinic-Rolla-Cancer and Hematology Rolla, Missouri
Mercy Hospital Coon Rapids, Minnesota
Mercy Hospital Coon Rapids, Minnesota	Site Public Contact - (mmcorc@healthpartners.com)
Mercy Hospital Fort Smith Fort Smith, Arkansas
Mercy Hospital Joplin Joplin, Missouri	Site Public Contact - (esmeralda.carrillo@mercy.net)
Mercy Hospital Oklahoma City Oklahoma City, Oklahoma
Mercy Hospital Pittsburg Pittsburg, Kansas
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 Hospital Washington Washington, Missouri
Mercy Infusion Center - Chippewa St Louis, Missouri
Mercy Medical Center Springfield, Massachusetts	Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Mercy Medical Center - Des Moines Des Moines, Iowa
Mercy Medical Center-West Lakes West Des Moines, Iowa
Mercy Oncology and Hematology - Clayton-Clarkson Ballwin, Missouri
Mercy San Juan Medical Center Carmichael, California	Site Public Contact - (ResearchInstituteInquiries@commonspirit.org)
Michigan Healthcare Professionals Pontiac Pontiac, Michigan	Site Public Contact - (Emily.Crofts@trinity-health.org)
Miller-Dwan Hospital Duluth, Minnesota	Site Public Contact - (CancerTrials@EssentiaHealth.org)
Minnesota Oncology - Burnsville Burnsville, Minnesota	Site Public Contact - (mmcorc@healthpartners.com)
Minnesota Oncology - Coon Rapids Coon Rapids, Minnesota	Site Public Contact - (mmcorc@healthpartners.com)
Minnesota Oncology - Edina Edina, Minnesota	Site Public Contact - (mmcorc@healthpartners.com)
Minnesota Oncology - Maple Grove Maple Grove, Minnesota	Site Public Contact - (mmcorc@healthpartners.com)
Minnesota Oncology Hematology PA-Chaska Chaska, 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)
Mission Hope Medical Oncology - Arroyo Grande Arroyo Grande, California	Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Mission Hope Medical Oncology - Santa Maria Santa Maria, California	Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Missouri Baptist Medical Center St Louis, Missouri
Missouri Baptist Sullivan Hospital Sullivan, Missouri
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MyMichigan Medical Center Alpena Alpena, Michigan	Site Public Contact - (CVResearch@mymichigan.org)
MyMichigan Medical Center Gladwin Gladwin, Michigan	Site Public Contact - (CVResearch@mymichigan.org)
MyMichigan Medical Center Gratiot Alma, Michigan	Site Public Contact - (CVResearch@mymichigan.org)
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MyMichigan Medical Center Tawas Tawas City, Michigan	Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro Jonesboro, Arkansas	Site Public Contact - (Emily.Carvell@bmhcc.org)
New Ulm Medical Center New Ulm, Minnesota	Site Public Contact - (mmcorc@healthpartners.com)
Newland Medical Associates-Clarkston Clarkston, Michigan
Newland Medical Associates-Pontiac Pontiac, Michigan	Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
North Memorial Medical Health Center Robbinsdale, Minnesota	Site Public Contact - (mmcorc@healthpartners.com)
Northside Hospital Atlanta, Georgia	Site Public Contact - (ClinicalTrials@northside.com)
Northwest Cancer Center - Crown Point Crown Point, Indiana	Site Public Contact - (CancerResearch@powershealth.org)
Northwest Cancer Center - Hobart Hobart, 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)
OSF Saint Anthony's Health Center Alton, Illinois
OSF Saint Francis Hospital and Medical Group Escanaba, Michigan	Site Public Contact - (WI_research_admin@hshs.org)
Oncology Associates at Mercy Medical Center Cedar Rapids, Iowa
PROncology San Juan,	Site Public Contact - (info@PRoncology.com)
Pacific Central Coast Health Center-San Luis Obispo San Luis Obispo, California	Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota	Site Public Contact - (mmcorc@healthpartners.com)
Parkland Health Center - Farmington Farmington, Missouri
Penrose-Saint Francis Healthcare Colorado Springs, Colorado	Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Phelps Health Delbert Day Cancer Institute Rolla, Missouri	Site Public Contact - (research@phelpshealth.org)
Pocono Medical Center East Stroudsburg, Pennsylvania	Site Public Contact - (Morgan_M.Horton@lvhn.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)
Puerto Rico Hematology Oncology Group Bayamón,
Regions Hospital Saint Paul, Minnesota	Site Public Contact - (mmcorc@healthpartners.com)
Reiman Cancer Center-Ascension Wisconsin Health Center-Rawson Franklin, Wisconsin	Site Public Contact - (AWRI.Inquiry@Ascension.org)
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Ridgeview Medical Center Waconia, Minnesota	Site Public Contact - (mmcorc@healthpartners.com)
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Rocky Mountain Cancer Centers-Penrose Colorado Springs, Colorado	Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
SIH Cancer Institute Carterville, Illinois	Site Public Contact - (clinical.research@sih.net)
SSM Health Good Samaritan Mount Vernon, Illinois	Site Public Contact - (gayla.hall@ssmhealth.com)
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Saint John's Hospital - Healtheast Maplewood, Minnesota	Site Public Contact - (mmcorc@healthpartners.com)
Saint Joseph Medical Center Hematology and Oncology - Silverdale Silverdale, Washington	Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
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Sainte Genevieve County Memorial Hospital Sainte Genevieve, Missouri
San Juan City Hospital San Juan,
San Juan Community Oncology Group San Juan,
Sanford Bismarck Medical Center Bismarck, North Dakota	Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
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Sanford Cancer Center Worthington Worthington, Minnesota
Sanford Joe Lueken Cancer Center Bemidji, Minnesota	Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
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Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota	Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org)
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UI Health Care Mission Cancer and Blood - Ankeny Clinic Ankeny, Iowa
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University of Kansas Cancer Center-Overland Park Overland Park, Kansas	Site Public Contact - (KUCC_Navigation@kumc.edu)
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University of New Mexico Cancer Center Albuquerque, New Mexico	Site Public Contact - (HSC-ClinicalTrialInfo@salud.unm.edu)
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Valley Radiation Oncology Peru, Illinois
West Michigan Cancer Center Kalamazoo, Michigan	Site Public Contact - (crcwm-regulatory@crcwm.org)
Women's Diagnostic Center - Munster Munster, Indiana	Site Public Contact - (mnicholson@comhs.org)
Woodland Memorial Hospital Woodland, California	Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)

A Study of Suvorexant (MK-4305) for the Treatment of Insomnia Disorder in Participants With Opioid Use Disorder (MK-4305-098)

Contact(s):

Toll Free Number - Trialsites@msd.com

Principal Investigator:

System ID: NCT06655883

Show full eligibility criteria

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following: * Has a primary diagnosis of OUD according to Diagnostic and Statistical Manual of Mental Disorder, 5th Edition (DSM-5), and confirmed through the Mini International Neuropsychiatric Interview (MINI). * Is on a verified, stable dose of medications for opioid use disorder (MOUD) treatment. * Meets DSM-5 criteria for the diagnosis of Insomnia Disorder * Has a regular bedtime between 8 PM (20:00) and 1 AM (01:00) and is willing to maintain it for the duration of the study. * Has not used opioids for a period of at least 4 weeks before entering the study.

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following: * Has current uncontrolled major co-morbid psychiatric illness including major depressive disorder, bipolar disorder, schizophrenia, or any psychiatric condition with psychotic features. * Has current diagnosis or history within 5 years of any of the following: narcolepsy, sleep paralysis, severe periodic limb movement disorder, restless leg syndrome, cataplexy, circadian rhythm sleep disorder, parasomnia including nightmare disorder, sleep terror disorder, sleepwalking disorder, rapid eye movement (REM) behavior disorder, significant degree of sleep-related breathing disorder, excessive daytime sleepiness (EDS), or primary hypersomnia. * Is at imminent risk of self-harm. * Has a known history of stroke that may confound the diagnosis of insomnia. * Has a clinically significant movement disorder such as akinesia. * Has a history of hepatitis or live disease. * Has habitual use of central nervous system (CNS)-depressants or stimulants that may be responsible for the participant's disturbed sleep. * Has a history of malignancy, ≤3 years prior to start of study, with the exception of nonmelanoma skin cancer, prostate cancer or localized carcinoma in situ of the cervix. * Has a history of hypersensitivity to more than 3 chemical classes of drugs, including prescription and over-the-counter medications. * Has donated blood products or had phlebotomy within 8 weeks prior to start of study. * Has a history of transmeridian travel within 2 weeks prior to start of study.

Interventions: DRUG: Suvorexant, DRUG: Placebo

Conditions: Insomnia

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Study Locations

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Location	Contacts
Adams Clinical Dallas ( Site 2007) DeSoto, Texas
Butler Hospital ( Site 1002) Providence, Rhode Island
CenExel iResearch, LLC ( Site 2010) Savannah, Georgia
Hassman Research Institute Marlton Site ( Site 2005) Marlton, New Jersey
Johns Hopkins University ( Site 1001) Baltimore, Maryland
Medical University of South Carolina ( Site 1005) Charleston, South Carolina
Memorial Hermann Village ( Site 2001) Houston, Texas
Penn Medicine University of Pennsylvania Health System- Center for Studies of Addiction ( Site 1006) Philadelphia, Pennsylvania
The Rivus Wellness & Research Institute ( Site 2014) Oklahoma City, Oklahoma
VCU Institute for Drug and Alcohol Studies ( Site 1004) Richmond, Virginia
Yale University School of Medicine ( Site 1003) New Haven, Connecticut

Testing Whether High Dose Chemotherapy and Infusion of the Patients' Own Stem Cells Improves Survival in Patients With Peripheral T-cell Lymphoma Who Achieved a Complete Response at the End of the Initial Chemotherapy

Contact(s):

Pamela Cogliano - ecog.rss@jimmy.harvard.edu

Principal Investigator:

System ID: NCT06724237

Show full eligibility criteria

Inclusion Criteria:

* Patient must be 18 to 75 years of age * Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Patient must have histologically proven peripheral T-cell lymphoma (PTCL) in one of the following categories: * Anaplastic large cell lymphoma (ALCL) ALK-negative * Angioimmunoblastic T-cell lymphoma (AITL) * Nodal PTCL with follicular helper T cell (TFH) phenotype * Peripheral T-cell lymphoma not otherwise specified (PTCL-NOS) * Patient must have undergone induction treatment with an anthracycline based chemotherapy. * NOTE: Patients who discontinued anthracycline during treatment are eligible as long as they received at least one dose and achieved complete remission * Patient must have achieved radiologic complete remission following induction therapy as defined by the Lugano criteria with a Deauville score between 1-3 by PET-CT * NOTE: There is no central review required. Confirmation of complete remission status is determined by the enrolling institution's review * NOTE: If a patient had a positive bone marrow biopsy at the time of initial diagnosis (pre-induction), a repeat biopsy must be completed post induction to confirm complete remission (CR) * Patient must be eligible for high dose chemotherapy and autologous stem cell transplant (ASCT) per the enrolling institutional guidelines at the transplant center and be ready to proceed with ASCT if randomized to the ASCT arm * Patient must not have active infection requiring intravenous systemic antimicrobial at time of randomization. Antibiotic prophylaxis is acceptable as long as the dose of the medication has been stable for at least 7 days prior to randomization * 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 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 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 must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse during the treatment phase of the study and thereafter according to institutional guidelines * Absolute neutrophil count (ANC) ≥ 1000/mcL (obtained ≤ 14 days prior to protocol randomization) * Platelets ≥ 75,000/mcL (obtained ≤ 14 days prior to protocol randomization) * Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (obtained ≤ 14 days prior to protocol randomization) * Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3.0 x institutional ULN (obtained ≤ 14 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

Interventions: PROCEDURE: Autologous Hematopoietic Stem Cell Transplantation, OTHER: Best Practice, PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Bone Marrow Biopsy, PROCEDURE: Computed Tomography, DRUG: High Dose Chemotherapy, PROCEDURE: Leukapheresis, PROCEDURE: Positron Emission Tomography, DRUG: Stem Cell Mobilization Therapy

Conditions: Anaplastic Large Cell Lymphoma, ALK-Negative, Follicular Helper T-Cell Lymphoma, Follicular Helper T-Cell Lymphoma, Angioimmunoblastic-Type, Peripheral T-Cell Lymphoma, Not Otherwise Specified

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Study Locations

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Location	Contacts
Alaska Breast Care and Surgery LLC Anchorage, Alaska	Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Alaska Oncology and Hematology LLC Anchorage, Alaska	Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Alaska Women's Cancer Care Anchorage, Alaska	Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Anchorage Associates in Radiation Medicine Anchorage, Alaska	Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
BASS Medical Group - Lennon Walnut Creek, California
Banner University Medical Center - Tucson Tucson, Arizona	Site Public Contact - (UACC-IIT@uacc.arizona.edu)
Bay Area Hospital Coos Bay, Oregon	Site Public Contact - (cherie.cox@bayareahospital.org)
Beebe Health Campus Rehoboth Beach, Delaware	Site Public Contact - (research@beebehealthcare.org)
Beebe Medical Center Lewes, Delaware	Site Public Contact - (research@beebehealthcare.org)
Beebe South Coastal Health Campus Millville, Delaware	Site Public Contact - (research@beebehealthcare.org)
Boulder Community Foothills Hospital Boulder, Colorado
Cancer Care Northwest - Spokane South Spokane, Washington	Site Public Contact - (research@ccnw.net)
Cancer Care Northwest-North Spokane Spokane, Washington	Site Public Contact - (research@ccnw.net)
Cancer Care Northwest-Valley Spokane, Washington	Site Public Contact - (research@ccnw.net)
Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina
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-Concord Health Center Chadds Ford, Pennsylvania	Site Public Contact - (lbarone@christianacare.org)
Christiana Care Health System-Wilmington Hospital Wilmington, Delaware	Site Public Contact - (lbarone@christianacare.org)
City of Hope Comprehensive Cancer Center Duarte, California	Site Public Contact - (becomingapatient@coh.org)
Clackamas Radiation Oncology Center Clackamas, Oregon	Site Public Contact - (CanRsrchStudies@providence.org)
Colorado Blood Cancer Institute Denver, Colorado
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)
Contra Costa Regional Medical Center Martinez, California
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)
Drexel Town Square Health Center Oak Creek, Wisconsin
Dublin Methodist Hospital Dublin, Ohio	Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
Duke University Medical Center Durham, North Carolina
Emory University Hospital/Winship Cancer Institute Atlanta, Georgia
Fairbanks Memorial Hospital Fairbanks, Alaska
Froedtert Menomonee Falls Hospital Menomonee Falls, Wisconsin
Froedtert West Bend Hospital/Kraemer Cancer Center West Bend, Wisconsin
Froedtert and MCW Moorland Reserve Health Center New Berlin, Wisconsin
Geisinger Medical Center Danville, Pennsylvania	Site Public Contact - (HemonCCTrials@geisinger.edu)
Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre, Pennsylvania	Site Public Contact - (HemonCCTrials@geisinger.edu)
Grady Memorial Hospital Delaware, Ohio	Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
Grant Medical Center Columbus, Ohio	Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
Helen F Graham Cancer Center Newark, Delaware	Site Public Contact - (lbarone@christianacare.org)
Huntsman Cancer Institute/University of Utah Salt Lake City, Utah	Site Public Contact - (cancerinfo@hci.utah.edu)
Indiana University/Melvin and Bren Simon Cancer Center Indianapolis, Indiana	Site Public Contact - (iutrials@iu.edu)
Jefferson Healthcare Port Townsend, Washington
Kadlec Clinic Hematology and Oncology Kennewick, Washington	Site Public Contact - (research@kadlecmed.org)
Katmai Oncology Group Anchorage, Alaska	Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
LSU Health Sciences Center at Shreveport Shreveport, Louisiana	Site Public Contact - (LPost@lsuhsc.edu)
Marshfield Medical Center-Marshfield Marshfield, Wisconsin	Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Matthews Radiation Oncology Center Matthews, North Carolina	Site Public Contact - (kashah@novanthealth.org)
Mayo Clinic Hospital in Arizona Phoenix, Arizona
Mayo Clinic in Florida Jacksonville, Florida
Mayo Clinic in Rochester Rochester, Minnesota
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)
Mercy Health - Paducah Cancer Center Paducah, Kentucky
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-International Plaza Tampa, Florida	Site Public Contact - (ClinicalTrials@moffitt.org)
Novant Health Cancer Institute - Huntersville Huntersville, North Carolina	Site Public Contact - (kashah@novanthealth.org)
Novant Health Cancer Institute - Kernersville Kernersville, North Carolina	Site Public Contact - (asmarrs@novanthealth.org)
Novant Health Cancer Institute - Matthews Matthews, North Carolina	Site Public Contact - (kashah@novanthealth.org)
Novant Health Cancer Institute - Mooresville Mooresville, North Carolina	Site Public Contact - (kashah@novanthealth.org)
Novant Health Cancer Institute - Mount Airy Mount Airy, North Carolina	Site Public Contact - (asmarrs@novanthealth.org)
Novant Health Cancer Institute - Statesville Stateville, North Carolina	Site Public Contact - (pjordan@novanthealth.org)
Novant Health Cancer Institute - Thomasville Thomasville, North Carolina	Site Public Contact - (pjordan@novanthealth.org)
Novant Health Cancer Institute - Wilkesboro Wilkesboro, North Carolina	Site Public Contact - (pjordan@novanthealth.org)
Novant Health Forsyth Medical Center Winston-Salem, North Carolina	Site Public Contact - (pjordan@novanthealth.org)
Novant Health Presbyterian Medical Center Charlotte, North Carolina	Site Public Contact - (kashah@novanthealth.org)
Novant Health Presbyterian Medical Center Huntersville Huntersville, North Carolina	Site Public Contact - (kashah@novanthealth.org)
Ochsner Medical Center Jefferson New Orleans, Louisiana	Site Public Contact - (Elisemarie.curry@ochsner.org)
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)
Oregon Health and Science University Portland, Oregon	Site Public Contact - (trials@ohsu.edu)
PeaceHealth Saint John Medical Center Longview, Washington	Site Public Contact - (kmakin-bond@peacehealth.org)
PeaceHealth Saint Joseph Medical Center Bellingham, Washington	Site Public Contact - (achapman1@peacehealth.org)
PeaceHealth Southwest Medical Center Vancouver, Washington	Site Public Contact - (kmakin-bond@peacehealth.org)
PeaceHealth United General Medical Center Sedro-Woolley, Washington	Site Public Contact - (achapman1@peacehealth.org)
Presbyterian - Saint Lukes Medical Center - Health One Denver, 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
Providence Alaska Medical Center Anchorage, Alaska	Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Providence Hood River Memorial Hospital Hood River, Oregon	Site Public Contact - (canrsrchstudies@provdience.org)
Providence Medical Foundation - Santa Rosa Santa Rosa, California
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 Queen of The Valley Napa, California
Providence Regional Cancer Partnership Everett, Washington	Site Public Contact - (marilyn.birchman@providence.org)
Providence Regional Cancer System-Aberdeen Aberdeen, Washington	Site Public Contact - (deidre.dillon@providence.org)
Providence Regional Cancer System-Centralia Centralia, Washington	Site Public Contact - (deidre.dillon@providence.org)
Providence Regional Cancer System-Lacey Lacey, Washington	Site Public Contact - (deidre.dillon@providence.org)
Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank, California	Site Public Contact - (Najee.Boucher@providence.org)
Providence Saint Mary Regional Cancer Center Walla Walla, Washington	Site Public Contact - (Cheryl.Dodd@providence.org)
Providence Saint Vincent Medical Center Portland, Oregon	Site Public Contact - (CanRsrchStudies@providence.org)
Providence Santa Rosa Memorial Hospital Santa Rosa, California
Providence Willamette Falls Medical Center Oregon City, Oregon	Site Public Contact - (CanRsrchStudies@providence.org)
Riverside Methodist Hospital Columbus, Ohio	Site Public Contact - (Jennifer.Sexton@ohiohealth.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-Longmont Longmont, 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
Rowan Regional Medical Center Salisbury, North Carolina	Site Public Contact - (nnechiporchik@novanthealth.org)
Saint Charles Health System Bend, Oregon	Site Public Contact - (nosall@stcharleshealthcare.org)
Saint Charles Health System-Redmond Redmond, Oregon
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 Patrick Hospital - Community Hospital Missoula, Montana	Site Public Contact - (amy.hanneman@providence.org)
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)
Skagit Regional Health Cancer Care Center Mount Vernon, Washington	Site Public Contact - (rcccclinicalresearch@skagitvalleyhospital.org)
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-Ballard Campus Seattle, Washington	Site Public Contact - (PCRC-NCORP@Swedish.org)
Swedish Medical Center-Cherry Hill Seattle, 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 Melanoma and Skin Cancer Institute Englewood, Colorado
The Women's Imaging Center Denver, Colorado
UC Irvine Health/Chao Family Comprehensive Cancer Center Orange, California	Site Public Contact - (ucstudy@uci.edu)
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care Irvine, California	Site Public Contact - (ucstudy@uci.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)
University of Alabama at Birmingham Cancer Center Birmingham, Alabama	Site Public Contact - (gingerreeves@uabmc.edu)
University of Arizona Cancer Center-North Campus Tucson, Arizona	Site Public Contact - (UACC-IIT@uacc.arizona.edu)
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 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 Hospital-Westwood Cancer Center Westwood, Kansas	Site Public Contact - (KUCC_Navigation@kumc.edu)
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma	Site Public Contact - (ou-clinical-trials@ouhsc.edu)
University of Rochester Rochester, New York
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)
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)
Wayne State University/Karmanos Cancer Institute Detroit, Michigan	Site Public Contact - (ctoadmin@karmanos.org)
Weisberg Cancer Treatment Center Farmington Hills, Michigan	Site Public Contact - (ctoadmin@karmanos.org)

DCIS: RECAST Trial Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment

Contact(s):

Kim Nelson, RN - k.nelson@qlhc.org

Principal Investigator:

System ID: NCT06075953

Show full eligibility criteria

Inclusion Criteria:

A. Female, at least 18 years old B. Previous diagnosis of HR+ DCIS (at least 50% ER or PR; biopsy will have been performed previously at diagnosis) with or without microinvasion * Patients with a diagnosis of hormone positive DCIS who have undergone surgery with positive margins that have not been re-excised are candidates to enroll in the trial. C. Patients who have previously received endocrine therapy should have a washout period of at minimum 4-6 weeks prior to the screening MRI on the RECAST-DCIS trial D. Bilateral mammogram performed within up to 6 months (180 days) of the start of trial treatment may be used for screening evaluation. If a bilateral mammogram has been performed within 1 year (12 months) of the start of trial treatment, then a diagnostic unilateral mammogram within 6 months (180 days) of the start of trial treatment will be acceptable for screening evaluation. E. MRI performed on an I SPY (RECAST) approved scanner within 2 months (60 days) of the start of trial treatment for lesion evaluation may be used for screening evaluation. F. CBC w/ diff, CMP, and Lipid Panel within normal limits within a year of the start of trial treatment. Abnormal labs to be repeated within 60 days prior to the start of trial treatment. Patients will be considered eligible for screening labs that are abnormal or out-of-range if the investigator has deemed the lab results not-clinically significant G. Negative urine or serum pregnancy test within 1 month of the start of trial treatment H. Controlled HIV positive patients are allowed as long as their current medication does not contraindicate the study's investigational agent I. Willingness and ability to provide tumor samples for research

Exclusion Criteria:

A. Pregnant or actively breastfeeding women B. History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent based on review of the medical record and patient history C. Invasive carcinoma or identification of a mass on MRI that is subsequently biopsied and found to be invasive cancer D. Co-enrollment in clinical trials of pharmacologic agents requiring an IND E. Ongoing treatment for DCIS other than what is specified in this protocol F. Uncontrolled intercurrent illness, including psychiatric conditions, that would limit compliance with study requirements G. Medical history or ongoing gastrointestinal disorders potentially affecting the absorption of investigational agent and/or tamoxifen. Active inflammatory bowel disease or chronic diarrhea, known active hepatitis A/B/C\*, hepatic cirrhosis, short bowel syndrome, or any upper gastrointestinal surgery including gastric resection or banding procedures \*Active hepatitis, defined as: A (positive HA antigen or positive IgM); B (either positive HBs antigen or positive hepatitis B viral DNA test above the lower limit of detection of the assay); C (positive hepatitis C antibody result, and quantitative hepatitis C (HCV) ribonucleic acid (RNA) results greater than the lower limits of detection of the assay) H. Participants who are unable to swallow normally or unable to take tablets and capsules. Predictable poor compliance with oral treatment

Interventions: DRUG: Tamoxifen, DRUG: Exemestane, DRUG: Letrozole, DRUG: Anastrazole, DRUG: Testosterone + Anastrazole, DRUG: Elacestrant, DRUG: Z-endoxifen

