AzTrials
AzTrials

Biliary Tract CarcinomaPhase 3KEYNOTE-966NCT04003636

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)

A Phase 3 study testing Pembrolizumab, Gemcitabine and Cisplatin in people with Biliary Tract Carcinoma, run by Merck Sharp & Dohme LLC at 185 sites in 24 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Biliary Tract Carcinoma
What is being tested?
Pembrolizumab, Gemcitabine and Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,069 participants
Where
185 sitesin 24 countries
Study dates
24 Sep 2019to 1 Apr 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

185 sites in 24 countries.

185 sites in 24 countries

China22 sites

  • Beijing Cancer Hospital ( Site 0138)

    Beijing, Beijing Municipality, 100036

  • Peking Union Medical College Hospital ( Site 0150)

    Beijing, Beijing Municipality, 100730

  • The First Hospital of Jilin University ( Site 0131)

    Changchun, Jilin, 130021

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

    Changsha, Hainan, 410013

  • Hunan Provincial People Hospital ( Site 0142)

    Changsha, Hunan, 410005

  • Hunan Cancer Hospital ( Site 0132)

    Changsha, Hunan, 410013

  • West China Hospital of Sichuan University ( Site 0147)

    Chengdu, Sichuan, 610041

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

    Chongqing, Chongqing Municipality, 400038

  • Fujian Provincial Cancer Hospital ( Site 0154)

    Fuzhou, Fujian, 350014

  • 900 Hospital of the Joint ( Site 0137)

    Fuzhou, Fujian, 350025

  • Guangdong Provincial People s Hospital ( Site 0161)

    Guangzhou, Guangdong, 510080

  • The First Affiliated Hospital Zhejiang University ( Site 0136)

    Hangzhou, Zhejiang, 310003

  • Zhejiang Cancer Hospital ( Site 0134)

    Hangzhou, Zhejiang, 310022

  • Harbin Medical University Cancer Hospital ( Site 0133)

    Harbin, Heilongjiang, 610000

  • Anhui Provincial Hospital ( Site 0140)

    Hefei, Anhui, 230001

  • The 81st Hospital of PLA ( Site 0128)

    Nanjing, Jiangsu, 210031

  • Zhongshan Hospital Fudan University ( Site 0129)

    Shanghai, Shanghai Municipality, 200032

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

    Shanghai, Shanghai Municipality, 200127

  • Fudan University Shanghai Cancer Center ( Site 0160)

    Shanghai, Shanghai Municipality, 201315

  • Tianjin Medical University Cancer Institute & Hospital ( Site 0155)

    Tianjin, Tianjin Municipality, 300060

  • Tangdu Hospital ( Site 0146)

    Xi’an, Shanxi, 710038

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

    Xi’an, Shanxi, 710048

Other trials in China

United States18 sites

  • Winship Cancer Institute of Emory University ( Site 0013)

    Atlanta, Georgia, 30322-1013

  • University of Colorado Hospital ( Site 0011)

    Aurora, Colorado, 80045

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

    Birmingham, Alabama, 35294

  • Charleston Oncology ( Site 0042)

    Charleston, South Carolina, 29414

  • Decatur Memorial Hospital ( Site 0056)

    Decatur, Illinois, 62526

  • Saint Francis Health System ( Site 0051)

    Greenville, South Carolina, 29607

  • Hartford Hospital ( Site 0057)

    Hartford, Connecticut, 06102

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

    La Jolla, California, 92093-0698

  • UCLA Hematology/Oncology - Santa Monica ( Site 0014)

    Los Angeles, California, 90404

  • Northwest Georgia Oncology Centers PC ( Site 0045)

    Marietta, Georgia, 30060

  • Winthrop University Hospital ( Site 0059)

    Mineola, New York, 11501

  • Yale University ( Site 0053)

    New Haven, Connecticut, 06510

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

    New York, New York, 10016

  • Columbia University/Herbert Irving Cancer Center ( Site 0009)

    New York, New York, 10032

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

    Oklahoma City, Oklahoma, 73104

  • OHSU Center for Health & Healing ( Site 0044)

