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A Study to Compare Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) Versus Pembrolizumab Alone as Treatment in Participants With Mismatch Repair Proficient Endometrial Cancer (MK-2870-033/TroFuse-033/GOG-3119/ENGOT-en29) (TroFuse-033)
Toll Free Number - Trialsites@msd.com
NCT06952504
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Key inclusion criteria include but are not limited to:
* Has a histologically confirmed diagnosis of primary advanced or recurrent endometrial carcinoma that has been confirmed as proficient mismatch repair (pMMR)
* Has radiographically evaluable disease, with measurable Stage III or either measurable or non-measurable Stage IV or recurrent disease per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1), as assessed by the investigator
* Has received no prior systemic therapy for endometrial carcinoma except the following conditions as pre-specified by the protocol: 1 prior line of systemic platinum-based adjuvant and/or neoadjuvant chemotherapy in the setting of curative-intent, prior radiation with or without radiosensitizing chemotherapy if \>2 weeks before the start of induction treatment, or prior hormonal therapy for treatment of endometrial carcinoma that was discontinued ≥1 week before the start of induction treatment
Key exclusion criteria include but are not limited to:
* Has carcinosarcoma, neuroendocrine tumors or endometrial sarcoma, including stromal sarcoma, leiomyosarcoma, adenosarcoma, or other types of sarcomas
* Has endometrial carcinoma of any histology that is mismatch repair deficient (dMMR)
* Is a candidate for debulking surgery resulting in complete removal of all tumor and no evidence of radiological disease following surgery, or curative-intent radiotherapy at the time of enrollment
* Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
* Human Immunodeficiency Virus-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
* Received prior therapy in any setting with any of the following: anti-programmed cell death 1 protein, anti-programmed cell death ligand 1, anti-programmed cell death ligand 2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor; trophoblast cell surface antigen 2-targeted antibody drug conjugate; or topoisomerase I inhibitor-containing antibody drug conjugate
BIOLOGICAL: Pembrolizumab, DRUG: Carboplatin, DRUG: Paclitaxel, DRUG: Docetaxel, BIOLOGICAL: Sacituzumab Tirumotecan
Endometrial Cancer
Programmed Cell Death-1 (PD1, PD-1), Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1), Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2), Trophoblast cell surface antigen 2 (TROP2)
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Show 253 locations
Study Locations
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| Location | Contacts |
|---|---|
| AHN West Penn Hospital ( Site 6006) Pittsburgh, Pennsylvania | |
| ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 1603) Chaïdári, Attica | |
| AZ Maria Middelares ( Site 0402) Ghent, Oost-Vlaanderen | |
| Aalborg Universitetshospital, Syd ( Site 1203) Aalborg, North Denmark | |
| Aarhus Universitetshospital, Skejby ( Site 1205) Aarhus, Central Jutland | |
| Addenbrookes Hospital ( Site 4002) Cambridge, Cambridgeshire | |
| AdventHealth Orlando-AdventHealth Medical Group Gynecological Oncology ( Site 6002) Orlando, Florida | |
| Affiliated Hospital of Guangdong Medical University ( Site 0823) Zhanjiang, Guangdong | |
| Agios Loukas Clinic-DEPARTMENT OF ONCOLOGY ( Site 1601) Thessaloniki, Central Macedonia | |
| Aichi Cancer Center ( Site 2217) Nagoya, Aichi-ken | |
| Akademiska Sjukhuset ( Site 3501) Uppsala, Uppsala County | |
| Alaska Women's Cancer Care ( Site 6036) Anchorage, Alaska | |
| Alexandra General Hospital of Athens ( Site 1604) Athens, Attica | |
| Anhui Provincial Hospital ( Site 0830) Hefei, Anhui | |
| Aretaieio Hospital ( Site 1602) Athens, Attica | |
| Asan Medical Center ( Site 3103) Seoul, | |
| Asklepios Kliniken Hamburg ( Site 1509) Hamburg, | |
| Azienda Ospedaliera Universitaria Careggi ( Site 2109) Florence, | |
| Azienda Ospedaliero Universitaria Pisana Ospedale S. Chiara ( Site 2108) Pisa, | |
| Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino ( Site 2111) Torino, | |
| BC Cancer Surrey ( Site 0621) Surrey, British Columbia | |
| Bialostockie Centrum Onkologii ( Site 3007) Bialystok, Podlaskie Voivodeship | |
| Blacktown Hospital ( Site 0201) Blacktown, New South Wales | |
| Bradfordhill ( Site 0703) Santiago, Region M. de Santiago | |
| CENTRE LEON BERARD ( Site 1401) Lyon, Rhone | |
| CHU Saint-Pierre ( Site 0405) Brussels, Bruxelles-Capitale, Region de | |
| CHU de Liege ( Site 0404) Liège, Wallonne, Region | |
| CIO - Centro de Inmuno-Oncología de Occidente ( Site 2402) Guadalajara, Jalisco | |
| CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0608) Sherbrooke, Quebec | |
| Cancer Hospital of Shantou University Medical College ( Site 0827) Shantou, Guangdong | |
| Cancer Institute Hospital of JFCR ( Site 2208) Koto, Tokyo | |
| CancerCare Manitoba ( Site 0617) Winnipeg, Manitoba | |
| CaritasKlinikum Saarbruecken St. Theresia ( Site 1508) Saarbrücken, Saarland | |
| Carmel Hospital ( Site 2023) Haifa, | |
| Centre Francois Baclesse ( Site 1412) Caen, Calvados | |
| Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0605) Montreal, Quebec | |
| Centro de Estudios Clínicos SAGA ( Site 0708) Santiago, Region M. de Santiago | |
| Centro de Investigacion Clinica de Oaxaca ( Site 2404) Oaxaca City, Oaxaca | |
| Centro de Investigación Oncológica Galerías SC ( Site 2405) Aguascalientes, | |
| Charité Campus Virchow-Klinikum ( Site 1501) Berlin, | |
| Chongqing University Cancer Hospital ( Site 0838) Chongqing, Chongqing Municipality | |
| Clínica San Felipe ( Site 2804) Jesus Maria, Lima region | |
| Cork University Hospital ( Site 1903) Cork, | |
| Debreceni Egyetem Klinikai Kozpont-Szülészeti és Nőgyógyászati Klinika ( Site 1701) Debrecen, | |
| Duke Cancer Institute ( Site 6049) Durham, North Carolina | |
| Département clinique de médecine de laboratoire du CHUM ( Site 0606) Montreal, Quebec | |
| Ehime University Hospital ( Site 2213) Tōon, Ehime | |
| Epworth Freemasons ( Site 0207) Melbourne, Victoria | |
| FALP ( Site 0702) Santiago, Region M. de Santiago | |
| FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0902) Bogotá, Bogota D.C. | |
| Faculty of Medicine - Khon Kaen University ( Site 3803) Khon Kaen, | |
| Faculty of Medicine Siriraj Hospital ( Site 3801) Bangkok, Bangkok | |
| Fakultni nemocnice Ostrava ( Site 1104) Ostrava, Ostrava Mesto | |
| Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 1103) Prague, | |
| FirstHealth of the Carolinas ( Site 6037) Pinehurst, North Carolina | |
| Florida Cancer Specialists ( Site 7002) St. Petersburg, Florida | |
| Florida Cancer Specialists - South ( Site 7003) Fort Myers, Florida | |
| Florida Cancer Specialists East ( Site 7001) West Palm Beach, Florida | |
| Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 2114) Milan, | |
| Fondazione Policlinico Universitario Agostino Gemelli ( Site 2105) Roma, | |
| Fujian Province Cancer Hospital ( Site 0802) Fuzhou, Fujian | |
| Fukushima Medical University Hospital ( Site 2218) Fukushima, | |
| Fundacion Colombiana de Cancerología Clinica Vida ( Site 0905) Medellín, Antioquia | |
| Fundación Instituto Valenciano de Oncología ( Site 3405) Valencia, | |
| Fundación Respirar ( Site 0101) Buenos Aires, Buenos Aires F.D. | |
| Grand Hôpital de Charleroi ( Site 0403) Charleroi, Wallonne, Region | |
| Groupe Hospitalier Diaconesses Croix Saint Simon ( Site 1409) Paris, | |
| Guangxi Medical University Affiliated Tumor Hospital. ( Site 0825) Nanning, Guangxi | |
| Gunma Prefectural Cancer Center ( Site 2202) Ōta, Gunma | |
| Hammersmith Hospital ( Site 4010) London, London, City of | |
| Harbin Medical University Cancer Hospital ( Site 0850) Harbin, Heilongjiang | |
| Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 1301) Helsinki, Uusimaa | |
| Henan Cancer Hospital ( Site 0806) Zhengzhou, Henan | |
| Herlev and Gentofte Hospital ( Site 1202) Copenhagen, Capital Region | |
| Holy Name Medical Center ( Site 6011) Teaneck, New Jersey | |
| Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 1411) Paris, | |
| Hospital Araújo Jorge ( Site 0521) Goiânia, Goiás | |
| Hospital Británico de Buenos Aires ( Site 0103) CABA, | |
| Hospital São Lucas da PUCRS ( Site 0522) Porto Alegre, Rio Grande do Sul | |
| Hospital Universitari Vall d''Hebron ( Site 3401) Barcelona, | |
| Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 2401) Monterrey, Nuevo León | |
| Hospital Universitario 12 de Octubre ( Site 3404) Madrid, | |
| Hospital Universitario La Paz ( Site 3406) Madrid, | |
| Hospital Universitario Ramon y Cajal ( Site 3403) Madrid, | |
| Hospital Universitario Reina Sofia ( Site 3402) Córdoba, | |
| Hospital of the University of Pennsylvania ( Site 5007) Philadelphia, Pennsylvania | |
| Hospital of the University of Pennsylvania ( Site 6023) Philadelphia, Pennsylvania | |
| Houston Methodist Hospital ( Site 6057) Houston, Texas | |
| Hunan Cancer Hospital ( Site 0826) Changsha, Hunan | |
| Hyogo Cancer Center ( Site 2216) Akashi, Hyōgo | |
| Hôpital Privé Des Côtes d'Armor ( Site 1404) Plérin, Cotes-d Armor | |
| IBCC - Instituto Brasileiro de Controle do Câncer ( Site 0525) São Paulo, São Paulo | |
| INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS ( Site 2805) Lima, | |
| IPOR Instituto Peruano de Oncología & Radioterapia ( Site 2803) San Isidro, Lima region | |
| IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 2107) Meldola, Forli-Cesena | |
| Iaso Genera ( Site 1605) Marousi, Attica | |
| Inova Schar Cancer Institute ( Site 6003) Fairfax, Virginia | |
| Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest ( Site 1405) Bordeaux, Gironde | |
| Institut Català d'Oncologia (ICO) - Girona ( Site 3407) Girona, Gerona | |
| Institut Català d'Oncologia - L'Hospitalet ( Site 3408) L'Hospitalet de Llobregat, Barcelona | |
| Institut Curie - site Saint-Cloud ( Site 1408) Saint-Cloud, Hauts-de-Seine | |
| Institut De Cancerologie De L Ouest ( Site 1403) Saint-Herblain, Loire-Atlantique | |
| Institut Paoli Calmettes ( Site 1410) Marseille, Bouches-du-Rhone | |
| Instituto Alexander Fleming ( Site 0105) Ciudad Autónoma de Buenos Aires, Buenos Aires | |
| Instituto Nacional de Câncer - INCA ( Site 0515) Rio de Janeiro, | |
| Instituto San Marcos ( Site 0106) San Juan, | |
| Instituto de Cancerología S.A.S ( Site 0904) Medellín, Antioquia | |
| Instituto de Investigaciones Clínicas Mar del Plata ( Site 0108) Mar del Plata, Buenos Aires | |
| Istituto Europeo di Oncologia ( Site 2110) Milan, | |
| Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 2104) Naples, | |
| Istituto Nazionale Tumori Regina Elena ( Site 2102) Roma, | |
| Iwate Medical University Hospital ( Site 2207) Shiwa-gun, Iwate | |
| Jiangxi Maternal and Child Health Hospital ( Site 0807) Nanchang, Jiangxi | |
| John Muir Health Cancer Center ( Site 6028) Walnut Creek, California | |
| Keimyung University Dongsan Hospital ( Site 3105) Daegu, Taegu-Kwangyokshi | |
| Keio University Hospital ( Site 2209) Shinjuku, Tokyo | |
| Kettering Health Main Campus-Kettering Health Cancer Center ( Site 5001) Kettering, Ohio | |
| Klinikum Mutterhaus der Borromäerinnen ( Site 1506) Trier, Rhineland-Palatinate | |
| Kuopion Yliopistollinen Sairaala ( Site 1304) Kuopio, Northern Savonia | |
| Kurume University Hospital ( Site 2204) Kurume, Fukuoka | |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 6004) New York, New York | |
| Leicester Royal Infirmary ( Site 4008) Leicester, | |
| Liga Norte Riograndense Contra o Câncer ( Site 0523) Natal, Rio Grande do Norte | |
| Linkou Chang Gung Memorial Hospital ( Site 3705) Taoyuan, | |
| Liuzhou People's Hospital ( Site 0831) Liuzhou, Guangxi | |
| Maastricht UMC+ ( Site 2501) Maastricht, Limburg | |
| Mackay Memorial Hospital ( Site 3704) Taipei, | |
| Maharaj Nakorn Chiang Mai Hospital ( Site 3804) Chiang Mai, | |
| Maidstone Hospital ( Site 4007) Maidstone, | |
| Maine Medical Center - Scarborough Campus ( Site 6042) Scarborough, Maine | |
| Mater Misericordiae University Hospital ( Site 1904) Dublin, | |
| Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 3004) Siedlce, Masovian Voivodeship | |
| McGill University Health Centre ( Site 0604) Montreal, Quebec | |
| MedStar Washington Hospital Center ( Site 5005) Washington D.C., District of Columbia | |
| Medizinische Universitaet Innsbruck-Univ.-Klinik f. Gynäkologie und Geburtshilfe ( Site 0301) Innsbruck, Tyrol | |
| Medizinische Universität Graz-Abteilung für Gynäkologie / Onkologie ( Site 0303) Graz, Styria | |
| Medizinische Universität Wien - Allg. Gynaekologie & Gyn. Onkologie ( Site 0302) Vienna, | |
| Meir Medical Center. ( Site 2021) Kfar Saba, | |
| Miami Valley Hospital South ( Site 6014) Centerville, Ohio | |
| Minnesota Oncology Hematology, PA ( Site 8003) Minneapolis, Minnesota | |
| Mount Sinai Braman Comprehensive Cancer Center ( Site 6031) Miami Beach, Florida | |
| NL Health Services ( Site 0602) St. John's, Newfoundland and Labrador | |
| Nanjing First Hospital ( Site 0828) Nanjing, Jiangsu | |
| Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 3006) Gliwice, Silesian Voivodeship | |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 3002) Warsaw, Masovian Voivodeship | |
| National Cancer Center ( Site 3106) Gyeonggi-do, Kyonggi-do | |
| National Cancer Center Hospital ( Site 2211) Chūō, Tokyo | |
| National Cancer Centre Singapore ( Site 3201) Singapore, Central Singapore | |
| National Cheng Kung University Hospital ( Site 3702) Tainan, | |
| National Hospital Organization Hokkaido Cancer Center ( Site 2212) Sapporo, Hokkaido | |
| National Hospital Organization Kyushu Cancer Center ( Site 2203) Fukuoka, | |
| National Hospital Organization Shikoku Cancer Center ( Site 2206) Matsuyama, Ehime | |
| National Taiwan University Hospital ( Site 3701) Taipei, | |
| National University Hospital ( Site 3202) Singapore, Central Singapore | |
| Nemocnice AGEL Novy Jicin a.s. ( Site 1102) Nový Jičín, | |
| Niigata Cancer Center Hospital ( Site 2210) Niigata, | |
| ONCOCENTRO APYS ( Site 0704) Viña del Mar, Valparaiso | |
| Obstetrics & Gynecology Hospital of Fudan University ( Site 0818) Shanghai, Shanghai Municipality | |
| Okayama University Hospital ( Site 2215) Okayama, | |
| Oklahoma Cancer Specialists and Research Institute, LLC ( Site 6047) Tulsa, Oklahoma | |
| Oncologos Del Occidente ( Site 0907) Pereira, Risaralda Department | |
| Oncology Associates of Oregon, P.C. ( Site 8005) Eugene, Oregon | |
| Oncopole Claudius Regaud ( Site 1407) Toulouse, Haute-Garonne | |
| Országos Onkológiai Intézet-Ngyógyászat ( Site 1702) Budapest, | |
| Oslo universitetssykehus, Radiumhospitalet ( Site 2701) Oslo, | |
| Ospedale Cannizzaro ( Site 2103) Catania, | |
| Ospedale Humanitas San Pio X ( Site 2106) Milan, Lombardy | |
| Ospedale Mauriziano ( Site 2101) Torino, | |
| Ospedale Santa Maria di Ca' Foncello ( Site 2112) Treviso, | |
| Parkview Research Center ( Site 6008) Fort Wayne, Indiana | |
| Peking University Peoples Hospital ( Site 0845) Beijing, Beijing Municipality | |
| Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 6055) Mineola, New York | |
| Pontificia Universidad Catolica de Chile ( Site 0705) Santiago, Region M. de Santiago | |
| Princess Margaret Cancer Center ( Site 0609) Toronto, Ontario | |
| Puerto Rico Cancer Specialists Clinical Trials ( Site 4201) San Juan, | |
| ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 4006) London, London, City of | |
| Ramathibodi Hospital. ( Site 3802) Bangkok, Bangkok | |
| Rambam Health Care Campus ( Site 2025) Haifa, | |
| Roskilde Sygehus ( Site 1204) Roskilde, Region Sjælland | |
| Royal Brisbane and Women's Hospital ( Site 0206) Brisbane, Queensland | |
| Royal Marsden Hospital (Sutton) ( Site 4005) London, Surrey | |
| Royal Victoria Regional Health Centre ( Site 0615) Barrie, Ontario | |
| Saitama Medical University International Medical Center ( Site 2201) Hidaka, Saitama | |
| Samsung Medical Center ( Site 3104) Seoul, | |
| Sault Area Hospital ( Site 0616) Sault Ste. Marie, Ontario | |
| Semmelweis Egyetem Szuleszeti es Nogyogyaszati Klinika ( Site 1703) Budapest, | |
| Seoul National University Hospital ( Site 3102) Seoul, | |
| Severance Hospital, Yonsei University Health System ( Site 3101) Seoul, | |
| Shaare Zedek Medical Center ( Site 2020) Jerusalem, | |
| Shandong Cancer Hospital ( Site 0803) Jinan, Shandong | |
| Shanghai Tenth People's Hospital ( Site 0847) Shanghai, Shanghai Municipality | |
| Shanxi Provincial Cancer Hospital ( Site 0843) Taiyuan, Shanxi | |
| Shizuoka Cancer Center ( Site 2205) Sunto-gun, Shizuoka | |
| Sir Charles Gairdner Hospital ( Site 0203) Nedlands, Western Australia | |
| Sitio Clínico UIS Chihuahua (Operadora Unidad de Investigación en Salud de Chihuahua SA de CV) ( Site 2406) Chihuahua City, | |
| Skånes Universitetssjukhus Lund ( Site 3502) Lund, Skåne County | |
| Sourasky Medical Center ( Site 2022) Tel Aviv, | |
| St. Dominic's Hospital ( Site 5004) Jackson, Mississippi | |
| St. James's Hospital ( Site 1901) Dublin, | |
| St. Joseph's/Candler Health System ( Site 6021) Savannah, Georgia | |
| St. Luke's University Health Network ( Site 6041) Bethlehem, Pennsylvania | |
| Stavanger Universitetssykehus ( Site 2703) Norway, Rogaland | |
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University ( Site 0801) Guangzhou, Guangdong | |
| Sun Yat-sen University Cancer Center ( Site 0846) Guangzhou, Guangdong | |
| Sunnybrook Research Institute ( Site 0610) Toronto, Ontario | |
| Swietokrzyskie Centrum Onkologii. ( Site 3008) Kielce, Świętokrzyskie Voivodeship | |
| TRIALS 365 ( Site 6005) Shreveport, Louisiana | |
| Taichung Veterans General Hospital ( Site 3703) Taichung, | |
| Taizhou Hospital of Zhejiang Province ( Site 0809) Linhai, Zhejiang | |
| Tampereen yliopistollinen sairaala ( Site 1303) Tampere, Pirkanmaa | |
| Texas Oncology - DFW ( Site 8004) Fort Worth, Texas | |
| Texas Oncology - Gulf Coast ( Site 8006) Webster, Texas | |
| Texas Oncology - Northeast Texas ( Site 8002) Palestine, Texas | |
| Texas Oncology-San Antonio Medical Center ( Site 8001) San Antonio, Texas | |
| The Affiliated Women's Hospital of Zhejiang University ( Site 0834) Hangzhou, Zhejiang | |
| The Christie NHS Foundation Trust ( Site 4003) Manchester, | |
| The First Affiliated Hospital of Wenzhou Medical University ( Site 0805) Wenzhou, Zhejiang | |
| The First Affiliated Hospital of Xi'an Jiaotong University ( Site 0816) Xi'an, Shaanxi | |
| The First Affiliated hospital of Xiamen University ( Site 0822) Xiamen, Fujian | |
| The First Hospital Of Jilin University ( Site 0815) Changchun, Jilin | |
| The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 6007) Columbus, Ohio | |
| The Second Affiliated Hospital of Zhengzhou University ( Site 0833) Zhengzhou, Henan | |
| The Second People's Hospital of Yibin ( Site 0840) Yibin, Sichuan | |
| Tufts Medical Center ( Site 6052) Boston, Massachusetts | |
| Turku University Hospital-Department of Obstetrics and Gynecology ( Site 1302) Turku, Southwest Finland | |
| UF Health Davis Cancer Pavilion and Shands Med Plaza ( Site 6026) Gainesville, Florida | |
| UZ Leuven ( Site 0401) Leuven, Vlaams-Brabant | |
| Universitaetsklinikum Jena ( Site 1503) Jena, Thuringia | |
| Universitaetsklinikum Leipzig ( Site 1505) Leipzig, Saxony | |
| Universitair Medisch Centrum Utrecht ( Site 2503) Utrecht, | |
| Universitetssykehuset Nord-Norge HF ( Site 2702) Tromsø, Troms | |
| University College London Hospital ( Site 4001) London, London, City of | |
| University Hospitals Sussex NHS Foundation Trust ( Site 4011) East Sussex, Brighton And Hove | |
| University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 6020) Orange, California | |
| University of Chicago Medical Center ( Site 5002) Chicago, Illinois | |
| University of New Mexico Comprehensive Cancer Center ( Site 6046) Albuquerque, New Mexico | |
| University of South Alabama, Mitchell Cancer Institute ( Site 6033) Mobile, Alabama | |
| Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 3011) Poznan, Greater Poland Voivodeship | |
| Uniwersyteckie Centrum Kliniczne-Klinika Ginekologii, Ginekologii Onkologicznej i Endokrynologii Gi ( Site 3001) Gdansk, Pomeranian Voivodeship | |
| VCU Health Adult Outpatient Pavillion ( Site 5000) Richmond, Virginia | |
| Vseobecna fakultni nemocnice v Praze-Gynekologicko-porodnicka klinika 1.LF a VFN ( Site 1101) Prague, | |
| West China Second University Hospital, Sichuan University ( Site 0849) Chengdu, Sichuan | |
| Western General Hospital ( Site 4012) Edinburgh, Midlothian | |
| Wielkopolskie Centrum Onkologii im. Marii Skłodowskiej-Curie ( Site 3003) Poznan, Greater Poland Voivodeship | |
| Windsor Regional Cancer Program ( Site 0614) Windsor, Ontario | |
| Women & Infants Hospital ( Site 5003) Providence, Rhode Island | |
| Women's Cancer Care ( Site 6010) Covington, Louisiana | |
| Wuhan Union Hospital Cancer Center ( Site 0824) Wuhan, Hubei | |
| Xiangya Hospital Central South University ( Site 0821) Changsha, Hunan | |
| Yale University School of Medicine ( Site 6009) New Haven, Connecticut | |
| Yamagata University Hospital ( Site 2219) Yamagata, | |
| Yunnan Province Cancer Hospital ( Site 0811) Kunming, Yunnan | |
| Zhujiang Hospital of Southern Medical University ( Site 0829) Guangzhou, Guangdong |
The Efficacy and Safety of Rilzabrutinib in Participants Aged 10 to 65 Years With Sickle-cell Disease (LIBRA)
Trial Transparency email recommended (Toll free for US & Canada) - contact-us@sanofi.com
NCT06975865
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Inclusion Criteria:
* Participants who have been diagnosed with SCD.
* Participants who have had between ≥2 and ≤10 episodes of documented clinical VOC within 12 months of the screening events.
* Participants who are either not on hydroxyurea and/or L-glutamine at the Screening Visit and does not plan to receive them during the course of the study or has received HU and/or L-glutamine for a minimum of 6 months. Participants on hydroxyurea and/or L-glutamine must have been on a stable weight-based dose level (mg/kg) for at least 3 months prior to the Screening Visit, with the intent to continue at the same weight-based dose level for the duration of the study, except for safety reasons.
* Participants with Eastern Cooperative Oncology Group (ECOG) performance status grade 2 or lower.
* Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* For participants ≥10 to \<18 years of age: the parent(s)/legal guardian(s) must provide written informed consent prior to any study-related procedures being performed.
Exclusion Criteria:
* Participants are excluded from the study if any of the following criteria apply: Participants with medical history of lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for the past 3 years.
* Clinically relevant cardiac abnormality, in the opinion of the Investigator or electrocardiogram (ECG) findings.
* Participants with history of stroke, or history of abnormal transcranial doppler.
* Participants with uncontrolled or active HBV infection and/or HCV infection including those receiving antiviral therapy at the time of screening.
* HIV infection.
* A history of active or latent tuberculosis (TB)
* Positive COVID-19 molecular test.
* Participant is taking or has received crizanlizumab (ADAKVEO®) within 90 days and/or voxelotor (OXBRYTA®) within 30 days prior to the Screening visit.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. DRUG: Rilzabrutinib, DRUG: Placebo
Sickle Cell Disease
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Show 53 locations
Study Locations
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| Location | Contacts |
|---|---|
| Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello-Site Number : 3800002 Palermo, | Rosario Di Maggio - (rdm83@hotmail.it) Alessandro Inzerillo - (aleinzerillo22@gmail.com) |
| Azienda Ospedaliera Universitaria San Luigi Gonzaga, SSD Microcitemie Malattie Rare Ematologiche-Site Number : 3800007 Orbassano, Torino | Rosa Maria Catena De Maria - (rosamaria.demaria@unito.it) Vincenzo Voi - (vincenzo.voi@unito.it) |
| Azienda Ospedaliera Universitaria, Università della Campania "Luigi Vanvitelli" Napoli-Site Number : 3800005 Naples, Napoli | Silverio Perrotta - (silverio.perrotta@unicampania.it) Laura Pinfildi - (pinfildilaura@gmail.com) |
| Azienda Ospedaliero Universitaria Careggi SOD Ematologia-Site Number : 3800006 Florence, Firenze | Valentina Carrai - (carraiv@aou-careggi.toscana) Silvia Querceto - (silvia.querceto@unifi.it) |
| Baylor College of Medicine- Site Number : 8400055 Houston, Texas | |
| Centro Ricerche Cliniche Verona s.r.l. presso Ospedale G.B. Rossi Borgo Roma-Site Number : 3800003 Verona, | Lucia De Franceschi - (filippo.mazzi@aovr.veneto.it) |
| Fundação Faculdade Regional de Medicina de São José do Rio Preto- Site Number : 0760001 São José do Rio Preto, São Paulo | |
| Hospital Samaritano De Sao Paulo- Site Number : 0760005 São Paulo, | |
| Hospital Santa Izabel- Site Number : 0760006 Salvador, Estado de Bahia | |
| IRCCS Ospedale Pediatrico Bambino Gesù-Site Number : 3800001 Rome, Roma | Centro Trial Oncoematologico - (centrotrial-oncoematologico@opbg.net) |
| Indiana University Health Riley Hospital for Children- Site Number : 8400056 Indianapolis, Indiana | |
| Investigational Site Number : 0560001 Leuven, | |
| Investigational Site Number : 0560002 Brussels, | |
| Investigational Site Number : 0560003 Brussels, | |
| Investigational Site Number : 2500001 Paris, | |
| Investigational Site Number : 2500002 Créteil, | |
| Investigational Site Number : 2500004 Toulouse, | |
| Investigational Site Number : 2500005 Marseille, | |
| Investigational Site Number : 2760002 Essen, | |
| Investigational Site Number : 2760004 Stuttgart, | |
| Investigational Site Number : 3000001 Athens, | |
| Investigational Site Number : 3000002 Pátrai, | |
| Investigational Site Number : 3000003 Athens, | |
| Investigational Site Number : 3760001 Afula, | |
| Investigational Site Number : 3760002 Afula, | |
| Investigational Site Number : 3760005 Haifa, | |
| Investigational Site Number : 3760006 Haifa, | |
| Investigational Site Number : 3800004 Milan, Milano | |
| Investigational Site Number : 5120001 Muscat, | |
| Investigational Site Number : 5280002 Rotterdam, | |
| Investigational Site Number : 7240001 Madrid, | |
| Investigational Site Number : 7240002 Madrid, | |
| Investigational Site Number : 7920001 Adana, | |
| Investigational Site Number : 7920002 Adana, | |
| Investigational Site Number : 7920003 Mersin, | |
| Investigational Site Number : 8260001 London, London, City of | |
| Investigational Site Number : 8260002 London, Harrow | |
| Louisiana State University Health Sciences Center - Shreveport- Site Number : 8400037 Shreveport, Louisiana | |
| Montefiore Medical Center - Moses Campus- Site Number : 8400057 The Bronx, New York | |
| Oncology & Hematology Associates of West Broward- Site Number : 8400029 Coral Springs, Florida | |
| Phoenix Children's Hospital- Site Number : 8400028 Phoenix, Arizona | |
| Pontifícia Universidade Católica do Rio de Janeiro- Site Number : 0760009 Rio de Janeiro, | |
| Prisma Health- Site Number : 8400051 Greenville, South Carolina | |
| Richmond University Medical Center- Site Number : 8400038 Staten Island, New York | |
| Southern Specialty Research- Site Number : 8400059 Flowood, Mississippi | |
| Sylvester Comprehensive Cancer Center- Site Number : 8400020 Miami, Florida | |
| Universidade Federal de Goias- Site Number : 0760002 Goiânia, Goiás | |
| University of Alabama at Birmingham- Site Number : 8400003 Birmingham, Alabama | |
| University of California San Francisco- Site Number : 8400040 Fresno, California | |
| University of Illinois-Chicago - College of Medicine- Site Number : 8400054 Chicago, Illinois | |
| University of Maryland School of Medicine - Baltimore- Site Number : 8400041 Baltimore, Maryland | |
| University of Michigan Health System - Ann Arbor- Site Number : 8400035 Ann Arbor, Michigan | |
| VCU Massey Cancer Center: Dalton Oncology Clinic- Site Number : 8400012 Richmond, Virginia |
ShortStop-HER2: 12 Months vs. 6 Months of HER2-targeted Medications for People With HER2+ Breast Cancer Who Had a Pathologic Complete Response After Chemotherapy Plus Trastuzumab
Jack Beranek - breastprotocols@alliancenctn.org
NCT06876714
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Inclusion Criteria:
* Patients (females and males) with clinical stage T1c-T3 (or Tx) and nodal stage N0-N1 (except T3N1 tumors, which are not eligible)
* Patients must have no residual invasive disease in the breast or lymph nodes after the completion of neoadjuvant therapy. Residual ductal carcinoma in situ (DCIS) is allowed. Patients with residual isolated tumor cells at surgery are considered node-positive and are not eligible
* HER2+ by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines. Central pathology review is not required. In cases where there were multiple tumor sites in breast/nodes that had HER2 testing at diagnosis, at least one site must have been HER2+ AND the treating investigator must feel it is in the patient's best interest to be treated as having HER2+ breast cancer
* Known hormone receptor status as defined by ASCO/CAP guidelines. Estrogen receptor (ER) and progesterone receptor (PR) of any values are allowed. Hormone receptor positive status can be determined by either known positive ER or known positive PR status; hormone receptor negative status must be determined by both known negative ER and known negative PR
* If invasive disease was present in both breasts, participation in the study is permitted as long as the eligibility criteria are met for both tumors/breasts (including the requirement that at least one biopsied site on each side must have been HER2+)
* Age ≥ 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Patients must have received neoadjuvant chemotherapy in combination with trastuzumab with or without pertuzumab for a minimum of 12 weeks. All chemotherapy must have been completed preoperatively
* Patient must complete a minimum of 12 weeks of coverage with trastuzumab and a maximum of 24 weeks in the combined neoadjuvant and adjuvant setting prior to trial registration. Trastuzumab may have been administered either weekly or once every 3 weeks (q3weeks). (For purposes of this eligibility criterion, a single dose of q3week trastuzumab would provide 3 weeks of coverage; a single dose of once a week (q1week) trastuzumab would provide 1 week of coverage. If a q3week dose of trastuzumab were administered and then the subsequent dose was delayed for any period of time, that would still count as 3 weeks of coverage.)
* Administration of endocrine therapy for treatment of this breast cancer is allowed prior to trial registration. If a patient received prior breast cancer endocrine therapy (eg tamoxifen or aromatase inhibitor) for DCIS or preventive indication, and endocrine therapy is indicated for treatment of their current breast cancer, then prior endocrine therapy must have been stopped \> 12 months prior to registration on this protocol
* No use of investigational anti-cancer agents at time of registration
* Patient must register within 14 weeks of final surgery
* Adequate excision: Surgical removal of all clinically evident disease in the breast and lymph nodes as follows:
* Breast surgery: Total mastectomy with grossly negative margins (in the opinion of the surgeon there is no disease grossly at the margins) or breast-conserving surgery with histologically negative margins (no ink on tumor, including DCIS) unless those margins are anterior at the skin or posterior at the chest wall and no additional margin re-excision can be performed
* Lymph node surgery: Lymph node surgery must have been performed and can include sentinel lymph node biopsy, targeted axillary dissection, or axillary dissection, at the discretion of the breast surgeon
* Adequate radiation: Patients who completed breast-conserving surgery (i.e. lumpectomy) must have received or plan to receive adjuvant radiation. If breast-conserving surgery was performed but patient will not be receiving breast radiation, the patient is not eligible. Patients for whom radiotherapy would be recommended for breast cancer treatment but for whom it is contraindicated because of medical reasons (e.g., connective tissue disorder or prior ipsilateral breast radiation) are not eligible
* Adjuvant radiation can be given on study, and in this case is encouraged to be given concurrently with adjuvant HER2-directed therapy, per investigator discretion
* Targeting of the regional nodal basins will be at treating investigator discretion
* Not pregnant and not nursing, because this study involves agents with known teratogenic potential. Therefore, for women of childbearing potential only, a negative serum or urine pregnancy test should be performed prior to receiving HER2-directed therapy according to local standard practice
* Adequate hepatic, renal and bone marrow function to receive adjuvant HER2-directed therapy in the opinion of the treating investigator. There are no specific required laboratory values for eligibility
* No stage IV (metastatic) breast cancer
* 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
* No history of any prior (ipsilateral \[ipsi-\] or contralateral) invasive breast cancer. Prior DCIS is allowed
* No evidence of recurrent disease following preoperative therapy and surgery
* Patients living with HIV who are healthy and deemed by their medical team to have a low risk of AIDS-related illnesses are included in this trial. Patients with Hepatitis B or Hepatitis C virus who are healthy and deemed by their medical team to meet all other enrollment criteria are included in this trial.
* Patients with inadequate cardiac function on most recent assessment of left ventricular ejection fraction (LVEF) are not eligible for this trial. Inadequate cardiac function is defined as LVEF \< 50% on echocardiogram (echo) or multiple-gated acquisition (MUGA)
* No history of grade 3 or 4 toxicity related to trastuzumab. If pertuzumab is planned to be given on trial, patient must also have no history of grade 3-4 toxicity related to pertuzumab
* No contraindication to receipt of further HER2-directed therapy
* No patients with severe, uncontrolled systemic disease that may interfere with planned trial therapy.