Conditions: Ductal Carcinoma in Situ

Keywords: active surveillance, hormone therapy, endocrine therapy

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Study Locations

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Location	Contacts
Atrium Health Wake Forest Baptist Comprehensive Cancer Center Winston-Salem, North Carolina	Brandy Baker and Lindsy Davis, RN - (brandy.baker@advocatehealth.org, lindsey.davis@advocatehealth.org) Sydney McEntire - (sydney.mcentire@advocatehealth.org)
Berkeley Outpatient Center Berkeley, California	Niloufar Abdollahi - (Niloufar.abdollahi@ucsf.edu) Dasha Peiris - (Dasha.Peiris@ucsf.edu)
Bryn Mawr Hospital Bryn Mawr, Pennsylvania
City of Hope Duarte, California	Mellissa Henry, RN, MSN, FNP-C - (mehenry@coh.org)
City of Hope - Lennar Foundation Cancer Center Irvine, California	Mellissa Henry, RN, MSN, FNP-C - (mehenry@coh.org)
City of Hope -Duarte Cancer Center Duarte, California	Mellissa Henry, RN, MSN, FNP-C - (mehenry@coh.org)
Duke Cancer Institute Durham, North Carolina	Breast Cancer Study Team - (breastcl@dm.duke.edu)
Englewood Hospital and Medical Center Englewood, New Jersey	Kayla Williams - (kayla.williams@ehmchealth.org)
Health Partners - Frauenshuh Cancer Center Saint Louis Park, Minnesota	Hannah Merrill - (hannah.merrill@parknicollet.com) Niki Hoese - (nicole.hoese@parknicollet.com)
Health Partners - Regions Hospital Saint Paul, Minnesota	Hannah Merrill - (hannah.merrill@parknicollet.com) Niki Hoese - (nicole.hoese@parknicollet.com)
Hennepin Healthcare -Minneapolis Minneapolis, Minnesota	Hannah Merrill - (hannah.merrill@parknicollet.com) Niki Hoese - (nicole.hoese@parknicollet.com)
Huntsman Cancer Institute Salt Lake City, Utah	Janna Espinosa - (Janna.Espinosa@hci.utah.edu)
Icahn School of Medicine at Mount Sinai New York, New York	Contact: Site Public Contact - (CRSU@mssm.edu)
John Muir Health Concord, California	Jen Johnson, Clinical Research Coordinator - (Jen.Johnson@johnmuirhealth.com)
Lankenau Medical Center Wynnewood, Pennsylvania
Maple Grove Cancer Center Maple Grove, Minnesota	Oncology Access Nurse - (ccinfo@umn.edu)
Moffitt Cancer Center Tampa, Florida	Neveen Abdo, Clinical Research Coordinator - (Neveen.abdo@moffitt.org)
Mount Sinai Chelsea New York, New York	Contact: Site Public Contact - (CRSU@mssm.edu)
Mount Sinai Union Square New York, New York	Contact: Site Public Contact - (CRSU@mssm.edu)
Mount Sinai West New York, New York	Contact: Site Public Contact - (CRSU@mssm.edu)
Paoli Hospital Paoli, Pennsylvania
UCLA Los Angeles, California	Sophia Quiroz, Clinical Research Coordinator - (SQuiroz@mednet.ucla.edu)
UCSF San Francisco, California	Dasha Peiris - (Dasha.Peiris@ucsf.edu)
University of Chicago Medical Center Chicago, Illinois	Vhenyse Encarnacion - (vhenyse.encarnacion@bsd.uchicago.edu)
University of Minnesota Minneota, Minnesota	Oncology Access Nurse - (ccinfo@umn.edu)
Vanderbilt University Medical Center Nashville, Tennessee	Oncology nursing - (cip@vumc.org) Jennifer Goodman, RN, BSN - (jennifer.e.goodman@vumc.org)
Virginia Commonwealth University Richmond, Virginia	Massey CTO Breast Team - (masseyctbrst@vcu.edu)
Winship Cancer Institute, Emory University Atlanta, Georgia	Winship Clinical Trials Office - (winshipcto@emory.edu) Trisha Burrello - (trisha.n.burrello@emory.edu)

Neoadjuvant Zanzalintinib Plus Nivolumab in Patients With Locally Advanced and/or Inoperable Clear Cell Renal Cell Carcinoma With or Without Non-measurable Metastasis (EXPLORE-RCC)

Contact(s):

Qian Qin, MD - Qian.qin@utsouthwestern.edu

Principal Investigator:

System ID: NCT06794229

Show full eligibility criteria

Inclusion Criteria:

• Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
• Age ≥ 18 years at the time of consent.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1 within 30 days prior to registration.
• Histologically confirmed (i.e., tissue from primary kidney tumor of interest) diagnosis of clear cell renal cell carcinoma with or without sarcomatoid features. NOTE: biopsy should be performed at least 5 days before the first dose of study treatment and must be completely healed before dosing.
• Locally advanced (cT3/T4, N0-1) OR deemed surgically challenging/inoperable per surgeon discretion. Satisfying either of the criteria allows for enrollment. NOTE: Surgically challenging/inoperable per surgeon discretion is based on one or more of the following, which will be documented on the Surgical Operability and Outcomes Form and evaluated per central surgery review: * cT4 disease * N1 disease * Surgery may be significantly complex and/or significantly affect residual renal function, where neoadjuvant therapy may downsize/downstage primary tumor for maximum renal preservation, including: * IVC tumor thrombus involvement * cT1-3 tumor with pre-surgery calculated creatinine clearance \<60 mL/min per Cockcroft-Gault formula OR solitary kidney (any calculated creatinine clearance), with potential to convert from radical to partial nephrectomy * High complexity on RENAL Nephrometry Score (score ≥ 10) * Other reversible comorbidity(ies) that in the opinion of the surgeon renders the patient surgically challenging/inoperable at baseline, where neoadjuvant therapy and medical optimization may allow subsequent surgery
• Non-measurable soft tissue metastasis with longest diameter \< 10mm or pathological lymph nodes \< 15 mm in short axis are allowed.
• Recovery to baseline or Grade ≤ 1 severity (CTCAE v5) from adverse events (AEs) related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy (eg, physiological replacement of corticosteroid). Low-grade or controlled toxicities such as alopecia, Grade ≤ 2 hypomagnesemia, Grade ≤ 2 neuropathy are permitted).
• Adequate organ and marrow function, based upon meeting all the following laboratory criteria within 30 days before first dose of study treatment: * Platelets (Plt): ≥ 100,000 /mm3; without transfusion within 2 weeks of screening laboratory sample collection * Absolute Neutrophil Count (ANC): ≥ 1500 K/mm3; without granulocyte colony-stimulating factor support within 2 weeks of screening laboratory sample collection * Hemoglobin (Hgb): ≥ 9 g/dL; without transfusion within 2 weeks of screening laboratory sample collection * Creatinine OR Calculated creatinine clearance: ≤ 1.5 x ULN OR ≥ 40 mL/min * Urine protein-to-creatinine ratio (UPCR): ≤ 1.5 mg/mg (≤ 169.8 mg/mmol) creatinine * Total bilirubin: ≤ 1.5 × upper limit of normal (ULN); for subjects with Gilbert's disease ≤ 3 x ULN * Aspartate aminotransferase (AST): ≤ 3× ULN * Alanine aminotransferase (ALT): ≤ 3 × ULN * Alkaline Phosphatase (ALP): ≤ 3 × ULN
• Females of childbearing potential must have a negative urine or serum pregnancy test within 48 hours of Cycle 1 Day 1. If a urine test is done and it is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Female subjects are considered to be of childbearing potential unless one of the following criteria is met: permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman \> 45 years-of-age in the absence of other biological or physiological causes. For females \< 55 years old, confirmation of menopausal status is per institutional standards. NOTE: documentation may include review of medical records, medical examination, or medical history interview by study site staff.
• Females of childbearing potential who are sexually active with a male able to father a child must be willing to abstain from penile-vaginal intercourse or must use an effective method(s) of contraception. Males able to father a child who are sexually active with a female of childbearing potential must be willing to abstain from penile-vaginal intercourse or use an effective method(s) of contraception.
• As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.

Exclusion Criteria:

• Non-clear cell histology.
• Measurable metastatic disease per RECIST 1.1 criteria and other non-measurable lesions including bone metastasis, leptomeningeal disease, lymphangitic involvement of lung or skin, pathologically confirmed-malignant ascites/pleural/pericardial effusion.
• Prior systemic therapy, including zanzalintinib, nivolumab and other vascular endothelial growth factor receptor-tyrosine kinase inhibitors (VEGFR-TKIs)/immune checkpoint inhibitors(IOs), for the treatment of renal cell carcinoma.
• Prior surgery and/or radiation to the primary renal cell carcinoma tumor of interest. NOTE: prior surgery and/or radiation to other areas of the kidney (i.e., prior small kidney tumor resection or radiation) is allowed if \> 4 weeks before first dose of study treatment.
• Concomitant anticoagulation with oral anticoagulants (eg, warfarin, direct thrombin inhibitors) and platelet inhibitors (eg, clopidogrel). NOTE: For prohibited anticoagulants, subjects must have discontinued the anticoagulant within 3 days or 5 half-lives prior to first dose of study treatment, whichever is longer. Allowed anticoagulants are the following: * Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH). * Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban in subjects without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen.
• Use of any complementary medications (eg, herbal supplements or traditional Chinese medicines) to treat the disease under study within 2 weeks before first dose of study treatment.
• The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions: * Unstable or deteriorating cardiovascular disorders: * Congestive heart failure New York Heart Association Class 3 or 4, class 2 or higher, unstable angina pectoris, new-onset angina, serious cardiac arrhythmias (eg, ventricular flutter, ventricular fibrillation, Torsades de pointes) * Uncontrolled hypertension defined as sustained blood pressure (BP) \> 140 mm Hg systolic or \> 90 mm Hg diastolic despite optimal antihypertensive treatment * Stroke (including transient ischemic attack \[TIA\]), myocardial infarction, or other clinically significant arterial thrombotic and/or ischemic event within 6 months before first dose of study treatment * Pulmonary embolism (PE) or deep vein thrombosis (DVT) or prior clinically significant venous or non-CVA/TIA arterial thromboembolic events within 3 months before to first dose of study treatment NOTE: Subjects with a diagnosis of DVT within 6 months are allowed if asymptomatic and stable at screening and are on stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen. NOTE: Subjects who don't require prior anticoagulation therapy may be eligible but must be discussed and approved by the Sponsor-Investigator. * Prior history of myocarditis * Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation: * Tumors invading the GI-tract from external viscera * Active peptic ulcer disease, inflammatory bowel disease, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, or acute pancreatitis * Acute obstruction of the bowel, gastric outlet, or pancreatic or biliary duct within 6 months before first dose unless cause of obstruction is definitively managed and subject is asymptomatic * Abdominal fistula, GI perforation, bowel obstruction, or intra-abdominal abscess within 6 months before first dose. Note: Complete healing of an intra-abdominal abscess must be confirmed before first dose of study treatment. * Known gastric or esophageal varices * Ascites, pleural effusion, or pericardial fluid requiring drainage in last 4 weeks
• Clinically significant hematuria, hematemesis, or hemoptysis of \> 0.5 teaspoon (2.5 ml) of red blood, or other history of significant bleeding (eg, pulmonary hemorrhage) within 12 weeks before first dose of study treatment.
• Symptomatic cavitating pulmonary lesion(s) or endobronchial disease (asymptomatic or radiated lesions allowed).
• Lesions invading a major blood vessel. NOTE: Subjects with intravascular tumor extension (eg, tumor thrombus in renal vein or inferior vena cava) are eligible.
• Active infection requiring systemic treatment. NOTE: Prophylactic antimicrobial treatments (antibiotics, antimycotic, antiviral) are allowed.
• Known infection with acute or chronic hepatitis B or C.
• Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness. NOTE: Subjects meeting all the following criteria: (1) on stable anti-retroviral therapy (ART); (2) CD4+ T cell count ≥ 200/µL; and (3) an undetectable viral load may be eligible. Subjects taking CYP inhibitors (eg, zidovudine, ritonavir, cobicistat, didanosine) or CYP3 inducers (efavirenz) must change to a different regimen not including these drugs at least 7 days prior to initiation of study treatment. ART must have been received for at least 4 weeks prior to the first dose. NOTE: CD4+ T cell counts, and viral load are monitored per standard of care by the local health care provider.
• Serious non-healing wound/ulcer/bone fracture.
• Malabsorption syndrome.
• Pharmacologically uncompensated, symptomatic hypothyroidism.
• Moderate to severe hepatic impairment (Child-Pugh B or C).
• Requirement for hemodialysis or peritoneal dialysis.
• History of solid organ or allogeneic stem cell transplant.
• Major surgery (as defined in Appendix A) within 8 weeks prior to first dose of study treatment. Prior laparoscopic surgeries (ie nephrectomy) within 4 weeks prior to first dose of study treatment. Minor surgery (eg, simple excision, tooth extraction) within 5 days before first dose of study treatment. Complete wound healing from major or minor surgery must have occurred at least prior to first dose of study treatment. NOTE: Tumor biopsies should be performed at least 5 days before the first dose of study treatment. Subjects with clinically relevant ongoing complications from prior surgical procedures, including biopsies, are not eligible.
• QTc calculated by the Fridericia formula \> 480 ms within 14 days per electrocardiogram (ECG) before first dose of study treatment. NOTE: Triplicate ECG evaluations will be performed at screening and the average of these 3 consecutive results for QTc will be used to determine eligibility.
• History of psychiatric illness likely to interfere with ability to comply with protocol requirements or give informed consent.
• Pregnant or lactating females.
• Inability to swallow tablets or ingest a suspension either orally or by a nasogastric (NG) or gastrostomy (PEG) tube.
• Previously identified allergy or hypersensitivity to components of the study treatment formulations.
• Another malignancy that requires active therapy and in the opinion of the Investigator would interfere with monitoring of radiologic assessments of response to study treatment within 2 years before first dose of study treatment. Superficial skin cancers, or localized, low grade tumors deemed cured and not treated with systemic therapy are allowed. Incidentally diagnosed prostate cancer is allowed if assessed as stage ≤ T2N0M0 and Gleason score ≤ 6.
• Other conditions, which in the opinion of the Investigator, would compromise the safety of the subject or the subject's ability to complete the study.
• Any active, known or suspected autoimmune disease. NOTE: Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
• Known positive test for tuberculosis infection if supported by clinical or radiographic evidence of disease.
• History of idiopathic pulmonary fibrosis, organizing pneumonia (eg, bronchiolitis obliterans), drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
• Known free thyroxine (FT4) outside the laboratory normal reference range. Asymptomatic subjects with FT4 abnormalities can be eligible after sponsor-investigator approval.
• Diagnosis of immunodeficiency or is receiving systemic steroid therapy (\> 10 mg daily prednisone equivalent) or any other form of immunosuppressive therapy within 2 weeks prior to first dose of study treatment. Inhaled, intranasal, intraarticular, and topical corticosteroids and mineralocorticoids are allowed. NOTE: Adrenal replacement steroid doses \> 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease. Transient short-term use of higher doses of systemic corticosteroids for allergic conditions (eg, contrast allergy) is also allowed.
• Administration of a live, attenuated vaccine within 30 days before first dose of study treatment.

Interventions: DRUG: Zanzalintinib, DRUG: Nivolumab

Conditions: Locally Advanced Renal Cell Carcinoma

Keywords: XL092, Zanzalintinib

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Location	Contacts
University of Texas Southwestern Medical Center Dallas, Texas	Amy Rowell, MS - (Amy.Rowell@utsouthwestern.edu)
Virginia Commonwealth University Richmond, Virginia	Elizabeth Youngblade Parke, MSN, RN - (elizabeth.parke@advocatehealth.org)
Washington University School of Medicine St Louis, Missouri	Hannah Black - (hannahblack@wustl.edu)

Integrating a Prescription Produce Program Within a Diabetes Prevention Program

Contact(s):

Ana Diallo - dialloa@vcu.edu

Principal Investigator:

System ID: NCT07472712

Show full eligibility criteria

Inclusion Criteria:

* ≥age 18 * rationale: adolescents who are at-risk of T2DM may have unique needs that will not be addressed in this study * Most recent BMI ≥ 25kg/m 2 and not pregnant * rationale: elevated BMI is associated with higher risk of developing T2DM * Elevated glucose as evidenced by one of the following criteria: * Hemoglobin A1c 5.7-6.4% indicative of prediabetes within the last 36 months * Fasting blood glucose 100-125mg/dl or 2-hour glucose 140-199mg/dl within the last six months * Physician diagnosis of prediabetes (impaired fasting glucose, impaired glucose intolerance) * These criteria indicate the presence of prediabetes and places individuals are risk of T2DM * Speak, read, and understand English * rationale: current version of PPP intervention (cooking classes) is available in English * Have a working U.S.- based phone number * rationale: participants must have a working phone number because they will receive automated text messages as reminders to receive session reminders; participants must have a working phone number in case adverse event monitoring contacts are required * Able to attend study-related sessions at the Health Hub @ 25th over the year long study (i.e., weekly for 4 months, then monthly for 7 months) * rationale: participants must be able to attend study activities at the community site in order to engage in the intervention and study related sessions.

Exclusion Criteria:

* Individuals with HbA1c or glucose levels above the indicated glucose ranges will be advised to see their physician and excluded from participation unless they receive physician consent to participate. * Pregnant adults (\>18 years old) will not be included in this current study because prediabetes (HbA1c levels between 5.7% - 6.4% within the last 36 months) during pregnancy presents unique physiological challenges that the study intervention does not address. * Pregnancy status will be based on participants self-report. We will not provide any pregnancy tests prior to enrollment.

Interventions: BEHAVIORAL: Diabetes Prevention Program (DPP), BEHAVIORAL: Produce Prescription Plan (PPP)

Conditions: Type2diabetes

Keywords: Health Coach, Food Insecurity, Prevention Program

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Location	Contacts
Virginia Commonwealth University Richmond, Virginia	Ana Diallo - (dialloa@vcu.edu)

A Study to Compare the Combination of Navlimetostat (BMS-986504) With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion (MountainTAP-29)

Contact(s):

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com - Clinical.Trials@bms.com

Principal Investigator:

System ID: NCT07063745

Show full eligibility criteria

Interventions: DRUG: BMS-986504, DRUG: Pembrolizumab, OTHER: Placebo, DRUG: Cisplatin, DRUG: Carboplatin, DRUG: Pemetrexed, DRUG: Paclitaxel, DRUG: Nab-paclitaxel

Conditions: Metastatic Non-small Cell Lung Cancer With MTAP Deletion

Keywords: PRMT5, Lung cancer, NSCLC, MTAP, CDKN2A, MRTX1719, First-line, Navlimetostat

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Location	Contacts
A. C. Camargo Cancer Center São Paulo, São Paulo
AO Santa Maria della Misericordia Perugia, Umbria
AOU della Campania Luigi Vanvitelli Naples, Campania
AZ Delta vzw Roeselare,
Alaska Oncology and Hematology Anchorage, Alaska
Alexandra General Hospital of Athens Athens, Attikí
Antwerp University Hospital Edegem,
Asan Medical Center SongpaGu, Seoul Teugbyeolsi
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano, Torino
Baptist Health Lexington Lexington, Kentucky
Bundeswehrkrankenhaus Ulm Ulm, Baden-Wurttemberg
CEDOES Vitória,
CHRU de Brest Brest, Finistère
CHU Bordeaux Haut-Leveque Pessac,
CHU Jean Minjoz Besançon, Doubs
CHU de Toulouse - Hopital Larrey Toulouse,
Centre Francois Baclesse Caen,
Centre Georges Francois Leclerc Dijon, CÔTE D'OR
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois Vandœuvre-lès-Nancy,
Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau Tours,
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou Rennes,
Centro Oncológico Korben Ciudad Autonoma Buenos Aires,
Centro de Pesquisa Sao Lucas Campinas,
Centrul de Diagnostic si Tratament Provita Bucharest,
Centrul de Oncologie "Sfântul Nectarie" Craiova,
Centrum Medyczne Pratia Poznan Poznan, Greater Poland Voivodeship
Centrum Onkologii im. Prof. Franciszka Lukaszczyka Bydgoszcz,
Chang Gung Medical Foundation-LinKou Branch Taoyuan,
Chi Mei Hospital - Liouying Branch Tainan,
Chu Gabriel Montpied Clermont-Ferrand, Puy-de-Dôme
Chungbuk National University Hospital Chungju,
Clinica de Oncologia Reichow Blumenau, Santa Catarina
Complex Oncology Center - Ruse EOOD Rousse,
Cro-Irccs Aviano, Friuli Venezia Giulia
Dana-Farber Cancer Institute Boston, Massachusetts
Errikos Dunant Hospital Center Athens,
Fakultni nemocnice Hradec Kralove Hradec Králové,
Fakultni nemocnice Olomouc Olomouc,
Farkasgyepui Tudogyogyintezet Farkasgyepű,
Fondazione IRCCS Istituto Nazionale dei Tumori Milan,
Fred Hutchinson Cancer Center Seattle, Washington
Fujian Cancer Hospital Fuzhou,
Fundação Faculdade Regional de Medicina de São José do Rio Preto São José do Rio Preto,
Fundação Pio XII - Hospital de Câncer de Barretos Barretos,
Grampians Health Ballarat Central, Victoria
Groupe hospitalier Paris saint Joseph Paris,
Guangdong Provincial People's Hospital Guangzhou,
Guangxi Medical University Affiliated Cancer Hospital Nanning, Guangxi
H.R.U Málaga - Hospital General Málaga,
Hadassah Medical Center Jerusalem,
Helios Clinical Research - Fort Lauderdale Fort Lauderdale, Florida
Highlands Oncology Group Springdale, Arkansas
Hokkaido University Hospital Sapporo, Hokkaido
Hospices Civils de Lyon - Hopital Louis Pradel Bron,
Hospital General Universitario Gregorio Marañon Madrid,
Hospital Nossa Senhora da Conceicao Porto Alegre, Rio Grande do Sul
Hospital Universitari Vall d'Hebron Barcelona,
Hospital Universitario 12 de Octubre Madrid,
Hospital Universitario Puerta de Hierro Majadahonda Madrid,
Hospital Universitario Virgen del Rocio Seville,
Hubei Cancer Hospital Wuhan,
Huntsman Cancer Institute Salt Lake City, Utah
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola Bologna,
Icesp - Instituto Do Câncer Do Estado de São Paulo São Paulo,
Institut Curie Paris,
Institut Paoli-Calmettes Marseille, Provence-Alpes-Côte d'Azur Region
Instituto Alexander Fleming Ciudad Autónoma de Buenos Aires, Buenos Aires
Instituto Nacional de Cancer - INCA Rio de Janeiro,
Institutul Oncologic Bucuresti "Prof. Dr. Alexandru Trestioreanu" Bucharest, Bucharest
Institutul Oncologic Cluj Cluj-Napoca,
Institutul Oncologic Cluj Cluj-Napoca,
Institutul Regional de Oncologie Iași,
Kaiser Permanente Interstate Medical Office Central Portland, Oregon
Klinik Floridsdorf Vienna,
Klinik Löwenstein Löwenstein,
Krankenhaus Barmherzige Brüder Regensburg Regensburg, Bavaria
Landeskrankenhaus Rankweil Rankweil,
Leicester Royal Infirmary Leicester,
Liaoning Cancer Hospital Shenyang, Liaoning
Liga Norte Riograndense Contra O Cancer Natal, Rio Grande do Norte
Linyi Cancer Hospital Linyi, Shandong
Local Institution - 0006 Thessaloniki, Kentrikí Makedonía
Local Institution - 0010 Kfar Saba, Central District
Local Institution - 0016 Afula, Northern District
Local Institution - 0017 Jerusalem, Jerusalem
Local Institution - 0047 London,
Local Institution - 0049 Beijing, Beijing Municipality
Local Institution - 0050 Vancouver, British Columbia
Local Institution - 0051 Toronto, Ontario
Local Institution - 0057 Changsha, Hunan
Local Institution - 0061 Créteil,
Local Institution - 0068 Qingdao, Shandong
Local Institution - 0069 Hangzhou, Zhejiang
Local Institution - 0072 Hefei, Anhui
Local Institution - 0075 Changchun, Jilin
Local Institution - 0077 Fortaleza, Ceará
Local Institution - 0080 Santa Cruz do Sul, Rio Grande do Sul
Local Institution - 0096 Drammen, Buskerud
Local Institution - 0104 Shenyang, Liaoning
Local Institution - 0106 Harbin, Heilongjiang
Local Institution - 0107 Zhengzhou, Henan
Local Institution - 0108 Chongqing, Chongqing Municipality
Local Institution - 0127 Scarborough, Maine
Local Institution - 0128 Rochester, New York
Local Institution - 0131 Fairfax, Virginia
Local Institution - 0163 Cleveland, Ohio
Local Institution - 0198 Berlin,
Local Institution - 0202 München, Bavaria
Local Institution - 0213 Créteil, Val-de-Marne
Local Institution - 0215 Saint-Herblain, Loire-Atlantique
Local Institution - 0220 Montpellier, Hérault
Local Institution - 0225 Yvoir, Namur
Local Institution - 0230 Arnhem,
Local Institution - 0232 Sendai, Miyagi
Local Institution - 0234 Bunkyo-ku, Tokyo
Local Institution - 0235 Shimotsuga, Tochigi
Local Institution - 0236 Kashiwa, Chiba
Local Institution - 0237 Matsusaka, Mie-ken
Local Institution - 0238 Yokohama, Kanagawa
Local Institution - 0240 Hirakata, Osaka
Local Institution - 0241 Nankoku, Kochi
Local Institution - 0242 Ube, Yamaguchi
Local Institution - 0243 Nagoya, Aichi-ken
Local Institution - 0245 Hidaka, Saitama
Local Institution - 0246 Fukuoka,
Local Institution - 0247 Kobe, Hyōgo
Local Institution - 0248 Hospitalet, Barcelona [Barcelona]
Local Institution - 0253 Barcelona, Catalunya [Cataluña]
Local Institution - 0255 Valencia,
Local Institution - 0257 Kawasaki, Kanagawa
Local Institution - 0259 Krakow, Lesser Poland Voivodeship
Local Institution - 0261 Warsaw, Masovian Voivodeship
Local Institution - 0263 Bangalore, Karnataka
Local Institution - 0264 Varanasi, Uttar Pradesh
Local Institution - 0265 Hyderabad, Telangana
Local Institution - 0266 Mumbai, Maharashtra
Local Institution - 0267 New Delhi, National Capital Territory of Delhi
Local Institution - 0270 Seoul, Seoul-teukbyeolsi [Seoul]
Local Institution - 0279 Nanjing, Jiangsu
Local Institution - 0281 Shenzhen, Guangdong
Local Institution - 0283 Taiyuan, Shanxi
Local Institution - 0284 Shenyang, Liaoning
Local Institution - 0286 Beijing, Beijing Municipality
Local Institution - 0288 Budapest,
Local Institution - 0290 Gyula, Bekes County
Local Institution - 0291 Gyöngyös, Heves County
Local Institution - 0293 Mexico City,
Local Institution - 0294 Mexico City, Mexico City
Local Institution - 0296 Guadalajara, Jalisco
Local Institution - 0297 Oaxaca City, Oaxaca
Local Institution - 0298 Monterrey, Nuevo León
Local Institution - 0305 Bogotá, Cundinamarca
Local Institution - 0306 Montería, Departamento de Córdoba
Local Institution - 0315 Panagyurishte, Pazardzhik
Local Institution - 0317 Adana,
Local Institution - 0318 Adana,
Local Institution - 0319 Edirne,
Local Institution - 0320 Bursa,
Local Institution - 0321 Ankara,
Local Institution - 0323 Shatin,
Local Institution - 0326 Guadalajara, Jalisco
Local Institution - 0327 Chihuahua City,
Local Institution - 0328 Querétaro,
Local Institution - 0330 Medellín, Antioquia
Local Institution - 0331 Puebla City,
Local Institution - 0334 Otashi, Gunma
Local Institution - 0335 Shiwa-gun Yahaba-cho, Iwate
Local Institution - 0336 Himeji, Hyōgo
Local Institution - 0340 Liège,
Local Institution - 0344 Bengaluru, Karnataka
Local Institution - 0345 Mumbai, Maharashtra
Local Institution - 0349 Izmir, Karsiyaka, İzmir
Local Institution - 0350 Antalya,
Local Institution - 0352 Nanjing, Jiangsu
Local Institution - 0353 Shijiazhuang, Hebei
Local Institution - 0355 São Caetano do Sul, São Paulo
Local Institution - 0356 Copenhagen, Capital Region
Local Institution - 0368 Garran,
Local Institution - 0377 The Woodlands, Texas
Local Institution - 0387 Changsha, Hunan
Local Institution - 0390 Kuching, Sarawak
Local Institution - 0405 Detroit, Michigan
Local Institution - 0408 Guiyang, Guizhou
Local Institution - 0411 Bangkok,
Local Institution - 0412 Bangkok,
Local Institution - 0413 Kuala Lumpur, Kuala Lumpur
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Local Institution - 0420 Traverse City, Michigan
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Local Institution - 0458 Wieliszew, Masovian Voivodeship
Local Institution - 0461 Göppingen, Baden-Wurttemberg
Local Institution - 0463 Rosario, Santa Fe Province
Local Institution - 0467 Lebanon, New Hampshire
Local Institution - 0468 Verona,
Local Institution - 0471 Seoul,
Local Institution - 0472 Buenos Aires,
Local Institution - 0473 Providencia, Santiago Metropolitan
Local Institution - 0475 Santiago,
Local Institution - 0476 Recoleta, Santiago Metropolitan
Local Institution - 0480 Madrid,
Local Institution - 0481 Thessaloniki,
Local Institution - 0483 Rome,
Local Institution - 0485 Candiolo, Turin
Local Institution - 0486 Siena, Tuscany
Local Institution - 0497 Los Alamitos, California
Local Institution - 0514 Winston-Salem, North Carolina
Local Institution - 0515 Knoxville, Tennessee
Local Institution - 0518 Schenectady, New York
Local Institution - 0523 Tampa, Florida
Local Institution - 0546 Beersheba,
Local Institution - 0551 Bonn, North Rhine-Westphalia
Local Institution - 0559 Hershey, Pennsylvania
Local Institution - 0566 Antofagasta,
Local Institution - 0568 Lujan de Cuyo, Mendoza Province
Local Institution - 0571 Suwon, Kyǒnggi-do
Local Institution - 0573 Seoul, Seoul-teukbyeolsi [Seoul]
Local Institution - 0574 Heerlen, Limburg
Local Institution - 0576 Porto Alegre, Rio Grande Do Sil
Local Institution - 0580 Tübingen, Baden-Wurttemberg
Local Institution - 0582 Hemer, North Rhine-Westphalia
Local Institution - 0583 Nice,
Local Institution - 0585 Marousi, North Athens
Local Institution - 0586 Reims,
Local Institution - 0591 St Leonards, New South Wales
Local Institution - 0593 Ankara,
Local Institution - 0594 Warsaw, Masovian Voivodeship
Local Institution - 0595 Istanbul,
Local Institution - 0599 Villejuif, Val-De-Marne
Local Institution - 0600 Manchester, New Hampshire
Local Institution - 0603 Oslo,
Local Institution - 0604 Elverum, Innlandet
Local Institution - 0605 Decatur, Illinois
Local Institution - 0606 Newark, Delaware
Local Institution - 0607 Oradea, Bihor County
Local Institution - 0608 Greenville, South Carolina
Local Institution - 0609 Mexico City, Mexico City
Local Institution - 0610 Guadalajara, Jalisco
Local Institution - 0612 Jelenia Góra, Lower Silesian Voivodeship
Local Institution - 0614 Ostrava, Ostrava Město
Local Institution - 0615 Zapopan, Jalisco
Local Institution - 0617 Donauwörth, Bavaria
Local Institution - 0618 Rosario, Santa Fe Province
Local Institution - 0619 Cluj-Napoca, Cluj
Local Institution - 0620 Nashik, Maharashtra
Local Institution - 0621 Beijing, Beijing Municipality
Local Institution - 0624 Monterrey, Nuevo León
LungenClinic Grosshansdorf Großhansdorf,
Lungenfachklinik Immenhausen Immenhausen,
Lyell McEwin Hospital Elizabeth Vale, South Australia
Mayo Clinic in Arizona - Phoenix Phoenix, Arizona
Mayo Clinic in Florida Jacksonville, Florida
Mayo Clinic in Rochester, Minnesota Rochester, Minnesota
NAIC - Instituto do Cancer Bauru, São Paulo
Nanjing First Hospital Nanjing,
National Cancer Center Ilsandong-gu, Goyang-si, Gyeonggi-do
National Cheng Kung University Hospital Tainan,
National Hospital Organization Okayama Medical Center Okayama, Okayama-ken
National Taiwan University Hospital Taipei,
Oncology Hematology West P.C. dba Nebraska Cancer Specialists Omaha, Nebraska
Ordensklinikum Linz GmbH Elisabethinen Linz,
Osaka City General Hospital Osaka,
Ospedale San Raffaele Milan,
Ospedale Santa Maria delle Croci Ravenna, Emilia-Romagna
Peking University People's Hospital Beijing, Beijing Municipality
Pius Hospital Oldenburg Oldenburg, Lower Saxony
Princess Alexandra Hospital Woolloongabba, Queensland
Providence Portland Medical Center Portland, Oregon
Queen Mary Hospital Hong Kong,
Radiology Therapeutic Center Otopeni, Ilfov
Rambam Health Care Campus Haifa,
Renovatio Clinical - El Paso El Paso, Texas
Robert Bosch Krankenhaus GmbH Stuttgart,
Royal Hobart Hospital Hobart, Tasmania
S.C. Centrul de Oncologie Euroclinic S.R.L. Iași,
SC Radiotherapy Center Cluj SRL Florești, Cluj
Sahlgrenska Universitetssjukhuset Gothenburg,
Samsung Medical Center GangnamGu, Seoul Teugbyeolsi
Sarah Cannon Research Institute UK London, London, City of
Seoul National University Bundang Hospital Seongnam-si, Gyeonggi-do
Severance Hospital, Yonsei University Health System Seoul,
Shanghai Chest Hospital Shanghai,
Sheba Medical Center Ramat Gan,
Sichuan Cancer Hospital Chengdu, Sichuan
Specialized Hospital for Active Treatment of Oncology - Haskovo Haskovo,
Spitalul Municipal Schuller Ploiești Ploieşti,
St. Luke's Cancer Institute: Boise Boise, Idaho
Sunshine Coast University Hospital Birtinya, Queensland
Szpital Specjalistyczny w Prabutach Spolka z o.o. Prabuty, Pomeranian Voivodeship
Taipei Medical University Hospital Taipei,
Tangdu Hospital of Fourth Military Medical University of Chinese People's Liberation Army Xi'an, Shaanxi
The First Affiliated Hospital of Xiamen University Xiamen, Fujian
The First Affiliated Hospital, Sun Yat-sen University Guangzhou, Guangdong
The First Affiliated Hospital, Zhejiang University School of Medicine Hangzhou, Zhejiang
The First affiliated hospital of Nanchang University (Xianghu campus) Nanchang,
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center Columbus, Ohio
Thoracic General Hospital of Athens "I Sotiria" Athens,
Trakia Hospital Stara Zagora,
USC/Norris Comprehensive Cancer Center Los Angeles, California
UZ Brussel Brussels, Brussels Capital
University General Hospital of Larissa Larissa,
University Hospital of Patras Pátrai,
University Medical Center Groningen Groningen,
University Multidisciplinary Hospital for Active Treatment "St. Ekaterina" Sofia,
University Multiprofile Hospital for Active Treatment "Tsaritsa Yoanna-ISUL" EAD Sofia,
University of Arizona Cancer Center Tucson, Arizona
University of Kentucky Chandler Medical Center Lexington, Kentucky
University of Texas MD Anderson Cancer Center Houston, Texas
Virginia Commonwealth University Richmond, Virginia
WMCHealth Advanced Physician Services Hawthorne, New York
West China Hospital Sichuan University Chengdu, Sichuan
Wuhan Union Hospital Cancer Center Wuhan, Hubei
Zhejiang Cancer Hospital Hangzhou,
Zhongshan Hospital,Fudan University Shanghai,

