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)

NCT ID: NCT04003636

Last Updated: 2025-04-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1069 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-24

Study Completion Date

2025-04-01

Brief Summary

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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).

Detailed Description

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Conditions

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Biliary Tract Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Arm A (Pembrolizumab+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.

Group Type EXPERIMENTAL

Pembrolizumab

Intervention Type BIOLOGICAL

Pembrolizumab by intravenous (IV) infusion

Gemcitabine

Intervention Type DRUG

Gemcitabine by IV infusion

Cisplatin

Intervention Type DRUG

Cisplatin by IV infusion

Arm B (Placebo+Gemcitabine+Cisplatin)

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.

Group Type PLACEBO_COMPARATOR

Gemcitabine

Intervention Type DRUG

Gemcitabine by IV infusion

Cisplatin

Intervention Type DRUG

Cisplatin by IV infusion

Placebo

Intervention Type DRUG

Placebo to pembrolizumab

Interventions

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Pembrolizumab

Pembrolizumab by intravenous (IV) infusion

Intervention Type BIOLOGICAL

Gemcitabine

Gemcitabine by IV infusion

Intervention Type DRUG

Cisplatin

Cisplatin by IV infusion

Intervention Type DRUG

Placebo

Placebo to pembrolizumab

Intervention Type DRUG

Other Intervention Names

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MK-3475 Gemzar Platinol® Platinol®-AQ

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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University of Alabama at Birmingham Comprehensive Cancer Ctr ( Site 0016)

Birmingham, Alabama, United States

Site Status

University of California San Diego Moores Cancer Center ( Site 0008)

La Jolla, California, United States

Site Status

UCLA Hematology/Oncology - Santa Monica ( Site 0014)

Los Angeles, California, United States

Site Status

University of California - San Francisco ( Site 0030)

San Francisco, California, United States

Site Status

University of Colorado Hospital ( Site 0011)

Aurora, Colorado, United States

Site Status

Hartford Hospital ( Site 0057)

Hartford, Connecticut, United States

Site Status

Yale University ( Site 0053)

New Haven, Connecticut, United States

Site Status

Winship Cancer Institute of Emory University ( Site 0013)

Atlanta, Georgia, United States

Site Status

Northwest Georgia Oncology Centers PC ( Site 0045)

Marietta, Georgia, United States

Site Status

Decatur Memorial Hospital ( Site 0056)

Decatur, Illinois, United States

Site Status

Winthrop University Hospital ( Site 0059)

Mineola, New York, United States

Site Status

Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0038)

New York, New York, United States

Site Status

Columbia University/Herbert Irving Cancer Center ( Site 0009)

New York, New York, United States

Site Status

University of Oklahoma- Stephenson Oklahoma Cancer Center ( Site 0055)

Oklahoma City, Oklahoma, United States

Site Status

OHSU Center for Health & Healing ( Site 0044)

Portland, Oregon, United States

Site Status

Charleston Oncology ( Site 0042)

Charleston, South Carolina, United States

Site Status

Saint Francis Health System ( Site 0051)

Greenville, South Carolina, United States

Site Status

Blue Ridge Cancer Care ( Site 0033)

Roanoke, Virginia, United States

Site Status

CEMIC ( Site 0581)

Buenos Aires, Buenos Aires F.D., Argentina

Site Status

Fundacion Favaloro ( Site 0578)

Ciudad de Buenos Aires, Buenos Aires F.D., Argentina

Site Status

Centro Medico San Roque ( Site 0579)

San Miguel de Tucumán, Tucumán Province, Argentina

Site Status

Hospital Municipal de Gastroenterologia Dr. Bonorino Udaondo ( Site 0580)

CABA, , Argentina

Site Status

Centro Oncologico Riojano Integral ( Site 0584)

La Rioja, , Argentina

Site Status

Liverpool Hospital ( Site 0707)

Liverpool, New South Wales, Australia

Site Status

Mid North Coast Cancer Institute ( Site 0708)

