Pembrolizumab (MK-3475) Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin for First-Line Advanced and/or Unresectable Biliary Tract Carcinoma (BTC) (MK-3475-966/KEYNOTE-966) (KEYNOTE-966)
Biliary Tract Carcinoma
About this trial
This is an interventional treatment trial for Biliary Tract Carcinoma focused on measuring Programmed cell death 1 (PD-1), Pembrolizumab, Cholangiocarcinoma, Gallbladder cancer, Checkpoint inhibitor, Immunotherapy, Biliary, Keytruda, Bile Duct Cancer
Eligibility Criteria
Inclusion Criteria
- Has histologically confirmed diagnosis of advanced (metastatic) and/or unresectable (locally advanced) biliary tract cancer (intra-or extrahepatic cholangiocarcinoma or gallbladder cancer)
- Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1), as determined by the site investigator
- Participants with a history of hepatitis B or hepatitis C can be enrolled if they meet study criteria
- Is able to provide archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion
- Has a life expectancy of greater than 3 months
- Has adequate organ function
Exclusion Criteria
- Has had previous systemic therapy for advanced (metastatic) or unresectable (locally advanced) biliary tract cancer (intra-or extra hepatic cholangiocarcinoma or gallbladder cancer)
- Has ampullary cancer
- Has small cell cancer, neuroendocrine tumors, lymphoma, sarcoma, mixed tumor histology and/or mucinous cystic neoplasms
- Has received prior therapy with an anti-programmed cell death 1 (anti-PD-1), anti- programmed cell death ligand 1 or 2 (anti-PD-L1, anti-PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX-40, CD137)
- Has a known history of, or any evidence of, central nervous system (CNS) metastases and/or carcinomatous meningitis, as assessed by local site investigator
- Has had an allogenic tissue/solid organ transplant
Sites / Locations
- University of Alabama at Birmingham Comprehensive Cancer Ctr ( Site 0016)
- University of California San Diego Moores Cancer Center ( Site 0008)
- UCLA Hematology/Oncology - Santa Monica ( Site 0014)
- University of California - San Francisco ( Site 0030)
- University of Colorado Hospital ( Site 0011)
- Hartford Hospital ( Site 0057)
- Yale University ( Site 0053)
- Winship Cancer Institute of Emory University ( Site 0013)
- Northwest Georgia Oncology Centers PC ( Site 0045)
- Decatur Memorial Hospital ( Site 0056)
- Winthrop University Hospital ( Site 0059)
- Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0038)
- Columbia University/Herbert Irving Cancer Center ( Site 0009)
- University of Oklahoma- Stephenson Oklahoma Cancer Center ( Site 0055)
- OHSU Center for Health & Healing ( Site 0044)
- Charleston Oncology ( Site 0042)
- Saint Francis Health System ( Site 0051)
- Blue Ridge Cancer Care ( Site 0033)
- CEMIC ( Site 0581)
- Fundacion Favaloro ( Site 0578)
- Centro Medico San Roque ( Site 0579)
- Hospital Municipal de Gastroenterologia Dr. Bonorino Udaondo ( Site 0580)
- Centro Oncologico Riojano Integral ( Site 0584)
- Liverpool Hospital ( Site 0707)
- Mid North Coast Cancer Institute ( Site 0708)
- Gallipoli Medical Research Foundation ( Site 0705)
- Eastern Health ( Site 0704)
- Western Health-Sunshine Hospital ( Site 0709)
- UZA University Hospital Antwerp ( Site 0202)
- Saint-Luc UCL ( Site 0200)
- Erasme Hospital ( Site 0204)
- Grand Hopital de Charleroi ( Site 0206)
- CHU de Liege ( Site 0201)
- UZ Gent ( Site 0203)
- UZ Leuven ( Site 0205)
- Oncobio Servicos de Saude SA ( Site 0604)
- Hospital de Caridade de Ijui ( Site 0602)
- Associacao Hospitalar Moinhos de Vento ( Site 0599)
- Hospital de Clinicas de Porto Alegre ( Site 0610)
- Hospital Nossa Senhora da Conceicao ( Site 0601)
- Instituto COI de Pesquisa Educacao e Gestao ( Site 0606)
- Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0607)
- Hospital Paulistano - Amil Clinical Research ( Site 0603)
- Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0609)
- A.C. Camargo Cancer Center ( Site 0600)
- Tom Baker Cancer Centre ( Site 0184)
- Cross Cancer Institute ( Site 0183)
- Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0182)
- Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0180)
- McGill University Health Centre ( Site 0179)
- Centro Investigación del Cáncer James Lind ( Site 0622)
- IC La Serena Research ( Site 0630)
- Servicios Medicos Urumed ( Site 0621)
- Fundacion Arturo Lopez Perez FALP ( Site 0623)
- Sociedad Oncovida S.A. ( Site 0626)
- Pontificia Universidad Catolica de Chile ( Site 0620)
- Anhui Provincial Hospital ( Site 0140)
- Beijing Cancer Hospital ( Site 0138)
- Peking Union Medical College Hospital ( Site 0150)
- First Affiliated Hospital of The Third Military Medical University ( Site 0130)
- Fujian Provincial Cancer Hospital ( Site 0154)
- 900 Hospital of the Joint ( Site 0137)
- Guangdong Provincial People s Hospital ( Site 0161)
- The Third Xiangya Hospital of Central South University ( Site 0157)
- Harbin Medical University Cancer Hospital ( Site 0133)
- Hunan Provincial People Hospital ( Site 0142)
- Hunan Cancer Hospital ( Site 0132)
- The 81st Hospital of PLA ( Site 0128)
- The First Hospital of Jilin University ( Site 0131)
- Zhongshan Hospital Fudan University ( Site 0129)
- Renji Hospital Shanghai Jiaotong University School of Medicine ( Site 0158)
- Fudan University Shanghai Cancer Center ( Site 0160)
- Tangdu Hospital ( Site 0146)
- The First Affiliated Hospital of Xi an Jiaotong University ( Site 0145)
- West China Hospital of Sichuan University ( Site 0147)
- Tianjin Medical University Cancer Institute & Hospital ( Site 0155)
- The First Affiliated Hospital Zhejiang University ( Site 0136)
- Zhejiang Cancer Hospital ( Site 0134)
- CHU Bordeaux Haut-Leveque Centre Francois Magendie ( Site 0245)
- A.P.H. Paris, Hopital Beaujon ( Site 0247)
- CHU de Montpellier - Hopital Saint-Eloi ( Site 0248)
- Centre Eugene Marquis ( Site 0242)
- CHU Clermont-Ferrand - Site Estaing ( Site 0249)
- Gustave Roussy ( Site 0244)
- Universitaetsklinikum Ulm ( Site 0267)
- Klinikum der Ludwig - Maximilian Universitat Munchen ( Site 0264)
- Krankenhaus Nordwest ( Site 0266)
- Medizinische Hochschule Hannover ( Site 0265)
- Universitaetsklinikum Aachen AOER ( Site 0275)
- Universitaetsklinikum Essen ( Site 0273)
- Universitaetsklinikum Koeln ( Site 0274)
- Universitaetsklinikum Magdeburg A.o.R. ( Site 0271)
- Staedtisches Klinikum Dresden ( Site 0272)
- Charite - Universtitatsmedizin Berlin CCM ( Site 0269)
- Universitaetsklinikum Hamburg-Eppendorf ( Site 0268)
- Pamela Youde Nethersole Eastern Hospital ( Site 0857)
- Prince of Wales Hospital ( Site 0855)
- Princess Margaret Hospital. ( Site 0856)
- Queen Mary Hospital ( Site 0851)
- Queen Elizabeth Hospital. ( Site 0854)
- Cork University Hospital ( Site 0538)
- Bon Secours Hospital ( Site 0526)
- Tallaght University Hospital ( Site 0522)
- St Vincents University Hospital ( Site 0521)
- Rambam Medical Center ( Site 0308)
- Hadassah Ein Karem - Sharett Institute of Oncology ( Site 0309)
- Rabin Medical Center ( Site 0307)
- Sourasky Medical Center ( Site 0306)
- Universita Cattolica del Sacro Cuore - Policlinico Gemelli ( Site 0329)
- Policlinico S. Orsola-Malpighi ( Site 0333)
- A.O. di Rilievo Nazionale e di alta Specializzazione Garibaldi ( Site 0330)
- ASST Grande Ospedale Metropolitano Niguarda ( Site 0332)
- Azienda Ospedaliero Universitaria Pisana ( Site 0326)
- Policlinico Universitario Campus Biomedico ( Site 0328)
- Azienda Ospedaliera Universitaria di Verona ( Site 0334)
- Aichi Cancer Center Hospital ( Site 0080)
- National Cancer Center Hospital East ( Site 0081)
- Kobe City Medical Center General Hospital ( Site 0087)
- Kagawa University Hospital ( Site 0086)
- Kanagawa Cancer Center ( Site 0079)
