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
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View full resultsBasic Information
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COMPLETED
PHASE3
1069 participants
INTERVENTIONAL
2019-09-24
2025-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
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.
Pembrolizumab
Pembrolizumab by intravenous (IV) infusion
Gemcitabine
Gemcitabine by IV infusion
Cisplatin
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.
Gemcitabine
Gemcitabine by IV infusion
Cisplatin
Cisplatin by IV infusion
Placebo
Placebo to pembrolizumab
Interventions
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Pembrolizumab
Pembrolizumab by intravenous (IV) infusion
Gemcitabine
Gemcitabine by IV infusion
Cisplatin
Cisplatin by IV infusion
Placebo
Placebo to pembrolizumab
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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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
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
University of California - San Francisco ( Site 0030)
San Francisco, California, United States
University of Colorado Hospital ( Site 0011)
Aurora, Colorado, United States
Hartford Hospital ( Site 0057)
Hartford, Connecticut, United States
Yale University ( Site 0053)
New Haven, Connecticut, United States
Winship Cancer Institute of Emory University ( Site 0013)
Atlanta, Georgia, United States
Northwest Georgia Oncology Centers PC ( Site 0045)
Marietta, Georgia, United States
Decatur Memorial Hospital ( Site 0056)
Decatur, Illinois, United States
Winthrop University Hospital ( Site 0059)
Mineola, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0038)
New York, New York, United States
Columbia University/Herbert Irving Cancer Center ( Site 0009)
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
Charleston Oncology ( Site 0042)
Charleston, South Carolina, United States
Saint Francis Health System ( Site 0051)
Greenville, South Carolina, United States
Blue Ridge Cancer Care ( Site 0033)
Roanoke, Virginia, United States
CEMIC ( Site 0581)
Buenos Aires, Buenos Aires F.D., Argentina
Fundacion Favaloro ( Site 0578)
Ciudad de Buenos Aires, Buenos Aires F.D., Argentina
Centro Medico San Roque ( Site 0579)
San Miguel de Tucumán, Tucumán Province, Argentina
Hospital Municipal de Gastroenterologia Dr. Bonorino Udaondo ( Site 0580)
CABA, , Argentina
Centro Oncologico Riojano Integral ( Site 0584)
La Rioja, , Argentina
Liverpool Hospital ( Site 0707)
Liverpool, New South Wales, Australia
Mid North Coast Cancer Institute ( Site 0708)
Port Macquarie, New South Wales, Australia
Gallipoli Medical Research Foundation ( Site 0705)
Brisbane, Queensland, Australia
Eastern Health ( Site 0704)
Box Hill, Victoria, Australia
Western Health-Sunshine Hospital ( Site 0709)
St Albans, Victoria, Australia
UZA University Hospital Antwerp ( Site 0202)
Edegem, Antwerpen, Belgium
Erasme Hospital ( Site 0204)
Brussels, Bruxelles-Capitale, Region de, Belgium
Saint-Luc UCL ( Site 0200)
Brussels, Bruxelles-Capitale, Region de, Belgium
Grand Hopital de Charleroi ( Site 0206)
Charleroi, Hainaut, Belgium
CHU de Liege ( Site 0201)
Liège, Liege, Belgium
UZ Gent ( Site 0203)
Ghent, Oost-Vlaanderen, Belgium
UZ Leuven ( Site 0205)
Leuven, Vlaams-Brabant, Belgium
Oncobio Servicos de Saude SA ( Site 0604)
Nova Lima, Minas Gerais, Brazil
Hospital de Caridade de Ijui ( Site 0602)
Ijuí, Rio Grande do Sul, 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
Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0607)
São Paulo, , Brazil
Hospital Paulistano - Amil Clinical Research ( Site 0603)
São Paulo, , Brazil
Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0609)
São Paulo, , Brazil
A.C. Camargo Cancer Center ( Site 0600)
São Paulo, , Brazil
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, Canada
IC La Serena Research ( Site 0630)
La Serena, Coquimbo Region, 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
Sociedad Oncovida S.A. ( Site 0626)
Santiago, Region M. de Santiago, Chile
Pontificia Universidad Catolica de Chile ( Site 0620)
Santiago, Region M. de Santiago, Chile
Centro Investigación del Cáncer James Lind ( Site 0622)
Temuco, Región de la Araucanía, Chile
Anhui Provincial Hospital ( Site 0140)
Hefei, Anhui, China
Beijing Cancer Hospital ( Site 0138)
