Biliary Tract Carcinoma Clinical Trial
— KEYNOTE-966Official title:
A Phase 3 Randomized, Double Blind Study of Pembrolizumab Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin as First-Line Therapy in Participants With Advanced and/or Unresectable Biliary Tract Carcinoma
| Verified date | March 2024 |
| Source | Merck Sharp & Dohme LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This is a study of pembrolizumab plus gemcitabine/cisplatin versus placebo plus gemcitabine/cisplatin as first-line therapy in participants with advanced and/or unresectable biliary tract carcinoma. The primary hypothesis is pembrolizumab plus gemcitabine/cisplatin is superior to placebo plus gemcitabine/cisplatin with respect to overall survival (OS).
| Status | Active, not recruiting |
| Enrollment | 1069 |
| Est. completion date | November 29, 2024 |
| Est. primary completion date | December 15, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | CEMIC ( Site 0581) | Buenos Aires | Caba |
| Argentina | Hospital Municipal de Gastroenterologia Dr. Bonorino Udaondo ( Site 0580) | Caba | |
| Argentina | Fundacion Favaloro ( Site 0578) | Ciudad de Buenos Aires | Caba |
| Argentina | Centro Oncologico Riojano Integral ( Site 0584) | La Rioja | |
| Argentina | Centro Medico San Roque ( Site 0579) | San Miguel de Tucuman | Tucuman |
| Australia | Eastern Health ( Site 0704) | Box Hill | Victoria |
| Australia | Gallipoli Medical Research Foundation ( Site 0705) | Brisbane | Queensland |
| Australia | Liverpool Hospital ( Site 0707) | Liverpool | New South Wales |
| Australia | Mid North Coast Cancer Institute ( Site 0708) | Port Macquarie | New South Wales |
| Australia | Western Health-Sunshine Hospital ( Site 0709) | St Albans | Victoria |
| Belgium | Saint-Luc UCL ( Site 0200) | Brussels | Bruxelles-Capitale, Region De |
| Belgium | Erasme Hospital ( Site 0204) | Bruxelles | Bruxelles-Capitale, Region De |
| Belgium | Grand Hopital de Charleroi ( Site 0206) | Charleroi | Hainaut |
| Belgium | UZA University Hospital Antwerp ( Site 0202) | Edegem | Antwerpen |
| Belgium | UZ Gent ( Site 0203) | Gent | Oost-Vlaanderen |
| Belgium | UZ Leuven ( Site 0205) | Leuven | Vlaams-Brabant |
| Belgium | CHU de Liege ( Site 0201) | Liège | Liege |
| Brazil | Hospital de Caridade de Ijui ( Site 0602) | Ijui | Rio Grande Do Sul |
| Brazil | Oncobio Servicos de Saude SA ( Site 0604) | Nova Lima | Minas Gerais |
| Brazil | Associacao Hospitalar Moinhos de Vento ( Site 0599) | Porto Alegre | Rio Grande Do Sul |
| Brazil | Hospital de Clinicas de Porto Alegre ( Site 0610) | Porto Alegre | Rio Grande Do Sul |
| Brazil | Hospital Nossa Senhora da Conceicao ( Site 0601) | Porto Alegre | Rio Grande Do Sul |
| Brazil | Instituto COI de Pesquisa Educacao e Gestao ( Site 0606) | Rio de Janeiro | |
| Brazil | A.C. Camargo Cancer Center ( Site 0600) | Sao Paulo | |
| Brazil | Hospital Paulistano - Amil Clinical Research ( Site 0603) | Sao Paulo | |
| Brazil | Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0607) | Sao Paulo | |
| Brazil | Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0609) | Sao Paulo | |
| Canada | Tom Baker Cancer Centre ( Site 0184) | Calgary | Alberta |
| Canada | Cross Cancer Institute ( Site 0183) | Edmonton | Alberta |
| Canada | Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0182) | Hamilton | Ontario |
| Canada | Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0180) | Montreal | Quebec |
| Canada | McGill University Health Centre ( Site 0179) | Montreal | Quebec |
| Chile | IC La Serena Research ( Site 0630) | La Serena | Coquimbo |
| Chile | Servicios Medicos Urumed ( Site 0621) | Rancagua | Lbtdr Gen Bernardo O Higgins |