Port Macquarie, New South Wales, Australia

Site Status

Gallipoli Medical Research Foundation ( Site 0705)

Brisbane, Queensland, Australia

Site Status

Eastern Health ( Site 0704)

Box Hill, Victoria, Australia

Site Status

Western Health-Sunshine Hospital ( Site 0709)

St Albans, Victoria, Australia

Site Status

UZA University Hospital Antwerp ( Site 0202)

Edegem, Antwerpen, Belgium

Site Status

Erasme Hospital ( Site 0204)

Brussels, Bruxelles-Capitale, Region de, Belgium

Site Status

Saint-Luc UCL ( Site 0200)

Brussels, Bruxelles-Capitale, Region de, Belgium

Site Status

Grand Hopital de Charleroi ( Site 0206)

Charleroi, Hainaut, Belgium

Site Status

CHU de Liege ( Site 0201)

Liège, Liege, Belgium

Site Status

UZ Gent ( Site 0203)

Ghent, Oost-Vlaanderen, Belgium

Site Status

UZ Leuven ( Site 0205)

Leuven, Vlaams-Brabant, Belgium

Site Status

Oncobio Servicos de Saude SA ( Site 0604)

Nova Lima, Minas Gerais, Brazil

Site Status

Hospital de Caridade de Ijui ( Site 0602)

Ijuí, Rio Grande do Sul, Brazil

Site Status

Associacao Hospitalar Moinhos de Vento ( Site 0599)

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Hospital de Clinicas de Porto Alegre ( Site 0610)

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Hospital Nossa Senhora da Conceicao ( Site 0601)

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Instituto COI de Pesquisa Educacao e Gestao ( Site 0606)

Rio de Janeiro, , Brazil

Site Status

Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0607)

São Paulo, , Brazil

Site Status

Hospital Paulistano - Amil Clinical Research ( Site 0603)

São Paulo, , Brazil

Site Status

Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0609)

São Paulo, , Brazil

Site Status

A.C. Camargo Cancer Center ( Site 0600)

São Paulo, , Brazil

Site Status

Tom Baker Cancer Centre ( Site 0184)

Calgary, Alberta, Canada

Site Status

Cross Cancer Institute ( Site 0183)

Edmonton, Alberta, Canada

Site Status

Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0182)

Hamilton, Ontario, Canada

Site Status

Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0180)

Montreal, Quebec, Canada

Site Status

McGill University Health Centre ( Site 0179)

Montreal, Quebec, Canada

Site Status

IC La Serena Research ( Site 0630)

La Serena, Coquimbo Region, Chile

Site Status

Servicios Medicos Urumed ( Site 0621)

Rancagua, Lbtdr Gen Bernardo O Higgins, Chile

Site Status

Fundacion Arturo Lopez Perez FALP ( Site 0623)

Santiago, Region M. de Santiago, Chile

Site Status

Sociedad Oncovida S.A. ( Site 0626)

Santiago, Region M. de Santiago, Chile

Site Status

Pontificia Universidad Catolica de Chile ( Site 0620)

Santiago, Region M. de Santiago, Chile

Site Status

Centro Investigación del Cáncer James Lind ( Site 0622)

Temuco, Región de la Araucanía, Chile

Site Status

Anhui Provincial Hospital ( Site 0140)

Hefei, Anhui, China

Site Status

Beijing Cancer Hospital ( Site 0138)

Beijing, Beijing Municipality, China

Site Status

Peking Union Medical College Hospital ( Site 0150)

Beijing, Beijing Municipality, China

Site Status

First Affiliated Hospital of The Third Military Medical University ( Site 0130)

Chongqing, Chongqing Municipality, China

Site Status

Fujian Provincial Cancer Hospital ( Site 0154)

Fuzhou, Fujian, China

Site Status

900 Hospital of the Joint ( Site 0137)

Fuzhou, Fujian, China

Site Status

Guangdong Provincial People s Hospital ( Site 0161)