Catheter-Related Early Thromboprophylaxis With Enoxaparin Studies (CRETE)

Contact(s):

E. Vincent Faustino, MD, MHS - vince.faustino@yale.edu

Principal Investigator:

System ID: NCT04924322

Show full eligibility criteria

Interventions: DRUG: Enoxaparin

Conditions: Deep Venous Thrombosis

Keywords: child, critical illness, venous thromboembolism, enoxaparin, thrombin generation, bleed

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Study Locations

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Location	Contacts
Arkansas Children's Hospital Little Rock, Arkansas	Masson Spriggs - (SpriggsMK@archildrens.org)
Children's Hospital Colorado Aurora, Colorado	Rachel Greer - (Rachel.Greer@childrenscolorado.org)
Children's Hospital St. Louis St Louis, Missouri	Jessica Archie-Dilworth - (j.archie-dilworth@wustl.edu)
Children's Hospital Wisconsin Milwaukee, Wisconsin	Sadaf Shad, MD - (sshad@mcw.edu)
Children's Hospital of Illinois at OSF Saint Francis Medical Center Peoria, Illinois	Carleen Chaput - (Carleen.M.Chaput@osfhealthcare.org)
Children's Hospital of Philadelphia Philadelphia, Pennsylvania	Alanah McKelvey - (mckelveya@chop.edu)
Children's Hospital of Richmond Richmond, Virginia
Children's Of Alabama Birmingham, Alabama	Meghan Murdock, RN - (Mmdmurdock@uabmc.edu)
Dell Children's Medical Canter Austin, Texas	Michael Box - (michael.box@ascension-external.org)
Golisano Children's Hospital Rochester, New York	Eileen Taillie - (Eileen_Taillie@URMC.Rochester.edu)
Hassenfeld Children's Hospital New York, New York	Sandra Deygoo - (nagamah.deygoo@nyulangone.org)
Johns Hopkins All Children's St. Petersburg, Florida	Lexi Dallas - (adallas2@jhmi.edu)
Maria Fareri Children's Hospital Valhalla, New York	Sere Politano - (Sere.Politano@wmchealth.org)
Nationwide Children's Hospital Columbus, Ohio
New York Presbyterian Hospital New York, New York	Oleksiy Svezhenets, MD - (ols4009@med.cornell.edu)
Penn State Hershey Children's Hospital Hershey, Pennsylvania	Debbie Spear, RN - (dspear@pennstatehealth.psu.edu)
Stead Family Children's Hospital Iowa City, Iowa	Maureen Austin, RN, MPH, BSN - (Maureen-Austin@uiowa.edu)
UH Rainbow Babies & Children's Hospital Cleveland, Ohio	Raj Rasal - (rajashri.rasal@uhhospitals.org) SaTia Sinclair - (satia.sinclair@uhhospitals.org)
UTSW Medical Center; Children's Medical Center of Dallas Dallas, Texas	Teddy Muisyo, MD - (Teddy.Muisyo@UTSouthwestern.edu) Selby Chu, MD - (Selby.Chu@UTSouthwestern.edu)
University of Florida -UF Health Gainesville, Florida	Melissa Lingus - (Melissa.Lingis@peds.ufl.edu)
University of Oklahoma Oklahoma City, Oklahoma	Tracy Jones - (Tracy-Jones@ouhsc.edu)
Yale-New Haven Children's Hospital New Haven, Connecticut	Michelle Ecarma - (michelle.ecarma@yale.edu)

A Study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Contact(s):

ctrrecruit@vcu.edu

Principal Investigator:

System ID: NCT04546399

Show full eligibility criteria

Inclusion Criteria:

* Patients must be \>= 1 and \< 31 years at time of enrollment * Patients must have first relapse of CD19+ B-ALL (relapse blasts must express CD19) in one of the following categories: * Isolated bone marrow relapse * Isolated central nervous system (CNS) (excluding known optic nerve/retinal and CNS chloromas) and/or testicular relapse * Combined bone marrow with extramedullary relapse in the CNS (excluding known optic nerve/retinal and CNS chloromas) and/or testes * Patients with Down syndrome (DS) are eligible in the following categories: * Isolated bone marrow relapse * Combined bone marrow with CNS (excluding known optic nerve/retinal and CNS chloromas) and/or testicular relapse * 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 * Of note, for patients with developmental delay (e.g., Down syndrome) regardless of age, Lansky scale may be substituted for Karnofsky scale. However, the requirement for ECOG 0-2 remains, regardless of known history of developmental delay * Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study * Patients with prior blinatumomab or CD19+ chimeric antigen receptor therapy in the upfront setting will be eligible, provided relapsed lymphoblasts retain CD19 expression * Patients must not have had a prior hematopoietic stem cell transplant * A single intrathecal chemotherapy at the time of relapse will be allowed. If \< 7 days have elapsed between this intrathecal therapy (IT) and the start of protocol therapy, then the day 1 intrathecal chemotherapy (i.e. methotrexate, cytarabine, or triple intrathecal) may be omitted * In the 28 days prior to enrollment, up to five days of post-relapse, pre-enrollment therapy (steroids and/or hydroxyurea only) is permissible * Patients with Down syndrome who received pre-enrollment therapy and have a white blood count (WBC) \>= 30,000/ul at the time of enrollment still must receive protocol specified cytoreductive therapy with vincristine and dexamethasone, and no "washout" is required * Patients with Down syndrome who received pre-enrollment therapy and have a WBC \< 30,000/ul at the time of enrollment must be given a 24 hour "washout" before starting immunotherapy * Note: There is no waiting period or "washout" for patients who relapse while receiving upfront therapy * Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^2 OR a serum creatinine based on age/sex as follows (within 7 calendar days prior to enrollment): * Age: Maximum serum creatinine (mg/dL) * 1 to \< 2 years: 0.6 (male), 0.6 (female) * 2 to \< 6 years: 0.8 (male), 0.8 (female) * 6 to \< 10 years: 1 (male), 1 (female) * 10 to \< 13 years: 1.2 (male), 1.2 (female) * 13 to \< 16 years: 1.5 (male), 1.4 (female) * \>= 16 years: 1.7 (male), 1.4 (female) * The threshold creatinine values in this Table were derived from the Schwartz formula for estimating GFR utilizing child length and stature data published by the Center for Disease Control (CDC) * Shortening fraction of \>= 27% by echocardiogram, or ejection fraction of \>= 50% by echocardiogram, cardiac magnetic resonance imaging (MRI) or radionuclide angiogram * No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry \> 94% if there is clinical indication for determination * 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:

* Patients with B-lymphoblastic lymphoma (B-LLy) * Patients with Burkitt leukemia/lymphoma or mature B-cell leukemia * Patients with Philadelphia chromosome positive (Ph+) B-ALL or ABL class Ph-like B-ALL (i.e. rearrangements involving ABL1, ABL2, CSF1R or PDGFRB and predicted to be sensitive to imatinib or dasatinib) * Patients with mixed phenotype acute leukemia (MPAL) * Patients with known Charcot-Marie-Tooth disease * Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL, regardless of blast immunophenotype * Patients with active, uncontrolled infection defined as: * Positive bacterial blood culture within 48 hours of study enrollment * Receiving IV or PO antibiotics for an infection with continued signs or symptoms. Note: Patients may be receiving IV or oral antibiotics to complete a course of therapy for a prior documented infection if cultures have been negative for at least 48 hours and signs or symptoms of active infection have resolved. For patients with clostridium (C.) difficile diarrhea, at least 72 hours of antibacterial therapy must have elapsed and stools must have normalized to baseline. * Fever above 38.2 degrees Celsius (C) within 48 hours of study enrollment with clinical signs of infection. Fever without clinical signs of infection that is attributed to tumor burden is allowed if blood cultures are negative for \> 48 hours * A positive fungal culture within 30 days of study enrollment or active therapy for presumed invasive fungal infection * Active viral or protozoal infection requiring IV treatment * Patients known to have one of the following concomitant genetic syndromes: Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome are not eligible. * Patients with uncontrolled HIV, hepatitis B, or hepatitis C infection. Of note, patients with known human immunodeficiency virus (HIV) infection on effective anti-retroviral therapy with undetectable viral load for at least the last 6 months prior to enrollment are eligible. Similarly, hepatitis B and hepatitis C positive patients who have been treated and have no viral detectable burden are also eligible * Patients with significant central nervous system pathology that would preclude treatment with blinatumomab, including history of severe neurologic disorder or autoimmune disease with CNS involvement * Note: Patients with a history of seizures that are well controlled on stable doses of anti-epileptic drugs are eligible Patients with a history of cerebrovascular ischemia/hemorrhage with residual deficits are not eligible. Patients with a history of cerebrovascular ischemia/hemorrhage remain eligible provided all neurologic deficits have resolved * Patients with an active known/suspected autoimmune disease are not eligible. However, patients with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll * Patients with DS patients with known non-hematopoietic, non-CNS/testicular extramedullary disease (i.e., chloromatous disease) are not eligible * Note: Group 3 and 4 patients with known non-hematopoietic, non-CNS/testicular extramedullary disease (i.e., chloromatous disease) are eligible if this is NOT the only site of relapsed disease * Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained within 7 days prior to enrollment. Patients who are sexually active and of reproductive potential are not eligible unless they agree to use an effective contraceptive method for the duration of this study. Men with female partners of childbearing potential should use effective contraception during the duration of their treatment. The effect of blinatumomab on fertility has not been evaluated. Blinatumomab is not recommended for pregnant women or women of childbearing potential (WOCBP) not using contraception. Females of reproductive potential must use effective contraception during treatment and for at least 48 hours after the last dose of blinatumomab. Studies in animal models have shown that nivolumab can adversely impair pregnancy. Thus, nivolumab is expected to cause fetal harm during pregnancy. WOCBP receiving nivolumab must continue contraception for a period of at least 5 months after the last dose of nivolumab. It is unknown whether nivolumab is present in breast milk, thus breastfeeding should be discontinued while a patient is receiving nivolumab * Lactating females are not eligible unless they agree to not breastfeed their infants. It is unknown whether blinatumomab or its metabolites are excreted in human breast milk. Women are not permitted to breastfeed while receiving blinatumomab and for the last 48 hours after the last blinatumomab dose. Due to the potential for serious adverse reactions in the breastfed infant, women are not permitted to breastfeed during treatment and for 5 months after the last nivolumab dose

Interventions: RADIATION: 3-Dimensional Conformal Radiation Therapy, DRUG: Asparaginase Erwinia chrysanthemi, PROCEDURE: Biospecimen Collection, BIOLOGICAL: Blinatumomab, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Bone Marrow Biopsy, DRUG: Calaspargase Pegol, DRUG: Cytarabine, DRUG: Dexamethasone, DRUG: Hydrocortisone Sodium Succinate, PROCEDURE: Lumbar Puncture, DRUG: Mercaptopurine, DRUG: Methotrexate, BIOLOGICAL: Nivolumab, DRUG: Pegaspargase, DRUG: Vincristine Sulfate

Conditions: Down Syndrome, Recurrent B Acute Lymphoblastic Leukemia

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Study Locations

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Location	Contacts
AdventHealth Orlando Orlando, Florida	Site Public Contact - (FH.Cancer.Research@flhosp.org)
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)
Ann M Wierman MD LTD Las Vegas, Nevada
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)
Banner Children's at Desert Mesa, Arizona
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
Beacon Kalamazoo Kalamazoo, Michigan
Blank Children's Hospital Des Moines, Iowa	Site Public Contact - (samantha.mallory@unitypoint.org)
British Columbia Children's Hospital Vancouver, British Columbia
Bronson Battle Creek Battle Creek, Michigan
Bronson Methodist Hospital Kalamazoo, Michigan	Site Public Contact - (crcwm-regulatory@crcwm.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)
Camden Clark Medical Center Parkersburg, West Virginia
Cancer Care Specialists - Reno Reno, Nevada
Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores, Michigan
CancerCare Manitoba Winnipeg, Manitoba	Site Public Contact - (ctu_web@cancercare.mb.ca)
Cardinal Glennon Children's Medical Center St Louis, Missouri
Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina
Carson Tahoe Regional Medical Center Carson City, Nevada
Cedars-Sinai Medical Center Los Angeles, California	Site Public Contact - (Cancer.trial.info@cshs.org)
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 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 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 Comprehensive Cancer Center Duarte, California
Cleveland Clinic Foundation Cleveland, Ohio
Comprehensive Cancer Centers of Nevada Las Vegas, Nevada
Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas, Nevada
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Connecticut Children's Medical Center Hartford, Connecticut
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Corewell Health Beaumont Troy Hospital Troy, Michigan
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Corewell Health Dearborn Hospital Dearborn, Michigan
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Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids, Michigan	Site Public Contact - (crcwm-regulatory@crcwm.org)
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Corewell Health William Beaumont University Hospital Royal Oak, Michigan
Covenant Children's Hospital Lubbock, Texas	Site Public Contact - (mbisbee@providence.org)
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire	Site Public Contact - (cancer.research.nurse@dartmouth.edu)
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)
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
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
Hope Cancer Care of Nevada-Pahrump Pahrump, Nevada
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)
Janeway Child Health Centre St. John's, Newfoundland and Labrador	Site Public Contact - (beverlyj.mitchell@easternhealth.ca)
John Hunter Children's Hospital Hunter Regional Mail Centre, New South Wales
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
Kaiser Permanente-Anaheim Anaheim, California	Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Bellflower Bellflower, California
Kaiser Permanente-Fontana Fontana, California	Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Oakland Oakland, California	Site Public Contact - (Kpoct@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
Las Vegas Cancer Center-Henderson Henderson, Nevada
Las Vegas Cancer Center-Medical Center Las Vegas, Nevada
Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York	Site Public Contact - (CancerTrials@nyulangone.org)
Legacy Emanuel Children's Hospital Portland, Oregon
Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania	Site Public Contact - (Morgan_M.Horton@lvhn.org)
Loma Linda University Medical Center Loma Linda, California
Loyola University Medical Center Maywood, Illinois
Lucile Packard Children's Hospital Stanford University Palo Alto, California	Site Public Contact - (ccto-office@stanford.edu)
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Torrance, California
Lurie Children's Hospital-Chicago Chicago, Illinois
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)
Maimonides Medical Center Brooklyn, New York
Maine Children's Cancer Program Scarborough, Maine	Site Public Contact - (clinicalresearch@mainehealth.org)
Mary Bridge Children's Hospital and Health Center Tacoma, Washington	Site Public Contact - (research@multicare.org)
Mattel Children's Hospital UCLA Los Angeles, California
Medical City Dallas Hospital Dallas, Texas
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Michigan State University East Lansing, Michigan
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NYU Langone Hospital - Long Island Mineola, New York	Site Public Contact - (cancertrials@nyulangone.org)
Natalie Warren Bryant Cancer Center at Saint Francis Tulsa, Oklahoma
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Nemours Children's Hospital Orlando, Florida	Site Public Contact - (Allison.bruce@nemours.org)
Newark Beth Israel Medical Center Newark, New Jersey	Site Public Contact - (Christine.Kosmides@rwjbh.org)
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima, Washington
Norton Children's Hospital Louisville, Kentucky	Site Public Contact - (CancerResource@nortonhealthcare.org)
OSF Children's Hospital of Illinois Peoria, Illinois	Site Public Contact - (ChildrensHospitalofIllinois@osfhealthcare.org)
Ochsner Medical Center Jefferson New Orleans, Louisiana
OptumCare Cancer Care at Charleston Las Vegas, Nevada
OptumCare Cancer Care at Fort Apache Las Vegas, Nevada
OptumCare Cancer Care at MountainView Las Vegas, Nevada
Oregon Health and Science University Portland, Oregon	Site Public Contact - (trials@ohsu.edu)
Overlake Medical Center Bellevue, Washington
PCR Oncology Arroyo Grande, California
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Perth Children's Hospital Perth, Western Australia	Site Public Contact - (helpdesk@childrensoncologygroup.org)
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Primary Children's Hospital Salt Lake City, Utah
Prisma Health Cancer Institute - Eastside Greenville, South Carolina	Site Public Contact - (Kim.Williams3@prismahealth.org)
Prisma Health Richland Hospital Columbia, South Carolina	Site Public Contact - (Kim.Williams3@prismahealth.org)
ProMedica Flower Hospital Sylvania, Ohio
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Providence Alaska Medical Center Anchorage, Alaska
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West Michigan Cancer Center Kalamazoo, Michigan
West Virginia University Charleston Division Charleston, West Virginia
West Virginia University Healthcare Morgantown, West Virginia	Site Public Contact - (cancertrialsinfo@hsc.wvu.edu)

A Phase II Platform Study to Evaluate Treatment With Cemiplimab Monotherapy or Cemiplimab Plus Fianlimab or Other Novel Combinations in Patients With Colorectal Cancer With Minimal Residual Disease Following Definitive Surgery and Chemotherapy (EMPIRE) (EMPIRE)

Contact(s):

Department of Site and Study Management (DSSM) - industry.trials@nsabp.org

Principal Investigator:

System ID: NCT07058012

Show full eligibility criteria

Inclusion Criteria:

* The patient must have consented to participate and, prior to beginning specific study procedures, must have signed and dated appropriate Institutional Review Board (IRB) -approved consent forms that conform to federal and institutional guidelines for study treatment. * Patients must be greater than or equal to18 years old. * The ECOG performance status must be 0-1. * Patients must have confirmed histologic and pathologic stage II/III colon, stage II/III rectal, or oligometastatic stage IV colorectal adenocarcinoma (per AJCC 8th edition). * There must be documentation by CT scan with contrast that the patient has no definitive evidence of (non-resected or non-ablated) metastatic disease including assessment of chest, abdomen, and pelvis at the time of study enrollment * All patients must have had a complete (R0) resection of their primary tumor and resected or ablated (radiofrequency ablation, stereotactic body radiation therapy \[SBRT\], microwave ablation, etc.\]) oligometastatic disease if present AND at least 3 months of a standard systemic chemotherapy regimen (e.g., FOLFOX or CAPOX or fluoropyrimidine monotherapy). This includes either adjuvant chemotherapy for colon cancer or perioperative (adjuvant or neoadjuvant) chemotherapy for rectal cancer or oligometastatic colon or rectal cancer. Chemoradiotherapy for rectal cancer (as a component of curative treatment) is acceptable. NOTE: Patients who achieve a clinical complete response and opt for a non-operative approach to their primary tumor management are not eligible. * Patients must be ctDNA-positive by an assay run in any CLIA-certified lab obtained within 2 weeks to 12 months following completion of definitive all curative therapy for colorectal cancer. * Tumor status of microsatellite stability (MSS) or Proficient mismatch repair (pMMR) is confirmed through a standard of care assay through a CLIA-certified lab. * At the time of study entry, blood counts performed within 28 days prior to study entry must meet the following criteria: * ANC must be greater than or equal to (≥) 1000/mm3, * Platelet count must be ≥ to 80,000/mm3; and * Hemoglobin must be ≥ 8 g/dL. (Note: transfusions may be used to correct hemoglobin for patients experiencing anemia from therapy who otherwise would be eligible for the study.) * Albumin greater than (\>) 3.0 g/dL. * The following criteria for evidence of adequate hepatic function performed within 28 days prior to study entry must be met: * Total bilirubin less than or equal to (≤) 1.5 x ULN * AST and ALT must be ≤ 3.0 x ULN for the lab. (Note: In patients with elevated ALT or AST, the values must be stable for at least 2 weeks and with no evidence of biliary obstruction on imaging.) * Creatinine must be ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 40mL/min. * All prior chemotherapy toxicities (excluding alopecia, amenorrhea, and peripheral neuropathy) must be less than (\<) Grade 2 at the time study therapy is to begin unless AE(s) are clinically stable on supportive therapy. * Patients must have no evidence of opportunistic infections. * Patients of childbearing potential must have a negative pregnancy per institutional policies prior to receiving the first dose of study therapy. * Male and female patients with reproductive potential must agree to use accepted effective methods of contraception while receiving study therapy and for at least 180 days (6 months) after the completion of study therapy. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the patient.