| Chile | Fundacion Arturo Lopez Perez FALP ( Site 0623) | Santiago | Region M. De Santiago |
| Chile | Pontificia Universidad Catolica de Chile ( Site 0620) | Santiago | Region M. De Santiago |
| Chile | Sociedad Oncovida S.A. ( Site 0626) | Santiago | Region M. De Santiago |
| Chile | Centro Investigación del Cáncer James Lind ( Site 0622) | Temuco | Araucania |
| China | Beijing Cancer Hospital ( Site 0138) | Beijing | Beijing |
| China | Peking Union Medical College Hospital ( Site 0150) | Beijing | Beijing |
| China | The First Hospital of Jilin University ( Site 0131) | Chanchun | Jilin |
| China | Hunan Cancer Hospital ( Site 0132) | Changsha | Hunan |
| China | Hunan Provincial People Hospital ( Site 0142) | Changsha | Hunan |
| China | The Third Xiangya Hospital of Central South University ( Site 0157) | Changsha | Hainan |
| China | West China Hospital of Sichuan University ( Site 0147) | Chengdu | Sichuan |
| China | First Affiliated Hospital of The Third Military Medical University ( Site 0130) | Chongqing | Chongqing |
| China | 900 Hospital of the Joint ( Site 0137) | Fuzhou | Fujian |
| China | Fujian Provincial Cancer Hospital ( Site 0154) | Fuzhou | Fujian |
| China | Guangdong Provincial People s Hospital ( Site 0161) | Guangzhou | Guangdong |
| China | The First Affiliated Hospital Zhejiang University ( Site 0136) | Hangzhou | Zhejiang |
| China | Zhejiang Cancer Hospital ( Site 0134) | Hangzhou | Zhejiang |
| China | Harbin Medical University Cancer Hospital ( Site 0133) | Harbin | Heilongjiang |
| China | Anhui Provincial Hospital ( Site 0140) | Hefei | Anhui |
| China | The 81st Hospital of PLA ( Site 0128) | Nanjing | Jiangsu |
| China | Fudan University Shanghai Cancer Center ( Site 0160) | Shanghai | Shanghai |
| China | Renji Hospital Shanghai Jiaotong University School of Medicine ( Site 0158) | Shanghai | Shanghai |
| China | Zhongshan Hospital Fudan University ( Site 0129) | Shanghai | Shanghai |
| China | Tianjin Medical University Cancer Institute & Hospital ( Site 0155) | Tianjin | Tianjin |
| China | Tangdu Hospital ( Site 0146) | XI An | Shanxi |
| China | The First Affiliated Hospital of Xi an Jiaotong University ( Site 0145) | XI An | Shanxi |
| France | CHU Clermont-Ferrand - Site Estaing ( Site 0249) | Clermont-Ferrand | Puy-de-Dome |
| France | A.P.H. Paris, Hopital Beaujon ( Site 0247) | Clichy | Hauts-de-Seine |
| France | CHU de Montpellier - Hopital Saint-Eloi ( Site 0248) | Montpellier | Herault |
| France | CHU Bordeaux Haut-Leveque Centre Francois Magendie ( Site 0245) | Pessac Cedex | Gironde |
| France | Centre Eugene Marquis ( Site 0242) | Rennes | Ille-et-Vilaine |
| France | Gustave Roussy ( Site 0244) | Villejuif | Val-de-Marne |
| Germany | Universitaetsklinikum Aachen AOER ( Site 0275) | Aachen | Nordrhein-Westfalen |
| Germany | Charite - Universtitatsmedizin Berlin CCM ( Site 0269) | Berlin | |
| Germany | Staedtisches Klinikum Dresden ( Site 0272) | Dresden | Sachsen |
| Germany | Universitaetsklinikum Essen ( Site 0273) | Essen | Nordrhein-Westfalen |
| Germany | Krankenhaus Nordwest ( Site 0266) | Frankfurt | Hessen |
| Germany | Universitaetsklinikum Hamburg-Eppendorf ( Site 0268) | Hamburg | |
| Germany | Medizinische Hochschule Hannover ( Site 0265) | Hannover | Niedersachsen |
| Germany | Universitaetsklinikum Koeln ( Site 0274) | Koeln | Nordrhein-Westfalen |
| Germany | Universitaetsklinikum Magdeburg A.o.R. ( Site 0271) | Magdeburg | Sachsen-Anhalt |
| Germany | Klinikum der Ludwig - Maximilian Universitat Munchen ( Site 0264) | Muenchen | Bayern |
| Germany | Universitaetsklinikum Ulm ( Site 0267) | Ulm | Baden-Wurttemberg |