Guangzhou, Guangdong, China

Site Status

The Third Xiangya Hospital of Central South University ( Site 0157)

Changsha, Hainan, China

Site Status

Harbin Medical University Cancer Hospital ( Site 0133)

Harbin, Heilongjiang, China

Site Status

Hunan Provincial People Hospital ( Site 0142)

Changsha, Hunan, China

Site Status

Hunan Cancer Hospital ( Site 0132)

Changsha, Hunan, China

Site Status

The 81st Hospital of PLA ( Site 0128)

Nanjing, Jiangsu, China

Site Status

The First Hospital of Jilin University ( Site 0131)

Changchun, Jilin, China

Site Status

Zhongshan Hospital Fudan University ( Site 0129)

Shanghai, Shanghai Municipality, China

Site Status

Renji Hospital Shanghai Jiaotong University School of Medicine ( Site 0158)

Shanghai, Shanghai Municipality, China

Site Status

Fudan University Shanghai Cancer Center ( Site 0160)

Shanghai, Shanghai Municipality, China

Site Status

Tangdu Hospital ( Site 0146)

Xi’an, Shanxi, China

Site Status

The First Affiliated Hospital of Xi an Jiaotong University ( Site 0145)

Xi’an, Shanxi, China

Site Status

West China Hospital of Sichuan University ( Site 0147)

Chengdu, Sichuan, China

Site Status

Tianjin Medical University Cancer Institute & Hospital ( Site 0155)

Tianjin, Tianjin Municipality, China

Site Status

The First Affiliated Hospital Zhejiang University ( Site 0136)

Hangzhou, Zhejiang, China

Site Status

Zhejiang Cancer Hospital ( Site 0134)

Hangzhou, Zhejiang, China

Site Status

CHU Bordeaux Haut-Leveque Centre Francois Magendie ( Site 0245)

Pessac, Gironde, France

Site Status

A.P.H. Paris, Hopital Beaujon ( Site 0247)

Clichy, Hauts-de-Seine, France

Site Status

CHU de Montpellier - Hopital Saint-Eloi ( Site 0248)

Montpellier, Herault, France

Site Status

Centre Eugene Marquis ( Site 0242)

Rennes, Ille-et-Vilaine, France

Site Status

CHU Clermont-Ferrand - Site Estaing ( Site 0249)

Clermont-Ferrand, Puy-de-Dome, France

Site Status

Gustave Roussy ( Site 0244)

Villejuif, Val-de-Marne, France

Site Status

Universitaetsklinikum Ulm ( Site 0267)

Ulm, Baden-Wurttemberg, Germany

Site Status

Klinikum der Ludwig - Maximilian Universitat Munchen ( Site 0264)

Munich, Bavaria, Germany

Site Status

Krankenhaus Nordwest ( Site 0266)

Frankfurt am Main, Hesse, Germany

Site Status

Medizinische Hochschule Hannover ( Site 0265)

Hanover, Lower Saxony, Germany

Site Status

Universitaetsklinikum Aachen AOER ( Site 0275)

Aachen, North Rhine-Westphalia, Germany

Site Status

Universitaetsklinikum Koeln ( Site 0274)

Cologne, North Rhine-Westphalia, Germany

Site Status

Universitaetsklinikum Essen ( Site 0273)

Essen, North Rhine-Westphalia, Germany

Site Status

Staedtisches Klinikum Dresden ( Site 0272)

Dresden, Saxony, Germany

Site Status

Universitaetsklinikum Magdeburg A.o.R. ( Site 0271)

Magdeburg, Saxony-Anhalt, Germany

Site Status

Charite - Universtitatsmedizin Berlin CCM ( Site 0269)

Berlin, , Germany

Site Status

Universitaetsklinikum Hamburg-Eppendorf ( Site 0268)

Hamburg, , Germany

Site Status

Pamela Youde Nethersole Eastern Hospital ( Site 0857)

Hong Kong, , Hong Kong

Site Status

Prince of Wales Hospital ( Site 0855)