    Portland, Oregon, 97239

  • Blue Ridge Cancer Care ( Site 0033)

    Roanoke, Virginia, 24014

  • University of California - San Francisco ( Site 0030)

    San Francisco, California, 94158

Other trials in United States

Germany11 sites

  • Universitaetsklinikum Aachen AOER ( Site 0275)

    Aachen, North Rhine-Westphalia, 52074

  • Charite - Universtitatsmedizin Berlin CCM ( Site 0269)

    Berlin, 10117

  • Universitaetsklinikum Koeln ( Site 0274)

    Cologne, North Rhine-Westphalia, 50937

  • Staedtisches Klinikum Dresden ( Site 0272)

    Dresden, Saxony, 01067

  • Universitaetsklinikum Essen ( Site 0273)

    Essen, North Rhine-Westphalia, 45147

  • Krankenhaus Nordwest ( Site 0266)

    Frankfurt am Main, Hesse, 60488

  • Universitaetsklinikum Hamburg-Eppendorf ( Site 0268)

    Hamburg, 20246

  • Medizinische Hochschule Hannover ( Site 0265)

    Hanover, Lower Saxony, 30625

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

    Magdeburg, Saxony-Anhalt, 39120

  • Klinikum der Ludwig - Maximilian Universitat Munchen ( Site 0264)

    Munich, Bavaria, 81377

  • Universitaetsklinikum Ulm ( Site 0267)

    Ulm, Baden-Wurttemberg, 89081

Other trials in Germany

Japan11 sites

  • National Hospital Organization Kyushu Cancer Center ( Site 0078)

    Fukuoka, 811-1395

  • National Cancer Center Hospital East ( Site 0081)

    Kashiwa, Chiba, 277-8577

  • Kagawa University Hospital ( Site 0086)

    Kita-gun, Kagawa-ken, 761-0793

  • Kobe City Medical Center General Hospital ( Site 0087)

    Kobe, Hyōgo, 650-0047

  • Kyoto University Hospital ( Site 0083)

    Kyoto, 606-8507

  • Kyorin University Hospital ( Site 0077)

    Mitaka, Tokyo, 181-8611

  • Aichi Cancer Center Hospital ( Site 0080)

    Nagoya, Aichi-ken, 464-8681

  • Osaka International Cancer Institute ( Site 0084)

    Osaka, 541-8567

  • Osaka University Hospital ( Site 0085)

    Suita, Osaka, 565-0871

  • The Cancer Institute Hospital of JFCR ( Site 0082)

    Tokyo, 135-8550

  • Kanagawa Cancer Center ( Site 0079)

    Yokohama, Kanagawa, 241-8515

Other trials in Japan

South Korea11 sites

  • Kyungpook National University Chilgok Hospital ( Site 0834)

    Daegu, Taegu-Kwangyokshi, 41404

  • Chungnam National University Hospital ( Site 0840)

    Daejeon, Taejon-Kwangyokshi, 35015

  • Chonnam National University Hwasun Hospital ( Site 0837)

    Hwasun Gun, Jeonranamdo, 58128

  • CHA Bundang Medical Center CHA University ( Site 0835)

    Seongnam, Kyonggi-do, 13496

  • Seoul National University Bundang Hospital ( Site 0833)

    Seongnam-si, Kyonggi-do, 13605

  • Severance Hospital Yonsei University Health System ( Site 0836)

    Seoul, 03722

  • Asan Medical Center ( Site 0830)

    Seoul, 05505

  • Samsung Medical Center ( Site 0831)

    Seoul, 06351

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

    Seoul, 06591

  • Korea University Guro Hospital ( Site 0832)

    Seoul, 08308

  • Ajou University Hospital, Clinical Research Center ( Site 0838)

    Suwon, Kyonggi-do, 16499

Other trials in South Korea

Brazil10 sites

  • Hospital de Caridade de Ijui ( Site 0602)

    Ijuí, Rio Grande do Sul, 98700-000

  • Oncobio Servicos de Saude SA ( Site 0604)

    Nova Lima, Minas Gerais, 34000-000

  • Associacao Hospitalar Moinhos de Vento ( Site 0599)