Exclusion Criteria:

* Colon cancer other than adenocarcinoma, e.g., sarcoma, lymphoma, carcinoid. * Patients with MSI-high (dMMR) tumors. * Use and/or receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, targeted therapy, biologic therapy, monoclonal anti-bodies) or radiation therapy within 4 weeks prior to receiving first dose of study therapy or associated with immune-mediated adverse events (imAEs) that were Grade ≥1 within 90 days prior to the first dose of study therapy or associated with toxicity that resulted in discontinuation of the immune-modulating agent. * History of active or latent tuberculosis (TB) infection. If the presence of TB (active or latent) is established, then treatment for TB must be completed according to local guidelines prior to the screening. * Active untreated or uncontrolled systemic fungal, bacterial, or viral infections, or active infection requiring systemic anti-infectious therapy. * Current or history of systemic autoimmune disease requiring systemic immunosuppressive therapy will not be allowed. Note: the following will not be exclusionary: 1) the presence of laboratory evidence of autoimmune disease (e.g., positive antinuclear antibody titer or lupus anticoagulant) without associated symptoms; 2) clinical evidence of vitiligo or other forms of depigmenting illness; 3) mild autoimmunity not impacting the function of major organs (e.g., controlled Hashimoto thyroiditis, limited psoriasis), Type I diabetes. * Patients will be excluded if they are on systemic steroid therapy that cannot be discontinued (except for the use of prednisone or equivalent \<0.125mg/kg/day as replacement therapy). Inhaled or topical steroids are permitted. * Receipt of live attenuated vaccination within 30 days prior to study entry. * Known active or chronic hepatitis B virus (HBV) or hepatitis C virus (HCB) infections. Note: Patients with a history of hepatitis C virus (HCV) infection must have been treated and with confirmation of cure, can be eligible. * History of allogeneic organ or bone marrow transplantation. * Any of the following cardiovascular conditions: * Documented NYHA Class II, III or IV congestive heart failure, * History of myocardial infarction (MI), angina pectoris, or coronary artery bypass graft (CABG) within 6 months prior to starting study treatment * Transient ischemic attack (TIA) or stroke within 1 year. * History of myocarditis * Troponin T (TnT) or troponin I (TnI) \> 2x institutional ULN at baseline. Patients with TnT or TnI levels between \> 1 to 2x ULN are permitted if repeat levels within 24 hours are ≤ 1x ULN. If TnT or TnI levels are \> 1 to 2x ULN within 24 hours, the subject may undergo a cardiac evaluation and be considered for treatment by the investigator based on medical judgement in the patient's best interest. * Active, documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis). * Major surgical procedure within 28 days prior to study entry. * Other malignancies: unless the patient is considered disease-free and has completed therapy for the malignancy greater than or equal to 36 months prior to study entry. Patients with the following cancers are eligible if diagnosed and definitively treated within the past 12 months: carcinoma in situ of the cervix, and basal cell and squamous cell carcinoma of the skin. Other in situ neoplasms will be reviewed by the Protocol Officer and/or Protocol Chair. * Psychiatric or addictive disorders or other conditions that in the opinion of the investigator would preclude the patient from meeting the study requirements or interfering with interpretation of study results. * Pregnancy or lactation at the time of study entry. * Use of any investigational agent within 28 days prior to the first dose of study therapy.

Interventions: DRUG: Cemiplimab, DRUG: cemiplimab plus fianlimab, DRUG: cemiplimab + REGN7075, OTHER: ctDNA testing

Conditions: Colo-rectal Cancer

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Study Locations

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Location	Contacts
Allegheny General Hospital Pittsburgh, Pennsylvania
Ballad Health Cancer Center - Kingsport Kingsport, Tennessee
Bon Secours St. Francis Medical Center Midlothian, Virginia
First Health of the Carolinas Pinehurst, North Carolina
Missouri Baptist St Louis, Missouri
University of Florida Gainesville, Florida
University of Iowa - Holden Comprehensive Cancer Center Iowa City, Iowa
University of Kansas Cancer Center Kansas City, Kansas
Virginia Commonwealth University - Massey Richmond, Virginia

A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes)

Contact(s):

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or - LillyTrials@Lilly.com

Principal Investigator:

System ID: NCT07165028

Show full eligibility criteria

Interventions: DRUG: Tirzepatide, DRUG: Retatrutide, DRUG: Placebo

Conditions: Metabolic Dysfunction-associated Steatotic Liver Disease

Keywords: Nonalcoholic Steatohepatitis, NASH, Fatty Liver, Fatty Liver Disease, SLD, Metabolic Dysfunction-Associated Fatty Liver Disease, MAFLD, Non-alcoholic Fatty Liver Disease, NAFLD, Hepatic Steatosis, Liver Related Outcomes, GLP1, Incretin, Non-Invasive Test

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Show 561 locations

Study Locations

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Location	Contacts
(G.I.R.I.) GI Research Institute Foundation Vancouver,
2nd Affiliated Hospital Chongqing Medical University Chongqing,
4 Medical Solutions, Ltd - London London,
4 Medical Solutions, Ltd - Manchester Clifton,
A.O.U. Policlinico Paolo Giaccone Palermo,
AMR Clinical Kansas City, Missouri
AMR Clinical Kansas City, Missouri
AMR Clinical Kansas City, Missouri
AMR Clinical Kansas City, Missouri
AZ Delta vzw Roeselare,
AZ Groeninge Campus Kennedylaan Kortrijk, West Flanders
AZ Maria Middelares Ghent,
AZ Oostende vzw Ostend,
Abe Clinic Ōita,
Aberdeen Royal Infirmary Aberdeen,
Acharya Vinoba Bhave Rural Hospital Wardha,
Adana Sehir Egitim ve Arastirma Hastanesi Adana,
Advanced Research Institute - Sandy Sandy City, Utah
Affiliated Hospital of Hangzhou Normal University Hangzhou,
Akron Gastro Research Akron, Ohio
All India Institute of Medical Sciences New Delhi,
All India Institute of Medical Sciences New Delhi,
All India Institute of Medical Sciences (AIIMS) - Nagpur Nagpur,
All India Institute of Medical Sciences - Rishikesh Rishikesh,
American Research Corporation Austin, Texas
American Research Corporation at Texas Liver Institute San Antonio, Texas
Amrita Institute of Medical Sciences and Research Center Ernākulam,
Amsterdam UMC, Locatie AMC Amsterdam,
Ankara Bilkent Sehir Hastanesi Ankara,
Antwerp University Hospital Edegem,
Aotearoa Clinical Trials Auckland,
Aotearoa Clinical Trials - Whangarei Whangarei,
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division Troy, Michigan
Ark Clinical Research Long Beach, California
Ark Clinical Research - Fountain Valley Fountain Valley, California
Arkansas Gastroenterology - North Little Rock North Little Rock, Arkansas
Artemis Institute For Clinical Research Riverside, California
Asahikawa Medical University Hospital Asahikawa,
Asan Medical Center SongpaGu, Seoul Teugbyeolsi
Asian Institute Of Gastroenterology Hyderabad,
Associação Protectora dos Diabéticos de Portugal Lisbon,
Assuta Medical Center Tel Aviv,
Atlantic Health System Morristown Medical Center Morristown, New Jersey
Austin Health Heidelberg, Victoria
Avant Sante Research Center San Pedro Garza García,
Avron Hospitals Ahmedabad,
Azienda Ospedale - Università Padova Padova,
Azienda Ospedaliera Universitaria Careggi Florence,
Azienda Ospedaliera Universitaria Federico II Naples,
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino Torino,
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII Bergamo, Lombardy
Barzilai Medical Center Ashkelon,
Beijing Ditan Hospital Beijing,
Beijing Friendship Hospital Affiliate of Capital University Beijing,
Beijing Youan Hospital Beijing,
Bell Land General Hospital Sakai,
Bellaire Clinical Research Bellaire, Texas
Biopharma Informatic, LLC McAllen, Texas
Biopharma Informatic, LLC McAllen, Texas
Boramae Medical Center Dongjak-gu,
Box Hill Hospital Box Hill, Victoria
Bursa Şehir Hastanesi Bursa,
CAMC Health Education and Research Institute Inc Charleston, West Virginia
CEDOES Vitória,
CEINV Salud Monterrey,
CHD Vendee La Roche-sur-Yon,
CHN - Complexo Hospitalar de Niterói Niterói,
CHOP - Hospital Universitario Montecelo Pontevedra,
CHU Besancon Besançon, Cedex
CHU Bordeaux Haut-Leveque Pessac,
CHU Rangueil Toulouse,
CHU d'Amiens-Picardie - Hopital SUD Amiens,
CHUAC-Complejo Hospitalario Universitario A Coruña A Coruña, A Coruña [LA Coruña]
CIPREC Buenos Aires,
CPHosp Medicina, Ensino e Pesquisa (CPQuali) São Paulo,
CRIOH Westlake, Ohio
CRZ Vidnovlennya Zhytomyr,
California Liver Research Center Pasadena, California
Capital Digestive Care - Chevy Chase Chevy Chase, Maryland
Care Access - Delray Beach Delray Beach, Florida
Care Access - Houston Houston, Texas
Care Access - New Iberia New Iberia, Louisiana
Care Access - Ogden Ogden, Utah
Care Access - St. Petersburg St. Petersburg, Florida
Care Access - Tamarac Tamarac, Florida
Care Access - Yonkers Yonkers, New York
Care United Research, LLC Forney, Texas
Carmel Hospital Haifa,
Carteret Medical Group Morehead City, North Carolina
Cathay General Hospital Taipei,
Center of Family Medicine Plus Kyiv,
Centre Hospitalier Lyon Sud Pierre-Bénite,
Centre Hospitalier Universitaire Brugmann Brussels,
Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand Dijon,
Centre Hospitalier Universitaire d'Angers Angers,
Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren Limoges,
Centre Hospitalier Universitaire de Nice - Hopital L'archet Nice,
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou Rennes,
Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares Mexico City,
Centro Hospitalar Universitario Lisboa Norte, E.P.E. - Hospital de Santa Maria Lisbon,
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada Buenos Aires,
Centro Multidisciplinar de Estudos Clinicos São Bernardo do Campo,
Centro Médico Lic. Arturo Montiel Rojas ISSEMYM Metepec,
Centro Médico Viamonte Buenos Aires,
Centro de Diagnóstico y Rehabilitación (CEDIR) Santa Fe,
Centro de Investigacion y Gastroenterologia Mexico City,
Centro de Investigaciones Clínicas Baigorria Granadero Baigorria,
Centro de Investigaciones Metabólicas (CINME) Buenos Aires,
Centro de Investigación Clínica y Medicina Traslacional (CIMeT) Guadalajara,
Centro de Investigación y Gastroenterología - S.C. Mexico City,
Centro de Pesquisa Clinica do Brasil Lago Sul,
Centrum Badan Klinicznych PI-House Sp. z o.o. Gdansk,
Centrum Medyczne Pratia Katowice Katowice,
Chang Gung Medical Foundation-LinKou Branch Taoyuan,
Chang Gung Memorial Hospital at Kaohsiung Kaohsiung City,
Charite Campus Virchow-Klinikum Berlin,
Charter Research - Orlando Orlando, Florida
Chi Mei Medical Center Tainan,
Chiayi Christian Hospital Chiayi City,
China Medical University Hospital Taichung,
Chronos Pesquisa Clinica Brasília,
Chung-Ang University Hospital Dongjak-gu, Seoul-teukbyeolsi [seoul]
Cicemo Srl Buenos Aires,
Cline Research Center Curitiba,
Clinica de Enfermedades Cronicas y Procedimientos Especiales, SC Morelia,
Clinical Diagnostic Center Ivano-Frankivsk,
Clinical Research Institute of Michigan, LLC Clinton Township, Michigan
Clinical Research of Ontario Scarborough Village, Ontario
Clinical Research of Philadelphia Pennington, New Jersey
Clinical Trials of Texas, LLC dba Flourish Research San Antonio, Texas
Cliniques Universitaires Saint-Luc Brussels,
Clínica Hepatogastro JK São Paulo,
Columbia Digestive Health Research Columbia, South Carolina
Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval Ferrol,
Consano Clinical Research, LLC Shavano Park, Texas
Constanta County Emergency Clinical Hospital Sf.Ap.Andrei Constanța,
Core Research Group Brisbane,
Cotton O'Neil Digestive Health Center Topeka, Kansas
Covenant Metabolic Specialists - Riverview Riverview, Florida
Covenant Metabolic Specialists, LLC University Park, Florida
DHR Health Institute for Research and Development (Administrative Office & Laboratory) McAllen, Texas
DIM Clinica Privada Ramos Mejía,
DOM Centro de Reumatología Buenos Aires,
Dallas Research Institute Farmers Branch, Texas
Dayanand Medical College and Hospital Ludhiana,
Dayton Gastroenterology - Beavercreek Beavercreek, Ohio
Deaconess Clinic- Gateway Newburgh, Indiana
Debreceni Egyetem Klinikai Kozpont Debrecen,
Del Sol Research Management, LLC Tucson, Arizona
Delta Health Care Bucharest,
Delta Research Partners of Bastrop, LLC Bastrop, Louisiana
Delta Research Partners of West Monroe West Monroe, Louisiana
Deutsches Diabetes-Zentrum (DDZ) Düsseldorf,
Diex Recherche Inc. Division Trois-Rivieres Trois-Rivières,
Diex Recherche Quebec Québec,
Digestive Research Alliance of Michiana South Bend, Indiana
Duke University - Main Hospital and Clinics Durham, North Carolina
E-DA Hospital Kaohsiung City,
ETG Zamosc Zamość,
EUGASTRO GmbH Leipzig,
Ecogene-21 Chicoutimi,
Edelweiss Medics Kyiv,
Ehime University Hospital Ehime, Toon,
Encore Borland-Groover Clinical Research Jacksonville, Florida
Encore Medical Research Hollywood, Florida
Epic Medical Research - DeSoto DeSoto, Texas
Epic Medical Research-Sun City Sun City, Arizona
Erasmus Medisch Centrum Rotterdam,
Evolution Clinical Trials Hialeah Gardens, Florida
Excel Clinical Research, LLC Las Vegas, Nevada
Eximia Research - Norfolk Norfolk, Virginia
Faculdade de Medicina da UNESP Botucatu,
Fakultni Nemocnice Ostrava Ostrava,
Fiona Stanley Hospital Murdoch, Western Australia
Flinders Medical Centre Bedford PK, South Australia
Florida Research Institute Lakewood Rch, Florida
Floridian Clinical Research, LLC Miami Lakes, Florida
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milan,
Fondazione Policlinico Universitario Agostino Gemelli Roma, Roma
Fondazione Policlinico Universitario Campus Bio-Medico Rome,
Fortis Hospital - Mohali Mohali,
Freeman Hospital Newcastle upon Tyne,
Fresno Clinical Research Center Fresno, California
Fu Jen Catholic University Hospital New Taipei City,
Fujian Medical University Mengchao Hepatobiliary Hospital (Fuzhou Infectious Disease Hospital) Fuzhou,
Fukuoka University Chikushi Hospital Chikushino-shi,
Fukuoka University Hospital Fukuoka, Fukuoka,
Fundacion Respirar Buenos Aires,
Fundación Santos y de la Garza Evia I.B.P San Pedro Garza García, Nuevo León
Fundação Pio XII - Hospital de Câncer de Barretos Barretos,
GI Alliance - Fort Worth Fort Worth, Texas
GI Alliance - Southlake Southlake, Texas
GI Associates - GIA and Endoscopy Center - Flowood Flowood, Mississippi
GI PROS Research Naples, Florida
Galen Medical Group - Galen Hepatology Chattanooga, Tennessee
Gallipoli Medical Research Ltd Brisbane,
Gastro One (Walnut Run Road) Cordova, Tennessee
Gastroenterology Consultants of Southwest Virginia Roanoke, Virginia
Gastroenterology Health Partners New Albany, Indiana
Gastrointestinal Specialists of Georgia Marietta, Georgia
General Hospital of Ningxia Medical University Ningxia,
Genesis Research Services Broadmeadow,
Gifu Municipal Hospital Gifu, Gifu,
Glenny Corp. S.A. Buenos Aires,
Gold Coast University Hospital Southport,
Great Lakes Research Institute Southfield, Michigan
Groupe hospitalier mutualiste Les Portes du sud Vénissieux,
Grupo Medico Camino Sc Mexico City,
Guangzhou 8th People's Hospital Guangzhou,
Guizhou Provincial People's Hospital Guiyang,
Gyeongsang National University Hospital Jinju,
Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero Katowice,
HRI Pasadena Pasadena, Texas
HRI- Medical Center Houston, Texas
Hacettepe Universitesi Ankara,
Hadassah Medical Center Jerusalem,
Hamamatsu University Hospital Shizuoka, Hamamatsu,
Hamanomachi Hospital Fukuoka,
Hanyang University Guri Hospital Guri-si,
Hanyang University Seoul Hospital Seoul,
Headlands Horizons, LLC dba Headlands Research-Brownsville Brownsville, Texas
Headlands Research Orlando Orlando, Florida
Health Awareness Jupiter, Florida
Health Sciences Centre Winnipeg Winnipeg,
Heritage Medical Research Clinic Calgary,
Herz - und Diabeteszentrum Nordrhein - Westfalen, Bad Oeynhausen Bad Oeynhausen,
Hiroshima University Hospital Hiroshima,
Hokkaido University Hospital Sapporo, Hokkaido
Hopital Beaujon Clichy,
Hopital Claude Huriez - CHU de Lille Lille, NORD
Hopital Saint Antoine Paris,
Hospital Brasilia Lago Sul,
Hospital Clinico de Valencia Valencia,
Hospital General Universitario Gregorio Marañon Madrid,
Hospital General de Occidente Zapopan,
Hospital Germans Trias I Pujol Badalona, Barcelona [barcelona]
Hospital Infanta Elena Huelva,
Hospital Moinhos de Vento Porto Alegre,
Hospital Universitari Son Espases Palma,
Hospital Universitari Vall d'Hebron Barcelona,
Hospital Universitari i Politécnic La Fe Valencia,
Hospital Universitario Joao de Barros Barreto Belém,
Hospital Universitario La Paz Madrid,
Hospital Universitario Marqués de Valdecilla Santander,
Hospital Universitario Virgen del Rocio Seville,
Hospital Universitario Walter Cantidio Fortaleza,
Hospital das Clinicas FMUSP São Paulo,
Hospital de Clínicas de Porto Alegre Porto AlegreRS,
Houston Research Institute Houston, Texas
Houston Research Institute (HRI) - Sugar Land Sugar Land, Texas
Hunan Provincial People's Hospital Changsha, Hunan
Hyogo Medical University Hospital Nishinomiya,
Hyogo Prefectural Amagasaki General Medical Center AmagasakiCity, Hyōgo
IBPClin - Instituto Brasil de Pesquisa Clínica Rio de Janeiro,
ID Clinic Mysłowice,
IMA Clinical Research Austin Austin, Texas
IMA Clinical Research Manhattan New York, New York
IMA Clinical Research San Antonio San Antonio, Texas
IMA Clinical Research Warren Warren Township, New Jersey
IMV Pesquisa Cardiologica - Porto Alegre - Rua Orfanotrofio Porto Alegre,
INECO Neurociencias Oroño Rosario,
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola Bologna,
IRCCS Istituto Clinico Humanitas Rozzano,
Indiana University Health University Hospital Indianapolis, Indiana
Inha University Hospital Incheon,
Inovace Pesquisa Clínica Salvador,
Institute of Science Tokyo Hospital Bunkyoku, Tokyo
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Mexico City,
Instituto de Diabetes, Obesidad y Nutricion Cuernavaca,
Instituto de Investigaciones Clinicas Mar del Plata Mar del Plata, Buenos Aires
Instituto de Investigaciones Clínicas Córdoba Córdoba,
Instituto de Investigaciones Clínicas Rosario Rosario,
Instituto de Pesquisa Clinica de Campinas Campinas, São Paulo
Instituto do Fígado e Tranplantes de Pernambuco Recife,
Institutul Regional de Gastroenterologie și Hepatologie Prof. Dr. Octavian Fodor Cluj-Napoca,
International University of Health and Welfare Narita Hospital Narita, Chiba
Iowa Diabetes and Endocrinology Research Center West Des Moines, Iowa
Ipswich Hospital Ipswich,
Ipswich Hospital Ipswich,
Isis Clinical Research Center Guaynabo,
Iwate Medical University Hospital Shiwa-gun,
Japanese Red Cross Musashino Hospital Musashino,
Jiangsu Province Hospital Nanjing, Jiangsu
Jichi Medical University Hospital Shimotsuke,
Jinhua Central Hospital Jinhua,
John C. Martin Centre for Liver Research & Innovations (JCMLRI) Kolkata,
Johnson County Clinical Trials Lenexa, Kansas
Jubilee Clinical Research NV. LLC Las Vegas, Nevada
Juntendo University Hospital Bunkyō City,
Juntendo University Shizuoka Hospital Shizuoka, Izunokuni,
K2 MEDICAL Research THE VILLAGES Lady Lake, Florida
K2 Medical Research - Daytona Beach Daytona Beach, Florida
K2 Medical Research WINTER GARDEN Clermont, Florida
KRESMED Sp. z o.o. Bialystok,
Kagawa Prefectural Central Hospital Takamatsu,
Kagawa University Hospital Kita-gun,
Kagoshima University Hospital Kagoshima, Kagoshima-ken
Kansai Rosai Hospital Amagasaki,
Kantonsspital Olten Olten,
Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung City,
Karadeniz Teknik Universitesi Tip Fakultesi Trabzon,
Karolinska Universitetssjukhuset Huddinge Huddinge,
Keimyung University Dongsan Hospital Daegu, Taegu-kwangyǒkshi
King's College Hospital London,
Klinical Investigations Group San Juan,
Klinik Landstraße Vienna,
Knowledge Research Center Orange, California
Kohler & Milstein Research S.A. De C.V. Mérida,
Korea University Ansan Hospital Ansan-si, Kyǒnggi-do
Krajská nemocnice Liberec Liberec,
Kumamoto Shinto General Hospital Kumamoto,
Kumamoto University Hospital Kumamoto,
Kurume University Hospital Fukuoka,
Kyungpook National University Hospital Daegu,
Landesklinikum Wiener Neustadt Wiener Neustadt,
Leids Universitair Medisch Centrum Leiden,
Liaocheng People's Hospital Liaocheng,
Limited liability company "Medical center Health Clinic" Vinnytsia,
Lisie Hospital Kochi, Kerala
Liverpool University Hospitals NHS Foundation Trust Liverpool,
Los Angeles Institute for Metabolic Research Los Angeles, California
Louisiana Research Center Shreveport, Louisiana
Lucida Clinical Trials New Bedford, Massachusetts
Luzern Kantonsspital Lucerne,
MFA Clinical Research Tuscaloosa, Alabama
MNGI Digestive Health Minneapolis, Minnesota
MTZ Clinical Research powered by Pratia Warsaw,
Maccabi Health Services - Petah Tikva Petah Tikva,
Mater Misericordiae Limited Brisbane,
Mautalen Salud e investigación CABA, Buenos Aires
Medbud Clinic Kyiv,
Medical Associates Research Group San Diego, California
Medical Center Metas Chihuahua City,
Medical Center Ok!Clinic+ Kyiv,
Medical Center Salutem Vinnytsia,
Medical Center of Limited Liability Company "Medical Center "Consilium Medical" Kiev,
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś Warsaw,
Medical Research Center of Connecticut Hamden, Connecticut
Medizinische Hochschule hannover Hanover,
Medizinische Universität Graz Graz,
Medizinische Universität Wien Vienna,
Medrasa Clinical Research Wylie, Texas
Meitetsu Hospital Nagoya,
Mercy Medical Center - Baltimore Baltimore, Maryland
Mestska nemocnice Ostrava Ostrava,
Midas Multispeciality Hospital Pvt.Ltd. Nagpur,
Mie University Hospital Tsu, Mie-ken
Monroe Biomedical Research Monroe, North Carolina
Municipal Nonprofit Enterprise "Vinnytsia Regional Clinical Hospital n.a. M. I. Pyrohov of Vinnytsia Regio -T Vinnytsia,
Mysore Medical College Mysore,
NUPEC - Cardio Belo Horizonte,
NYU Langone Health New York, New York
NZOZ GynCentrum - Oddział Warszawa Warsaw,
Nagano Municipal Hospital Hanishina-gun,
Nagasaki University Hospital Nagasaki,
Nagoya City University Hospital Nagoya,
Nara Medical University Hospital Nara, Kashihara,
National Center for Global Health and Medicine Shinjuku, Tokyo
National Cheng Kung University Hospital Tainan,
National Hospital Organization Nagasaki Medical Center Ōmura,
National Hospital Organization Osaka National Hospital Osaka,
National Hospital Organization Takasaki General Medical Center Takasaki-shi,
National Hospital Organization Ureshino Medical Center Ureshino,
National Kohnodai Medical Center Ichikawa,
National Taiwan University Hospital Taipei,
Nature Coast Clinical Research - Inverness Inverness, Florida
New York Gastroenterology Associates New York, New York
New Zealand Clinical Research (Auckland) Auckland,
NewData Clinical Research - Aracaju Aracaju,
Nightingale Research Adelaide, South Australia
Nihon University Itabashi Hospital Tokyo, Itabashi-ku,
Ningbo 2nd Hospital Ningbo,
Ningbo Medical Center Ningbo,
Nouvel Hôpital Civil (NHC) Strasbourg,
Ogaki Municipal Hospital Ōgaki, Gifu
Oita Cardiovascular Hospital Ōita,
Okayama University Hospital Okayama,
Om Research LLC Lancaster, California
Oncare Vasconcelos San Pedro Garza García,
Orange County Research Center Lake Forest, California
Osaka General Medical Center Osaka,
Osaka Keisatsu Hospital Osaka,
Osaka Metropolitan University Hospital Osaka, Osaka
Osaka Rosai Hospital Sakai,
Osaka Saiseikai Suita hospital Suita,
Oslo Universitetssykehus Ullevål Oslo,
Panthera Biopartners - Glasgow Glasgow,
Panthera Biopartners - Manchester Rochdale,
Panthera Biopartners - North London Enfield,
Panthera Biopartners - Preston Preston,
Panthera Biopartners - Sheffield Sheffield,
Panthera Clinic - York York,
Państwowy Instytut Medyczny MSWiA Warsaw,
Peking University People's Hospital Beijing, Beijing Municipality
Peking University Shenzhen Hospital Shenzhen,
Penn Medicine: University of Pennsylvania Health System Philadelphia, Pennsylvania
PingXiang People's Hospital Pingxiang,
Pinnacle Clinical Research Austin, Texas
Pitie Salpetriere University Hospital Paris,
Postgraduate Institute of Medical Education & Research Chandigarh,
Prince of Wales Hospital Shatin,
Private Practice - Dr. Arechavaleta Granell Maria del Rosario Guadalajara,
Private Practice - Dr. Lukasz Krupa Rzeszów,
Private Practice - Dr. Stephane M. Gauthier North Bay,
Progastro Clinic Lviv,
Progress Clinical Research - Den Bosch 's-Hertogenbosch,
Progress Clinical Research - Zwolle Zwolle,
Progressive Medical Research Port Orange, Florida
Przychodnie Care Access Warsaw,
Pusan National University Yangsan Hospital Yangsan, Gyeongsangnam-do
QEII Health Sciences Centre - Victoria General Site Halifax,
Queen Mary Hospital Hong Kong,
Quest Clinical Research San Francisco, California
Rabin Medical Center Petah Tikva,
Radboudumc Nijmegen,
Rambam Health Care Campus Haifa,
Recep Tayyip Erdogan University Training and Research Hospital Rize,
Research Foundation of SUNY - University of Buffalo Buffalo, New York
Research Physicians Network, LLC Houston, Texas
Richmond Veterans Affairs Medical Center (Richmond VA Medical Center) Richmond, Virginia
Rophe Adult and Pediatric Medicine/SKYCRNG Union City, Georgia
Royal Brisbane and Women's Hospital Herston, Queensland
Royal Free Hospital London,
Royal London Hospital London,
Ruijin Hospital Shanghai Jiaotong University School of Medicine Shanghai,
Ruppiner Kliniken Neuruppin,
Ruschel Medicina e Pesquisa Clínica Rio de Janeiro,
SR Kalla Memorial Gastro & General Hospital Jaipur,
Saga University Hospital Saga,
Saint Marina Hospital Pleven,
Saiseikai Maebashi Hospital Maebashi,
Samsung Medical Center GangnamGu, Seoul Teugbyeolsi
San Fernando Valley Health Institute Canoga Park, California
Sanjay Gandhi Post Graduate Institute of Medical Sciences Lucknow,
Santa Familia PTG Lodz Lodz,
Sekino Hospital Toshimaku,
Seoul National University Hospital Seoul, Seoul Teugbyeolsi
Severance Hospital, Yonsei University Health System Seoul,
Severance Hospital, Yonsei University Health System Seoul,
Shaare Zedek Medical Center Jerusalem,
Sheba Medical Center Ramat Gan,
Shengjing Hospital of China Medical University Shenyang,
Shimane University Hospital Izumo,
Sichuan Provincial People's Hospital Chengdu,
Sir Ganga Ram Hospital New Delhi,
Soma Clinical Trials Denison, Texas
Soon Chun Hyang University Bucheon Hospital Bucheon-si,
Soroka Medical Center Beersheba,
Sourasky Medical Center Tel Aviv,
South Denver Gastroenterology Engelwood, Colorado
South Texas Research Institute Edinburg, Texas
South Texas Research Institute - Brownsville Brownsville, Texas
Southeast Clinical Research Center Dalton, Georgia
Southern Endocrinology Associates Mesquite, Texas
Southern Medical University Nanfang Hospital Guangzhou,
Southwest Gastroenterology Associates Albuquerque, New Mexico
Southwest General Healthcare Center Fort Myers, Florida
Spectrum Research Institute Gilbert, Arizona
Spital Judetean de Urgenta Satu Mare,
Spitalul Clinic Colentina Bucharest,
St. Joseph's Health Centre Toronto,
St. Marianna University Hospital Kawasaki-shi,
Städtisches Klinikum Brandenburg Brandenburg,
Surat Institute of Digestive Sciences Hospitals Surat,
Szabolcs Szatmár Bereg Vármegyei Oktatókórház Nyíregyháza,
Szpital Czerniakowski Warsaw,
T.C. Sağlik Bakanliği- Marmara Üniversitesi İstanbul Pendik Eğitim Ve Araştirma Hastanesi Pendik,
Taichung Veterans General Hospital Taichung,
Taipei Medical University Hospital Taipei,
Taipei Tzu Chi General Hospital New Taipei City,
Taipei Veterans General Hospital Taipei,
Tampa Bay Medical Research - Largo Largo, Florida
Tandem Clinical Research Marrero, Louisiana
Tandem Clinical Research - Freehold Freehold, New Jersey
Teak Research Consults Lawrenceville, Georgia
Texas Valley Clinical Research Weslaco, Texas
The Affiliated Hospital of Guizhou Medical University Guiyang,
The Affiliated Hospital of Southwest Medical University Luzhou,
The Catholic Univ. of Korea Seoul St. Mary's Hospital Seoul,
The Catholic University of Korea, Eunpyeong St. Mary's Hospital Seoul, Seoul-teukbyeolsi [seoul]
The Cognitive and Research Center of New Jersey - Ridgewood Ridgewood, New Jersey
The First Affiliated Hospital of Henan University of Science &Technology Luoyang,
The First Affiliated Hospital of Nanyang Medical College Nanyang,
The First Affiliated Hospital of Ningbo University Ningbo,
The First Affiliated Hospital of Wenzhou Medical University Wenzhou, Zhejiang
The First Affiliated Hospital of Xi'An Jiaotong University Xi'an,
The First Affiliated hospital of Fujian Medical University Fuzhou,
The First People's Hospital of Foshan Foshan,
The First affiliated hospital of Nanchang University (Xianghu campus) Nanchang,
The Institute for Liver Health II dba Arizona Clinical Trials - Chandler Chandler, Arizona
The Institute for Liver Health II dba Arizona Clinical Trials - Tucson Tucson, Arizona
The Institute for Liver Health II dba Arizona Liver Health - Peoria Peoria, Arizona
The John Radcliffe Hospital Oxford,
The Royal Melbourne Hospital Parkville, Victoria
The Second Affiliated Hospital of Nanchang University Nanchang, Jiangxi
The Second Xiangya Hospital of Central South University Changsha,
The Third Hospital of Hebei Medical University Shijiazhuang,
The University of Osaka Hospital Suita,
The University of Tokyo Hospital Bunkyo-ku, Tokyo
Tianjin People' s Hospital Tianjin,
Tokyo Medical University Hospital Tokyo,
Tokyo Metropolitan Komagome Hospital Bunkyō City,
Tokyo Saiseikai Central Hospital Minatoku,
Tokyo Women's Medical University Tokyo,
Topiwala National Medical College & B. Y. L. Nair Charitable Hospital Mumbai,
Toranomon Hospital Tokyo, Minato-ku,
Toronto General Hospital Toronto, Ontario
TrialsWest - Osborne Park Osborne Park,
Tuen Mun Hospital Tuenmen,
UCSD - Altman Clinical and Translational Research Institute (ACTRI) La Jolla, California
UMHATEM 'N.I. Pirogov' Sofia,
US Digestive Health - Flourtown Flourtown, Pennsylvania
US Digestive Health - Wyomissing Wyomissing, Pennsylvania
UW Medicine Diabetes Institute Seattle, Washington
UZ Brussel Brussels, Brussels Capital
UZ Gent Ghent, Oost-Vlaanderen
Unidad de Investigación Clínica y Atención Médica HEPA S.C. Guadalajara,
Uniklinikum Salzburg Salzburg,
United Medical Doctors - Murrieta Murrieta, California
Universidade Federal de Goias Goiânia,
Universidade Federal do Rio de Janeiro Barra,
UniversitaetsKlinikum Heidelberg Heidelberg,
Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden Dresden,
Universitaetsklinikum Des Saarlandes Homburg,
Universitair Medisch Centrum Utrecht Utrecht,
Universitatsklinikum Leipzig Leipzig,
Universitetssjukhuset i Linköping Linköping,
Universitetssykehuset Nord-Norge HF Tromsø,
University Gastroenterology Providence, Rhode Island
University Hospital "St. Ivan Rilski" Gorna Oryahovitsa,
University Hospital - London Health Sciences Centre London,
University Hospital Basel Basel,
University Hospital,Kyoto Prefectural University of Medicine Kyoto,
University of Alberta Hospital Edmonton, Alberta
University of Colorado Anschutz Medical Campus Aurora, Colorado
University of Florida College of Medicine Jacksonville, Florida
University of the Ryukyus Hospital Ginowan,
Universitätsklinikum Frankfurt Goethe-Universität Frankfurt,
Universitätsmedizin Johannes Gutenberg Universität Mainz Mainz,
Université Libre de Bruxelles - Hôpital Erasme Brussels, Bruxelles-capitale, Région de
Uniwersyteckie Centrum Stomatologii i Medycyny Specjalistycznej Poznan,
VITAZ Sint-Niklaas,
Vancouver General Hospital Vancouver,
Virginia Commonwealth University (VCU) Medical Center Richmond, Virginia
Vseobecna Fakultni Nemocnice v Praze Prague,
Washington Gastroenterology - Bellevue Bellevue, Washington
Washington Gastroenterology - Tacoma Tacoma, Washington
Wells Research Group Edmonton,
Westmead Hospital Westmead, New South Wales
Wonju Severance Christian Hospital Wŏnju, Kang-won-do
Xiangya Hospital Central South University Changsha,
Xinhua Hospital Affiliated To Shanghai Jiaotong University School of Medicine Shanghai,
Yamagata University Hospital Yamagata, Yamagata
Yamanashi Prefectural Central Hospital Kofu,
Yeungnam Univeristy Medical Center Nam-gu,
Yokohama City University Hospital Yokohama,
Zhongshan Hospital,Fudan University Shanghai,
Zhoukou Central Hospital Zhoukou,
hospital Italiano de Buenos Aires Ciudad Autonoma Buenos Aires,
Çukurova Üniversitesi Tıp Fakültesi Adana Hastanesi Adana,
Óbudai Egészségügyi Centrum Budapest,

Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.

Contact(s):

Novartis Pharmaceuticals - novartis.email@novartis.com

Principal Investigator:

System ID: NCT06846281

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Interventions: DRUG: Remibrutinib oral treatment, DRUG: Ocrelizumab

Conditions: Relapsing Multiple Sclerosis

Keywords: MS, RMS, Remibrutinib, LOU064, Ocrelizumab, Age, MRI, T2 lesions, NEDA-3

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Study Locations

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Location	Contacts
Advent Health Orlando Orlando, Florida	McKinzie McTyeire - (mckinzie.mctyeire@adventhealth.com)
Aqualane Clinical Research Naples, Florida	Taylor Kerskie - (taylor@aqualaneresearch.com)
Austin Regional Clinic Austin, Texas	Katerina Rodriguez - (krodriguez@innovoresearch.com)
Center for Neurological Disorders G Greenfield, Wisconsin	Emily Barraza - (Emily.barraza@cndmilwaukee.com)
Cleveland Clinic Foundation Cleveland, Ohio	Laurinda Keelen - (keelenl@ccf.org)
Cleveland Clinic Foundation Cleveland, Ohio	Dawn Maniawski - (maniawd@ccf.org)
Holy Name Medical Center Teaneck, New Jersey	Diome Kramer - (dkramer@holyname.org)
John Peter Smith Hospital Fort Worth, Texas	Valentina Jovic - (Vjovic@jpshealth.org)
Lahey Hospital and Medical Center Burlington, Massachusetts	Anish Panda - (Anish.Panda@lahey.org)
MedStar Montgomery Medical Center Olney, Maryland	Yemisrach Tadesse - (yemisrach.g.tadesse@medstar.net)
Medical College of Wisconsin Milwaukee, Wisconsin	Anna Freiberg - (afreiberg@mcw.edu)
Medstar Washington Hospital Center Washington D.C., District of Columbia	Anu Bhooshan - (anu.r.bhooshan@medstar.net)
Memorial HC Ins for Neuroscience Owosso, Michigan	Samantha Katt - (skatt@memorialhealthcare.org)
Michigan Institute of Neurological Farmington Hills, Michigan	Emily Blazejewski - (eblazejewski@mindonline.com)
Neurology Associates PA Maitland, Florida	Kelly Holley - (admin@naparesearch.com)
Neurology Center of New England PC Foxborough, Massachusetts	Brianne Calitri - (bcalitri@neurocenterne.com)
Neurology of Central FL Res Ctr Altamonte Springs, Florida	Adiana Perez - (adiresearchcfl@gmail.com)
Novartis Investigative Site Leicester,
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Ohio Health Research Institute Columbus, Ohio	Megan Heckathorn - (Megan.Heckathorn@ohiohealth.com)
Orlando Health Clinical Trials Orlando, Florida	Charlene Carlo - (Charlene.carlo@orlandohealth.com)
Perseverance Research Center Scottsdale, Arizona	Adriana Romero - (aromero@prcresearcheducation.com)
Premier Health Centerville, Ohio	Don McHone - (djmchone@premierhealth.com)
Premier Neurology Greenville, South Carolina	Jada Crawford - (jada.c@premier-neuro.com)
Rush University Medical Center Chicago, Illinois	Rebecca Mc Williams - (rebecca_mcwilliams@rush.edu)
SUNY Buffalo The Jacobs Neuro Inst Buffalo, New York	Kara Patrick - (kpatrick@buffalo.edu)
Sanford Health Fargo, North Dakota	Destini Spaeth - (destini.spaeth@sanfordhealth.org)
Saturn Research Solutions LLC Plano, Texas	Maxine Fligg - (mfligg@saturnclinical.com)
Sibyl Wray MD Neurology PC Knoxville, Tennessee	Kim Puccio - (kpuccio@hopeneuro.com)
Tallahassee Neurological Clinic Tallahassee, Florida	Sharon Devore - (sharondevore@hotmail.com)
Tufts Medical Center Boston, Massachusetts	Ashley Paro - (ashley.paro@tuftsmedicine.org)
Univ of Cincinnati Medical Center Cincinnati, Ohio	Gideon Gyebi - (gyebign@ucmail.uc.edu)
Univ of Texas Southwest Med Center Dallas, Texas	Manuel Huichapa - (manuel.huichapa@utsouthwestern.edu)
University of California Irvine Irvine, California	Michelle Tanumiharja - (tanumihm@hs.uci.edu)
University of Florida Gainesville, Florida	Whitney Miller - (wjm1433@ufl.edu)
University of Kansas Hospital Kansas City, Kansas	Vonda Whitley - (vwhitley@kumc.edu)
University of New Mexico Albuquerque, New Mexico	Emily Reese - (ejreese@salud.unm.edu)
University of South Florida Tampa, Florida	Amber McPherson - (amjackson@usf.edu)
Velocity Clinical Research Seattle, Washington	Harsh Patel - (HPatel@velocityclinical.com)
Vero Beach Neurology Vero Beach, Florida	Clellia Bergamino - (cbergamino@geodysseyrsch.com)
Virginia Commonwealth University Richmond, Virginia	Aarati Pokharel - (aarati.pokharel@vcuhealth.org)
WA Uni School Of Med St Louis, Missouri	Kiontay Watson - (k.watson@wustl.edu)

Modeling Mortality in Duchenne Muscular Dystrophy Cardiomyopathy: Identification of Surrogate Outcome Measures for DMD Drug Trials

Contact(s):

Jonathan Soslow, MD, MSCI - DMDMachineLearning@vumc.org

Principal Investigator:

System ID: NCT07674758

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Conditions: Duchenne Muscular Dystrophy (DMD), Cardiomyopathy, Becker Muscular Dystrophy, Carrier of Duchenne Muscular Dystrophy

Keywords: Duchenne Muscular Dystrophy, cardiomyopathy, machine learning, cardiac MRI, Biomarker, Outcome measures

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Location	Contacts
Children's Hospital of Richmond at VCU Richmond, Virginia	Study Coordinator - (DMDmachinelearning@vumc.org)
Children's National Washington D.C., District of Columbia	Study Coordinator - (DMDmachinelearning@vumc.org)
Duke Children's Hospital Durham, North Carolina	Study Coordinator - (DMDmachinelearning@vumc.org)
Lurie Children's Chicago, Illinois
Nationwide Children's Columbus, Ohio	Study Coordinator - (DMDmachinglearning@vumc.org)
Riley Children's Hospital Indianapolis, Indiana	Study Coordinator - (DMDMachineLearning@vumc.org)
Seattle Children's Seattle, Washington	Study Coordinator - (DMDmachinelearning@vumc.org)
UC Davis Sacramento, California	Study Coordinator - (DMDmachinelearning@vumc.org)
Vanderbilt University Medical Center Nashville, Tennessee	Study Coordinator - (DMDMachineLearning@vumc.org)

Study of Intralesional Cemiplimab in Adult Patients With Early Stage Cutaneous Squamous Cell Carcinoma

Contact(s):

Clinical Trials Administrator - clinicaltrials@regeneron.com

Principal Investigator:

System ID: NCT06585410

Show full eligibility criteria

Interventions: DRUG: Cemiplimab, PROCEDURE: Standard of care

Conditions: Cutaneous Squamous Cell Carcinoma (CSCC)

Keywords: Dermato-Oncology, Cemiplimab, Early Stage, Skin Cancer, Non-Melanoma Skin Cancer, UV Skin Damage, Chronic Sun Exposure

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Location	Contacts
Arkansas Research Trials North Little Rock, Arkansas
Buckeye Dermatology - Springfield Office Springfield, Ohio
Center for Clinical Studies at Webster Clear Lake Webster, Texas
Cleveland Clinic Cleveland, Ohio
Clinical Research Center of the Carolinas Charleston, South Carolina
Columbia University Medical Center - Herbert Irving Center for Dermatology and Skin Cancer - Herbert Irving Pavilion New York, New York
Dana-Farber Cancer Institute Boston, Massachusetts
Dawes Fretzin Clinical Research - Shadeland Ave. Indianapolis, Indiana
Dermatology Associates of the Palm Beaches, Integri Research at Dermatology Associates Delray Beach, Florida
Dermatology Health Specialists Bend, Oregon
Dermatology Institute of Victoria (DIV) South Yarra, Victoria
Dermatology and Skin Cancer Center Lee's Summit, Missouri
Epiphany Dermatology Lewisville, Texas
Equity Medical, LLC Bowling Green, Kentucky
Fremantle Dermatology Fremantle, Western Australia
George Washington University Medical Faculty Associates Washington D.C., District of Columbia
Las Vegas Dermatology Las Vegas, Nevada
Life Clinical Trials Coral Springs, Florida
Mayo Clinic - Arizona Phoenix, Arizona
Medical Dermatology Specialists - Phoenix Phoenix, Arizona
Memorial Sloan Kettering Cancer Center New York, New York
Metropolitan Dermatology Clark, New Jersey
MyMichigan Dermatologic Oncology Midland, Michigan
Northeast Dermatology Associates Beverly, Massachusetts
Oak Dermatology Naperville, Illinois
Oregon Health & Science University Portland, Oregon
Peak Dermatology, Aesthetics and Wellness Visalia, California
Penn Medicine, Perelman Center For Advanced Medicine Philadelphia, Pennsylvania
Penn State Hershey Medical Center Hershey, Pennsylvania
Princess Alexandra Hospital Woolloongabba, Queensland
Profound Research, Dermatology Medical Group - Oceanside Oceanside, California
Reveal Research Institute Dallas, Texas
Rochester Dermatologic Surgery, P.C. Victor, New York
Somerset Skin Centre Troy, Michigan
Stanford University Palo Alto, California
StracSkin, PLLC Portsmouth, New Hampshire
Texas Dermatology and Laser Specialists San Antonio, Texas
The Skin Hospital Darlinghurst, New South Wales
The University of Texas MD Anderson Cancer Center Houston, Texas
The University of Texas at Austin Dell Medical School Ascension Medical Group Austin, Texas
UC San Diego Moores Cancer Center La Jolla, California
UNC Hospitals Dermatology and Skin Cancer Center at Southern Village Chapel Hill, North Carolina
US Dermatology Partners DBA DermAssociates, PC Rockville, Maryland
University of Arizona Cancer Center Tucson, Arizona
University of Chicago Medical Center Chicago, Illinois
University of New Mexico Albuquerque, New Mexico
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma
University of South Florida Tampa, Florida
University of Utah Hospital Salt Lake City, Utah
VCU Massey Cancer Center Richmond, Virginia
Washington University in St. Louis - Center for Dermatologic and Cosmetic Surgery St Louis, Missouri
Westmead Hospital Westmead, New South Wales

Testing the Addition of an Anti-Cancer Drug, Gemcitabine, to Usual Treatment (BCG Alone) in People Whose Non-Muscle Invasive Bladder Cancer (NMIBC) Came Back After Prior BCG Therapy (GAIN-BCG)

Contact(s):

Aishwarya Vijendran - guprotocols@alliancenctn.org

Principal Investigator:

System ID: NCT07000084

Show full eligibility criteria

Inclusion Criteria:

* Documentation of Disease: Histologic confirmation of urothelial carcinoma that is high grade Ta, high grade T1, or Tis (Tis/carcinoma in situ \[CIS\] only disease) within 120 days prior to randomization * Any component of neuroendocrine carcinoma (i.e., small cell or large cell) is not allowed. Other histologic subtypes/variant histologies are allowed so long as there is a predominantly urothelial component. \* Note: Pure squamous cell carcinoma or pure adenocarcinoma without a urothelial component are not allowed * All visible papillary lesions must be macroscopically resected by TURBT within 90 days of randomization. (Residual CIS is permitted). \* If the treating urologist did not perform the TURBT, the treating urologist must perform a cystoscopy within 45 days prior to randomization to confirm the absence of visible papillary disease * All patients with high grade T1 must undergo a restaging TURBT within 90 days of randomization. Patients who undergo a restaging TURBT that shows no residual cancer in the specimen are still eligible for trial based on prior TURBT * Patients must have BCG-Exposed non muscle invasive bladder carcinoma (NMIBC), defined as recurrent high grade NMIBC within 24 months of last BCG exposure but not meeting the definition of BCG unresponsive disease * Note: Up to 26 months from the last BCG instillation is allowed for the treating physician to perform a transurethral resection of bladder tumor (TURBT) so long as there is evidence/suspicion of recurrent disease (by positive cytology, imaging, or cystoscopy) within 24 months of last exposure to BCG. * Note: A patient who previously met the definition of BCG unresponsive NMIBC but no longer currently meets unresponsive criteria may still enroll in this trial so long as the treating urologist believes re-treatment with BCG is a reasonable treatment option for that patient. * BCG-exposed NMIBC criteria is defined as: * Any high grade NMIBC recurrence within 24 months of induction only BCG, or * A high grade papillary NMIBC (Ta/T1) recurrence between 6-24 months of last exposure to induction + maintenance BCG, or * A high-grade CIS (with or without Ta/T1 papillary disease) recurrence within 12-24 months of last exposure to induction + maintenance BCG. * Patient must not have BCG-unresponsive NMIBC, defined as: * Persistent or recurrent high-grade papillary NMIBC (Ta/T1) \< 6 months of "adequate" BCG, or * A high-grade CIS (with or without Ta/T1 papillary disease) recurrence \< 12 months of "adequate" BCG, or * A high grade T1 recurrence at the first 3-month assessment from induction BCG * "Adequate" BCG is defined as ≥5 of 6 doses of induction BCG therapy with either * ≥ 2 of 3 doses of maintenance BCG, or * ≥ 2 of planned 6 instillations of repeat induction BCG given within a 6 month time period * More than one prior induction course of BCG and/or prior maintenance BCG is allowed so long as the patient does not currently met the definition of BCG unresponsive disease * Prior treatment with any intravesical chemotherapy (both perioperative and induction course) for NMIBC is allowed, including gemcitabine either alone or in combination (ie. gemcitabine plus docetaxel) or gemcitabine delivered through a intravesical delivery system (ie. TAR-200) * Prior treatment with any systemic or intravesical agents for NMIBC is allowed, regardless of whether it is given either alone or in prior combination with BCG (ie. Prior treatment with pembrolizumab, other immune checkpoint inhibitors, nadofaragene firadenovec, nogapendekin alfa inbakicept, cretostimogene grenadenorepvec, etc. are all allowed) * Patients must not have a history of intolerance to BCG (ie needing to stop BCG induction or maintenance due to toxicity) or intolerance to any other intravesical therapies * Patients must not have compromised bladder function such that they are unlikely to tolerate further intravesical therapies * Patient must not have any prior history or current evidence of muscle-invasive (i.e., T2, T3, T4), locally advanced unresectable, or metastatic urothelial carcinoma as assessed on radiographic imaging obtained within 120 days prior to randomization. \* The radiographic imaging includes a CT Scan or MRI of the abdomen/pelvis with intravenous contrast, with a CT or MRI urogram preferred. If a patient is unable to receive intravenous contrast due to renal function or allergy, then either a CT scan or MRI of the abdomen/pelvis without intravenous contrast is acceptable * Patients with a history of upper tract urothelial carcinoma are allowed so long as they had localized non-muscle invasive (Ta, T1, Tis) that has been definitively treated with surgery (nephroureterectomy or ureterectomy) with at least one post-treatment disease assessment imaging study that demonstrates no evidence of residual upper tract disease * Patients with a history of, or current evidence of, non-invasive (Ta/Tis) urothelial carcinoma of the prostatic urethra are eligible so long as a transurethral resection of prostate (TURP) is performed before enrollment and there is prostatic glandular tissue without evidence of lamina propria invasion or prostatic stromal invasion * HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial * Age ≥ 18 years * 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 * Not pregnant and not nursing, 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 sexual orientation or 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 * 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)

Interventions: BIOLOGICAL: BCG Solution, PROCEDURE: Biopsy of Bladder, PROCEDURE: Cystoscopy, PROCEDURE: Computed Tomography, PROCEDURE: Magnetic Resonance Imaging, PROCEDURE: Biospecimen Collection, PROCEDURE: Transurethral Resection of Bladder Tumor, DRUG: Gemcitabine