Exclusion Criteria:
\- BIOLOGICAL: Trastuzumab (Herceptin), BIOLOGICAL: Pertuzumab, PROCEDURE: Echocardiography, PROCEDURE: Multigated Acquisition Scan, PROCEDURE: Mammography, PROCEDURE: Ultrasound, PROCEDURE: Magnetic Resonance Imaging, PROCEDURE: Biospecimen Collection, OTHER: Questionnaire Administration
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Early Stage HER2+ Breast Cancer
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Show 671 locations
Study Locations
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| Location | Contacts |
|---|---|
| AMG Crystal Lake - Oncology Crystal Lake, Illinois | Site Public Contact - (advocateresearch@advocate.com) |
| AMG Libertyville - Oncology Libertyville, Illinois | Site Public Contact - (advocateresearch@advocatehealth.com) |
| Abbott-Northwestern Hospital Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Adams Cancer Center Gettysburg, Pennsylvania | |
| Advocate Christ Medical Center Oak Lawn, Illinois | |
| Advocate Good Samaritan Hospital Downers Grove, Illinois | Site Public Contact - (Barbara.barhamand@advocatehealth.com) |
| Advocate Good Shepherd Hospital Barrington, Illinois | |
| Advocate Illinois Masonic Medical Center Chicago, Illinois | |
| Advocate Lutheran General Hospital Park Ridge, Illinois | |
| Advocate Outpatient Center - Oak Lawn Oak Lawn, Illinois | Site Public Contact - (ncorp@aah.org) |
| Advocate Sherman Hospital Elgin, Illinois | |
| Advocate South Suburban Hospital Hazel Crest, Illinois | |
| Alegent Health Bergan Mercy Medical Center Omaha, Nebraska | |
| Alegent Health Immanuel Medical Center Omaha, Nebraska | |
| Alegent Health Lakeside Hospital Omaha, Nebraska | |
| Allegheny General Hospital Pittsburgh, Pennsylvania | |
| Allegiance Health Jackson, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Arnold Palmer Cancer Center Medical Oncology Norwin N. Huntingdon, Pennsylvania | Site Public Contact - (ClinicalResearchServices@upmc.edu) |
| Asante Rogue Regional Medical Center Medford, Oregon | Site Public Contact - (research@asante.org) |
| Ascension Via Christi Hospitals Wichita Wichita, Kansas | Site Public Contact - (research@viachristi.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) |
| Asplundh Cancer Pavilion Willow Grove, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Atrium Medical Center-Middletown Regional Hospital Franklin, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Aultman Alliance Community Hospital Alliance, Ohio | |
| 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) |
| Baystate Medical Center Springfield, Massachusetts | Site Public Contact - (tamara.wrenn@baystatehealth.org) |
| Beaufort Memorial Hospital Beaufort, South Carolina | Site Public Contact - (kwade@bmhsc.org) |
| Beebe Health Campus Rehoboth Beach, Delaware | Site Public Contact - (research@beebehealthcare.org) |
| Beebe Medical Center Lewes, Delaware | |
| Beebe South Coastal Health Campus Millville, Delaware | Site Public Contact - (research@beebehealthcare.org) |
| Benefis Sletten Cancer Institute Great Falls, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Bethesda North Hospital Cincinnati, Ohio | |
| Beverly Hospital Cancer Center at Anna Jaques Newburyport, Massachusetts | |
| Billings Clinic Cancer Center Billings, Montana | Site Public Contact - (research@billingsclinic.org) |
| Billings Clinic-Cody Cody, Wyoming | |
| Bon Secours Cancer Institute at Reynolds Crossing Richmond, Virginia | |
| Bon Secours Memorial Regional Medical Center Mechanicsville, Virginia | Site Public Contact - (anne_carmellat@bshsi.org) |
| Bon Secours Richmond Community Hospital Richmond, Virginia | |
| Bon Secours Saint Francis Medical Center Midlothian, Virginia | Site Public Contact - (anne_carmellat@bshsi.org) |
| Bon Secours Saint Mary's Hospital Richmond, Virginia | Site Public Contact - (anne_carmellat@bshsi.org) |
| Bon Secours Westchester Emergency Center Midlothian, Virginia | |
| 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 | |
| CHI Health Good Samaritan Kearney, Nebraska | |
| CHI Health Saint Francis Grand Island, Nebraska | |
| Camden Clark Medical Center Parkersburg, West Virginia | Site Public Contact - (cancertrialsinfo@hsc.wvu.edu) |
| 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@AllianceNCTN.org) |
| Cancer Center at Saint Joseph's Phoenix, Arizona | |
| Cancer Center of Kansas - Chanute Chanute, Kansas | Site Public Contact - (research@viachristi.org) |
| Cancer Center of Kansas - Dodge City Dodge City, Kansas | Site Public Contact - (research@viachristi.org) |
| Cancer Center of Kansas - El Dorado El Dorado, Kansas | Site Public Contact - (research@viachristi.org) |
| Cancer Center of Kansas - Newton Newton, Kansas | Site Public Contact - (research@viachristi.org) |
| Cancer Center of Kansas - Parsons Parsons, Kansas | Site Public Contact - (research@viachristi.org) |
| Cancer Center of Kansas - Pratt Pratt, Kansas | Site Public Contact - (research@viachristi.org) |
| Cancer Center of Kansas - Salina Salina, Kansas | Site Public Contact - (research@viachristi.org) |
| Cancer Center of Kansas - Wellington Wellington, Kansas | Site Public Contact - (research@viachristi.org) |
| Cancer Center of Kansas - Wichita Wichita, Kansas | Site Public Contact - (research@viachristi.org) |
| Cancer Center of Kansas - Winfield Winfield, Kansas | Site Public Contact - (research@viachristi.org) |
| Cancer Center of Kansas-Independence Independence, Kansas | Site Public Contact - (research@viachristi.org) |
| Cancer Center of Kansas-Kingman Kingman, Kansas | Site Public Contact - (research@viachristi.org) |
| Cancer Center of Kansas-Liberal Liberal, Kansas | Site Public Contact - (research@viachristi.org) |
| Cancer Center of Kansas-Wichita Medical Arts Tower Wichita, Kansas | Site Public Contact - (research@viachristi.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 BroMenn Medical Center Normal, Illinois | Site Public Contact - (Research@Carle.com) |
| Carle Cancer Center Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Cancer Institute Normal Normal, Illinois | Site Public Contact - (Research@Carle.com) |
| Carle Physician Group-Effingham Effingham, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Mattoon/Charleston Mattoon, Illinois | Site Public Contact - (Research@carle.com) |
| Carle at The Riverfront Danville, Illinois | Site Public Contact - (Research@Carle.com) |
| Cedars-Sinai Cancer - Tarzana Tarzana, California | |
| Centra Alan B Pearson Regional Cancer Center Lynchburg, Virginia | Site Public Contact - (Kevin.Patel@centrahealth.com) |
| Central Care Cancer Center - Bolivar Bolivar, Missouri | |
| Central Care Cancer Center - Garden City Garden City, Kansas | |
| Central Care Cancer Center - Great Bend Great Bend, Kansas | |
| Central Vermont Medical Center/National Life Cancer Treatment Berlin Corners, Vermont | |
| 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) |
| Christiana Care - Union Hospital Elkton, Maryland | |
| Christiana Care Health System-Christiana Hospital Newark, Delaware | |
| Christiana Care Health System-Concord Health Center Chadds Ford, Pennsylvania | |
| Christiana Care Health System-Wilmington Hospital Wilmington, Delaware | |
| Coborn Cancer Center at Saint Cloud Hospital Saint Cloud, Minnesota | Site Public Contact - (coborncancercenter@centracare.com) |
| CommonSpirit Cancer Center Mercy Durango, Colorado | |
| CommonSpirit Saint Anthony Hospital Cancer Center Lakewood, Colorado | |
| CommonSpirit Saint Joseph Hospital - Bardstown Bardstown, Kentucky | |
| CommonSpirit Saint Joseph Hospital - Lexington Lexington, Kentucky | |
| CommonSpirit Saint Joseph Hospital London London, Kentucky | |
| CommonSpirit Saint Joseph Hospital Mount Sterling Mount Sterling, Kentucky | |
| CommonSpirit Saint Joseph Medical Center - East Lexington Lexington, Kentucky | |
| Commonwealth Cancer Center-Corbin Corbin, Kentucky | |
| Community Hospital of Anaconda Anaconda, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Scranton, Pennsylvania | Site Public Contact - (mccinfo@mtcancer.org) |
| Condell Memorial Hospital Libertyville, Illinois | Site Public Contact - (advocateresearch@advocatehealth.com) |
| Cooper Hospital University Medical Center Camden, New Jersey | |
| Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Lakeland Hospitals - Niles Hospital Niles, Michigan | |
| Corewell Health Lakeland Hospitals - Saint Joseph Hospital Saint Joseph, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Reed City Hospital Reed City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Cox Cancer Center Branson Branson, Missouri | |
| CoxHealth South Hospital Springfield, Missouri | |
| Crossroads Cancer Center Effingham, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Dana-Farber Cancer Institute Boston, Massachusetts | |
| Dartmouth Cancer Center - North Saint Johnsbury, Vermont | Site Public Contact - (cancer.research.nurse@hitchcock.org) |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire | Site Public Contact - (cancer.research.nurse@dartmouth.edu) |
| Decatur Memorial Hospital Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Divine Providence Hospital Williamsport, Pennsylvania | Site Public Contact - (protocols@AllianceNCTN.org) |
| Doctors Cancer Center Manati, | |
| Drexel Town Square Health Center Oak Creek, Wisconsin | |
| Duke Cancer Center Cary Cary, North Carolina | Site Public Contact - (NCTNStudyTeam@dm.duke.edu) |
| Duke University Medical Center Durham, North Carolina | |
| Duke Women's Cancer Care Raleigh Raleigh, North Carolina | |
| Duluth Clinic Ashland Ashland, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Edwards Comprehensive Cancer Center Huntington, West Virginia | Site Public Contact - (Christina.Cole@chhi.org) |
| Emory Decatur Hospital Decatur, Georgia | Site Public Contact - (clinicaltrialsoncology@dekalbmedical.org) |
| Emory Johns Creek Hospital Johns Creek, Georgia | Site Public Contact - (m.lisa.hwang@emory.edu) |
| Emory Saint Joseph's Hospital Atlanta, Georgia | |
| Emory University Hospital Midtown Atlanta, Georgia | |
| Emory University Hospital/Winship Cancer Institute Atlanta, Georgia | |
| Englewood Hospital and Medical Center Englewood, New Jersey | |
| Enloe Medical Center Chico, 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 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 Sandstone Sandstone, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Virginia Clinic Virginia, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Fairview Southdale Hospital Edina, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Farmington Health Center Farmington, Utah | Site Public Contact - (cancerinfo@hci.utah.edu) |
| FirstHealth of the Carolinas-Moore Regional Hospital Pinehurst, North Carolina | Site Public Contact - (jcwilliams@firsthealth.org) |
| Forbes Hospital Monroeville, Pennsylvania | |
| Freeman Health System Joplin, Missouri | |
| Fremont - Rideout Cancer Center Marysville, California | |
| 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 Cancer Center Dickson City Dickson City, Pennsylvania | Site Public Contact - (hemoncctrials@geisinger.edu) |
| Geisinger Medical Center-Cancer Center Hazleton Hazleton, 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) |
| Gene Upshaw Memorial Tahoe Forest Cancer Center Truckee, California | |
| Genesys Hurley Cancer Institute Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Good Samaritan Hospital - Cincinnati Cincinnati, Ohio | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Grady Health System Atlanta, Georgia | |
| Great Falls Clinic Great Falls, Montana | |
| Greater Baltimore Medical Center Baltimore, Maryland | |
| Gundersen Lutheran Medical Center La Crosse, Wisconsin | Site Public Contact - (cancerctr@gundersenhealth.org) |
| Guthrie Medical Group PC-Robert Packer Hospital Sayre, Pennsylvania | |
| HSHS Saint Elizabeth's Hospital O'Fallon, Illinois | |
| HSHS Saint Nicholas Hospital Sheboygan, Wisconsin | |
| Hackensack University Medical Center Hackensack, New Jersey | |
| Harold Alfond Center for Cancer Care Augusta, Maine | |
| HaysMed Hays, Kansas | |
| Heartland Regional Medical Center Saint Joseph, Missouri | |
| Helen F Graham Cancer Center Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Hematology Oncology Associates of CNY at Camillus Camillus, New York | |
| Hematology Oncology Associates of Central New York-East Syracuse East Syracuse, New York | |
| Hematology Oncology Consultants-Clarkston Clarkston, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Henry Ford Cancer Institute-Downriver Brownstown, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford Health Providence Novi Hospital Novi, Michigan | Site Public Contact - (kfife3@hfhs.org) |
| Henry Ford Health Providence Southfield Hospital Southfield, Michigan | Site Public Contact - (kfife3@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) |
| Hi-Line Sletten Cancer Center Havre, Montana | |
| Hope Cancer Center Pontiac, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Houston Methodist Cypress Hospital Cypress, Texas | Site Public Contact - (irb@houstonmethodist.org) |
| Houston Methodist Hospital Houston, Texas | |
| Houston Methodist Saint John Hospital Nassau Bay, Texas | Site Public Contact - (protocols@AllianceNCTN.org) |
| Houston Methodist San Jacinto Hospital Baytown, Texas | Site Public Contact - (protocols@AllianceNCTN.org) |
| Houston Methodist Sugar Land Hospital Sugar Land, Texas | |
| Houston Methodist The Woodlands Hospital The Woodlands, Texas | Site Public Contact - (hmthewoodlands@houstonmethodist.org) |
| Houston Methodist West Hospital Houston, Texas | |
| Huntington Memorial Hospital Pasadena, California | |
| Huntsman Cancer Institute/University of Utah Salt Lake City, Utah | Site Public Contact - (cancerinfo@hci.utah.edu) |
| IRMC Cancer Center Indiana, Pennsylvania | Site Public Contact - (haneydl@upmc.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) |
| Illinois CancerCare - Washington Washington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Bloomington Bloomington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Canton Canton, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Carthage Carthage, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Dixon Dixon, Illinois | |
| Illinois CancerCare-Eureka Eureka, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Galesburg Galesburg, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Kewanee Clinic Kewanee, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Macomb Macomb, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Ottawa Clinic Ottawa, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Pekin Pekin, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Peoria Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Peru Peru, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Princeton Princeton, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Indiana University/Melvin and Bren Simon Cancer Center Indianapolis, Indiana | Site Public Contact - (iutrials@iu.edu) |
| Ingalls Memorial Hospital Harvey, Illinois | Site Public Contact - (clinicaltrials@ingalls.org) |
| Iowa Methodist Medical Center Des Moines, Iowa | |
| Jefferson Cherry Hill Hospital Cherry Hill, New Jersey | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Jefferson Hospital Jefferson Hills, Pennsylvania | Site Public Contact - (ddefazio@wpahs.org) |
| Jefferson Torresdale Hospital Philadelphia, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| John H Stroger Jr Hospital of Cook County Chicago, Illinois | |
| Jupiter Medical Center Jupiter, Florida | Site Public Contact - (clinicaltrials@jupitermed.com) |
| 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) |
| LSU Health Sciences Center at Shreveport Shreveport, Louisiana | Site Public Contact - (LPost@lsuhsc.edu) |
| Lafayette Family Cancer Center-EMMC Brewer, Maine | |
| 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) |
| Lake Regional Hospital Osage Beach, Missouri | Site Public Contact - (clinicaltrials@lakeregional.com) |
| Lawrence Memorial Hospital Lawrence, Kansas | Site Public Contact - (Stephanie.Norris@LMH.ORG) |
| Legacy Cancer Institute Medical Oncology and Day Treatment Vancouver, Washington | Site Public Contact - (oncologyresearch@lhs.org) |
| Legacy Good Samaritan Hospital and Medical Center Portland, Oregon | Site Public Contact - (cancer@lhs.org) |
| Legacy Meridian Park Hospital Tualatin, Oregon | |
| Legacy Mount Hood Medical Center Gresham, Oregon | |
| Legacy Salmon Creek Hospital Vancouver, Washington | |
| Lexington Medical Center West Columbia, South Carolina | Site Public Contact - (research@lexhealth.org) |
| Logan Health Medical Center Kalispell, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Loma Linda University Medical Center Loma Linda, California | |
| Longmont United Hospital Longmont, Colorado | |
| Loyola University Medical Center Maywood, Illinois | |
| Lyndon Baines Johnson General Hospital Houston, Texas | |
| 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 LincolnHealth Hospital Damariscotta, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| MaineHealth Maine Medical Center- Scarborough Scarborough, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| Margaret R Pardee Memorial Hospital Hendersonville, North Carolina | Site Public Contact - (pardeecancerresearch@unchealth.unc.edu) |
| Mary Greeley Medical Center Ames, Iowa | |
| Matthews Radiation Oncology Center Matthews, North Carolina | |
| Mayo Clinic Health System-Eau Claire Clinic Eau Claire, Wisconsin | |
| Mayo Clinic Health System-Franciscan Healthcare La Crosse, Wisconsin | |
| Mayo Clinic Health Systems-Mankato Mankato, Minnesota | |
| Mayo Clinic Hospital in Arizona Phoenix, Arizona | |
| Mayo Clinic in Florida Jacksonville, Florida | |
| Mayo Clinic in Rochester Rochester, Minnesota | |
| 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 | |
| Mease Countryside Hospital Safety Harbor, Florida | Site Public Contact - (research.cto@baycare.org) |
| MedStar Franklin Square Medical Center/Weinberg Cancer Institute Baltimore, Maryland | |
| MedStar Georgetown University Hospital Washington D.C., District of Columbia | |
| MedStar Good Samaritan Hospital Baltimore, Maryland | Site Public Contact - (Barbara.rector@medstar.net) |
| MedStar Health Bel Air Medical Campus Bel Air, Maryland | Site Public Contact - (David.j.perry2@medstar.net) |
| MedStar Montgomery Medical Center Olney, Maryland | |
| MedStar Southern Maryland Hospital Center Clinton, Maryland | |
| Medical Center of the Rockies Loveland, Colorado | |
| Medical College of Wisconsin Milwaukee, Wisconsin | |
| Medical Oncology Hematology Consultants PA Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Medical University of South Carolina Charleston, South Carolina | Site Public Contact - (hcc-clinical-trials@musc.edu) |
| Medstar Washington Hospital Center Washington D.C., District of Columbia | |
| Memorial Hospital East Shiloh, Illinois | Site Public Contact - (dschwab@wustl.edu) |
| Memorial Hospital North Colorado Springs, Colorado | |
| Memorial Hospital of Carbondale Carbondale, Illinois | |
| Mercy Cancer Center Merced, California | |
| 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 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 | |
| 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 | |
| Mercy Medical Center - Des Moines Des Moines, Iowa | |
| Mercy Oncology and Hematology - Clayton-Clarkson Ballwin, Missouri | |
| Mercy San Juan Medical Center Carmichael, California | Site Public Contact - (ResearchInstituteInquiries@commonspirit.org) |
| Methodist Medical Center of Illinois Peoria, Illinois | |
| Methodist Willowbrook Hospital Houston, Texas | Site Public Contact - (protocols@AllianceNCTN.org) |
| Miami Valley Cancer Care and Infusion Greenville, Ohio | |
| Miami Valley Hospital Dayton, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Miami Valley Hospital North Dayton, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Miami Valley Hospital South Centerville, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Michigan Healthcare Professionals Pontiac Pontiac, Michigan | Site Public Contact - (Emily.Crofts@trinity-health.org) |
| Mission Hope Medical Oncology - Arroyo Grande Arroyo Grande, California | |
| Mission Hope Medical Oncology - Santa Maria Santa Maria, California | |
| Missouri Baptist Medical Center St Louis, Missouri | |
| Missouri Baptist Sullivan Hospital Sullivan, Missouri | |
| Montefiore Medical Center-Einstein Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Morristown Medical Center Morristown, New Jersey | |
| Morton Plant Hospital Clearwater, Florida | |
| Mount Sinai Medical Center Miami Beach, Florida | Site Public Contact - (Yvonne.Enriquez@msmc.com) |
| 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) |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York | Site Public Contact - (cancerclinicaltrials@cumc.columbia.edu) |
| NYP/Weill Cornell Medical Center New York, New York | |
| Nebraska Medicine-Bellevue Bellevue, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| Nebraska Medicine-Village Pointe Omaha, Nebraska | |
| New Hampshire Oncology Hematology PA-Concord Concord, New Hampshire | |
| New York-Presbyterian/Brooklyn Methodist Hospital Brooklyn, New York | Site Public Contact - (Adg9003@nyp.org) |
| Newland Medical Associates-Clarkston Clarkston, Michigan | |
| Newland Medical Associates-Pontiac Pontiac, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Northern Westchester Hospital Mount Kisco, New York | Site Public Contact - (AMellor@northwell.edu) |
| Northwell Health Cancer Institute at Huntington Greenlawn, New York | |
| Northwell Health/Center for Advanced Medicine Lake Success, New York | |
| 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 | |
| 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) |
| Novant Health Breast Surgery - Greensboro Greensboro, North Carolina | |
| 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 - Rowan Salisbury, North Carolina | |
| Novant Health Cancer Institute - Statesville Stateville, North Carolina | |
| Novant Health Cancer Institute - Thomasville Thomasville, North Carolina | Site Public Contact - (pjordan@novanthealth.org) |
| Novant Health Cancer Institute - Wilkesboro North Wilkesboro, North Carolina | |
| Novant Health Colon and Rectal Clinic Clemmons, North Carolina | |
| Novant Health Forsyth Medical Center Winston-Salem, North Carolina | Site Public Contact - (pjordan@novanthealth.org) |
| Novant Health New Hanover Regional Medical Center Wilmington, North Carolina | |
| Novant Health Presbyterian Medical Center Charlotte, North Carolina | Site Public Contact - (kashah@novanthealth.org) |
| Novant Health Presbyterian Medical Center Huntersville Huntersville, North Carolina | |
| 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) |
| Ochsner Hematology Oncology North Shore - Covington (West Region) Covington, Louisiana | Site Public Contact - (Cheryl.kesler@ochsner.org) |
| Ochsner LSU Health Monroe Medical Center Monroe, Louisiana | Site Public Contact - (LPost@lsuhsc.edu) |
| Ochsner Medical Center Jefferson New Orleans, Louisiana | Site Public Contact - (Elisemarie.curry@ochsner.org) |
| Ohio State University Comprehensive Cancer Center Columbus, Ohio | Site Public Contact - (Jamesline@osumc.edu) |
| Oncology Associates at Mercy Medical Center Cedar Rapids, Iowa | |
| Overlook Hospital Summit, New Jersey | |
| PROncology San Juan, | Site Public Contact - (info@PRoncology.com) |
| Pacific Central Coast Health Center-San Luis Obispo San Luis Obispo, California | |
| Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Parkland Health Center - Farmington Farmington, Missouri | |
| Penn State Milton S Hershey Medical Center Hershey, Pennsylvania | Site Public Contact - (CTO@hmc.psu.edu) |
| Penobscot Bay Medical Center Rockport, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| Penrose-Saint Francis Healthcare Colorado Springs, Colorado | |
| Phelps Health Delbert Day Cancer Institute Rolla, Missouri | |
| Phelps Memorial Hospital Center Sleepy Hollow, New York | |
| Phoebe Putney Memorial Hospital Albany, Georgia | |
| Pluta Cancer Center Rochester, New York | Site Public Contact - (ctsucontact@westat.com) |
| Poudre Valley Hospital Fort Collins, Colorado | |
| Presbyterian Kaseman Hospital Albuquerque, New Mexico | Site Public Contact - (WBurman@phs.org) |
| Presbyterian Rust Medical Center/Jorgensen Cancer Center Rio Rancho, New Mexico | Site Public Contact - (WBurman@phs.org) |
| Prisma Health Cancer Institute - Butternut Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Easley Easley, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Eastside Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Faris Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Greer Greer, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Seneca Seneca, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Spartanburg Boiling Springs, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| ProHealth D N Greenwald Center Mukwonago, Wisconsin | Site Public Contact - (research.institute@phci.org) |
| ProHealth Oconomowoc Memorial Hospital Oconomowoc, Wisconsin | |
| ProHealth Waukesha Memorial Hospital Waukesha, Wisconsin | |
| ProMedica Flower Hospital Sylvania, Ohio | Site Public Contact - (PCIOncResearch@promedica.org) |
| Providence Hood River Memorial Hospital Hood River, Oregon | Site Public Contact - (canrsrchstudies@provdience.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) |
| Rapid City Regional Hospital Rapid City, South Dakota | Site Public Contact - (research@monument.health) |
| Reading Hospital West Reading, Pennsylvania | |
| Reading Hospital McGlinn Cancer Institute at Phoenixville Phoenixville, Pennsylvania | |
| Regions Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Rhode Island Hospital Providence, Rhode Island | |
| Rocky Mountain Cancer Centers-Penrose Colorado Springs, Colorado | |
| Roswell Park Cancer Institute Buffalo, New York | Site Public Contact - (askroswell@roswellpark.org) |
| Rowan Regional Medical Center Salisbury, North Carolina | |
| Rush MD Anderson Cancer Center Chicago, Illinois | Site Public Contact - (Cancer_Studies@rush.edu) |
| Rush MD Anderson Cancer Center at Rush Lisle Lisle, Illinois | Site Public Contact - (Cancer_Studies@rush.edu) |
| Rush MD Anderson Cancer Center at Rush Oak Park Oak Park, Illinois | Site Public Contact - (Cancer_Studies@rush.edu) |
| Rush-Copley Healthcare Center Yorkville, Illinois | Site Public Contact - (Cancer.Research@rushcopley.com) |
| Rush-Copley Medical Center Aurora, Illinois | |
| SIH Cancer Institute Carterville, Illinois | Site Public Contact - (clinical.research@sih.net) |
| SSM Health Good Samaritan Mount Vernon, Illinois | |
| Sacred Heart Hospital Pensacola, Florida | Site Public Contact - (eebrou@ascension.org) |
| Saint Alphonsus Cancer Care Center-Nampa Nampa, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Saint Anthony North Hospital Westminster, Colorado | |
| Saint Anthony Regional Hospital Carroll, Iowa | Site Public Contact - (sbenson@iora.org) |
| Saint Anthony's Hospital Cancer Care Center St. Petersburg, Florida | Site Public Contact - (Research.CTO@baycare.org) |
| Saint Catherine Hospital Indianapolis, Indiana | Site Public Contact - (protocols@AllianceNCTN.org) |
| Saint Charles Health System Bend, Oregon | Site Public Contact - (nosall@stcharleshealthcare.org) |
| Saint Francis Cancer Center Greenville, South Carolina | |
| Saint Francis Medical Center Cape Girardeau, Missouri | Site Public Contact - (sfmc@sfmc.net) |
| Saint John's Cancer Institute Santa Monica, California | |
| Saint Joseph Medical Center Hematology and Oncology - Silverdale Silverdale, Washington | |
| Saint Joseph Radiation Oncology Resource Center Lexington, Kentucky | |
| Saint Joseph's Hospital/Children's Hospital-Tampa Tampa, Florida | Site Public Contact - (jennifer.manns@baycare.org) |
| Saint Joseph's Medical Center Stockton, California | |
| 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 Corwin Medical Center Pueblo, Colorado | |
| Saint Mary Medical Center Hobart, Indiana | Site Public Contact - (CancerResearch@COMHS.org) |
| Saint Mary's Hospital Centralia, Illinois | |
| Saint Mary's Medical Center West Palm Beach, Florida | |
| 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) |
| Sainte Genevieve County Memorial Hospital Sainte Genevieve, Missouri | |
| Salina Regional Health Center Salina, Kansas | Site Public Contact - (mleepers@srhc.com) |
| San Juan City Hospital San Juan, | |
| 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 Cancer Center Worthington Worthington, Minnesota | |
| 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 Thief River Falls Medical Center Thief River Falls, Minnesota | |
| Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org) |
| Sechler Family Cancer Center Lebanon, Pennsylvania | Site Public Contact - (doxenberg@wellspan.org) |
| Shaw Cancer Center Edwards, Colorado | |
| 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) |
| Sinai Hospital of Baltimore Baltimore, Maryland | |
| 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) |
| Smilow Cancer Hospital Care Center - Guilford Guilford, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center - Waterford Waterford, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center - Westerly Westerly, Rhode Island | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center at Glastonbury Glastonbury, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center at Greenwich Greenwich, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center at Long Ridge Stamford, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center at Saint Francis Hartford, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center-Fairfield Fairfield, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center-Trumbull Trumbull, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital-Derby Care Center Derby, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital-Torrington Care Center Torrington, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital-Waterbury Care Center Waterbury, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Solinsky Center for Cancer Care Manchester, New Hampshire | |
| South Florida Baptist Hospital Plant City, Florida | Site Public Contact - (Claudia.Quinones@baycare.org) |
| South Jordan Health Center South Jordan, Utah | Site Public Contact - (cancerinfo@hci.utah.edu) |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| Springfield Clinic Springfield, Illinois | |
| Springfield Memorial Hospital Springfield, Illinois | Site Public Contact - (pallante.beth@mhsil.com) |
| Stanford Cancer Center Emeryville Emeryville, California | Site Public Contact - (ccto-office@stanford.edu) |
| Stanford Cancer Center South Bay San Jose, California | Site Public Contact - (ccto-office@stanford.edu) |
| Stanford Cancer Institute Palo Alto Palo Alto, California | Site Public Contact - (ccto-office@stanford.edu) |
| Staten Island University Hospital Staten Island, New York | |
| Stony Brook University Medical Center Stony Brook, New York | |
| 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 Community Hospital Munster, Indiana | |
| The Iowa Clinic PC West Des Moines, Iowa | |
| The James Graham Brown Cancer Center at University of Louisville Louisville, Kentucky | |
| The New York Hospital Medical Center of Queens Flushing, New York | Site Public Contact - (ctsucontact@westat.com) |
| The University of Kansas Cancer Center - Olathe Olathe, Kansas | Site Public Contact - (OlatheCCResearch@kumc.edu) |
| The Watson Clinic Lakeland, Florida | |
| ThedaCare Regional Cancer Center Appleton, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| ThedaCare Regional Medical Center - Neenah Neenah, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| Thomas Jefferson University Hospital Philadelphia, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Three Rivers Community Hospital Grants Pass, Oregon | |
| Tidelands Georgetown Memorial Hospital Georgetown, South Carolina | Site Public Contact - (broe@tidelandshealth.org) |
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| UM Baltimore Washington Medical Center/Tate Cancer Center Glen Burnie, Maryland | |
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Adding the Immunotherapy Drug Cemiplimab to Usual Treatment for People With Advanced Non-Small Cell Lung Cancer Who Had Previous Treatment With Platinum Chemotherapy and Immunotherapy (An Expanded Lung-MAP Treatment Trial)
Jennifer Beeler - jbeeler@swog.org
NCT06616584
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Inclusion Criteria:
* Participants must have been assigned to S1800E by the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC). Assignment to S1800E is determined by the LUNGMAP protocol
* Participants must have measurable or non-measurable disease documented by CT or MRI. The CT from a combined positron emission tomography (PET)/CT may be used to document only non-measurable disease unless it is of diagnostic quality. Measurable disease must be assessed within 28 days prior to randomization. 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 randomization. All 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 registration
* Participants must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to randomization
* Participants must have received exactly one anti-PD-1 or anti-PD-L1 therapy for advanced disease (stage IV or recurrent disease, or stage I-III disease in certain circumstances outlined below). Anti-PD-1 or anti-PD-L1 therapy may have been given alone or in combination with other therapy. For participants who received neoadjuvant, adjuvant, and/or consolidation anti-PD-1 or anti-PD-L1 therapy for stage I-III disease:
* If they experienced disease progression within (≤) 365 days from initiation (cycle 1 day 1) or anti-PD-1 or anti-PD-L1 therapy, this counts as the single allowed anti-PD-1 or anti-PD-L1 therapy for advanced disease
* If they experienced disease progression more than (\>) 365 days from initiation (cycle 1 day 1) or anti-PD-1 or anti-PD-L1 therapy, this is not considered anti-PD-1 or anti-PD-L1 therapy for advance disease. These participants must have received anti-PD-1 or anti-PD-L1 therapy for stage IV or recurrent disease
* Participants must have experienced disease progression (in the opinion of the treating investigator) more than (\>) 84 days following initiation (cycle 1 day 1) of their most recent anti-PD-1 or anti-PD-L1 therapy
* Participants who received anti-PD-1 or anti-PD-L1 therapy for stage IV or recurrent disease must have had a best response of stable disease, partial response or complete response (in the opinion of the treating investigator) on the anti-PD-1 or anti-PD-L1 therapy for stage IV or recurrent disease
* Participants must have received platinum-based chemotherapy and experienced disease progression (in the opinion of the treating investigator) during or after this regimen
* Participants with a known sensitizing molecular alteration for which a Food and Drug Administration (FDA)-approved targeted therapy for NSCLC exists (e.g., EGFR, ALK, ROS1, BRAF, RET, NTRK, KRAS, HER2, and MET sensitizing mutations), must have previously received at least one of the approved therapy(s). Prior targeted therapy for participants with targetable alterations is allowed if all other eligibility criteria are also met
* Participants must have recovered (≤ grade 1) from any side effects from the most recent anti-cancer treatment prior to randomization
* Participants must not have received prior therapy with docetaxel for this disease
* Participants must not have received any palliative radiation therapy within 14 days (or palliative bone radiation therapy within 7 days) prior to randomization
* Participants must not be planning to receive any concurrent chemotherapy, immunotherapy, or biologic therapy for cancer treatment while receiving treatment on this study
* Participants must not have undergone major surgery within 28 days prior to randomization, or subcutaneous venous access device placement within 7 days prior to randomization. Participants must not have postoperative bleeding complications or wound complications from a surgical procedure performed within 2 months prior to randomization. The participant must not have elective or planned major surgery to be performed during the course of this study
* Absolute neutrophil count ≥ 1.5 x 10\^3/uL (within 28 days prior to randomization)
* Hemoglobin ≥ 9.0 g/dL (within 28 days prior to randomization)
* Platelets ≥ 100 x 10\^3/uL (within 28 days prior to randomization)
* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (within 28 days prior to randomization) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x institutional ULN (within 28 days prior to randomization). Participants with history of liver metastasis must have AST and ALT ≤ 5 x ULN
* Participants must have a creatinine ≤ the institutional (I)ULN or calculated creatinine clearance ≥ 50 mL/min using the following Cockcroft-Gault formula. This specimen must have been drawn and processed within 28 days prior to randomization
* Participants must have a urinary protein test performed within 28 days prior to randomization
* Participants' most recent Zubrod/Eastern Cooperative Oncology Group (ECOG) performance status must be 0-1 and be documented within 28 days prior to randomization
* Participants must have a completed medical history and physical exam within 28 days prior to randomization
* 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 randomization, if indicated by the treating investigator
* 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 randomization, if indicated by the treating investigator
* Participants with known human immunodeficiency virus (HIV) infection are eligible, provided they are on effective anti-retroviral therapy and have undetectable viral load at their most recent viral load test and within 6 months prior to randomization
* Participants must not have a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen
* Participants must not have an active autoimmune disease that has required systemic treatment within 730 days prior to randomization (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed
* Participants must not have any history of primary immunodeficiency
* Participants must be able to safely receive study therapy and must not have experienced the following:
* Any grade 3 or worse immune-mediated adverse event. Exception: asymptomatic nonbullous/nonexfoliative rash
* Any unresolved grade 2 immune-mediated adverse event
* Any toxicity that led to permanent discontinuation of prior anti-PD-1/PD-L1 immunotherapy
* Exception to the above: Toxicities of any grade that requires replacement therapy and has stabilized on therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) are allowed
* Participants must not have any history of organ transplant that requires use of immunosuppressives
* Participants must not have received a live or live attenuated vaccine within 28 days prior to randomization. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster, yellow fever rabies, Bacillus Calmette-Guerin (BCG) and typhoid vaccine. Seasonal influenza vaccines and COVID-19 vaccines are allowed, however, intranasal influenza vaccines (e.g. Flu-Mist) are live attenuated and are not allowed
* Participants must not have clinical signs or symptoms of active tuberculosis infection
* Participants must not have a history of (non-infectious) pneumonitis that required steroids or current pneumonitis/interstitial lung disease
* Participants must not have had a serious or nonhealing wound, ulcer, or bone fracture within 28 days prior to randomization
* Participants must not have a history of gastrointestinal perforation or fistula within 6 months prior to randomization
* Participants must not have grade 3-4 gastrointestinal bleeding (defined by National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\] version \[v\]5) within 3 months prior to randomization. No history of gastrointestinal (GI) bleed within 3 months prior to randomization
* Participants must not have any grade III/IV cardiac disease as defined by the New York Heart Association criteria (i.e., participants with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, and myocardial infarction within 6 months prior to randomization, or serious uncontrolled cardiac arrhythmia
* Participants must not have experienced any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to randomization
* Participants must not have gross hemoptysis within two months prior to randomization (defined as bright red blood or ≥ 1/2 teaspoon) or with radiographic evidence of intratumor cavitation or has radiologically documented evidence of major blood vessel invasion or encasement by cancer
* Participants must not have been diagnosed with venous thrombosis within 3 months prior to randomization. Participants with venous thrombosis diagnosed more than 3 months prior to randomization must be on stable doses of anticoagulants
* Participants must not have cirrhosis at a level of Child-Pugh B (or worse) AND a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis, OR any degree of cirrhosis
* 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 be offered participation in specimen banking. With participant consent, specimens must be collected and submitted via the SWOG specimen tracking system
* NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the 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 PROCEDURE: Biospecimen Collection, BIOLOGICAL: Cemiplimab, PROCEDURE: Computed Tomography, DRUG: Dexamethasone, DRUG: Docetaxel, PROCEDURE: Magnetic Resonance Imaging, BIOLOGICAL: Ramucirumab
Recurrent Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8
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Show 386 locations
Study Locations
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| Location | Contacts |
|---|---|
| AMG Crystal Lake - Oncology Crystal Lake, Illinois | Site Public Contact - (advocateresearch@advocate.com) |
| AMG Libertyville - Oncology Libertyville, Illinois | Site Public Contact - (advocateresearch@advocatehealth.com) |
| Abbott-Northwestern Hospital Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| 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 | |
| AnMed Health Cancer Center Anderson, South Carolina | Site Public Contact - (rhonda.ballew@anmedhealth.org) |
| Arnold Palmer Cancer Center Medical Oncology Norwin N. Huntingdon, Pennsylvania | Site Public Contact - (ClinicalResearchServices@upmc.edu) |
| Atlanta VA Medical Center Decatur, Georgia | |
| Atrium Medical Center-Middletown Regional Hospital Franklin, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Aultman Health Foundation Canton, Ohio | Site Public Contact - (ClinicalReserachDept@aultman.com) |
| Aurora Bay Area Medical Group-Marinette Marinette, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora BayCare Medical Center Green Bay, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Grafton Grafton, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Kenosha South Kenosha, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Milwaukee Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Milwaukee West Wauwatosa, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Racine Racine, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Southern Lakes VLCC Burlington, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Health Care Germantown Health Center Germantown, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Medical Center in Summit Summit, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Saint Luke's Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Saint Luke's South Shore Cudahy, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Sinai Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora West Allis Medical Center West Allis, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| BJC Outpatient Center at Sunset Hills Sunset Hills, Missouri | |
| Banner University Medical Center - Tucson Tucson, Arizona | Site Public Contact - (UACC-IIT@uacc.arizona.edu) |
| Baptist 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) |
| Baystate Medical Center Springfield, Massachusetts | Site Public Contact - (tamara.wrenn@baystatehealth.org) |
| Beebe Health Campus Rehoboth Beach, Delaware | Site Public Contact - (research@beebehealthcare.org) |
| Beebe South Coastal Health Campus Millville, Delaware | Site Public Contact - (research@beebehealthcare.org) |
| Benefis Sletten Cancer Institute Great Falls, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| 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) |
| Camden Clark Medical Center Parkersburg, West Virginia | Site Public Contact - (cancertrialsinfo@hsc.wvu.edu) |
| 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 Centers of Southwest Oklahoma Research Lawton, Oklahoma | |
| Cancer Hematology Centers - Flint Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Carle BroMenn Medical Center Normal, Illinois | Site Public Contact - (Research@Carle.com) |
| Carle Cancer Center Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Cancer Institute Normal Normal, Illinois | Site Public Contact - (Research@Carle.com) |
| Carle Physician Group-Effingham Effingham, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Mattoon/Charleston Mattoon, Illinois | Site Public Contact - (Research@carle.com) |
| Carle at The Riverfront Danville, Illinois | Site Public Contact - (Research@Carle.com) |
| Cedars-Sinai Cancer - Tarzana Tarzana, California | |
| Cedars-Sinai Medical Center Los Angeles, California | Site Public Contact - (Cancer.trial.info@cshs.org) |
| Centra Alan B Pearson Regional Cancer Center Lynchburg, Virginia | Site Public Contact - (Kevin.Patel@centrahealth.com) |
| City of Hope Antelope Valley Lancaster, California | Site Public Contact - (becomingapatient@coh.org) |
| City of Hope Comprehensive Cancer Center Duarte, California | Site Public Contact - (becomingapatient@coh.org) |
| City of Hope South Bay Torrance, California | |
| City of Hope Upland Upland, California | Site Public Contact - (becomingapatient@coh.org) |
| City of Hope at Irvine Lennar Irvine, California | |
| Columbus Oncology and Hematology Associates Dublin, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Columbus Oncology and Hematology Associates Inc Columbus, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Community Hospital of Anaconda Anaconda, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Scranton, Pennsylvania | Site Public Contact - (mccinfo@mtcancer.org) |
| Condell Memorial Hospital Libertyville, Illinois | Site Public Contact - (advocateresearch@advocatehealth.com) |
| Crossroads Cancer Center Effingham, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Dartmouth Cancer Center - North Saint Johnsbury, Vermont | Site Public Contact - (cancer.research.nurse@hitchcock.org) |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire | Site Public Contact - (cancer.research.nurse@dartmouth.edu) |
| Decatur Memorial Hospital Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Delaware Health Center-Grady Cancer Center Delaware, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Divine Providence Hospital Williamsport, Pennsylvania | Site Public Contact - (protocols@swog.org) |
| Doctors Hospital Columbus, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Dublin Methodist Hospital Dublin, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Duluth Clinic Ashland Ashland, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Durham VA Medical Center Durham, North Carolina | Site Public Contact - (VHADURcancertrials@va.gov) |
| Edwards Comprehensive Cancer Center Huntington, West Virginia | Site Public Contact - (Christina.Cole@chhi.org) |
| Eisenhower Medical Center Rancho Mirage, California | |
| Emory Johns Creek Hospital Johns Creek, Georgia | Site Public Contact - (m.lisa.hwang@emory.edu) |
| Emory Saint Joseph's Hospital Atlanta, Georgia | |
| Emory University Hospital Midtown Atlanta, Georgia | |
| Emory University Hospital/Winship Cancer Institute Atlanta, Georgia | |
| Enloe Medical Center Chico, 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 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 Sandstone Sandstone, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Virginia Clinic Virginia, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Fairview Southdale Hospital Edina, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| FirstHealth of the Carolinas-Moore Regional Hospital Pinehurst, North Carolina | Site Public Contact - (jcwilliams@firsthealth.org) |
| Fox Chase Cancer Center Philadelphia, Pennsylvania | |
| Fremont - Rideout Cancer Center Marysville, California | |
| Gene Upshaw Memorial Tahoe Forest Cancer Center Truckee, California | |
| Genesee Hematology Oncology PC Flint, Michigan | |
| Genesys Hurley Cancer Institute Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Gibbs Cancer Center-Gaffney Gaffney, South Carolina | Site Public Contact - (kmertz-rivera@gibbscc.org) |
| Gibbs Cancer Center-Pelham Greer, South Carolina | Site Public Contact - (kmertz-rivera@gibbscc.org) |
| Good Samaritan University Hospital West Islip, New York | |
| Grady Health System Atlanta, Georgia | |
| Grady Memorial Hospital Delaware, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Grant Medical Center Columbus, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Gulf Health Hospitals Inc/Infirmary Cancer Care - Malbis Daphne, Alabama | Site Public Contact - (donna.goggins@infirmaryhealth.org) |
| Gulf Health Hospitals Inc/Infirmary Cancer Care - Saraland Saraland, Alabama | Site Public Contact - (donna.goggins@infirmaryhealth.org) |
| Gulfport Memorial Hospital Gulfport, Mississippi | Site Public Contact - (emede1@lsuhsc.edu) |
| 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) |
| Harold Alfond Center for Cancer Care Augusta, Maine | |
| HaysMed Hays, Kansas | |
| 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) |
| IRMC Cancer Center Indiana, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| 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) |
| Indiana University/Melvin and Bren Simon Cancer Center Indianapolis, Indiana | Site Public Contact - (iutrials@iu.edu) |
| Integris Southwest Medical Center Oklahoma City, Oklahoma | Site Public Contact - (ctsucontact@westat.com) |
| James J Peters VA Medical Center The Bronx, New York | Site Public Contact - (kl2965@cumc.columbia.edu) |
| Kaiser Permanente - Largo Medical Center Largo, Maryland | Site Public Contact - (Charmaine.A.Mckie@kp.org) |
| Kaiser Permanente - Panorama City Panorama City, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente Downtown Commons Sacramento, California | Site Public Contact - (kpoct@kp.org) |
| Kaiser Permanente Fresno Orchard Plaza Fresno, California | |
| Kaiser Permanente Los Angeles Medical Center Los Angeles, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente Lutherville - Timonium Medical Center Lutherville, Maryland | Site Public Contact - (Charmaine.A.Mckie@kp.org) |
| Kaiser Permanente Medical Center - Santa Clara Santa Clara, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente San Leandro San Leandro, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente South Bay Harbor City, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente Tysons Corner Medical Center McLean, Virginia | Site Public Contact - (Charmaine.A.Mckie@kp.org) |
| Kaiser Permanente West Los Angeles Los Angeles, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Anaheim Anaheim, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Baldwin Park Baldwin Park, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Bellflower Bellflower, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Capitol Hill Medical Center Washington D.C., District of Columbia | Site Public Contact - (Charmaine.A.Mckie@kp.org) |
| Kaiser Permanente-Caton Hill Medical Center Woodbridge, Virginia | Site Public Contact - (Charmaine.A.Mckie@kp.org) |
| Kaiser Permanente-Fontana Fontana, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Fresno Fresno, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Gaithersburg Medical Center Gaithersburg, Maryland | Site Public Contact - (Charmaine.A.Mckie@kp.org) |
| Kaiser Permanente-Irvine Irvine, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Oakland Oakland, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Ontario Ontario, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Riverside Riverside, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Roseville Roseville, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-San Diego Zion San Diego, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-San Francisco San Francisco, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-San Marcos San Marcos, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Santa Teresa-San Jose San Jose, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-South San Francisco South San Francisco, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Vallejo Vallejo, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Walnut Creek Walnut Creek, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Woodland Hills Woodland Hills, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Woodlawn Medical Center Baltimore, Maryland | Site Public Contact - (Charmaine.A.Mckie@kp.org) |
| Kaiser San Rafael-Gallinas San Rafael, California | Site Public Contact - (Kpoct@kp.org) |
| Kansas City Veterans Affairs Medical Center Kansas City, Missouri | |
| Katmai Oncology Group Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.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) |
| 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) |
| Lake Regional Hospital Osage Beach, Missouri | Site Public Contact - (clinicaltrials@lakeregional.com) |
| Lawrence Memorial Hospital Lawrence, Kansas | Site Public Contact - (Stephanie.Norris@LMH.ORG) |
| Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah, Georgia | Site Public Contact - (underberga@sjchs.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 | |
| 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 LincolnHealth Hospital Damariscotta, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| MaineHealth Waldo Hospital Belfast, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| 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) |
| Mather Veteran Affairs Medical Center Mather, California | Site Public Contact - (protocols@swog.org) |
| Medical Oncology Hematology Consultants PA Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Medical University of South Carolina Charleston, South Carolina | Site Public Contact - (hcc-clinical-trials@musc.edu) |
| Memorial Hospital East Shiloh, Illinois | Site Public Contact - (dschwab@wustl.edu) |
| Mercy Hospital Coon Rapids, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Mercy Hospital Oklahoma City Oklahoma City, Oklahoma | |
| Mercy Hospital South St Louis, Missouri | Site Public Contact - (Danielle.Werle@mercy.net) |
| Miami Valley Cancer Care and Infusion Greenville, Ohio | |
| Miami Valley Hospital Dayton, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Miami Valley Hospital North Dayton, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Miami Valley Hospital South Centerville, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Mills Health Center San Mateo, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Minnesota Oncology Hematology PA-Woodbury Woodbury, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Missouri Baptist Medical Center St Louis, Missouri | |
| Missouri Baptist Sullivan Hospital Sullivan, Missouri | |
| Mobile Infirmary Medical Center Mobile, Alabama | |
| Moffitt Cancer Center Tampa, Florida | Site Public Contact - (ClinicalTrials@moffitt.org) |
| Montefiore Medical Center-Einstein Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.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 | |
| North Memorial Medical Health Center Robbinsdale, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Northeast Georgia Medical Center-Gainesville Gainesville, Georgia | Site Public Contact - (cancerpatient.navigator@nghs.com) |
| Northside Hospital Atlanta, Georgia | Site Public Contact - (ClinicalTrials@northside.com) |
| Northside Hospital - Duluth Duluth, Georgia | Site Public Contact - (Clinical.trials@northside.com) |
| Northside Hospital - Gwinnett Lawrenceville, Georgia | Site Public Contact - (Clinical.trials@northside.com) |
| Northwestern Medicine Cancer Center Delnor Geneva, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Cancer Center Kishwaukee DeKalb, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Cancer Center Warrenville Warrenville, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Glenview Outpatient Center Glenview, Illinois | |
| Northwestern Medicine Grayslake Outpatient Center Grayslake, Illinois | |
| Northwestern Medicine Lake Forest Hospital Lake Forest, Illinois | Site Public Contact - (cancertrials@northwestern.edu) |
| Northwestern Medicine Oak Brook Oak Brook, Illinois | Site Public Contact - (nctnprogram_rhlccc@northwestern.edu) |
| Northwestern Medicine Orland Park Orland Park, Illinois | Site Public Contact - (nctnprogram_rhlccc@northwestern.edu) |
| Northwestern University Chicago, Illinois | Site Public Contact - (cancer@northwestern.edu) |
| OSF Saint Francis Hospital and Medical Group Escanaba, Michigan | Site Public Contact - (WI_research_admin@hshs.org) |
| 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) |
| Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Parkland Health Center - Farmington Farmington, Missouri | |
| Penobscot Bay Medical Center Rockport, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| Premier Blood and Cancer Center Dayton, Ohio | |
| Presbyterian Intercommunity Hospital Whittier, California | |
| 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) |
| Rapid City Regional Hospital Rapid City, South Dakota | Site Public Contact - (research@monument.health) |
| Regions Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Richard L. Roudebush Veterans Affairs Medical Center Indianapolis, Indiana | Site Public Contact - (iutrials@iu.edu) |
| Riverside Methodist Hospital Columbus, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| SMC Center for Hematology Oncology Union Union, South Carolina | Site Public Contact - (kmertz-rivera@gibbscc.org) |
| Saint Agnes Hospital Baltimore, Maryland | |
| Saint Alphonsus Cancer Care Center-Baker City Baker City, Oregon | Site Public Contact - (mccinfo@mtcancer.org) |
| Saint Alphonsus Cancer Care Center-Boise Boise, Idaho | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Saint Alphonsus Cancer Care Center-Caldwell Caldwell, Idaho | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Saint Alphonsus Cancer Care Center-Nampa Nampa, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Saint Alphonsus Cancer Care Center-Ontario Ontario, Oregon | Site Public Contact - (mccinfo@mtcancer.org) |
| Saint Francis Medical Center Cape Girardeau, Missouri | Site Public Contact - (sfmc@sfmc.net) |
| Saint Joseph's/Candler - Bluffton Campus Bluffton, South Carolina | Site Public Contact - (underberga@sjchs.org) |
| Saint Luke's Cancer Institute - Boise Boise, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Fruitland Fruitland, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Meridian Meridian, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Nampa Nampa, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Sheboygan Sheboygan, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Sainte Genevieve County Memorial Hospital Sainte Genevieve, Missouri | |
| Salem Hospital Salem, Oregon | |
| 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 Cancer Center Worthington Worthington, Minnesota | |
| 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) |
| Sechler Family Cancer Center Lebanon, Pennsylvania | Site Public Contact - (doxenberg@wellspan.org) |
| Sheboygan Physicians Group Sheboygan, Wisconsin | Site Public Contact - (wi_research_admin@hshs.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) |
| Smilow Cancer Hospital Care Center - Guilford Guilford, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center - Waterford Waterford, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center at Glastonbury Glastonbury, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center at Greenwich Greenwich, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center at Long Ridge Stamford, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center at Saint Francis Hartford, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center-Fairfield Fairfield, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center-Trumbull Trumbull, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital-Derby Care Center Derby, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital-Torrington Care Center Torrington, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital-Waterbury Care Center Waterbury, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Solinsky Center for Cancer Care Manchester, New Hampshire | |
| South Carolina Cancer Specialists PC Hilton Head Island, South Carolina | Site Public Contact - (underberga@sjchs.org) |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| Spartanburg Medical Center Spartanburg, South Carolina | Site Public Contact - (kmertz-rivera@gibbscc.org) |
| Springfield Clinic Springfield, Illinois | |
| Springfield Memorial Hospital Springfield, Illinois | Site Public Contact - (pallante.beth@mhsil.com) |
| Temple University Hospital Philadelphia, Pennsylvania | |
| The Cancer Institute at Saint Francis Hospital East Hills, New York | |
| The Don and Sybil Harrington Cancer Center Amarillo, Texas | Site Public Contact - (Gina.Cravey@bsahs.org) |
| The University of Kansas Cancer Center - Olathe Olathe, Kansas | Site Public Contact - (OlatheCCResearch@kumc.edu) |
| Thomas Hospital Fairhope, Alabama | |
| Torrance Memorial Physician Network - Cancer Care Torrance, California | Site Public Contact - (courtney.steeneken@tmphysicians.com) |
| Tower Cancer Research Foundation Beverly Hills, California | Site Public Contact - (towercancerresearch@toweroncology.com) |
| 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 Moores Cancer Center La Jolla, California | Site Public Contact - (cancercto@ucsd.edu) |
| UMass Memorial Medical Center - University Campus Worcester, Massachusetts | Site Public Contact - (cancer.research@umassmed.edu) |
| UPMC Cancer Center at UPMC Horizon Farrell, Pennsylvania | Site Public Contact - (protocols@swog.org) |
| UPMC Cancer Center at UPMC McKeesport McKeesport, Pennsylvania | |
| UPMC Cancer Center at UPMC Northwest Seneca, Pennsylvania | |
| UPMC Cancer Center-Natrona Heights Natrona Heights, Pennsylvania | |
| UPMC Cancer Center-Uniontown Uniontown, Pennsylvania | Site Public Contact - (protocols@swog.org) |
| UPMC Cancer Center-Washington Washington, Pennsylvania | Site Public Contact - (protocols@swog.org) |
| UPMC Cancer Centers - Arnold Palmer Pavilion Greensburg, Pennsylvania | |
| UPMC Hillman Cancer Center - Monroeville Monroeville, Pennsylvania | Site Public Contact - (ClinicalResearchServices@upmc.edu) |
| UPMC Hillman Cancer Center - New Castle New Castle, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC Hillman Cancer Center - Part of Frick Hospital Mount Pleasant, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC Hillman Cancer Center - Passavant - Cranberry Cranberry Township, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC Hillman Cancer Center Erie Erie, Pennsylvania | Site Public Contact - (ClinicalResearchServices@upmc.edu) |
| UPMC Hillman Cancer Center at Butler Health System Butler, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion Mechanicsburg, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC Hillman Cancer Center in Coraopolis Moon Township, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC Pinnacle Cancer Center/Community Osteopathic Campus Harrisburg, Pennsylvania | Site Public Contact - (klitchfield@PINNACLEHEALTH.org) |
| UPMC Susquehanna Williamsport, Pennsylvania | |
| UPMC Western Maryland Cumberland, Maryland | |
| UPMC-Heritage Valley Health System Beaver Beaver, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC-Johnstown/John P. Murtha Regional Cancer Center Johnstown, Pennsylvania | |
| UPMC-Passavant Hospital Pittsburgh, Pennsylvania | |
| UPMC-Saint Clair Hospital Cancer Center Pittsburgh, Pennsylvania | |
| UPMC-Saint Margaret Pittsburgh, Pennsylvania | |
| United Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| United Hospital Center Bridgeport, West Virginia | Site Public Contact - (cancertrialsinfo@hsc.wvu.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 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 New Mexico Cancer Center Albuquerque, New Mexico | Site Public Contact - (HSC-ClinicalTrialInfo@salud.unm.edu) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Pittsburgh Cancer Institute (UPCI) Pittsburgh, Pennsylvania | |
| University of Rochester Rochester, New York | |
| University of Virginia Cancer Center Charlottesville, Virginia | Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu) |
| 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) |
| Upper Valley Medical Center Troy, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| VA Palo Alto Health Care System Palo Alto, California | |
| 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) |
| Veteran Administration Eastern Kansas Healthcare Leavenworth, Kansas | Site Public Contact - (protocols@swog.org) |
| Veterans Affairs Medical Center - San Francisco San Francisco, California | |
| 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) |
| WVUH-Berkely Medical Center Martinsburg, West Virginia | Site Public Contact - (cancertrialsinfo@hsc.wvu.edu) |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| WellSpan Medical Oncology and Hematology Hanover, Pennsylvania | |
| West Virginia University Healthcare Morgantown, West Virginia | Site Public Contact - (cancertrialsinfo@hsc.wvu.edu) |
| Wheeling Hospital/Schiffler Cancer Center Wheeling, West Virginia | |
| White River Junction Veteran Administration Medical Center White River Junction, Vermont | |
| Wilmot Cancer Institute at Webster Webster, New York | Site Public Contact - (WCICTOresearch@urmc.rochester.edu) |
| Yale University New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Yale-New Haven Hospital North Haven Medical Center North Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
A Study Comparing the Combination of Pembrolizumab and Sacituzumab Govitean-hziy Versus Standard of Care in the Treatment of Advanced Urothelial Cancer
ctrrecruit@vcu.edu
NCT06524544
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Inclusion Criteria:
* Patient must be ≥ 18 years of age
* Patient must have Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
* Patient must have locally advanced (unresectable and/or not amenable to curative intent therapy) or metastatic urothelial cancer
* Patient must have histologically proven conventional urothelial carcinoma (UC) of any urinary tract origin \[any histologic subtype except neuroendocrine (small or large cell)\] are permitted so long as tumors include ≥ 1% conventional urothelial histology). NOTE: Pure non-urothelial histology is excluded
* Patient must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Baseline imaging must be obtained ≤ 35 days prior to randomization
* Patient must have the following prior treatment(s). Patient must have had progression on or after the immediate prior anti-cancer therapy
* Patient must have had prior exposure to anti-PD(L)1 therapy \[anti -PD(L)1 monotherapy or as a combination regimen in any disease/therapy setting for UC\]. Patients must have received at least 1 dose of anti-PD(L)1 therapy
* NOTE: Anti-PD(L)1 therapy does not need to be the most recent therapy received prior to enrollment on this protocol
* NOTE: Patient must not have had progression within 12 weeks of starting their first anti-PD(L) 1 therapy, even if anti-PD-(L)1 treatment was given in more than one lines of therapy
* Patient must have had ≥ 1 line of systemic therapy given in the advanced/metastatic disease setting, except for patients who had received anti-PD(L)1 + enfortumab vedotin in the localized disease setting (e.g., neoadjuvant and/or adjuvant) and had cancer progression within 12 months from the last systemic therapy dose
* For tumors with known FGFR3+ susceptible alteration (for FGFR inhibitor), patients must have received a prior FGFR inhibitor unless contraindicated per physician discretion
* Patient must have received prior enfortumab vedotinor any other Nectin-4 directed therapy or other MMAE-containing therapy in any disease/therapy setting unless contraindicated per physician
* Patient must have had no prior exposure to Sacituzumab govitean-hziy or other TROP-2 directed therapies or antibody-drug conjugate that contains topo-isomerase I inhibitor, e.g. trastuzumab deruxtecan
* Patient must have Bellmunt score of 0-2. The Bellmunt score assesses a patient's risk and is calculated based on ECOG PS, hemogloblin level and presence of liver metastases
* Patient must not have history of grade 3 or higher immune-related adverse events on prior anti-PD1/L1, except for endocrinopathies on adequate hormone therapy repletion and/or clinically insignificant laboratory abnormalities
* Patient must have recovered (i.e., ≤ grade 1) from clinically significant AEs due to previously administered systemic therapy agent, except for endocrinopathies on adequate hormone therapy repletion
* NOTE: Patients with ≤ grade 2 neuropathy, any grade of alopecia, or any grade of non-clinically significant laboratory abnormality are exceptions to this criterion and are allowed in this trial.
* Examples of non-clinically significant laboratory abnormalities include, but are not limited to:
* Lymphopenia or monopenia
* Lymphocytosis or monocytosis
* Increase in amylase or lipase with no clinical correlation
* Any other abnormal laboratory findings that have no clinical relevance per the treating investigator.
* NOTE: If patient has undergone major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to randomization
* Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy. A patient of childbearing potential is defined as anyone, regardless of whether they have undergone tubal ligation, who meets the following criteria: 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 nurse infants while on protocol treatment and for 4 months after the last dose of protocol treatment
* Patient must not expect to conceive or father children by using an accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study. Patients of childbearing potential must continue contraceptive method(s) or abstain for 6 months after the last dose of protocol treatment. Patients with partners who could become pregnant should use effective contraception during therapy and for 3 months after the last dose of protocol treatment
* Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible
* Absolute neutrophil count (ANC) ≥ 1,500/uL (obtained ≤ 14 days prior to randomization)
* Platelets ≥ 100,000/uL (obtained ≤ 14 days prior to randomization)
* Albumin ≥ 3 g/dL (obtained ≤ 14 days prior to randomization)
* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (obtained ≤ 14 days prior to randomization)
* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3 × institutional ULN or ≤ 5.0 x institutional ULN if known liver metastases (obtained ≤ 14 days prior to randomization)
* Creatinine clearance (CrCl) ≥ 30 mL/min (obtained ≤ 14 days prior to randomization) NOTE: CrCl is estimated using the Cockcroft-Gault formula (or can be measured by 24-hour urine collection if needed)
* Hemoglobin (Hb) ≥ 8.5 mg/dl (obtained ≤ 14 days prior to randomization)
* Patient must not have a known genetic UGT1A1 deficiency (Gilbert's syndrome). Patients with variant type UGT1A1\*28 allele may have increased levels of SN-38 metabolite (due to reduced SN-38 metabolism and clearance) and are at higher risk for severe adverse events when compared to wild-type.
* NOTE: If a patient's UGT1A1 status is unknown, they are eligible to enroll (the study does not require this test as part of screening)
* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible
* 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 history of hepatitis C virus (HCV) infection must have been treated and considered cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression and are not using steroids \> 10 mg of prednisone (or equivalent) daily for brain metastases for at least 7 days prior to randomization
* Patients with prior or concurrent malignancy that is not considered clinically significant and whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen (at the discretion of the treating physician) are eligible
* Patient must not be on systemic immunosuppressive medication, including steroids (if doses exceed the equivalent of prednisone 10 mg daily). Short courses of steroids, e.g. "burst", which are discontinued prior to randomization are acceptable. Patients on inhaled, intranasal, intra-articular and/or topical steroids are eligible
* Patient must be English or Spanish speaking to be eligible for the HRQOL component of the study.
