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Pembrolizumab (MK-3475) Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin for First-Line Advanced and/or Unresectable Biliary Tract Carcinoma (BTC) (MK-3475-966/KEYNOTE-966) (KEYNOTE-966)

Primary Purpose

Biliary Tract Carcinoma

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pembrolizumab
Gemcitabine
Cisplatin
Placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Biliary Tract Carcinoma focused on measuring Programmed cell death 1 (PD-1), Pembrolizumab, Cholangiocarcinoma, Gallbladder cancer, Checkpoint inhibitor, Immunotherapy, Biliary, Keytruda, Bile Duct Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

  • Has histologically confirmed diagnosis of advanced (metastatic) and/or unresectable (locally advanced) biliary tract cancer (intra-or extrahepatic cholangiocarcinoma or gallbladder cancer)
  • Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1), as determined by the site investigator
  • Participants with a history of hepatitis B or hepatitis C can be enrolled if they meet study criteria
  • Is able to provide archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion
  • Has a life expectancy of greater than 3 months
  • Has adequate organ function

Exclusion Criteria

  • Has had previous systemic therapy for advanced (metastatic) or unresectable (locally advanced) biliary tract cancer (intra-or extra hepatic cholangiocarcinoma or gallbladder cancer)
  • Has ampullary cancer
  • Has small cell cancer, neuroendocrine tumors, lymphoma, sarcoma, mixed tumor histology and/or mucinous cystic neoplasms
  • Has received prior therapy with an anti-programmed cell death 1 (anti-PD-1), anti- programmed cell death ligand 1 or 2 (anti-PD-L1, anti-PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX-40, CD137)
  • Has a known history of, or any evidence of, central nervous system (CNS) metastases and/or carcinomatous meningitis, as assessed by local site investigator
  • Has had an allogenic tissue/solid organ transplant