| Hong Kong | Pamela Youde Nethersole Eastern Hospital ( Site 0857) | Hong Kong | |
| Hong Kong | Prince of Wales Hospital ( Site 0855) | Hong Kong | |
| Hong Kong | Princess Margaret Hospital. ( Site 0856) | Hong Kong | |
| Hong Kong | Queen Mary Hospital ( Site 0851) | Hong Kong | |
| Hong Kong | Queen Elizabeth Hospital. ( Site 0854) | Kowloon | |
| Ireland | Bon Secours Hospital ( Site 0526) | Cork | |
| Ireland | Cork University Hospital ( Site 0538) | Cork | |
| Ireland | St Vincents University Hospital ( Site 0521) | Dublin | |
| Ireland | Tallaght University Hospital ( Site 0522) | Dublin | |
| Israel | Rambam Medical Center ( Site 0308) | Haifa | |
| Israel | Hadassah Ein Karem - Sharett Institute of Oncology ( Site 0309) | Jerusalem | |
| Israel | Rabin Medical Center ( Site 0307) | Petah Tikva | |
| Israel | Sourasky Medical Center ( Site 0306) | Tel Aviv | |
| Italy | Policlinico S. Orsola-Malpighi ( Site 0333) | Bologna | |
| Italy | A.O. di Rilievo Nazionale e di alta Specializzazione Garibaldi ( Site 0330) | Catania | |
| Italy | ASST Grande Ospedale Metropolitano Niguarda ( Site 0332) | Milano | |
| Italy | Azienda Ospedaliero Universitaria Pisana ( Site 0326) | Pisa | |
| Italy | Policlinico Universitario Campus Biomedico ( Site 0328) | Roma | |
| Italy | Universita Cattolica del Sacro Cuore - Policlinico Gemelli ( Site 0329) | Rome | Abruzzo |
| Italy | Azienda Ospedaliera Universitaria di Verona ( Site 0334) | Verona | |
| Japan | National Hospital Organization Kyushu Cancer Center ( Site 0078) | Fukuoka | |
| Japan | National Cancer Center Hospital East ( Site 0081) | Kashiwa | Chiba |
| Japan | Kagawa University Hospital ( Site 0086) | Kita-gun | Kagawa |
| Japan | Kobe City Medical Center General Hospital ( Site 0087) | Kobe | Hyogo |
| Japan | Kyoto University Hospital ( Site 0083) | Kyoto | |
| Japan | Kyorin University Hospital ( Site 0077) | Mitaka | Tokyo |
| Japan | Aichi Cancer Center Hospital ( Site 0080) | Nagoya | Aichi |
| Japan | Osaka International Cancer Institute ( Site 0084) | Osaka | |
| Japan | Osaka University Hospital ( Site 0085) | Suita | Osaka |
| Japan | The Cancer Institute Hospital of JFCR ( Site 0082) | Tokyo | |
| Japan | Kanagawa Cancer Center ( Site 0079) | Yokohama | Kanagawa |
| Korea, Republic of | Kyungpook National University Chilgok Hospital ( Site 0834) | Daegu | Taegu-Kwangyokshi |
| Korea, Republic of | Chungnam National University Hospital ( Site 0840) | Daejeon | Taejon-Kwangyokshi |
| Korea, Republic of | Chonnam National University Hwasun Hospital ( Site 0837) | Hwasun Gun | Jeonranamdo |
| Korea, Republic of | CHA Bundang Medical Center CHA University ( Site 0835) | Seongnam | Kyonggi-do |
| Korea, Republic of | Seoul National University Bundang Hospital ( Site 0833) | Seongnam-si | Kyonggi-do |
| Korea, Republic of | Asan Medical Center ( Site 0830) | Seoul | |
| Korea, Republic of | Korea University Guro Hospital ( Site 0832) | Seoul | |
| Korea, Republic of | Samsung Medical Center ( Site 0831) | Seoul | |
| Korea, Republic of | Severance Hospital Yonsei University Health System ( Site 0836) | Seoul | |
| Korea, Republic of | The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 0839) | Seoul | |
| Korea, Republic of | Ajou University Hospital, Clinical Research Center ( Site 0838) | Suwon-si | Kyonggi-do |
| Malaysia | Hospital Pulau Pinang ( Site 0773) | Georgetown | Pulau Pinang |
| Malaysia | Hospital Sultan Ismail ( Site 0772) | Johor Bahru | Johor |
| Malaysia | Hospital Kuala Lumpur ( Site 0768) | Kuala Lumpur | |
| Malaysia | Pantai Hospital Kuala Lumpur ( Site 0771) | Kuala Lumpur | |
| Malaysia | University Malaya Medical Centre ( Site 0770) | Lembah Pantai | Kuala Lumpur |