* NOTE: Sites cannot translate the associated HRQOL forms PROCEDURE: Biospecimen Collection, DRUG: Carboplatin, DRUG: Cisplatin, PROCEDURE: Computed Tomography, DRUG: Docetaxel, DRUG: Gemcitabine, PROCEDURE: Magnetic Resonance Imaging, DRUG: Paclitaxel, BIOLOGICAL: Pembrolizumab, OTHER: Questionnaire Administration, BIOLOGICAL: Sacituzumab Govitecan
Locally Advanced Urothelial Carcinoma, Metastatic Urothelial Carcinoma, Unresectable Urothelial Carcinoma
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Show 152 locations
Study Locations
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| Location | Contacts |
|---|---|
| Abbott-Northwestern Hospital Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Allegheny General Hospital Pittsburgh, Pennsylvania | |
| Allegheny Valley Hospital Natrona Heights, Pennsylvania | Site Public Contact - (Dawnmarie.DeFazio@ahn.org) |
| Avera Cancer Institute Sioux Falls, South Dakota | Site Public Contact - (OncRegulatory@avera.org) |
| Avera Cancer Institute - Mitchell Mitchell, South Dakota | Site Public Contact - (OncRegulatory@avera.org) |
| Avera Cancer Institute at Marshall Marshall, Minnesota | Site Public Contact - (OncRegulatory@avera.org) |
| Avera Cancer Institute at Pierre Pierre, South Dakota | Site Public Contact - (OncRegulatory@avera.org) |
| Avera Cancer Institute at Yankton Yankton, South Dakota | Site Public Contact - (OncRegulatory@avera.org) |
| Avera Cancer Institute-Aberdeen Aberdeen, South Dakota | Site Public Contact - (oncregulatory@avera.org) |
| BJC Outpatient Center at Sunset Hills Sunset Hills, Missouri | |
| Benefis Sletten Cancer Institute Great Falls, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Billings Clinic Cancer Center Billings, Montana | Site Public Contact - (research@billingsclinic.org) |
| Bozeman Health Deaconess Hospital Bozeman, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Cancer Care Center of O'Fallon O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Care Specialists of Illinois - Decatur Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Center at Saint Joseph's Phoenix, Arizona | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.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 Vermont Medical Center/National Life Cancer Treatment Berlin Corners, Vermont | |
| Community Hospital of Anaconda Anaconda, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Scranton, Pennsylvania | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Scranton, Pennsylvania | Site Public Contact - (Lennette.Gonzales@rwjbh.org) |
| Crossroads Cancer Center Effingham, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire | Site Public Contact - (cancer.research.nurse@dartmouth.edu) |
| Decatur Memorial Hospital Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Duluth Clinic Ashland Ashland, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Emory Saint Joseph's Hospital Atlanta, Georgia | |
| Emory University Hospital Midtown Atlanta, Georgia | |
| Emory University Hospital/Winship Cancer Institute Atlanta, Georgia | |
| Essentia Health - Deer River Clinic Deer River, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Cancer Center Duluth, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health 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 Sandstone Sandstone, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Virginia Clinic Virginia, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| FHCC Overlake Bellevue, Washington | |
| FHCC at EvergreenHealth Kirkland, Washington | |
| FHCC at Northwest Hospital Seattle, Washington | |
| Fairview Southdale Hospital Edina, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Forbes Hospital Monroeville, Pennsylvania | |
| Fred Hutchinson Cancer Center Seattle, Washington | |
| 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) |
| 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) |
| HaysMed Hays, Kansas | |
| Hematology Oncology Associates of Fredericksburg Inc Fredericksburg, Virginia | Site Public Contact - (cvaughn@hoafredericksburg.com) |
| Houston Methodist Cypress Hospital Cypress, Texas | Site Public Contact - (irb@houstonmethodist.org) |
| Houston Methodist Hospital Houston, Texas | |
| Houston Methodist Saint John Hospital Nassau Bay, Texas | Site Public Contact - (ctsucontact@westat.com) |
| Houston Methodist San Jacinto Hospital Baytown, Texas | Site Public Contact - (ctsucontact@westat.com) |
| Houston Methodist Sugar Land Hospital Sugar Land, Texas | |
| Houston Methodist The Woodlands Hospital The Woodlands, Texas | Site Public Contact - (hmthewoodlands@houstonmethodist.org) |
| Houston Methodist West Hospital Houston, Texas | |
| IRMC Cancer Center Indiana, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| Jefferson Hospital Jefferson Hills, Pennsylvania | Site Public Contact - (ddefazio@wpahs.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) |
| Logan Health Medical Center Kalispell, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Louisiana Hematology Oncology Associates LLC Baton Rouge, Louisiana | Site Public Contact - (clinicalresearch@marybird.com) |
| Margaret R Pardee Memorial Hospital Hendersonville, North Carolina | Site Public Contact - (pardeecancerresearch@unchealth.unc.edu) |
| Mary Bird Perkins Cancer Center - Metairie Metairie, Louisiana | |
| Mary Greeley Medical Center Ames, Iowa | |
| McFarland Clinic - Ames Ames, Iowa | Site Public Contact - (ksoder@mcfarlandclinic.com) |
| McFarland Clinic - Boone Boone, Iowa | |
| McFarland Clinic - Jefferson Jefferson, Iowa | |
| McFarland Clinic - Marshalltown Marshalltown, Iowa | |
| McFarland Clinic - Trinity Cancer Center Fort Dodge, Iowa | |
| Memorial Hospital East Shiloh, Illinois | Site Public Contact - (dschwab@wustl.edu) |
| Mercy Hospital Coon Rapids, Minnesota | |
| Mercy Hospital Coon Rapids, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Methodist Willowbrook Hospital Houston, Texas | Site Public Contact - (ctsucontact@westat.com) |
| Missouri Baptist Medical Center St Louis, Missouri | |
| Missouri Baptist Sullivan Hospital Sullivan, Missouri | |
| Monmouth Medical Center Long Branch, New Jersey | Site Public Contact - (mary.danish@rwjbh.org) |
| Ohio State University Comprehensive Cancer Center Columbus, Ohio | Site Public Contact - (Jamesline@osumc.edu) |
| Oncology Associates at Mercy Medical Center Cedar Rapids, Iowa | |
| Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Parkland Health Center - Farmington Farmington, Missouri | |
| Penn State Milton S Hershey Medical Center Hershey, Pennsylvania | Site Public Contact - (CTO@hmc.psu.edu) |
| Reading Hospital West Reading, Pennsylvania | |
| Regions Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Robert Wood Johnson University Hospital Somerset Somerville, New Jersey | Site Public Contact - (Siby.Varughese@rwjbh.org) |
| Roswell Park Cancer Institute Buffalo, New York | Site Public Contact - (askroswell@roswellpark.org) |
| Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey | |
| Rutgers New Jersey Medical School Newark, New Jersey | |
| Saint Barnabas Medical Center Livingston, New Jersey | Site Public Contact - (joanne.loeb@rwjbh.org) |
| Saint Francis Medical Center Cape Girardeau, Missouri | Site Public Contact - (sfmc@sfmc.net) |
| Saint Vincent Hospital Erie, Pennsylvania | |
| Sainte Genevieve County Memorial Hospital Sainte Genevieve, Missouri | |
| Salina Regional Health Center Salina, Kansas | Site Public Contact - (mleepers@srhc.com) |
| 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 James Graham Brown Cancer Center at University of Louisville Louisville, Kentucky | |
| 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) |
| 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 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 | |
| UMass Memorial Medical Center - University Campus Worcester, Massachusetts | Site Public Contact - (cancer.research@umassmed.edu) |
| UPMC Cancer Center-Washington Washington, Pennsylvania | Site Public Contact - (ecog.rss@jimmy.harvard.edu) |
| UPMC Cancer Centers - Arnold Palmer Pavilion Greensburg, Pennsylvania | |
| UPMC Hillman Cancer Center - Monroeville Monroeville, Pennsylvania | Site Public Contact - (ClinicalResearchServices@upmc.edu) |
| UPMC Hillman Cancer Center Erie Erie, Pennsylvania | Site Public Contact - (ClinicalResearchServices@upmc.edu) |
| UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion Mechanicsburg, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC Pinnacle Cancer Center/Community Osteopathic Campus Harrisburg, Pennsylvania | Site Public Contact - (klitchfield@PINNACLEHEALTH.org) |
| UPMC-Passavant Hospital Pittsburgh, Pennsylvania | |
| UPMC-Saint Margaret Pittsburgh, Pennsylvania | |
| United Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| University Health Truman Medical Center Kansas City, Missouri | |
| University of Illinois Chicago, Illinois | |
| University of Kansas Cancer Center Kansas City, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Cancer Center - Briarcliff Kansas City, Missouri | |
| University of Kansas Cancer Center - Lee's Summit Lee's Summit, Missouri | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Cancer Center - North Kansas City, Missouri | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Cancer Center-Overland Park Overland Park, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Health System Saint Francis Campus Topeka, Kansas | |
| University of Kansas Hospital-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 Pittsburgh Cancer Institute (UPCI) Pittsburgh, Pennsylvania | |
| University of Vermont Medical Center Burlington, Vermont | Site Public Contact - (rpo@uvm.edu) |
| University of Vermont and State Agricultural College Burlington, Vermont | Site Public Contact - (rpo@uvm.edu) |
| University of Washington Medical Center - Montlake Seattle, Washington | |
| UofL Health Medical Center Northeast Louisville, Kentucky | Site Public Contact - (ctoinfo@louisville.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) |
| Virginia Cancer Institute Richmond, Virginia | Site Public Contact - (smoore@vacancer.com) |
| 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) |
Adagrasib + SRS for Patients With Metastatic KRAS G12C-mutated NSCLC With Untreated Brain Metastases
Ryan Gentzler, MD, MS - rg2uc@uvahealth.org
NCT06248606
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Inclusion Criteria:
• Written informed consent and 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.
• ECOG Performance Status of 0-1 within 28 days prior to registration.
• Confirmation of stage IV non-small cell lung cancer (NSCLC) per AJCC, 8th edition, or metastatic recurrence after treatment for earlier stage disease.
• Known to have a KRAS G12C mutation. KRAS G12C mutation can be determined based on local tissue and/or ctDNA testing.
• Presence of brain metastases that meet the following criteria: * Patients must have at least 1 untreated enhancing intracranial lesion, per local radiology interpretation, measuring at least 2mm. NOTE: intracranial lesions do not need to be measurable by RECIST 1.1 criteria to be eligible. * Must have no single metastasis measuring larger than 3 cm. * Patients with surgically resected brain metastases are eligible provided there are additional brain metastases amenable to SRS * Patients with progression of previously radiated or surgically resected CNS metastases are eligible if solid component of lesion has enlarged and there is no concern for radionecrosis based on investigator discretion. * Patients who received SRS within 4 weeks prior to registration are eligible provided baseline brain MRI prior to SRS treatment is within 4 weeks of study registration and SRS treatment meets requirements in #7 below. * Symptomatic brain metastases are permitted if the following criteria are met: * No evidence of cerebral herniation or symptomatic leptomeningeal disease * No seizures within past 14 days; antiepileptic medications are permitted * Patients on steroids must have stable or improving neurologic symptoms that have not worsened during a steroid taper. Must be receiving the equivalent of dexamethasone 8 mg total daily dose or less at the time of registration.
• CNS lesions have already been treated with SRS (within 3 weeks prior to Cycle 1 Day 1) or are amenable to SRS as determined by radiation oncologist and/or neurosurgeon. SRS treatment must use GammaKnife or linear accelerator-based treatments with nominal x-ray energy of 6MV or greater.
• No contraindications to SRS. Patients on anticoagulation must be able to hold anticoagulation for SRS treatment based on investigator discretion.
• Patients may be treatment-naïve OR have received up to 2 prior lines of systemic therapy. Treatment with systemic therapy for Stage I-III disease \> 12 months prior to development of metastases do not count as a line of therapy. Treatment with platinum-doublet chemotherapy and checkpoint inhibitor immunotherapy (PD-1, PD-L1, CTLA-4, etc.) either in combination or sequentially counts as one line of therapy.
• Demonstrate adequate organ function as defined below. All screening labs to be obtained within 28 days prior to registration. * Hemoglobin (Hgb): ≥ 8.0 g/dL in the absence of transfusions within 7 days prior to testing. * Calculated creatinine clearance: ≥ 60 mL/min * Bilirubin: ≤ 1.5 mg/dL * Aspartate aminotransferase (AST): ≤ 3.0 × ULN * Alanine aminotransferase (ALT): ≤ 3.0 × ULN
• Females of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to treatment initiation.
• Females of childbearing potential who are sexually active with a male able to father a child must be willing to abstain from heterosexual activity or to use an effective method(s) of contraception. Males able to father a child who are sexually active with female of childbearing potential must be willing to abstain from heterosexual activity or to use an effective method(s) of contraception.
• HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial. Testing is not required at screening unless mandated by local policy.
• 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, the HCV viral load must be undetectable to be eligible for this trial. Testing is not required at screening unless mandated by local policy.
• 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:
• Prior treatment with KRAS G12C tyrosine kinase inhibitor.
• Active infection requiring systemic therapy with the exception of #13 and #14 above.
• Uncontrolled, significant intercurrent or recent illness.
• Prolonged QTc interval \> 480 milliseconds or history of congenital Long QT Syndrome
• Currently receiving radiation treatment at the time of enrollment to any extra-cranial lesion for prophylaxis or pain control. Patients may enroll after completion of palliative RT.
• Ongoing need for treatment with concomitant medication known as a strong inhibitor or inducer of CYP3A enzyme and that cannot be switched to an alternative treatment prior to study enrollment. NOTE: Discontinuation of CYP3A4 inducers should occur a minimum of 7 days or 5 times their half-life, whichever is longer, prior to C1D1 study treatment.
• Treatment with any investigational drug within 28 days prior to registration.
• Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
• Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen, per treating physician discretion, are not eligible for this trial.
DRUG: Adagrasib, RADIATION: Stereotactic Radiosurgery
Non Small Cell Lung Cancer, NSCLC, KRAS G12C
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| Location | Contacts |
|---|---|
| Ohio State University Comprehensive Cancer Center Columbus, Ohio | Sarah Jewell - (sarah.jewell@osumc.edu) |
| University of Virginia Health System Charlottesville, Virginia | Gracie Hockenberry, RN - (mgt4n@virginia.edu) |
| Virginia Commonwealth University Richmond, Virginia | Nicole Knight - (nknight@vcu.edu) |
A Study to Learn About a Study Medicine Called Ibuzatrelvir in Adult and Adolescent Patients With COVID-19 Who Are Not Hospitalized But Are at Risk For Severe Disease
Pfizer CT.gov Call Center - ClinicalTrials.gov_Inquiries@pfizer.com
NCT06679140
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Inclusion Criteria:
• 12 to \<18 years of age, weighing at least 40 kg, or ≥18 years of age of any weight at screening.
• Presence of risk factors for progression to severe COVID-19 at the time of screening based on age:
• 12 to 49 years of age with at least two risk factors, where one must be moderate immunocompromise;
• 50 to 64 years of age with at least two risk factors;
• 65 to 74 years of age with at least one risk factor;
• For participants 75 years of age or older, there are no requirements related to risk factors. The list of risk factors includes: BMI ≥35 kg/m2; Current smoker; Chronic lung disease; Cardiovascular disease; Type 1 or Type 2 diabetes mellitus; Mild to moderate renal impairment; Neurodevelopmental disorders; Sickle cell disease; Moderate immunosuppression.
• Confirmed SARS-CoV-2 infection as determined by RAT in nasal or NP specimen collected within 1 day prior to randomization. Initial onset of symptoms attributable to COVID-19 within 5 days prior to randomization and at least 1 of the specified symptoms attributable to COVID-19 present on the day of randomization. Randomization must occur no later than the 5th day, where the onset of symptoms is the first day.
• Participants must be unable or unwilling to take nirmatrelvir/ritonavir.
Exclusion Criteria:
• Current need or anticipated need for hospitalization within 24 hours, due to signs of severe COVID-19 illness (eg, SpO2 \<94% on room air, respiratory rate \>30 breaths/minute, or lung infiltrates \>50%) or due to other medical conditions requiring hospitalization in the opinion of the site investigator.
• Receiving dialysis or have known severe renal impairment \[ie, eGFR consistently \<30 mL/min/1.73 m2 for adults or CrCl \<30 mL/min for adolescents\], using the serum creatinine-based CKD-EPI formula or the Cockroft Gault, respectively.
• Active liver disease with AST or ALT \>3 ULN, Total bilirubin ≥2 × ULN (for Gilbert's syndrome, direct bilirubin \>ULN is exclusionary) within the past 3 months, or liver function impairment with Class C per Child Pugh classification.
• Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study intervention.
• Ongoing Long COVID or Post Acute Sequelae of COVID-19 diagnosis.
• Severely immunocompromised.
• Any comorbidity requiring hospitalization and/or surgery within 7 days prior to study entry, or that is considered life threatening within 30 days prior to study entry, as determined by the investigator.
• History of hypersensitivity or other contraindication to any of the components of the study interventions.
• Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
• Current use of any prohibited concomitant medication(s).
• Has received any other antiviral for the treatment of COVID-19, including remdesivir, nirmatrelvir/ritonavir, molnupiravir, or COVID-19 mAbs within 30 days or 5 half-lives \[whichever is longer\] prior to screening, or received convalescent COVID-19 plasma within 12 months.
• Received any dose of a COVID-19 vaccine within 4 months of randomization or expected to receive one through Day 34.
• Previous administration of an investigational product (drug or vaccine) within 30 days or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer).
• Prior participation in this clinical trial or any other clinical trial of ibuzatrelvir.
• Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
DRUG: ibuzatrelvir, DRUG: placebo
COVID-19 SARS-CoV-2 Infection
Pneumonia, Viral, Pneumonia, Respiratory Tract Infections, Infections, Virus Diseases, Coronavirus Infections, Coronaviridae Infections, Nidovirales Infections, RNA Virus Infections, Lung Diseases, Respiratory Tract Diseases, COVID-19, Viral Protease Inhibitors, Protease Inhibitors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action, Antiviral Agents, Anti-Infective Agents, ibuzatrelvir
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Study Locations
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| Location | Contacts |
|---|---|
| 310 Clinical Research Inglewood, California | |
| AMB4YOU s.r.o. Hlohovec, Trnava Region | |
| ANIMA Research Alken, Limburg | |
| Aalborg Universitetshospital, Syd Gistrup, | |
| Acclaim Clinical Research San Diego, California | |
| Acibadem Universitesi Atakent Hastanesi Istanbul, İ̇stanbul | |
| Adult Medicine of Lake County, Inc. Mt. Dora, Florida | |
| Ajou University Hospital Suwon, | |
| Alpine Research Organization Clinton, Utah | |
| Ambulatory for Individual Primary Medical Care - Dr. Pavlina Petrova - Poli ET Sofia, | |
| Ankara Bilkent Sehir Hastanesi Ankara, | |
| Ankara University Ibni Sina Hospital Ankara, | |
| Applied Research Center of Arkansas Little Rock, Arkansas | |
| Arké SMO S.A de C.V Veracruz, | |
| Artromac n.o. Košice, Košice Region | |
| Asociación Mexicana para la Investigación Clínica A.C. Pachuca, Hidalgo | |
| Beijing Ditan Hospital Capital Medical Beijing, | |
| Bio-Medical Research LLC Miami, Florida | |
| Breathe Clear Institute for Sinus and Allergy Relief Torrance, California | |
| Brigham and Women's Hospital Boston, Massachusetts | |
| C & R Research Services USA Fort Myers, Florida | |
| CECIP - Centro de Estudos do Interior Paulista Jaú, São Paulo | |
| CHUAC-Complejo Hospitalario Universitario A Coruña A Coruña, | |
| CHUVI- Hospital Alvaro Cunqueiro Vigo, Pontevedra [pontevedra] | |
| Centennial Medical Group Columbia, Maryland | |
| Centro Avançado de Tratamento Oncológico - CENANTRON Belo Horizonte, Minas Gerais | |
| Centro Médico São Francisco Curitiba, Paraná | |
| Centro de Investigaciones Medicas Mar del Plata Mar del Plata, Buenos Aires | |
| Centro de Pesquisa Clínica - CPC/UFSM Santa Maria, Rio Grande do Sul | |
| Centro de Referencia e Treinamento DST/Aids São Paulo, São Paulo | |
| Chang Gung Medical Foundation-LinKou Branch Taoyuan, | |
| Charite - Universitatsmedizin Berlin Berlin, | |
| Chonnam National University Hospital Gwangju, | |
| Chung-Ang University Hospital Dongjak-gu, | |
| Clinica Mayo de Urgencias Medicas Cruz Blanca S.R.L San Miguel de Tucumán, Tucumán Province | |
| Clinica mi Salud by Focil Med Oxnard, California | |
| Clinical Research of Ontario Toronto, | |
| Coastal Heritage Clinical Research Hinesville, Georgia | |
| Community Care Building Winchester, Ontario | |
| Complexo Hospital de Clínicas da Universidade Federal do Paraná Curitiba, Paraná | |
| DBC Research USA Pembroke Pines, Florida | |
| Diagnostic Consultative Center "Sveti Georgi" Plovdiv Plovdiv, | |
| Diagnostic Consultative Center - 1 - Sevlievo EOOD Sevlievo, Gabrovo | |
| Diagnostic Consultative Center - 1 Lom EOOD Lom, Montana | |
| Doktor Brno Brno, Brno-město | |
| Downtown L.A. Research Center, Inc. Los Angeles, California | |
| Dundas Manor Nursing Home Winchester, Ontario | |
| Eastside Research Associates Redmond, Washington | |
| Emerson Clinical Research Institute Washington D.C., District of Columbia | |
| Epic Clinical Research Lewisville, Texas | |
| Equipo Ciencia CABA, | |
| Eukarya Pharmasite S.C. Monterrey, Nuevo León | |
| FOMAT Medical Research Santa Maria, California | |
| FVR, Etelä-Helsingin rokotetutkimusklinikka Helsinki, Uusimaa | |
| FVR, Oulun rokotetutkimusklinikka Oulu, North Ostrobothnia | |
| FVR, Tampereen rokotetutkimusklinikka Tampere, Pirkanmaa | |
| Faculdade de Medicina do ABC Santo André, São Paulo | |
| Far Eastern Memorial Hospital New Taipei City, | |
| First Affiliated Hospital of Shanxi Medical University Taiyuan, Shanxi | |
| Fukuwa Clinic Chuo-ku, Tokyo | |
| GCP , Global Clinical Professionals St. Petersburg, Florida | |
| Gachon University Gil Medical Center Namdong-gu, Incheon-gwangyeoksi [incheon] | |
| Gangnam Severance Hospital, Yonsei University Health System Gangnam-gu, | |
| Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi Gaziantep, | |
| Georgetown University Medical Center Washington D.C., District of Columbia | |
| Global Clinical Trials Pretoria, Gauteng | |
| Global Health Research Center - Tampa Tampa, Florida | |
| Global Health Research Center, Inc. Miami Lakes, Florida | |
| Gulf Coast Clinical Research - Houston Houston, Texas | |
| Hacettepe Universite Hastaneleri Ankara, | |
| Hallym University Kangnam Sacred Heart Hospital Seoul, Seoul-teukbyeolsi [seoul] | |
| Henry Ford St. John Hospital Grosse Pointe Woods, Michigan | |
| Herco Medical and Research Center Inc Flagami, Florida | |
| Hillcrest Medical Research DeLand, Florida | |
| Hillcrest Medical Research LLC DeLand, Florida | |
| Hospital General Universitario Dr. Balmis Alicante, | |
| Hospital Germans Trias I Pujol Badalona, | |
| Hospital Italiano de la Plata La Plata, Buenos Aires | |
| Hospital Sao Lucas da PUCRS Porto Alegre, | |
| Hospital Universitari Vall d'Hebron Barcelona, | |
| Hospital Universitario Infanta Leonor Madrid, | |
| Hospital Universitario La Paz Madrid, | |
| Hospital Universitario Reina Sofia Córdoba, | |
| Hospital Universitario Virgen de Valme Seville, | |
| Hospital Universitário Professor Edgard Santos Salvador, Estado de Bahia | |
| Hospital Vithas Xanit Internacional Benalmádena, Andalusia | |
| Hospital e Maternidade Celso Pierro Campinas, São Paulo | |
| Huashan Hospital, Fudan University Shanghai, | |
| IKF Pneumologie Frankfurt, Clinical Research Center, Departments: Pulmonology, Endocrinology, Cardio Frankfurt am Main, Hesse | |
| IRS - Medicinska cinnost s.r.o., Vseobecna ambulancia pre dospelych Kosice-Juh, Košice Region | |
| Incheon Medical Center Donggu, Incheon-gwangyeoksi [incheon] | |
| Infection Control Belo Horizonte, Minas Gerais | |
| Infinite Clinical Research Miami, Florida | |
| Innovation Medical Research Center Palmetto Bay, Florida | |
| Innovative Research of West Florida Clearwater, Florida | |
| Instituto Atena de Pesquisa Clinica Natal, Rio Grande do Norte | |
| Instituto Médico Platense (IMP) La Plata, Buenos Aires | |
| Instituto Médico Río Cuarto Río Cuarto, Córdoba Province | |
| Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Mexico City, | |
| Instituto Nacional de Infectologia Evandro Chagas Rio de Janeiro, | |
| Instituto de Infectologia Emilio Ribas São Paulo, | |
| International University of Health and Welfare Narita Hospital Narita, | |
| Invictus Clinical Research Group Coconut Creek, Florida | |
| Irmandade da Santa Casa de Misericordia de Porto Alegre Porto Alegre, Rio Grande do Sul | |
| JM Research SC Cuernavaca, Morelos | |
| Jadestone Clinical Research Silver Spring, Maryland | |
| Javara - Privia Medical Group Georgia - Fayetteville Fayetteville, Georgia | |
| Javara - Privia Medical Group Gulf Coast - Sugarland Sugar Land, Texas | |
| Javara - Privia Medical Group North Texas - Stephenville Stephenville, Texas | |
| Jiangxi Provincial People's Hospital Nanchang, Jiangxi | |
| Jongaie Research Pretoria, Gauteng | |
| Kamezawa Clinic Kasugai, Aichi-ken | |
| Karadeniz Technical University Trabzon, | |
| Keimyung University Dongsan Hospital Daegu, | |
| Kendall South Medical Center Miami, Florida | |
| Kocaeli Üniversitesi Kocaeli, | |
| Koch Family Medicine Morton, Illinois | |
| Koga General Hospital Koga-shi, Ibaraki | |
| Korea University Anam Hospital Seoul, | |
| Korea University Ansan Hospital Ansan-si, | |
| Korea University Guro Hospital Seoul, | |
| LMU Klinikum München Munich, Bavaria | |
| Langeberg Clinical Trials Cape Town, Western Cape | |
| Las Vegas Clinical Trials North Las Vegas, Nevada | |
| Long Beach Clinical Trials Long Beach, California | |
| Long Beach Research Institute Long Beach, California | |
| Lékařský dům v Mezibranské Prague, Praha 1 | |
| MHAT "Rahila Angelova" Pernik Pernik, | |
| MHAT Samokov Samokov, Sofia | |
| ML MED, s.r.o., Vseobecna ambulancia pre dospelych Moldava nad Bodvou, Košice Region | |
| MUDr. Viliam Cibik, PhD., s.r.o. Pruské, Trenčín Region | |
| McGill Family Practice Papillion, Nebraska | |
| MeVac - Meilahti Vaccine Research Center Helsinki, Uusimaa | |
| Medical Center Diana Med 2001 Yambol, | |
| Medical Center Hera EOOD Sofia, | |
| Medical Center Pulmo - 2018 EOOD Haskovo, | |
| Medical Center Sveti Ivan Rilski Chudotvorets - 2010 Plovdiv, | |
| Medical Centre "Asklepiy" Dupnitsa, Kyustendil | |
| Medical Corporation Kouhoukai Takagi Hospital Okawa-shi, Fukuoka | |
| Memorial Hermann Hospital TMC Houston, Texas | |
| Mercury Clinical Research - North Houston Internal Medicine & Pediatric Clinic Tomball, Texas | |
| Mercury Clinical Research - Santa Clara Family Clinic Houston, Texas | |
| Mercury Street Medical Group, PLLC Butte, Montana | |
| Military Medical Academy Sofia, Sofia (stolitsa) | |
| Monroe Biomedical Research Monroe, North Carolina | |
| Musashino Emergency Hospital Kodaira-shi, Tokyo | |
| National Hospital Organization Okinawa Hospital Ginowan, Okinawa | |
| National Institute of Clinical Research - Bakersfield Bakersfield, California | |
| Newtown Clinical Research Johannesburg, Gauteng | |
| Next Level Urgent Care Houston, Texas | |
| Nishioka Hospital Sapporo, Hokkaido | |
| Nordsjællands Hospital - Hillerød Hilleroed, Capital Region | |
| Novopraxis Berlin GbR Berlin, | |
| Nuovida Research Center Miami, Florida | |
| ORL MUDr Pavel Navratil Olomouc, | |
| Ordinace Hradebni s.r.o. České Budějovice, South Bohemian Region | |
| PULMO, s.r.o., Pneumologicko-ftizeologicka ambulancia Prešov, Presov | |
| Paarl Research Centre Paarl, Western Cape | |
| Pacific Clinical Studies Inc. Los Alamitos, California | |
| Paradigm Clinical Research, LLC Wheat Ridge, Colorado | |
| Paradigm Clinical Research, LLC Wheat Ridge, Colorado | |
| Peking University People's Hospital Beijing, | |
| Plucna ambulancia Hrebenar, s.r.o., Pneumologicko-ftizeologicka ambulancia Spišská Nová Ves, Košice Region | |
| Pneumocare Erpent, | |
| Praxis am Ebertplatz Cologne, North Rhine-Westphalia | |
| Praxisgemeinschaft Heimeranplatz Munich, Bavaria | |
| Preferred Primary Care Physicians Uniontown, Pennsylvania | |
| Prime Global Research The Bronx, New York | |
| Private Practice - Dr. Peter Sebastian Silverglen Durban, KwaZulu-Natal | |
| Proactive Clinical Research,LLC Fort Lauderdale, Florida | |
| Qway Research LLC Hialeah, Florida | |
| Rakuwakai Otowa Hospital Kyoto, Kyoto | |
| Real Hospital Portugues Recife, Pernambuco | |
| Regionshospitalet Gødstrup Herning, Central Jutland | |
| Remington-Davis, Inc Columbus, Ohio | |
| Revival Research Institute, LLC Dearborn, Michigan | |
| Rigshospitalet Copenhagen, | |
| Roskilde Sygehus Roskilde, Region Sjælland | |
| SALUBER SK s.r.o., Vseobecna ambulancia pre dospelych Nové Mesto nad Váhom, Trenčín Region | |
| SHATPD Troyan Troyan Municipality, Lovech | |
| Sakarya Training and Research Hospital Sakarya, | |
| Sanatorio Güemes Ciudad de Buenos Aires, Buenos Aires | |
| Sandton Medical Research Centre Sandton, Gauteng | |
| School of Medicine Federal University of Minas Gerais Belo Horizonte, Minas Gerais | |
| Shanghai Children's Medical Center Shanghai, Shanghai Municipality | |
| Shanghai Minhang District Central Hospital Shanghai, Shanghai Municipality | |
| Shonan Fujisawa Tokushukai Hospital Fujisawa, Kanagawa | |
| Shonan Kamakura General Hospital Kamakura, Kanagawa | |
| Sir Run Run Shaw Hospital Zhejiang University School of Medicine Hangzhou, Zhejiang | |
| Southwest Family Medicine Associates Dallas, Texas | |
| Southwest Mind and Body Care Dallas, Texas | |
| St. Luke's Children's Boise, Idaho | |
| St. Luke's Elks Children's Pavilion Boise, Idaho | |
| St. Luke's Humphreys Diabetes Center Boise, Idaho | |
| Studien Rahman & Detho Obertshausen, Hesse | |
| Sunbright Health Medical Centers Homestead, Florida | |
| Swing Nozaki Clinic Musashino-shi, Tokyo | |
| Synapta Clinical Research Centre Durban, KwaZulu-Natal | |
| TREAD Research Parow, Western Cape | |
| Taichung Veterans General Hospital Taichung, | |
| Taipei Veterans General Hospital Taipei, | |
| Tashiro Endocrinology Clinic Fukuoka, Fukuoka | |
| Terada Clinic Respiratory Medicine & General Practice Himeji, Hyōgo | |
| The Catholic University of Korea, Eunpyeong St. Mary's Hospital Eunpyeong-gu, | |
| The Crofoot Research Center Houston, Texas | |
| The First People's Hospital of Yunnan Province Kunming, | |
| The Hope Clinic of Emory University Decatur, Georgia | |
| The People's Hospital of Chizhou Chizhou, Anhui | |
| The Second Affiliated Hospital of Guangxi Medical University Nanning, Guangxi | |
| The Third Hospital of Changsha Changsha, Hunan | |
| The University of Texas Health Science Center at Houston Houston, Texas | |
| Tianjin First Central Hospital Tianjin, Tianjin Municipality | |
| Tri-Service General Hospital Taipei, | |
| Tsuchiura Beryl Clinic Tsuchiura, Ibaraki | |
| Tweedy Medical Group - Charity Health South Gate, California | |
| UL International Travel Clinic Louisville, Kentucky | |
| UT Physicians Houston, Texas | |
| Universal Axon Clinical Research, LLC Doral, Florida | |
| Universitaetsklinikum Hamburg-Eppendorf Hamburg, | |
| Universitatsklinik Freiburg Freiburg im Breisgau, | |
| University of Louisville Hospital Louisville, Kentucky | |
| University of Louisville School of Medicine Louisville, Kentucky | |
| University of Massachusetts Chan Medical School Worcester, Massachusetts | |
| University of Rostock Rostock, | |
| Universitätsklinikum Augsburg Augsburg, | |
| Upstate Connect Care Syracuse, New York | |
| Upstate Global Health Institute East Syracuse, New York | |
| VL.AK s.r.o. Vseobecna ambulancia pre dospelych Trnava, Trnava Region | |
| Vancouver Infectious Diseases Centre Vancouver, British Columbia | |
| Velocity Clinical Research, Grand Island Grand Island, Nebraska | |
| Velocity Clinical Research, Huntington Park Huntington Park, California | |
| Velocity Clinical Research, Omaha Omaha, Nebraska | |
| Velocity Clinical Research, Savannah Savannah, Georgia | |
| Velocity Clinical Research, Suffolk Suffolk, Virginia | |
| Velocity Clinical Research, Waco Waco, Texas | |
| WR-ClinSearch, LLC Chattanooga, Tennessee | |
| Winchester District Memorial Hospital Winchester, Ontario | |
| Wonju Severance Christian Hospital Wŏnju, | |
| Yoshijima Hospital Hiroshima, | |
| Zdravi-fit Protivín, South Bohemian Region | |
| Zenos Clinical Research Dallas, Texas | |
| Zhongshan Hospital Fudan University (Xiamen Branch) Xiamen, Fujian | |
| Zhongshan Hospital Xiamen University Xiamen, Fujian | |
| Zhujiang Hospital of Southern Medical University Guangzhou, Guangdong | |
| hospital Italiano de Buenos Aires Buenos Aires, | |
| i9 Pesquisas Clínicas - Loema Instituto de Pesquisa Clínica e Consultores SS Ltda Campinas, São Paulo | |
| the First Hospital of Jilin University Changchun, | |
| zibp Zentrum für lnfektiologie Berlin Prenzlauer Berg GmbH Berlin, |
SPENDD: Quantitative Sensory Testing and Analgesic Response for Painful Peripheral Neuropathy.
Rachel De Guzman - rachel_deguzman@urmc.rochester.edu
NCT06614322
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5\. INCLUSION AND EXCLUSION CRITERIA
• Between 18 and 80 years old (inclusive).
• Have a diagnosis of peripheral neuropathic pain in both feet from generalized distal sensory polyneuropathy based on the following criteria
• A history of a relevant lesion of the peripheral nervous system, disease, toxic exposure, or no known cause (i.e., idiopathic).
• Pain distribution in a neuroanatomically plausible distribution consistent with a symmetrical generalized polyneuropathy (i.e., with a "glove and stocking" distal to proximal gradient).
• DN4 score≥ 4
• Have experienced the neuropathic pain in the feet for at least 6 months.
• Have at least one of the following sensory signs upon clinical examination: abnormal pinprick perception, allodynia, hyperalgesia, abnormal light touch perception, abnormal vibratory perception, or abnormal proprioception.
• Have average daily baseline worst pain intensity in their feet of 4 or greater and less than 10, on a 0-10 numeric rating scale of pain intensity (0 = "no pain," 10= "most intense pain imaginable") as measured on the daily diary during screening from at least 5 measurements.
• Able to understand and read English. This requirement is to ensure that participants can provide informed consent and complete PROs.
• Have been on stable dosages of all pain medications or using all non-pharmacologic treatments for neuropathy pain at consistent frequency for at least 1 month and willing and able to stay on those dosages (or use those frequencies) (except acetaminophen rescue) throughout the duration of the study.
• If taking cannabinoid products for any reason, must be at stable dosages for at least 1 month prior to the screening visit and willing to stay on that dosage for the duration of the study.
• Willing and able to complete electronic patient-reported outcomes at home using a REDCap link.
• Taking any opioid medication with a daily mean morphine equivalent (MME) of \> 30.
• Have a different diagnosis of pain in the feet including but not limited to musculoskeletal pain (e.g., foot arthritis, plantar fasciitis) or lumbar sacral radiculopathy that they rate to be worse than their neuropathic pain in their feet, or that in the opinion of the investigator, precludes the participant from rating their neuropathy pain in their feet.
• Have a central cause of neuropathic pain (e.g., demyelinating disease, spinal cord injury, Parkinson's disease).
• Have a history of an inciting traumatic or surgical cause that corresponds with the development of features consistent with a peripheral neuropathy.
• Bilateral polyradiculopathy, with a distal distribution (i.e., symptoms extending into the feet).
• History of acute polyneuropathy (e.g., Guillain-Barre Syndrome, acute motor sensory axonal neuropathy \[AMSAN\]) within 6 months prior to Visit 1.
• Have autoimmune-mediated neuropathy (e.g., RA, lupus, Sjogren syndrome, Lyme disease, chronic inflammatory demyelinating polyneuropathy (CIDP)) unless the associated inflammation is controlled and, in the opinion of the investigator, is expected to remain stable throughout the course of the study.
• Charcot-Marie-Tooth disease in which nociceptive pain from joint deformity confounds assessment of neuropathic pain.
• Have taken the treatment that caused the participant's neuropathy (e.g., neurotoxic chemotherapy, certain HIV therapies) less than 6 months prior to Visit 1.
• Have taken duloxetine (at least 60mg/day) in the past 6 months or have taken duloxetine at any dosage within a week prior to the screening visit.\*\*
• Have taken pregabalin (at least 300mg/day) OR gabapentin (at least 1200mg/day) in the past 6 months or have taken pregabalin or gabapentin at any dosage within a week prior to the screening visit.##
• Have ever previously taken BOTH pregabalin (or gabapentin) AND duloxetine at sufficient dosages and for a sufficient length of time that, in the opinion of the investigator, the participant should have experienced pain relief if they were going to respond, but they did not receive benefit from EITHER drug.
• Taking venlafaxine, buproprion, tramadol, or St. John's Wort. Concomitant use of one medication that inhibits the reuptake of serotonin is allowed at certain dosages. (See Appendix A for maximum allowed dosages for common selective serotonin reuptake inhibitors (SSRIs) and tricyclic antidepressants (TCAs); maximum dosages for other applicable drugs will be decided by the research team leadership composed of a) clinical pharmacist with extensive experience in chronic pain management, b) a physician board-certified in pain medicine and psychiatry, and c) a board-certified neurologist.\*\*
• Taking a monoamine oxidase inhibitor.\*\*
• Taking CYP1A2 inhibitors or thioridazine.
• Have a spinal cord stimulator.
• Have an active, uncontrolled/unstable medical condition (e.g., neurological, gastrointestinal, renal, hepatic, cardiovascular, pulmonary, metabolic, endocrine, hematological, genitourinary, cancer, or other major disorder), psychotic disorder or any other uncontrolled psychiatric illness that in the opinion of the investigator makes it unsafe to participate or inclusion of the participant will have a negative effect on the study.
• Had a clinically significant illness or operative procedure within four weeks of screening.
• Known hypersensitivity to pregabalin. ##
• Known hypersensitivity to duloxetine.\*\*
• Known history of chronic kidney disease that in the opinion of the investigator would make it unsafe to participate.
• Known history of chronic liver disease that in the opinion of the investigator would make it unsafe to participate.
• Excessive consumption of alcohol (i.e., more than 5 drinks / day for males and more than 4 drinks / day for females).
• A history of illicit drug use in the past year or planning to take any illicit drugs during the course of the study (other than cannabinoid products).
• Patients who are at significant risk of suicide, or are a danger to self or others, in the opinion of the investigator, based upon clinical interview and the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening and baseline. Affirmative answer to suicidal ideation questions 4 or 5, within the last 6 months and / or suicidal behavior (actual attempt, interrupted attempt, aborted attempt, and/or preparatory acts/behavior) within the last 2 years are exclusionary.
• Evidence of cognitive impairment including dementia or a psychiatric condition (e.g., schizophrenia, bipolar disorder) that may interfere with the subject's ability to complete assessments.
• Amputation of lower limbs (foot, ankle, leg, or thigh). Isolated toe amputations are permitted.
• Pregnant or planning to become pregnant during the study period or breastfeeding (screened via self-report).
• Enrolled in another investigational medication trial or a trial of any intervention for pain in your feet.
• Unable or unwilling to provide informed consent.
• Any additional reason that, in the opinion of the site investigator, would make it unsafe to participate or inclusion of the participant would hurt the study.
Inclusion Criteria:
Patients eligible for inclusion in this study must fulfill all of the following criteria:
• Between 18 and 80 years old (inclusive).
• Have a diagnosis of peripheral neuropathic pain in both feet from generalized distal sensory polyneuropathy based on the following criteria
• A history of a relevant lesion of the peripheral nervous system, disease, toxic exposure, or no known cause (i.e., idiopathic).
• Pain distribution in a neuroanatomically plausible distribution consistent with a symmetrical generalized polyneuropathy (i.e., with a "glove and stocking" distal to proximal gradient).
• DN4 score≥ 4
• Have experienced the neuropathic pain in the feet for at least 6 months.
• Have at least one of the following sensory signs upon clinical examination: abnormal pinprick perception, allodynia, hyperalgesia, abnormal light touch perception, abnormal vibratory perception, or abnormal proprioception.
• Have average daily baseline worst pain intensity in their feet of 4 or greater and less than 10, on a 0-10 numeric rating scale of pain intensity (0 = "no pain," 10= "most intense pain imaginable") as measured on the daily diary during screening from at least 5 measurements.
• Able to understand and read English. This requirement is to ensure that participants can provide informed consent and complete PROs.
• Have been on stable dosages of all pain medications or using all non-pharmacologic treatments for neuropathy pain at consistent frequency for at least 1 month and willing and able to stay on those dosages (or use those frequencies) (except acetaminophen rescue) throughout the duration of the study.
• If taking cannabinoid products for any reason, must be at stable dosages for at least 1 month prior to the screening visit and willing to stay on that dosage for the duration of the study.
• Willing and able to complete electronic patient-reported outcomes at home using a REDCap link.
Exclusion Criteria:
* Exclusion criteria 10, 13, 14, 20 pertain only to trial protocols that include duloxetine.
* Exclusion criterion 11, 19 pertain only to trial protocols that include pregabalin.
• Taking any opioid medication with a daily mean morphine equivalent (MME) of \> 30.
• Have a different diagnosis of pain in the feet including but not limited to musculoskeletal pain (e.g., foot arthritis, plantar fasciitis) or lumbar sacral radiculopathy that they rate to be worse than their neuropathic pain in their feet, or that in the opinion of the investigator, precludes the participant from rating their neuropathy pain in their feet.
• Have a central cause of neuropathic pain (e.g., demyelinating disease, spinal cord injury, Parkinson's disease).
• Have a history of an inciting traumatic or surgical cause that corresponds with the development of features consistent with a peripheral neuropathy.
• Bilateral polyradiculopathy, with a distal distribution (i.e., symptoms extending into the feet).
• History of acute polyneuropathy (e.g., Guillain-Barre Syndrome, acute motor sensory axonal neuropathy \[AMSAN\]) within 6 months prior to Visit 1.
• Have autoimmune-mediated neuropathy (e.g., RA, lupus, Sjogren syndrome, Lyme disease, chronic inflammatory demyelinating polyneuropathy (CIDP)) unless the associated inflammation is controlled and, in the opinion of the investigator, is expected to remain stable throughout the course of the study.
• Charcot-Marie-Tooth disease in which nociceptive pain from joint deformity confounds assessment of neuropathic pain.
• Have taken the treatment that caused the participant's neuropathy (e.g., neurotoxic chemotherapy, certain HIV therapies) less than 6 months prior to Visit 1.
• Have taken duloxetine (at least 60mg/day) in the past 6 months or have taken duloxetine at any dosage within a week prior to the screening visit.\*\*
• Have taken pregabalin (at least 300mg/day) OR gabapentin (at least 1200mg/day) in the past 6 months or have taken pregabalin or gabapentin at any dosage within a week prior to the screening visit.##
• Have ever previously taken BOTH pregabalin (or gabapentin) AND duloxetine at sufficient dosages and for a sufficient length of time that, in the opinion of the investigator, the participant should have experienced pain relief if they were going to respond, but they did not receive benefit from EITHER drug.
• Taking venlafaxine, buproprion, tramadol, or St. John's Wort. Concomitant use of one medication that inhibits the reuptake of serotonin is allowed at certain dosages. (See Appendix A for maximum allowed dosages for common selective serotonin reuptake inhibitors (SSRIs) and tricyclic antidepressants (TCAs); maximum dosages for other applicable drugs will be decided by the research team leadership composed of a) clinical pharmacist with extensive experience in chronic pain management, b) a physician board-certified in pain medicine and psychiatry, and c) a board-certified neurologist.\*\*
• Taking a monoamine oxidase inhibitor.\*\*
• Taking CYP1A2 inhibitors or thioridazine.
• Have a spinal cord stimulator.
• Have an active, uncontrolled/unstable medical condition (e.g., neurological, gastrointestinal, renal, hepatic, cardiovascular, pulmonary, metabolic, endocrine, hematological, genitourinary, cancer, or other major disorder), psychotic disorder or any other uncontrolled psychiatric illness that in the opinion of the investigator makes it unsafe to participate or inclusion of the participant will have a negative effect on the study.
• Had a clinically significant illness or operative procedure within four weeks of screening.
• Known hypersensitivity to pregabalin. ##
• Known hypersensitivity to duloxetine.\*\*
• Known history of chronic kidney disease that in the opinion of the investigator would make it unsafe to participate.
• Known history of chronic liver disease that in the opinion of the investigator would make it unsafe to participate.
• Excessive consumption of alcohol (i.e., more than 5 drinks / day for males and more than 4 drinks / day for females).
• A history of illicit drug use in the past year or planning to take any illicit drugs during the course of the study (other than cannabinoid products).
• Patients who are at significant risk of suicide, or are a danger to self or others, in the opinion of the investigator, based upon clinical interview and the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening and baseline. Affirmative answer to suicidal ideation questions 4 or 5, within the last 6 months and / or suicidal behavior (actual attempt, interrupted attempt, aborted attempt, and/or preparatory acts/behavior) within the last 2 years are exclusionary.
• Evidence of cognitive impairment including dementia or a psychiatric condition (e.g., schizophrenia, bipolar disorder) that may interfere with the subject's ability to complete assessments.
• Amputation of lower limbs (foot, ankle, leg, or thigh). Isolated toe amputations are permitted.
• Pregnant or planning to become pregnant during the study period or breastfeeding (screened via self-report).
• Enrolled in another investigational medication trial or a trial of any intervention for pain in your feet.
• Unable or unwilling to provide informed consent.
• Any additional reason that, in the opinion of the site investigator, would make it unsafe to participate or inclusion of the participant would hurt the study.
DRUG: Pregabalin, DRUG: Duloxetine, OTHER: Placebo
Painful Peripheral Neuropathy, Diabetic Peripheral Neuropathic Pain (DPN), Chemotherapy Induced Peripheral Neuropathy (CIPN), Idiopathic Peripheral Neuropathy
Peripheral Neuropathy, Pregabalin, Duloxetine, QST
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| Location | Contacts |
|---|---|
| Beth Israel Deaconess Medical Center for Autonomic and Peripheral Nerve Disorders Boston, Massachusetts | Nicholas Steed - (nsteed@bidmc.harvard.edu) |
| Ichan School of Medicine at Mount Sinai New York, New York | Kaitlyn Coyle - (kaitlyn.coyle@mssm.edu) |
| University of Pittsburgh Pittsburgh, Pennsylvania | Bhagyasri Dharmaraj - (bhd20@pitt.edu) |
| University of Rochester Rochester, New York | Rachel De Guzman - (rachel_deguzman@urmc.rochester.edu) |
| University of Utah Salt Lake City, Utah | Mariana Doudova - (Mariana.Doudova@hsc.utah.edu) |
| University of Vermont Burlington, Vermont | Jane Low - (jane.low@uvmhealth.org) |
| VCU Medical Center Richmond, Virginia | Stephanie Taylor - (stephanie.taylor@vcuhealth.org) |
A Study to Evaluate Safety, Tolerability, and Efficacy of AB-1009 Gene Therapy (GAA Gene) in Adult Participants With Late Onset Pompe Disease (PROGRESS-GT LOPD)
AskFirst Patient Engagement - AskFirst@AskBio.com
NCT07282847
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Inclusion Criteria:
• Participant must be ≥18 years of age at the time of signing the informed consent form.
• Confirmed GAA enzyme deficiency from any tissue source and/or confirmed biallelic GAA gene mutations.
• Undergone enzyme replacement treatment (ERT) (either alglucosidase alfa (Lumizyme®) or avalglucosidase alfa-ngpt (Nexviazyme®)), for at least 6 months (at least 10 infusions) before signing the initial informed consent form. During the screening process, participants need to remain on their current ERT until close to dosing;
• FVC in the upright position ≥30% and ≤80% of predicted;
• Capable of walking at least 100 meters in the 6MWT (use of a cane, quad cane, or standard walker is permitted);
• Contraceptive/barrier use by men and women requirements as per protocol.
• Capable of giving informed consent and able to understand and comply with all study procedures.
Exclusion Criteria:
• Severe cardiomyopathy, defined as left ventricular ejection fraction (LVEF) \<40% or New York Heart Association (NYHA) functional class 3 or above;
• Require invasive mechanical ventilation, or rely on noninvasive ventilation during the day;
• Intolerance to ERT or investigator-assessed intolerance to ERT, prior experience of serious ERT-related infusion-associated reactions (IARs);
• Have known intrinsic liver diseases, including hepatitis, HIV-related liver disease, prior diagnosis of portal hypertension, splenomegaly, hepatic encephalopathy, severe fatty liver, cirrhosis or liver fibrosis ≥stage 2, ultrasound-identified liver neoplasms, or laboratory tests suggesting elevated alpha-fetoprotein. Patients with liver function tests including ALT or AST \>3× upper limit of normal (ULN) or any total bilirubin above ULN during screening will also be excluded;
• Prior or ongoing medical condition(s), physical finding(s), assessment findings, or laboratory abnormality that, in the investigator's opinion, would impact participant's safety and compliance with the study procedures.
• Have received gene therapy prior to screening;
• Have received any systemic immunosuppressants (except inhalation or topical use) other than glucocorticoids or investigator-recommended immunosuppressants 30 days prior to screening through completion of screening, and/or known intolerance to immunosuppressants such as glucocorticoids;
• Use of investigational drugs or drugs that could affect this study as evaluated by the investigator within 30 days prior to screening through completion of Week 52 or within 5 half-lives of the investigational drug (whichever is longer);
• Have received any vaccine within 30 days prior to dosing;
• Other conditions that make the participant not eligible for the study according to the investigator.