Hong Kong, , Hong Kong

Site Status

Princess Margaret Hospital. ( Site 0856)

Hong Kong, , Hong Kong

Site Status

Queen Mary Hospital ( Site 0851)

Hong Kong, , Hong Kong

Site Status

Queen Elizabeth Hospital. ( Site 0854)

Kowloon, , Hong Kong

Site Status

Cork University Hospital ( Site 0538)

Cork, , Ireland

Site Status

Bon Secours Hospital ( Site 0526)

Cork, , Ireland

Site Status

Tallaght University Hospital ( Site 0522)

Dublin, , Ireland

Site Status

St Vincents University Hospital ( Site 0521)

Dublin, , Ireland

Site Status

Rambam Medical Center ( Site 0308)

Haifa, , Israel

Site Status

Hadassah Ein Karem - Sharett Institute of Oncology ( Site 0309)

Jerusalem, , Israel

Site Status

Rabin Medical Center ( Site 0307)

Petah Tikva, , Israel

Site Status

Sourasky Medical Center ( Site 0306)

Tel Aviv, , Israel

Site Status

Universita Cattolica del Sacro Cuore - Policlinico Gemelli ( Site 0329)

Rome, Abruzzo, Italy

Site Status

Policlinico S. Orsola-Malpighi ( Site 0333)

Bologna, , Italy

Site Status

A.O. di Rilievo Nazionale e di alta Specializzazione Garibaldi ( Site 0330)

Catania, , Italy

Site Status

ASST Grande Ospedale Metropolitano Niguarda ( Site 0332)

Milan, , Italy

Site Status

Azienda Ospedaliero Universitaria Pisana ( Site 0326)

Pisa, , Italy

Site Status

Policlinico Universitario Campus Biomedico ( Site 0328)

Roma, , Italy

Site Status

Azienda Ospedaliera Universitaria di Verona ( Site 0334)

Verona, , Italy

Site Status

Aichi Cancer Center Hospital ( Site 0080)

Nagoya, Aichi-ken, Japan

Site Status

National Cancer Center Hospital East ( Site 0081)

Kashiwa, Chiba, Japan

Site Status

Kobe City Medical Center General Hospital ( Site 0087)

Kobe, Hyōgo, Japan

Site Status

Kagawa University Hospital ( Site 0086)

Kita-gun, Kagawa-ken, Japan

Site Status

Kanagawa Cancer Center ( Site 0079)

Yokohama, Kanagawa, Japan

Site Status

Osaka University Hospital ( Site 0085)

Suita, Osaka, Japan

Site Status

Kyorin University Hospital ( Site 0077)

Mitaka, Tokyo, Japan

Site Status

National Hospital Organization Kyushu Cancer Center ( Site 0078)

Fukuoka, , Japan

Site Status

Kyoto University Hospital ( Site 0083)

Kyoto, , Japan

Site Status

Osaka International Cancer Institute ( Site 0084)

Osaka, , Japan

Site Status

The Cancer Institute Hospital of JFCR ( Site 0082)

Tokyo, , Japan

Site Status

Hospital Sultan Ismail ( Site 0772)

Johor Bahru, Johor, Malaysia

Site Status

University Malaya Medical Centre ( Site 0770)

Lembah Pantai, Kuala Lumpur, Malaysia

Site Status

Hospital Pulau Pinang ( Site 0773)

George Town, Pulau Pinang, Malaysia

Site Status

Institut Kanser Negara - National Cancer Institute ( Site 0767)

Putrajaya, Putrajaya, Malaysia

Site Status

Hospital Kuala Lumpur ( Site 0768)

Kuala Lumpur, , Malaysia

Site Status

Pantai Hospital Kuala Lumpur ( Site 0771)

Kuala Lumpur, , Malaysia

Site Status

Maastricht University Medical Centre ( Site 0347)

Maastricht, Limburg, Netherlands

Site Status

AMC ( Site 0348)