Sites / Locations

  • University of Alabama at Birmingham Comprehensive Cancer Ctr ( Site 0016)
  • University of California San Diego Moores Cancer Center ( Site 0008)
  • UCLA Hematology/Oncology - Santa Monica ( Site 0014)
  • University of California - San Francisco ( Site 0030)
  • University of Colorado Hospital ( Site 0011)
  • Hartford Hospital ( Site 0057)
  • Yale University ( Site 0053)
  • Winship Cancer Institute of Emory University ( Site 0013)
  • Northwest Georgia Oncology Centers PC ( Site 0045)
  • Decatur Memorial Hospital ( Site 0056)
  • Winthrop University Hospital ( Site 0059)
  • Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0038)
  • Columbia University/Herbert Irving Cancer Center ( Site 0009)
  • University of Oklahoma- Stephenson Oklahoma Cancer Center ( Site 0055)
  • OHSU Center for Health & Healing ( Site 0044)
  • Charleston Oncology ( Site 0042)
  • Saint Francis Health System ( Site 0051)
  • Blue Ridge Cancer Care ( Site 0033)
  • CEMIC ( Site 0581)
  • Fundacion Favaloro ( Site 0578)
  • Centro Medico San Roque ( Site 0579)
  • Hospital Municipal de Gastroenterologia Dr. Bonorino Udaondo ( Site 0580)
  • Centro Oncologico Riojano Integral ( Site 0584)
  • Liverpool Hospital ( Site 0707)
  • Mid North Coast Cancer Institute ( Site 0708)
  • Gallipoli Medical Research Foundation ( Site 0705)
  • Eastern Health ( Site 0704)
  • Western Health-Sunshine Hospital ( Site 0709)
  • UZA University Hospital Antwerp ( Site 0202)
  • Saint-Luc UCL ( Site 0200)
  • Erasme Hospital ( Site 0204)
  • Grand Hopital de Charleroi ( Site 0206)
  • CHU de Liege ( Site 0201)
  • UZ Gent ( Site 0203)
  • UZ Leuven ( Site 0205)
  • Oncobio Servicos de Saude SA ( Site 0604)
  • Hospital de Caridade de Ijui ( Site 0602)
  • Associacao Hospitalar Moinhos de Vento ( Site 0599)
  • Hospital de Clinicas de Porto Alegre ( Site 0610)
  • Hospital Nossa Senhora da Conceicao ( Site 0601)
  • Instituto COI de Pesquisa Educacao e Gestao ( Site 0606)
  • Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0607)
  • Hospital Paulistano - Amil Clinical Research ( Site 0603)
  • Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0609)
  • A.C. Camargo Cancer Center ( Site 0600)
  • Tom Baker Cancer Centre ( Site 0184)
  • Cross Cancer Institute ( Site 0183)
  • Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0182)
  • Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0180)
  • McGill University Health Centre ( Site 0179)
  • Centro Investigación del Cáncer James Lind ( Site 0622)
  • IC La Serena Research ( Site 0630)
  • Servicios Medicos Urumed ( Site 0621)
  • Fundacion Arturo Lopez Perez FALP ( Site 0623)
  • Sociedad Oncovida S.A. ( Site 0626)
  • Pontificia Universidad Catolica de Chile ( Site 0620)
  • Anhui Provincial Hospital ( Site 0140)
  • Beijing Cancer Hospital ( Site 0138)
  • Peking Union Medical College Hospital ( Site 0150)
  • First Affiliated Hospital of The Third Military Medical University ( Site 0130)
  • Fujian Provincial Cancer Hospital ( Site 0154)
  • 900 Hospital of the Joint ( Site 0137)
  • Guangdong Provincial People s Hospital ( Site 0161)
  • The Third Xiangya Hospital of Central South University ( Site 0157)
  • Harbin Medical University Cancer Hospital ( Site 0133)
  • Hunan Provincial People Hospital ( Site 0142)
  • Hunan Cancer Hospital ( Site 0132)
  • The 81st Hospital of PLA ( Site 0128)
  • The First Hospital of Jilin University ( Site 0131)
  • Zhongshan Hospital Fudan University ( Site 0129)
  • Renji Hospital Shanghai Jiaotong University School of Medicine ( Site 0158)
  • Fudan University Shanghai Cancer Center ( Site 0160)
  • Tangdu Hospital ( Site 0146)
  • The First Affiliated Hospital of Xi an Jiaotong University ( Site 0145)
  • West China Hospital of Sichuan University ( Site 0147)
  • Tianjin Medical University Cancer Institute & Hospital ( Site 0155)
  • The First Affiliated Hospital Zhejiang University ( Site 0136)
  • Zhejiang Cancer Hospital ( Site 0134)
  • CHU Bordeaux Haut-Leveque Centre Francois Magendie ( Site 0245)
  • A.P.H. Paris, Hopital Beaujon ( Site 0247)
  • CHU de Montpellier - Hopital Saint-Eloi ( Site 0248)
  • Centre Eugene Marquis ( Site 0242)
  • CHU Clermont-Ferrand - Site Estaing ( Site 0249)
  • Gustave Roussy ( Site 0244)