GENETIC: AB-1009 (GAA Gene)
Pompe Disease (Late-onset), Pompe Disease Late-Onset, LOPD
Pompe Disease, Glycogen Storage Disease, Lysosomal Storage Diseases, Acid Maltase Deficiency, Acid Maltase Deficiency Disease, Gene Therapy, AB-1009, Neuromuscular Disease, LOPD, Acid-Alpha Glucoside (GAA), GAA gene, Adeno-Associated Virus (AAV), Late-Onset Pompe Disease
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| Location | Contacts |
|---|---|
| Barrow Neurological Institute Phoenix, Arizona | |
| Duke University Durham, North Carolina | Ming Xu, RN, MSN - (mingfen.xu@duke.edu) |
| Hospital of the University of Pennsylvania Philadelphia, Pennsylvania | Amanda Hicks - (Amanda.Hicks@pennmedicine.upenn.edu) Abigail Browngoehl - (Abigail.Browngoehl@Pennmedicine.upenn.edu) |
| NYU Langone New York, New York | |
| Stanford Neuroscience Health Center Palo Alto, California | |
| University of California, Irvine (UCI) Irvine, California | UCI Alpha Clinic - (alphaclinic@hs.uci.edu) |
| University of Pittsburgh Medical Center (UPMC) Pittsburgh, Pennsylvania | |
| University of Texas Southwest Medical Center Dallas, Texas | Markey McNutt, MD, PhD - (geneticsresearch@utsouthwestern.edu) Juana Luevao - (geneticsresearch@utsouthwestern.edu) |
| Virginia Commonwealth University (VCU) Richmond, Virginia |
Elucidating the Role of Cholinergic Degeneration in Cognitive Fluctuations in Lewy Body Dementia
Kara McHaney - Kara.McHaney@vcuhealth.org
NCT07284290
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Inclusion Criteria:
Arm 1:
* Age range: 50 ≤ age \< 90.
* Diagnosis of dementia with Lewy bodies (DLB), Parkinson disease dementia (PDD), Parkinson disease with Mild Cognitive Impairment (PD-MCI), Mild Cognitive Impairment with Lewy bodies (MCI-LB).
* DLB participants must fulfill criteria for clinically probable DLB based on the 2017 4th consensus report of the DLB consortium.
* PDD participants must meet criteria for clinically probable PD according to the MDS Clinical Diagnostic Criteria for Parkinson's Disease and must also meet criteria for probable PDD based on the 2007 Movement Disorders Society clinical diagnostic criteria.
* PD-MCI participants must meet criteria for clinically probable PD according to the MDS Clinical Diagnostic Criteria for Parkinson's Disease and meet criteria for Mild Cognitive Impairment on cognitive testing at screening.
* MCI-LB participants with must meet established research criteria.
* Capacity to provide informed consent or, if unable, availability of a legally authorized representative or guardian who can provide informed consent.
* Availability of informant (for participants meeting criteria for dementia).
* Ability and willingness to comply with the study-related procedures.
* Fluent in spoken and written English (due to cognitive testing)
Exclusion Criteria:
Arm 1
* History of cognitive disorder or psychiatric disorder other than that related to dementia with Lewy bodies or Parkinson disease dementia.
* History of deep brain stimulation or any neurosurgical procedure.
* History of structural brain disease or known significant cerebrovascular disease.
* History of seizures or epilepsy and/or use of sodium channel blockers, i.e. carbamazepine, oxcarbazepine, phenytoin, topiramate, lamotrigine, felbamate, zonisamide, rufinamide, lacosamide, eslicarbazepine, and valproate.
* Greater than two alcoholic drinks per day for men and one per day for women.
* Regular use of benzodiazepines or barbiturates. (If benzodiazepines are taken as needed only, these medications cannot be taken within 5 half-lives of screening visit or between screening visit and EEG.)
* Severe dementia (based on PI assessment of subject dependence level for instrumental activities of daily living)
* Any contraindication to brain MRI.
* Any medical condition that would interfere with ability to complete all study procedures.
* Participants must not be pregnant, planning to become pregnant, or father a child for the duration of the study
Inclusion Criteria:
Arm 2 (Cholinesterase inhibitor cohort) inclusion criteria:
* Completed Aim 1.
* Clinical diagnosis of LBD (DLB or PDD) with CF.
* Not taking a cholinesterase inhibitor and has not taken a cholinesterase inhibitor in the previous 90 days.
* Ability and willingness to comply with the ChEI Cohort procedures (including galantamine administration), or a caregiver willing and able to ensure compliance.
Exclusion Criteria:
Arm 2 (Cholinesterase inhibitor cohort) exclusion criteria:
* Severe hepatic impairment.
* Renal failure.
* Significant bradycardia (\<50 bpm) at screening or history of AV block.
* Any contraindication to galantamine administration based on PI discretion.
Inclusion criteria:
Arm 3 (Healthy Controls)
* Age range: 50 ≤ age \< 90.
* Healthy controls should not have any known neurologic conditions that could interfere with study procedures or results.
* Capacity to provide informed consent or, if unable, availability of a legally authorized representative or guardian who can provide informed consent.
* Availability of informant (for participants meeting criteria for dementia).
* Ability and willingness to comply with the study-related procedures.
* Fluent in spoken and written English (due to cognitive testing).
Exclusion Criteria:
Arm 3 (Healthy Controls)
* No History of cognitive disorder or psychiatric disorder other than that related to dementia with Lewy bodies or Parkinson disease dementia.
* No History of deep brain stimulation or any neurosurgical procedure.
* No History of structural brain disease or known significant cerebrovascular disease.
* No History of seizures or epilepsy and/or use of sodium channel blockers, i.e. carbamazepine, oxcarbazepine, phenytoin, topiramate, lamotrigine, felbamate, zonisamide, rufinamide, lacosamide, eslicarbazepine, and valproate.
* Any medical condition that would interfere with ability to complete all study procedures.
* Participants must not be pregnant, planning to become pregnant, or father a child for the duration of the study PROCEDURE: Syn-One skin biopsy, DIAGNOSTIC_TEST: Multi modal MRI, DIAGNOSTIC_TEST: Assessment of dynamic EEG features over 48-hour periods across all study aims, DIAGNOSTIC_TEST: Plasma biomarkers, DRUG: Galantamine HBr extended-release 8mg capsules (8mg ER).
Dementia With Lewy Bodies, Parkinson Disease Dementia, Healthy Controls
Parkinson Disease with Mild Cognitive Impairment, Mild Cognitive Impairment with Lewy Bodies
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| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia | Kara McHaney - (Kara.McHaney@vcuhealth.org) |
Phase 2 Study of SAT-3247 in Pediatric Ambulatory Patients (BASECAMP)
Satellos Medical Information - medicalinfo@satellos.com
NCT07287189
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Key
Inclusion Criteria:
* Has a definitive diagnosis of DMD based on documented clinical findings and prior genetic testing with a confirmed mutation in the DMD gene.
* Male DMD patients who are ambulatory and aged ≥ 7 to \< 10 years at the time of screening.
* Stable dose of systemic glucocorticoids (i.e., prednisolone, deflazacort, or vamorolone) according to the standard of care for ≥ 3 months prior to the Screening Visit and for the duration of the trial. Patients who are not receiving glucocorticosteroids are also eligible if stopped ≥ 3 months prior to the Screening Visit.
* Stable doses of prescription medicines including ACE inhibitors, β-blockers, and diuretics (excluding glucocorticosteroids) and over-the-counter medicines and/or herbal supplements for supportive care ≥ 1 month prior to the Screening Visit and for the duration of the trial.
* Participants that have previously received delandistrogene moxeparvovec (brand name Elevidys) either in a prior clinical trial or in the commercial setting \> 18 months prior to screening whose muscle function tests have stabilized or demonstrated decline ≥ 3 months prior to Screening, as determined by investigator and documented in chart notes, will be eligible.
* Participants that have previously received an exon skipper \> 6 months prior to Screening whose muscle function tests have stabilized or demonstrated decline ≥ 3 months prior to Screening, as determined by investigator and documented in chart notes, will be eligible.
* Participants receiving a stable dose of givinostat (brand name Duvyzat) for at least 18 months or longer prior to the Screening Visit will be eligible. Participants unable to tolerate givinostat who discontinued treatment before 18 months are eligible to enroll if date of last dose is ≥ 30 days from the Screening date. Givinostat should not be discontinued, if tolerated, to meet study entry criteria.
* Participants that have received prior treatment with an investigational gene therapy product (other than delandistrogene moxeparvovec) ≥ 24 months prior to the Screening Visit.
* If participating in a physical therapy/strength training regimen, must be stable for ≥ 2 months prior to the Screening Visit and for the duration of the trial.
Key Exclusion Criteria:
* Ambulatory patients expected to experience loss of ambulation within ≤ 12 months.
* Participants for whom MRI or open muscle biopsy are contraindicated.
* Evidence of significant hepatic dysfunction, defined as GLDH \> 2X upper limit of normal (ULN) at the Screening Visit.
* Impaired cardiac function defined as a left ventricular ejection fraction of \< 50% on screening cardiac assessments (echocardiogram or MRI) or evidence of symptomatic cardiomyopathy.
* A forced vital capacity \< 60% predicted at the Screening Visit.
* Ongoing participation in any other therapeutic clinical trial or follow-up study for a therapeutic intervention
* Consumption of grapefruit juice or grapefruit containing products
* Severe behavioural or cognitive problems that preclude participation in the study, in the opinion of the investigator.
Additional entry criteria will be reviewed with the clinical site investigator. DRUG: SAT-3247, DRUG: Placebo
Duchenne Muscular Dystrophy, Duchenne, DMD, Neuromuscular Diseases, Muscular Dystrophies
muscle regeneration, satellite cell, asymmetric division, dystrophin
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| Location | Contacts |
|---|---|
| Children's Hospital Eastern Ontario Ottawa, Ontario | Emilie Hill-Smith - (EHillSmith@cheo.on.ca) |
| Children's Hospital at Westmead Westmead, New South Wales | Natasha Edirisinghege - (Natasha.Edirisinghege@health.nsw.gov.au) |
| Clinic of Neurology and Psychiatry for Children and Youth Belgrade, | Ana Kosac - (kosacana@gmail.com) |
| Colorado Children's Aurora, Colorado | Nana Welnick - (Nanastasia.Welnick@childrenscolorado.org) |
| Great Ormond Street London, UK | Marta Zancolli - (m.zancolli@ucl.ac.uk) |
| Hospital Infantil i Hospital de la Dona Barcelona, | Juan José Palmí Perales - (juan.palmi@vhir.org) |
| Hospital Universitario Donostia Donostia / San Sebastian, | Josune Domínguez García - (JOSUNE.DOMINGUEZGARCIA@bio-gipuzkoa.eus) |
| Hospital Universitario y Politécnico La Fe Valencia, Valencia | Marta Campo Rodrigo - (marta_campo@iislafe.es) |
| Hôpital De La Citadelle (CHR) Liège, Liège | Laurie Medard - (laurie.medard@citadelle.be) |
| Instytut Centrum Zdrowia Matki Polki Lodz, | Joanna Wawrzynczak - (joanna.wawrzynczak@iczmp.edu.pl) |
| Kennedy Krieger Institute Baltimore, Maryland | Georgina D'Sanson - (dsanson@kennedykrieger.org) |
| Klinika Neurologii Rozwojowej Uniwersyteckie Gdansk, Pomeranian Voivodeship | Angelika Kamińska - (ankaminska@uck.gda.pl) |
| Lurie Children's Chicago, Illinois | Alka Maheshwari - (amaheshwari@luriechildrens.org) |
| Mother and Child Health Care Institute Belgrade, Serbia | Snezana Popovic - (andjajockic@gmail.com) |
| Nationwide Children's Hospital Columbus, Ohio | Jeremy Thompson - (jeremy.thompson@nationwidechildrens.org) |
| Royal Children's Hospital Melbourne Melbourne, Victoria | Ian Woodcock, MD - (neurology.department@rch.org.au) |
| Seattle Children's Seattle, Washington | Marissa Robertson - (marissa.robertson@seattlechildrens.org) |
| UMass Memorial Medical Center Worcester, Massachusetts | Sarah Figueira - (Sarah.figueira@umassmed.edu) |
| UZ Gent Ghent, | Julie Vancraeynest - (julie.vancraeynest@uzgent.be) |
| University Children's Clinic Tirsova Belgrade, Serbia | Raus Misela - (michelleraus@gmail.com) |
| University of California Los Angeles Los Angeles, California | Denisse Velazquez - (Denissevelazquez@mednet.ucla.edu) |
| University of Kansas Westwood, Kansas | Dan Le - (Hle10@kumc.edu) |
| University of Texas Southwestern Dallas, Texas | Holly Lawrence - (Holly.lawrence@utsouthwestern.edu) |
| Virginia Commonwealth University Richmond, Virginia | Andrea Jewell - (Andrea.jewell@vcuhealth.org) |
| Washington University St Louis, Missouri | Natalie Goedeker - (NeuromusclePediatricResearch@wustl.edu) |
Efficacy of Daromun Neoadjuvant Intratumoral Treatment in Clinical Stage IIIB/C/D Melanoma Patients (NeoDREAM)
Sheila Dakhel, PhD - sheila.dakhel@philogen.com
NCT03567889
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Inclusion Criteria:
• Histologically or cytologically confirmed diagnosis of clinical stage IIIB, IIIC, and IIID (AJCC 8th edition) locoregional melanoma that is eligible for complete surgical resection of all metastases (surgically resectable).
• Eligible subjects must have measurable disease and must be candidate for intralesional therapy with at least one injectable cutaneous, subcutaneous, or nodal melanoma lesion (≥ 10 mm in longest diameter) or with multiple injectable lesions that in aggregate have a longest diameter of ≥ 10 mm.
• Prior anti-tumor treatment for the primary melanoma lesion, including surgery and approved adjuvant treatments (e.g., radiotherapy, immune checkpoint inhibitors, BRAF/MEK inhibitors, etc.) is allowed. Before enrollment in the study, a wash-out period of 6 weeks is required and toxicities from prior treatments should be resumed to Grade ≤1.
• Males or females, age ≥ 18 years.
• ECOG Performance Status/WHO Performance Status ≤ 1.
• Life expectancy of \> 24 months.
• Absolute neutrophil count \> 1.5 x 109/L.
• Hemoglobin \> 9.0 g/dL.
• Platelets \> 100 x 109/L.
• Total bilirubin ≤ 30 μmol/L (or ≤ 2.0 mg/dl).
• ALT and AST ≤ 2.5 x the upper limit of normal (ULN).
• Serum creatinine \< 1.5 x ULN.
• LDH serum level ≤ 1.5 x ULN.
• Documented negative test for HIV, HBV and HCV. For HBV serology, the determination of HBsAg and anti-HBcAg Ab is required. In patients with serology documenting previous exposure to HBV (i.e. positive anti-HBsAg with not vaccination and/or positive anti-HBcAg Ab), negative serum HBV-DNA is also required.
• All acute toxic effects (excluding alopecia) of any prior therapy must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (v4.03) Grade ≤ 1 unless otherwise specified above.
• All women of childbearing potential (WOCBP) must have negative pregnancy test results at the screening. WOCBP must be using, from the screening to three months following the last study drug administration, highly effective contraception methods. WOCBP and effective contraception methods are defined by the "Recommendations for contraception and pregnancy testing in clinical trials" issued by the Head of Medicine Agencies' Clinical Trial Facilitation Group and which include, for instance, progesterone-only or combined (estrogen- and progesterone-containing) hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone-releasing systems, bilateral tubal occlusion, vasectomized partner or sexual abstinence. Pregnancy test will be repeated at the safety visit (only WOCBP and only for patients in Arm 1).
• Male patients with WOCBP partners must agree to use simultaneously two acceptable methods of contraception (i.e. spermicidal gel plus condom) from the screening to three months following the last study drug administration.
• Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
• Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures. Exclusion Criteria
• Uveal melanoma or mucosal melanoma
• Evidence of distant metastases at screening.
• Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except: cervical carcinoma in situ, curatively treated basal cell carcinoma, superficial bladder tumors (Ta, Tis \& T1), second primary melanoma in situ or any cancer curatively treated ≥ 5 years prior to study entry.
• Presence of active infections (e.g. requiring antimicrobial therapy) or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study.
• History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris.
• Inadequately controlled cardiac arrhythmias including atrial fibrillation.
• Heart insufficiency (\> Grade II, New York Heart Association (NYHA) criteria).
• LVEF ≤ 50% and/or abnormalities observed during baseline ECG and Echocardiogram investigations that are considered as clinically significant by the investigator.
• Uncontrolled hypertension.
• Ischemic peripheral vascular disease (Grade IIb-IV).
• Severe diabetic retinopathy.
• Active autoimmune disease.
• History of organ allograft or stem cell transplantation.
• Recovery from major trauma including surgery within 4 weeks prior to enrollment.
• Known history of allergy to IL2, TNF, or other human proteins/peptides/antibodies or any other constituent of the product.
• Breast feeding female.
• Anti-tumor therapy (except small surgery) within 4 weeks before enrollment.
• Previous in vivo exposure to monoclonal antibodies for biological therapy in the 6 weeks before enrollment.
• Planned administration of growth factors or immunomodulatory agents within 7 days before enrollment.
• Patient requiring or taking corticosteroids or other immunosuppressant drugs on a long-term basis will be evaluated case by case with the Sponsor for inclusion/exclusion in the study. Limited use of corticosteroids to treat or prevent acute hypersensitivity reactions is not considered an exclusion criteria.
• Any conditions that in the opinion of the investigator could hamper compliance with the study protocol.
• Previous enrolment and randomization in the same study.
DRUG: Daromun, PROCEDURE: Surgery, DRUG: Adjuvant therapy
Melanoma Stage IIIB, Melanoma Stage IIIC, Melanoma Stage IIID
Melanoma Stage IIIB, Melanoma Stage IIIC, Melanoma Stage IIID
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Show 37 locations
Study Locations
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| Location | Contacts |
|---|---|
| Ambulatory Care Center at NYC Langarone Health New York, New York | |
| Duke University Medical Center - Duke Cancer Center Durham, North Carolina | |
| El Hospital Universitario De Gran Canaria Dr. Negrin Las Palmas de Gran Canaria, Canarie | Elena Castro Gonzalez - (elenan.castrogonzalez@gmail.com) |
| Fir Huvh Fundacio Institut De Recerca Hospital Universitari Vall De Hebron Barcelona, Barcelona | Eva Muñoz Couselo - (emunoz@vhio.net) |
| Fox Chase Cancer Center 333 Cottman Avenue Philadelphia, Pennsylvania | |
| Fundacion Onkologikoa Fundazioa Donostia / San Sebastian, Gipuzkoa | Karmele Mujika Eizmendi - (kmujika@onkologikoa.org) |
| Hospital Clinic Barcelona Barcelona, | Josep Malvehy Guilera - (jmalvehy@clinic.cat) |
| Hospital Clinico Universitario Virgen de la Arrixaca El Palmar, Murcia | Pablo Cerezuela Fuentes - (pcerezuelaf@seom.org) |
| Hospital De La Santa Creu I Sant Pau Barcelona, | Margarita Majem Tarruella - (MMajem@santpau.cat) |
| Hospital General Universitario de Valencia Valencia, | Alfonso Berrocal Jaime - (berrocal.alf@gmail.com) |
| Hospital Universitari Germans Trias i Pujol Barcelona, | José Luis Manzano Mozo - (jmanzano@iconcologia.net) |
| Hospital Universitario 12 de Octubre Madrid, | Pedro Luis Ortiz Romero - (pablo.ortiz@salud.madrid.org) |
| Hospital Universitario Regional de Málaga Málaga, Malaga | Elisabeth Pérez Ruiz - (elisaonco@gmail.com) |
| Hospital Universitario Virgen De La Macarena Seville, | |
| Huntsman Cancer Institute, University of Utah 2000 Circle of Hope Salt Lake City, UT, Utah | |
| Hôpitaux Universitaires de Genève Geneva, | |
| Insel Gruppe AG Bern, | |
| Istituto Oncologico della Svizzera Italiana Bellinzona, | |
| Kantonsspital St.Gallen Sankt Gallen, Canton of St. Gallen | |
| MD Anderson Cancer Center Houston, Texas | |
| Mayo Clinic Rochester, Minnesota | |
| Mayo Clinic Hospital Phoenix, Arizona | |
| Memorial Sloan Kettering Cancer Center - Main Campus New York, New York | |
| Moffitt Cancer Center Tampa, Florida | |
| Ohio State University Wexner Medical Center Colombus, Ohio | |
| Penn State Cancer Institute Hershey, Pennsylvania | |
| Rush University Medical Center Chicago, Illinois | |
| Rutgers Cancer Institute, 195 Little Albany Street New Brunswick, New Jersey | |
| St. Luke's Cancer Center, Clinical Trial, 3rd floor, 1600 St. Luke's Blvd. Easton, Pennsylvania | |
| The University of Texas M.D. Anderson Cancer Center Houston, Texas | |
| UC Irvine Health-Chao Family Comprehensive Cancer Center Orange, California | |
| UC San Diego Moores Cancer Center La Jolla, California | |
| University of Iowa Hospitals and Clinics Iowa City, Iowa | |
| Universitätsspital Basel Basel, | |
| Universitätsspital Zürich (USZ) Zurich, Canton of Zurich | |
| VCU - McGlothlin Medical Education Center Richmond, Virginia | |
| Winship Cancer Institute, Emory University Atlanta, Georgia |
Testing the Addition of an Anti-Cancer Drug, Cabozantinib to the Immunotherapy Drug Cemiplimab (REGN2810), in Adolescents and Adults With Advanced Adrenocortical Cancer
ctrrecruit@vcu.edu
NCT06900595
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Inclusion Criteria:
* STEP 1: Patients must have documented histologically or cytologically confirmed adrenocortical carcinoma
* STEP 1: Locally advanced unresectable or recurrent/metastatic disease
* STEP 1: Evaluable disease as defined by RECIST v 1.1
* STEP 1: Up to 3 prior lines of systemic therapy will be allowed in the unresectable/recurrent/metastatic setting. Treatment naïve patients will be allowed.
* Note: Combination etoposide, doxorubicin, cisplatin, and mitotane (EDP-M) is considered 1 line of therapy. For patients who received mitotane ≤ 6 months prior to registration, mitotane should be discontinued 28 days prior to study registration AND a mitotane level must be documented to be \< 2 mg/L prior to registration. Patients who have received mitotane within 6 months of enrollment and who have mitotane levels ≥ 2 mg/L will not be eligible to enroll
* STEP 1: No prior treatment with cabozantinib or other cMET inhibitors, or anti-CTLA-4, or anti-PD-1/PD-L1 therapy
* STEP 1: Prior external beam radiation therapy (any area radiated within a month prior to study registration cannot be used as an index lesion and only growth outside of the radiation field can be considered for disease progression), systemic cytotoxic chemotherapy, targeted therapies will be allowed, as long as not administered within 14 days before study registration, and provided any acute treatment-related associated toxicities have recovered to ≤ grade 1 except for alopecia, peripheral neuropathy or other residual toxicities that are not deemed clinically significant
* STEP 1: Potential trial participants should have recovered from clinically significant adverse events, and wound healing is clinically adequate of their most recent therapy/intervention prior to enrollment
* STEP 1: Age 12 years and above; and BSA ≥ 1.2m\^2
* STEP 1:
* Eastern Cooperative Oncology Group (ECOG) performance 0 - 2 (age 18 and above); or
* Patients 12 to \<16 years of age will be assessed by the Lansky scale and should have a score ≥ 50; or
* Patients ≥ 16 to \<18 years of age will be assessed by the Karnofsky scale, and should have a score ≥ 50
* STEP 1: Absolute neutrophil count (ANC) ≥ 1,000/mcL without colony stimulating factor support within 2 weeks prior
* Transfusion support is allowed if ≥ 7 days from obtaining required initial laboratory
* STEP 1: Platelet count ≥ 100,000/mcL
* Transfusion support is allowed if ≥ 7 days from obtaining required initial laboratory
* STEP 1: Hemoglobin ≥ 8 g/dL
* Transfusion support is allowed if ≥ 7 days from obtaining required initial laboratory
* STEP 1: Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
* For patients with known Gilbert's disease, bilirubin ≤ 3 mg/dL
* STEP 1: Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/ alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3 x upper limit of normal (ULN)
* STEP 1: Random Urine Creatinine Ratio (UPCR) ≤ 1 mg/mg
* STEP 1: Calculated (Calc.) creatinine clearance ≥ 30 mL/min
* STEP 1: Mitotane level \< 2 mg/L\*
* Only applicable for patients who have received mitotane ≤ 6 months prior to registration
* STEP 1: Must have assessment of adrenal steroid production within 3 months prior to registration as patients will be stratified based on corticosteroid production
* Patients will be classified as corticosteroid producing if random plasma adrenocorticotropic hormone (ACTH) is \< 20 pg/mL plus random serum cortisol is \> 20 mcg/dL in the absence of anti-cortisol therapy. Patients already on anti-cortisol therapy will be classified as having corticosteroid producing tumors regardless of their plasma ACTH and serum cortisol levels, as these levels can be affected by anti-cortisol therapy
* STEP 1: Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects based on animal reproduction studies. Therefore, for women of childbearing potential only, a negative urine or serum pregnancy test, per institution standard, done ≤ 14 days prior to registration is required
* STEP 1: 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 within 28 days of registration. To be eligible for this trial, patients should be class II or better
* STEP 1: No known history of congenital long QT syndrome
* STEP 1: No known history of myocarditis
* STEP 1: No myocardial infarction (MI) or unstable angina within 6 months of registration
* STEP 1: No clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding within 6 months of registration including, but not limited to: active peptic ulcer, known endoluminal metastatic lesion(s) with history of bleeding, inflammatory bowel disease, or other gastrointestinal conditions with increased risk of perforation
* STEP 1: No history of gastrointestinal (GI) perforation within 6 months of registration
* STEP 1: No known tumor with invasion into the GI tract from the outside causing increased risk of perforation or bleeding within 28 days of registration
* STEP 1: No current radiologic or clinical evidence of pancreatitis
* STEP 1: No history of clinically significant non-healing wounds or ulcers within 28 days of registration
* STEP 1: No uncontrolled hypertension within 14 days of registration (defined as sustained systolic blood pressure (SBP) ≥ 150 mmHg and/or diastolic blood pressure (DBP) ≥ 90 mmHg despite optimal medical management)
* STEP 1: No known endobronchial lesions involving the main or lobar bronchi and/or lesions infiltrating major pulmonary vessels that increase the risk of pulmonary hemorrhage. (CT with contrast is recommended to evaluate such lesions.). No hemoptysis greater than ½ teaspoon (2.5 mL) or any other signs of pulmonary hemorrhage within the 3 months prior to registration
* STEP 1: No history of pneumonitis
* STEP 1: No known tumor invading or encasing any major blood vessels
* STEP 1: No history of fracture within 28 days of registration
* STEP 1: No known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks after major surgery (e.g., removal or biopsy of brain metastasis) before registration. Eligible patients must be neurologically asymptomatic and without corticosteroid treatment at the time of the start of study treatment
* STEP 1: Major surgery (e.g., laparoscopic nephrectomy, GI surgery, within 2 weeks before registration. Minor surgeries within 10 days before registration. Patients with clinically relevant ongoing complications from prior surgery are not eligible
* STEP 1: Verbalizes the ability to swallow oral tablet formulation
* STEP 1: No history of allergic reaction attributed to compounds of similar chemical or biological composition to cabozantinib
* STEP 1: 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 will be eligible
* STEP 1: HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial
* STEP 1: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
* STEP 1: 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
* STEP 1: No active autoimmune disease: or history of autoimmune disease that might recur, and which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids. These include but are not limited to patients with a history of:
* immune related neurologic disease,
* multiple sclerosis,
* autoimmune (demyelinating) neuropathy,
* Guillain-Barre syndrome (GBS), myasthenia gravis,
* systemic autoimmune disease such as systemic lupus erythematosus (SLE),
* connective tissue diseases,
* scleroderma, inflammatory bowel disease (IBD),
* Crohn's, ulcerative colitis,
* patients with a history of toxic epidermal necrolysis (TEN),
* Stevens-Johnson syndrome, or phospholipid syndrome should be excluded because of the risk of recurrence or exacerbation of disease,
* Patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible,
* Patients with rheumatoid arthritis and other arthropathies, Sjögren's syndrome, and psoriasis controlled with topical medication and patients with only positive serology, such as antinuclear antibodies (ANA) or anti-thyroid antibodies, should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible
* STEP 1: No steroid use \> 10 mg prednisone equivalents daily. A brief course of corticosteroids for prophylaxis or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted, as is steroid pre-medication for contrast allergy
* STEP 1: Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study
* STEP 1: Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment
* STEP 1: Herbal supplements and traditional Chinese medicines are not allowed
* STEP 1: Active treatment with coumarin agents (e.g., warfarin), direct thrombin inhibitors (e.g., dabigatran), direct Xa inhibitor betrixaban or platelet inhibitors (e.g., clopidogrel) within 5 days of registration. Allowed use of anticoagulants include: 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, apixaban. Also use of anticoagulants is allowed in patients with known brain metastases who are on a stable dose of the anticoagulant for at least 1 week prior to registration without clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor
* STEP 2 (CROSSOVER): Patients must have demonstrated radiographic progression of disease on cabozantinib monotherapy (Arm A) per RECIST version 1.1 criteria
* Patients must cross-over to Arm C within 4 weeks (+/- 1 week) after radiographic documented progression and do not need to have a repeat radiographic assessment prior to starting cabozantinib and cemiplimab (REGN2810). The progression CT may serve as eligibility for crossover and as the baseline tumor measurement
* STEP 2 (CROSSOVER): Patients that were discontinued on cabozantinib, or currently meet criteria for discontinuation of cabozantinib due to toxicity are not eligible to cross-over.
* Note: Patients who underwent dose reduction of cabozantinib during treatment on Arm A will not re-escalate dose at or after cross-over to Cabo-Cemiplimab (REGN2810) (Arm B)
* STEP 2 (CROSSOVER): Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative serum or urine pregnancy test done ≤ 14 days prior to re-registration is required PROCEDURE: Biospecimen Collection, DRUG: Cabozantinib, BIOLOGICAL: Cemiplimab, PROCEDURE: Computed Tomography, PROCEDURE: Magnetic Resonance Imaging
Locally Advanced Adrenal Cortical Carcinoma, Metastatic Adrenal Cortical Carcinoma, Recurrent Adrenal Cortical Carcinoma, Stage III Adrenal Cortical Carcinoma AJCC v8, Stage IV Adrenal Cortical Carcinoma AJCC v8, Unresectable Adrenal Cortical Carcinoma
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Show 71 locations
Study Locations
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| Location | Contacts |
|---|---|
| BI-LO Charities Children's Cancer Center Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Broadlawns Medical Center Des Moines, Iowa | |
| 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) |
| 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 Mercy Hospitals and Clinics Kansas City, Missouri | Site Public Contact - (COGResearchGroup@cmh.edu) |
| CoxHealth South Hospital Springfield, Missouri | |
| Dana-Farber Cancer Institute Boston, Massachusetts | |
| Dell Children's Medical Center of Central Texas Austin, Texas | Site Public Contact - (TXAUS-DL-SFCHemonc.research@ascension.org) |
| Duke Cancer Center Cary Cary, North Carolina | Site Public Contact - (NCTNStudyTeam@dm.duke.edu) |
| Duke Cancer Center Raleigh Raleigh, North Carolina | Site Public Contact - (NCTNStudyTeam@dm.duke.edu) |
| Duke University Medical Center Durham, North Carolina | |
| Fred Hutchinson Cancer Center Seattle, Washington | |
| Iowa Methodist Medical Center Des Moines, Iowa | |
| Lurie Children's Hospital-Chicago Chicago, Illinois | |
| 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 Medical Center - Des Moines Des Moines, Iowa | |
| Nebraska Medicine-Bellevue Bellevue, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| Nebraska Medicine-Village Pointe Omaha, Nebraska | |
| 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) |
| Prisma Health Cancer Institute - Butternut Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Easley Easley, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Eastside Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Faris Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Greer Greer, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Seneca Seneca, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Spartanburg Boiling Springs, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Richland Hospital Columbia, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Saint Anthony Regional Hospital Carroll, Iowa | Site Public Contact - (sbenson@iora.org) |
| Saint Jude Children's Research Hospital Memphis, Tennessee | Site Public Contact - (referralinfo@stjude.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) |
| UC San Diego Moores Cancer Center La Jolla, California | Site Public Contact - (cancercto@ucsd.edu) |
| UCHealth University of Colorado Hospital Aurora, Colorado | |
| UI Health Care Mission Cancer and Blood - Ankeny Clinic Ankeny, Iowa | |
| UI Health Care Mission Cancer and Blood - Des Moines Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - Laurel Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - Waukee Clinic Waukee, Iowa | |
| UI Health Care Mission Cancer and Blood - West Des Moines Clinic Clive, Iowa | |
| UI Healthcare Mission Cancer and Blood - Fort Dodge Fort Dodge, Iowa | Site Public Contact - (trials@missioncancer.com) |
| University of Michigan Rogel Cancer Center Ann Arbor, Michigan | Site Public Contact - (CancerAnswerLine@med.umich.edu) |
| University of Nebraska Medical Center Omaha, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Texas Health Science Center at San Antonio San Antonio, Texas | Site Public Contact - (phoresearchoffice@uthscsa.edu) |
| 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) |
| Valley Children's Hospital Madera, California | Site Public Contact - (Research@valleychildrens.org) |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
Combining Immunotherapy and Radiation Therapy to Help Patients Avoid Bladder Removal After Treatment Shrinks Muscle Invasive Bladder Cancer, BRIGHT Trial
ctrrecruit@vcu.edu
NCT07061964
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Inclusion Criteria:
* Participants must have histologic evidence of cT2-T4aN0M0 muscle invasive urothelial carcinoma of the bladder within 180 days prior to starting neoadjuvant therapy (NAT)
* Participants must have had CT chest/abdomen/pelvis (C/A/P), MRI C/A/P or PET within 60 days prior to starting NAT to determine cT2-T4aN0M0
* Participants must have undergone TURBT with biopsy of areas of prior disease and systematic biopsies (left and right lateral, dome, posterior wall and trigone) and radiologic staging showing clinically T0-T1 disease within 60 days after the last dose of NAT. At least 4 out of 5 systematic biopsies must be performed
* NOTE: This TURBT must be within 90 days prior to registration. Registration must be within 90 days after the last dose of NAT
* Participants must have imaging of the chest, abdomen, and pelvis performed using CT or MRI preferably with contrast. Fludeoxyglucose F-18 (FDG) PET-CT can also be used for staging. If FDG PET-CT is used, then it is at the discretion of the investigator if they want to additionally obtain diagnostic CT or MRI with contrast within 60 days after the last dose of NAT
* Participants with lymph nodes ≥ 1.0 cm in the shortest cross-sectional diameter on imaging (CT or MRI of abdomen and pelvis) after completion of NAT must have a PET-CT within 70 days prior to registration. A biopsy in the setting of negative PET-CT is not required unless there is strong clinical suspicion for nodal involvement with tumor. Participants with a positive PET are deemed ineligible unless a biopsy is performed and shows no evidence of tumor involvement
* NOTE: For questions regarding the above eligibility criteria, please contact the study chairs in addition to the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC)
* Participants must not have evidence of ≥ T2, or N1-3, or M1 disease after NAT
* Participants must not have the presence of small cell, neuroendocrine carcinoma, plasmacytoid variants on any pathology
* Participants must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder within 24 months prior to registration except Ta/T1/carcinoma in situ (CIS) of the upper urinary tract, including renal pelvis or ureter if the participant underwent complete nephroureterectomy
* NOTE: Participants with mixed variant histology will be eligible for the trial if the majority (\> 50%) of the tumor is urothelial cell carcinoma
* Participants will be allowed to continue PD-1/L-1 inhibitor therapy received as part of standard of care neoadjuvant therapy while they undergo pre-registration assessments (TURBT and imaging)
* Participants must have received at least 3 and no more than 6 cycles of Food and Drug Administration (FDA) approved NAT for MIBC. These include cisplatin-based combination chemotherapy (e.g. cisplatin and gemcitabine \[GC\] with or without PD-1/L1 inhibitors) dose dense or accelerated methotrexate, vinblastine, doxorubicin and cisplatin (MVAC) or enfortumab vedotin with PD-1/L1 inhibitor
* Participants must not have had anti-PD-1, anti PD-L1, anti PD-L2 or anti-CTLA4 antibody, any other antibody or drug targeting T-cell co-stimulation, enfortumab vedotin, or any other drug targeting nectin-4 other than for neoadjuvant treatment for MIBC
* NOTE: Prior intravesical immunotherapy or chemotherapy for non-muscle invasive disease is allowed
* Participants must not have had prior pelvic radiotherapy
* Participants must not have received a live attenuated vaccination within 28 days prior to registration
* Participants with conditions requiring immunosuppressive doses of steroids (\> 10 mg/day of prednisone or equivalent) or other immunosuppressive medications must not be taking steroids at time of trial registration
* Participants must be ≥ 18 years old at the time of registration
* Participants must have Zubrod performance status of 0-2
* Participants must have a complete medical history and physical exam within 28 days prior to registration
* Leukocytes ≥ 3 x 10\^3/uL (within 28 days prior to registration)
* Absolute neutrophil count ≥ 1.5 x 10\^3/uL (within 28 days prior to registration)
* Platelets ≥ 100 x 10\^3/uL (within 28 days prior to registration)
* Total bilirubin ≤ institutional upper limit of normal (ULN) unless history of Gilbert's disease (within 28 days prior to registration)
* Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN
* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 x institutional ULN (within 28 days prior to registration)
* Participants must have a creatinine ≤ the institutional (I)ULN OR measured OR calculated creatinine clearance ≥ 40 mL/min using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to registration
* Participants 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
* Participants with a history of human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration
* For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured (defined as undetectable HCV viral load)
* 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
* Participants must not be pregnant or nursing (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 be offered the opportunity to participate in specimen banking
* Participants who can complete the PRO-CTCAE questionnaire in English or Spanish will be offered the opportunity to participate in the optional patient-reported outcome study
* NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the 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
* For 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 PROCEDURE: Biospecimen Collection, PROCEDURE: Computed Tomography, PROCEDURE: Cystoscopy, PROCEDURE: Magnetic Resonance Imaging, BIOLOGICAL: Pembrolizumab, RADIATION: Photon Beam Radiation Therapy, PROCEDURE: Positron Emission Tomography, OTHER: Questionnaire Administration, PROCEDURE: Transurethral Resection of Bladder Tumor
Muscle Invasive Bladder Urothelial Carcinoma, Stage II Bladder Cancer AJCC v8, Stage IIIA Bladder Cancer AJCC v8
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Study Locations
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| Location | Contacts |
|---|---|
| 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 MD Anderson Cancer Center Gilbert, Arizona | |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas | Site Public Contact - (burton@bcm.edu) |
| Billings Clinic Cancer Center Billings, Montana | Site Public Contact - (research@billingsclinic.org) |
| CTCA at Southeastern Regional Medical Center Newnan, Georgia | |
| Camden Clark Medical Center Parkersburg, West Virginia | Site Public Contact - (cancertrialsinfo@hsc.wvu.edu) |
| 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) |
| 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) |
| Cedars-Sinai Cancer - Tarzana Tarzana, California | |
| Cedars-Sinai Medical Center Los Angeles, California | Site Public Contact - (Cancer.trial.info@cshs.org) |
| City of Hope Antelope Valley Lancaster, California | Site Public Contact - (becomingapatient@coh.org) |
| City of Hope Comprehensive Cancer Center Duarte, California | Site Public Contact - (becomingapatient@coh.org) |
| City of Hope Corona Corona, California | Site Public Contact - (becomingapatient@coh.org) |
| City of Hope South Pasadena South Pasadena, California | Site Public Contact - (becomingapatient@coh.org) |
| City of Hope Upland Upland, California | Site Public Contact - (becomingapatient@coh.org) |
| City of Hope at Irvine Lennar Irvine, California | |
| Community Medical Center Scranton, Pennsylvania | |
| Crossroads Cancer Center Effingham, Illinois | |
| Dana-Farber Cancer Institute Boston, Massachusetts | |
| Dartmouth Cancer Center - North Saint Johnsbury, Vermont | Site Public Contact - (cancer.research.nurse@hitchcock.org) |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire | Site Public Contact - (cancer.research.nurse@dartmouth.edu) |
| Decatur Memorial Hospital Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Fairview Southdale Hospital Edina, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| HSHS Saint Elizabeth's Hospital O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Highlands Oncology Group Springdale, Arkansas | Site Public Contact - (research@hogonc.com) |
| Highlands Oncology Group - Fayetteville Fayetteville, Arkansas | Site Public Contact - (research@hogonc.com) |
| Highlands Oncology Group - Rogers Rogers, Arkansas | Site Public Contact - (research@hogonc.com) |
| Hunterdon Medical Center Flemington, New Jersey | |
| Huntsman Cancer Institute/University of Utah Salt Lake City, Utah | Site Public Contact - (cancerinfo@hci.utah.edu) |
| 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 | |