Amsterdam, North Holland, Netherlands

Site Status

Erasmus University Medical Center ( Site 0352)

Rotterdam, South Holland, Netherlands

Site Status

UMCG ( Site 0349)

Groningen, , Netherlands

Site Status

Universitair Medisch Centrum Utrecht ( Site 0351)

Utrecht, , Netherlands

Site Status

Auckland City Hospital ( Site 0725)

Auckland, , New Zealand

Site Status

Chonnam National University Hwasun Hospital ( Site 0837)

Hwasun Gun, Jeonranamdo, South Korea

Site Status

CHA Bundang Medical Center CHA University ( Site 0835)

Seongnam, Kyonggi-do, South Korea

Site Status

Seoul National University Bundang Hospital ( Site 0833)

Seongnam-si, Kyonggi-do, South Korea

Site Status

Ajou University Hospital, Clinical Research Center ( Site 0838)

Suwon, Kyonggi-do, South Korea

Site Status

Kyungpook National University Chilgok Hospital ( Site 0834)

Daegu, Taegu-Kwangyokshi, South Korea

Site Status

Chungnam National University Hospital ( Site 0840)

Daejeon, Taejon-Kwangyokshi, South Korea

Site Status

Severance Hospital Yonsei University Health System ( Site 0836)

Seoul, , South Korea

Site Status

Asan Medical Center ( Site 0830)

Seoul, , South Korea

Site Status

Samsung Medical Center ( Site 0831)

Seoul, , South Korea

Site Status

The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 0839)

Seoul, , South Korea

Site Status

Korea University Guro Hospital ( Site 0832)

Seoul, , South Korea

Site Status

Hospital Universitario General de Asturias ( Site 0434)

Oviedo, Principality of Asturias, Spain

Site Status

Hospital General Universitari Vall d Hebron ( Site 0432)

Barcelona, , Spain

Site Status

Hospital General Universitario Gregorio Maranon ( Site 0433)

Madrid, , Spain

Site Status

Hospital Universitario HM Sanchinarro ( Site 0435)

Madrid, , Spain

Site Status

Hospital Regional Universitario Carlos Haya ( Site 0431)

Málaga, , Spain

Site Status

Taipei Veterans General Hospital ( Site 0861)

Taipei,, Taipei, Taiwan

Site Status

Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0865)

Kaohsiung City, , Taiwan

Site Status

China Medical University Hospital ( Site 0862)

Taichung, , Taiwan

Site Status

National Cheng Kung University Hospital ( Site 0864)

Tainan City, , Taiwan

Site Status

National Taiwan University Hospital ( Site 0860)

Taipei, , Taiwan

Site Status

Koo Foundation Sun Yat-Sen Cancer Center ( Site 0863)

Taipei, , Taiwan

Site Status

Chang Gung Medical Foundation. Linkou ( Site 0853)

Taoyuan District, , Taiwan

Site Status

King Chulalongkorn Memorial Hospital ( Site 0884)

Bangkok, Bangkok, Thailand

Site Status

Ramathibodi Hospital. ( Site 0889)

Bangkok, Bangkok, Thailand

Site Status

Siriraj Hospital ( Site 0888)

Bangkok, Bangkok, Thailand

Site Status

Sunpasithiprasong Hospital ( Site 0883)

Ubonratchathani, Changwat Ubon Ratchathani, Thailand

Site Status

Maharaj Nakorn Chiang Mai Hospital ( Site 0887)

Chiang Mai, , Thailand

Site Status

Srinagarind Hospital ( Site 0885)

Khon Kaen, , Thailand

Site Status

Udon Thani Cancer Hospital ( Site 0886)

Udon Thani, , Thailand

Site Status

Inonu Universitesi Medical Fakultesi ( Site 0501)

Malatya, Adana, Turkey (Türkiye)

Site Status

Baskent University Adana Training Hospital ( Site 0499)

Adana, , Turkey (Türkiye)