| Malaysia | Institut Kanser Negara - National Cancer Institute ( Site 0767) | Putrajaya | Wilayah Persekutuan Putrajaya |
| Netherlands | AMC ( Site 0348) | Amsterdam | Noord-Holland |
| Netherlands | UMCG ( Site 0349) | Groningen | |
| Netherlands | Maastricht University Medical Centre ( Site 0347) | Maastricht | Limburg |
| Netherlands | Erasmus University Medical Center ( Site 0352) | Rotterdam | Zuid-Holland |
| Netherlands | Universitair Medisch Centrum Utrecht ( Site 0351) | Utrecht | |
| New Zealand | Auckland City Hospital ( Site 0725) | Auckland | |
| Spain | Hospital General Universitari Vall d Hebron ( Site 0432) | Barcelona | |
| Spain | Hospital General Universitario Gregorio Maranon ( Site 0433) | Madrid | |
| Spain | Hospital Universitario HM Sanchinarro ( Site 0435) | Madrid | |
| Spain | Hospital Regional Universitario Carlos Haya ( Site 0431) | Malaga | |
| Spain | Hospital Universitario General de Asturias ( Site 0434) | Oviedo | Asturias |
| Taiwan | Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0865) | Kaohsiung | |
| Taiwan | China Medical University Hospital ( Site 0862) | Taichung | |
| Taiwan | National Cheng Kung University Hospital ( Site 0864) | Tainan | |
| Taiwan | Koo Foundation Sun Yat-Sen Cancer Center ( Site 0863) | Taipei | |
| Taiwan | National Taiwan University Hospital ( Site 0860) | Taipei | |
| Taiwan | Taipei Veterans General Hospital ( Site 0861) | Taipei, | Taipei |
| Taiwan | Chang Gung Medical Foundation. Linkou ( Site 0853) | Taoyuan | |
| Thailand | King Chulalongkorn Memorial Hospital ( Site 0884) | Bangkok | Krung Thep Maha Nakhon |
| Thailand | Ramathibodi Hospital. ( Site 0889) | Bangkok | Krung Thep Maha Nakhon |
| Thailand | Siriraj Hospital ( Site 0888) | Bangkok | Krung Thep Maha Nakhon |
| Thailand | Maharaj Nakorn Chiang Mai Hospital ( Site 0887) | Chiang Mai | |
| Thailand | Srinagarind Hospital ( Site 0885) | Khon Kaen | |
| Thailand | Sunpasithiprasong Hospital ( Site 0883) | Ubonratchathani | Ubon Ratchathani |
| Thailand | Udon Thani Cancer Hospital ( Site 0886) | Udon Thani | |
| Turkey | Baskent University Adana Training Hospital ( Site 0499) | Adana | |
| Turkey | Abdurrahman Yurtaslan Onkoloji Hastanesi ( Site 0494) | Ankara | |
| Turkey | Gazi Universitesi Tip Fakultesi ( Site 0496) | Ankara | |
| Turkey | Hacettepe University Faculty of Medicine ( Site 0498) | Ankara | |
| Turkey | Göztepe Prof. Dr. Süleyman Yalçin Sehir Hastanesi-oncology ( Site 0495) | Istanbul | |
| Turkey | Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0506) | Istanbul | |
| Turkey | Izmir Medical Park Hospital Department of Medical Oncology ( Site 0502) | Izmir | |
| Turkey | Erciyes Universitesi Tip Fakultesi ( Site 0500) | Kayseri | |
| Turkey | Inonu Universitesi Medical Fakultesi ( Site 0501) | Malatya | Adana |
| United Kingdom | Aberdeen Royal Infirmary ( Site 0529) | Aberdeen | Aberdeen City |
| United Kingdom | Belfast City Hospital ( Site 0517) | Belfast | |
| United Kingdom | University Hospital Coventry and Warwickshire NHS Trust ( Site 0518) | Coventry | |
| United Kingdom | Imperial College Healthcare NHS Trust - Hammersmith Hospital ( Site 0525) | London | London, City Of |
| United Kingdom | Royal Free London NHS Foundation Trust ( Site 0520) | London | London, City Of |
| United Kingdom | Royal Marsden Hospital ( Site 0536) | London | London, City Of |
| United Kingdom | The Christie NHS Foundation Trust ( Site 0537) | Manchester | |
| United Kingdom | Royal Marsden NHS Foundation Trust ( Site 0535) | Sutton | Surrey |
| United States | Winship Cancer Institute of Emory University ( Site 0013) | Atlanta | Georgia |