| Jefferson Cherry Hill Hospital Cherry Hill, New Jersey | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Jersey City Medical Center Jersey City, New Jersey | Site Public Contact - (ctsucontact@westat.com) |
| Kootenai Clinic Cancer Services - Post Falls Post Falls, Idaho | |
| Kootenai Clinic Cancer Services - Sandpoint Sandpoint, Idaho | |
| Kootenai Health - Coeur d'Alene Coeur d'Alene, Idaho | |
| Los Angeles General Medical Center Los Angeles, California | Site Public Contact - (uscnorrisinfo@med.usc.edu) |
| Mary Greeley Medical Center Ames, Iowa | |
| Mayo Clinic Hospital in Arizona Phoenix, Arizona | |
| Mayo Clinic in Florida Jacksonville, Florida | |
| 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 | |
| Mercy Cancer Center-West Lakes Clive, Iowa | |
| Mercy Medical Center - Des Moines Des Moines, Iowa | |
| Moffitt Cancer Center Tampa, Florida | Site Public Contact - (ClinicalTrials@moffitt.org) |
| Moffitt Cancer Center - McKinley Campus Tampa, Florida | Site Public Contact - (ClinicalTrials@moffitt.org) |
| Moffitt Cancer Center at SouthShore Ruskin, Florida | Site Public Contact - (ClinicalTrials@moffitt.org) |
| Moffitt Cancer Center at Wesley Chapel Wesley Chapel, Florida | Site Public Contact - (ClinicalTrials@moffitt.org) |
| Moffitt Cancer Center-International Plaza Tampa, Florida | Site Public Contact - (ClinicalTrials@moffitt.org) |
| NYP/Weill Cornell Medical Center New York, New York | |
| NorthShore University HealthSystem-Evanston Hospital Evanston, Illinois | |
| NorthShore University HealthSystem-Glenbrook Hospital Glenview, Illinois | |
| NorthShore University HealthSystem-Highland Park Hospital Highland Park, Illinois | |
| Northwestern Medicine Cancer Center Delnor Geneva, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Cancer Center Kishwaukee DeKalb, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Cancer Center Warrenville Warrenville, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Glenview Outpatient Center Glenview, Illinois | |
| Northwestern Medicine Grayslake Outpatient Center Grayslake, Illinois | |
| Northwestern Medicine Lake Forest Hospital Lake Forest, Illinois | Site Public Contact - (cancertrials@northwestern.edu) |
| Northwestern Medicine Oak Brook Oak Brook, Illinois | Site Public Contact - (nctnprogram_rhlccc@northwestern.edu) |
| Northwestern Medicine Orland Park Orland Park, Illinois | Site Public Contact - (nctnprogram_rhlccc@northwestern.edu) |
| Northwestern University Chicago, Illinois | Site Public Contact - (cancer@northwestern.edu) |
| OSF Saint Francis Medical Center Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| OSF Saint Francis Radiation Oncology at Peoria Cancer Center Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| OSF Saint Joseph Medical Center Bloomington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Ochsner Medical Center Jefferson New Orleans, Louisiana | Site Public Contact - (Elisemarie.curry@ochsner.org) |
| Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Parkland Memorial Hospital Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| Poudre Valley Hospital Fort Collins, Colorado | |
| Reiman Cancer Center-Ascension Wisconsin Health Center-Rawson Franklin, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Rush-Copley Medical Center Aurora, Illinois | Site Public Contact - (RCMC_Cancer_Research@rush.edu) |
| Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey | |
| Saint Barnabas Medical Center Livingston, New Jersey | Site Public Contact - (joanne.loeb@rwjbh.org) |
| Saint Francis Medical Center Cape Girardeau, Missouri | Site Public Contact - (sfmc@sfmc.net) |
| Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Sheboygan Sheboygan, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Sanford 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) |
| Scott and White Memorial Hospital Temple, Texas | |
| Shaw Cancer Center Edwards, Colorado | |
| Sidney Kimmel Cancer Center Washington Township Sewell, New Jersey | Site Public Contact - (ONCTrialNow@jefferson.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 | |
| Swedish Medical Center-First Hill Seattle, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| The Iowa Clinic PC West Des Moines, Iowa | |
| The James Graham Brown Cancer Center at University of Louisville Louisville, Kentucky | |
| The New York Hospital Medical Center of Queens Flushing, New York | Site Public Contact - (ctsucontact@westat.com) |
| The West Clinic - Wolf River Germantown, Tennessee | Site Public Contact - (afletcher@westclinic.com) |
| Thomas Jefferson University Hospital Philadelphia, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Tower Cancer Research Foundation Beverly Hills, California | Site Public Contact - (towercancerresearch@toweroncology.com) |
| Tufts Medical Center Boston, Massachusetts | Site Public Contact - (ContactUsCancerCenter@TuftsMedicalCenter.org) |
| UCHealth - Cherry Creek Denver, Colorado | Site Public Contact - (protocols@swog.org) |
| UCHealth Greeley Hospital Greeley, Colorado | Site Public Contact - (protocols@swog.org) |
| UCHealth Highlands Ranch Hospital Highlands Ranch, Colorado | |
| UCHealth Lone Tree Health Center Lone Tree, Colorado | Site Public Contact - (protocols@swog.org) |
| UCHealth University of Colorado Hospital Aurora, Colorado | |
| UI Health Care Mission Cancer and Blood - Ankeny Clinic Ankeny, Iowa | |
| UI Health Care Mission Cancer and Blood - Des Moines Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - Laurel Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - Waukee Clinic Waukee, Iowa | |
| UI Health Care Mission Cancer and Blood - West Des Moines Clinic Clive, Iowa | |
| UMass Memorial Medical Center - University Campus Worcester, Massachusetts | Site Public Contact - (cancer.research@umassmed.edu) |
| USC / Norris Comprehensive Cancer Center Los Angeles, California | |
| 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 Medical Center New Orleans New Orleans, Louisiana | Site Public Contact - (emede1@lsuhsc.edu) |
| University of Alabama at Birmingham Cancer Center Birmingham, Alabama | Site Public Contact - (gingerreeves@uabmc.edu) |
| University of California Davis Comprehensive Cancer Center Sacramento, California | |
| University of Cincinnati Cancer Center-UC Medical Center Cincinnati, Ohio | Site Public Contact - (cancer@uchealth.com) |
| University of Cincinnati Cancer Center-West Chester West Chester, Ohio | Site Public Contact - (cancer@uchealth.com) |
| University of Kentucky/Markey Cancer Center Lexington, Kentucky | |
| University of Mississippi Medical Center Jackson, Mississippi | |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Pennsylvania/Abramson Cancer Center Philadelphia, Pennsylvania | Site Public Contact - (PMCancerResearch@pennmedicine.upenn.edu) |
| University of Texas Health Science Center at San Antonio San Antonio, Texas | Site Public Contact - (phoresearchoffice@uthscsa.edu) |
| UofL Health Medical Center Northeast Louisville, Kentucky | Site Public Contact - (ctoinfo@louisville.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) |
| West Virginia University Healthcare Morgantown, West Virginia | Site Public Contact - (cancertrialsinfo@hsc.wvu.edu) |
A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal-DR) in Participants With Newly Diagnosed Multiple Myeloma (MajesTEC-7)
Study Contact - Participate-In-This-Study1@its.jnj.com
NCT05552222
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Inclusion Criteria:
* Have a diagnosis of multiple myeloma according to the International Myeloma Working Group (IMWG) diagnostic criteria
* Be newly diagnosed and not considered a candidate for high-dose chemotherapy with autologous stem cell transplant (ASCT) due to: ineligible due to advanced age OR; ineligible due to the presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT OR; deferral of high-dose chemotherapy with ASCT as initial treatment
* Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
* A participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment
* A participant must agree not to plan to father a child while enrolled in this study or within 100 days after the last dose of study treatment
Exclusion Criteria:
* Received any prior therapy for multiple myeloma or smoldering myeloma other than a short course of corticosteroids (not to exceed total of 160 milligrams \[mg\] dexamethasone or equivalent). In addition, received a cumulative dose of systemic corticosteroids equivalent to greater than or equals to (\>=) 20 mg of dexamethasone within 14 days before randomization
* Had plasmapheresis within 28 days of randomization
* Had a stroke, transient ischemic attack, or seizure within 6 months prior to randomization
* Known allergies, hypersensitivity, or intolerance to teclistamab or talquetamab excipients
* Known contraindications to the use of daratumumab or lenalidomide per local prescribing information
* Myeloma Frailty Index of \>=2 with the exception of participants who have a score of 2 based on age alone DRUG: Teclistamab, DRUG: Daratumumab, DRUG: Lenalidomide, DRUG: Dexamethasone, DRUG: Talquetamab
Multiple Myeloma
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Show 270 locations
Study Locations
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| Location | Contacts |
|---|---|
| A O U Sant Orsola Malpighi Bologna, | |
| ASST Papa Giovanni XXIII Bergamo Bergamo, | |
| AZ Groeninge Kortrijk, | |
| Aalborg University Hospital Aalborg, | |
| Addenbrooke's Hospital Cambridge, | |
| AdventHealth Medical Group Blood & Marrow Transplant at Orlando Orlando, Florida | |
| Alexander T. Augusta Military Medical Center Fort Belvoir, Virginia | |
| Alexandra General Hospital of Athens Athens, Attikí | |
| Allegheny Health Network Pittsburgh, Pennsylvania | |
| Ankara Universitesi Tip Fakultesi Cebeci Arastirma ve Uygulama Hastanesi Ankara, | |
| Arthur J E Child Comprehensive Cancer Centre Calgary, Alberta | |
| Asan Medical Center Seoul, | |
| Astera Cancer Care East Brunswick, New Jersey | |
| Atrium Health Wake Forest Baptist Comprehensive Cancer Center Winston-Salem, North Carolina | |
| Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino Torino, | |
| Azienda Ospedaliera di Rilievo Nazionale A Cardarelli Naples, | |
| Banner MD Anderson Cancer Center Gilbert, Arizona | |
| Barwon Health - University Hospital Geelong Geelong, | |
| Beijing Chaoyang Hospital Chaoyang District, | |
| Beijing Tongren Hospital CMU Beijing, | |
| Blackpool Victoria Hospital Blackpool, | |
| British Columbia Cancer Agency Vancouver, British Columbia | |
| CHU Henri Mondor Créteil, | |
| CHU Hôpital Saint Antoine Paris, | |
| CHU Nantes Nantes, | |
| CHU Poitiers - Hopital la Miletrie Poitiers, | |
| CHU de Bordeaux - Hospital Haut-Leveque Pessac, | |
| CHU de Quebec L Hotel Dieu de Quebec Québec, Quebec | |
| CHU de Rennes - Hopital Pontchaillou Rennes, | |
| Calvary Mater Newcastle Hospital Waratah, New South Wales | |
| Cancer And Hematology Centers of Western Michigan PC Grand Rapids, Michigan | |
| Cancer and Blood Specialty Clinic Los Alamitos, California | |
| Careggi University Hospital Florence, | |
| Center For Cancer and Blood Disorders Bethesda, Maryland | |
| Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli Lublin, | |
| Champalimaud Foundation Champalimaud Centre Lisbon, | |
| Changzhou No 2 Peoples Hospital Changzhou, | |
| Chiba Cancer Center Chiba, Chiba | |
| Chongqing University Cancer Hospital Chongqing, Chongqing Municipality | |
| Chonnam National University Hwasun Hospital Hwasun-gun, | |
| ChristianaCare Helen F Graham Cancer Center and Research Institute Newark, Delaware | |
| Christus St. Vincent Regional Cancer Center Santa Fe, New Mexico | |
| City of Hope Duarte Duarte, California | |
| City of Hope Orange County Lennar Foundation Cancer Center Irvine, California | |
| City of Hope cancer Center Newnan, Georgia | |
| Cleveland Clinic Florida Weston, Florida | |
| Cleveland Clinic Main Campus Cleveland, Ohio | |
| Clinica Medica Sao Germano S/S LTDA São Paulo, | |
| Complexo Hospitalar de Niterói Niterói, | |
| Cross Cancer Institute Edmonton, Alberta | |
| Dartmouth Hitchcock Medical Center Lebanon, New Hampshire | |
| Dokuz Eylul University Medical Faculty Izmir, | |
| Dong-A University Hospital Busan, | |
| Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital Ankara, | |
| Durham VAMC Durham, North Carolina | |
| Fakultni Nemocnice Ostrava Ostrava, | |
| Fakultni nemocnice Brno Brno, | |
| Fakultni nemocnice Hradec Kralove Hradec Králové, | |
| Fakultni nemocnice Olomouc Olomouc, | |
| Fakultni nemocnice Plzen PLZE, | |
| Falu Lasarett Falun, | |
| Fujian Meidical University Union Hospital Fuzhou, | |
| Fujita Health University Hospital Aichi, | |
| Fundacao Pio XII Barretos, | |
| G Papanikolaou Hospital of Thessaloniki Thessalonikis, | |
| Gachon University Gil Medical Center Namdong-gu, Incheon-gwangyeoksi [incheon] | |
| Gelre Ziekenhuis Apeldoorn, | |
| Ghent University Hospital Ghent, | |
| Hanusch Krankenhaus Vienna, | |
| Harbin Medical University Cancer Hospital Harbin, | |
| Helios Kliniken Berlin Buch Gmbh Berlin, | |
| Hematology-Oncology Associates of CNY East Syracuse, New York | |
| Henan Cancer Hospital Zhengzhou, Henan | |
| Henry Ford Cancer - Detroit Brigitte Harris Cancer Pavilion Detroit, Michigan | |
| Henry Ford Providence Novi Hospital Novi, Michigan | |
| Henry Ford Providence Southfield CK Potluri Cancer Center Southfield, Michigan | |
| Henry-Joyce Cancer Clinic Nashville, Tennessee | |
| Hopital Claude Huriez Lille, | |
| Hopitaux Universitaires de Strasbourg - Hopital de Hautepierre Strasbourg, | |
| Hosp Clinico Univ de Salamanca Salamanca, | |
| Hosp Univ Hm Sanchinarro Madrid, | |
| Hosp Univ Vall D Hebron Barcelona, | |
| Hosp. Clinico Univ. de Valencia Valencia, | |
| Hosp. Mutua Terrassa Terrassa, | |
| Hosp. Quiron Madrid Pozuelo Pozuelo de Alarcón, | |
| Hosp. Univ. 12 de Octubre Madrid, | |
| Hosp. Univ. Germans Trias I Pujol Badalona, | |
| Hosp. Univ. La Paz Madrid, | |
| Hosp. Univ. Son Espases Palma de Mallorca, | |
| Hosp. Univ. Virgen de Las Nieves Granada, | |
| Hosp. de Jerez de La Frontera Jerez de la Frontera, | |
| Hosp. de La Santa Creu I Sant Pau Barcelona, | |
| Hospices Civils de Lyon HCL Lyon, | |
| Hospital Das Clinicas Da Faculdade De Medicina Da USP Cerqueira César, | |
| Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP Ribeirão Preto, | |
| Hospital Nove de Julho São Paulo, | |
| Hospital Sao Rafael São Paulo, São Paulo | |
| Hospital de Clínicas de Porto Alegre Porto Alegre, | |
| Houston Methodist Hospital Houston, Texas | |
| Huntsman Cancer Institute Salt Lake City, Utah | |
| Hyogo Medical University Hospital Nishinomiya, | |
| Imperial College Healthcare London, | |
| Inselspital Universitätsspital Bern Bern, | |
| Institut Catala d Oncologia L Hospitalet Barcelona, | |
| Institut Jules Bordet Anderlecht, | |
| Institut Universitaire du Cancer Toulouse Oncopole Toulouse, | |
| Institute of Hematology and Blood Diseases Hospital Tianjin, | |
| Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E. Porto, | |
| Instituto do Cancer do Ceara Fortaleza, Ceará | |
| Irccs Policlinico San Matteo, Universita Degli Studi Di Pavi Pavia, | |
| Istituto Clinico Humanitas Rozzano, | |
| Japanese Red Cross Medical Center Shibuya-ku, | |
| Joe Arrington Cancer Research Treatment Center Lubbock, Texas | |
| Johns Hopkins University School of Medicine JHUSOM Baltimore, Maryland | |
| Jolimont Haine Saint Paul La Louviere, | |
| Juntendo University Hospital Bunkyō City, | |
| Kameda Medical Center Chiba, | |
| Kanazawa University Hospital Kanazawa, | |
| Kansai Medical University Hospital Hirakata, | |
| Kantonsspital St Gallen Sankt Gallen, | |
| Karolinska University Hospital Huddinge Stockholm, | |
| Kent and Canterbury Hospital Canterbury, | |
| Klinikum Nuernberg Nord Nuremberg, | |
| Kumamoto University Hospital Kumamoto, | |
| Kyungpook National University Hospital Daegu, | |
| LSUHSC Shreveport Feist-Weiller Cancer Center Shreveport, Louisiana | |
| Lakeridge Health Oshawa Oshawa, Ontario | |
| Levine Cancer Institute Charlotte, North Carolina | |
| Liga Norte Riograndense Contra O Cancer Natal, | |
| Liga Paranaense de Combate ao Cancer Curitiba, | |
| Liv Hospital Ankara Ankara, | |
| Liverpool Hospital Liverpool, New South Wales | |
| Loyola University Medical Center Maywood, Illinois | |
| MUSC-Hollings Cancer Center Charleston, South Carolina | |
| Matsuyama Red Cross Hospital Matsuyama, Ehime | |
| Med. Universitatsklinik Essen Essen, | |
| Medical University Vienna Vienna, | |
| Medipol Mega Universite Hastanesi Istanbul, | |
| Memorial Antalya Hospital Antalya, | |
| Memorial Healthcare System Pembroke Pines, Florida | |
| Memorial Sloan Kettering Cancer Center New York, New York | |
| MidAmerica Cancer Care Kansas City, Missouri | |
| NYU Langone Hospital Long Island Mineola, New York | |
| Nanfang Hospital Guangzhou, | |
| Nanjing Drum Tower Hospital Nanjing, | |
| National Cancer Center Goyang-si, | |
| National Hospital Organization Hokkaido Cancer Center Sapporo, | |
| National Hospital Organization Mito Medical Center Higashiibaraki, Ibaraki | |
| National Hospital Organization Nagasaki Medical Center Ōmura, | |
| National Hospital Organization Okayama Medical Center Okayama, Okayama-ken | |
| National Hospital Organization Shibukawa Medical Center Shibukawa, | |
| Nebraska Cancer Specialists Omaha, Nebraska | |
| New Cross Hospital Wolverhampton, | |
| No.1 Affiliated Hospital, Medical College of Zhejiang University Hangzhou, | |
| Northwell Health Cancer Institute Lake Success, New York | |
| Northwest Medical Specialties, PLLC Puyallup, Washington | |
| Norton Cancer Institute Louisville, Kentucky | |
| Novant Health Charlotte, North Carolina | |
| Novant Health Forsyth Medical Center Winston-Salem, North Carolina | |
| Novant Health Zimmer Cancer Institute Wilmington, North Carolina | |
| OhioHealth Columbus, Ohio | |
| Oncology Hematology Care Cincinnati, Ohio | |
| Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi Samsun, | |
| Ordensklinikum Linz GmbH Elisabethinen LINZ CET, | |
| Osaka Metropolitan University Hospital Osaka, | |
| Oslo University Hospital HF Ulleval sykehus Oslo, | |
| Ospedale San Raffaele Milan, | |
| Pamukkale University Medical Faculty Denizli, | |
| Peking Union Medical College Hospital Beijing, | |
| Peking University First Hospital Beijing, | |
| Peking University Shenzhen Hospital Shenzhen, | |
| Penn State Milton S Hershey Medical Ctr Hershey, Pennsylvania | |
| Perlmutter Cancer Center at NYU Langone Health New York, New York | |
| Pratia Onkologia Katowice Katowice, | |
| Princess Alexandra Hospital Brisbane, Queensland | |
| Pusan National University Hospital Busan, | |
| Qilu Hospital of Shandong University Jinan, | |
| Rabin Petah Tikva, | |
| Rambam Medical Center Haifa, | |
| Regionshospitalet Godstrup Herning, | |
| Reinier de Graaf Gasthuis Delft, | |
| Renji Hospital, Shanghai Jiaotong University School of Medicine Shanghai, | |
| Rhode Island Hospital Providence, Rhode Island | |
| Richmond VA Medical Center Richmond, Virginia | |
| Royal Prince Alfred Hospital Sydney, New South Wales | |
| Ruijin Hospital Shanghai Jiao Tong University Shanghai, | |
| SCRI CCCIT gem GmbH Salzburg, | |
| Saitama Medical University Hospital Iruma-gun, | |
| Samsung Medical Center Seoul, | |
| Santa Casa de Misericordia de Belo Horizonte Belo Horizonte, | |
| Seoul National University Hospital Seoul, | |
| Severance Hospital Yonsei University Health System SeodaemunGu, Seoul Teugbyeolsi | |
| Shaare Zedek Medical Center Jerusalem, | |
| Shanghai Fourth People s Hospital Shanghai, | |
| Sheba Medical Center Ramat Gan, | |
| Shengjing Hospital of China Medical University Shenyang, | |
| Shizuoka Cancer Center Nagaizumi-cho,Sunto-gun, | |
| Sichuan Provincial Peoples Hospital Chengdu, | |
| Sir Charles Gairdner Hospital Perth, | |
| Skanes universitetssjukhus Lund, | |
| Soroka Medical Center Beersheba, | |
| St. Antonius Ziekenhuis Nieuwegein Nieuwegein, | |
| St. Olavs Hospital Trondheim, | |
| Sun Yat -Sen University Cancer Center Guangzhou, | |
| Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach Kielce, | |
| Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza Brzozów, | |
| Szpital Uniwersytecki im Karola Marcinkowskiego w Zielonej Gorze Zielona Góra, | |
| Szpital Uniwersytecki nr 2 im. Jana Biziela w Bydgoszczy Bydgoszcz, | |
| Tel Aviv Sourasky Medical Center Tel Aviv, | |
| The Catholic University of Korea Seoul St Mary s Hospital Seoul, | |
| The Christ Hospital Cancer Center Cincinnati, Ohio | |
| The First Affiliated Hospital of Guangxi Medical University Nanning, | |
| The First Affiliated Hospital of Wenzhou Medical University Wenzhou, | |
| The First Affiliated Hospital of Xiamen University Xiamen, Fujian | |
| The First Affliated Hospital Of Nanchang University Nanchang, | |
| The Ohio State University- James Cancer Hospital Columbus, Ohio | |
| The Second Affiliated Hospital of Xi'an Jiaotong University Xi'an, | |
| The Second Affiliated Hospital of Zhejiang University Hangzhou, | |
| The Second Xiangya Hospital of Central South Hospital Changsha, | |
| Theageneio Cancer Hospital Thessaloniki, | |
| Tianjin Medical University Cancer Institute and Hospital Tianjin, | |
| Tokai University Hospital Isehara Kanagawa, | |
| UCSF Fresno Fresno, California | |
| Uls Braga - Hosp. Braga Braga, | |
| Uls Hosp Sao Joao Porto, | |
| Universita Degli Studi di Roma Tor Vergata Roma, | |
| Universitaetsklinik Hamburg-Eppendorf Hamburg, | |
| Universitaetsklinikum Halle Saale Halle, | |
| Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II, Tübingen, | |
| Universitaetsklinikum Wuerzburg Würzburg, | |
| Universitair Ziekenhuis Leuven Leuven, | |
| Universitetssjukhuset Örebro Örebro, | |
| University College London Hospitals London, | |
| University Hospitals Birmingham NHS Foundation Trust Edgbaston, | |
| University Hospitals Bristol and Weston Bristol, | |
| University Hospitals Cleveland Medical Center Cleveland, Ohio | |
| University of Arizona Cancer Center Tucson, Arizona | |
| University of Cincinnati Cincinnati, Ohio | |
| University of Connecticut Farmington, Connecticut | |
| University of Illinois Medical Center Chicago, Illinois | |
| University of Iowa Health Care Waukee, Iowa | |
| University of Michigan Ann Arbor, Michigan | |
| University of Nebraska Medical Center Omaha, Nebraska | |
| University of Texas Southwestern Medical Center Dallas, Texas | |
| University of Virginia Charlottesville, Virginia | |
| Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie Lublin, | |
| Uniwersytecki Szpital Kliniczny W Poznaniu Poznan, | |
| Uniwersyteckie Centrum Kliniczne Gdansk, | |
| Utah Cancer Specialists Salt Lake City, Utah | |
| VFN v Praze Prague, | |
| VUmc Amsterdam Amsterdam, | |
| Valkyrie Clinical Trials Los Angeles, California | |
| Vejle Sygehus Vejle, | |
| Virginia Commonwealth University Medical Center Richmond, Virginia | |
| Virginia Oncology Associates Brock Cancer Center Norfolk, Virginia | |
| Weill Cornell Medical College New York, New York | |
| Western General Hospital Edinburgh, Scotland | |
| Wojewodzki Szpital Kliniczny w Bialej Podlaskiej Biała Podlaska, | |
| Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi Lodz, | |
| Wollongong Hospital Wollongong, New South Wales | |
| Wuhan Tongji Hospital Tongji Medical College Wuhan, | |
| Yale New Haven Hospital New Haven, Connecticut | |
| Yamagata University Hospital Yamagata, | |
| Yamanashi Prefectural Central Hospital Kofu, | |
| ZAS Augustinus Antwerp, | |
| ZAS Cadix Antwerp, | |
| Zealand University Hospital Roskilde, | |
| Zhongda Hospital Southeast University Nanjing, | |
| Zuyderland Medical Center Sittard-Geleen, | |
| the First Hospital of Jilin University Changchun, |
A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) (cAMeLot-2)
Study Contact - Participate-In-This-Study1@its.jnj.com
NCT06852222
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Inclusion criteria:
* Be 18 years of age or older at the time of informed consent
* Previously untreated lysine N-methyltransferase 2A gene rearranged (KMT2Ar) or nucleophosmin 1 gene mutated (NPM1m) acute myeloid leukemia (AML) with greater than or equal to (\> or =) 10% bone marrow blasts per 2022 international Consensus Classification criteria
* Ineligible for intensive chemotherapy based on the following criteria: a) \>= 75 years of age and ineligible per physician's discretion, with Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, b) \>=18 to \<75 years of age with \>= 1 of the following comorbidities: i) ECOG performance status of 2, ii) Severe cardiac disorder, iii) Severe pulmonary disorder, iv) Renal impairment, v) Moderate hepatic impairment vi) Comorbidity that, in the investigator's opinion, makes the participant unsuitable for intensive chemotherapy, which must be documented before enrollment as defined in the protocol. Ineligibility for intensive chemotherapy should be explicitly approved by a multidisciplinary team in countries in which this process is standard of care
* Participants must have adequate hepatic and renal function
* A female participant must agree not to be pregnant, breast-feed, plan to become pregnant and use protocol-specified contraception while enrolled in this study and for 6 months after the last dose of study treatment
* A male participant must agree to use protocol-specified contraception while enrolled in this study for at least 90 days after the last dose of study treatment
* Must sign an informed consent form indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study
Exclusion criteria:
* Diagnosis of acute promyelocytic leukemia (APL)
* Known active leukemic involvement of the central nervous system (CNS)
* Recipient of solid organ transplant
* Any cardiac disorders such as heart attack, uncontrolled/unstable chest pain, congestive heart failure, uncontrolled or symptomatic irregular heartbeat, blockage of a blood vessel to brain, or transient ischemic (decreased oxygen in tissue) attack within 6 months of randomization
* Active infectious hepatitis
* Live, attenuated vaccine within 4 weeks of randomization
* Known allergies, hypersensitivity, or intolerance of bleximenib, azacitidine, or venetoclax excipients
DRUG: Bleximenib, DRUG: Venetoclax (VEN), DRUG: Azacitidine (AZA), DRUG: Placebo
Leukemia, Myeloid, Acute
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Show 253 locations
Study Locations
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| Location | Contacts |
|---|---|
| A O U Sant Orsola Malpighi Bologna, | |
| AHEPA University General Hospital of Thessaloniki Thessaloniki, | |
| ASST Grande Ospedale Metropolitano Niguarda Milan, | |
| ASST Papa Giovanni XXIII Bergamo Bergamo, | |
| AST Pesaro e Urbino Ospedale San Salvatore Pesaro, | |
| AZ Sint-Jan Bruges, | |
| Aalborg University Hospital Aalborg, | |
| Addenbrookes Hospital Cambridge, | |
| Aiiku Hospital Sapporo, Hokkaido | |
| Algemeen Ziekenhuis Delta Roeselare, West-Vlaanderen | |
| Ankara Etlik Sehir Hastanesi Ankara, | |
| Ankara University School of Medicine Cebeci Hospital Ankara, | |
| Arthur J E Child Comprehensive Cancer Centre Calgary, Alberta | |
| Asan Medical Center Seoul, | |
| Atrium Health Charlotte, North Carolina | |
| Atrium Health Wake Forest Baptist Comprehensive Cancer Center Winston-Salem, North Carolina | |
| Azienda Ospedaliera Spedali Civili di Brescia Brescia, | |
| Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino Torino, | |
| Azienda Ospedaliera di Perugia Ospedale S.Maria della Misericordia Perugia, | |
| Baylor University Medical Center Dallas, Texas | |
| CHRU de Nancy - Hôpitaux de Brabois Vandœuvre-lès-Nancy, | |
| CHU De Nice Hopital De l'Archet Nice, | |
| CHU Lyon Sud Pierre-Bénite, | |
| CHU Reims Hopital Robert Debre Reims, | |
| CHU d'Angers Angers, | |
| CHU de Clermont Ferrand - Site Estaing Clermont-Ferrand, | |
| CHU de Montpellier Hopital Saint Eloi Montpellier, | |
| CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont Montreal, Quebec | |
| Cancer Treatment Center of America Phoenix Goodyear, Arizona | |
| CancerCare Manitoba Winnipeg, Manitoba | |
| Carmel Medical Center Haifa, | |
| Carolina Oncology Specialists Charlotte, North Carolina | |
| Casa Sollievo della Sofferenza IRCCS San Giovanni Rotondo, | |
| Centro de Investigacion Clinica Chapultepec Mexico City, | |
| Chaim Sheba Medical Center Ramat Gan, | |
| Chi Mei Medical Center Liouying Branch Tainan, | |
| Chu Helora Hospital La Louviere Site Jolimont La Louvière, | |
| Chu Rennes Hopital Pontchaillou Rennes, | |
| Chungnam National University Hospital Daejeon, | |
| City of Hope Duarte, California | |
| Cleveland Clinic Cleveland, Ohio | |
| Cleveland Clinic Florida Weston, Florida | |
| Clinica Univ. de Navarra Pamplona, | |
| Clinica Univ. de Navarra Madrid Madrid, | |
| Clinique Saint Pierre Ottignies, | |
| Colchester Hospital University NHS Colchester, | |
| DF Star Rede D or Brasília, | |
| Dana Farber Cancer Institute Boston, Massachusetts | |
| Dartmouth Hitchcock Medical Center Lebanon, New Hampshire | |
| Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely Budapest, | |
| Derriford Hospital Plymouth, | |
| Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital Ankara, | |
| Einstein-Montefiore Medical Center The Bronx, New York | |
| Evaggelismos Hospital Athens, | |
| Fakultni Nemocnice Ostrava Ostrava, | |
| Fakultni nemocnice Hradec Kralove Hradec Králové, | |
| Fakultni nemocnice Kralovske Vinohrady Prague, Prague | |
| Fakultni nemocnice Plzen PLZE, | |
| Fakultní nemocnice Brno, Interní hematologická a onkologická klinika Brno, | |
| First Affiliated Hospital SooChow University Suzhou, | |
| Flinders Medical Centre Adelaide, | |
| Florida Cancer Specialists & Research Institute Fort Myers, Florida | |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milan, | |
| Fondazione IRCCS Policlinico San Matteo Pavia, | |
| Fox Chase Cancer Center Philadelphia, Pennsylvania | |
| Fred Hutchinson Cancer Center Seattle, Washington | |
| Fukushima Medical University Hospital Fukushima, | |
| Fundacao Pio XII Barretos, | |
| Gabrail Cancer Center Canton, Ohio | |
| General University Hospital of Patras Rio Patras, | |
| Geniko Nosokomeio Thessalonikis George Papanikolaou Thessaloniki, | |
| Ghent University Hospital Ghent, | |
| Gifu Municipal Hospital Gifu, | |
| Grande Ospedale Metropolitano 'Bianchi-Melacrino-Morelli' Reggio Calabria Reggio Calabria, | |
| Gunmaken Saiseikai Maebashi Hospital Maebashi, | |
| Guys' and St Thomas' NHS Trust London, | |
| Hadassah University Hospita Ein Kerem Jerusalem, | |
| Henan Cancer Hospital Zhengzhou, Henan | |
| Henry Ford Health System Southfield, Michigan | |
| Hopital Saint Louis Paris, Île-de-France Region | |
| Hopital Saint Vincent de Paul Lille, | |
| Hosp Clinico Univ de Salamanca Salamanca, | |
| Hosp Univ A Coruna A Coruña, | |
| Hosp Univ Vall D Hebron Barcelona, | |
| Hosp. Clinic de Barcelona Barcelona, | |
| Hosp. Quiron Madrid Pozuelo Pozuelo de Alarcón, | |
| Hosp. San Pedro de Alcantara Cáceres, | |
| Hosp. Univ. 12 de Octubre Madrid, | |
| Hosp. Univ. I Politecni La Fe Valencia, | |
| Hosp. Univ. Marques de Valdecilla Santander, | |
| Hosp. Univ. Ramon Y Cajal Madrid, | |
| Hosp. Virgen Del Rocio Seville, | |
| Hosp. de Jerez de La Frontera Jerez de la Frontera, | |
| Hosp. de La Santa Creu I Sant Pau Barcelona, | |
| IRCCS Istituto Clinico Humanitas Rozzano, | |
| Illinois Cancer Specialists Arlington Heights, Illinois | |
| Inst. Cat. Doncologia-H Duran I Reynals L'Hospitalet de Llobregat, | |
| Institut Gustave Roussy Villejuif, | |
| Institut Paoli Calmettes Marseille, | |
| Institut Universitaire du Cancer Toulouse Oncopole Toulouse, | |
| Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences Tijian, | |
| Instituto D Or de Pesquisa e Ensino São Paulo, | |
| Instituto Nacional De Cancerologia Mexico City, | |
| Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Mexico City, | |
| Instituto Portugues de Oncologia Porto Porto, | |
| Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI) Rio de Janeiro, | |
| Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori Meldola, | |
| Japanese Red Cross Osaka Hospital Osaka, | |
| John Theurer Cancer Center at Hackensack University Medical Center Hackensack, New Jersey | |
| Jupiter Research Jupiter, Florida | |
| Juravinski Cancer Centre Hamilton, Ontario | |
| Kanazawa University Hospital Kanazawa, | |
| Kaohsiung Chang Gung Memorial Hospital Kaohsiung City, | |
| Kent and Canterbury Hospital Canterbury, | |
| Kepler Universitatsklinikum GmbH Linz, | |
| Klinikum Augsburg Augsburg, | |
| Klinikum Wels Grieskirchen Wels, | |
| Klinikum der Universitaet Muenchen Munich, | |
| Kobe City Medical Center General Hospital Hyōgo, | |
| Koc University Medical Faculty Istanbul, | |
| Kyushu University Hospital Fukuoka, | |
| Liga Norte Riograndense Contra O Cancer Natal, | |
| Liga Paranaense de Combate ao Cancer Curitiba, | |
| Linkou Chang Gung Memorial Hospital Taoyuan, | |
| London Health Sciences Centre Victoria Hospital London, Ontario | |
| MD Anderson Cancer Center Houston, Texas | |
| Mary Bird Perkins Cancer Center Baton Rouge, Louisiana | |
| Medical Oncology Hematology Consultants, PA Newark, Delaware | |
| Medical University of Vienna Universitatsklinik fur Innere Medizin I Vienna, | |
| Memorial Antalya Hospital Antalya, | |
| Memorial Cancer Institute Pembroke Pines, Florida | |
| Ministerio da Saude Instituto Nacional do Cancer Rio de Janeiro, | |
| Moffit Cancer Center Tampa, Florida | |
| Nagoya University Hospital Nagoya, | |
| National Cancer Center Goyang-si, | |
| National Hospital Organization Kumamoto Medical Center Kumamoto Kumamoto, | |
| National Taiwan University Hospital Taipei, | |
| New York Presbyterian - Weill Cornell New York, New York | |
| Nippon Medical School Hospital Tokyo, Bunkyo-ku, | |
| Norton Cancer Institute Louisville, Kentucky | |
| Novant Health Charlotte Charlotte, North Carolina | |
| Novant Health Winston Salem Winston-Salem, North Carolina | |
| Odense University Hospital Odense, | |
| Okayama University Hospital Okayama Okayama, | |
| Oncology Hematology Care Cincinnati, Ohio | |
| Ondokuz Mayis University Samsun, | |
| Ordensklinikum Linz GmbH Elisabethinen LINZ CET, | |
| Orlando Health Cancer Institute Orlando, Florida | |
| Ospedale S. Maria Delle Croci Ravenna, | |
| Pecsi Tudomanyegyetem Klinikai Kozpont Pécs, | |
| Peking University First Hospital Beijing, | |
| Peking University People's Hospital Beijing, | |
| Peking University Third Hospital Beijing, | |
| Peter MacCallum Cancer Centre Melbourne, Victoria | |
| Princess Alexandra Hospital Brisbane, Queensland | |
| Princess Margaret Cancer Centre University Health Network Toronto, Ontario | |
| Providence Oncology and Hematology Care Clinic Westside Portland, Oregon | |
| Providence Portland Medical Center Portland, Oregon | |
| Qilu Hospital of Shandong University Jinan, | |
| Queen Elizabeth II Health Sciences Centre Halifax, Nova Scotia | |
| Queen Mary Hospital Hksar, | |
| Rabin Medical Center Petah Tikva, | |
| Rambam Medical Center Haifa, | |
| Real e Benemérita Associação Portuguesa de Beneficência São Paulo, | |
| Rigshospitalet Copenhagen, | |
| Rocky Mountain Cancer Centers Denver, Colorado | |
| Roswell Park Comprehensive Cancer Center Buffalo, New York | |
| Royal Prince Alfred Hospital Sydney, New South Wales | |
| Royal Sussex County Hospital Brighton, | |
| Sakarya University Training and Research Hospital Sakarya, | |
| Samsung Medical Center Seoul, | |
| Seoul National University Bundang Hospital Seongnam, | |
| Seoul National University Hospital Seoul, | |
| Shaare Zedek Medical Center Jerusalem, | |
| Shamir Medical Center Assaf Harofeh Beer Yaakov, | |
| Shengjing Hospital of China Medical University Shenyang, | |
| Sichuan Provincial Peoples Hospital Chengdu, | |
| Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein São Paulo, | |
| St George Hospital Kogarah, New South Wales | |
| St Vincents Hospital Melbourne Fitzroy, Victoria | |
| Sun Yat Sen University Cancer Center Guangzhou, Guangdong | |
| Swedish Cancer Institute Seattle, Washington | |
| Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach Kielce, | |
| Tel Aviv Sourasky Medical Center Tel Aviv, | |
| Texas Oncology - Northeast Tyler, Texas | |
| The Catholic University of Korea Seoul St Marys Hospital Seoul, | |
| The Clatterbridge Cancer Centre Liverpool, | |
| The First Affiliated Hospital Zhejiang University College of Medicine Hangzhou, | |
| The First Affiliated Hospital of Chongqing Medical University Chongqing, Chongqing Municipality | |
| The First Affiliated Hospital of Guangxi Medical University Nanning, | |
| The First Affiliated Hospital of NanChang University Nanchang, | |
| The First Affiliated Hospital of USTC Anhui Provincial Hospital Hefei, | |
| The First Affiliated Hospital of Wenzhou Medical University Wenzhou, | |
| The First Affiliated Hospital of Xiamen University Xiamen, Fujian | |
| The Second Affiliated Hospital of Xi'an Jiaotong University Xi'an, | |
| The Second Hospital & Clinical Medical School Lanzhou University Lanzhou, | |
| The Second People's Hospital of Shenzhen Shenzhen, | |
| The University of Arizona Cancer Center Tucson, Arizona | |
| The first Affiliated Hospital of Jilin University Changchun, | |
| Thomas Jefferson University Philadelphia, Pennsylvania | |
| Tohoku University Hospital Miyagi, | |
| Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital Tokyo, | |
| TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology Wuhan, | |
| Trinity Health Michigan Heart - Ann Arbor Campus Ypsilanti, Michigan | |
| UZ Antwerpen Edegem, | |
| Uls Santa Maria Hosp. Santa Maria Lisbon, | |
| Uls Santo Antonio - Hosp. Santo Antonio Porto, | |
| Uls Sao Joao - Hosp. Sao Joao Porto, | |
| Uls Sao Jose - Hosp. Sto Antonio Dos Capuchos Lisbon, | |
| Union Hospital Tongji Medical College of Huazhong University of Science and Technology Wuhan, | |
| UniversitaetsKlinikum Heidelberg Heidelberg, | |
| Universitaetsklinikum Carl Gustav Carus TU Dresden Dresden, | |
| Universitaetsklinikum Frankfurt Frankfurt, | |
| Universitaetsklinikum Freiburg Freiburg im Breisgau, | |
| Universitaetsklinikum Hamburg Eppendorf Hamburg, | |
| Universitaetsklinikum Koeln Cologne, North Rhine-Westphalia | |
| Universitaetsklinikum Leipzig Leipzig, | |
| Universitaetsklinikum Salzburg Landeskrankenhaus Salzburg, | |
| Universitaetsklinikum Schleswig Holstein Campus Kiel Kiel, | |
| Universitaetsklinikum Wuerzburg Würzburg, | |
| Universitair Ziekenhuis Leuven Leuven, | |
| University General Hospital Attikon General Hospital Of West Attica H Agia Varvara Chaïdári, | |
| University General Hospital of Ioannina Ioannina, | |
| University Hospital of Alexandroupolis Alexandroupoli, | |
| University Hospitals Cleveland Medical Center Cleveland, Ohio | |
| University of Alabama at Birmingham Birmingham, Alabama | |
| University of Arkansas at Little Rock Little Rock, Arkansas | |
| University of Chicago Medicine Chicago, Illinois | |
| University of Fukui Hospital Yoshida, | |
| University of Kentucky Markey Cancer Center Lexington, Kentucky | |
| University of Pittsburgh Medical Center Pittsburgh, Pennsylvania | |
| University of Rochester Medical Center Rochester, New York | |
| University of Tennessee Knoxville, Tennessee | |
| Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu Wroclaw, | |
| Uniwersytecki Szpital Kliniczny w Bialymstoku Bialystok, | |
| Uniwersyteckie Centrum Kliniczne Gdansk, | |
| UofL Health Brown Cancer Center Louisville, Kentucky | |
| Ustav hematologie a krevni transfuze Prague, | |
| VM Medical Park Mersin Hospital Mersin, | |
| Vancouver General Hospital Vancouver, | |
| Vanderbilt Ingram Cancer Center Nashville, Tennessee | |
| Virginia Commonwealth University - Massey Cancer Center Richmond, Virginia | |
| Vseobecna Fakultni Nemocnice Prague, | |
| Washington University in St Louis St Louis, Missouri | |
| West China Hospital Si Chuan University Chengdu, | |
| Western General Hospital Edinburgh, Scotland | |
| Wiener Gesundheitsverbund Klinik Hietzing Vienna, | |
| Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi Lodz, | |
| Worthing Hospital Worthing, | |
| Yamagata University Hospital Yamagata, | |
| Zealand University Hospital Roskilde, | |
| Zhongda Hospital Southeast University Nanjing, | |
| Ziekenhuis Oost-Limburg Genk, |
Triptorelin for the Prevention of Ovarian Damage in Adolescents and Young Adults With Cancer
ctrrecruit@vcu.edu
NCT06513962
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Inclusion Criteria:
* \< 40 years of age at the time of enrollment
* Patient must be a post-menarchal female and report that their initial menstrual period occurred \> 6 months prior to enrollment. (Current menstrual status is not part of the inclusion criteria.)
* Newly diagnosed with first cancer, exclusive of breast cancer.
* Note: Apart from breast carcinoma, other tumor types originating in the breast are permitted (e.g., sarcoma, lymphoma).
* Planned treatment must include one or more of the following alkylating agents delivered with curative intent: cyclophosphamide, ifosfamide, procarbazine, chlorambucil, carmustine (BCNU), lomustine (CCNU), melphalan, thiotepa, busulfan, nitrogen mustard, or dacarbazine (DTIC).
* Expected cumulative cyclophosphamide equivalent dose (CED):
* For patients \< 20 years of age at enrollment, the expected alkylator dose must be ≥ 4 g/m\^2 cumulative CED calculated according to the equation and specified drugs listed. Dacarbazine is not an eligible drug in this age group.
* For patients ≥ 20 years of age and \< 35 years old at enrollment, any planned alkylator dose is permitted. Eligible patients must receive at least one of the alkylators listed below that contribute to CED. Dacarbazine is not an eligible drug in this age group.
* For patients ≥ 35 years of age at enrollment, any planned alkylator dose is permitted. Eligible patients must receive at least one of the alkylators listed that contribute to CED and/or dacarbazine, which IS an eligible drug in this age group.
Note that CED includes all administration routes: intravenous (IV), oral (PO), IM.
* The planned total duration of therapy with eligible alkylators is expected to be completed within one year after enrollment. Note: treatment plans with prolonged maintenance periods extending beyond one year are permitted so long as those maintenance treatments are not expected to contain eligible alkylators.
* 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:
* Any planned radiation to the pelvis; or cranial radiation ≥ 30 gray (Gy) to the hypothalamus, inclusive of any total body irradiation (TBI).
* Planned bilateral oophorectomy. Note: A participant's desire to pursue alternative fertility preservation procedures (i.e., embryo, oocyte, or ovarian tissue cryopreservation) will be allowed (and in fact encouraged).
* Congenital syndromes associated with infertility and decreased ovarian reserve at baseline. For example: Turner's Syndrome, Fragile X premutation carriers, Down syndrome, etc.
* Pre-existing seizure disorder, congenital long QT syndrome, pseudotumor cerebri; history of pulmonary embolism, venous thrombosis, or myocardial infarction. Note: Contact study chairs if questions arise about other pre-existing conditions.
* Receipt of long acting (depot) GnRH agonists within 6 months before enrollment. In contrast, subcutaneous GnRH agonist used for oocyte retrieval is not an exclusion; oral and other hormonal contraceptive use is also not an exclusion. Note: Please see protocol for the concomitant therapy restrictions for patients during the study treatment period. See protocol for information about oral and other hormonal contractive use during the study treatment period.
* Receipt of systemic chemotherapy (except for steroids and intrathecal chemotherapy) more than 7 days prior to study enrollment.
* Any prior radiation to the pelvis; or cranial radiation ≥ 30 Gy to the hypothalamus, inclusive of any total body irradiation (TBI).
* Patients who are pregnant are not eligible. A pregnancy test is required for female patients of childbearing potential.
* Lactating females who plan to breastfeed their infants for the duration of triptorelin therapy (24 weeks per dose).
* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of triptorelin therapy (24 weeks per dose). OTHER: Best Practice, PROCEDURE: Biospecimen Collection, OTHER: Electronic Health Record Review, OTHER: Survey Administration, DRUG: Triptorelin Pamoate
Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
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Show 205 locations
Study Locations
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| Location | Contacts |
|---|---|
| AdventHealth Orlando Orlando, Florida | Site Public Contact - (FH.Cancer.Research@flhosp.org) |
| Advocate Children's Hospital-Oak Lawn Oak Lawn, Illinois | |
| Advocate Children's Hospital-Park Ridge Park Ridge, Illinois | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Albany Medical Center Albany, New York | |
| Alfred I duPont Hospital for Children Wilmington, Delaware | Site Public Contact - (Allison.bruce@nemours.org) |
| Arkansas Children's Hospital Little Rock, Arkansas | |
| Aurora Sinai Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Banner University Medical Center - Tucson Tucson, Arizona | Site Public Contact - (UACC-IIT@uacc.arizona.edu) |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas | Site Public Contact - (burton@bcm.edu) |
| Beacon Kalamazoo Kalamazoo, Michigan | |
| Beacon Kalamazoo Cancer Center Kalamazoo, Michigan | |
| 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) |
| Blank Children's Hospital Des Moines, Iowa | Site Public Contact - (samantha.mallory@unitypoint.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) |
| C S Mott Children's Hospital Ann Arbor, Michigan | |
| CARTI Cancer center Little Rock, Arkansas | Site Public Contact - (Research@CARTI.com) |
| CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL) Québec, | Site Public Contact - (rechclinique@crchudequebec.ulaval.ca) |
| Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores, Michigan | Site Public Contact - (connie.szczepanek@crcwm.org) |
| CancerCare Manitoba Winnipeg, Manitoba | Site Public Contact - (ctu_web@cancercare.mb.ca) |
| Carilion Children's Roanoke, Virginia | Site Public Contact - (wpmccarty@carilionclinic.org) |
| Carle BroMenn Medical Center Normal, Illinois | Site Public Contact - (Research@Carle.com) |
| Carle Cancer Center Urbana, Illinois | |
| Carle Cancer Institute Normal Normal, Illinois | Site Public Contact - (Research@Carle.com) |
| Carle Physician Group-Effingham Effingham, Illinois | |
| Carle Physician Group-Mattoon/Charleston Mattoon, Illinois | |
| Carle at The Riverfront Danville, Illinois | |
| 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) |
| Centre Hospitalier Universitaire Sainte-Justine Montreal, Quebec | Site Public Contact - (yvan.samson@umontreal.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 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 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 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) |
| 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) |
| Cleveland Clinic Foundation Cleveland, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Connecticut Children's Medical Center Hartford, Connecticut | |
| Cook Children's Medical Center Fort Worth, Texas | Site Public Contact - (CookChildrensResearch@cookchildrens.org) |
| Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Lakeland Hospitals - Niles Hospital Niles, Michigan | |
| Corewell Health Lakeland Hospitals - Saint Joseph Hospital Saint Joseph, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Reed City Hospital Reed City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Cox Cancer Center Branson Branson, Missouri | |
| CoxHealth South Hospital Springfield, Missouri | |
| Dayton Children's Hospital Dayton, Ohio | |
| Duke University Medical Center Durham, North Carolina | |
| El Paso Children's Hospital El Paso, Texas | Site Public Contact - (ranjan.bista@ttuhsc.edu) |
| Fred Hutchinson Cancer Center Seattle, Washington | |
| Freeman Health System Joplin, Missouri | Site Public Contact - (LJCrockett@freemanhealth.com) |
| Golisano Children's Hospital of Southwest Florida Fort Myers, Florida | Site Public Contact - (molly.arnstrom@leehealth.org) |
| Greater Regional Medical Center Creston, Iowa | |
| Hackensack University Medical Center Hackensack, New Jersey | |
| 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) |
| Indiana University/Melvin and Bren Simon Cancer Center Indianapolis, Indiana | Site Public Contact - (iutrials@iu.edu) |
| Iowa Methodist Medical Center Des Moines, Iowa | |
| Kaiser Permanente-Oakland Oakland, California | Site Public Contact - (Kpoct@kp.org) |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | |
| Lake Regional Hospital Osage Beach, Missouri | Site Public Contact - (clinicaltrials@lakeregional.com) |
| Loma Linda University Medical Center Loma Linda, California | |
| Lurie Children's Hospital-Chicago Chicago, Illinois | |
| Madigan Army Medical Center Tacoma, Washington | Site Public Contact - (melissa.a.forouhar.mil@health.mil) |
| Maine Children's Cancer Program Scarborough, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| MaineHealth Maine Medical Center- Scarborough Scarborough, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| Mattel Children's Hospital UCLA Los Angeles, California | |
| Medical City Dallas Hospital Dallas, Texas | |
| Medical Oncology Hematology Consultants PA Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Medical University of South Carolina Charleston, South Carolina | Site Public Contact - (hcc-clinical-trials@musc.edu) |
| Memorial Hospital East Shiloh, Illinois | Site Public Contact - (dschwab@wustl.edu) |
| Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood, Florida | Site Public Contact - (OHR@mhs.net) |
| Mercy Cancer Center - Cape Girardeau Cape Girardeau, Missouri | |
| Mercy Cancer Center-West Lakes Clive, Iowa | |
| Mercy Clinic-Rolla-Cancer and Hematology Rolla, Missouri | |
| 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 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 - Des Moines Des Moines, Iowa | |
| Mercy Medical Center-West Lakes West Des Moines, Iowa | |
| Mercy Oncology and Hematology - Clayton-Clarkson Ballwin, Missouri | |
| Miami Cancer Institute Miami, Florida | |
| Montefiore Medical Center - Moses Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Munson Medical Center Traverse City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York | Site Public Contact - (cancerclinicaltrials@cumc.columbia.edu) |
| NYP/Weill Cornell Medical Center New York, New York | |
| Nationwide Children's Hospital Columbus, Ohio | Site Public Contact - (Melinda.Triplet@nationwidechildrens.org) |
| Nemours Children's Clinic - Pensacola Pensacola, Florida | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Nemours Children's Clinic-Jacksonville Jacksonville, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| Nemours Children's Hospital Orlando, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| Nicklaus Children's Hospital Miami, Florida | |
| Northwestern Medicine Cancer Center Delnor Geneva, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Cancer Center Kishwaukee DeKalb, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Cancer Center Warrenville Warrenville, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Glenview Outpatient Center Glenview, Illinois | |
| Northwestern Medicine Grayslake Outpatient Center Grayslake, Illinois | |
| Northwestern Medicine Lake Forest Hospital Lake Forest, Illinois | Site Public Contact - (cancertrials@northwestern.edu) |
| Northwestern Medicine Orland Park Orland Park, Illinois | Site Public Contact - (nctnprogram_rhlccc@northwestern.edu) |
| Northwestern University Chicago, Illinois | Site Public Contact - (cancer@northwestern.edu) |
| Norton Children's Hospital Louisville, Kentucky | Site Public Contact - (CancerResource@nortonhealthcare.org) |
| OSF Saint Anthony's Health Center Alton, Illinois | |
| Ochsner Medical Center Jefferson New Orleans, Louisiana | Site Public Contact - (Elisemarie.curry@ochsner.org) |
| Oregon Health and Science University Portland, Oregon | Site Public Contact - (trials@ohsu.edu) |
| Parkland Memorial Hospital Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| Penn State Children's Hospital Hershey, Pennsylvania | |
| Phelps Health Delbert Day Cancer Institute Rolla, Missouri | Site Public Contact - (research@phelpshealth.org) |
| Phoenix Childrens Hospital Phoenix, Arizona | |
| Presbyterian Hospital Albuquerque, New Mexico | Site Public Contact - (wburman@phs.org) |
| Prisma Health Richland Hospital Columbia, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Providence Sacred Heart Medical Center and Children's Hospital Spokane, Washington | Site Public Contact - (HopeBeginsHere@providence.org) |
| Rady Children's Hospital - San Diego San Diego, California | |
| Rhode Island Hospital Providence, Rhode Island | |
| Riley Hospital for Children Indianapolis, Indiana | |
| Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver, Colorado | Site Public Contact - (PSGResearchSharedMailbox@HCAHealthcare.com) |
| Rush-Copley Healthcare Center Yorkville, Illinois | |
| Rush-Copley Medical Center Aurora, Illinois | |
| SSM Health Good Samaritan Mount Vernon, Illinois | Site Public Contact - (gayla.hall@ssmhealth.com) |
| Saint Anthony Regional Hospital Carroll, Iowa | Site Public Contact - (sbenson@iora.org) |
| Saint Christopher's Hospital for Children Philadelphia, Pennsylvania | |
| Saint John's Hospital Springfield, Illinois | Site Public Contact - (diana.weyhenmeyer@st-johns.org) |
| Saint Joseph's Hospital/Children's Hospital-Tampa Tampa, Florida | |
| Saint Jude Children's Research Hospital Memphis, Tennessee | Site Public Contact - (referralinfo@stjude.org) |
| Saint Mary's Hospital Centralia, Illinois | |
| Saint Mary's Medical Center West Palm Beach, Florida | |
| Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Sheboygan Sheboygan, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Sanford Bismarck Medical Center Bismarck, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Broadway Medical Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org) |
| Seattle Children's Hospital Seattle, Washington | |
| Sheboygan Physicians Group Sheboygan, Wisconsin | Site Public Contact - (wi_research_admin@hshs.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) |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| Stony Brook University Medical Center Stony Brook, New York | |
| Sutter Medical Center Sacramento Sacramento, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Tampa General Hospital Tampa, Florida | Site Public Contact - (syapchanyk@tgh.org) |
| The Children's Hospital at TriStar Centennial Nashville, Tennessee | |
| The Iowa Clinic PC West Des Moines, Iowa | |
| The Montreal Children's Hospital of the MUHC Montreal, Quebec | Site Public Contact - (info@thechildren.com) |
| Trinity Health Grand Rapids Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Trinity Health Muskegon Hospital Muskegon, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| UC San Diego Medical Center - Hillcrest San Diego, California | |
| UC San Diego Moores Cancer Center La Jolla, California | Site Public Contact - (cancercto@ucsd.edu) |
| UF Health Cancer Institute - Gainesville Gainesville, Florida | Site Public Contact - (cancer-center@ufl.edu) |
| UI Health Care Mission Cancer and Blood - Ankeny Clinic Ankeny, Iowa | |
| UI Health Care Mission Cancer and Blood - Des Moines Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - Laurel Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - Waukee Clinic Waukee, Iowa | |
| UI Health Care Mission Cancer and Blood - West Des Moines Clinic Clive, Iowa | |
| UI Healthcare Mission Cancer and Blood - Fort Dodge Fort Dodge, Iowa | Site Public Contact - (trials@missioncancer.com) |
| UI Healthcare Mission Cancer and Blood - Pella Pella, Iowa | Site Public Contact - (trials@missioncancer.com) |
| UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina | Site Public Contact - (cancerclinicaltrials@med.unc.edu) |
| USA Health Strada Patient Care Center Mobile, Alabama | |
| UT MD Anderson Cancer Center Houston, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| University of Alabama at Birmingham Cancer Center Birmingham, Alabama | Site Public Contact - (gingerreeves@uabmc.edu) |
| University of Illinois Chicago, Illinois | |
| University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa | |
| University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida | |
| University of Michigan Health - West Wyoming, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| University of Michigan Rogel Cancer Center Ann Arbor, Michigan | Site Public Contact - (CancerAnswerLine@med.umich.edu) |
| University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota | |
| University of Mississippi Medical Center Jackson, Mississippi | |
| University of Nebraska Medical Center Omaha, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| University of New Mexico Cancer Center Albuquerque, New Mexico | Site Public Contact - (HSC-ClinicalTrialInfo@salud.unm.edu) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Rochester Rochester, New York | |
| University of Washington Medical Center - Montlake Seattle, Washington | |
| University of Wisconsin Carbone Cancer Center - Eastpark Medical Center Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| University of Wisconsin Carbone Cancer Center - University Hospital Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Vanderbilt University/Ingram Cancer Center Nashville, Tennessee | |
| Wake Forest University Health Sciences Winston-Salem, North Carolina | |
| Walter Reed National Military Medical Center Bethesda, Maryland | |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| West Michigan Cancer Center Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
A Study of Pembrolizumab (MK-3475) With or Without Intismeran Autogene (V940) in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009)
Toll Free Number - Trialsites@msd.com
NCT06623422
Show full eligibility criteria
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Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
* Has histologically/cytologically confirmed diagnosis of previously untreated and pathologically confirmed resectable clinical Stage II, IIIA, or IIIB (N2) non-small cell lung cancer (NSCLC) \[American Joint Committee on Cancer (AJCC) 8th Edition\]
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before the first dose of study intervention
* Participants who have not achieved a pathological complete response (pCR) following completion of neoadjuvant chemotherapy and pembrolizumab followed by surgery will be eligible
* Confirmation that epidermal growth factor receptor (EGFR)-directed therapy is not indicated as primary therapy (documentation of absence of tumor-activating EGFR mutations \[eg, DEL19 or L858R\])
* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART)
* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization
* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
* Diagnosis of small cell lung cancer (SCLC) or, for mixed tumors, presence of small cell elements, or has a neuroendocrine tumor with large-cell components, or a sarcomatoid carcinoma, or a pancoast tumor
* Documentation by local test report indicating presence of anaplastic lymphoma kinase (ALK) gene rearrangements
* Received prior neoadjuvant therapy for their current NSCLC diagnosis
* Received prior therapy with an anti-programmed cell death 1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti-programmed cell-death ligand 2 (PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein \[CTLA-4\], OX-40, CD137)
* Received prior systemic anticancer therapy including investigational agents other than what is specified in this protocol
* Received prior treatment with a cancer vaccine
* Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention BIOLOGICAL: Pembrolizumab, DRUG: Cisplatin, DRUG: Carboplatin, DRUG: Pemetrexed, DRUG: Gemcitabine, DRUG: Paclitaxel, BIOLOGICAL: Intismeran autogene, OTHER: Placebo
Carcinoma, Non-Small-Cell Lung
Programmed Cell Death-1 (PD1, PD-1), Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1), Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2), Individualized neoantigen therapy (INT)
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Show 236 locations
Study Locations
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| Location | Contacts |
|---|---|
| AOU Renato Dulbecco ( Site 1661) Catanzaro, Calabria | |
| ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 1460) Chaïdári, Attica | |
| Adana Medical Park Seyhan Hastanesi ( Site 2010) Adana, | |
| Ajou University Hospital ( Site 2306) Suwon, Kyonggi-do | |
| Aliada ( Site 2753) Lima, | |
| Ankara Bilkent Sehir Hastanesi ( Site 2002) Ankara, | |
| Banner MD Anderson Cancer Center ( Site 0181) Gilbert, Arizona | |
| Banner MD Anderson Cancer Center at North Colorado Medical Center ( Site 0207) Greeley, Colorado | |
| Beacon Cancer Care ( Site 0127) Post Falls, Idaho | |
| Bradford Hill Norte ( Site 2563) Antofagasta, | |
| Bradfordhill ( Site 2552) Santiago, Region M. de Santiago | |
| Bristol Haematology and Oncology Centre ( Site 2072) Bristol, Bristol, City of | |
| CEMIC ( Site 2454) Caba., Buenos Aires | |
| CENTRE LEON BERARD ( Site 1351) Lyon, Rhone | |
| CHU Besançon ( Site 1358) Besançon, Franche-Comte | |
| CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA ( Site 2502) Fortaleza, Ceará | |
| Cabinet Medical Oncomed ( Site 1803) Timișoara, Timiș County | |
| Calvary Mater Newcastle ( Site 2106) Waratah, New South Wales | |
| Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau ( Site 1354) Tours, Centre-Val de Loire | |
| Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre ( Site 1359) Caen, Basse-Normandie | |
| Centro Médico IPAM ( Site 2452) Rosario, Santa Fe Province | |
| Centro Ricerche Cliniche di Verona ( Site 1659) Verona, | |
| Centrul Medical Medicover Victoria ( Site 1802) Bucharest, Bucharest | |
| Centura Health - St. Anthony North Health Campus ( Site 0189) Westminster, Colorado | |
| Chang Gung Memorial Hospital ( Site 2361) Taoyuan, | |
| Chiba University Hospital ( Site 1154) Chiba, | |
| China Medical University Hospital ( Site 2358) Taichung, | |
| Chung Shan Medical University Hospital ( Site 2351) Taichung, | |
| Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 2604) Bogotá, Bogota D.C. | |
| Cliniques Universitaires Saint-Luc ( Site 1203) Brussels, Bruxelles-Capitale, Region de | |
| Clínica Internacional - Sede San Borja ( Site 2752) Lima, | |
| Clínica RedSalud Vitacura ( Site 2556) Santiago, Region M. de Santiago | |
| Complejo Hospitalario Universitario A Coruna ( Site 1916) A Coruña, La Coruna | |
| Cork University Hospital ( Site 1553) Cork, | |
| Dana Farber Cancer Hospital ( Site 0155) Boston, Massachusetts | |
| Debreceni Egyetem Altalanos Orvostudomanyi Kar Tudogyogyaszati Tanszek ( Site 1508) Debrecen, Hajdú-Bihar | |
| Detecta Clínica ( Site 2751) Lima, | |
| Dokkyo Medical University Hospital ( Site 1152) Shimotsuga-gun, Tochigi | |
| Dolnoslaskie Centrum Onkologii Pulmonologii i Hematologii ( Site 1765) Wroclaw, Lower Silesian Voivodeship | |
| Dunedin Hospital ( Site 2202) Dunedin, Otago | |
| Eastern CT Hematology & Oncology Associates ( Site 0202) Norwich, Connecticut | |
| Ellis Fischel Cancer Center ( Site 0133) Columbia, Missouri | |
| Elliston Place Medical Oncology & Hematology ( Site 0215) Nashville, Tennessee | |
| Erciyes Universitesi Tıp Fakultesi Hastaneleri ( Site 2009) Kayseri, | |
| Errikos Dunant Hospital Center ( Site 1457) Athens, Attica | |
| FALP ( Site 2551) Santiago, Region M. de Santiago | |
| FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 2603) Bogotá, Bogota D.C. | |
| Faculty of Medicine - Khon Kaen University ( Site 2401) Muang, Changwat Khon Kaen | |
| Faculty of Medicine Siriraj Hospital ( Site 2403) Bangkoknoi, Bangkok | |
| Fejér Megyei Szent György Egyetemi Oktató Kórház ( Site 1506) Székesfehérvár, Fejér | |
| Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1656) Milan, | |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1653) Rome, Lazio | |
| Fondazione Policlinico Universitario Campus Bio-Medico ( Site 1660) Rome, Roma | |
| Frisius Medisch Centrum ( Site 1702) Leeuwarden, Provincie Friesland | |
| Fukushima Medical University Hospital ( Site 1151) Fukushima, | |
| Fundacion Intecnus ( Site 2456) Bariloche, Río Negro Province | |
| Fundacion Valle del Lili- CIC ( Site 2601) Cali, Valle del Cauca Department | |
| Grampians Health ( Site 2101) Ballarat, Victoria | |
| Gustave Roussy ( Site 1353) Villejuif, Île-de-France Region | |
| Guys Hospital ( Site 2057) London, London, City of | |
| Hacettepe Universite Hastaneleri ( Site 2001) Sıhhiye, Ankara | |
| Hadassah Medical Center ( Site 1605) Jerusalem, | |
| Hamilton Health Sciences - Juravinski Site ( Site 1104) Hamilton, Ontario | |
| Hematology-Oncology Associates of CNY ( Site 0164) East Syracuse, New York | |
| Hiroshima University Hospital ( Site 1165) Hiroshima, | |
| Hospital Araújo Jorge ( Site 2514) Goiânia, Goiás | |
| Hospital Clinic de Barcelona ( Site 1919) Barcelona, | |
| Hospital General Universitario Gregorio Maranon ( Site 1912) Madrid, | |
| Hospital Insular de Gran Canaria ( Site 1911) Canarias, Canary Islands | |
| Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 2459) Ciudad Autonoma de Buenos Aires., Buenos Aires | |
| Hospital Moinhos de Vento ( Site 2510) Porto Alegre, Rio Grande do Sul | |
| Hospital Nossa Senhora Da Conceicao ( Site 2512) Porto Alegre, Rio Grande do Sul | |
| Hospital Quiron Malaga ( Site 1914) Málaga, | |
| Hospital Tacchini ( Site 2506) Bento Gonçalves, Rio Grande do Sul | |
| Hospital Universitari Vall D Hebron ( Site 1910) Barcelona, | |
| Hospital Universitario Quiron Madrid ( Site 1913) Pozuelo de Alarcón, Madrid | |
| Hospital Universitario San Ignacio ( Site 2610) Bogotá, Bogota D.C. | |
| Hospital de Amor - Barretos ( Site 2511) Barretos, São Paulo | |
| Hospital de Clínicas de Passo Fundo ( Site 2504) Passo Fundo, Rio Grande do Sul | |
| Hospital of the University of Occupational and Environmental Health, Japan ( Site 1166) Kitakyushu, Fukuoka | |
| Houston Methodist Cancer Center ( Site 0191) Houston, Texas | |
| IEO Istituto Europeo di Oncologia ( Site 1655) Milan, | |
| IMAT S.A.S ( Site 2602) Montería, Departamento de Córdoba | |
| IRCCS Istituto Oncologico Veneto ( Site 1654) Padova, | |
| IUCPQ ( Site 1112) Québec, Quebec | |
| Icahn School of Medicine at Mount Sinai ( Site 0116) New York, New York | |
| Institut Cœur Poumon -CHU Lille ( Site 1352) Lille, Nord | |
| Institut De Cancerologie De L Ouest ( Site 1357) Saint-Herblain, Loire-Atlantique | |
| Instituto Medico Especializado Alexander Fleming ( Site 2457) Buenos Aires, | |
| Instituto Nacional de Câncer - INCA ( Site 2501) Rio de Janeiro, | |
| Instituto Oncologico de Cordoba -IONC ( Site 2455) Córdoba, | |
| Instituto de Oncologia Saint Gallen ( Site 2507) Santa Cruz do Sul, Rio Grande do Sul | |
| Institutul Regional de Oncologie ( Site 1804) Iași, | |
| Instytut Gruzlicy i Chorob Pluc w Warszawie ( Site 1764) Warsaw, Masovian Voivodeship | |
| Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1657) Naples, | |
| Istituto Nazionale Tumori Regina Elena ( Site 1651) Rome, Roma | |
| Jeroen Bosch Hospital ( Site 1701) 's-Hertogenbosch, North Brabant | |
| Jessa Ziekenhuis ( Site 1204) Hasselt, Limburg | |
| Kanagawa Cancer Center ( Site 1158) Yokohama, Kanagawa | |
| Karadeniz Technical University ( Site 2008) Trabzon, | |
| Karolinska Universitetssjukhuset Solna ( Site 1951) Stockholm, Stockholm County | |
| Kindai University Hospital ( Site 1162) Sakai, Osaka | |
| Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 1105) Kingston, Ontario | |
| Klinikverbund Allgäu gGmbH ( Site 1408) Kempten (Allgäu), Bavaria | |
| Koo Foundation Sun Yat-Sen Cancer Center ( Site 2359) Taipei, | |
| Krakowski Szpital Specjalistyczny im. Jana Pawla II ( Site 1756) Krakow, Lesser Poland Voivodeship | |
| Lake Regional Hospital-Cancer Center ( Site 0123) Osage Beach, Missouri | |
| Lakeridge Health ( Site 1107) Oshawa, Ontario | |
| Leicester Royal Infirmary ( Site 2051) Leicester, | |
| Liga Norte Riograndense Contra o Cancer ( Site 2513) Natal, Rio Grande do Norte | |
| MBAL Uni Hospital ( Site 1253) Panagyurishte, Pazardzhik | |
| MD Anderson Cancer Center ( Site 0150) Houston, Texas | |
| MHAT - Heart and Brain ( Site 1252) Pleven, | |
| Maastricht UMC+ ( Site 1705) Maastricht, Limburg | |
| Mackay Memorial Hospital ( Site 2355) Taipei, | |
| Maharaj Nakorn Chiang Mai Hospital ( Site 2404) Muang, Chiang Mai | |
| Marienhaus Klinikum Mainz ( Site 1403) Mainz, Rhineland-Palatinate | |
| Maryland Oncology Hematology (MOH) ( Site 8102) Rockville, Maryland | |
| Massachusetts General Hospital ( Site 0136) Boston, Massachusetts | |
| McGill University Health Centre ( Site 1103) Montreal, Quebec | |
| Meander Medisch Centrum ( Site 1703) Amersfoort, Utrecht | |
| Meir Medical Center ( Site 1606) Kfar Saba, | |
| Memorial Hermann Cancer Center ( Site 0172) Houston, Texas | |
| Memorial Sloan Kettering Cancer Center ( Site 0137) New York, New York | |
| Metropolitan Hospital ( Site 1459) Athens, Attica | |
| Miami Cancer Institute at Baptist Health, Inc. ( Site 0214) Miami, Florida | |
| Michael E. DeBakey VA Medical Center ( Site 0197) Houston, Texas | |
| Montefiore Medical Center ( Site 0160) The Bronx, New York | |
| Mátrai Gyógyintézet ( Site 1504) Mátraháza, Heves County | |
| Namık Kemal University Medical Faculty ( Site 2007) Tekirdağ, Tekirdas | |
| National Cancer Center ( Site 2305) Goyang-si, Kyonggi-do | |
| National Cancer Center Hospital ( Site 1156) Chūō, Tokyo | |
| National Cancer Centre Singapore ( Site 2251) Singapore, Central Singapore | |
| National Cheng Kung University Hospital ( Site 2354) Tainan, | |
| National Hospital Organization Kyushu Cancer Center ( Site 1167) Fukuoka, | |
| National Taiwan University Cancer Center (NTUCC) ( Site 2360) Taipei, | |
| Nottingham City Hospital ( Site 2058) Nottingham, Nottinghamshire | |
| Novant Health Forsyth Medical Center ( Site 0166) Winston-Salem, North Carolina | |
| Novant Health Weisiger Cancer Insititute ( Site 0266) Charlotte, North Carolina | |
| O'Quinn Medical Tower at McNair Campus ( Site 0131) Houston, Texas | |
| ONCOCENTRO APYS ( Site 2554) Viña del Mar, Valparaiso | |
| Okayama University Hospital ( Site 1164) Okayama, | |
| Oncologos del Occidente ( Site 2608) Pereira, Risaralda Department | |
| One Clinical Research ( Site 2103) Nedlands, Western Australia | |
| Orlandi Oncologia ( Site 2555) Santiago, Region M. de Santiago | |
| Orszagos Koranyi Pulmonologiai Intezet ( Site 1501) Budapest, | |
| Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 1161) Osaka, | |
| Ospedale Santa Maria delle Croci ( Site 1652) Ravenna, Emilia-Romagna | |
| Oulun yliopistollinen sairaala ( Site 1301) Oulu, Northern Savonia | |
| Papageorgiou General Hospital of Thessaloniki ( Site 1454) Thessaloniki, | |
| Petz Aladár Megyei Oktató Kórház ( Site 1502) Győr, Győr-Moson-Sopron | |
| Pitie Salpetriere University Hospital ( Site 1355) Paris, | |
| Pius Hospital Oldenburg ( Site 1407) Oldenburg, Lower Saxony | |
| Princess Alexandra Hospital ( Site 2102) Woolloongabba, Queensland | |
| Providence St. Jude Medical Center ( Site 0106) Fullerton, California | |
| Queen Alexandra Hospital ( Site 2059) Portsmouth, | |
| Queen Elizabeth II Health Sciences Centre ( Site 1101) Halifax, Nova Scotia | |
| ROYAL MARSDEN HOSPITAL (CHELSEA)-Lung Unit ( Site 2075) London, Kensington and Chelsea | |
| Radboudumc ( Site 1706) Nijmegen, Gelderland | |
| Ramathibodi Hospital ( Site 2405) Ratchathewi, Bangkok | |
| Rambam Health Care Campus ( Site 1603) Haifa, | |
| Reformatus Pulmonologiai Centrum-Onkopulmonologiai Jarobeteg Centrum ( Site 1505) Törökbálint, Pest County | |
| Robert-Bosch-Krankenhaus ( Site 1401) Stuttgart, Baden-Wurttemberg | |
| Roswell Park Cancer Institute ( Site 0184) Buffalo, New York | |
| Royal Free Hospital ( Site 2074) London, London, City of | |
| Royal Marsden Hospital (Sutton) ( Site 2076) London, London, City of | |
| S.C. ONCO CARD S.R.L ( Site 1805) Brasov, | |
| SUNY Upstate Cancer Center ( Site 0140) Syracuse, New York | |
| Sakarya Universitesi Tip Fakultesi Hastanesi ( Site 2006) Adapazarı, Sakarya | |
| Samsung Medical Center ( Site 2304) Seoul, | |
| Seoul National University Hospital ( Site 2303) Seoul, | |
| Seoul St. Mary's Hospital ( Site 2307) Seoul, | |
| Severance Hospital Yonsei University Health System ( Site 2302) Seoul, | |
| Shaare Zedek Medical Center ( Site 1601) Jerusalem, | |
| Sheba Medical Center ( Site 1602) Ramat Gan, | |
| Shizuoka Cancer Center ( Site 1160) Sunto-gun, Shizuoka | |
| Somogy Vármegyei Kaposi Mór Oktató Kórház-Oncology center ( Site 1507) Kaposvár, Somogy County | |
| Songklanagarind Hospital ( Site 2402) Hat Yai, Changwat Songkhla | |
| St Bartholomews Hospital ( Site 2052) London, London, City of | |
| St James University Hospital ( Site 2055) Leeds, | |
| St. James's Hospital ( Site 1554) Dublin, | |
| St. Joseph Medical Center Hematology and Oncology - Silverdale ( Site 0192) Silverdale, Washington | |
| St. Lukes Hospital and Health Network ( Site 0186) Bethlehem, Pennsylvania | |
| St. Marianna University Hospital ( Site 1159) Kawasaki, Kanagawa | |
| St.-Antonius-Hospital ( Site 1411) Eschweiler, North Rhine-Westphalia | |
| Sunnybrook Research Institute ( Site 1106) Toronto, Ontario | |
| Swedish Cancer Institute ( Site 0143) Seattle, Washington | |
| Swietokrzyskie Centrum Onkologii. ( Site 1754) Kielce, Świętokrzyskie Voivodeship | |
| TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi ( Site 2003) Istanbul, | |
| THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA"-3rd Dept of Internal Medicine and Laboratory, Oncol ( Site 1451) Athens, Attica | |
| Taipei Medical University Hospital ( Site 2352) Taipei, | |
| Taipei Veterans General Hospital ( Site 2357) Taipei, | |
| Tallaght University Hospital ( Site 1551) Dublin, | |
| Tan Tock Seng Hospital ( Site 2252) Singapore, Central Singapore | |
| Tasman Oncology Research ( Site 2104) Southport, Queensland | |
| Tauranga Hospital-Bay of Plenty Clinical Trials Unit ( Site 2201) Tauranga, Bay of Plenty | |
| Tennessee Oncology, PLLC - Chattanooga Downtown ( Site 0315) Chattanooga, Tennessee | |
| Texas Oncology - DFW ( Site 8103) Dallas, Texas | |
| The Blavatnik Family- Chelsea Medical Center at Mount Sinai ( Site 0216) New York, New York | |
| The Catholic University of Korea St. Vincent s Hospital ( Site 2301) Suwon, Kyonggi-do | |
| The Christie NHS Foundation Trust ( Site 2066) Manchester, | |
| The Clatterbridge Cancer Centre ( Site 2069) Metropolitan Borough of Wirral, | |
| The Oncology Institute of Hope and Innovation - Fort Lauderdale ( Site 0156) Fort Lauderdale, Florida | |
| The University of Arizona Cancer Center - North Campus ( Site 0163) Tucson, Arizona | |
| The University of Chicago Medical Center ( Site 0118) Chicago, Illinois | |
| The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center ( Site 0148) Tyler, Texas | |
| Thompson Cancer Survival Center ( Site 0168) Knoxville, Tennessee | |
| Thoraxklinik-Heidelberg gGmbH ( Site 1412) Heidelberg, Baden-Wurttemberg | |
| Tokyo Medical University Hospital ( Site 1157) Shinjuku, Tokyo | |
| Turku University Hospital ( Site 1303) Turku, Southwest Finland | |
| UCHealth Memorial Hospital Central ( Site 0125) Colorado Springs, Colorado | |
| UCLA Jonsson Comprehensive Cancer Center ( Site 0135) Los Angeles, California | |
| UCSF Medical Center at Mission Bay ( Site 0178) San Francisco, California | |
| UKGM Gießen/Marburg ( Site 1404) Giessen, Hesse | |
| UNIVERSITY HOSPITAL OF PATRAS-DIVISION OF ONCOLOGY ( Site 1452) Pátrai, Achaia | |
| USC Norris Comprehensive Cancer Center ( Site 0205) Los Angeles, California | |
| UT Southwestern Medical Center ( Site 0190) Dallas, Texas | |
| UZ Gent ( Site 1201) Ghent, Oost-Vlaanderen | |
| University General Hospital of Herakleion ( Site 1458) Heraklion, Irakleio | |
| University General Hospital of Larissa-Oncology Clinic ( Site 1453) Larissa, Thessaly | |
| University Medical Center Groningen ( Site 1707) Groningen, | |
| University of Cincinnati Medical Center ( Site 0119) Cincinnati, Ohio | |
| University of Colorado Anschutz Medical Campus ( Site 0151) Aurora, Colorado | |
| Universitätsklinikum Münster - Albert Schweitzer Campus ( Site 1405) Münster, North Rhine-Westphalia | |
| Uniwersyteckie Centrum Kliniczne ( Site 1758) Gdansk, Pomeranian Voivodeship | |
| VA Long Beach Healthcare System ( Site 0199) Long Beach, California | |
| VCU Health Adult Outpatient Pavillion ( Site 0193) Richmond, Virginia | |
| Virginia Cancer Specialists ( Site 0167) Fairfax, Virginia | |
| Virginia Oncology Associates (VOA) ( Site 8101) Norfolk, Virginia | |
| Waikato Hospital ( Site 2204) Hamilton, Waikato Region | |
| Wakayama Medical University Hospital ( Site 1163) Wakayama, | |
| Warmińsko - Mazurskie Centrum Chorób Płuc w Olsztynie ( Site 1760) Olsztyn, Warmian-Masurian Voivodeship | |
| Westchester Medical Center ( Site 0196) Valhalla, New York | |
| Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 1763) Poznan, Greater Poland Voivodeship | |
| Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1759) Przemyśl, Podkarpackie Voivodeship | |
| Yale University School of Medicine ( Site 0201) New Haven, Connecticut |
Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer (ECHO)
Maureen A Lemens, BSN - lemens.maureen@mayo.edu
NCT05051722
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Inclusion Criteria for Cohort 1:
Patients will be ≥45 years of age and meet one of the following criteria:
* Abnormal uterine bleeding
* Postmenopausal bleeding
OR
Patients ages 18 - 44 years of age and meet these criteria
* Abnormal uterine bleeding
* One risk factor for endometrial cancer (BMI ≥30 or PCOS or Tamoxifen use)
Exclusion Criteria for Cohort 1:
* Prior hysterectomy
* Current known pregnancy diagnosis
* Any prior pelvic or vaginal radiotherapy
* Any prior cancer (except basal cell skin cancer) within the past 5 years
* Chemotherapy within the past 5 years
* Current biopsy-proven cervical, vaginal, or vulvar cancer or lower genital tract dysplasia
* Current biopsy-proven endometrial cancer or endometrial hyperplasia
* Current biopsy-proven benign endometrial polyp
* Endometrial biopsy/sampling within the preceding 1 month showing benign endometrium
Inclusion Criteria for Cohort 2:
Patients will be ≥18 years of age and meet at least one of the following criteria:
* Presence of biopsy-proven EC (any histology, including uterine carcinosarcoma) and surgical intervention planned. Surgical intervention can include any of the following: hysterectomy, D\&C, hysteroscopic resection
* Biopsy showing AEH or EIN with surgical intervention planned. Surgical intervention can include any of the following: hysterectomy, D\&C, hysteroscopic resection, etc)
Exclusion Criteria for Cohort 2:
* Undergoing surgical procedure for recurrent or metastatic EC
* Received preoperative neoadjuvant chemotherapy or radiotherapy for current EC diagnosis
* Prior hysterectomy
* Current known pregnancy diagnosis
* Prior or current biopsy-proven cervical cancer
* Presence of concomitant biopsy-proven cervical dysplasia
* Any prior pelvic or vaginal radiotherapy
* Any prior cancer (except basal cell skin cancer) within the past 5 years
* Chemotherapy within the past 5 years
* Prior intervention or surgery with intent to completely remove the target pathology
Inclusion Criteria for Cohort 3:
Patients will be ≥18 years of age, have a cervix and meet at least one of the following criteria:
* History of current abnormal cervical/endocervical Pap test for which the patient is presenting for colposcopy
* Cervical mass identified on physical exam and patient referred for cervical biopsy, even if colposcopy not recommended or indicated
* Planned clinically indicated surgical excisional biopsy or removal of the cervix (cold knife cone, LEEP, hysterectomy) for abnormal Pap test, cervical dysplasia, cervical mass, or biopsy-proven invasive cervical cancer (adenocarcinoma, squamous cell carcinoma, adenosquamous carcinoma, or less common primary cervical carcinomas all eligible)
Exclusion Criteria for Cohort 3:
* History of pelvic or vaginal radiotherapy
* Prior total hysterectomy (cervix removed) for any indication
* Current known pregnancy diagnosis
* Cervical mass biopsy-proven to be EC or a cancer metastatic from a non-cervical origin
* Any prior cancer (except basal cell skin cancer) within the past 5 years
* Chemotherapy within the past 5 years
* Patients presenting for colposcopy as part of lower genital tract dysplasia or cancer surveillance after prior curative intent treatment and no current Pap abnormality or cervical mass
* Prior intervention or surgery with intent to completely remove the target pathology for the current lesion / diagnosis during the current episode
Inclusion Criteria for Cohort 4:
Patients will be ≥45 years of age and should meet at least one of the following criteria:
* Undergoing hysterectomy with biopsy-proven or clinically presumed (based on imaging and/or clinical symptoms) benign gynecologic or uterine pathology of fibroids, endometriosis, adenomyosis, or benign endometrial polyps.
* Undergoing any gynecologic surgery in which a benign pathologic tissue diagnosis of fibroids, endometriosis, adenomyosis, or benign endometrial polyp is anticipated to be confirmed.
Exclusion Criteria for Cohort 4:
* Endometrial biopsy or office hysteroscopy within 2 weeks preceding the planned gynecologic surgery procedure for fibroids, endometriosis, benign endometrial polyps, or adenomyosis
* Any surgery within the past 3 months
* Prior hysterectomy
* Current known pregnancy diagnosis
* Prior or current biopsy-proven gynecologic cancer
* Current biopsy-proven AEH/EIN, cervical, vaginal, or vulvar dysplasia
* Prior pelvic or vaginal radiotherapy
* Any prior cancer (except basal cell skin cancer) within the past 5 years
* Chemotherapy within the past 5 years
* Undergoing hysterectomy for prolapse without a coexisting known or presumed benign uterine pathologic diagnosis of fibroids, endometriosis, benign endometrial polyps, or adenomyosis
* Prior intervention or surgery with intent to completely remove the target pathology for the current lesion / diagnosis during the current episode
Inclusion Criteria for Cohort 5:
Patients with a uterus will be ≥45 years of age and should meet the following criteria:
* Presenting for GYN wellness exam, ± Pap test
* No change in medical conditions, new diagnoses, or new medications within the past 6 months
Exclusion Criteria for Cohort 5:
* Pap test or cervical biopsy within the past 1 month
* Endometrial biopsy or office hysteroscopy within the past 1 month
* Any surgery within the past 3 months
* Prior hysterectomy
* Current known pregnancy diagnosis
* Prior or current biopsy-proven gynecologic cancer
* Current biopsy-proven AEH/EIN, cervical, vaginal, or vulvar dysplasia
* Prior pelvic or vaginal radiotherapy
* Any prior cancer (except basal cell skin cancer) within the past 5 years
* Chemotherapy within the past 5 years
* Criteria met for inclusion in any of the other study cohorts
Inclusion Criteria for Cohort 6:
Patients ≥50 years of age and:
* Postmenopausal
* At least 1 intact ovary
* Diagnosis of an adnexal mass or a clinical suspicion of early-stage ovarian cancer (including fallopian tube cancer)
* Planned surgery for the adnexal mass
* For vaginal fluid collection, patient must have a uterus, cervix and at least 1 intact fallopian tube\* (without prior tubal ligation/occlusion)
Exclusion criteria for Cohort 6:
* Any current or prior cancer diagnosis (except basal cell or squamous cell skin cancer, non-gyn)
* Chemotherapy for cancer treatment within the past 5 years prior to collection
* Clinically suspected advanced stage ovarian cancer (Stage III or IV) on presentation, if known prior to specimen collection
* Surgical candidates for recurrent ovarian cancer
* History of pelvic or vaginal radiation therapy
* Known current synchronous endometrial cancer or hyperplasia
* Known current cervical, vaginal, or vulvar dysplasia
Inclusion criteria for Cohort 7:
Women will be ≥18 years of age and meet the following criteria:
* Presence of clinically probable ovarian, fallopian tube, or primary peritoneal cancer (all under the umbrella of OC) based on clinical findings of any/all of the following: imaging showing adnexal and/or abdominal masses consistent with probable ovarian cancer, omental caking, elevated CA125, ascites, imaging-guided biopsy consistent with OC pathology
* Newly diagnosed with ovarian, fallopian tube or primary peritoneal cancer without neoadjuvant therapy
* At least one intact ovary
* For vaginal fluid collection, patient must have a uterus, cervix and at least 1 intact fallopian tube\* (without prior tubal ligation/occlusion)
Exclusion criteria for Cohort 7:
* Patients with recurrent OC
* Any current or prior cancer diagnosis (except basal cell or squamous cell skin cancer, non-gyn) within the past 5 years
* Chemotherapy for cancer treatment within the past 5 years prior to collection
* History of pelvic or vaginal radiation therapy
* Known current synchronous endometrial cancer or hyperplasia
* Known current cervical, vaginal, or vulvar dysplasia
* Current known pregnancy diagnosis
DIAGNOSTIC_TEST: Vaginal Fluid Collection, DIAGNOSTIC_TEST: Blood Collection
Endometrial Cancer, Cervical Cancer, Atypical Endometrial Hyperplasia, Cervical Dysplasia, Adnexal Mass, Ovarian Cancer
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Show 24 locations
Study Locations
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| Location | Contacts |
|---|---|
| Altru Health System Grand Forks, North Dakota | Alexis Tatum, CRC - (atatum@altru.org) Tina Schmitz, BSN - (tkschmitz@altru.org) |
| Cleveland Clinic Cleveland, Ohio | Tori Carpenter, CRC - (carpent3@ccf.org) Sarah Neale, CRC - (neales@ccf.org) |
| Genoma Research, Inc. Miami, Florida | Laura Lucia, BHSc, CRC - (lauralucia@genoma.comcastbiz.net) |
| Mayo Clinic Rochester, Minnesota | Favy Trujillo - (trujillo.faviola@mayo.edy) |
| Mayo Clinic Rochester, Minnesota | Ashley N Shelton, CRC - (Shelton.Ashley@mayo.edu) |
| Mayo Clinic Rochester, Minnesota | Maureen A Lemens, BSN - (lemens.maureen@mayo.edu) |
| Mayo Clinic Health System - Northwest Wisconsin Eau Claire, Wisconsin | Stephanie L Larson, ACRC - (larson.stephanie3@mayo.edu) Christina M Scinto, ACRC - (cinto.christina@mayo.edu) |
| Mayo Clinic Health System - Southwest Wisconsin La Crosse, Wisconsin | Kate L Zboralski, ACRC - (zboralski.kathryn@mayo.edu) Taylor Cammer, ACRC - (cammer.taylor@mayo.edu) |
| Medical Colleagues of Texas, LLP Katy, Texas | Erika Keller, CRC - (erika.keller@elligodirect.com) Gabriella Coletta, CRC - (gabiella.coletta@elligodirect.com) |
| Medical College of Wisconsin Milwaukee, Wisconsin | |
| My GYN Care Miami, Florida | |
| Ochsner Clinic Foundation Jefferson, Louisiana | Ashley Samuel, CRC - (ashley.samuel@ochsner.org) Veronica Hixon Calliet, BSN - (veronica.hixoncalliet@ochsner.org) |
| Orlando Health Orlando, Florida | Donya Shahnavaz, CRC - (donya.shahnavaz@orlandohealth.com) Bianca Henry, CRC - (bianca.henry@orlandohealth.com) |
| Piedmont Healthcare Atlanta, Georgia | Dionne Jean, CRC - (dionne.jean@piedmont.org) |
| Providea Health Partners, LLC Evergreen Park, Illinois | |
| Sarasota Memorial Health Care System Sarasota, Florida | Rachael Sanacore - (Rachael-Sanacore@smh.com) Megan Swiger - (Megan-Swiger@smh.com) |
| Signature Women's Healthcare, LLC Pembroke Pines, Florida | |
| The Woman's Health Pavilion Westbury, New York | Monica Martinez, CRC - (mmartinez@ilovemygyn.com) |
| The Woman's Health Pavilion Westbury, New York | Monica Martinez, CRC - (mmartinez@ilovemygyn.com) |
| Total Women's Care of the Heights Houston, Texas | Tatiana Rivera - (ma@twcheights.com) |
| University of Chicago Chicago, Illinois | Calla O'Connor, MPH - (calla.oconnor@bsd.uchicago.edu) Veronika Sesari - (vseseri@bsd.uchicago.edu) |
| University of Mississippi Medical Center Jackson, Mississippi | Adriana Dodson, RN - (adodson2@umc.edu) Kenna H Nettles, PA-C - (knettles1@umc.edu) |
| Valley OB-GYN Clinic Saginaw, Michigan | Jacqueline Lang, CCRC - (jacqueline.lang@elligodirect.com) |
| Virginia Commonwealth University/ Massey Cancer Center Richmond, Virginia | Morgan DeHart - (dehart2@vcu.edu) Faith McFadden, MSN - (mcfaddenfr@vcu.edu) |
A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease (AXemplify-357)
Incyte Corporation Call Center (US) - medinfo@incyte.com
NCT06585774
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Inclusion Criteria:
* ≥ 12 years of age at the time of informed consent.
* New-onset moderate or severe cGVHD, as defined by the 2014 NIH Consensus Development Project Criteria for Clinical Trials in cGVHD, requiring systemic therapy.
* History of allo-HCT from any donor HLA type (related or unrelated donor with any degree of HLA matching) using any graft source (bone marrow, peripheral blood stem cells, or cord blood). Recipients of myeloablative, nonmyeloablative, or reduced-intensity conditioning are eligible.
* Adequate hematologic function with ANC ≥ 0.5 × 109/L independent of growth factors for at least 7 days prior to study entry.
* Willingness to avoid pregnancy or fathering children.
Exclusion Criteria:
* Received more than 1 prior allo-HCT. Prior autologous HCT is allowed.
* Has overlap cGVHD, defined as simultaneous presence of features or characteristics of aGVHD in a patient with cGVHD.
* Received more than 7 days of systemic corticosteroid treatment for cGVHD or unable to begin a prednisone dose ≥ 1.0 mg/kg per day (or methylprednisolone equivalent) for cGVHD.
* Received previous systemic treatment for cGVHD, including extracorporeal photopheresis.
* Systemic treatment with CNIs or mTOR inhibitors started within 2 weeks prior to C1D1.
* Prior treatment with CSF-1R targeted therapies.
* Active, uncontrolled bacterial, fungal, parasitic, or viral infection.
* Evidence of relapse of the primary hematologic disease or treatment for relapse after the allo-HCT was performed, including DLIs for the treatment of molecular relapse.
* History of acute or chronic pancreatitis.
* Active symptomatic myositis.
* History or current diagnosis of cardiac disease indicating significant risk of safety for participation in the study, such as uncontrolled or significant cardiac disease.
* Severe renal impairment, that is, estimated CrCl \< 30 mL/min measured or calculated by Cockcroft-Gault equation in adults and Schwartz formula in pediatric participants, or endstage renal disease on dialysis.
* Impaired liver function, defined as total bilirubin \> 1.5 × ULN and/or ALT and AST \> 3 × ULN in participants with no evidence of liver cGVHD.
* Pregnant or breastfeeding.
Other protocol-defined Inclusion/Exclusion Criteria may apply. DRUG: INCA034176, DRUG: Placebo, DRUG: Corticosteroids
Chronic Graft-versus-host-disease
cGVHD
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Show 125 locations
Study Locations
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| Location | Contacts |
|---|---|
| ASST degli Spedali Civili di Brescia Brescia, | |
| Akh Und Medizinische Universitat Wien Universitatsklinik Fur Innere Medizin I Vienna, | |
| Alberta's Children Hospital Calgary, Alberta | |
| Amsterdam University Medical Centre Amsterdam, | |
| Anjo Kosei Hospital Aichi-ken, | |
| Aou Policlinico Consorziale Di Bari Bari, | |
| Austin Health Medical Oncology and Clinical Haematology Heidelberg, Victoria | |
| Azienda Ospedaliera Card. G. Panico Tricase, | |
| Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello Palermo, | |
| Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli Naples, | |
| Azienda Ospedaliero Universitaria Policlinico G.Rodolico San Marco Catania, | |
| Azienda Ospedaliero Universitaria delle Marche Ancona, | |
| Azienda Ospedaliero-Universitaria Di Alessandria Ss.Antonio E Biagio E Cesare Arrigo Alessandria, | |
| Azienda Policlinico Umberto 1 Universita Sapienza Di Roma Rome, | |
| Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda Milan, | |
| BC Children's Hospital Vancouver, British Columbia | |
| Baptist Cancer Center Memphis, Tennessee | |
| Bristol Haematology and Oncology Centre Bristol, | |
| CHU Amiens PICARDIE - Hopital SUD Amiens, | |
| Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hotel-Dieu Nantes, | |
| Centro Ricerche Cliniche di Verona Verona, | |
| Charité Universitätsmedizin Berlin Berlin, | |
| Childrens National Hospital Washington D.C., District of Columbia | |
| Chu de Nice - Hospital L Archet Nice, | |
| Colorado Blood Cancer Institute Denver, Colorado | |
| Corewell Health Hematology Oncology Grand Rapids, Michigan | |
| Dana Farber Cancer Institute Boston, Massachusetts | |
| Emory University-Winship Cancer Institute Atlanta, Georgia | |
| Fujita Health University Hospital Aichi, | |
| Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli Reggio Calabria, | |
| Gunma Saiseikai Maebashi Hospital Maebashi, | |
| Hackensack University Medical Center Hackensack, New Jersey | |
| Henry Ford Hospital Detroit, Michigan | |
| Hiroshima University Hospital Hiroshima, | |
| Hokkaido University Hospital Sapporo Hokkaido, | |
| Hopitaux De Brabois Nancy, | |
| Hospices Civils de Lyon Centre Hospitalier Lyon Sud Pierre-Bénite, | |
| Hospital De La Santa Creu I Sant Pau Barcelona, | |
| Hospital General Universitario Gregorio Marañon Madrid, | |
| Hospital General Universitario Vall D Hebron Barcelona, | |
| Hospital Maisonneuve Rosemont Montreal, Quebec | |
| Hospital Puerta De Hierro Majadahonda, | |
| Hospital Saint Antoine Paris, | |
| Hospital Saint Louis Paris, | |
| Hospital Universitari i Politécnic La Fe Valencia, | |
| Hospital Universitario Donostia Donostia / San Sebastian, | |
| Hospital Universitario Miguel Servet Zaragoza, | |
| Hospital Universitario Virgen del Rocio Seville, | |
| Hospital Universitario de Gran Canaria Doctor Negrín Las Palmas de Gran Canaria, | |
| I.R.C.C.S. Casa Sollievo Della Sofferenza San Giovanni Rotondo, | |
| IRCCS Azienda Ospedaliera Universitaria San Martino Genova, | |
| Innsbruck University Hospital Innsbruck, | |
| Institut Catala Doncologia Ico - Hospital Duran I Reynals Location L'Hospitalet de Llobregat, | |
| Institut Paoli Calmettes Marseille, | |
| Intermountain Blood and Marrow Transplant Salt Lake City, Utah | |
| Irccs Fondazione Policlinico San Matteo Pavia, | |
| Jefferson University Hospitals Philadelphia, Pennsylvania | |
| John Hopkins Hospital Baltimore, Maryland | |
| Juravinski Cancer Centre Hamilton, Ontario | |
| Klinikum Der Philipps-Universitaet Marburg Marburg, | |
| Kobe City Medical Center General Hospital Hyōgo, | |
| Kyushu University Hospital Fukuoka, | |
| Landeskrankenhaus Universitatsklinikum Graz Graz, | |
| Maastricht University Medical Center Maastricht, | |
| Manchester University NHS Foundation Trust Manchester, | |
| Massachusetts General Hospital Boston, Massachusetts | |
| Medical University of South Carolina Charleston, South Carolina | |
| Memorial Cancer Institute Pembroke Pines, Florida | |
| Miami Cancer Institute Miami, Florida | |
| National Hospital Organization Kumamoto Medical Center Kumamoto Kumamoto, | |
| Northwestern Memorial Hospital Chicago, Illinois | |
| Nottingham University Hospitals Nottingham, | |
| Okayama University Hospital Okayama Okayama, | |
| Ordensklinikum Linz GmbH Elisabethinen LINZ CET, | |
| Oregon Health and Science University Portland, Oregon | |
| Orlando Health Cancer Institute Downtown Orlando Orlando, Florida | |
| Osaka Metropolitan University Hospital Osaka, | |
| Ospedale Pediatrico Bambino Gesu Irccs Rome, | |
| Ospedale San Raffaele - Milano Milan, | |
| Plymouth Hospitals NHS Trust Plymouth, | |
| Princess Margaret Cancer Center Toronto, Ontario | |
| Prisma Health Upstate Greenville, South Carolina | |
| Queen Elizabeth II Health Sciences Centre Halifax, Nova Scotia | |
| Queen Elizabeth University Hospital Glasgow, | |
| Rigshospitalet Copenhagen, | |
| Royal Adelaide Hospital Adelaide, South Australia | |
| Royal Marsden Hospital London, | |
| Royal Prince Alfred Hospital Sydney, New South Wales | |
| Rutgers Cancer Institute of Nj New Brunswick, New Jersey | |
| St David'S South Austin Medical Center Austin, Texas | |
| St. Anna Childrens Hospital Vienna, | |
| St. James Hospital Dublin, | |
| Stollery Children's Hospital Edmonton, Alberta | |
| Stony Brook University Medical Center Stony Brook, New York | |
| Texas Transplant Institute San Antonio, Texas | |
| The University of Kansas Cancer Center Kansas City, Kansas | |
| Tohoku University Hospital Miyagi, | |
| Tokai University Hospital Isehara Kanagawa, | |
| Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital Tokyo, | |
| UCSF San Francisco, California | |
| Universitaetsklinikum Bonn, University Hospital Bonn Bonn, | |
| Universitaetsklinikum Erlangen Erlangen, | |
| Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole Toulouse, | |
| Universitatsklinikum Essen Essen, | |
| Universitatsklinikum Halle (Saale) Halle, | |
| Universitatsklinikum Leipzig Leipzig, | |
| Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii Mainz, | |
| University Clinic Carl Gustav Carus Technical University Dresden Dresden, | |
| University College London Hospitals (UCLH) London, | |
| University Hospital Duesseldorf Düsseldorf, | |
| University Hospital Schleswig-Holstein Campus Kiel Kiel, | |
| University Hospital of Ulm, Universitatsklinikum Ulm Ulm, | |
| University Medical Center Rwth Aachen Aachen, | |
| University of Alabama Birmingham Birmingham, Alabama | |
| University of Arizona Cancer Center-Out Pt. Tucson, Arizona | |
| University of California San Diego Medical Center, Moores Cancer Center La Jolla, California | |
| University of Illinois Chicago, Illinois | |
| University of Michigan Ann Arbor, Michigan | |
| University of Rochester Medical Center Rochester, New York | |
| University of Southern California Los Angeles, California | |
| Universitätsklinikum Münster Münster, | |
| Vancouver General Hospital Vancouver, | |
| Virginia Commonwealth University Massey Cancer Center Richmond, Virginia | |
| Wake Forest Baptist Medical Center Winston-Salem, North Carolina | |
| West Virginia University Cancer Institute Morgantown, West Virginia |
A Clinical Study of Zilovertamab Vedotin (MK-2140) Plus Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Polatuzumab Vedotin Plus R-CHP in People With Diffuse Large B-cell Lymphoma (DLBCL) (MK-2140-011/waveLINE-011)
Toll Free Number - Trialsites@msd.com
NCT06890884
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Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
* Has histologically confirmed diagnosis of germinal center B-cell (GCB) subtype of diffuse large B-cell lymphoma (DLBCL), by prior biopsy, according to the World Health Organization (WHO) classification of neoplasms of the hematopoietic and lymphoid tissues.
* Has positron emission tomography (PET) positive disease at screening, defined as 4 to 5 on the Lugano 5-point scale.
* Has received no prior treatment for their DLBCL.
* Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART).
* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load prior to randomization.
* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
* Has a history of transformation of indolent disease to DLBCL.
* Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL) or Grey zone lymphoma.
* Has Ann Arbor Stage I DLBCL.
* Has clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (\<6 months prior to enrollment), myocardial infarction (\<6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class ≥II), or serious cardiac arrhythmia requiring medication.
* Has clinically significant pericardial or pleural effusion.
* Has ongoing Grade \>1 peripheral neuropathy.
* Has a demyelinating form of Charcot-Marie-Tooth disease.
* HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
* Has ongoing corticosteroid therapy.
* Known additional malignancy that is progressing or has required active treatment within the past 2 years.
* Known active central nervous system (CNS) lymphoma.
* Has active autoimmune disease that has required systemic treatment in the past 2 years.
* Has active infection requiring systemic therapy.
* Has active HBV (defined as HBsAg positive and detectable HBV deoxyribonucleic acid (DNA)) and HCV (defined as anti-HCV antibody positive and detectable HCV ribonucleic acid (RNA)) infection.