- Osaka University Hospital ( Site 0085)
- Kyorin University Hospital ( Site 0077)
- National Hospital Organization Kyushu Cancer Center ( Site 0078)
- Kyoto University Hospital ( Site 0083)
- Osaka International Cancer Institute ( Site 0084)
- The Cancer Institute Hospital of JFCR ( Site 0082)
- Chonnam National University Hwasun Hospital ( Site 0837)
- Seoul National University Bundang Hospital ( Site 0833)
- CHA Bundang Medical Center CHA University ( Site 0835)
- Ajou University Hospital, Clinical Research Center ( Site 0838)
- Kyungpook National University Chilgok Hospital ( Site 0834)
- Chungnam National University Hospital ( Site 0840)
- Severance Hospital Yonsei University Health System ( Site 0836)
- Asan Medical Center ( Site 0830)
- Samsung Medical Center ( Site 0831)
- The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 0839)
- Korea University Guro Hospital ( Site 0832)
- Hospital Sultan Ismail ( Site 0772)
- University Malaya Medical Centre ( Site 0770)
- Hospital Pulau Pinang ( Site 0773)
- Institut Kanser Negara - National Cancer Institute ( Site 0767)
- Hospital Kuala Lumpur ( Site 0768)
- Pantai Hospital Kuala Lumpur ( Site 0771)
- Maastricht University Medical Centre ( Site 0347)
- AMC ( Site 0348)
- Erasmus University Medical Center ( Site 0352)
- UMCG ( Site 0349)
- Universitair Medisch Centrum Utrecht ( Site 0351)
- Auckland City Hospital ( Site 0725)
- Hospital Universitario General de Asturias ( Site 0434)
- Hospital General Universitari Vall d Hebron ( Site 0432)
- Hospital General Universitario Gregorio Maranon ( Site 0433)
- Hospital Universitario HM Sanchinarro ( Site 0435)
- Hospital Regional Universitario Carlos Haya ( Site 0431)
- Taipei Veterans General Hospital ( Site 0861)
- Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0865)
- China Medical University Hospital ( Site 0862)
- National Cheng Kung University Hospital ( Site 0864)
- National Taiwan University Hospital ( Site 0860)
- Koo Foundation Sun Yat-Sen Cancer Center ( Site 0863)
- Chang Gung Medical Foundation. Linkou ( Site 0853)
- King Chulalongkorn Memorial Hospital ( Site 0884)
- Ramathibodi Hospital. ( Site 0889)
- Siriraj Hospital ( Site 0888)
- Sunpasithiprasong Hospital ( Site 0883)
- Maharaj Nakorn Chiang Mai Hospital ( Site 0887)
- Srinagarind Hospital ( Site 0885)
- Udon Thani Cancer Hospital ( Site 0886)
- Inonu Universitesi Medical Fakultesi ( Site 0501)
- Baskent University Adana Training Hospital ( Site 0499)
- Hacettepe University Faculty of Medicine ( Site 0498)
- Abdurrahman Yurtaslan Onkoloji Hastanesi ( Site 0494)
- Gazi Universitesi Tip Fakultesi ( Site 0496)
- Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0506)
- Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 0495)
- Izmir Medical Park Hospital Department of Medical Oncology ( Site 0502)
- Erciyes Universitesi Tip Fakultesi ( Site 0500)
- Aberdeen Royal Infirmary ( Site 0529)
- Royal Free London NHS Foundation Trust ( Site 0520)
- Royal Marsden Hospital ( Site 0536)
- Imperial College Healthcare NHS Trust - Hammersmith Hospital ( Site 0525)
- Royal Marsden NHS Foundation Trust ( Site 0535)
- Belfast City Hospital ( Site 0517)
- University Hospital Coventry and Warwickshire NHS Trust ( Site 0518)
- The Christie NHS Foundation Trust ( Site 0537)
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Arm A (Pembrolizumab+Gemcitabine+Cisplatin)
Arm B (Placebo+Gemcitabine+Cisplatin)
Pembrolizumab, 200 mg, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m^2, Q3W, Day 1 and Day 8 of each cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m^2, Q3W, Day 1 and Day 8 of each cycle for up to 8 cycles.
Placebo to Pembrolizumab, 200 mg, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m^2, Q3W, Day 1 and Day 8 of each cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m^2, Q3W, Day 1 and Day 8 of each cycle for up to 8 cycles.