Conditions: Recurrent Non-Muscle Invasive Bladder Carcinoma, Stage 0a Bladder Cancer AJCC v8, Stage I Bladder Cancer AJCC v8

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Location	Contacts
Banner MD Anderson Cancer Center Gilbert, Arizona
Benefis Helena Specialty Center Helena, Montana	Site Public Contact - (mccinfo@mtcancer.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)
Billings Clinic-Cody Cody, Wyoming	Site Public Contact - (research@billingsclinic.org)
Bozeman Health Deaconess Hospital Bozeman, Montana	Site Public Contact - (mccinfo@mtcancer.org)
Brigham and Women's Hospital Boston, Massachusetts
Community Hospital of Anaconda Anaconda, Montana	Site Public Contact - (mccinfo@mtcancer.org)
Community Medical Center Missoula, Montana	Site Public Contact - (mccinfo@mtcancer.org)
FMH James M Stockman Cancer Institute Frederick, Maryland
Fairbanks Memorial Hospital Fairbanks, Alaska	Site Public Contact - (Veronica.Stevenson@foundationhealth.org)
Fox Chase Cancer Center Philadelphia, Pennsylvania
Fox Chase Cancer Center-Rockledge Rockledge, Pennsylvania	Site Public Contact - (ctsucontact@westat.com)
Geisinger Cancer Center Dickson City Dickson City, Pennsylvania	Site Public Contact - (hemoncctrials@geisinger.edu)
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)
Great Falls Clinic Great Falls, Montana	Site Public Contact - (mccinfo@mtcancer.org)
Hackensack University Medical Center Hackensack, New Jersey
Hi-Line Sletten Cancer Center Havre, Montana	Site Public Contact - (protocols@AllianceNCTN.org)
IU Health Methodist Hospital Indianapolis, Indiana	Site Public Contact - (iutrials@iu.edu)
IU Health North Hospital Carmel, Indiana	Site Public Contact - (iutrials@iu.edu)
IU Health West Hospital Avon, Indiana	Site Public Contact - (iutrials@iu.edu)
Indiana University/Melvin and Bren Simon Cancer Center Indianapolis, Indiana	Site Public Contact - (iutrials@iu.edu)
Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland	Site Public Contact - (jhcccro@jhmi.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)
Lahey Clinic Burlington, Massachusetts	Site Public Contact - (lhmc-cancer-clinical-trials@lahey.org)
Lahey Clinic Peabody Peabody, Massachusetts	Site Public Contact - (lhmc-cancer-clinical-trials@lahey.org)
Logan Health Medical Center Kalispell, Montana	Site Public Contact - (mccinfo@mtcancer.org)
Loyola University Medical Center Maywood, Illinois
Marjorie Weinberg Cancer Center at Loyola-Gottlieb Melrose Park, Illinois
Mary Bird Perkins Cancer Center - Metairie Metairie, Louisiana
Mayo Clinic Hospital in Arizona Phoenix, Arizona
Mayo Clinic in Florida Jacksonville, Florida
Mayo Clinic in Rochester Rochester, Minnesota
Medical University of South Carolina Charleston, South Carolina	Site Public Contact - (hcc-clinical-trials@musc.edu)
Memorial Hospital of Laramie County Cheyenne, Wyoming	Site Public Contact - (protocols@AllianceNCTN.org)
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
Northwestern University Chicago, Illinois	Site Public Contact - (cancer@northwestern.edu)
Ohio State University Comprehensive Cancer Center Columbus, Ohio	Site Public Contact - (Jamesline@osumc.edu)
Ralph H Johnson VA Medical Center Charleston, South Carolina	Site Public Contact - (ashley.salvo@va.gov)
Roswell Park Cancer Institute Buffalo, New York	Site Public Contact - (askroswell@roswellpark.org)
Sibley Memorial Hospital Washington D.C., District of Columbia	Site Public Contact - (jquiver1@jhmi.edu)
UC Irvine Health/Chao Family Comprehensive Cancer Center Orange, California	Site Public Contact - (ucstudy@uci.edu)
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care Irvine, California	Site Public Contact - (ucstudy@uci.edu)
UF Health Cancer Institute - Gainesville Gainesville, Florida	Site Public Contact - (cancer-center@ufl.edu)
University of Alabama at Birmingham Cancer Center Birmingham, Alabama	Site Public Contact - (gingerreeves@uabmc.edu)
University of Illinois Chicago, Illinois
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma	Site Public Contact - (ou-clinical-trials@ouhsc.edu)
VCU Massey Comprehensive Cancer Center Richmond, Virginia	Site Public Contact - (CTOclinops@vcu.edu)

Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients

Contact(s):

ITI Clinical Trials - ITCIClinicalTrials@itci-inc.com

Principal Investigator:

System ID: NCT06372964

Show full eligibility criteria

Inclusion Criteria:

• Able to provide consent as follows: * The Legally Authorized Representative (LAR) must provide written, informed consent. * The patient must provide written assent;
• Male or female patients 10 to 17 years of age, inclusive;
• Have a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of bipolar I or bipolar II disorder with a current MDE without psychosis as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL);
• Subject has a lifetime history of at least one manic or hypomanic episode.
• Subject's current major depressive episode is ≥ 4 weeks and less than 12 months in duration;
• CDRS-R total score ≥ 45 with ≥ 5 on Item 11 (depressed feelings) at Screening and Baseline;
• Young Mania Rating Scale (YMRS) score ≤ 15 (with YMRS Item 1 \[elevated mood\] score ≤ 2) at Screening and Baseline.

Exclusion Criteria:

• Has a primary psychiatric diagnosis other than bipolar I or bipolar II disorder. Exception includes: * Attention deficit hyperactivity disorder (ADHD). If a subject is taking medications for ADHD, they must have been on a stable treatment regimen of these medication(s) for 30 days prior to screening and the treatment regimen is expected to remain stable throughout the study.
• Intellectual disability based on Investigator opinion and DSM-5 criteria
• Patient has been hospitalized for a bipolar manic episode within the 30 days prior to randomization;
• Demonstrates a ≥ 25% decrease (improvement) in the CDRS-R total score between Screening and Baseline visits, or the CDRS-R is below 45 at Baseline;
• In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during his/her participation in the study or
• At Screening, the patient scores "yes" on Suicidal Ideation Items 3, 4, or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) within 6 months prior to Screening or, at Baseline, the patient scores "yes" on Suicidal Ideation Items 3, 4, or 5 since the Screening Visit;
• At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening; or
• At Screening or Baseline, scores \> 3 on Item 13 (suicidal ideation) on the CDRS-R; or
• The patient is considered to be an imminent danger to him/herself or others.

Interventions: DRUG: Lumateperone, DRUG: Placebo

Conditions: Bipolar Depression

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Location	Contacts
AP Medical Research Miami, Florida
APG Research LLC Orlando, Florida
Advanced Discovery Research Atlanta, Georgia
Advanced Research Center, Inc Anaheim, California
Advanced Research Institute of Miami Homestead, Florida
Alivation Research LLC Lincoln, Nebraska
Ann & Robert H. Lurie Children's Hospital of Chicago Chicago, Illinois
BioBehavioral Research of Austin PC Austin, Texas
Care Research Center Inc Miami, Florida
CenExeli Research LLC Atlanta, Georgia
CenExeli Research LLC 1 Savannah, Georgia
Centro de Investigaciones del Sistema Nervioso Grupo Cisne Ltda. Bogotá,
Centro de Investigaciones y Proyectos en Neurociencias CIPNA Barranquilla,
Charak Center for Health and Wellness Garfield Heights, Ohio
Chopda Medicare & Research Centre Nashik,
Clinic of Neurology and Psychiatry for Children and Youth Belgrade,
Clinical Center of Vojvodina Novi Sad,
Columbus Clinical Services LLC Miami, Florida
Core Clinical Research Everett, Washington
Cutting Edge Research Group Oklahoma City, Oklahoma
Deva Institute of Healthcare And Research Pvt Ltd Varanasi,
Empresa Social del Estado Hospital Mental de Antioquia Maria Upegui HOMO Bello,
Envision Trials LLC Miami, Florida
GTL Medical and Research Group Miami, Florida
Haidar Almhana Nieding Avon Lake, Ohio
Harmonex Neuroscience Research Dothan, Alabama
Health Synergy Clinical Research West Palm Beach, Florida
HealthMed Clinical Center Inc Miami, Florida
Indiana University Indianapolis, Indiana
Inland Psychiatric Medical Group Inc Redlands, California
Institute of Mental Health Serbia Belgrade,
Kaleidoscope Clinical Research Houston, Texas
Links Clinical Trials Miami, Florida
MCB Clinical Research Centers LLC Colorado Springs, Colorado
MTP Psychiatry LLC Baltimore, Maryland
Midwest Research Group Saint Charles, Missouri
NYU Child Study Center New York, New York
Neurobehavioral Medicine Group Bloomfield Hills, Michigan
New Med Research Inc Miami Gardens, Florida
Next Level Clinical Trials, LLC West Covina, California
North Pointe Psychiatry Flower Mound, Texas
Northwest Clinical Research Center Bellevue, Washington
Ocean Blue Medical Research Center Inc. Miami, Florida
Perceptive Pharma Research Richmond, Texas
Pillar Clinical Research, LLC Little Rock, Arkansas
Psynapsis Salud Mental S.A. Pereira,
REX Clinical Trials LLC Beaumont, Texas
Ratandeep Surgical Hospital And Endoscopy Clinic Ahmedabad,
Red Oak Psychiatry Associates Houston, Texas
Revive Research Institute Elgin, Illinois
Riveldi Biomedical Research Miami Lakes, Florida
Royal Palm Clinical Research Fort Myers, Florida
SP Research, PLLC (dba Rivus Wellness & Research Institute) Oklahoma City, Oklahoma
Salveo Integrative Health Inc Lawrenceville, Georgia
Society for Psychiatric Update and Research Shanti Nursing Home Aurangabad,
Sooner Clinical Research Oklahoma City, Oklahoma
SouthGen Clinical Research LLC Miami, Florida
The Angel Medical Research Corporation Miami Gardens, Florida
The University of Texas at Austin Austin, Texas
UC Davis Health System Sacramento, California
United Research Institute Hialeah, Florida
University Clinical Center Nis Niš,
University of California San Diego Medical Center San Diego, California
University of Cincinnati Medical Center Cincinnati, Ohio
Virginia Commonwealth University Richmond, Virginia
Vital Care Research Miami, Florida
Washington University School of Medicine Child and Adolescent Psychiatry Clinic St Louis, Missouri
Westlake America Clinic Westlake, Ohio

A Study to Learn About the Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Late Isolated Microvascular Inflammation (TRANSPIRE)

Contact(s):

US Biogen Clinical Trial Center - clinicaltrials@biogen.com

Principal Investigator:

System ID: NCT07219043

Show full eligibility criteria

Key

Inclusion Criteria:

* MVI (MVI ≥2), donor specific antibody (DSA)-negative that is either complement activation (C4d) negative or C4d positive (biopsy-confirmed) without T cell-mediated rejection (TCMR) per central reading, as defined by the Banff 2022 criteria. * Biopsy must be within 3 months (preferably within 1 month) prior to randomization and meet adequate criteria (option a preferred over option b):
• Adequate: 10 or more non-sclerotic/evaluable glomeruli and two muscular arteries
• Minimally Adequate: at least 7 non-sclerotic/evaluable glomeruli and one muscular artery * For participants who received any prior treatment for antibody-mediated rejection (AMR), MVI, or TCMR as outlined in Exclusion Criterion 5, the biopsy must be performed at least 6 weeks after completing (or stopping) prior treatment. * Kidney transplant at least 6 months prior to Screening visit (recipients of either living or deceased donors). * DSA: Human leukocyte antigen (HLA) Class I and II antigen-specific DSA-negative (preformed and de novo DSA) as determined by the local laboratory's definition of positivity using single-antigen bead-based assays within 3 months prior to randomization. Key

Exclusion Criteria:

* Transplant: Blood type (ABO)-incompatible transplant. * History of multiple organ transplants including en bloc and dual kidney transplants. * Presence of HLA donor-specific antibodies. * Acute, rapid decline in renal function, defined as a participant likely to require renal replacement therapy within the next 30 days as determined by the Investigator. * Prior AMR or TCMR treatment (with the exception of corticosteroids) within 3 months prior to randomization is excluded as listed below. Participants who received any of these treatments between 3 and 6 months prior to randomization must have both a renal biopsy (IC3) and DSA testing at least 6 weeks after completing (or stopping) treatment in order to confirm continuing MVI≥2 and DSA negative status and to determine eligibility:
• Intravenous or subcutaneous immunoglobulin (IVIg or subcutaneous immunoglobulin \[SCIg\]) or plasma exchange (PLEX).
• Complement system inhibitors (e.g., eculizumab).
• Proteasome inhibitors (e.g., bortezomib).
• The anti-interleukin-6 receptor (anti-IL-6R) tocilizumab.
• Any B cell-depleting therapy (including anti-CD20 agents \[e.g., rituximab\]) within 3 months prior to randomization.
• Any other investigational agent within 3 months or 5 half-lives (whichever is longer) of randomization. Note: Other protocol-defined Inclusion/Exclusion criteria may apply.

Interventions: DRUG: Felzartamab, DRUG: Placebo

Conditions: Microvascular Inflammation

Keywords: Kidney Transplant, Kidney Transplant Rejection

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Location	Contacts
Cedars-Sinai Medical Center Los Angeles, California
Centre Hospitalier Universitaire (CHU) de Bordeaux - Hôpital Pellegrin Bordeaux,
Centre Hospitalier Universitaire (CHU) de GreNble Alpes - Hôpital Michallon La Tronche,
Centre Hospitalier Universitaire (CHU) de Toulouse - Hôpital de Rangueil Toulouse,
Charite - Universitatsmedizin Berlin Berlin,
Cleveland Clinic Cleveland, Ohio
Clínica Privada Velez Sarsfield Córdoba,
Cooperman Barnabas Medical Center West Orange, New Jersey
Duke University Hospital Durham, North Carolina
Hospices Civils de Lyon - Hôpital Édouard Herriot Lyon,
Hospital Clinic de Barcelona Barcelona,
Hospital Del Mar Barcelona,
Hospital Universitario Miguel Servet Zaragoza,
Hospital Universitario Vall d'Hebron Barcelona,
Hospital de Base Da Faculdade de Medicina de Sao Jose Do Rio Preto Vila São José, São José Do Rio Preto
Hospital do Rim - Fundação Oswaldo Ramos São Paulo,
Houston Methodist Hospital Houston, Texas
Institut klinicke a experimentalni mediciny (IKEM) Prague,
Instituto de Trasplante y Alta Complejidad (ITAC) Buenos Aires, Ciudad Autónoma de Buenos Aires (caba)
Keck Hispital of University of Southern California (USC) Los Angeles, California
Loma Linda University Medical Center Loma Linda, California
Mayo Clinic Rochester Rochester, Minnesota
Medical College of Wisconsin Milwaukee, Wisconsin
Medizinische Universität Wien Vienna,
Princess Alexandra Hospital Woolloongabba, Queensland
Providence St. Joseph Hospital Orange Orange, California
Sutter Health - California Pacific Medical Center San Francisco, California
The Ohio State University Columbus, Ohio
The University of Kansas Medical Center Kansas City, Kansas
Universitaetsklinikum Carl Gustav Carus Dresden Dresden,
Universitatsklinikum Hamburg-Eppendorf Hamburg,
Universitatsspital Zurich Zurich,
University of California San Fransisco (UCSF) Medical Center San Francisco, California
University of Michigan Medical Center Ann Arbor, Michigan
University of Nebraska Medical Center Omaha, Nebraska
University of Texas Southwestern Medical Center Dallas, Texas
University of Washington Medical Center Seattle, Washington
Virginia Commonwealth University (VCU) Medical Center (Main Hospital) Hume-Lee Transplant Center Richmond, Virginia
Washington University School of Medicine St Louis, Missouri

Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder (ASD) in Pediatric Patients

Contact(s):

ITI Clinical Trials - ITCIClinicalTrials@itci-inc.com

Principal Investigator:

System ID: NCT06706674

Show full eligibility criteria

Inclusion Criteria:

• All patients must have a legally authorized representative LAR (eg, parent or legal guardian) who is willing and able to be responsible for the safety and well-being of the patient, provide information about the patient's condition, and accompany the patient to study visits.
• Able to provide consent as follows:
• The patient's LAR must provide written, informed consent.
• When developmentally appropriate based on Investigator judgment, the patient should provide written assent.
• Male or female patients 5 to 17 years of age. Currently, only patients aged 13 to 17 years will be eligible for enrollment.
• Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of ASD as confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL);
• ABC-I subscale score of \>18 at Screening and Baseline;
• CGI-S score \> 4 with respect to irritability associated with ASD at Screening and Baseline.

Exclusion Criteria:

• Has a primary psychiatric diagnosis other than ASD. Exceptions include:
• Attention Deficit Hyperactivity Disorder (ADHD). If a patient is taking medication(s) for ADHD, they must be on a stable treatment regimen of these medication(s) for 30 days prior to screening and the treatment regimen is expected to remain stable throughout the study. This must be confirmed by the Investigator and noted in the source records.
• Mild and moderate intellectual disability based on Investigator judgment and DSM-5 criteria (severe and profound intellectual disability are excluded).
• History or current diagnosis of Rett syndrome or Fragile X syndrome;
• In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during their participation in the study or
• At Screening, the patient scores "yes" on Suicidal Ideation Items 3, 4, or 5 of the Columbia-Suicide Severity Rating Scale (CSSRS) within 6 months prior to Screening or, at Baseline, the patient scores "yes" on Suicidal Ideation Items 3, 4, or 5 since the Screening Visit;
• At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening; or
• The patient is considered to be an imminent danger to themselves or others.

Interventions: DRUG: Lumateperone high dose, DRUG: Lumateperone low dose, DRUG: Placebo

Conditions: Irritability Associated With Autism Spectrum Disorder

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Study Locations

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Location	Contacts
AP Medical Research Miami, Florida
APG Research LLC Orlando, Florida
Advanced Discovery Research Atlanta, Georgia
Advanced Research Institute of Miami Homestead, Florida
Advantage Clinical Trials The Bronx, New York
Alivation Research LLC Lincoln, Nebraska
Baber Research Group Naperville, Illinois
BioBehavioral Research of Austin PC Austin, Texas
Blue Medical Research Miami, Florida
California Neuroscience Research Sherman Oaks, California
Care Research Center Inc Miami, Florida
Clinical Research Center of Florida Pompano Beach, Florida
Core Clinical Research Everett, Washington
EmVenio Research at Chicago Chicago, Illinois
Future Search Trials of Dallas Dallas, Texas
Louisiana State University Health Sciences Center Shreveport Shreveport, Louisiana
Medical University of South Carolina Charleston, South Carolina
NYU Child Study Center New York, New York
Nathan Kline Institute Orangeburg, New York
Neurobehavioral Medicine Group Bloomfield Hills, Michigan
New Med Research Inc Miami Gardens, Florida
North Texas Clinical Trials Fort Worth, Texas
Orlando Psychiatric Associates Orlando, Florida
Pillar Clinical Research, LLC Little Rock, Arkansas
Quest Therapeutics of Avon Lake Avon Lake, Ohio
Red Oak Psychiatry Associates Houston, Texas
Richmond Behavioral Associates Staten Island, New York
Riley Hospital for Children at Indiana University Health Indianapolis, Indiana
Riveldi Biomedical Research Miami Lakes, Florida
SP Research, PLLC (dba Rivus Wellness & Research Institute) Oklahoma City, Oklahoma
Salveo Integrative Health Inc Lawrenceville, Georgia
Sooner Clinical Research Oklahoma City, Oklahoma
United Research Institute Hialeah, Florida
University of California - Davis Sacramento, California
University of South Florida Rothman Center of Neuropsychiatry St. Petersburg, Florida
Virginia Commonwealth University Richmond, Virginia
Vital Care Research Miami, Florida
Yale University School of Medicine North Haven, Connecticut

Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder

Contact(s):

ITI Clinical Trials - ITCIClinicalTrials@itci-inc.com

Principal Investigator:

System ID: NCT06229210

Show full eligibility criteria

Inclusion Criteria:

* Able to provide consent as follows: * The patient's legally authorized representative (LAR) (eg, parent or guardian) must provide written, informed consent; * The patient must provide written assent to study enrollment; * Male or female patients aged 13 to 17 years (inclusive) with schizophrenia; male or female patients aged 10 to 17 years (inclusive) with bipolar I or II disorder; or male or female patients aged 5 to 17 years (inclusive) with autism spectrum disorder; * Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of schizophrenia, bipolar I or II disorder, or autism spectrum disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL). * Is currently an outpatient and is anticipated to maintain outpatient status for the duration of the study. Rollover Patients entering from the lead-in study must have safely completed the lead-in study, in the opinion of the Investigator.

Exclusion Criteria:

* Has a primary psychiatric diagnosis other than schizophrenia, bipolar I or bipolar II disorder or autism spectrum disorder. Schizophrenia with catatonia, or bipolar disorder with psychotic features are not allowed. Exceptions include: * ADHD: If a subject is taking psychostimulant(s) for ADHD, they must have been on a stable treatment regimen of these medication(s) for 30 days prior to Screening. The treatment regimen should remain stable throughout the study. This must be confirmed by the Investigator and noted in the source records. * For ASD patients only, based on Investigator opinion and DSM-5 criteria, mild or moderate intellectual disability is allowed. Severe or profound intellectual disability is exclusionary. * In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during their participation in the study or * At Screening, the patient scores "yes" on Suicidal Ideation Items 3, 4, or 5 of the Columbia-Suicide Severity Rating Scale (C SSRS) within 6 months prior to Screening or, at Baseline, the patient scores "yes" on Suicidal Ideation Items 3, 4, or 5 since the Screening Visit; * At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening; or * At Screening or Baseline, scores \> 3 on Item 13 (suicidal ideation) of the CDRS-R (for bipolar disorder patients only); or * The patient is considered to be an imminent danger to him/herself or others.

Interventions: DRUG: Lumateperone

Conditions: Schizophrenia, Bipolar Disorder, Autism Spectrum Disorder

Keywords: Pediatric

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Study Locations

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Location	Contacts
AIM Trials Plano, Texas
AP Medical Research Miami, Florida
APG Research LLC Orlando, Florida
Access Clinical Trials Nashville, Tennessee
Advanced Research Center, Inc Anaheim, California
Advanced Research Institute of Miami Homestead, Florida
Alivation Research LLC Lincoln, Nebraska
Atlanta Behavioral Research, LLC Atlanta, Georgia
Atlanta Center for Medical Research Atlanta, Georgia
Baber Research Group Naperville, Illinois
Blue Medical Research Miami, Florida
Care Research Center Inc Miami, Florida
CenExeli Research LLC Atlanta, Georgia
CenExeli Research LLC 1 Savannah, Georgia
Charak Center for Health and Wellness Garfield Heights, Ohio
Clinic of Neurology and Psychiatry for Children and Youth Belgrade,
Clinical Center of Vojvodina Novi Sad,
Clinical Research Center of Florida Pompano Beach, Florida
Clinical Research of Southern Nevada, LLC Las Vegas, Nevada
Columbus Clinical Services LLC Miami, Florida
Core Clinical Research Everett, Washington
Cutting Edge Research Group Oklahoma City, Oklahoma
Diverse Clinical Research LLC Miami, Florida
Envision Trials LLC Miami, Florida
Excell Research Inc Oceanside, California
GTL Medical and Research Group Miami, Florida
Health Synergy Clinical Research West Palm Beach, Florida
Inland Psychiatric Medical Group Inc Redlands, California
Institute of Mental Health Serbia Belgrade,
Kaleidoscope Clinical Research Houston, Texas
Links Clinical Trials Miami, Florida
MCB Clinical Research Centers LLC Colorado Springs, Colorado
Midwest Research Group 1 Saint Charles, Missouri
National Institute Of Clinical Research Garden Grove, California
Neurobehavioral Medicine Group Bloomfield Hills, Michigan
New Med Research Inc Miami Gardens, Florida
Next Level Clinical Trials, LLC West Covina, California
Northwest Clinical Research Center Bellevue, Washington
Perceptive Pharma Research Richmond, Texas
Pillar Clinical Research, LLC Little Rock, Arkansas
PsyMed Solutions Fort Worth, Texas
Quest Therapeutics of Avon Lake Avon Lake, Ohio
Red Oak Psychiatry Associates Houston, Texas
Richmond Behavioral Associates Staten Island, New York
Riley Hospital for Children at Indiana University Health Indianapolis, Indiana
Riveldi Biomedical Research Miami Lakes, Florida
Royal Palm Clinical Research Fort Myers, Florida
Salveo Integrative Health Inc Lawrenceville, Georgia
Sarkis Clinical Trials Gainesville, Florida
Sooner Clinical Research Oklahoma City, Oklahoma
Southwest Autism Research and Resource Center Phoenix, Arizona
Texas Research Group Coppell, Texas
The Angel Medical Research Corporation Miami Gardens, Florida
United Research Institute Hialeah, Florida
University Clinical Center Nis Niš,
University of California - Davis Sacramento, California
University of California San Diego San Diego, California
University of Cincinnati Medical Center Cincinnati, Ohio
University of South Florida Rothman Center of Neuropsychiatry St. Petersburg, Florida
Virginia Commonwealth University Richmond, Virginia
Vital Care Research Miami, Florida

LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis

Contact(s):

Boehringer Ingelheim - clintriage.rdg@boehringer-ingelheim.com

Principal Investigator:

System ID: NCT06632444

Show full eligibility criteria

Interventions: COMBINATION_PRODUCT: Survodutide, COMBINATION_PRODUCT: Placebo

Conditions: Metabolic Dysfunction Associated Steatohepatitis (MASH), Liver Fibrosis