* Has history of stem cell/solid organ transplant. BIOLOGICAL: Zilovertamab vedotin, BIOLOGICAL: Rituximab, DRUG: Cyclophosphamide, DRUG: Doxorubicin, BIOLOGICAL: Rituximab Biosimilar, DRUG: Prednisone, DRUG: Prednisolone, BIOLOGICAL: Polatuzumab vedotin, DRUG: Rescue Medication
Lymphoma, Large B-Cell, Diffuse
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Show 138 locations
Study Locations
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| Location | Contacts |
|---|---|
| AZ Delta ( Site 0303) Roeselare, West-Vlaanderen | |
| AZ Sint-Maarten, Campus Leopoldstraat 2 ( Site 0306) Mechelen, Antwerpen | |
| Abramson Cancer Center and Perelman Center for Advanced Medicine ( Site 0131) Philadelphia, Pennsylvania | |
| Aichi Cancer Center ( Site 1007) Nagoya, Aichi-ken | |
| Alliance Cancer Specialists (ACS) ( Site 8010) Sellersville, Pennsylvania | |
| Arcispedale Santa Maria Nuova ( Site 0706) Reggio Emilia, | |
| Atlantic Health Morristown Medical Center ( Site 0163) Morristown, New Jersey | |
| Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO ( Site 0702) Palermo, | |
| Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo ( Site 0703) Alessandria, | |
| Baptist Health Hardin ( Site 0154) Elizabethtown, Kentucky | |
| Baptist Health Lexington ( Site 0127) Lexington, Kentucky | |
| Baptist MD Anderson Cancer Center ( Site 0176) Jacksonville, Florida | |
| Bass Medical Group ( Site 0123) Walnut Creek, California | |
| Beacon Cancer Care ( Site 0142) Post Falls, Idaho | |
| Beth Israel Deaconess Medical Center ( Site 0161) Boston, Massachusetts | |
| Boca Raton Regional Hospital-Lynn Cancer Institute ( Site 0130) Boca Raton, Florida | |
| Bozeman Health Deaconess Hospital ( Site 0183) Bozeman, Montana | |
| Bristol Haematology and Oncology Centre ( Site 0908) Bristol, Bristol, City of | |
| CHU HELORA asbl ( Site 0304) Mons, Brabant Wallon | |
| Cancer Care Associates Of York ( Site 0174) York, Pennsylvania | |
| Centrum für Hämatologie und Onkologie Bethanien ( Site 0417) Frankfurt am Main, Hesse | |
| Christie Hospital NHS Trust ( Site 0901) Manchester, | |
| Churchill Hospital ( Site 0903) Oxford, Oxfordshire | |
| City of Hope - Phoenix ( Site 0202) Goodyear, Arizona | |
| City of Hope Comprehensive Cancer Center ( Site 0191) Duarte, California | |
| Clatterbridge Cancer Centre - Liverpool ( Site 0911) Liverpool, | |
| Cleveland Clinic - Hillcrest Hospital-Hillcrest Hospital Cancer Center ( Site 0199) Mayfield Heights, Ohio | |
| Cleveland Clinic Main ( Site 0101) Cleveland, Ohio | |
| Cliniques Universitaires Saint-Luc ( Site 0302) Brussels, Bruxelles-Capitale, Region de | |
| Colorado West Healthcare System-Grand Valley Oncology ( Site 0165) Grand Junction, Colorado | |
| Dana Farber Cancer Institute ( Site 0111) Boston, Massachusetts | |
| Dietrich Bonhoeffer Klinikum-Neubrandenburg ( Site 0439) Neubrandenburg, Mecklenburg-Vorpommern | |
| Edith Wolfson Medical Center ( Site 0602) Holon, | |
| Erie County Medical Center ( Site 0175) Buffalo, New York | |
| Fairview Hospital-Moll Cancer Center ( Site 0198) Cleveland, Ohio | |
| Fujita Health University Hospital ( Site 1003) Toyoake, Aichi-ken | |
| Genesis Cancer and Blood Institute ( Site 0193) Hot Springs, Arkansas | |
| Georgetown University Medical Center ( Site 0117) Washington D.C., District of Columbia | |
| Guy s & St Thomas NHS Foundation Trust ( Site 0904) London, London, City of | |
| HELIOS Klinikum Wuppertal ( Site 0435) Wuppertal, North Rhine-Westphalia | |
| Haddasah Medical Center ( Site 0601) Jerusalem, | |
| Hammersmith Hospital ( Site 0915) London, London, City of | |
| Hokkaido University Hospital ( Site 1004) Sapporo, Hokkaido | |
| IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 0707) Meldola, Forli-Cesena | |
| Illinois Cancer Care ( Site 7005) Peoria, Illinois | |
| Infirmary Cancer Care ( Site 0157) Mobile, Alabama | |
| Intermountain Healthcare - St. George ( Site 0203) St. George, Utah | |
| Intermountain Medical Center ( Site 0182) Murray, Utah | |
| Ironwood Cancer & Research Centers ( Site 0204) Chandler, Arizona | |
| Istituto Clinico Humanitas ( Site 0704) Rozzano, Milano | |
| Istituto Europeo di Oncologia ( Site 0701) Milan, | |
| KRH Klinikum Siloah ( Site 0441) Hanover, Lower Saxony | |
| Kansai Medical University Hospital ( Site 1006) Hirakata, Osaka | |
| Klinikum Chemnitz gGmbH ( Site 0405) Chemnitz, Saxony | |
| Klinikum Stuttgart. Klinik fur Hamatologie. Onkologie. Palliativmedizin und Stammzelltransplantation ( Site 0419) Stuttgart, Baden-Wurttemberg | |
| LMU Klinikum ( Site 0428) Munich, Bavaria | |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 0108) New York, New York | |
| Lincoln County Hospital ( Site 0906) Lincoln, Lincolnshire | |
| Louisiana State University Health Sciences Shreveport ( Site 0195) Shreveport, Louisiana | |
| MEDICAL COLLEGE OF WISCONSIN ( Site 0103) Milwaukee, Wisconsin | |
| Mater Misercordiae University Hospital ( Site 0501) Dublin, | |
| Medical Oncology Hematology Consultants (MOHC) ( Site 8007) Newark, Delaware | |
| Medical University of South Carolina ( Site 0153) Charleston, South Carolina | |
| Mid Florida Hematology and Oncology Center ( Site 0152) Orange City, Florida | |
| Minnesota Oncology Hematology (MNO) ( Site 8004) Burnsville, Minnesota | |
| Mission Blood & Cancer Care ( Site 0114) Waukee, Iowa | |
| Mount Sinai Braman Comprehensive Cancer Center ( Site 0140) Miami Beach, Florida | |
| NHO Revive Research Institute, LLC ( Site 0121) Lincoln, Nebraska | |
| Nagasaki University Hospital ( Site 1008) Nagasaki, | |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0803) Warsaw, Masovian Voivodeship | |
| National Cancer Center Hospital ( Site 1009) Chūō, Tokyo | |
| National Hospital Organization Sendai Medical Center ( Site 1005) Sendai, Miyagi | |
| Nippon Medical School Hospital ( Site 1001) Bunkyo, Tokyo | |
| Northwest Cancer Specialists (Compass Oncology) ( Site 8000) Vancouver, Washington | |
| Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0185) Louisville, Kentucky | |
| Novant Health Forsyth Medical Center ( Site 0206) Winston-Salem, North Carolina | |
| Novant Health Presbyterian Medical Center ( Site 0177) Charlotte, North Carolina | |
| Ochsner Clinic Foundation ( Site 0189) New Orleans, Louisiana | |
| Ochsner LSU Health - Monroe Medical Center, Family Medicine Clinic ( Site 0209) Monroe, Louisiana | |
| Optum Medical Care, PC ( Site 0122) Westbury, New York | |
| Otto-Von-Guericke-Universitaet Magdeburg ( Site 0411) Magdeburg, Saxony-Anhalt | |
| Our Lady of the Lake Physician Group-Medical Oncology ( Site 0180) Baton Rouge, Louisiana | |
| Palo Verde Cancer Specialists ( Site 0105) Glendale, Arizona | |
| Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0208) Mineola, New York | |
| Pratia MCM Krakow ( Site 0804) Krakow, Lesser Poland Voivodeship | |
| Pratia Onkologia Katowice ( Site 0801) Katowice, Silesian Voivodeship | |
| Providence Oncology and Hematology Clinic Westside ( Site 0179) Portland, Oregon | |
| Providence Portland Medical Center ( Site 0120) Portland, Oregon | |
| Queen Elizabeth Hospital Birmingham ( Site 0912) Birmingham, | |
| Rabin Medical Center ( Site 0607) Petah Tikva, | |
| Rambam Health Care Campus ( Site 0604) Haifa, | |
| Rocky Mountain Cancer Centers (RMCC) ( Site 8001) Aurora, Colorado | |
| Roswell Park Cancer Institute ( Site 0192) Buffalo, New York | |
| Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center ( Site 0135) Burbank, California | |
| Royal Devon & Exeter Hospital ( Site 0910) Exeter, Devon | |
| SCRI Oncology Partners ( Site 7002) Nashville, Tennessee | |
| SSM Health Dean Medical Group ( Site 0106) Madison, Wisconsin | |
| SUNY Upstate Cancer Center ( Site 0178) Syracuse, New York | |
| Saint Elizabeth Medical Center Edgewood ( Site 0141) Edgewood, Kentucky | |
| Sheba Medical Center ( Site 0603) Ramat Gan, | |
| Shimane University Hospital ( Site 1002) Izumo, Shimane | |
| Soroka Medical Center ( Site 0606) Beersheba, | |
| Sourasky Medical Center ( Site 0608) Tel Aviv, | |
| Specjalistyczny Szpital im. Dr Alfreda Sokolowskiego w Walbrzychu ( Site 0807) Wałbrzych, Lower Silesian Voivodeship | |
| St Vincent's University Hospital ( Site 0502) Dublin, Dublin | |
| Stoke Mandeville Hospital ( Site 0917) Aylesbury, Buckinghamshire | |
| Szpital Specjalistyczny im. Jedrzeja Sniadeckiego w Nowym Saczu ( Site 0806) Nowy Sącz, Lesser Poland Voivodeship | |
| Temple University Hospital ( Site 0133) Philadelphia, Pennsylvania | |
| Tennessee Cancer Specialists ( Site 7004) Knoxville, Tennessee | |
| Texas Oncology - Central/South Texas ( Site 8006) Austin, Texas | |
| Texas Oncology - Northeast Texas ( Site 8002) Palestine, Texas | |
| Texas Oncology - San Antonio ( Site 8009) San Antonio, Texas | |
| Texas Oncology - West Texas ( Site 8008) Amarillo, Texas | |
| The James Cook University Hospital ( Site 0909) Middlesbrough, England | |
| The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center ( Site 0145) Tyler, Texas | |
| UT Southwestern Medical Center ( Site 0190) Dallas, Texas | |
| UZ Leuven ( Site 0301) Leuven, Vlaams-Brabant | |
| Uniklinik Erlangen ( Site 0412) Erlangen, Bavaria | |
| Universita degli Studi di Napoli Federico II ( Site 0705) Naples, | |
| UniversitaetsklInikum Tuebingen ( Site 0410) Tübingen, Baden-Wurttemberg | |
| Universitaetsklinikum Schleswig-Holstein - Campus Luebeck ( Site 0425) Lübeck, Schleswig-Holstein | |
| Universitaetsklinikum Wuerzburg ( Site 0401) Würzburg, Bavaria | |
| University Hospital Limerick ( Site 0503) Limerick, | |
| University Hospitals Plymouth NHS Trust ( Site 0905) Plymouth, Devon | |
| University Hospitals of Cleveland ( Site 0155) Cleveland, Ohio | |
| University Of Nebraska Medical Center ( Site 0110) Omaha, Nebraska | |
| University of Chicago Medical Center ( Site 0126) Chicago, Illinois | |
| University of Cincinnati Medical Center ( Site 0156) Cincinnati, Ohio | |
| University of Iowa-Holden Comprehensive Cancer Center ( Site 0139) Iowa City, Iowa | |
| University of North Carolina Medical Center ( Site 0136) Chapel Hill, North Carolina | |
| Universitätsklinikum Aachen ( Site 0418) Aachen, North Rhine-Westphalia | |
| Universitätsklinikum Jena ( Site 0438) Jena, Thuringia | |
| Uniwersyteckie Centrum Kliniczne ( Site 0802) Gdansk, Pomeranian Voivodeship | |
| VCU Health Adult Outpatient Pavillion ( Site 0138) Richmond, Virginia | |
| VITAZ ( Site 0307) Sint-Niklaas, Oost-Vlaanderen | |
| Valley Health Systems - Ridgewood Campus ( Site 0125) Paramus, New Jersey | |
| Virginia Cancer Specialists, PC ( Site 8003) Manassas, Virginia | |
| ZIV Medical Center ( Site 0605) Safed, |
E-Mindfulness Approaches for Living After Breast Cancer (HEAL-ABC)
Director Regulatory Affairs - langerj@nrgoncology.org
NCT06748222
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Inclusion Criteria:
* The participant or a legally authorized representative must provide study-specific informed consent prior to pre-entry and, for participants treated in the U.S., authorization permitting release of personal health information.
* The participant must have been greater than or equal to 18 or less than or equal to 50 years of age at the time of breast cancer diagnosis.
* The participant must have a first-time diagnosis of non-metastatic breast cancer which is Stage 0, I, II, or III.
* The participant must have a score of greater than or equal to 5 and less than or equal to 14 on the Patient Health Questionnaire-8 item (PHQ-8).
* Participants must have completed all primary breast cancer treatments at least 6 months prior to and no more than 5 years prior to registration. Note: Primary treatments include surgery, radiation therapy, adjuvant chemotherapy, targeted therapies (e.g., PARP (poly-ADP ribose polymerase) inhibitors, CDK4/6 inhibitors, TDM-1, pertuzumab, or immunotherapy). (Participants may still be taking adjuvant therapy with trastuzumab or adjuvant endocrine therapy or completing minor reconstructive surgery.)
* Participant must be able to understand, speak, read, and write in English or Spanish.
* Participant must be willing to participate in a 6-week program to receive training in mindfulness.
* Participant must be able to use a smartphone, tablet, or other digital device.
* Sex assigned at birth must be female.
Exclusion Criteria:
* Patient Health Questionnaire-8 item (PHQ-8) score of less than 5 or greater than 14 .
* Any history or current evidence of recurrent or metastatic breast cancer.
* Current or past history of another cancer. Participants with a history of only non-melanoma skin cancer or in situ cervical cancer without chemotherapy treatment would be eligible.
* Currently pregnant or planning to become pregnant in the near future.
* Participants who are enrolled in other cancer control or behavioral intervention trials that require frequent assessments or training activities. BEHAVIORAL: Mindfulness (MAPs) Live Online, BEHAVIORAL: Mindfulness (MAPs) Digital App, BEHAVIORAL: Meditation Only Control Group
Breast Cancer, Depression
Breast Cancer, Mindfulness, Meditation, Digital
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Show 364 locations
Study Locations
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| Location | Contacts |
|---|---|
| AIS Cancer Center at San Joaquin Community Hospital Bakersfield, California | |
| Adams Cancer Center Gettysburg, Pennsylvania | |
| Addison Gilbert Hospital Gloucester, Massachusetts | |
| Allegiance Health Jackson, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Annie Penn Memorial Hospital Reidsville, North Carolina | Site Public Contact - (stacey.phelps@conehealth.com) |
| Armes Family Cancer Center Findlay, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Arnold Palmer Cancer Center Medical Oncology Norwin N. Huntingdon, Pennsylvania | Site Public Contact - (ClinicalResearchServices@upmc.edu) |
| 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) |
| AtlantiCare Health Park-Cape May Court House Cape May Court House, New Jersey | |
| AtlantiCare Surgery Center Egg Harbor, New Jersey | |
| Atrium Health Cabarrus/LCI-Concord Concord, North Carolina | |
| Atrium Health Cleveland/LCI-Cleveland Shelby, North Carolina | |
| Atrium Health Lincoln/LCI-Lincolnton Lincolnton, North Carolina | |
| Atrium Health Pineville/LCI-Pineville Charlotte, North Carolina | |
| Atrium Health Stanly/LCI-Albemarle Albemarle, North Carolina | |
| Atrium Health Union/LCI-Union Monroe, North Carolina | |
| Atrium Health University City/LCI-University Charlotte, North Carolina | |
| Baptist Cancer Center-Grenada Grenada, Mississippi | 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) |
| Bayshore Community Hospital Holmdel, New Jersey | Site Public Contact - (Roster@nrgoncology.org) |
| Beaufort Memorial Hospital Beaufort, South Carolina | Site Public Contact - (kwade@bmhsc.org) |
| Beverly Hospital Beverly, Massachusetts | |
| Blanchard Valley Hospital Findlay, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Bon Secours Memorial Regional Medical Center Mechanicsville, Virginia | Site Public Contact - (anne_carmellat@bshsi.org) |
| Bon Secours Richmond Community Hospital Richmond, Virginia | Site Public Contact - (anne_carmellat@bshsi.org) |
| Bon Secours Saint Francis Medical Center Midlothian, Virginia | Site Public Contact - (anne_carmellat@bshsi.org) |
| Bon Secours Saint Mary's Hospital Richmond, Virginia | Site Public Contact - (anne_carmellat@bshsi.org) |
| CHI Health Good Samaritan Kearney, 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) |
| Carilion Roanoke Memorial Hospital Roanoke, Virginia | |
| 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) |
| Carlisle Regional Cancer Center Carlisle, Pennsylvania | Site Public Contact - (Roster@nrgoncology.org) |
| Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina | |
| Centra Alan B Pearson Regional Cancer Center Lynchburg, Virginia | Site Public Contact - (Kevin.Patel@centrahealth.com) |
| Central Maryland Radiation Oncology in Howard County Columbia, Maryland | |
| Centro Comprensivo de Cancer de UPR San Juan, | Site Public Contact - (Roster@nrgoncology.org) |
| Chester County Hospital West Chester, Pennsylvania | Site Public Contact - (PMCancerResearch@pennmedicine.upenn.edu) |
| CommonSpirit Saint Joseph Hospital - Bardstown Bardstown, Kentucky | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| CommonSpirit Saint Joseph Medical Center - East Lexington Lexington, Kentucky | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Cone Health Cancer Center Greensboro, North Carolina | Site Public Contact - (stacey.phelps@conehealth.com) |
| Cone Health Cancer Center at Alamance Regional Burlington, North Carolina | Site Public Contact - (stacey.phelps@conehealth.com) |
| Cone Health Cancer Center at Drawbridge Parkway Greensboro, North Carolina | Site Public Contact - (stacey.phelps@conehealth.com) |
| Cone Health MedCenter Asheboro Asheboro, North Carolina | Site Public Contact - (stacey.phelps@conehealth.com) |
| Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Reed City Hospital Reed City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Cotton O'Neil Cancer Center / Stormont Vail Health Topeka, Kansas | |
| Crossroads Cancer Center Effingham, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Edward Hospital/Cancer Center Naperville, Illinois | |
| Edward Hospital/Cancer Center?Plainfield Plainfield, Illinois | Site Public Contact - (Cancerresearch@edward.org) |
| Eisenhower Medical Center Rancho Mirage, California | |
| Elmhurst Memorial Hospital Elmhurst, Illinois | Site Public Contact - (Jrohde@emhc.org) |
| Emory Decatur Hospital Decatur, Georgia | Site Public Contact - (clinicaltrialsoncology@dekalbmedical.org) |
| Emory Johns Creek Hospital Johns Creek, Georgia | Site Public Contact - (m.lisa.hwang@emory.edu) |
| Emory Saint Joseph's Hospital Atlanta, Georgia | |
| Emory University Hospital Midtown Atlanta, Georgia | |
| Emory University Hospital/Winship Cancer Institute Atlanta, Georgia | |
| Enloe Medical Center Chico, California | |
| Ephrata Cancer Center Ephrata, Pennsylvania | |
| 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 Saint Joseph's Medical Center Brainerd, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Fremont - Rideout Cancer Center Marysville, California | |
| Garnet Health Medical Center Middletown, New York | Site Public Contact - (jgerlach@garnethealth.org) |
| Geisinger Cancer Center Dickson City Dickson City, Pennsylvania | Site Public Contact - (hemoncctrials@geisinger.edu) |
| Geisinger Cancer Services-Pottsville Pottsville, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Geisinger Medical Center Danville, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Geisinger Medical Center-Cancer Center Hazleton Hazleton, 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) |
| Gene Upshaw Memorial Tahoe Forest Cancer Center Truckee, California | |
| Genesis Healthcare System Cancer Care Center Zanesville, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Glens Falls Hospital Glens Falls, New York | |
| Goshen Center for Cancer Care Goshen, Indiana | Site Public Contact - (cccois@goshenhealth.com) |
| Grady Health System Atlanta, Georgia | |
| Gundersen Lutheran Medical Center La Crosse, Wisconsin | Site Public Contact - (cancerctr@gundersenhealth.org) |
| Halifax Health Cancer Center for Hope - Daytona Beach Daytona Beach, Florida | |
| Heartland Regional Medical Center Saint Joseph, Missouri | Site Public Contact - (Trisha.England2@mymlc.com) |
| Henry Ford Cancer Institute-Downriver Brownstown, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford Health Providence Novi Hospital Novi, Michigan | Site Public Contact - (kfife3@hfhs.org) |
| Henry Ford Health Providence Southfield Hospital Southfield, Michigan | Site Public Contact - (kfife3@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) |
| Hunterdon Medical Center Flemington, New Jersey | |
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Induction Pembrolizumab and Chemotherapy Followed by Pembrolizumab Before Chemoradiation and Pembrolizumab Maintenance Compared to Standard Chemoradiation With Pembrolizumab Followed by Pembrolizumab Maintenance in High-Risk Cervical Cancer
ctrrecruit@vcu.edu
NCT07061977
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Inclusion Criteria:
* Patients must have pathologically confirmed newly diagnosed cervical cancer. Eligible pathologic types: squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma
* Patients must have locally advanced cervical cancer (LACC) with T3 or T4 disease with or without lymph node involvement:
* IIIA (T3aN0M0)
* IIIB (T3bN0M0)
* IIIC1(T3aN1M0, T3bN1M0)
* IIIC2 (T3aN2M0, T3bN2M0)
* IVA (T4aN0M0, T4aN1M0, T4aN2M0) No prior hysterectomy defined as removal of the entire uterus.
* NOTE: prior partial/subtotal hysterectomy for reasons other than cervical cancer are eligible to participate in the study. No plan to perform a hysterectomy as part of initial cervical cancer therapy.
No paraaortic lymph node (PALN) metastases above the T12/L1 interspace.
* Note: Nodal status can be confirmed by imaging (CT, MRI, or PET/CT), fine needle aspirate/core biopsy, extra peritoneal biopsy, laparoscopic biopsy, or lymphadenectomy.
Radiologic definition of lymph node staging:
* N1:
* One or more pelvic lymph nodes with short axis diameter of ≥ 15 mm (axial plane) by CT or MRI, and/or
* One or more pelvic lymph nodes with short axis diameter of ≥ 10 mm and standardized uptake value maximum (SUVmax) ≥ 2.5 by fludeoxyglucose (FDG)-PET
* N2:
* One or more para-aortic lymph node with short axis diameter of ≥ 15 mm (axial plane) by CT or MRI, and/or
* One or more para-aortic lymph node with short axis diameter of ≥ 10 mm and SUVmax ≥ 2.5 by FDG-PET
* No prior definitive surgical, radiation, or systemic therapy for cervical cancer
* No prior immunotherapy
* No prior pelvic radiation therapy for any disease
* Age ≥ 18
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
* Not pregnant and not nursing
* Absolute neutrophil count (ANC) ≥ 1,500 cells/mm\^3
* Platelets ≥ 100,000 cells/mm\^3
* Hemoglobin ≥ 8 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobulin \[Hgb\] ≥ 8 g/dl is acceptable)
* Creatinine clearance (CrCL) of ≥ 50 mL/min by the Cockcroft-Gault formula
* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x institutional ULN may be enrolled)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x institutional ULN
* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
* No active infection requiring parenteral antibiotics
* No live vaccine within 30 days prior to registration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacille Calmette Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines are live attenuated vaccines and are not allowed
* No diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior registration
* No active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed
* No history of (non-infectious) pneumonitis that required steroids, or current pneumonitis
* No history of allergic reaction to the study agent(s) or compounds of similar chemical or biologic composition to the study agent(s) (or any of its excipients) PROCEDURE: Biospecimen Collection, RADIATION: Brachytherapy, DRUG: Carboplatin, PROCEDURE: Chest Radiography, DRUG: Cisplatin, PROCEDURE: Computed Tomography, RADIATION: External Beam Radiation Therapy, RADIATION: Intensity-Modulated Radiation Therapy, PROCEDURE: Magnetic Resonance Imaging, DRUG: Paclitaxel, BIOLOGICAL: Pembrolizumab, PROCEDURE: Positron Emission Tomography
Locally Advanced Cervical Adenocarcinoma, Locally Advanced Cervical Adenosquamous Carcinoma, Locally Advanced Cervical Squamous Cell Carcinoma, Stage IIIA Cervical Cancer FIGO 2018, Stage IIIB Cervical Cancer FIGO 2018, Stage IIIC1 Cervical Cancer FIGO 2018, Stage IIIC2 Cervical Cancer FIGO 2018, Stage IVA Cervical Cancer FIGO 2018
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Study Locations
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| Location | Contacts |
|---|---|
| Allegheny General Hospital Pittsburgh, Pennsylvania | |
| Asplundh Cancer Pavilion Willow Grove, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Atrium Health Cabarrus/LCI-Concord Concord, North Carolina | |
| Atrium Medical Center-Middletown Regional Hospital Franklin, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Aultman Health Foundation Canton, Ohio | Site Public Contact - (ClinicalReserachDept@aultman.com) |
| Avera Cancer Institute Sioux Falls, South Dakota | Site Public Contact - (OncRegulatory@avera.org) |
| Beebe Health Campus Rehoboth Beach, Delaware | Site Public Contact - (research@beebehealthcare.org) |
| Beebe South Coastal Health Campus Millville, Delaware | Site Public Contact - (research@beebehealthcare.org) |
| Billings Clinic Cancer Center Billings, Montana | Site Public Contact - (research@billingsclinic.org) |
| Bronson Methodist Hospital Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Broward Health Medical Center Fort Lauderdale, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| CTCA at Southeastern Regional Medical Center Newnan, Georgia | |
| Camden Clark Medical Center Parkersburg, West Virginia | Site Public Contact - (cancertrialsinfo@hsc.wvu.edu) |
| Cancer Care Specialists of Illinois - Decatur Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Capital Health Medical Center-Hopewell Pennington, New Jersey | Site Public Contact - (clinicaltrials@capitalhealth.org) |
| Carilion Roanoke Memorial Hospital Roanoke, Virginia | |
| Carle Cancer Center Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Effingham Effingham, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Mattoon/Charleston Mattoon, Illinois | Site Public Contact - (Research@carle.com) |
| Carle at The Riverfront Danville, Illinois | Site Public Contact - (Research@Carle.com) |
| Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina | |
| Case Western Reserve University Cleveland, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| Chelsea Hospital Chelsea, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| City of Hope Antelope Valley Lancaster, California | |
| City of Hope Comprehensive Cancer Center Duarte, California | Site Public Contact - (becomingapatient@coh.org) |
| City of Hope Corona Corona, California | Site Public Contact - (becomingapatient@coh.org) |
| City of Hope South Pasadena South Pasadena, California | Site Public Contact - (becomingapatient@coh.org) |
| City of Hope Upland Upland, California | Site Public Contact - (becomingapatient@coh.org) |
| City of Hope at Irvine Lennar Irvine, California | |
| Clackamas Radiation Oncology Center Clackamas, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Cleveland Clinic Foundation Cleveland, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Community Medical Center Scranton, Pennsylvania | |
| Cooper Hospital University Medical Center Camden, New Jersey | |
| Crossroads Cancer Center Effingham, Illinois | |
| Danbury Hospital Danbury, Connecticut | |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire | Site Public Contact - (cancer.research.nurse@dartmouth.edu) |
| Decatur Memorial Hospital Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Duke University Medical Center Durham, North Carolina | |
| Duke Women's Cancer Care Raleigh Raleigh, North Carolina | |
| Duluth Clinic Ashland Ashland, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| East Jefferson General Hospital Metairie, Louisiana | Site Public Contact - (emede1@lsuhsc.edu) |
| Emory Decatur Hospital Decatur, Georgia | Site Public Contact - (clinicaltrialsoncology@dekalbmedical.org) |
| Emory University Hospital Midtown Atlanta, Georgia | |
| Emory University Hospital/Winship Cancer Institute Atlanta, Georgia | |
| Essentia Health - Deer River Clinic Deer River, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Cancer Center Duluth, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Hibbing Clinic Hibbing, Minnesota | |
| Essentia Health Saint Joseph's Medical Center Brainerd, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Saint Mary's Hospital - Superior Superior, Wisconsin | |
| Essentia Health Sandstone Sandstone, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Virginia Clinic Virginia, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Farmington Health Center Farmington, Utah | Site Public Contact - (cancerinfo@hci.utah.edu) |
| Forbes Hospital Monroeville, Pennsylvania | |
| Fox Chase Cancer Center Philadelphia, Pennsylvania | |
| Fred Hutchinson Cancer Center Seattle, Washington | |
| Freeman Health System Joplin, Missouri | Site Public Contact - (LJCrockett@freemanhealth.com) |
| Geauga Hospital Chardon, Ohio | Site Public Contact - (CTUReferral@UHhospitals.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) |
| Gibbs Cancer Center-Gaffney Gaffney, South Carolina | Site Public Contact - (kmertz-rivera@gibbscc.org) |
| Gibbs Cancer Center-Pelham Greer, South Carolina | Site Public Contact - (kmertz-rivera@gibbscc.org) |
| Health Central Ocoee, Florida | Site Public Contact - (Roster@nrgoncology.org) |
| Helen F Graham Cancer Center Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Highlands Oncology Group Springdale, Arkansas | Site Public Contact - (research@hogonc.com) |
| Highlands Oncology Group - Fayetteville Fayetteville, Arkansas | Site Public Contact - (research@hogonc.com) |
| Highlands Oncology Group - Rogers Rogers, Arkansas | Site Public Contact - (research@hogonc.com) |
| Hillcrest Hospital Cancer Center Mayfield Heights, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Huntsman Cancer Institute/University of Utah Salt Lake City, Utah | Site Public Contact - (cancerinfo@hci.utah.edu) |
| IRMC Cancer Center Indiana, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| IU Health North Hospital Carmel, Indiana | Site Public Contact - (iutrials@iu.edu) |
| Indiana University/Melvin and Bren Simon Cancer Center Indianapolis, Indiana | Site Public Contact - (iutrials@iu.edu) |
| Inova Alexandria Hospital Alexandria, Virginia | Site Public Contact - (Stephanie.VanBebber@inova.org) |
| Inova Fair Oaks Hospital Fairfax, Virginia | Site Public Contact - (Stephanie.VanBebber@inova.org) |
| Inova Fairfax Hospital Falls Church, Virginia | Site Public Contact - (Stephanie.VanBebber@inova.org) |
| Inova Loudoun Hospital Leesburg, Virginia | Site Public Contact - (Keary.janet@inova.org) |
| Inova Schar Cancer Institute Fairfax, Virginia | Site Public Contact - (Stephanie.VanBebber@inova.org) |
| Iowa Methodist Medical Center Des Moines, Iowa | |
| Jefferson Hospital Jefferson Hills, Pennsylvania | Site Public Contact - (ddefazio@wpahs.org) |
| Jersey City Medical Center Jersey City, New Jersey | Site Public Contact - (Roster@nrgoncology.org) |
| Kaiser Permanente - Panorama City Panorama City, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente Los Angeles Medical Center Los Angeles, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente Northwest Portland, Oregon | Site Public Contact - (information@kpchr.org) |
| Kaiser Permanente South Bay Harbor City, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente West Los Angeles Los Angeles, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Bellflower Bellflower, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Irvine Irvine, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-San Diego Zion San Diego, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-San Marcos San Marcos, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Woodland Hills Woodland Hills, California | Site Public Contact - (clinical.trials@kp.org) |
| Kootenai Clinic Cancer Services - Post Falls Post Falls, Idaho | |
| Kootenai Health - Coeur d'Alene Coeur d'Alene, Idaho | |
| LSU Healthcare Network / Metairie Multi-Specialty Clinic Metairie, Louisiana | Site Public Contact - (emede1@lsuhsc.edu) |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York | Site Public Contact - (CancerTrials@nyulangone.org) |
| Legacy Good Samaritan Hospital and Medical Center Portland, Oregon | Site Public Contact - (cancer@lhs.org) |
| Legacy Meridian Park Hospital Tualatin, Oregon | |
| Legacy Salmon Creek Hospital Vancouver, Washington | |
| 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) |
| Lenox Hill Hospital New York, New York | |
| Levine Cancer Institute-Gaston Gastonia, North Carolina | |
| Loyola University Medical Center Maywood, Illinois | |
| MaineHealth Cancer Care Center of York County Sanford, Maine | |
| MaineHealth Coastal Cancer Treatment Center Bath, Maine | Site Public Contact - (Roster@nrgoncology.org) |
| MaineHealth Maine Medical Center - Portland Portland, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| MaineHealth Maine Medical Center- Scarborough Scarborough, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| Manhattan Eye Ear and Throat Hospital New York, New York | |
| Matthews Radiation Oncology Center Matthews, North Carolina | Site Public Contact - (kashah@novanthealth.org) |
| Medical College of Wisconsin Milwaukee, Wisconsin | |
| Medical Oncology Hematology Consultants PA Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Medical University of South Carolina Charleston, South Carolina | Site Public Contact - (hcc-clinical-trials@musc.edu) |
| Memorial Hospital West Pembroke Pines, Florida | |
| Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood, Florida | Site Public Contact - (OHR@mhs.net) |
| Memorial Sloan Kettering Basking Ridge Basking Ridge, New Jersey | |
| Memorial Sloan Kettering Bergen Montvale, New Jersey | |
| Memorial Sloan Kettering Cancer Center New York, New York | |
| Memorial Sloan Kettering Commack Commack, New York | |
| Memorial Sloan Kettering Monmouth Middletown, New Jersey | |
| Memorial Sloan Kettering Nassau Uniondale, New York | |
| Memorial Sloan Kettering Westchester Harrison, New York | |
| Mercy Hospital Coon Rapids, Minnesota | |
| Mercy Hospital Saint Louis St Louis, Missouri | |
| Mercy Hospital Springfield Springfield, Missouri | |
| Mercy Medical Center - Des Moines Des Moines, Iowa | |
| Miami Valley Cancer Care and Infusion Greenville, Ohio | |
| Miami Valley Hospital Dayton, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Miami Valley Hospital North Dayton, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Miami Valley Hospital South Centerville, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Midwestern Regional Medical Center Zion, Illinois | |
| Miller-Dwan Hospital Duluth, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Moffitt Cancer Center Tampa, Florida | Site Public Contact - (ClinicalTrials@moffitt.org) |
| Moffitt Cancer Center - McKinley Campus Tampa, Florida | Site Public Contact - (ClinicalTrials@moffitt.org) |
| Moffitt Cancer Center at SouthShore Ruskin, Florida | Site Public Contact - (ClinicalTrials@moffitt.org) |
| Moffitt Cancer Center at Wesley Chapel Wesley Chapel, Florida | Site Public Contact - (ClinicalTrials@moffitt.org) |
| Moffitt Cancer Center-International Plaza Tampa, Florida | Site Public Contact - (ClinicalTrials@moffitt.org) |
| Montefiore Medical Center - Moses Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Montefiore Medical Center-Einstein Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Montefiore Medical Center-Weiler Hospital The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Mount Sinai Chelsea New York, New York | Site Public Contact - (CCTO@mssm.edu) |
| Mount Sinai Hospital New York, New York | Site Public Contact - (CCTO@mssm.edu) |
| NYU Langone Hospital - Long Island Mineola, New York | Site Public Contact - (cancertrials@nyulangone.org) |
| Nebraska Methodist Hospital Omaha, Nebraska | |
| Northern Westchester Hospital Mount Kisco, New York | Site Public Contact - (AMellor@northwell.edu) |
| Northwell Health Cancer Institute at Huntington Greenlawn, New York | |
| Northwell Health Imbert Cancer Center Bay Shore, New York | |
| Northwell Health Physician Partners at Flushing Flushing, New York | Site Public Contact - (nhppflushing@northwell.edu) |
| Northwell Health Physicians Partners Radiation Medicine at Queens Forest Hills, New York | |
| Northwell Health/Center for Advanced Medicine Lake Success, New York | |
| 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) |
| 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 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) |
| Norwalk Hospital Danbury, Connecticut | Site Public Contact - (jennifer.long@norwalkhealth.org) |
| Novant Cancer Institute Radiation Oncology - Supply Supply, North Carolina | |
| Novant Health Cancer Institute - Huntersville Huntersville, North Carolina | Site Public Contact - (kashah@novanthealth.org) |
| Novant Health Cancer Institute Radiation Oncology - Wilmington Wilmington, North Carolina | |
| Novant Health Forsyth Medical Center Winston-Salem, North Carolina | Site Public Contact - (pjordan@novanthealth.org) |
| Novant Health New Hanover Regional Medical Center Wilmington, North Carolina | |
| Novant Health Presbyterian Medical Center Charlotte, North Carolina | Site Public Contact - (kashah@novanthealth.org) |
| OSF Saint Francis Medical Center Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| OSF Saint Francis Radiation Oncology at Peoria Cancer Center Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Ochsner Baptist Medical Center New Orleans, Louisiana | Site Public Contact - (Elisemarie.curry@ochsner.org) |
| Ochsner Medical Center Jefferson New Orleans, Louisiana | Site Public Contact - (Elisemarie.curry@ochsner.org) |
| Ohio State University Comprehensive Cancer Center Columbus, Ohio | Site Public Contact - (Jamesline@osumc.edu) |
| Oklahoma Cancer Specialists and Research Institute-Tulsa Tulsa, Oklahoma | |
| Oncology Associates at Mercy Medical Center Cedar Rapids, Iowa | |
| Oregon Health and Science University Portland, Oregon | Site Public Contact - (trials@ohsu.edu) |
| Orlando Health Cancer Institute Orlando, Florida | Site Public Contact - (CancerClinicalTrials@orlandohealth.com) |
| Parkland Memorial Hospital Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| Parkview Regional Medical Center Fort Wayne, Indiana | |
| Penn State Milton S Hershey Medical Center Hershey, Pennsylvania | Site Public Contact - (CTO@hmc.psu.edu) |
| Phelps Health Delbert Day Cancer Institute Rolla, Missouri | Site Public Contact - (research@phelpshealth.org) |
| Phelps Memorial Hospital Center Sleepy Hollow, New York | |
| Piedmont Hospital Atlanta, Georgia | Site Public Contact - (ORS@piedmont.org) |
| Pocono Medical Center East Stroudsburg, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| ProHealth D N Greenwald Center Mukwonago, Wisconsin | Site Public Contact - (research.institute@phci.org) |
| ProHealth Oconomowoc Memorial Hospital Oconomowoc, Wisconsin | |
| 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) |
| Queens Cancer Center Rego Park, New York | |
| 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) |
| Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey | |
| Rutgers New Jersey Medical School Newark, New Jersey | |
| Saint Alphonsus Cancer Care Center-Boise Boise, Idaho | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Saint Alphonsus Cancer Care Center-Caldwell Caldwell, Idaho | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Saint Alphonsus Cancer Care Center-Nampa Nampa, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Saint Luke's Cancer Center - Allentown Allentown, Pennsylvania | |
| 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 Hospital - Monroe Campus Stroudsburg, Pennsylvania | Site Public Contact - (Roster@nrgoncology.org) |
| Saint Luke's Hospital - Upper Bucks Campus Quakertown, Pennsylvania | |
| Saint Luke's Hospital-Anderson Campus Easton, Pennsylvania | Site Public Contact - (Roster@nrgoncology.org) |
| Saint Luke's University Hospital-Bethlehem Campus Bethlehem, Pennsylvania | |
| Saint Mary Medical Center Hobart, Indiana | Site Public Contact - (CancerResearch@COMHS.org) |
| Sidney and Lois Eskenazi Hospital Indianapolis, Indiana | Site Public Contact - (iutrials@iu.edu) |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| Spartanburg Medical Center Spartanburg, South Carolina | Site Public Contact - (kmertz-rivera@gibbscc.org) |
| Springfield Clinic Springfield, Illinois | |
| Springfield Memorial Hospital Springfield, Illinois | Site Public Contact - (pallante.beth@mhsil.com) |
| State University of New York Upstate Medical University Syracuse, New York | |
| Stony Brook University Medical Center Stony Brook, New York | |
| Temple University Hospital Philadelphia, Pennsylvania | |
| The Community Hospital Munster, Indiana | |
| Thomas Jefferson University Hospital Philadelphia, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Trinity Health Medical Center - Brighton Brighton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Medical Center - Canton Canton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Joseph Mercy Hospital Ann Arbor Ann Arbor, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Joseph Mercy Oakland Hospital Pontiac, Michigan | |
| Trinity Health Saint Mary Mercy Livonia Hospital Livonia, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| UC Irvine Health/Chao Family Comprehensive Cancer Center Orange, California | Site Public Contact - (ucstudy@uci.edu) |
| UC San Diego Moores Cancer Center La Jolla, California | Site Public Contact - (cancercto@ucsd.edu) |
| UCHealth Highlands Ranch Hospital Highlands Ranch, Colorado | |
| UCHealth University of Colorado Hospital Aurora, Colorado | |
| UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care Irvine, California | Site Public Contact - (ucstudy@uci.edu) |
| UH Seidman Cancer Center at Lake Health Mentor Campus Mentor, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| UH Seidman Cancer Center at Saint John Medical Center Westlake, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| UHHS-Chagrin Highlands Medical Center Beachwood, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| UI Health Care Mission Cancer and Blood - Ankeny Clinic Ankeny, Iowa | |
| UI Health Care Mission Cancer and Blood - Des Moines Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - Laurel Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - Waukee Clinic Waukee, Iowa | |
| UI Health Care Mission Cancer and Blood - West Des Moines Clinic Clive, Iowa | |
| UM Sylvester Comprehensive Cancer Center at Coral Gables Coral Gables, Florida | |
| UM Sylvester Comprehensive Cancer Center at Coral Springs Coral Springs, Florida | |
| UM Sylvester Comprehensive Cancer Center at Deerfield Beach Deerfield Beach, Florida | |
| UM Sylvester Comprehensive Cancer Center at Doral Doral, Florida | Site Public Contact - (kginnity@med.miami.edu) |
| UM Sylvester Comprehensive Cancer Center at Hollywood Hollywood, Florida | |
| UM Sylvester Comprehensive Cancer Center at Kendall Miami, Florida | |
| UM Sylvester Comprehensive Cancer Center at Plantation Plantation, Florida | |
| UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina | Site Public Contact - (cancerclinicaltrials@med.unc.edu) |
| UPMC Cancer Center at UPMC Northwest Seneca, Pennsylvania | |
| UPMC Cancer Centers - Arnold Palmer Pavilion Greensburg, Pennsylvania | |
| UPMC Hillman Cancer Center Erie Erie, Pennsylvania | Site Public Contact - (ClinicalResearchServices@upmc.edu) |
| UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion Mechanicsburg, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC Pinnacle Cancer Center/Community Osteopathic Campus Harrisburg, Pennsylvania | Site Public Contact - (klitchfield@PINNACLEHEALTH.org) |
| UPMC-Magee Womens Hospital Pittsburgh, Pennsylvania | |
| UPMC-Passavant Hospital Pittsburgh, Pennsylvania | |
| UT Southwestern Clinical Center at Richardson/Plano Richardson, Texas | Site Public Contact - (Suzanne.cole@utsouthwestern.edu) |
| UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| UT Southwestern/Simmons Cancer Center-Fort Worth Fort Worth, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| UW Cancer Center at ProHealth Care Waukesha, Wisconsin | Site Public Contact - (Chanda.miller@phci.org) |
| UW Health Carbone Cancer Center Rockford Rockford, Illinois | Site Public Contact - (lkline@uwhealth.org) |
| University Hospitals Parma Medical Center Parma, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| University Medical Center New Orleans New Orleans, Louisiana | Site Public Contact - (emede1@lsuhsc.edu) |
| University of Alabama at Birmingham Cancer Center Birmingham, Alabama | Site Public Contact - (gingerreeves@uabmc.edu) |
| University of Arkansas for Medical Sciences Little Rock, Arkansas | |
| University of Cincinnati Cancer Center-UC Medical Center Cincinnati, Ohio | Site Public Contact - (cancer@uchealth.com) |
| University of Cincinnati Cancer Center-West Chester West Chester, Ohio | Site Public Contact - (cancer@uchealth.com) |
| University of Illinois Chicago, Illinois | |
| University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa | |
| University of Kansas Cancer Center Kansas City, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas 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-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 Maryland/Greenebaum Cancer Center Baltimore, Maryland | |
| University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida | |
| University of Miami Sylvester Comprehensive Cancer Center at Sole Mia North Miami, Florida | Site Public Contact - (kginnity@med.miami.edu) |
| University of Nebraska Medical Center Omaha, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| University of New Mexico Cancer Center Albuquerque, New Mexico | Site Public Contact - (HSC-ClinicalTrialInfo@salud.unm.edu) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Utah Sugarhouse Health Center Salt Lake City, Utah | Site Public Contact - (cancerinfo@hci.utah.edu) |
| University of Virginia Cancer Center Charlottesville, Virginia | Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu) |
| University of Wisconsin Carbone Cancer Center - Eastpark Medical Center Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| University of Wisconsin Carbone Cancer Center - University Hospital Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| Upper Valley Medical Center Troy, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Upstate Cancer Center Radiation Oncology at Oswego Oswego, New York | Site Public Contact - (BinghamE@upstate.edu) |
| Upstate Cancer Center at Hill Radiation Oncology Syracuse, New York | Site Public Contact - (BinghamE@upstate.edu) |
| Upstate Cancer Center at Verona Verona, New York | Site Public Contact - (McDowelE@upstate.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Wake Forest University Health Sciences Winston-Salem, North Carolina | |
| West Jefferson Medical Center Marrero, Louisiana | Site Public Contact - (emede1@lsuhsc.edu) |
| West Michigan Cancer Center Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| West Penn Hospital Pittsburgh, Pennsylvania | |
| West Virginia University Healthcare Morgantown, West Virginia | Site Public Contact - (cancertrialsinfo@hsc.wvu.edu) |
| Wexford Health and Wellness Pavilion Wexford, Pennsylvania | Site Public Contact - (Dawnmarie.DeFazio@ahn.org) |
| Women and Infants Hospital Providence, Rhode Island | |
| Women's Cancer Center of Nevada Las Vegas, Nevada | |
| Women's Diagnostic Center - Munster Munster, Indiana | Site Public Contact - (mnicholson@comhs.org) |
mHealth Intervention for Pain Self Management (PsyMINT)
Sun Jung Kim, Ph.D - sjkim2@vcu.edu
NCT07332377
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Inclusion Criteria:
* In a post-treatment stage with no evidence of disease (complete remission)
* Diagnosed with cancer in the past three years
* Experiencing cancer/treatment-related pain
* ≥ 18 years of age at the time of first diagnosis
* Cognitively able to actively participate in an online-based study
* Able to read, write, and understand English
Exclusion Criteria:
* Individuals who currently use any medication for psychiatric reasons (including stimulants, and mood stabilizers)
* Patients with major psychotic disorders (bipolar disorder or schizophrenia) and/or substance use disorders.
* Those who are currently pregnant or plan to become pregnant in the next three months BEHAVIORAL: Mobile Health (mHealth) Intervention
Pain, Pain Management, Symptom Monitoring, Symptom Management, Cancer Survivorship
cancer survivorship, pain management, mHealth, behavioral intervention, nonpharmacologic intervention, app, digital health
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Study Locations
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| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia | Sun Jung Kim, Ph.D - (sjkim2@vcu.edu) |
Radiotherapy to Block Oligoprogression In Metastatic Non-Small-Cell Lung Cancer (CURB2)
Pierre-Olivier Gaudreau - p-ogaudreau@ctg.queensu.ca
NCT06686771
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Inclusion Criteria:
* Metastatic disease (stage IV) detected on imaging and histologically and/or cytologically confirmed NSCLC as per the WHO Classification of Tumors and AJCC 8th Edition TNM Classification, without a driver mutation with an actionable first-line targeted therapy, for whom either ICI alone or combination ICI + chemotherapy is indicated
* Oligoprogression on first-line ICI +/- chemotherapy systemic therapy after at least 3 cycles.
* All sites of oligoprogression can be safely treated with SBRT or ablative radiotherapy as determined by radiation treatment preplan, including availability and tolerability of necessary technologies (e.g., active breathing control, MRLinac, fiducial insertion, etc.) and accounting for previous radiotherapy overlap. Safety must be assessed and determined by a radiation oncologist.
* Patients with treated CNS disease who have radiologic and clinical evidence of stable brain metastases, with no evidence of cavitation or hemorrhage in the brain lesion, are eligible providing that they are asymptomatic and do not require corticosteroids (must have discontinued steroids at least 1 week prior to randomization).
* Candidate for regulatory approved SOC first-line orsecond-line systemic therapy options.
* Participants must be ≥ 18 years of age.
* ECOG performance status of 0, 1 or 2.
* Participants that received prior adjuvant/neoadjuvant/consolidation systemic therapy (including chemotherapy and ICI ) are eligible if at least 6 months have elapsed between the completion of prior therapy and start of first-line treatment for metastatic disease.
* Participants must have recovered to ≤ grade 1 from all reversible toxicity related to prior systemic therapy. If participants experienced prior immune-mediated toxicity and have not yet re-initiated ICI therapy, please contact CCTG. Please also contact CCTG if participants have ongoing toxicity ≥ grade 1 felt to be clinically insignificant.
* Previous surgery related to NSCLC in the curative or metastatic disease setting is permitted. Previous major surgery is permitted provided that surgery occurred at least 28 days prior to participant enrollment and that wound healing has occurred.
* Prior external beam radiation related to NSCLC in the metastatic disease setting is permitted provided a minimum of 14 days (2 weeks) have elapsed between the last dose of radiation and date of enrollment. Patients that received prior external beam radiation therapy in the NSCLC curative disease setting (including the primary lesion) are eligible. Oligoprogressive lesions previously treated with external beam radiation are eligible as long they are clinically asymptomatic, and re-treatment is possible according to the investigator.
* Prior conventional, non-stereotactic radiotherapy for palliative purposes is allowed, and if the palliated lesion subsequently progressed but asymptomatic not requiring immediate RT, the lesion can still be counted toward one of the five oligoprogressive lesions.
* For Arm 1, SBRT must be initiated within 3 weeks of participant enrollment.
* Participant is able (i.e. sufficiently fluent) and willing to complete the quality of life and/or health utility questionnaires in either English, French, or Spanish.
* Reimbursement of continued SOC ICI and chemotherapy systemic therapies may not be uniform across all sites. In the event that site/investigator is unable to provide access to the drug, participant will not be eligible for this trial.
* Participants must be accessible for treatment and follow-up. Investigators must assure themselves the participants enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.
* Participants of childbearing potential must have agreed to use a highly effective contraceptive method.
Exclusion Criteria:
* Large-cell neuroendocrine carcinoma (LCNEC), pulmonary carcinoid tumour or mixed small cell and non-small cell lung cancer are not eligible.
* Presence of leptomeningeal disease.
* Pregnancy.
* Serious medical conditions in which radiotherapy of target lesions is contraindicated (e.g., scleroderma, Ataxia Telangiectasia (ATM), interstitial lung disease (ILD), Child-Pugh C liver function).
* Any other condition in which in the judgement of the investigator would make the patient inappropriate for study entry.
* Participants 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.
* Concomitant medications should only exclude participants from trial participation when clinically relevant known or predicted drug-drug interactions or potential overlapping toxicities will impact safety or efficacy; please consult the relevant product monographies.
* Concurrent treatment with other anti-cancer therapy, including investigational agents.
* Live attenuated vaccination administered within 30 days prior to enrollment/randomization. RADIATION: SBRT, OTHER: First or second-line standard of care therapy
Non-small Cell Lung Cancer
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Study Locations
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| Location | Contacts |
|---|---|
| Alton Memorial Hospital Alton, Illinois | |
| CTCA at Southeastern Regional Medical Center Newnan, Georgia | |
| CancerCare Manitoba Winnipeg, Manitoba | Site Public Contact - (ctu_web@cancercare.mb.ca) |
| City of Hope Comprehensive Cancer Center Duarte, California | Site Public Contact - (becomingapatient@coh.org) |
| City of Hope at Irvine Lennar Irvine, California | |
| Coborn Cancer Center at Saint Cloud Hospital Saint Cloud, Minnesota | Site Public Contact - (coborncancercenter@centracare.com) |
| Cross Cancer Institute Edmonton, Alberta | |
| Crossroads Cancer Center Effingham, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Decatur Memorial Hospital Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Geisinger Medical Center Danville, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Geisinger Medical Oncology-Lewisburg Lewisburg, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| HSHS Saint Elizabeth's Hospital O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Iowa Methodist Medical Center Des Moines, Iowa | |
| Lenox Hill Hospital New York, New York | |
| Manhattan Eye Ear and Throat Hospital New York, New York | |
| Mayo Clinic Hospital in Arizona Phoenix, Arizona | |
| Mayo Clinic in Rochester Rochester, Minnesota | |
| Memorial Hospital East Shiloh, Illinois | Site Public Contact - (dschwab@wustl.edu) |
| Mercy Hospital Coon Rapids, Minnesota | |
| Mercy Medical Center - Des Moines Des Moines, Iowa | |
| Miller-Dwan Hospital Duluth, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Montefiore Medical Center - Moses Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Montefiore Medical Center-Einstein Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Mount Sinai Chelsea New York, New York | Site Public Contact - (CCTO@mssm.edu) |
| Mount Sinai Hospital New York, New York | Site Public Contact - (CCTO@mssm.edu) |
| Mount Sinai West New York, New York | Site Public Contact - (CCTO@mssm.edu) |
| Nebraska Medicine-Bellevue Bellevue, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| Nebraska Medicine-Village Pointe Omaha, Nebraska | |
| Northwell Health/Center for Advanced Medicine Lake Success, New York | |
| Northwest Wisconsin Cancer Center Ashland, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| 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) |
| Odette Cancer Centre- Sunnybrook Health Sciences Centre Toronto, Ontario | |
| Ohio State University Comprehensive Cancer Center Columbus, Ohio | Site Public Contact - (Jamesline@osumc.edu) |
| Oncology Associates at Mercy Medical Center Cedar Rapids, Iowa | |
| Penn State Milton S Hershey Medical Center Hershey, Pennsylvania | Site Public Contact - (CTO@hmc.psu.edu) |
| Queens Cancer Center Rego Park, New York | |
| Saint Francis Medical Center Cape Girardeau, Missouri | Site Public Contact - (sfmc@sfmc.net) |
| 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) |
| 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) |
| State University of New York Upstate Medical University Syracuse, New York | |
| Stony Brook University Medical Center Stony Brook, New York | |
| The Don and Sybil Harrington Cancer Center Amarillo, Texas | Site Public Contact - (Gina.Cravey@bsahs.org) |
| Thomas Jefferson University Hospital Philadelphia, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| UI Health Care Mission Cancer and Blood - Ankeny Clinic Ankeny, Iowa | |
| UI Health Care Mission Cancer and Blood - Des Moines Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - Laurel Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - Waukee Clinic Waukee, Iowa | |
| UI Health Care Mission Cancer and Blood - West Des Moines Clinic Clive, Iowa | |
| UI Healthcare Mission Cancer and Blood - Pella Pella, Iowa | Site Public Contact - (trials@missioncancer.com) |
| UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion Mechanicsburg, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC-Shadyside Hospital Pittsburgh, Pennsylvania | |
| University Health Network-Princess Margaret Hospital Toronto, Ontario | Site Public Contact - (clinical.trials@uhn.on.ca) |
| University of Nebraska Medical Center Omaha, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Rochester Rochester, New York | |
| VCU Massey Cancer Center at Stony Point Richmond, Virginia | Site Public Contact - (ctoclinops@vcu.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Vanderbilt University/Ingram Cancer Center Nashville, Tennessee | |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
A Study to Learn About the Study Medicine Ibuzatrelvir in Adults With COVID-19 Who Are Severely Immunocompromised
Pfizer CT.gov Call Center - ClinicalTrials.gov_Inquiries@pfizer.com
NCT07013474
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Inclusion Criteria:
• 18 years of age or older at screening who are non-hospitalized or hospitalized for observation or with the intent of administering the study intervention.