| United States | University of Colorado Hospital ( Site 0011) | Aurora | Colorado |
| United States | University of Alabama at Birmingham Comprehensive Cancer Ctr ( Site 0016) | Birmingham | Alabama |
| United States | Charleston Oncology ( Site 0042) | Charleston | South Carolina |
| United States | Decatur Memorial Hospital ( Site 0056) | Decatur | Illinois |
| United States | Saint Francis Health System ( Site 0051) | Greenville | South Carolina |
| United States | Hartford Hospital ( Site 0057) | Hartford | Connecticut |
| United States | University of California San Diego Moores Cancer Center ( Site 0008) | La Jolla | California |
| United States | UCLA Hematology/Oncology - Santa Monica ( Site 0014) | Los Angeles | California |
| United States | Northwest Georgia Oncology Centers PC ( Site 0045) | Marietta | Georgia |
| United States | Winthrop University Hospital ( Site 0059) | Mineola | New York |
| United States | Yale University ( Site 0053) | New Haven | Connecticut |
| United States | Columbia University/Herbert Irving Cancer Center ( Site 0009) | New York | New York |
| United States | Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0038) | New York | New York |
| United States | University of Oklahoma- Stephenson Oklahoma Cancer Center ( Site 0055) | Oklahoma City | Oklahoma |
| United States | OHSU Center for Health & Healing ( Site 0044) | Portland | Oregon |
| United States | Blue Ridge Cancer Care ( Site 0033) | Roanoke | Virginia |
| United States | University of California - San Francisco ( Site 0030) | San Francisco | California |
| Lead Sponsor | Collaborator |
|---|---|
| Merck Sharp & Dohme LLC |
United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, China, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Korea, Republic of, Malaysia, Netherlands, New Zealand, Spain, Taiwan, Thailand, Turkey, United Kingdom,
Kelley RK, Ueno M, Yoo C, Finn RS, Furuse J, Ren Z, Yau T, Klumpen HJ, Chan SL, Ozaka M, Verslype C, Bouattour M, Park JO, Barajas O, Pelzer U, Valle JW, Yu L, Malhotra U, Siegel AB, Edeline J, Vogel A; KEYNOTE-966 Investigators. Pembrolizumab in combinat — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall Survival (OS) | Overall survival was defined as the time from randomization to death due to any cause. | Up to approximately 38 months | |
| Secondary | Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (BICR) | PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 by BICR, or death due to any cause, whichever occurred first. | Up to approximately 26 months | |
| Secondary | Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) | ORR was defined as the percentage of participants who have a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: a =30% decrease in the sum of diameters [SOD] of target lesions) as assessed by BICR per RECIST 1.1, which was adjusted for this study to allow a maximum of 10 target lesions in total and 5 per organ. | Up to approximately 26 months | |
| Secondary | Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR | For participants who demonstrate a confirmed CR or PR, DOR was the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurred first. | Up to approximately 38 months | |
| Secondary | Number of Participants Who Experience One or More Adverse Events (AE) | An adverse event (AE) was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study. | Up to approximately 38 months | |
| Secondary | Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE) | An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurs during the course of the study. | Up to approximately 38 months |
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