    Porto Alegre, Rio Grande do Sul, 90035-001

  • Hospital de Clinicas de Porto Alegre ( Site 0610)

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Hospital Nossa Senhora da Conceicao ( Site 0601)

    Porto Alegre, Rio Grande do Sul, 91350-200

  • Instituto COI de Pesquisa Educacao e Gestao ( Site 0606)

    Rio de Janeiro, 22793-080

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

    São Paulo, 01246-000

  • Hospital Paulistano - Amil Clinical Research ( Site 0603)

    São Paulo, 01321-001

  • Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0609)

    São Paulo, 01321-001

  • A.C. Camargo Cancer Center ( Site 0600)

    São Paulo, 01509-900

Other trials in Brazil

Turkey (Türkiye)9 sites

  • Baskent University Adana Training Hospital ( Site 0499)

    Adana, 01250

  • Hacettepe University Faculty of Medicine ( Site 0498)

    Ankara, 06100

  • Abdurrahman Yurtaslan Onkoloji Hastanesi ( Site 0494)

    Ankara, 06200

  • Gazi Universitesi Tip Fakultesi ( Site 0496)

    Ankara, 06500

  • Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0506)

    Istanbul, 34098

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

    Istanbul, 34722

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

    Izmir, 35520

  • Erciyes Universitesi Tip Fakultesi ( Site 0500)

    Kayseri, 38039

  • Inonu Universitesi Medical Fakultesi ( Site 0501)

    Malatya, Adana, 44280

Other trials in Turkey (Türkiye)

United Kingdom8 sites

  • Aberdeen Royal Infirmary ( Site 0529)

    Aberdeen, Aberdeen City, AB252ZN

  • Belfast City Hospital ( Site 0517)

    Belfast, BT9 7AB

  • University Hospital Coventry and Warwickshire NHS Trust ( Site 0518)

    Coventry, CV2 2DX

  • Royal Free London NHS Foundation Trust ( Site 0520)

    London, London, City of, NW3 2QG

  • Royal Marsden Hospital ( Site 0536)

    London, London, City of, SW3 6JJ

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

    London, London, City of, W12 0HS

  • The Christie NHS Foundation Trust ( Site 0537)

    Manchester, M20 4BX

  • Royal Marsden NHS Foundation Trust ( Site 0535)

    Sutton, Surrey, SM2 5PT

Other trials in United Kingdom

Belgium7 sites

  • Erasme Hospital ( Site 0204)

    Brussels, Bruxelles-Capitale, Region de, 1070

  • Saint-Luc UCL ( Site 0200)

    Brussels, Bruxelles-Capitale, Region de, 1200

  • Grand Hopital de Charleroi ( Site 0206)

    Charleroi, Hainaut, 6000

  • UZA University Hospital Antwerp ( Site 0202)

    Edegem, Antwerpen, 2650

  • UZ Gent ( Site 0203)

    Ghent, Oost-Vlaanderen, 9000

  • UZ Leuven ( Site 0205)

    Leuven, Vlaams-Brabant, 3000

  • CHU de Liege ( Site 0201)

    Liège, Liege, 4000

Other trials in Belgium

Italy7 sites

  • Policlinico S. Orsola-Malpighi ( Site 0333)

    Bologna, 40138

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

    Catania, 95124

  • ASST Grande Ospedale Metropolitano Niguarda ( Site 0332)

    Milan, 20162

  • Azienda Ospedaliero Universitaria Pisana ( Site 0326)

    Pisa, 56127

  • Policlinico Universitario Campus Biomedico ( Site 0328)

    Roma, 00128

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

    Rome, Abruzzo, 00168

  • Azienda Ospedaliera Universitaria di Verona ( Site 0334)

    Verona, 37134

Other trials in Italy

Taiwan7 sites

  • Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0865)

    Kaohsiung City, 833

  • China Medical University Hospital ( Site 0862)

    Taichung, 40447

  • National Cheng Kung University Hospital ( Site 0864)

    Tainan, 704

  • National Taiwan University Hospital ( Site 0860)