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital ( Site 0150)
Beijing, Beijing Municipality, China
First Affiliated Hospital of The Third Military Medical University ( Site 0130)
Chongqing, Chongqing Municipality, China
Fujian Provincial Cancer Hospital ( Site 0154)
Fuzhou, Fujian, China
900 Hospital of the Joint ( Site 0137)
Fuzhou, Fujian, China
Guangdong Provincial People s Hospital ( Site 0161)
Guangzhou, Guangdong, China
The Third Xiangya Hospital of Central South University ( Site 0157)
Changsha, Hainan, China
Harbin Medical University Cancer Hospital ( Site 0133)
Harbin, Heilongjiang, China
Hunan Provincial People Hospital ( Site 0142)
Changsha, Hunan, China
Hunan Cancer Hospital ( Site 0132)
Changsha, Hunan, China
The 81st Hospital of PLA ( Site 0128)
Nanjing, Jiangsu, China
The First Hospital of Jilin University ( Site 0131)
Changchun, Jilin, China
Zhongshan Hospital Fudan University ( Site 0129)
Shanghai, Shanghai Municipality, China
Renji Hospital Shanghai Jiaotong University School of Medicine ( Site 0158)
Shanghai, Shanghai Municipality, China
Fudan University Shanghai Cancer Center ( Site 0160)
Shanghai, Shanghai Municipality, China
Tangdu Hospital ( Site 0146)
Xi’an, Shanxi, China
The First Affiliated Hospital of Xi an Jiaotong University ( Site 0145)
Xi’an, Shanxi, China
West China Hospital of Sichuan University ( Site 0147)
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital ( Site 0155)
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital Zhejiang University ( Site 0136)
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital ( Site 0134)
Hangzhou, Zhejiang, China
CHU Bordeaux Haut-Leveque Centre Francois Magendie ( Site 0245)
Pessac, Gironde, 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
Centre Eugene Marquis ( Site 0242)
Rennes, Ille-et-Vilaine, France
CHU Clermont-Ferrand - Site Estaing ( Site 0249)
Clermont-Ferrand, Puy-de-Dome, France
Gustave Roussy ( Site 0244)
Villejuif, Val-de-Marne, France
Universitaetsklinikum Ulm ( Site 0267)
Ulm, Baden-Wurttemberg, Germany
Klinikum der Ludwig - Maximilian Universitat Munchen ( Site 0264)
Munich, Bavaria, Germany
Krankenhaus Nordwest ( Site 0266)
Frankfurt am Main, Hesse, Germany
Medizinische Hochschule Hannover ( Site 0265)
Hanover, Lower Saxony, Germany
Universitaetsklinikum Aachen AOER ( Site 0275)
Aachen, North Rhine-Westphalia, Germany
Universitaetsklinikum Koeln ( Site 0274)
Cologne, North Rhine-Westphalia, Germany
Universitaetsklinikum Essen ( Site 0273)
Essen, North Rhine-Westphalia, Germany
Staedtisches Klinikum Dresden ( Site 0272)
Dresden, Saxony, Germany
Universitaetsklinikum Magdeburg A.o.R. ( Site 0271)
Magdeburg, Saxony-Anhalt, Germany
Charite - Universtitatsmedizin Berlin CCM ( Site 0269)
Berlin, , Germany
Universitaetsklinikum Hamburg-Eppendorf ( Site 0268)
Hamburg, , Germany
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, , Hong Kong
Cork University Hospital ( Site 0538)
Cork, , Ireland
Bon Secours Hospital ( Site 0526)
Cork, , Ireland
Tallaght University Hospital ( Site 0522)
Dublin, , Ireland
St Vincents University Hospital ( Site 0521)
Dublin, , Ireland
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, , Israel
Universita Cattolica del Sacro Cuore - Policlinico Gemelli ( Site 0329)
Rome, Abruzzo, 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)
Milan, , Italy
Azienda Ospedaliero Universitaria Pisana ( Site 0326)
Pisa, , Italy
Policlinico Universitario Campus Biomedico ( Site 0328)
Roma, , Italy
Azienda Ospedaliera Universitaria di Verona ( Site 0334)
Verona, , Italy
Aichi Cancer Center Hospital ( Site 0080)
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East ( Site 0081)
Kashiwa, Chiba, Japan
Kobe City Medical Center General Hospital ( Site 0087)
Kobe, Hyōgo, Japan
Kagawa University Hospital ( Site 0086)
Kita-gun, Kagawa-ken, Japan
Kanagawa Cancer Center ( Site 0079)
Yokohama, Kanagawa, Japan
Osaka University Hospital ( Site 0085)
Suita, Osaka, Japan
Kyorin University Hospital ( Site 0077)
Mitaka, Tokyo, Japan
National Hospital Organization Kyushu Cancer Center ( Site 0078)
Fukuoka, , Japan
Kyoto University Hospital ( Site 0083)
Kyoto, , Japan
Osaka International Cancer Institute ( Site 0084)
Osaka, , Japan
The Cancer Institute Hospital of JFCR ( Site 0082)
Tokyo, , Japan
Hospital Sultan Ismail ( Site 0772)
Johor Bahru, Johor, Malaysia
University Malaya Medical Centre ( Site 0770)