• Confirmed SARS-CoV-2 infection as determined by RAT (or other locally approved test) collected within 2 days prior to randomization. Initial onset of symptoms attributable to COVID-19 within 5 days prior to the day of randomization and at least 1 of the specified symptoms attributable to COVID-19 present on the day of randomization.
• Severely immunocompromised due to: * Solid organ or islet cell transplant recipient who is receiving immunosuppressive therapy; * Active hematologic malignancy (eg, chronic lymphocytic leukemia, non-Hodgkin lymphoma, multiple myeloma, acute leukemia); * Receipt of CAR-T-cell therapy or HCT either within 2 years of transplantation or who are receiving immunosuppressive therapy; * Currently receiving or recently received B-cell depleting therapies (eg, rituximab), where the immunosuppressive effect is still ongoing.
Exclusion Criteria:
• Severe COVID-19, or current need for supplemental oxygen for treatment of COVID-19.
• Receiving dialysis or have current kidney failure (ie, eGFR consistently \<15 mL/min/1.73 m2)
• Active liver disease
• History of hypersensitivity or other contraindication to any of the components of the study interventions, as determined by the investigator
• Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study intervention.
• Life expectancy less than 30 days at study entry due to an underlying condition, in the judgement of the investigator.
• Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
• Has received any other antiviral for the treatment of the current COVID-19 infection
• Current use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s).
• Current or previous administration of an investigational product (drug or vaccine) within 30 days (or as determined by local requirement) or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer). Authorized or products with conditional approval are not considered investigational.
• Prior participation in this trial or any clinical trial of ibuzatrelvir.
• Females who are pregnant, breastfeeding, or who are planning to become pregnant within the timeframe of the study.
• Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
DRUG: ibuzatrelvir, DRUG: remdesivir, DRUG: placebo for ibuzatrelvir, DRUG: placebo for remdesivir
COVID-19 Infection
COVID-19 infection, pneumonia, respiratory tract infections, coronavirus infection, RNA virus infection, lung disease, pneumonia, viral, infections, virus, viral protease inhibitor, protease inhibitor, enzyme inhibitor, severe immunocompromise, anti-viral agents, anti-infectives, ibuzatrelvir, remdesivir, COVID-19
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Show 148 locations
Study Locations
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| Location | Contacts |
|---|---|
| AZ Sint-Jan Brugge-Oostende AV Bruges, West-vlaanderen | |
| Aalborg Universitetshospital, Syd Gistrup, | |
| Aarhus Universitetshospital, Skejby Aarhus, Central Jutland | |
| Acibadem Universitesi Atakent Hastanesi Istanbul, İ̇stanbul | |
| Alexandra General Hospital of Athens Athens, Attikí | |
| Amicis Research Center - Granada Hills Granada Hills, California | |
| Asan Medical Center Seoul, | |
| Aso Iizuka Hospital Iizuka, Fukuoka | |
| BRCR Global Puerto Rico San Juan, | |
| BRCR Medical Center - Ponce Ponce, | |
| BRP- Hialeah Hospital Hialeah, Florida | |
| Baylor Scott & White Health - Center for Advanced Heart and Lung Disease Dallas, Texas | |
| Baylor Scott & White Research Institute - Clinical Trials Office Dallas, Texas | |
| Baylor University Medical Center Dallas, Texas | |
| Brigham and Women's Hospital Boston, Massachusetts | |
| CECIP - Centro de Estudos do Interior Paulista Jaú, São Paulo | |
| CHUAC-Complejo Hospitalario Universitario A Coruña A Coruña, | |
| CHUVI- Hospital Alvaro Cunqueiro Vigo, Pontevedra [pontevedra] | |
| Canas Medical Center Ponce, | |
| Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand Dijon, | |
| Centro Médico São Francisco Curitiba, Paraná | |
| Chonnam National University Hospital Gwangju, | |
| Clinical Trials Center Boston, Massachusetts | |
| Clinical Trials Hub Boston, Massachusetts | |
| D&H Cancer Research Center LLC Margate, Florida | |
| Duke University - Main Hospital and Clinics Durham, North Carolina | |
| Duke Vaccine and Trials Unit Durham, North Carolina | |
| Duke Vaccine and Trials Unit Durham, North Carolina | |
| Erasmus MC Rotterdam, | |
| Evangelismos General Hospital of Athens Athens, Attikí | |
| FAICIC S. de R.L. de C.V. Veracruz, Veracruz Ignacio de LA Llave | |
| Fakultna Nemocnica Trnava Trnava, Trnava Region | |
| Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica Banská Bystrica, | |
| Far Eastern Memorial Hospital New Taipei City, | |
| Fujita Health University Hospital Aichi, | |
| Fundación Santos y de la Garza Evia I.B.P San Pedro Garza García, | |
| Gachon University Gil Medical Center Namdong-gu, Incheon-gwangyeoksi [incheon] | |
| Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi Gaziantep, | |
| General Hospital of Athens "Laiko" Goudi/Athens, | |
| Georgetown University Medical Center Washington D.C., District of Columbia | |
| Hacettepe Universite Hastaneleri Ankara, | |
| Henry Ford Hospital Detroit, Michigan | |
| Holy Name Medical Center Teaneck, New Jersey | |
| Hope Clinical Research, Inc. Canoga Park, California | |
| Hopital Claude Huriez - CHU de Lille Lille, | |
| Hopital Saint Antoine Paris, | |
| Hopital Saint-Louis Paris, Île-de-France Region | |
| Hospital De La Santa Creu I Sant Pau Barcelona, | |
| Hospital General Universitario Dr. Balmis Alicante, | |
| Hospital Germans Trias I Pujol Badalona, | |
| Hospital Italiano de la Plata La Plata, Buenos Aires | |
| Hospital Nossa Senhora das Gracas Curitiba, Paraná | |
| Hospital Universitari Vall d'Hebron Barcelona, | |
| Hospital Universitario La Paz Madrid, | |
| Hospital Universitario Reina Sofia Córdoba, | |
| Hospital Universitario Virgen de Valme Seville, | |
| Hospital de Clínicas de Porto Alegre Porto Alegre, | |
| Hospital e Maternidade Celso Pierro Campinas, São Paulo | |
| Houston Methodist Hospital Houston, Texas | |
| Humphreys Diabetes Center Boise, Idaho | |
| Hôpital Bichat - Claude-Bernard Paris, | |
| Ibni Sina Hospital Ankara, | |
| Icesp - Instituto Do Câncer Do Estado de São Paulo São Paulo, | |
| Instituto Médico Río Cuarto Río Cuarto, Córdoba Province | |
| Instituto Nacional de Infectologia Evandro Chagas Rio de Janeiro, | |
| International University of Health and Welfare Narita Hospital Narita, | |
| Ippokrateio General Hospital of Thessaloniki Thessaloniki, | |
| Jacobs Medical Center at UC San Diego Health La Jolla, California | |
| Jadestone Clinical Research Silver Spring, Maryland | |
| Johns Hopkins Hospital Baltimore, Maryland | |
| Jules Bordet Institute Anderlecht, | |
| Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung City, | |
| Karadeniz Technical University Trabzon, | |
| Karolinska Universitetssjukhuset Huddinge Huddinge, | |
| Kendall South Medical Center Miami, Florida | |
| Kocaeli Üniversitesi Kocaeli, | |
| Medical University of South Carolina Charleston, South Carolina | |
| Medical University of South Carolina Infectious Disease Clinic Charleston, South Carolina | |
| Medical University of South Carolina Investigational Drug Services (IDS) Charleston, South Carolina | |
| Medical University of South Carolina Investigational Drug Services Pharmacy Charleston, South Carolina | |
| Medical University of South Carolina Research Nexus Clinic Charleston, South Carolina | |
| Medical University of South Carolina Translational Research Nexus Clinic and Laboratory Charleston, South Carolina | |
| Memorial Hermann Hospital Houston, Texas | |
| Nagasaki University Hospital Nagasaki, | |
| Narodny Onkologicky Ustav Bratislava, | |
| Narodny ustav detskych chorob Bratislava, Bratislava Region | |
| National Center for Global Health and Medicine Shinjyuku-ku, | |
| National Hospital Organization Kyushu Medical Center Fukuoka, | |
| Nemocnica s poliklinikou Stefana Kukuru Michalovce, a.s. Michalovce, | |
| Northwestern Memorial Hospital Chicago, Illinois | |
| Northwestern University Feinberg School of Medicine Chicago, Illinois | |
| Odense Universitetshospital Odense, Region Syddanmark | |
| Parc de Salut Mar - Hospital del Mar Barcelona, | |
| Profound Research LLC Oceanside, California | |
| Radboudumc Nijmegen, | |
| Rigshospitalet Copenhagen, | |
| Rinku General Medical Center Izumisano, Osaka | |
| Saga University Hospital Saga, | |
| Sakarya Training and Research Hospital Sakarya, | |
| Sanatorio Sagrado Corazón Buenos Aires, | |
| School of Medicine Federal University of Minas Gerais Belo Horizonte, Minas Gerais | |
| Seattle Rheumatology Associates Seattle, Washington | |
| Skylight Health Research, - Burlington Burlington, Massachusetts | |
| Skånes Universitetssjukhus Malmö Malmö, Skåne LÄN [se-12] | |
| Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein São Paulo, | |
| St. Luke's Idaho Elks Children's Pavilion Boise, Idaho | |
| Swedish Ambulatory Infusion Center- First Hill Seattle, Washington | |
| Swedish Cancer Institute Treatment Center Seattle, Washington | |
| Swedish Medical Center - First Hill Campus Seattle, Washington | |
| Swedish Medical Center- Innovative Therapeutics & Research Unit Seattle, Washington | |
| Swedish Organ Transplant and Liver Center Seattle, Washington | |
| TRC Pittsburgh, Pennsylvania | |
| TUM Klinikum München, Bavaria | |
| Tachikawa Hospital Tachikawa, Tokyo | |
| Taichung Veterans General Hospital Taichung, | |
| Taipei Veterans General Hospital Taipei, | |
| The Catholic University of Korea, Eunpyeong St. Mary's Hospital Eunpyeong-gu, | |
| The University of Texas Health Science Center at Houston Houston, Texas | |
| Tokyo Medical University Hachioji Medical Center Tokyo, Hachioji, | |
| UC Davis CTSC Clinical Research Center Sacramento, California | |
| UC San Diego Medical Center - Hillcrest San Diego, California | |
| UCHealth Anschutz Inpatient Pavilion - Anschutz Medical Campus Aurora, Colorado | |
| UKE Hamburg Hamburg, | |
| UPMC Division of Infectious Disease Clinic Pittsburgh, Pennsylvania | |
| UPMC Hillman Cancer Center Pittsburgh, Pennsylvania | |
| UPMC Presbyterian IDS Pittsburgh, Pennsylvania | |
| UPMC Presbyterian Shadyside Pittsburgh, Pennsylvania | |
| UPMC Shadyside Pittsburgh, Pennsylvania | |
| UPMC Shadyside IDS Pittsburgh, Pennsylvania | |
| UT Physicians Houston, Texas | |
| UZ Brussel Brussels, | |
| Universitaetsklinikum Koeln Cologne, North Rhine-Westphalia | |
| University General Hospital of Alexandroupoli Alexandroupoli, Anatolikí Makedonía KAI Thráki | |
| University of California Davis Health Sacramento, California | |
| University of California San Diego Health San Diego, California | |
| University of Cincinnati College of Medicine (UC Holmes) Cincinnati, Ohio | |
| University of Cincinnati Medical Center Cincinnati, Ohio | |
| University of Colorado Anschutz Medical Campus Aurora, Colorado | |
| University of Colorado Clinical and Translational Research Center Aurora, Colorado | |
| University of Colorado Hospital Aurora, Colorado | |
| University of Massachusetts Chan Medical School Worcester, Massachusetts | |
| University of Michigan Ann Arbor, Michigan | |
| University of Pittsburgh Medical Center Pittsburgh, Pennsylvania | |
| Université Libre de Bruxelles - Hôpital Erasme Brussels, | |
| Velocity Clinical Research, Savannah Savannah, Georgia | |
| West Tennessee Research Institute Jackson, Tennessee | |
| Zenos Clinical Research Dallas, Texas | |
| hospital Italiano de Buenos Aires Buenos Aires, |
Testing the Addition of the Drug BMX-001, a Radioprotector, or a Placebo to the Usual Chemoradiation Therapy for Patients With Head and Neck Cancer
ctrrecruit@vcu.edu
NCT06532279
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Inclusion Criteria:
* Patients must be planned to receive radiation and concurrent cisplatin chemotherapy as definitive therapy. Patients planned to receive concurrent cisplatin and radiation therapy in the adjuvant setting are not eligible.
* At least two subsites (buccal mucosa, lips, retromolar trigone, floor of mouth, oral tongue, tonsil, soft palate, or hard palate) must have at least 1cc or 1% of the subsite volume receiving \>= 50 Gy. In cases of uncertainty, the enrolling clinician can ensure coverage by inspecting the 50 Gy isodose line and using the table describing the anatomic boundaries of the individual subsites contained within the extended cavity contour. The two or more subsites receiving \>= 50 Gy must be documented by the enrolling physician.
* Pathologically confirmed (histologically or cytologically) squamous cell carcinoma of the oropharynx, larynx, hypopharynx, nasopharynx, or oral cavity.
* P16 and/or human papillomavirus (HPV) status (via polymerase chain reaction \[PCR\] or in situ hybridization \[ISH\]) must be documented for patients with oropharynx cancer.
* No patients with T0/Tx/unknown primary disease.
* No definitive clinical or radiologic evidence of metastatic (M1) disease related to current diagnosis.
* Able to receive intensity-modulated radiation therapy (IMRT) delivered as daily fractions of 2.0 Gy once per weekday with a cumulative radiation dose of 70 Gy.
* Age \>= 18.
* Zubrod performance status of 0-2.
* Potassium ≥ institutional lower limit of normal (LLN) and magnesium ≥ institutional LLN. Oral or intravenous (IV) replacement therapy of potassium or magnesium is permitted if parameters can be met after repletion.
* Absolute neutrophil count (ANC) \>= 1,500 cells/mm\^3.
* Platelets \>= 100,000 cells/mm\^3.
* Hemoglobin \>= 9.0 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin \[Hgb\] \>= 10.0 g/dl is acceptable).
* Adequate renal function defined as creatinine clearance (CrCL) \> 50 mL/min by the Cockcroft-Gault formula.
* Total bilirubin =\< 2 x institutional upper limit of normal (ULN) (not applicable to patients with known Gilbert's syndrome).
* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3 x institutional ULN.
* No prior radiotherapy that would result in overlap of radiation treatment fields with planned treatment for study cancer, e.g., breast cancer with irradiation of the supraclavicular fossa/level 4 neck.
* No concurrent treatment with nitrates or other drugs that may, in the judgment of the treating investigator, create a risk for a precipitous decrease in blood pressure.
* No prior history of gross total excision of both primary and nodal disease; this includes tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease. In other words, to participate in this protocol, the patient must have clinically or radiographically evident gross disease for which disease response can be assessed.
* No current treatment of adjuvant post-operative (op) chemoradiation.
* No systemic treatment with inducers or strong inhibitors of cytochrome P450 =\< 4 days before registration. Note: Patients undergoing steroid treatment as a component of the anti-emetic regimen for cisplatin are eligible for the study. Treatment with the antifungal medications, nystatin, fluconazole , miconazole and clotrimazole are allowed.
* No prior induction chemotherapy treatment.
* No prior unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ, basal cell skin carcinoma, resected T1-2N0M0 differentiated thyroid cancers, Ta bladder cancers, or low risk prostate cancer.
* No clinically significant hearing impairment that precludes cisplatin, as per physician assessment.
* No serious cardiovascular disease or cerebrovascular disease in the last 6 months prior to study enrollment; defined as a cerebrovascular accident, myocardial infarction, unstable angina, serious cardiac arrhythmia uncontrolled by medication or with the potential to interfere with protocol treatment, or current New York Heart Association (NYHA) grade II or greater congestive heart failure (CHF), or admission within last 6 months for CHF exacerbation; (Note: 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).
* No valvular heart disease.
* No significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months prior to enrollment.
* No history or evidence upon physical/neurological examination of central nervous system disease (e.g., seizures) unrelated to cancer unless adequately controlled by medication.
* No acute bacterial, viral, or fungal infection requiring intravenous antimicrobials within 7 days of enrollment.
* No history of chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration.
* No known personal or family history of long QT Syndrome; no marked baseline prolongation of QT/corrected QT (QTc) interval (i.e., ≥ 2 electrocardiograms \[EKGs\] in prior 3 months of a QTc interval \> 450 milliseconds (ms) for males and \> 470 ms for females using the specific/usual choice by clinical center for correction factor.
* Persistent grade 3-4 (CTCAE version 5.0) electrolyte abnormalities must be reversible to ≤ grade 1 with supplementation.
* No poorly controlled hypertension (systolic blood pressure \[SBP\] \> 160 and/or diastolic blood pressure \[DBP\] \> 95) over 2 repeated measures within 30 days prior to registration.
* No grade \>= 2 oral mucositis per CTCAE version 5.0.
* No grade \>= 2 hypotension per CTCAE v. 5.0.
* No medical necessity for anti-arrhythmics with significant risk of QTc prolongation such as class I and class III anti-arrhythmics. These include but are not limited to amiodarone, quinidine, dofetilide, sotalol, flecainide, and lidocaine.
* No medical necessity for medications listed as prohibited.
* For standard management of oral mucositis, clinicians may consult the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO) Clinical Practice Guidelines for the Management of Mucositis Secondary to Cancer Therapy. The only intervention against mucositis that is supported by level I evidence is low-level laser therapy (LLLT). Honey is rated at level II and benzydamine, which isn't available in the United States (US), is rated at level III. There are no other positively rated interventions.
* LLLT is prohibited in this study as its availability remains limited, it is not Food and Drug Administration (FDA) approved in the US, and it is considered investigational in many circumstances requiring enrollment in a dedicated protocol who requirements could conflict with this one. Therefore, institutions that use LLLT should only enroll patients who would not be eligible for (or do not want) that intervention. Honey is not on the list of prohibited medications for this study. Given the MASCC recommendation, benzydamine is allowed, although there is lack of availability in the United States of America (USA). The other listed prohibited medications are not recommended by MASCC and some are potentially harmful, such as glutamine, which is associated with mortality in patients receiving stem cell transplant.
* No history of allergic reaction to the study agent(s), compounds of similar chemical or biologic composition to the study agent (s) (or any of its excipients).
* Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. OTHER: Best Practice, PROCEDURE: Biospecimen Collection, DRUG: Cisplatin, PROCEDURE: Computed Tomography, RADIATION: Image Guided Radiation Therapy, RADIATION: Intensity-Modulated Radiation Therapy, PROCEDURE: Magnetic Resonance Imaging, DRUG: MnSOD Mimetic BMX-001, DRUG: Placebo Administration, OTHER: Questionnaire Administration
Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Head and Neck Squamous Cell Carcinoma, Hypopharyngeal Squamous Cell Carcinoma, Laryngeal Squamous Cell Carcinoma, Nasopharyngeal Squamous Cell Carcinoma, Oral Cavity Squamous Cell Carcinoma, Oropharyngeal Squamous Cell Carcinoma, Stage 0 Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8, Stage 0 Hypopharyngeal Carcinoma AJCC v8, Stage 0 Nasopharyngeal Carcinoma AJCC v8, Stage 0 Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage I Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8, Stage I Hypopharyngeal Carcinoma AJCC v8, Stage I Laryngeal Cancer AJCC v8, Stage I Lip and Oral Cavity Cancer AJCC v8, Stage I Nasopharyngeal Carcinoma AJCC v8, Stage I Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage II Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8, Stage II Hypopharyngeal Carcinoma AJCC v8, Stage II Laryngeal Cancer AJCC v8, Stage II Lip and Oral Cavity Cancer AJCC v8, Stage II Nasopharyngeal Carcinoma AJCC v8, Stage II Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage III Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8, Stage III Hypopharyngeal Carcinoma AJCC v8, Stage III Laryngeal Cancer AJCC v8, Stage III Lip and Oral Cavity Cancer AJCC v8, Stage III Nasopharyngeal Carcinoma AJCC v8, Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage IVA Hypopharyngeal Carcinoma AJCC v8, Stage IVA Laryngeal Cancer AJCC v8, Stage IVA Lip and Oral Cavity Cancer AJCC v8, Stage IVA Nasopharyngeal Carcinoma AJCC v8, Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage IVB Hypopharyngeal Carcinoma AJCC v8, Stage IVB Laryngeal Cancer AJCC v8, Stage IVB Lip and Oral Cavity Cancer AJCC v8, Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stomatitis
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Show 153 locations
Study Locations
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| Location | Contacts |
|---|---|
| Adams Cancer Center Gettysburg, Pennsylvania | |
| Arizona Center for Cancer Care Tempe, Arizona | Site Public Contact - (penny.labriola@arizonaccc.com) |
| Arizona Center for Cancer Care - Gilbert Gilbert, Arizona | Site Public Contact - (penny.labriola@arizonaccc.com) |
| Arizona Center for Cancer Care - Phoenix Phoenix, Arizona | Site Public Contact - (penny.labriola@arizonaccc.com) |
| Arizona Center for Cancer Care - Scottsdale Scottsdale, Arizona | Site Public Contact - (penny.labriola@arizonaccc.com) |
| Arizona Center for Cancer Care-Peoria Peoria, Arizona | |
| Arizona Center for Cancer Care-Surprise Surprise, Arizona | Site Public Contact - (Roster@nrgoncology.org) |
| Aspirus Cancer Care - James Beck Cancer Center Rhinelander, Wisconsin | Site Public Contact - (Beth.Knetter@aspirus.org) |
| Aspirus Cancer Care - Stevens Point Stevens Point, Wisconsin | Site Public Contact - (Beth.Knetter@aspirus.org) |
| Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids, Wisconsin | |
| Aspirus Regional Cancer Center Wausau, Wisconsin | |
| Atrium Health Cabarrus/LCI-Concord Concord, North Carolina | |
| Atrium Health Cleveland/LCI-Cleveland Shelby, North Carolina | |
| Atrium Health Pineville/LCI-Pineville Charlotte, North Carolina | |
| Atrium Health Stanly/LCI-Albemarle Albemarle, North Carolina | |
| Atrium Health Union/LCI-Union Monroe, North Carolina | |
| Atrium Health University City/LCI-University Charlotte, North Carolina | |
| Aultman Health Foundation Canton, Ohio | Site Public Contact - (ClinicalReserachDept@aultman.com) |
| Baptist Cancer Center-Grenada Grenada, Mississippi | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baptist Health Floyd New Albany, Indiana | Site Public Contact - (Roster@nrgoncology.org) |
| Baptist Health Hardin Elizabethtown, Kentucky | |
| 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) |
| Boston Medical Center Boston, Massachusetts | |
| 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) |
| CaroMont Regional Medical Center Gastonia, North Carolina | Site Public Contact - (tammy.cozad@caromonthealth.org) |
| Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina | |
| Chambersburg Hospital Chambersburg, Pennsylvania | Site Public Contact - (Roster@nrgoncology.org) |
| Dartmouth Cancer Center - North Saint Johnsbury, Vermont | Site Public Contact - (cancer.research.nurse@hitchcock.org) |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire | Site Public Contact - (cancer.research.nurse@dartmouth.edu) |
| Drexel Town Square Health Center Oak Creek, Wisconsin | |
| Duke University Medical Center Durham, North Carolina | |
| Ephrata Cancer Center Ephrata, Pennsylvania | |
| Florida Cancer Specialists - Sarasota Sarasota, Florida | Site Public Contact - (Roster@nrgoncology.org) |
| Florida Cancer Specialists - Sarasota Downtown Sarasota, Florida | Site Public Contact - (ClinicalTrials@FLCancer.com) |
| Florida Cancer Specialists - Venice Pinebrook Venice, Florida | Site Public Contact - (ClinicalTrials@FLCancer.com) |
| Froedtert Menomonee Falls Hospital Menomonee Falls, Wisconsin | |
| Froedtert West Bend Hospital/Kraemer Cancer Center West Bend, Wisconsin | |
| George Washington University Medical Center Washington D.C., District of Columbia | |
| Greater Baltimore Medical Center Baltimore, Maryland | |
| Hayworth Cancer Center High Point, North Carolina | |
| 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-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 | |
| Karmanos Cancer Institute at McLaren Greater Lansing Lansing, Michigan | Site Public Contact - (ctoadmin@karmanos.org) |
| Keck Medicine of USC Buena Park Buena Park, California | |
| Lake Regional Hospital Osage Beach, Missouri | Site Public Contact - (clinicaltrials@lakeregional.com) |
| Lancaster Radiation Therapy Center Lancaster, South Carolina | |
| Langlade Hospital and Cancer Center Antigo, Wisconsin | Site Public Contact - (Juli.Alford@aspirus.org) |
| Levine Cancer Institute-Gaston Gastonia, North Carolina | |
| Levine Cancer Institute-Rock Hill Rock Hill, South Carolina | |
| Los Angeles General Medical Center Los Angeles, California | |
| McFarland Clinic - Ames Ames, Iowa | Site Public Contact - (ksoder@mcfarlandclinic.com) |
| McLaren Cancer Institute-Bay City Bay City, Michigan | Site Public Contact - (ctoadmin@karmanos.org) |
| McLaren Cancer Institute-Central Michigan Mount Pleasant, Michigan | Site Public Contact - (ctoadmin@karmanos.org) |
| McLaren Cancer Institute-Clarkston Clarkston, Michigan | Site Public Contact - (ctoadmin@karmanos.org) |
| McLaren Cancer Institute-Flint Flint, Michigan | Site Public Contact - (ctoadmin@karmanos.org) |
| McLaren Cancer Institute-Lapeer Region Lapeer, Michigan | Site Public Contact - (ctoadmin@karmanos.org) |
| McLaren Cancer Institute-Macomb Mount Clemens, Michigan | Site Public Contact - (ctoadmin@karmanos.org) |
| McLaren Cancer Institute-Northern Michigan Petoskey, Michigan | Site Public Contact - (ctoadmin@karmanos.org) |
| McLaren-Port Huron Port Huron, Michigan | Site Public Contact - (ctoadmin@karmanos.org) |
| Medical College of Wisconsin Milwaukee, Wisconsin | |
| Mercy Hospital Coon Rapids, Minnesota | |
| Mercy Medical Center - Des Moines Des Moines, Iowa | |
| Miller-Dwan Hospital Duluth, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Moffitt Cancer Center Tampa, Florida | Site Public Contact - (ClinicalTrials@moffitt.org) |
| Moffitt Cancer Center - McKinley Campus Tampa, Florida | Site Public Contact - (ClinicalTrials@moffitt.org) |
| Moffitt Cancer Center at SouthShore Ruskin, Florida | Site Public Contact - (ClinicalTrials@moffitt.org) |
| Moffitt Cancer Center at Wesley Chapel Wesley Chapel, Florida | Site Public Contact - (ClinicalTrials@moffitt.org) |
| Moffitt Cancer Center-International Plaza Tampa, Florida | Site Public Contact - (ClinicalTrials@moffitt.org) |
| Montefiore Medical Center - Moses Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Montefiore Medical Center-Einstein Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro Jonesboro, Arkansas | Site Public Contact - (Emily.Carvell@bmhcc.org) |
| Northwest Wisconsin Cancer Center Ashland, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| 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 Oak Brook Oak Brook, Illinois | Site Public Contact - (nctnprogram_rhlccc@northwestern.edu) |
| Northwestern Medicine Orland Park Orland Park, Illinois | Site Public Contact - (nctnprogram_rhlccc@northwestern.edu) |
| Northwestern University Chicago, Illinois | Site Public Contact - (cancer@northwestern.edu) |
| OSF Saint Francis Medical Center Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| OSF Saint Joseph Medical Center Bloomington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Ohio State University Comprehensive Cancer Center Columbus, Ohio | Site Public Contact - (Jamesline@osumc.edu) |
| Oncology Associates at Mercy Medical Center Cedar Rapids, Iowa | |
| Penn State Milton S Hershey Medical Center Hershey, Pennsylvania | Site Public Contact - (CTO@hmc.psu.edu) |
| ProHealth D N Greenwald Center Mukwonago, Wisconsin | |
| ProHealth Oconomowoc Memorial Hospital Oconomowoc, Wisconsin | |
| Renown Regional Medical Center Reno, Nevada | Site Public Contact - (research@sncrf.org) |
| Rock Hill Radiation Therapy Center Rock Hill, South Carolina | |
| Saint Francis Medical Center Cape Girardeau, Missouri | Site Public Contact - (sfmc@sfmc.net) |
| Salina Regional Health Center Salina, Kansas | Site Public Contact - (mleepers@srhc.com) |
| Sarasota Memorial Health Care Center at University Parkway Sarasota, Florida | |
| Sarasota Memorial Hospital Sarasota, Florida | |
| Sarasota Memorial Hospital-Venice N. Venice, Florida | |
| Sechler Family Cancer Center Lebanon, Pennsylvania | Site Public Contact - (doxenberg@wellspan.org) |
| Shaw Cancer Center Edwards, Colorado | |
| Summa Health System - Akron Campus Akron, Ohio | Site Public Contact - (cancerresearch@summahealth.org) |
| UC San Diego Health System - Encinitas Encinitas, California | |
| UC San Diego Medical Center - Hillcrest San Diego, California | Site Public Contact - (rhabbaba@health.ucsd.edu) |
| UC San Diego Moores Cancer Center La Jolla, California | Site Public Contact - (cancercto@ucsd.edu) |
| UI Health Care Mission Cancer and Blood - Ankeny Clinic Ankeny, Iowa | |
| UI Health Care Mission Cancer and Blood - Des Moines Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - Laurel Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - Waukee Clinic Waukee, Iowa | |
| UI Health Care Mission Cancer and Blood - West Des Moines Clinic Clive, Iowa | |
| UPMC Cancer Center - Monroeville Monroeville, Pennsylvania | Site Public Contact - (Roster@nrgoncology.org) |
| UPMC Cancer Center at UPMC Horizon Farrell, Pennsylvania | Site Public Contact - (Roster@nrgoncology.org) |
| UPMC Cancer Centers - Arnold Palmer Pavilion Greensburg, Pennsylvania | |
| UPMC Hillman Cancer Center - Monroeville Monroeville, Pennsylvania | Site Public Contact - (ClinicalResearchServices@upmc.edu) |
| UPMC Hillman Cancer Center - New Castle New Castle, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC Hillman Cancer Center Erie Erie, Pennsylvania | Site Public Contact - (ClinicalResearchServices@upmc.edu) |
| UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion Mechanicsburg, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC Pinnacle Cancer Center/Community Osteopathic Campus Harrisburg, Pennsylvania | Site Public Contact - (klitchfield@PINNACLEHEALTH.org) |
| UPMC-Passavant Hospital Pittsburgh, Pennsylvania | |
| UPMC-Saint Clair Hospital Cancer Center Pittsburgh, Pennsylvania | |
| UPMC-Saint Margaret Pittsburgh, Pennsylvania | |
| UPMC-Shadyside Hospital Pittsburgh, Pennsylvania | |
| USC / Norris Comprehensive Cancer Center Los Angeles, California | |
| USC Norris Oncology/Hematology-Newport Beach Newport Beach, California | |
| UW Cancer Center at ProHealth Care Waukesha, Wisconsin | |
| University of Cincinnati Cancer Center-UC Medical Center Cincinnati, Ohio | Site Public Contact - (cancer@uchealth.com) |
| University of Cincinnati Cancer Center-West Chester West Chester, Ohio | Site Public Contact - (cancer@uchealth.com) |
| University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa | |
| University of Kansas Cancer Center Kansas City, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Hospital-Westwood Cancer Center Westwood, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of New Mexico Cancer Center Albuquerque, New Mexico | Site Public Contact - (HSC-ClinicalTrialInfo@salud.unm.edu) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Pittsburgh Cancer Institute (UPCI) Pittsburgh, Pennsylvania | |
| University of Tennessee - Knoxville Knoxville, Tennessee | |
| 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) |
| Wake Forest University Health Sciences Winston-Salem, North Carolina | |
| 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) |
| WellSpan Health-York Cancer Center York, Pennsylvania | |
| Zablocki Veterans Administration Medical Center Milwaukee, Wisconsin |
Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia
ctrrecruit@vcu.edu
NCT06317662
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Inclusion Criteria:
* All patients must be enrolled on APEC14B1 and consented to eligibility screening (part A) prior to treatment and enrollment on AALL2321
* Infants (aged 365 days or less) on the date of diagnosis are eligible; infants must be \> 36 weeks gestational age at the time of enrollment
* Patients must have newly diagnosed B-acute lymphoblastic leukemia (B-ALL, 2017 World Health Organization \[WHO\] classification), also termed B-precursor ALL, or acute leukemia of ambiguous lineage (ALAL), which includes mixed phenotype acute leukemia. For patients with ALAL, the immunophenotype of the leukemia must comprise at least 50% B lineage
* Diagnostic immunophenotype: Leukemia cells must express CD19
Exclusion Criteria:
* Patients with Down Syndrome
* Patients with secondary B-ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy
* Patients must not have received any cytotoxic chemotherapy for either the current diagnosis of infant ALL or for any cancer diagnosis prior to the initiation of protocol therapy, with the exception of:
* Steroid pretreatment:
* PredniSONE, prednisoLONE, or methylPREDNISolone for ≤ 72 hours (3 days) in the 7 days prior to enrollment. The dose of predniSONE, prednisoLONE or methylPREDNISolone does not affect eligibility
* Inhaled and topical steroids are not considered pretreatment
* Note: Pretreatment with dexamethasone in the 28 days prior to initiation of protocol therapy is not allowed with the exception of a single dose of dexamethasone used during or within 6 hours prior to or after sedation to prevent or treat airway edema. However, prior exposure to ANY steroids that occurred \> 28 days before enrollment does not affect eligibility
* Intrathecal cytarabine or methotrexate:
* An intrathecal dose of cytarabine or methotrexate in the 7 days prior to enrollment does not affect eligibility
* Note: The preference is to defer the diagnostic lumbar puncture with intrathecal chemotherapy to day 1 of induction to allow for cytoreduction of circulating blasts and decrease the potential for central nervous system (CNS) contamination due to a traumatic tap. If done prior to day 1 of induction, these results will be used to determine CNS status
* Hydroxyurea:
* Pretreatment with ≤ 72 hours (3 days) of hydroxyurea in the 7 days prior to enrollment does not affect eligibility
* 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 DRUG: Asparaginase Erwinia chrysanthemi, PROCEDURE: Biospecimen Collection, BIOLOGICAL: Blinatumomab, PROCEDURE: Bone Marrow Aspiration, DRUG: Calaspargase Pegol, PROCEDURE: Computed Tomography, DRUG: Cyclophosphamide, DRUG: Cytarabine, DRUG: Daunorubicin, DRUG: Dexamethasone, DRUG: Doxorubicin, PROCEDURE: Echocardiography Test, PROCEDURE: FDG-Positron Emission Tomography, DRUG: Leucovorin, DRUG: Levoleucovorin, PROCEDURE: Lumbar Puncture, PROCEDURE: Magnetic Resonance Imaging, DRUG: Mercaptopurine, DRUG: Methotrexate, DRUG: Methylprednisolone, PROCEDURE: Multigated Acquisition Scan, DRUG: Prednisolone, DRUG: Prednisone, DRUG: Therapeutic Hydrocortisone, DRUG: Thioguanine, DRUG: Venetoclax, DRUG: Vincristine
Acute Leukemia of Ambiguous Lineage, B Acute Lymphoblastic Leukemia
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Show 113 locations
Study Locations
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| Location | Contacts |
|---|---|
| AdventHealth Orlando Orlando, Florida | Site Public Contact - (FH.Cancer.Research@flhosp.org) |
| Advocate Children's Hospital-Oak Lawn Oak Lawn, Illinois | |
| Advocate Children's Hospital-Park Ridge Park Ridge, Illinois | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Albany Medical Center Albany, New York | |
| Alfred I duPont Hospital for Children Wilmington, Delaware | Site Public Contact - (Allison.bruce@nemours.org) |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| 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 | |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas | Site Public Contact - (burton@bcm.edu) |
| Blank Children's Hospital Des Moines, Iowa | Site Public Contact - (samantha.mallory@unitypoint.org) |
| Bronson Methodist Hospital Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| C S Mott Children's Hospital Ann Arbor, Michigan | |
| Carilion Children's Roanoke, Virginia | Site Public Contact - (wpmccarty@carilionclinic.org) |
| Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina | |
| 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 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 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 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) |
| Connecticut Children's Medical Center Hartford, Connecticut | |
| Cook Children's Medical Center Fort Worth, Texas | Site Public Contact - (CookChildrensResearch@cookchildrens.org) |
| Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Dana-Farber Cancer Institute Boston, Massachusetts | |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire | Site Public Contact - (cancer.research.nurse@dartmouth.edu) |
| Dayton Children's Hospital Dayton, Ohio | |
| 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 | |
| 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) |
| Hackensack University Medical Center Hackensack, New Jersey | |
| Johns Hopkins All Children's Hospital St. Petersburg, Florida | Site Public Contact - (Ashley.Repp@jhmi.edu) |
| Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland | Site Public Contact - (jhcccro@jhmi.edu) |
| Kaiser Permanente-Oakland Oakland, California | Site Public Contact - (Kpoct@kp.org) |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York | Site Public Contact - (CancerTrials@nyulangone.org) |
| Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Loma Linda University Medical Center Loma Linda, California | |
| Lurie Children's Hospital-Chicago Chicago, Illinois | |
| Maine Children's Cancer Program Scarborough, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| Medical City Dallas Hospital Dallas, Texas | |
| Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood, Florida | Site Public Contact - (OHR@mhs.net) |
| Memorial Sloan Kettering Cancer Center New York, New York | |
| Mercy Hospital Saint Louis St Louis, Missouri | |
| Methodist Children's Hospital of South Texas San Antonio, Texas | Site Public Contact - (Vinod.GidvaniDiaz@hcahealthcare.com) |
| Miller Children's and Women's Hospital Long Beach Long Beach, California | |
| Montefiore Medical Center - Moses Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Morristown Medical Center Morristown, New Jersey | |
| NYP/Weill Cornell Medical Center New York, New York | |
| Nemours Children's Clinic - Pensacola Pensacola, Florida | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Nemours Children's Clinic-Jacksonville Jacksonville, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| Nemours Children's Hospital Orlando, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| New York Medical College Valhalla, New York | |
| Norton Children's Hospital Louisville, Kentucky | Site Public Contact - (CancerResource@nortonhealthcare.org) |
| Ochsner Medical Center Jefferson New Orleans, Louisiana | Site Public Contact - (Elisemarie.curry@ochsner.org) |
| Prisma Health Richland Hospital Columbia, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo, Ohio | Site Public Contact - (PCIOncResearch@promedica.org) |
| Providence Alaska Medical Center Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Providence Sacred Heart Medical Center and Children's Hospital Spokane, Washington | Site Public Contact - (HopeBeginsHere@providence.org) |
| Rainbow Babies and Childrens Hospital Cleveland, Ohio | |
| Rhode Island Hospital Providence, Rhode Island | |
| Riley Hospital for Children Indianapolis, Indiana | |
| Roswell Park Cancer Institute Buffalo, New York | Site Public Contact - (askroswell@roswellpark.org) |
| Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick, New Jersey | |
| Saint Joseph's Hospital/Children's Hospital-Tampa Tampa, Florida | Site Public Contact - (jennifer.manns@baycare.org) |
| Saint Joseph's Regional Medical Center Paterson, New Jersey | Site Public Contact - (HallL@sjhmc.org) |
| Saint Jude Children's Research Hospital Memphis, Tennessee | Site Public Contact - (referralinfo@stjude.org) |
| Saint Luke's Cancer Institute - Boise Boise, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Mary's Medical Center West Palm Beach, Florida | |
| Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Sanford Broadway Medical Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org) |
| Seattle Children's Hospital Seattle, Washington | |
| Sinai Hospital of Baltimore Baltimore, Maryland | |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| State University of New York Upstate Medical University Syracuse, New York | |
| The Children's Hospital at TriStar Centennial Nashville, Tennessee | |
| The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park, New York | |
| UCSF Benioff Children's Hospital Oakland Oakland, California | Site Public Contact - (PedOncRschOAK@ucsf.edu) |
| UCSF Medical Center-Mission Bay San Francisco, California | Site Public Contact - (cancertrials@ucsf.edu) |
| UF Health Cancer Institute - Gainesville Gainesville, Florida | Site Public Contact - (cancer-center@ufl.edu) |
| UMass Memorial Medical Center - University Campus Worcester, Massachusetts | Site Public Contact - (cancer.research@umassmed.edu) |
| UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina | Site Public Contact - (cancerclinicaltrials@med.unc.edu) |
| UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| University Pediatric Hospital San Juan, | |
| University of California Davis Comprehensive Cancer Center Sacramento, California | |
| University of Chicago Comprehensive Cancer Center Chicago, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| University of Kentucky/Markey Cancer Center Lexington, Kentucky | |
| University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida | |
| University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota | |
| University of Mississippi Medical Center Jackson, Mississippi | |
| University of 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) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Vanderbilt University/Ingram Cancer Center Nashville, Tennessee | |
| Wake Forest University Health Sciences Winston-Salem, North Carolina | |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Yale University New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
Enzalutamide Implants (Enolen) in Patients With Prostate Cancer
Bonnie Wettersten, MS - bonnie.wettersten@alessatherapeutics.com
NCT06257693
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Inclusion Criteria:
• Age at least 21 years old
• Histologically confirmed adenocarcinoma of the prostate
• Study participant qualified and planning for radical prostatectomy
• At least 1 prostate lesion measurable by MRI greater or equal to 0.5 cm
• Cohort A and Cohort B: Gleason score 3+4 or higher Cohort C: Gleason score 3+3 with high risk features or 3+4
• Study participant must be willing to undergo post-treatment imaging by MRI
• Participants must be able to understand and sign the informed consent form
• ECOG performance status 0 or 1
• Adequate organ function, including absolute neutrophil count (ANC) ≥1000 cells/μL, hemoglobin ≥9 g/dL, platelets ≥100,000 cells/μL, estimated creatinine clearance ≥50 mL/min, bilirubin \<1.5x ULN (\< 3x ULN for documented Gilbert's syndrome)
• Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and Alkaline phosphatase \<2.5x ULN
• The effects of Enolen on the developing human fetus are unknown. For this reason and because other therapeutic agents used in this trial are known to be teratogenic, men must agree to use a highly effective form of contraception or abstinence at the time of study entry and continuing through three months after radical prostatectomy/implant removal. Highly effective forms of contraception include: Vasectomy Condom with spermicide Partner use of one of the following methods: Postmenopausal \>1 year or age \>55y Bilateral tubal ligation Intrauterine devices (IUDs) Hormonal implants (Implanon, Nexplanon, etc.) Combination oral contraceptives Progestin-only injections (Depo-Provera) Hormonal patches Vaginal Ring Should a woman become pregnant or suspect she is pregnant while her partner is participating in this study, the treating physician should be informed immediately.
Exclusion Criteria:
• Prior radiotherapy or surgery for prostate cancer
• Ongoing hormonal therapy for prostate cancer or hormone therapy \<3 months prior to the start of treatment
• Prior prostate procedures such as transurethral resection of the prostate, transurethral microwave thermotherapy of the prostate, high-intensity focused ultrasound or minimally invasive Benign Prostate Hyperplasia (BPH) procedure
• Study participant unwilling or unable to undergo MRI, including participants with contra-indications to MRI, such as cardiac pacemakers, non-compatible intracranial vascular clips, etc.
• Metallic hip implant or any other metallic implant or device that distorts the quality of prostatic MR images.
• Study participants who, because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent.
• Presence of any metastatic disease.
• No evidence of extracapsular extension of disease.
• Study participants, who in the opinion of the treating clinician, would be at increased risk of refractory urinary retention due to a transperineal procedure such as the Enolen implant.
• History of prostate infection within 2 years.
• No intercurrent medical condition or circumstances that would preclude prostatectomy.
• History of bleeding diathesis or currently on anti-coagulation therapy that cannot be safely discontinued for implant procedure.
• Any condition that, in the opinion of the Principal Investigator, which would impair the participant's ability to comply with study procedures and undergo prostatectomy.
DRUG: enzalutamide
Prostate Adenocarcinoma
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Show 7 locations
Study Locations
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| Location | Contacts |
|---|---|
| Atlantic Urology Specialists Myrtle Beach, South Carolina | Taylor Stephenson - (taylor.stephenson@startresearch.com) |
| Aurora Urology Milwaukee, Wisconsin | Greg Anderson - (gregory.anderson@aah.org) |
| Mary Bird Cancer Center Metairie, Louisiana | Mandy Shipp - (mshipp@marybird.com) |
| National Institutes of Health Clinical Center Bethesda, Maryland | Katie Evans, RN - (katie.evans@nih.gov) |
| Northwestern University Chicago, Illinois | Sophia Kallas - (sophia.kallas@northwestern.edu) |
| VA Portland Health Care System Portland, Oregon | Laura Onstad - (laura.onstad@va.gov) |
| Virginia Commonwealth University Richmond, Virginia | Genelle Gaudinez - (gaudinezg@vcu.edu) |
Safety, Tolerability, Pharmacodynamic, Efficacy, and Pharmacokinetic Study of DYNE-101 in Participants With Myotonic Dystrophy Type 1 (ACHIEVE)
Dyne Clinical Trials - clinicaltrials@dyne-tx.com
NCT05481879
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Inclusion Criteria:
* Diagnosis of DM1 with trinucleotide repeat size \>100.
* Age of onset of DM1 muscle symptoms ≥12 years.
* Clinically apparent myotonia equivalent to hand opening time of at least 2 seconds in the opinion of the Investigator.
* Hand grip strength and ankle dorsiflexion strength.
* Able to complete 10-MWRT, stair ascend/descend (MAD cohorts only), and 5×STS at screening without the use of assistive devices such as canes, walkers, or orthoses.
Exclusion Criteria:
* History of major surgical procedure within 12 weeks prior to the start of investigative product administration or an expectation of a major surgical procedure (eg, implantation of cardiac defibrillator) during the study.
* History of anaphylaxis.
* Medical condition other than DM1 that would significantly impact ambulation or participation in functional assessments.
* Treatment with medications that can improve myotonia within a period of 5 half-lives of the medication prior to performing screening assessments.
* Electrocardiogram (ECG) with the corrected QT interval by Fridericia's Formula (QTcF) ≥450 milliseconds (ms) in men and QTcF ≥460 ms in women, PR ≥240 ms, left bundle-branch block, or a conduction defect, which is clinically significant in the opinion of the Investigator.
* Percent predicted forced vital capacity (FVC) \<50%.
* History of tibialis anterior biopsy within 3 months of Day 1 or planning to undergo tibialis anterior biopsies during study period for reasons unrelated to the study.
* Participant has a history of suicide attempt, suicidal behavior, or has any suicidal ideation within 6 months prior to Screening that meets criteria at a level of 4 or 5 of the Columbia Suicide Severity Rating Scale (C-SSRS) or who, in the opinion of the Investigator, is at significant risk to commit suicide.
* Use of glucagon-like peptide 1 (GLP-1) agonist medications including semaglutide, dulaglutide, liraglutide, exenatide, or tirzepatide within a period of 5 half-lives of the medication prior to performing screening assessments.
* Significant weight loss during study participation may impact weight-based dosing, performance on muscle function assessments, and pharmacodynamic (PD) biomarkers.
Note: Other inclusion and exclusion criteria may apply. DRUG: DYNE-101, DRUG: Placebo
Myotonic Dystrophy Type 1 (DM1)
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Show 20 locations
Study Locations
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| Location | Contacts |
|---|---|
| CHU de Nantes Nantes, | Marie-Agnès Sourdril - (marieagnes.sourdril@chu-nantes.fr) |
| Centro Clinico Nemo Milan, | Maribel Evoli - (maribel.evoli@centrocliniconemo.it) |
| Charite - Universitatsmedizin Berlin Berlin, | Susanne Behr-Perst - (susanne.behr-perst@charite.de) |
| Fondazione Policlinico Universitario A Gemelli-Rome Rome, | Maria Pirozzoli - (mariaceleste.pirozzoli@policlinicogemelli.it) |
| Indiana University School of Medicine Indianapolis, Indiana | Patti Hogan, BSN RN, CCRA - (hoganpr@iu.edu) |
| Institut de Myologie Paris, | Asma Balloumi - (a.balloumi@institut-myologie.org) |
| John Walton Muscular Dystrophy Research Centre Newcastle upon Tyne, | Nicola McLarty - (nicola.mclarty1@nhs.net) |
| Ludwig Maximilians University, Munich - Friedrich Baur Institut Munich, | Corinna Wirner-Piotrowski - (Corinna.Wirner@med.uni-muenchen.de) |
| NZCR Auckland Auckland, | Miriam Rodrigues - (MRodrigues@adhb.govt.nz) |
| Neurology Rare Disease Center Denton, Texas | Isabella Herman - (Research@neuromdcenter.com) |
| Radboud Medical Center Nijmegen, | Eline Sanders - (clinicalresearchunit@radboudumc.nl) |
| Salford Royal Hospital Salford, | Bethan Blackledge - (Bethan.blackledge@nca.nhs.uk) |
| St. Vincent's Hospital Darlinghurst, New South Wales | Alan Lai - (alan.lai@svha.org.au) |
| Stanford University Redwood City, California | Lidia Choniawko - (lidiacho@stanford.edu) |
| University College London Hospitals London, | Nikoletta Nikolenko - (n.nikolenko@nhs.net) |
| University of Florida College of Medicine Gainesville, Florida | Debbye Landers - (debralanders@peds.ufl.edu) |
| University of Iowa Iowa City, Iowa | Heena Olade, RN, MSN - (heena-olalde@uiowa.edu) |
| University of Rochester Medical Center Rochester, New York | Jim Hilbert - (james_hilbert@urmc.rochester.edu) |
| Virginia Commonwealth University (VCU) Richmond, Virginia | Jodie Howell - (Jodie.howell@vcuhealth.org) Anarosa Rezeq - (anarosa.rezeq@vcuhealth.org) |
| Washington University in St. Louis St Louis, Missouri | Natalie Goedeker - (ngoedeker@wustl.edu) |