    Taipei, 10048

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

    Taipei, 112

  • Taipei Veterans General Hospital ( Site 0861)

    Taipei,, Taipei, 112

  • Chang Gung Medical Foundation. Linkou ( Site 0853)

    Taoyuan, 333

Other trials in Taiwan

Thailand7 sites

  • King Chulalongkorn Memorial Hospital ( Site 0884)

    Bangkok, Bangkok, 10330

  • Ramathibodi Hospital. ( Site 0889)

    Bangkok, Bangkok, 10400

  • Siriraj Hospital ( Site 0888)

    Bangkok, Bangkok, 10700

  • Maharaj Nakorn Chiang Mai Hospital ( Site 0887)

    Chiang Mai, 50200

  • Srinagarind Hospital ( Site 0885)

    Khon Kaen, 40002

  • Sunpasithiprasong Hospital ( Site 0883)

    Ubonratchathani, Changwat Ubon Ratchathani, 34000

  • Udon Thani Cancer Hospital ( Site 0886)

    Udon Thani, 41330

Other trials in Thailand

Chile6 sites

  • IC La Serena Research ( Site 0630)

    La Serena, Coquimbo Region, 1720430

  • Servicios Medicos Urumed ( Site 0621)

    Rancagua, Lbtdr Gen Bernardo O Higgins, 2852424

  • Fundacion Arturo Lopez Perez FALP ( Site 0623)

    Santiago, Region M. de Santiago, 7500921

  • Sociedad Oncovida S.A. ( Site 0626)

    Santiago, Region M. de Santiago, 7510032

  • Pontificia Universidad Catolica de Chile ( Site 0620)

    Santiago, Region M. de Santiago, 8330032

  • Centro Investigación del Cáncer James Lind ( Site 0622)

    Temuco, Araucania, 4780000

Other trials in Chile

France6 sites

  • CHU Clermont-Ferrand - Site Estaing ( Site 0249)

    Clermont-Ferrand, Puy-de-Dome, 63003

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

    Clichy, Hauts-de-Seine, 92110

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

    Montpellier, Herault, 34295

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

    Pessac, Gironde, 33604

  • Centre Eugene Marquis ( Site 0242)

    Rennes, Ille-et-Vilaine, 35042

  • Gustave Roussy ( Site 0244)

    Villejuif, Val-de-Marne, 94805

Other trials in France

Malaysia6 sites

  • Hospital Pulau Pinang ( Site 0773)

    George Town, Pulau Pinang, 10990

  • Hospital Sultan Ismail ( Site 0772)

    Johor Bahru, Johor, 81100

  • Hospital Kuala Lumpur ( Site 0768)

    Kuala Lumpur, 50586

  • Pantai Hospital Kuala Lumpur ( Site 0771)

    Kuala Lumpur, 59100

  • University Malaya Medical Centre ( Site 0770)

    Lembah Pantai, Kuala Lumpur, 59100

  • Institut Kanser Negara - National Cancer Institute ( Site 0767)

    Putrajaya, Putrajaya, 62250

Other trials in Malaysia

Argentina5 sites

  • CEMIC ( Site 0581)

    Buenos Aires, Buenos Aires F.D., C1431FWO

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

    CABA, C1264AAA

  • Fundacion Favaloro ( Site 0578)

    Ciudad de Buenos Aires, Buenos Aires F.D., C1093AAS

  • Centro Oncologico Riojano Integral ( Site 0584)

    La Rioja, F5300COE

  • Centro Medico San Roque ( Site 0579)

    San Miguel de Tucumán, Tucumán Province, T4000IAK

Other trials in Argentina

Australia5 sites

  • Eastern Health ( Site 0704)

    Box Hill, Victoria, 3128

  • Gallipoli Medical Research Foundation ( Site 0705)

    Brisbane, Queensland, 4120

  • Liverpool Hospital ( Site 0707)

    Liverpool, New South Wales, 2170

  • Mid North Coast Cancer Institute ( Site 0708)

    Port Macquarie, New South Wales, 2444

  • Western Health-Sunshine Hospital ( Site 0709)