Lembah Pantai, Kuala Lumpur, Malaysia
Hospital Pulau Pinang ( Site 0773)
George Town, Pulau Pinang, Malaysia
Institut Kanser Negara - National Cancer Institute ( Site 0767)
Putrajaya, Putrajaya, Malaysia
Hospital Kuala Lumpur ( Site 0768)
Kuala Lumpur, , Malaysia
Pantai Hospital Kuala Lumpur ( Site 0771)
Kuala Lumpur, , Malaysia
Maastricht University Medical Centre ( Site 0347)
Maastricht, Limburg, Netherlands
AMC ( Site 0348)
Amsterdam, North Holland, Netherlands
Erasmus University Medical Center ( Site 0352)
Rotterdam, South Holland, Netherlands
UMCG ( Site 0349)
Groningen, , Netherlands
Universitair Medisch Centrum Utrecht ( Site 0351)
Utrecht, , Netherlands
Auckland City Hospital ( Site 0725)
Auckland, , New Zealand
Chonnam National University Hwasun Hospital ( Site 0837)
Hwasun Gun, Jeonranamdo, South Korea
CHA Bundang Medical Center CHA University ( Site 0835)
Seongnam, Kyonggi-do, South Korea
Seoul National University Bundang Hospital ( Site 0833)
Seongnam-si, Kyonggi-do, South Korea
Ajou University Hospital, Clinical Research Center ( Site 0838)
Suwon, Kyonggi-do, South Korea
Kyungpook National University Chilgok Hospital ( Site 0834)
Daegu, Taegu-Kwangyokshi, South Korea
Chungnam National University Hospital ( Site 0840)
Daejeon, Taejon-Kwangyokshi, South Korea
Severance Hospital Yonsei University Health System ( Site 0836)
Seoul, , South Korea
Asan Medical Center ( Site 0830)
Seoul, , South Korea
Samsung Medical Center ( Site 0831)
Seoul, , South Korea
The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 0839)
Seoul, , South Korea
Korea University Guro Hospital ( Site 0832)
Seoul, , South Korea
Hospital Universitario General de Asturias ( Site 0434)
Oviedo, Principality of Asturias, 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)
Málaga, , Spain
Taipei Veterans General Hospital ( Site 0861)
Taipei,, Taipei, Taiwan
Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0865)
Kaohsiung City, , Taiwan
China Medical University Hospital ( Site 0862)
Taichung, , Taiwan
National Cheng Kung University Hospital ( Site 0864)
Tainan City, , Taiwan
National Taiwan University Hospital ( Site 0860)
Taipei, , Taiwan
Koo Foundation Sun Yat-Sen Cancer Center ( Site 0863)
Taipei, , Taiwan
Chang Gung Medical Foundation. Linkou ( Site 0853)
Taoyuan District, , Taiwan
King Chulalongkorn Memorial Hospital ( Site 0884)
Bangkok, Bangkok, Thailand
Ramathibodi Hospital. ( Site 0889)
Bangkok, Bangkok, Thailand
Siriraj Hospital ( Site 0888)
Bangkok, Bangkok, Thailand
Sunpasithiprasong Hospital ( Site 0883)
Ubonratchathani, Changwat Ubon Ratchathani, Thailand
Maharaj Nakorn Chiang Mai Hospital ( Site 0887)
Chiang Mai, , Thailand
Srinagarind Hospital ( Site 0885)
Khon Kaen, , Thailand
Udon Thani Cancer Hospital ( Site 0886)
Udon Thani, , Thailand
Inonu Universitesi Medical Fakultesi ( Site 0501)
Malatya, Adana, Turkey (Türkiye)
Baskent University Adana Training Hospital ( Site 0499)
Adana, , Turkey (Türkiye)
Hacettepe University Faculty of Medicine ( Site 0498)
Ankara, , Turkey (Türkiye)
Abdurrahman Yurtaslan Onkoloji Hastanesi ( Site 0494)
Ankara, , Turkey (Türkiye)
Gazi Universitesi Tip Fakultesi ( Site 0496)
Ankara, , Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0506)
Istanbul, , Turkey (Türkiye)
Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 0495)
Istanbul, , Turkey (Türkiye)
Izmir Medical Park Hospital Department of Medical Oncology ( Site 0502)
Izmir, , Turkey (Türkiye)
Erciyes Universitesi Tip Fakultesi ( Site 0500)
Kayseri, , Turkey (Türkiye)
Aberdeen Royal Infirmary ( Site 0529)
Aberdeen, Aberdeen City, 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
Imperial College Healthcare NHS Trust - Hammersmith Hospital ( Site 0525)
London, London, City of, United Kingdom
Royal Marsden NHS Foundation Trust ( Site 0535)
Sutton, Surrey, United Kingdom
Belfast City Hospital ( Site 0517)
Belfast, , United Kingdom
University Hospital Coventry and Warwickshire NHS Trust ( Site 0518)
Coventry, , United Kingdom
The Christie NHS Foundation Trust ( Site 0537)
Manchester, , United Kingdom
Countries
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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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Merck Clinical Trials Information
Plain Language Summary
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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