Site Status

Hacettepe University Faculty of Medicine ( Site 0498)

Ankara, , Turkey (Türkiye)

Site Status

Abdurrahman Yurtaslan Onkoloji Hastanesi ( Site 0494)

Ankara, , Turkey (Türkiye)

Site Status

Gazi Universitesi Tip Fakultesi ( Site 0496)

Ankara, , Turkey (Türkiye)

Site Status

Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0506)

Istanbul, , Turkey (Türkiye)

Site Status

Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 0495)

Istanbul, , Turkey (Türkiye)

Site Status

Izmir Medical Park Hospital Department of Medical Oncology ( Site 0502)

Izmir, , Turkey (Türkiye)

Site Status

Erciyes Universitesi Tip Fakultesi ( Site 0500)

Kayseri, , Turkey (Türkiye)

Site Status

Aberdeen Royal Infirmary ( Site 0529)

Aberdeen, Aberdeen City, United Kingdom

Site Status

Royal Free London NHS Foundation Trust ( Site 0520)

London, London, City of, United Kingdom

Site Status

Royal Marsden Hospital ( Site 0536)

London, London, City of, United Kingdom

Site Status

Imperial College Healthcare NHS Trust - Hammersmith Hospital ( Site 0525)

London, London, City of, United Kingdom

Site Status

Royal Marsden NHS Foundation Trust ( Site 0535)

Sutton, Surrey, United Kingdom

Site Status

Belfast City Hospital ( Site 0517)

Belfast, , United Kingdom

Site Status

University Hospital Coventry and Warwickshire NHS Trust ( Site 0518)

Coventry, , United Kingdom

Site Status

The Christie NHS Foundation Trust ( Site 0537)

Manchester, , United Kingdom

Site Status

Countries

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United States Argentina Australia Belgium Brazil Canada Chile China France Germany Hong Kong Ireland Israel Italy Japan Malaysia Netherlands New Zealand South Korea Spain Taiwan Thailand Turkey (Türkiye) United Kingdom

References

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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 combination with gemcitabine and cisplatin compared with gemcitabine and cisplatin alone for patients with advanced biliary tract cancer (KEYNOTE-966): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2023 Jun 3;401(10391):1853-1865. doi: 10.1016/S0140-6736(23)00727-4. Epub 2023 Apr 16.

Reference Type RESULT
PMID: 37075781 (View on PubMed)

Jiang C, Zhou K, Shu P. Cost-effectiveness analysis of pembrolizumab plus chemotherapy as first-line treatment for advanced biliary tract cancer: perspectives from US and Chinese payers. BMJ Open. 2025 Apr 23;15(4):e094047. doi: 10.1136/bmjopen-2024-094047.

Reference Type DERIVED
PMID: 40268484 (View on PubMed)

Luo X, Cai T, Wu J, Li X, Wang X, Ma H. Cost-effectiveness of pembrolizumab plus chemotherapy vs. chemotherapy as first-line treatment for advanced biliary tract cancer in China and the US. Front Pharmacol. 2024 Aug 14;15:1393559. doi: 10.3389/fphar.2024.1393559. eCollection 2024.

Reference Type DERIVED
PMID: 39206260 (View on PubMed)

Keller HR, Fluke L, Forrester JA, Wolf RF. Identifying Indications for Neoadjuvant Therapy in Cholangiocarcinoma. Oncology (Williston Park). 2024 Apr 11;38(4):160-162. doi: 10.46883/2024.25921017.

Reference Type DERIVED
PMID: 38661512 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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MK-3475-966

Identifier Type: OTHER

Identifier Source: secondary_id

KEYNOTE-966

Identifier Type: OTHER

Identifier Source: secondary_id

195007

Identifier Type: REGISTRY

Identifier Source: secondary_id

2023-506657-38

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1294-1943

Identifier Type: REGISTRY

Identifier Source: secondary_id

2019-000944-82

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

3475-966

Identifier Type: -

Identifier Source: org_study_id

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