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310 Clinical Research Inglewood, California	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
AKH - Medical University of Vienna Vienna,	Boehringer Ingelheim - (oesterreich@bitrialsupport.com)
ASHA Clinical Research - Munster, LLC Hammond, Indiana	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
AZ Delta Roeselare,	Boehringer Ingelheim - (belgique@bitrialsupport.com)
Aberdeen Royal Infirmary Aberdeen,	Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Accellacare - South London Orpington, London,	Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Accellacare North London Northwood,	Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Access research Institute Brooksville, Florida	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Acclaim Clinical Research San Diego, California	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Acibadem City Clinic Tokuda University Hospital EAD Sofia,	Boehringer Ingelheim - (balgariya@bitrialsupport.com)
Adobe Clinical Research, Llc Tucson, Arizona	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Affiliated Hospital, Xuzhou Medical college Xuzhou,	Boehringer Ingelheim - (china@bitrialsupport.com)
Albert SchweitzerZiekenhuis Dordrecht,	Boehringer Ingelheim - (nederland@bitrialsupport.com)
All India Institute of Medical Sciences New Delhi,	Boehringer Ingelheim - (india@bitrialsupport.com)
American Research Corporation - Austin Austin, Texas	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
American Research Corporation at the Texas Liver Institute San Antonio, Texas	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Amsterdam UMC Locatie VUMC Amsterdam,	Boehringer Ingelheim - (nederland@bitrialsupport.com)
Ankara Üniversitesi Tıp Fakültesi Hastanesi Ankara,	Boehringer Ingelheim - (turkiye@bitrialsupport.com)
Arensia Clinics S.R.L. Bucharest,	Boehringer Ingelheim - (romania@bitrialsupport.com)
Arizona Liver Health - Tucson Tucson, Arizona	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Ark Clinical Research Long Beach, California	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Ark Clinical Research Long Beach, California	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Aryav Superspeciality Hospital Ahemdabad,	Boehringer Ingelheim - (india@bitrialsupport.com)
Asan Medical Center SongpaGu, Seoul Teugbyeolsi	Boehringer Ingelheim - (namhan@bitrialsupport.com)
Asfendiyarov Kazakh National Medical University Almaty,	Boehringer Ingelheim - (kazakhstan@bitrialsupport.com)
Atharva Multispecialty Hospital and research Centre Lucknow,	Boehringer Ingelheim - (india@bitrialsupport.com)
Austin Health Heidelberg, Victoria	Boehringer Ingelheim - (australia@bitrialsupport.com)
Az.Osp. Universitaria "Ospedali Riuniti" Foggia,	Boehringer Ingelheim - (italia@bitrialsupport.com)
Azienda Ospedaliera Universitaria Integrata Verona Verona,	Boehringer Ingelheim - (italia@bitrialsupport.com)
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo,	Boehringer Ingelheim - (italia@bitrialsupport.com)
BAPS Pramukh Swami Hospital Surat,	Boehringer Ingelheim - (india@bitrialsupport.com)
Basil Clinical Laurelton, New York	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Beijing Ditan Hospital Capital Medical University Beijing,	Boehringer Ingelheim - (china@bitrialsupport.com)
Beijing Friendship Hospital Beijing,	Boehringer Ingelheim - (china@bitrialsupport.com)
Beijing Tsinghua Changgung Hospital Beijing,	Boehringer Ingelheim - (china@bitrialsupport.com)
Beijing Youan Hospital, Capital Medical University Beijing,	Boehringer Ingelheim - (china@bitrialsupport.com)
Bellaire Clinical Research, LLC Bellaire, Texas	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Ben Taub General Hospital Houston, Texas	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi Fatih,	Boehringer Ingelheim - (turkiye@bitrialsupport.com)
BioMed Research & Medical Center Miami, Florida	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Biopharma Informatic LLC McAllen, Texas	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Biopharma Informatic, Inc. Research Center Houston, Texas	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Bodyclinic sp. z o.o. sp.k. Warsaw,	Boehringer Ingelheim - (polska@bitrialsupport.com)
Boston Medical Center Boston, Massachusetts	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Brooke Army Medical Center Fort Sam Houston, Texas	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Buenos Aires Macula S.A. Buenos Aires,	Boehringer Ingelheim - (argentina@bitrialsupport.com)
CHU Amiens-Picardie Amiens,	Boehringer Ingelheim - (france@bitrialsupport.com)
CIPREC Buenos Aires,	Boehringer Ingelheim - (argentina@bitrialsupport.com)
Cadena Care Institute, LLC Poway, California	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
California Liver Research Institute Pasadena, California	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Care United Research Forney, Texas	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Carolina Researche Greenville, North Carolina	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Catalina Research Institute, Llc Montclair, California	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Cenara Clinical Research Cutler Bay, Florida	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Centex Studies, Inc. McAllen, Texas	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Centre Hospitalier Lyon Sud Pierre-Bénite,	Boehringer Ingelheim - (france@bitrialsupport.com)
Centre Hospitalier Universitaire d'Angers Angers,	Boehringer Ingelheim - (france@bitrialsupport.com)
Centre Hospitalier Universitaire de Bordeaux Pessac,	Boehringer Ingelheim - (france@bitrialsupport.com)
Centre Hospitalier Universitaire de Liege Liège,	Boehringer Ingelheim - (belgique@bitrialsupport.com)
Centre Hospitalier de L'Universite de Montreal (CHUM) Montreal, Quebec	Boehringer Ingelheim - (canada@bitrialsupport.com)
Centre Hospitalier de Versailles Le Chesnay,	Boehringer Ingelheim - (france@bitrialsupport.com)
Centre de Médecine Métabolique de Lanaudière Terrebonne, Quebec	Boehringer Ingelheim - (canada@bitrialsupport.com)
Centricity Research (New Bern) New Bern, North Carolina	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Centro De Investigaciones Clínicas Viña Del Mar Viña del Mar,	Boehringer Ingelheim - (chile@bitrialsupport.com)
Centro de Alta Especialidad del Estado de Veracruz Xalapa,	Boehringer Ingelheim - (mexico@bitrialsupport.com)
Centro de Investigacion Clinica del Pacifico (CICPA) Acapulco de Juárez,	Boehringer Ingelheim - (mexico@bitrialsupport.com)
Centro de Investigacion y Gastroenterologia Mexico City,	Boehringer Ingelheim - (mexico@bitrialsupport.com)
Centro de Investigacion y Gastroenterologia Mexico City,	Boehringer Ingelheim - (mexico@bitrialsupport.com)
Centro de Investigaciones Metabólicas (CINME) Buenos Aires,	Boehringer Ingelheim - (argentina@bitrialsupport.com)
Centro de Investigaciones Médicas UC Santiago,	Boehringer Ingelheim - (chile@bitrialsupport.com)
Centro de Pesquisa Clinica do Brasil Lago Sul,	Boehringer Ingelheim - (brasil@bitrialsupport.com)
Chang Gung Medical Foundation (CGMF) - Linkou Bran Taoyuan,	Boehringer Ingelheim - (taiwan@bitrialsupport.com)
Changhua Christian Hospital Changhua,	Boehringer Ingelheim - (taiwan@bitrialsupport.com)
Changi General Hospital Singapore,	Boehringer Ingelheim - (singapore@bitrialsupport.com)
Changzhou Third People's Hospital Changzhou Shi,	Boehringer Ingelheim - (china@bitrialsupport.com)
Charite - Universitatsmedizin Berlin Berlin,	Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Charlotte Maxeke Johannesburg Academic Hospital Johannesburg,	Boehringer Ingelheim - (southafrica@bitrialsupport.com)
Charter Research The Villages, Florida	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Charter Research The Villages, Florida	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Chelsea and Westminster Hospital London,	Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Chi Mei Medical Center Tainan,	Boehringer Ingelheim - (taiwan@bitrialsupport.com)
Chiba University Hospital Chiba, Chiba,	Boehringer Ingelheim - (nippon@bitrialsupport.com)
Chongqing Three Gorges Central Hospital Chongqing,	Boehringer Ingelheim - (china@bitrialsupport.com)
Christchurch Hospital Christchurch,	Boehringer Ingelheim - (newzealand@bitrialsupport.com)
Chung Shan Medical University Hospital Taichung,	Boehringer Ingelheim - (taiwan@bitrialsupport.com)
Chung-Ang University Hospital Dongjak-gu, Seoul-teukbyeolsi [seoul]	Boehringer Ingelheim - (namhan@bitrialsupport.com)
ClinSearch, LLC Chattanooga, Tennessee	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Clinical Research Institute of Michigan, LLC Clinton Township, Michigan	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Clinical Research Professionals Chesterfield, Missouri	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Clinical Research of South Nevada Las Vegas, Nevada	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Clinical Trials of Texas, LLC San Antonio, Texas	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Clinicos Asociados BOCM SC Mexico City,	Boehringer Ingelheim - (mexico@bitrialsupport.com)
Cliniques Universitaires Saint-Luc Brussels,	Boehringer Ingelheim - (belgique@bitrialsupport.com)
Clinnova Research Solutions Orange, California	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Cluj Napoca Clinical County Hospital Cluj-Napoca,	Boehringer Ingelheim - (romania@bitrialsupport.com)
Coastal Research Institute, LLC Fayetteville, North Carolina	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Complejo Hospitalario Universitario A Coruna A Coruña,	Boehringer Ingelheim - (espana@bitrialsupport.com)
Complexo Hospitalario Universitario de Pontevedra Pontevedra,	Boehringer Ingelheim - (espana@bitrialsupport.com)
Concord Repatriation General Hospital Concord, New South Wales	Boehringer Ingelheim - (australia@bitrialsupport.com)
Connecticut Gastroenterology Clinical Research Foundation Bristol, Connecticut	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Conquest Research Winter Park, Florida	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Covenant Metabolic Specialist, LLC - Riverview Riverview, Florida	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Covenant Metabolic Specialists, LLC - Fort Myers Fort Myers, Florida	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Covenant Metabolic Specialists, LLC - University Park University Park, Florida	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
DIM Clinica Privada Ramos Mejía,	Boehringer Ingelheim - (argentina@bitrialsupport.com)
Del Sol Research Management, LLC Tucson, Arizona	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet Budapest,	Boehringer Ingelheim - (magyarorszag@bitrialsupport.com)
Delta Research Partners, LLC Los Angeles, California	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Diagnostic Consultative Center Alexandrovska Sofia,	Boehringer Ingelheim - (balgariya@bitrialsupport.com)
Diex Recherche Quebec Québec,	Boehringer Ingelheim - (canada@bitrialsupport.com)
Digestive Research Alliance of Michiana South Bend, Indiana	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Dr. Rethy Pal Hospital Békéscsaba,	Boehringer Ingelheim - (magyarorszag@bitrialsupport.com)
Duke University Medical Center Durham, North Carolina	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
E-DA Hospital Kaohsiung City,	Boehringer Ingelheim - (taiwan@bitrialsupport.com)
ECIR Miami Holdings LLC dba IMIC Miami, Florida	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
EMC Instytut Medyczny S.A. - Wroclaw Wroclaw,	Boehringer Ingelheim - (polska@bitrialsupport.com)
EUGASTRO GmbH Leipzig,	Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Edificio Fleming La Serena,	Boehringer Ingelheim - (chile@bitrialsupport.com)
Ege Universitesi Tip Fakultesi Izmir,	Boehringer Ingelheim - (turkiye@bitrialsupport.com)
Ehime University Hospital Ehime, Toon,	Boehringer Ingelheim - (nippon@bitrialsupport.com)
Elpida Clinical Trials - Ashton Clinic Ashton in Makerfield,	Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Elpida Clinical Trials - Edgware Community Hospital Edgware,	Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
EmVenio Research Center at Prime Healthcare - Farmers Branch Garden City, Texas	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
EmVenio Research Center at Prime Healthcare - Riverdale Riverdale, Georgia	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Endoscopic Research, Inc Orlando, Florida	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Entrust Clinical Research Miami, Florida	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Epic Clinical Research Lewisville, Texas	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Epic Medical Research - Carrollton Carrollton, Texas	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Epic Medical Research - DeSoto DeSoto, Texas	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Epic Medical Research - Garland Garland, Texas	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Epic Medical Research - Plano Plano, Texas	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Erasmus Medisch Centrum Rotterdam,	Boehringer Ingelheim - (nederland@bitrialsupport.com)
Evolution Clinical Trials Hialeah Gardens, Florida	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Excel Clinical Research Las Vegas, Nevada	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
FDI Clinical Research San Juan,	Boehringer Ingelheim - (support@bitrialsupport.com)
FOMAT Medical Research Oxnard, California	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Ficramed Research Institute Poway, California	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
First Affiliated Hospital of Xi'an JiaoTong University Xi'an,	Boehringer Ingelheim - (china@bitrialsupport.com)
Florida Medical Clinic, P.A. Zephyrhills, Florida	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Florida Research Institute Lakewood Rch, Florida	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Floridian Clinical Research Miami Lakes, Florida	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Fondazione Epatocentro Ticino Arzo,	Boehringer Ingelheim - (suisse@bitrialsupport.com)
Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico Milan,	Boehringer Ingelheim - (italia@bitrialsupport.com)
Fondazione Policlinico Universitario Agostino Gemelli Irccs Roma,	Boehringer Ingelheim - (italia@bitrialsupport.com)
Fondazione Policlinico Universitario Campus Bio-Medico Rome,	Boehringer Ingelheim - (italia@bitrialsupport.com)
Fortis Hospital, Mohali Mohali,	Boehringer Ingelheim - (india@bitrialsupport.com)
Franciscus Gasthuis Schiedam,	Boehringer Ingelheim - (nederland@bitrialsupport.com)
Fresno Clinical Research Center Fresno, California	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Frimley Park Hospital Camberley,	Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Fujian Medical University Union Hospital Fuzhou, Fujian	Boehringer Ingelheim - (china@bitrialsupport.com)
Fujita Health University Hospital Toyoake, Aichi-ken	Boehringer Ingelheim - (nippon@bitrialsupport.com)
Fukuiken Saiseikai Hospital Fukui,	Boehringer Ingelheim - (nippon@bitrialsupport.com)
Future Innovative Treatments Colorado Springs, Colorado	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
FutureMeds Lodz Lodz,	Boehringer Ingelheim - (polska@bitrialsupport.com)
FutureMeds Warszawa Centrum Warsaw,	Boehringer Ingelheim - (polska@bitrialsupport.com)
FutureMeds Wroclaw Wroclaw,	Boehringer Ingelheim - (polska@bitrialsupport.com)
GI Alliance Research - Dallas Dallas, Texas	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
GI Alliance Research - Mansfield Mansfield, Texas	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
GI PROS Research Naples, Florida	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
GI Select Health Research LLC Richmond, Virginia	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Gastroenterology Associates of Central Georgia Macon, Georgia	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Gastrointestinal Associates, PA Flowood, Mississippi	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Gastromedica Srl Iași,	Boehringer Ingelheim - (romania@bitrialsupport.com)
Gazi Universitesi Tip Fakultesi Ankara,	Boehringer Ingelheim - (turkiye@bitrialsupport.com)
Geisinger Scenery Park State College, Pennsylvania	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
General Faculty Hospital, Prague Prague,	Boehringer Ingelheim - (support@bitrialsupport.com)
General Hospital of Ningxia Medical University Ningxia,	Boehringer Ingelheim - (china@bitrialsupport.com)
Gifu Municipal Hospital Gifu, Gifu,	Boehringer Ingelheim - (nippon@bitrialsupport.com)
Glenny Corp - Centro Médico Saavedra Buenos Aires,	Boehringer Ingelheim - (argentina@bitrialsupport.com)
Global Clinical Professionals St. Petersburg, Florida	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Global Research Associates Homestead, Florida	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Great Lakes Gastroenterology Research, LLC Mentor, Ohio	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Guangzhou Eighth People's Hospital,Guangzhou Medical University Guangzhou,	Boehringer Ingelheim - (china@bitrialsupport.com)
Guangzhou First People's Hospital Guangzhou,	Boehringer Ingelheim - (china@bitrialsupport.com)
Guizhou People's Hospital Guiyang,	Boehringer Ingelheim - (china@bitrialsupport.com)
Gujarat Gastro and Vascular Hospital Surat,	Boehringer Ingelheim - (india@bitrialsupport.com)
HASresearch San Antonio, Texas	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
HOP Dijon-Bourgogne Côte-d'Or,	Boehringer Ingelheim - (france@bitrialsupport.com)
HRI Medical Center Houston, Texas	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Hamamatsu University Hospital Shizuoka, Hamamatsu,	Boehringer Ingelheim - (nippon@bitrialsupport.com)
Hi Tech and Global Research, LLC Coral Gables, Florida	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Hiroshima Red Cross Hospital and Atomic-bomb Survivors Hospital Hiroshima,	Boehringer Ingelheim - (nippon@bitrialsupport.com)
Hiroshima University Hospital Hiroshima,	Boehringer Ingelheim - (nippon@bitrialsupport.com)
Hope Clinical Research Canoga Park, California	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Hopital Beaujon Clichy,	Boehringer Ingelheim - (france@bitrialsupport.com)
Hopital Claude Huriez Lille,	Boehringer Ingelheim - (france@bitrialsupport.com)
Hopital Cochin Paris,	Boehringer Ingelheim - (france@bitrialsupport.com)
Hopital Henri Mondor Créteil,	Boehringer Ingelheim - (france@bitrialsupport.com)
Hopital de la Croix-Rousse Lyon,	Boehringer Ingelheim - (france@bitrialsupport.com)
Hopitaux Universitaires Pitié-Salpétrière Paris,	Boehringer Ingelheim - (france@bitrialsupport.com)
Hopitaux Universitaires de Geneve (HUG) Geneva,	Boehringer Ingelheim - (suisse@bitrialsupport.com)
Hospital Ampang Ampang,	Boehringer Ingelheim - (malaysia@bitrialsupport.com)
Hospital Clinico de Santiago Santiago de Compostela,	Boehringer Ingelheim - (espana@bitrialsupport.com)
Hospital Das Clinicas Da Faculdade De Medicina Da USP Cerqueira César,	Boehringer Ingelheim - (brasil@bitrialsupport.com)
Hospital El Cruce San Juan Bautista,	Boehringer Ingelheim - (argentina@bitrialsupport.com)
Hospital General de Agudos Dr. J. M. Ramos Mejia Ciudad Autonoma Buenos Aires,	Boehringer Ingelheim - (argentina@bitrialsupport.com)
Hospital Puerta De Hierro Majadahonda,	Boehringer Ingelheim - (espana@bitrialsupport.com)
Hospital Universitari Vall d'Hebron Barcelona,	Boehringer Ingelheim - (espana@bitrialsupport.com)
Hospital Universitario 12 de Octubre Madrid,	Boehringer Ingelheim - (espana@bitrialsupport.com)
Hospital Universitario Austral Pilar,	Boehringer Ingelheim - (argentina@bitrialsupport.com)
Hospital Universitario Joao de Barros Barreto Belém,	Boehringer Ingelheim - (brasil@bitrialsupport.com)
Hospital Universitario Marqués de Valdecilla Santander,	Boehringer Ingelheim - (espana@bitrialsupport.com)
Hospital Universitario Reina Sofia Córdoba,	Boehringer Ingelheim - (espana@bitrialsupport.com)
Hospital Universiti Sains Malaysia Kota Bharu,	Boehringer Ingelheim - (malaysia@bitrialsupport.com)
Hospital das Clinicas da Universidade Federal de Minas Gerais (HC-UFMG) Belo Horizonte,	Boehringer Ingelheim - (brasil@bitrialsupport.com)
Hospital de Base São José do Rio Preto,	Boehringer Ingelheim - (brasil@bitrialsupport.com)
Hospitalar Moinhos de Vento Porto Alegre,	Boehringer Ingelheim - (brasil@bitrialsupport.com)
Huashan Hospital, Fudan University Shanghai, Shanghai Municipality	Boehringer Ingelheim - (china@bitrialsupport.com)
Hull Royal Infirmary Hull,	Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Hunan Provincial People's Hospital (The First Affiliated Hospital of Hunan Normal University) Changsha,	Boehringer Ingelheim - (china@bitrialsupport.com)
Hyogo College of Medicine Hospital Hyogo, Nishinomiya,	Boehringer Ingelheim - (nippon@bitrialsupport.com)
Hôpital Erasme Brussels,	Boehringer Ingelheim - (belgique@bitrialsupport.com)
Hôpital Rangueil - CHU de Toulouse Toulouse,	Boehringer Ingelheim - (france@bitrialsupport.com)
Hôpital de l'Archet Nice,	Boehringer Ingelheim - (france@bitrialsupport.com)
ID Clinic Mysłowice,	Boehringer Ingelheim - (polska@bitrialsupport.com)
IDIM - Instituto de Diagnóstico e Investigaciones Metabólicas Buenos Aires,	Boehringer Ingelheim - (argentina@bitrialsupport.com)
IMA Clinical Research Austin Austin, Texas	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
IMA Clinical Research-Warren-69742 Warren Township, New Jersey	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
IRCCS Ospedale "Casa Sollievo della Sofferenza" San Giovanni Rotondo,	Boehringer Ingelheim - (italia@bitrialsupport.com)
ISR-GEO Med Res Clin Healthycore Tbilisi,	Boehringer Ingelheim - (sakartvelo@bitrialsupport.com)
Icahn School of Medicine at Mount Sinai New York, New York	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Inha University Hospital Incheon,	Boehringer Ingelheim - (namhan@bitrialsupport.com)
Inland Empire Clinical Trials, LLC Rialto, California	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Innovation Medical Research Center Palmetto Bay, Florida	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Innovative Clinical Research Clarksville, Tennessee	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Insitute of Liver and Billiary Sciences New Delhi,	Boehringer Ingelheim - (india@bitrialsupport.com)
Inspired GI Care Plumstead,	Boehringer Ingelheim - (southafrica@bitrialsupport.com)
Institute of Gastroenterology, Hepatology and Metabolism LLP Almaty,	Boehringer Ingelheim - (kazakhstan@bitrialsupport.com)
Institute of Science Tokyo Hospital Bunkyoku, Tokyo	Boehringer Ingelheim - (nippon@bitrialsupport.com)
Instituto de Diabetes, Obesidad y Nutrición S.C. Cuernavaca,	Boehringer Ingelheim - (mexico@bitrialsupport.com)
International Center for Research Tampa, Florida	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
International University of Health and Welfare Narita Hospital Narita, Chiba	Boehringer Ingelheim - (nippon@bitrialsupport.com)
Iowa Diabetes and Endocrinology Research Center West Des Moines, Iowa	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Iowa Digestive Disease Center Clive, Iowa	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Istituto Clinico Humanitas Rozzano,	Boehringer Ingelheim - (italia@bitrialsupport.com)
Iwate Medical University Hospital Shiwa-gun,	Boehringer Ingelheim - (nippon@bitrialsupport.com)
JCHO Shimonoseki Medical Center Shimonoseki,	Boehringer Ingelheim - (nippon@bitrialsupport.com)
Japan Community Health Care Organization Hokkaido Hospital Hokkaido, Sapporo,	Boehringer Ingelheim - (nippon@bitrialsupport.com)
Japan Institute for Health Security National Kohnodai Medical Center Chiba, Ichikawa,	Boehringer Ingelheim - (nippon@bitrialsupport.com)
Japanese Red Cross Musashino Hospital Musashino,	Boehringer Ingelheim - (nippon@bitrialsupport.com)
Jolimont Hôpital La Louvière,	Boehringer Ingelheim - (belgique@bitrialsupport.com)
Jordan University Hospital Jordan,	Boehringer Ingelheim - (support@bitrialsupport.com)
Jubilee Clinical Research, Inc Las Vegas, Nevada	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Juntendo University Shizuoka Hospital Shizuoka, Izunokuni,	Boehringer Ingelheim - (nippon@bitrialsupport.com)
K2 Medical Research Orlando, Florida	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
K2 Medical Research Orlando, Florida
K2 Medical Research - Winter Garden Clermont, Florida	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Kagawa University Hospital Kita-gun,	Boehringer Ingelheim - (nippon@bitrialsupport.com)
Kagoshima University Hospital Kagoshima, Kagoshima-ken	Boehringer Ingelheim - (nippon@bitrialsupport.com)
Kanazawa University Hospital Kanazawa, Ishikawa-ken	Boehringer Ingelheim - (nippon@bitrialsupport.com)
Kansas City Research Institute Kansas City, Missouri	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Kansas Medical Clinic PA Topeka, Kansas	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung City,	Boehringer Ingelheim - (taiwan@bitrialsupport.com)
King Abdulaziz Medical City, National Guard Health Affairs Riyadh,	Boehringer Ingelheim - (saudi@bitrialsupport.com)
King Faisal Specialist Hospital and Research Center Riyadh,	Boehringer Ingelheim - (saudi@bitrialsupport.com)
King's College Hospital London,	Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Klinical Investigations Group, LLC San Juan,	Boehringer Ingelheim - (support@bitrialsupport.com)
Klinik Hietzing Vienna,	Boehringer Ingelheim - (oesterreich@bitrialsupport.com)
Klinik Landstraße Vienna,	Boehringer Ingelheim - (oesterreich@bitrialsupport.com)
Klinikum Wels - Grieskirchen GmbH Wels,	Boehringer Ingelheim - (oesterreich@bitrialsupport.com)
Kobe University Hospital Kobe,	Boehringer Ingelheim - (nippon@bitrialsupport.com)
Koc Universitesi Hastanesi Istanbul,	Boehringer Ingelheim - (turkiye@bitrialsupport.com)
Korea University Guro Hospital Seoul,	Boehringer Ingelheim - (namhan@bitrialsupport.com)
Krajska Nemocnice Liberec a.s. Liberec,	Boehringer Ingelheim - (support@bitrialsupport.com)
Kumamoto Shinto General Hospital Kumamoto,	Boehringer Ingelheim - (nippon@bitrialsupport.com)
Kumamoto University Hospital Kumamoto,	Boehringer Ingelheim - (nippon@bitrialsupport.com)
Kurume University Hospital Fukuoka,	Boehringer Ingelheim - (nippon@bitrialsupport.com)
Lake Center for Clinical Research Lady Lake, Florida	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Latin Clinical Trial Center San Juan,	Boehringer Ingelheim - (support@bitrialsupport.com)
Lenasia Clinical Trial Centre Johannesburg,	Boehringer Ingelheim - (southafrica@bitrialsupport.com)
Liaocheng People's Hospital Liaocheng,	Boehringer Ingelheim - (china@bitrialsupport.com)
Liver Institute of Virginia-Bremo Newport News, Virginia	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Liverpool Hospital Liverpool, New South Wales	Boehringer Ingelheim - (australia@bitrialsupport.com)
Louisiana Research Center, LLC Shreveport, Louisiana	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Ltd "Health" Batumi,	Boehringer Ingelheim - (sakartvelo@bitrialsupport.com)
M3 Wake Research, Inc. Raleigh, North Carolina	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
MHAT Sv. Ivan Rilski EOOD Gorna Oryahovitsa,	Boehringer Ingelheim - (balgariya@bitrialsupport.com)
MNGI Digestive Health, PA Minneapolis, Minnesota	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
ManglamPlus Medicity Hospital Jaipur,	Boehringer Ingelheim - (india@bitrialsupport.com)
Mautalen- Salud e Investigacion CABA,	Boehringer Ingelheim - (argentina@bitrialsupport.com)
McGill University Health Centre (MUHC) Montreal, Quebec	Boehringer Ingelheim - (canada@bitrialsupport.com)
Medical Associates Research Group, Inc. San Diego, California	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Medical Care and Research Mérida,	Boehringer Ingelheim - (mexico@bitrialsupport.com)
Medical Center New Rehabilitation Center EOOD Stara Zagora,	Boehringer Ingelheim - (balgariya@bitrialsupport.com)
Medical Centre FutureMeds Krakow Krakow,	Boehringer Ingelheim - (polska@bitrialsupport.com)
Medical Military Academy MHAT Sofia Sofia,	Boehringer Ingelheim - (balgariya@bitrialsupport.com)
Medical University of Graz Graz,	Boehringer Ingelheim - (oesterreich@bitrialsupport.com)
Medical University of South Carolina Charleston, South Carolina	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Memorial Bahçelievler Hospital Istanbul,	Boehringer Ingelheim - (turkiye@bitrialsupport.com)
Mercy Medical Center Springfield, Massachusetts	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Metro Clinical Trials San Bernardino, California	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Midas Multispeciality Hospital Pvt. Ltd. Nagpur,	Boehringer Ingelheim - (india@bitrialsupport.com)
Middlemore Hospital Papatoetoe, Auckland	Boehringer Ingelheim - (newzealand@bitrialsupport.com)
Mie University Hospital Tsu, Mie-ken	Boehringer Ingelheim - (nippon@bitrialsupport.com)
Monash Health Clayton, Victoria	Boehringer Ingelheim - (australia@bitrialsupport.com)
MplusM - Best Choice Medical and Research Service Pembroke Pines, Florida	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Multi-profile Hospital For Active Treatment-Uni Hospital Ltd. Panagyurishte,	Boehringer Ingelheim - (balgariya@bitrialsupport.com)
Nagano Municipal Hospital Hanishina-gun,	Boehringer Ingelheim - (nippon@bitrialsupport.com)
Nagasaki Medical Center Nagasaki, Omura,	Boehringer Ingelheim - (nippon@bitrialsupport.com)
NanFang Hosptial Guangzhou,	Boehringer Ingelheim - (china@bitrialsupport.com)
Nanjing Drum Tower Hospital Nanjing,	Boehringer Ingelheim - (china@bitrialsupport.com)
Nara Medical University Hospital Nara, Kashihara,	Boehringer Ingelheim - (nippon@bitrialsupport.com)
National Cheng Kung University Hospital Tainan,	Boehringer Ingelheim - (taiwan@bitrialsupport.com)
National Hospital Organization Kure Medical Center and Chugoku Cancer Center Kure,	Boehringer Ingelheim - (nippon@bitrialsupport.com)
National Hospital Organization Kyushu Medical Center Fukuoka,	Boehringer Ingelheim - (nippon@bitrialsupport.com)
National Hospital Organization Takasaki General Medical Center Takasaki-shi,	Boehringer Ingelheim - (nippon@bitrialsupport.com)
National Taiwan University Hospital Taipei,	Boehringer Ingelheim - (taiwan@bitrialsupport.com)
National University Hospital Singapore,	Boehringer Ingelheim - (singapore@bitrialsupport.com)
Neoclinical Research Hialeah, Florida	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Nepean Hospital Kingswood, New South Wales	Boehringer Ingelheim - (australia@bitrialsupport.com)
New Zealand Clinical Research (NZCR) Grafton, Auckland	Boehringer Ingelheim - (newzealand@bitrialsupport.com)
NewYork-Presbyterian Brooklyn Methodist Hospital Brooklyn, New York	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Newcastle General Hospital Newcastle upon Tyne,	Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Nihon University Itabashi Hospital Tokyo, Itabashi-ku,	Boehringer Ingelheim - (nippon@bitrialsupport.com)
Niigata University Medical and Dental Hospital Niigata, Niigata	Boehringer Ingelheim - (nippon@bitrialsupport.com)
Ningbo Second Hospital Ningbo,	Boehringer Ingelheim - (china@bitrialsupport.com)
Nippon Medical School Hospital Tokyo, Bunkyo-ku,	Boehringer Ingelheim - (nippon@bitrialsupport.com)
North Texas Research Institute - Dallas Dallas, Texas	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Northshore Gastroenterology Research Westlake, Ohio	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Objective Health-Digestive Research of Central Texas Waco, Texas	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
ObjectiveHealth-Columbia Digestive Health Research Columbia, South Carolina	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
ObjectiveHealth-DSI Research - Springboro, LLC Springboro, Ohio	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
ObjectiveHealth-Digestive Health Research of North Texas Wichita Falls, Texas	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
ObjectiveHealth-GI Associates Research Columbia, Missouri	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Obudai Egeszegugyi Centrum Budapest,	Boehringer Ingelheim - (magyarorszag@bitrialsupport.com)
Oita Cardiovascular Hospital Ōita,	Boehringer Ingelheim - (nippon@bitrialsupport.com)
Okayama University Hospital Okayama,	Boehringer Ingelheim - (nippon@bitrialsupport.com)
Om Research, LLC Victorville, California	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Om Research, LLC Victorville, California	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Omega Research Orlando, LLC Orlando, Florida	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Optimus U Corporation-Miami-69452 Miami, Florida	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Options Health Research Tulsa, Oklahoma	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Ordensklinikum Linz GmbH Linz,	Boehringer Ingelheim - (oesterreich@bitrialsupport.com)
Osaka City University Hospital Osaka,	Boehringer Ingelheim - (nippon@bitrialsupport.com)
Osaka Rosai Hospital Sakai,	Boehringer Ingelheim - (nippon@bitrialsupport.com)
Osmania Medical College & Hospital Hyderabad, Afzalgunj,	Boehringer Ingelheim - (india@bitrialsupport.com)
Ospedale Maggiore Della Carita Novara,	Boehringer Ingelheim - (italia@bitrialsupport.com)
Otto-von-Guericke-Universitat Magdeburg Magdeburg,	Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Pacific Gastroenterology Associates Vancouver, British Columbia	Boehringer Ingelheim - (canada@bitrialsupport.com)
Palmetto Clinical Research Summerville, South Carolina	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences Rohtak,	Boehringer Ingelheim - (india@bitrialsupport.com)
Panthera Biopartners - Enfield Enfield, London,	Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Panthera Biopartners - Glasgow Glasgow,	Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Panthera Biopartners - Preston Preston,	Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Panthera Biopartners - Rochdale Rochdale,	Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Panthera Biopartners - Sheffield Sheffield,	Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Panthera Biopartners - York York,	Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Peking University People's Hospital Beijing, Beijing Municipality	Boehringer Ingelheim - (china@bitrialsupport.com)
Penn State Milton S. Hershey Medical Center Hershey, Pennsylvania	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
PingXiang People's Hospital Pingxiang,	Boehringer Ingelheim - (china@bitrialsupport.com)
Pinnacle Clinical Research - Austin Austin, Texas	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Pinnacle Clinical Research - Corpus Christi Corpus Christi, Texas	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Pinnacle Clinical Research - San Antonio San Antonio, Texas	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Pinnacle Clinical Research, LLC San Antonio, Texas	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Pinnacle Clinical Research, LLC San Antonio, Texas	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Policlinico S. Orsola-Malpighi Bologna,	Boehringer Ingelheim - (italia@bitrialsupport.com)
Post Graduate Institute of Medical Education and Research Chandigarh,	Boehringer Ingelheim - (india@bitrialsupport.com)
Practice Dr Rosa Isela Luna Ceballos Veracruz,	Boehringer Ingelheim - (mexico@bitrialsupport.com)
Progressive Medical Research Port Orange, Florida	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Pusan National University Hospital Seogu, Busan Gwang'Yeogsi	Boehringer Ingelheim - (namhan@bitrialsupport.com)
QingDao Municipal Hospital Qingdao,	Boehringer Ingelheim - (china@bitrialsupport.com)
Queen Elizabeth Hospital Putrajaya,	Boehringer Ingelheim - (malaysia@bitrialsupport.com)
Queen Elizabeth Hospital Birmingham Edgbaston, Birmingham,	Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Queen's Medical Centre Nottingham,	Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Radboud Universitair Medisch Centrum Nijmegen,	Boehringer Ingelheim - (nederland@bitrialsupport.com)
Recep Tayyip Erdogan Universitesi Egitim ve Arastirma Hastanesi Rize,	Boehringer Ingelheim - (turkiye@bitrialsupport.com)
Regional Institute of Gastroenterology Hepatology "Prof. Dr. O. Fodor" Cluj-Napoca,	Boehringer Ingelheim - (romania@bitrialsupport.com)
Renji Hospital Shanghai Jiaotong Univesrity School of Medicine Shanghai,	Boehringer Ingelheim - (china@bitrialsupport.com)
Renmin Hospital of Wuhan University Wuhan,	Boehringer Ingelheim - (china@bitrialsupport.com)
Research Associates of South Florida, LLC Miami, Florida	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Research Physicians Network Houston, Texas	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Research Site S.R.O. Pilsen,	Boehringer Ingelheim - (support@bitrialsupport.com)
Rocco e Nazato Servicos Medicos LTDA São Paulo,	Boehringer Ingelheim - (brasil@bitrialsupport.com)
Royal Devon and Exeter Hospital, Wonford Exeter,	Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Royal Free Hospital London,	Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Royal Melbourne Hospital Parkville, Victoria	Boehringer Ingelheim - (australia@bitrialsupport.com)
Royal Perth Hospital Perth, Western Australia	Boehringer Ingelheim - (australia@bitrialsupport.com)
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Shanghai,	Boehringer Ingelheim - (china@bitrialsupport.com)
SMG-SNU Boramae Medical Center Seoul,	Boehringer Ingelheim - (namhan@bitrialsupport.com)
SR Kalla Memorial Hospital Jaipur,	Boehringer Ingelheim - (india@bitrialsupport.com)
Saga University Hospital Saga,	Boehringer Ingelheim - (nippon@bitrialsupport.com)
Samsung Medical Center GangnamGu, Seoul Teugbyeolsi	Boehringer Ingelheim - (namhan@bitrialsupport.com)
Santa SP. z o.o Lodz,	Boehringer Ingelheim - (polska@bitrialsupport.com)
Sapporo Kosei General Hospital Sapporo,	Boehringer Ingelheim - (nippon@bitrialsupport.com)
Schiff Center Liver Diseases Miami, Florida	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Scottsdale Medical Specialists, Ltd Scottsdale, Arizona	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Second Affiliated Hospital of Xi'an JiaoTong University Xi'an,	Boehringer Ingelheim - (china@bitrialsupport.com)
Seichokai Bell Land General Hospital Sakai,	Boehringer Ingelheim - (nippon@bitrialsupport.com)
Semmelweis Egyetem Sebeszeti, Transzplantacios es Gasztroenterologiai Klinika Budapest,	Boehringer Ingelheim - (magyarorszag@bitrialsupport.com)
Sendai Tokushukai Hospital Sendai,	Boehringer Ingelheim - (nippon@bitrialsupport.com)
Seoul National University Hospital Seoul, Seoul Teugbyeolsi	Boehringer Ingelheim - (namhan@bitrialsupport.com)
Shanghai East Hospital Shanghai,	Boehringer Ingelheim - (china@bitrialsupport.com)
Shanghai General Hospital Shanghai,	Boehringer Ingelheim - (china@bitrialsupport.com)
Shanghai Public Health Clinical Center Shanghai,	Boehringer Ingelheim - (china@bitrialsupport.com)
Shimane University Hospital Izumo,	Boehringer Ingelheim - (nippon@bitrialsupport.com)
Shin-Yurigaoka General Hospital Kanagawa, Kawasaki,	Boehringer Ingelheim - (nippon@bitrialsupport.com)
Shinshu University Hospital Nagano, Matsumoto,	Boehringer Ingelheim - (nippon@bitrialsupport.com)
Singapore General Hospital Singapore,	Boehringer Ingelheim - (singapore@bitrialsupport.com)
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine Hangzhou,	Boehringer Ingelheim - (china@bitrialsupport.com)
Sixth People's Hospital of Zhengzhou Zhengzhou,	Boehringer Ingelheim - (china@bitrialsupport.com)
Soma Clinical Trials Denison, Texas	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Soon Chun Hyang University Hospital Bucheon Bucheon-si,	Boehringer Ingelheim - (namhan@bitrialsupport.com)
South Denver Gastroenterology PC Englewood, Colorado	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
South Texas Research Institute - Brownsville Brownsville, Texas	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
South Texas Research Institute-Edinburg-67012 Edinburg, Texas	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Southampton General Hospital Southampton,	Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Southern California Research Center Coronado, California	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Spital Judetean De Urgenta Satu Mare Satu Mare,	Boehringer Ingelheim - (romania@bitrialsupport.com)
Spitalul Clinic Judetean De Urgenta Craiova Craiova,	Boehringer Ingelheim - (romania@bitrialsupport.com)
St George's Hospital Tooting, London,	Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
St. Josefs-Hospital Wiesbaden Wiesbaden,	Boehringer Ingelheim - (deutschland@bitrialsupport.com)
St. Marianna University Hospital Kawasaki-shi,	Boehringer Ingelheim - (nippon@bitrialsupport.com)
Suita Hospital Suita-Shi,	Boehringer Ingelheim - (nippon@bitrialsupport.com)
Sunshine Coast University Hospital Birtinya, Queensland	Boehringer Ingelheim - (australia@bitrialsupport.com)
Surat Institute of Digestive Sciences Surat,	Boehringer Ingelheim - (india@bitrialsupport.com)
Synergy Healthcare Bradenton, Florida	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Synergy Healthcare of Tampa Brandon, Florida	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Taichung Veterans General Hospital Taichung,	Boehringer Ingelheim - (taiwan@bitrialsupport.com)
Taipei Medical University Hospital Taipei,	Boehringer Ingelheim - (taiwan@bitrialsupport.com)
Taipei Veterans General Hospital Taipei,	Boehringer Ingelheim - (taiwan@bitrialsupport.com)
Tampa Bay Medical Research Clearwater, Florida	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Tandem Clinical Research Marrero, Louisiana	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Technische Universitat Dresden Dresden,	Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Texas Clinical Research Institute, LLC Arlington, Texas	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
The Affiliated Hospital of Hangzhou Normal University Hangzhou,	Boehringer Ingelheim - (china@bitrialsupport.com)
The Fifth People's Hospital of Suzhou Suzhou,	Boehringer Ingelheim - (china@bitrialsupport.com)
The First Affiliated Hospital of Henan University of Science and Technology Luoyang,	Boehringer Ingelheim - (china@bitrialsupport.com)
The First Affiliated Hospital of NanChang University Nanchang,	Boehringer Ingelheim - (china@bitrialsupport.com)
The First Affiliated Hospital of Wenzhou Medical University Wenzhou, Zhejiang	Boehringer Ingelheim - (china@bitrialsupport.com)
The First Affiliated Hospital, Zhejiang University Hangzhou,	Boehringer Ingelheim - (china@bitrialsupport.com)
The First Affiliated Hospital,Sun Yat-sen University Guangzhou,	Boehringer Ingelheim - (china@bitrialsupport.com)
The First Affiliated hospital of Fujian Medical University Fuzhou,	Boehringer Ingelheim - (china@bitrialsupport.com)
The First Hospital of Jiaxing Jiaxing,	Boehringer Ingelheim - (china@bitrialsupport.com)
The First People's Hospital of Foshan Foshan,	Boehringer Ingelheim - (china@bitrialsupport.com)
The Institute for Liver Health II DBA Arizona Clinical Trials Peoria, Arizona	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
The Ohio State University Wexner Medical Center Columbus, Ohio	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
The Second Affiliated Hospital to Nanchang University Nanchang,	Boehringer Ingelheim - (china@bitrialsupport.com)
The Second Hospital of Nanjing Nanjing,	Boehringer Ingelheim - (china@bitrialsupport.com)
The Sixth People's Hospital of Shenyang Shenyang,	Boehringer Ingelheim - (china@bitrialsupport.com)
The Speciality Hospital (TSH) Amman,	Boehringer Ingelheim - (support@bitrialsupport.com)
The Third People's Hospital of Shenzhen Shenzhen,	Boehringer Ingelheim - (china@bitrialsupport.com)
The Third People's Hospital of Zhenjiang Zhenjiang,	Boehringer Ingelheim - (china@bitrialsupport.com)
The University of Osaka Hospital Suita,	Boehringer Ingelheim - (nippon@bitrialsupport.com)
The University of Tokyo Hospital Bunkyo-ku, Tokyo	Boehringer Ingelheim - (nippon@bitrialsupport.com)
The third affiliated hospital of Sun Yat-Sen University Guangzhou,	Boehringer Ingelheim - (china@bitrialsupport.com)
Tianjin Second People's Hospital Tianjin,	Boehringer Ingelheim - (china@bitrialsupport.com)
Tianjin Third Central Hospital Tianjin,	Boehringer Ingelheim - (china@bitrialsupport.com)
Tokai University Hospital Iseharashi, Kanagawa	Boehringer Ingelheim - (nippon@bitrialsupport.com)
Tokyo Medical University Hospital Tokyo,	Boehringer Ingelheim - (nippon@bitrialsupport.com)
Tokyo Medical University Ibaraki Medical Center Ibaraki, Inashiki-gun,	Boehringer Ingelheim - (nippon@bitrialsupport.com)
Toranomon Hospital Tokyo, Minato-ku,	Boehringer Ingelheim - (nippon@bitrialsupport.com)
Toronto Liver Centre Toronto, Ontario	Boehringer Ingelheim - (canada@bitrialsupport.com)
Tweesteden Ziekenhuis, locatie Tilburg Tilburg,	Boehringer Ingelheim - (nederland@bitrialsupport.com)
US Digestive Health Wyomissing, Pennsylvania	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
US Digestive Health Wyomissing, Pennsylvania	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
US Digestive Health Wyomissing, Pennsylvania	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
UZ Leuven Leuven, Vlaams-Brabant
Uludag Universitesi Tip Fakultesi Bursa,	Boehringer Ingelheim - (turkiye@bitrialsupport.com)
Universidade Estadual Paulista 'Julio De Mesquita Filho' Botucatu,	Boehringer Ingelheim - (brasil@bitrialsupport.com)
Universidade Federal do Rio Grande do Sul Porto Alegre,	Boehringer Ingelheim - (brasil@bitrialsupport.com)
Universidade Federal do Rio de Janeiro Barra,	Boehringer Ingelheim - (brasil@bitrialsupport.com)
Universita Degli Studi di Torino Torino,	Boehringer Ingelheim - (italia@bitrialsupport.com)
Universitair Ziekenhuis Antwerpen Edegem,	Boehringer Ingelheim - (belgique@bitrialsupport.com)
Universitair Ziekenhuis Gent Ghent,	Boehringer Ingelheim - (belgique@bitrialsupport.com)
Universitatsklinikum Heidelberg Heidelberg,	Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Universitatsklinikum Heidelberg Heidelberg,	Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Universitatsklinikum Schleswig-Holstein, Campus Lubeck Lübeck,	Boehringer Ingelheim - (deutschland@bitrialsupport.com)
University Hospital Bern Bern,	Boehringer Ingelheim - (suisse@bitrialsupport.com)
University Hospital Kyoto Prefectural University of Medicine Kyoto,	Boehringer Ingelheim - (nippon@bitrialsupport.com)
University Hospital Zurich Zurich,	Boehringer Ingelheim - (suisse@bitrialsupport.com)
University Malaya Medical Centre Kuala Lumpur,	Boehringer Ingelheim - (malaysia@bitrialsupport.com)
University Multiprofile Hospital for Active Treatment St. Ivan Rilski EAD Sofia,	Boehringer Ingelheim - (balgariya@bitrialsupport.com)
University of Alabama at Birmingham Birmingham, Alabama	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
University of British Columbia Vancouver, British Columbia	Boehringer Ingelheim - (canada@bitrialsupport.com)
University of Calgary Calgary, Alberta	Boehringer Ingelheim - (canada@bitrialsupport.com)
University of Florida Gainesville, Florida	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
University of Kansas Medical Center Kansas City, Kansas	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
University of Miyazaki Hospital Miyazaki,	Boehringer Ingelheim - (nippon@bitrialsupport.com)
University of Nebraska Medical Center Omaha, Nebraska	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
University of Rochester Medical Center Rochester, New York	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Università degli Studi di Genova Modena,	Boehringer Ingelheim - (italia@bitrialsupport.com)
Universität Des Saarlandes Homburg,	Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Universitätsklinikum Erlangen Erlangen,	Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Universitätsklinikum Frankfurt Frankfurt am Main,	Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH Bochum,	Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Universitätsklinikum Köln (AöR) Cologne,	Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Universitätsklinikum Münster Münster,	Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Universitätsklinikum Tübingen Tübingen,	Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Universitätsklinikum Würzburg AÖR Würzburg,	Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Universitätsmedizin der Johannes Gutenberg-Universität Mainz Mainz,	Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie Lublin,	Boehringer Ingelheim - (polska@bitrialsupport.com)
VCU Medical Center West Hospital Richmond, Virginia	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Vanderbilt University Medical Center Nashville, Tennessee	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Velocity Clinical Research, Austin Austin, Texas	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Velocity Clinical Research, Bristol Bristol,	Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Velocity Clinical Research, San Diego La Mesa, California	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Velocity Clinical Research, Santa Ana Santa Ana, California
Velocity Clinical Research, Seattle Seattle, Washington	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Velocity Clinical Research, Van Nuys Van Nuys, California	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Velocity Clinical Research, Waco Waco, Texas	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Velocity Clinical Research, Westlake Los Angeles, California	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Velocity Clinical Research-Chula Vista Chula Vista, California	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Velocity Clinical Research-Dallas-69170 Dallas, Texas	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Velocity Clinical Research-Gardena-69773 Gardena, California	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Velocity Clinical Research-Huntington Park Huntington Park, California	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Velocity Clinical Research-Spokane-69716 Spokane, Washington	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Viable Clinical Research Bridgewater, Nova Scotia	Boehringer Ingelheim - (canada@bitrialsupport.com)
Waikato Hospital Hamilton, Waikato Region	Boehringer Ingelheim - (newzealand@bitrialsupport.com)
Wakayama Medical University Hospital Wakayama,	Boehringer Ingelheim - (nippon@bitrialsupport.com)
West Michigan Clinical Research Center Wyoming, Michigan	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Westmead Hospital Westmead, New South Wales	Boehringer Ingelheim - (australia@bitrialsupport.com)
Wuxi No. 5 People's Hospital Wuxi,	Boehringer Ingelheim - (china@bitrialsupport.com)
Yale University School of Medicine North Haven, Connecticut	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Yanbian University Hospital Yanji,	Boehringer Ingelheim - (china@bitrialsupport.com)
Yashoda Hospitals - Secunderabad Secunderabad,	Boehringer Ingelheim - (india@bitrialsupport.com)
Yeungnam University Medical Center Deagu,	Boehringer Ingelheim - (namhan@bitrialsupport.com)
Yokohama City University Hospital Yokohama,	Boehringer Ingelheim - (nippon@bitrialsupport.com)
Yonsei University Wonju Severance Christian Hospital Wŏnju,	Boehringer Ingelheim - (namhan@bitrialsupport.com)
Yueyang Central Hospital Yueyang,	Boehringer Ingelheim - (china@bitrialsupport.com)
Yuncheng Center Hopsital - West Compus Yuncheng,	Boehringer Ingelheim - (china@bitrialsupport.com)
Zenos Clinical Research Dallas, Texas	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Zhejiang Hospital Hangzhou,	Boehringer Ingelheim - (china@bitrialsupport.com)
Ziekenhuis Oost-Limburg Genk,	Boehringer Ingelheim - (belgique@bitrialsupport.com)
hospital Italiano de Buenos Aires Ciudad Autonoma Buenos Aires,	Boehringer Ingelheim - (argentina@bitrialsupport.com)
the First Hospital of Jilin University Changchun, Jilin	Boehringer Ingelheim - (china@bitrialsupport.com)