    St Albans, Victoria, 3021

Other trials in Australia

Canada5 sites

  • Tom Baker Cancer Centre ( Site 0184)

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute ( Site 0183)

    Edmonton, Alberta, T6G 1Z2

  • Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0182)

    Hamilton, Ontario, L8V5C2

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

    Montreal, Quebec, H2X 3E4

  • McGill University Health Centre ( Site 0179)

    Montreal, Quebec, H4A 3J1

Other trials in Canada

Hong Kong5 sites

  • Pamela Youde Nethersole Eastern Hospital ( Site 0857)

    Hong Kong

  • Prince of Wales Hospital ( Site 0855)

    Hong Kong

  • Princess Margaret Hospital. ( Site 0856)

    Hong Kong

  • Queen Mary Hospital ( Site 0851)

    Hong Kong

  • Queen Elizabeth Hospital. ( Site 0854)

    Kowloon

Other trials in Hong Kong

Netherlands5 sites

  • AMC ( Site 0348)

    Amsterdam, North Holland, 1105 AZ

  • UMCG ( Site 0349)

    Groningen, 9713 GZ

  • Maastricht University Medical Centre ( Site 0347)

    Maastricht, Limburg, 6229 HX

  • Erasmus University Medical Center ( Site 0352)

    Rotterdam, South Holland, 3015 GD

  • Universitair Medisch Centrum Utrecht ( Site 0351)

    Utrecht, 3584 CX

Other trials in Netherlands

Spain5 sites

  • Hospital General Universitari Vall d Hebron ( Site 0432)

    Barcelona, 08035

  • Hospital General Universitario Gregorio Maranon ( Site 0433)

    Madrid, 28009

  • Hospital Universitario HM Sanchinarro ( Site 0435)

    Madrid, 28050

  • Hospital Regional Universitario Carlos Haya ( Site 0431)

    Málaga, 29010

  • Hospital Universitario General de Asturias ( Site 0434)

    Oviedo, Principality of Asturias, 33011

Other trials in Spain

Ireland4 sites

  • Cork University Hospital ( Site 0538)

    Cork, T12 DC4A

  • Bon Secours Hospital ( Site 0526)

    Cork, T12 DV56

  • Tallaght University Hospital ( Site 0522)

    Dublin, D24 NROA

  • St Vincents University Hospital ( Site 0521)

    Dublin, DO4 YN63

Other trials in Ireland

Israel4 sites

  • Rambam Medical Center ( Site 0308)

    Haifa, 3109601

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

    Jerusalem, 9112001

  • Rabin Medical Center ( Site 0307)

    Petah Tikva, 4941492

  • Sourasky Medical Center ( Site 0306)

    Tel Aviv, 6423906

Other trials in Israel

New Zealand1 site

  • Auckland City Hospital ( Site 0725)

    Auckland, 1023

Other trials in New Zealand

About this study

Official 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

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).

Being tested
Pembrolizumab, Gemcitabine, Cisplatin, Placebo
Keywords
Programmed cell death 1 (PD-1), Pembrolizumab, Cholangiocarcinoma, Gallbladder cancer, Checkpoint inhibitor, Immunotherapy, Biliary, Keytruda, Bile Duct Cancer
Medical subject headings
Parkinson Disease 4, Autosomal Dominant Lewy Body, Cholangiocarcinoma, Gallbladder Neoplasms, Bile Duct Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PembrolizumabBiological

    Also called MK-3475

    Pembrolizumab by intravenous (IV) infusion

  • GemcitabineDrug

    Also called Gemzar

    Gemcitabine by IV infusion

  • CisplatinDrug

    Also called Platinol®, Platinol®-AQ

    Cisplatin by IV infusion

  • PlaceboDrug

    Placebo to pembrolizumab

Study groups in NCT04003636
Study groupRoleWhat they receive
Arm A (Pembrolizumab+Chemotherapy)ExperimentalParticipants receive pembrolizumab, 200 mg intravenous (IV) infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS gemcitabine, 1000 mg/m^2, IV infusion Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS cisplatin, 25 mg/m^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles. Eligible participants who stop the initial course of pembrolizumab with stable disease (SD) or better but progress after discontinuation will initiate a second course of pembrolizumab 200 mg IV Q3W, Day 1 of each 3-week cycle for up to 17 cycles. Treatment with gemcitabine can be stopped at anytime in first or second course due to toxicity or disease progression.
Receives: Biological: Pembrolizumab; Drug: Gemcitabine; Drug: Cisplatin
Arm B (Placebo+Chemotherapy)Placebo comparatorParticipants receive placebo to pembrolizumab, 200 mg IV infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS gemcitabine, 1000 mg/m^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS cisplatin, 25 mg/m^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles.
Receives: Drug: Gemcitabine; Drug: Cisplatin; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    Overall survival was defined as the time from randomization to death due to any cause.

    Measured: Up to approximately 38 months

Secondary outcomes (5)

  1. 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 disease progression (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. PFS as assessed by BICR per RECIST 1.1 was presented.

    Measured: Up to approximately 26 months

  2. 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.

    Measured: Up to approximately 26 months

  3. Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR

    For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of a CR or PR until PD or death. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions as well as an absolute increase of at least a 5 mm in the sum of diameters. The appearance of one or more new lesions was also considered PD. DOR assessments were based on BICR with confirmation. The DOR as assessed using RECIST 1.1 for all participants who experienced a confirmed CR or PR was presented.

    Measured: Up to approximately 38 months

  4. 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. Number of participants who experienced one or more AEs were reported.

    Measured: Up to approximately 65 months

  5. Number of Participants Who Discontinued Study Intervention Due to an 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. Number of participants who discontinued study intervention due to an AE were reported.

    Measured: Up to approximately 63 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2019
  2. Study start24 Sep 2019
  3. Primary completion15 Dec 2022
  4. Study completion1 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
1,069 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04003636
Sponsor's protocol ID
3475-966
Other IDs
MK-3475-966, KEYNOTE-966, 195007, 2023-506657-38-00, U1111-1294-1943, 2019-000944-82, 2019, 2023
Acronym
KEYNOTE-966
Status last verified
Mar 2026
First submitted
28 Jun 2019
Last updated
24 Mar 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

  • 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.

    PubMed 37075781

  • Ueno M, Yoo C, Ren Z, Furuse J, Kelley RK, Chan SL, Edeline J, Klumpen HJ, Yau T, Verslype C, Ozaka M, Bouattour M, Park JO, Vogel A, Valle JW, Starkopf L, Malhotra U, Siegel AB, Qin S, Finn RS; KEYNOTE-966 Investigatorst; KEYNOTE-966 Investigators. Pembrolizumab plus gemcitabine and cisplatin for advanced biliary tract cancer: longer-term follow-up from the randomised, double-blind, placebo-controlled, phase 3 KEYNOTE-966 trial. EClinicalMedicine. 2026 Oct 12;100:104213. doi: 10.1016/j.eclinm.2026.104213. eCollection 2026 Oct.

    PubMed 42898854

  • Ren Z, Liang T, Gu S, Gou H, Peng C, Pan Y, Song T, Su H, Cao K, Liang H, Ying J, Geng Z, Yu W, Zhao H, Bai Y, Hao C, Mao Y, Li W, Wang L, Li D, Wang W, Li N, Malhotra U, Qin S. First-Line Pembrolizumab Plus Chemotherapy for Advanced Biliary Tract Cancer: China Subgroup Analysis of the Randomized Phase 3 KEYNOTE-966 Study. Adv Ther. 2026 Sep;43(9):3871-3885. doi: 10.1007/s12325-026-03578-4. Epub 2026 May 23.

    PubMed 42176183

  • 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.

    PubMed 40268484

  • 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.

    PubMed 39206260

  • 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.

    PubMed 38661512

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pembrolizumab, Gemcitabine and Cisplatin in people with Biliary Tract Carcinoma, run by Merck Sharp & Dohme LLC at 185 sites in 24 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 185 sites in China, United States, Germany, Japan, South Korea and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: Up to approximately 38 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04003636, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in