A Study to Assess the Efficacy and Safety of Emicizumab in Participants With Type 3 Von Willebrand Disease (WILL-EMI)

Contact(s):

Reference Study ID Number: WP45338 https://forpatients.roche.com/ - global-roche-genentech-trials@gene.com

Principal Investigator:

System ID: NCT06998524

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Interventions: DRUG: Emicizumab, DRUG: von Willebrand Factor (VWF) Concentrates, DRUG: Factor VIII (FVIII) Concentrates, DRUG: von Willebrand Factor (VWF) and Factor VIII (FVIII) Concentrates, DRUG: Bypassing Agents

Conditions: Von Willebrand Disease, Type 3

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Location	Contacts
AOU Careggi Florence, Tuscany
Charlotte Maxeke Johannesburg Academic Hospital Johannesburg,
Erasmus MC Rotterdam,
Gerinnungszentrum Rhein-Ruhr;Gerinnungsambulanz Duisburg,
Great Ormond Street Hospital London,
Groupe Hospitalier Necker Enfants Malades Paris,
Hopital Claude Huriez - CHU Lille Lille,
Hospital Universitario La Paz Madrid,
Hospital Universitario Virgen del Rocio Seville,
Hämophiliezentrum Med. Klinik III/Institut für Transfusionsmedizin Frankfurt/M.,
IPS SURA Industriales Medellín Medellín,
IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan, Lombardy
Instytut Hematologii I Transfuzjologii Warsaw,
Kurume University Hospital Fukuoka,
Manchester Royal Infirmary Manchester,
McGill University Health Center Montreal, Quebec
Nagoya University Hospital Nagoya,
Sahlgrenska Universitetssjukhuset Gothenburg,
St Thomas' Hospital London,
The Hospital for Sick Children Toronto, Ontario
UC Davis Sacramento, California
UZ Leuven Gasthuisberg Leuven,
Universita' Degli Studi La Sapienza-Ist.Di Ematologia Rome, Lazio
Universitatsklinikum Bonn Bonn,
University of Florida Gainesville, Florida
University of Minnesota Medical Center Minneapolis, Minnesota
Virginia Commonwealth University Richmond, Virginia
Washington University School of Medicine St Louis, Missouri

Establishing Biomarkers and Clinical Endpoints in Myotonic Dystrophy Type 1 (END-DM1) Extension (END-EXT)

Contact(s):

Jennifer Raymond - Jennifer.raymond@vcuhealth.org

Principal Investigator:

System ID: NCT07700225

Show full eligibility criteria

Conditions: DM1, Myotonic Dystrophy, Myotonic Dystrophy 1, Myotonic Dystrophy Type 1, Myotonic Dystrophy Type-1, Myotonic Dystrophy, Type 1 (DM1), Myotonic Muscular Dystrophy

Keywords: DM1, END-EXT, END-DM1 Extension, Myotonic Dystrophy Type 1, Steinert's Disease, Muscular Dystrophy, Neuromuscular Disease, DMPK, Natural History, Myotonia, DMCRN, Myotonic Dystrophy Clinical Research Network

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Location	Contacts
Virginia Commonwealth University Richmond, Virginia	Jennifer Raymond - (Jennifer.raymond@vcuhealth.org)

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