  • Universitaetsklinikum Ulm ( Site 0267)
  • Klinikum der Ludwig - Maximilian Universitat Munchen ( Site 0264)
  • Krankenhaus Nordwest ( Site 0266)
  • Medizinische Hochschule Hannover ( Site 0265)
  • Universitaetsklinikum Aachen AOER ( Site 0275)
  • Universitaetsklinikum Essen ( Site 0273)
  • Universitaetsklinikum Koeln ( Site 0274)
  • Universitaetsklinikum Magdeburg A.o.R. ( Site 0271)
  • Staedtisches Klinikum Dresden ( Site 0272)
  • Charite - Universtitatsmedizin Berlin CCM ( Site 0269)
  • Universitaetsklinikum Hamburg-Eppendorf ( Site 0268)
  • Pamela Youde Nethersole Eastern Hospital ( Site 0857)
  • Prince of Wales Hospital ( Site 0855)
  • Princess Margaret Hospital. ( Site 0856)
  • Queen Mary Hospital ( Site 0851)
  • Queen Elizabeth Hospital. ( Site 0854)
  • Cork University Hospital ( Site 0538)
  • Bon Secours Hospital ( Site 0526)
  • Tallaght University Hospital ( Site 0522)
  • St Vincents University Hospital ( Site 0521)
  • Rambam Medical Center ( Site 0308)
  • Hadassah Ein Karem - Sharett Institute of Oncology ( Site 0309)
  • Rabin Medical Center ( Site 0307)
  • Sourasky Medical Center ( Site 0306)
  • Universita Cattolica del Sacro Cuore - Policlinico Gemelli ( Site 0329)
  • Policlinico S. Orsola-Malpighi ( Site 0333)
  • A.O. di Rilievo Nazionale e di alta Specializzazione Garibaldi ( Site 0330)
  • ASST Grande Ospedale Metropolitano Niguarda ( Site 0332)
  • Azienda Ospedaliero Universitaria Pisana ( Site 0326)
  • Policlinico Universitario Campus Biomedico ( Site 0328)
  • Azienda Ospedaliera Universitaria di Verona ( Site 0334)
  • Aichi Cancer Center Hospital ( Site 0080)
  • National Cancer Center Hospital East ( Site 0081)
  • Kobe City Medical Center General Hospital ( Site 0087)
  • Kagawa University Hospital ( Site 0086)
  • Kanagawa Cancer Center ( Site 0079)
  • Osaka University Hospital ( Site 0085)
  • Kyorin University Hospital ( Site 0077)
  • National Hospital Organization Kyushu Cancer Center ( Site 0078)
  • Kyoto University Hospital ( Site 0083)
  • Osaka International Cancer Institute ( Site 0084)
  • The Cancer Institute Hospital of JFCR ( Site 0082)
  • Chonnam National University Hwasun Hospital ( Site 0837)
  • Seoul National University Bundang Hospital ( Site 0833)
  • CHA Bundang Medical Center CHA University ( Site 0835)
  • Ajou University Hospital, Clinical Research Center ( Site 0838)
  • Kyungpook National University Chilgok Hospital ( Site 0834)
  • Chungnam National University Hospital ( Site 0840)
  • Severance Hospital Yonsei University Health System ( Site 0836)
  • Asan Medical Center ( Site 0830)
  • Samsung Medical Center ( Site 0831)
  • The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 0839)
  • Korea University Guro Hospital ( Site 0832)
  • Hospital Sultan Ismail ( Site 0772)
  • University Malaya Medical Centre ( Site 0770)
  • Hospital Pulau Pinang ( Site 0773)
  • Institut Kanser Negara - National Cancer Institute ( Site 0767)
  • Hospital Kuala Lumpur ( Site 0768)
  • Pantai Hospital Kuala Lumpur ( Site 0771)
  • Maastricht University Medical Centre ( Site 0347)
  • AMC ( Site 0348)
  • Erasmus University Medical Center ( Site 0352)
  • UMCG ( Site 0349)
  • Universitair Medisch Centrum Utrecht ( Site 0351)
  • Auckland City Hospital ( Site 0725)
  • Hospital Universitario General de Asturias ( Site 0434)
  • Hospital General Universitari Vall d Hebron ( Site 0432)
  • Hospital General Universitario Gregorio Maranon ( Site 0433)
  • Hospital Universitario HM Sanchinarro ( Site 0435)
  • Hospital Regional Universitario Carlos Haya ( Site 0431)
  • Taipei Veterans General Hospital ( Site 0861)
  • Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0865)
  • China Medical University Hospital ( Site 0862)
  • National Cheng Kung University Hospital ( Site 0864)
  • National Taiwan University Hospital ( Site 0860)
  • Koo Foundation Sun Yat-Sen Cancer Center ( Site 0863)
  • Chang Gung Medical Foundation. Linkou ( Site 0853)
  • King Chulalongkorn Memorial Hospital ( Site 0884)
  • Ramathibodi Hospital. ( Site 0889)
  • Siriraj Hospital ( Site 0888)
  • Sunpasithiprasong Hospital ( Site 0883)
  • Maharaj Nakorn Chiang Mai Hospital ( Site 0887)
  • Srinagarind Hospital ( Site 0885)
  • Udon Thani Cancer Hospital ( Site 0886)
  • Inonu Universitesi Medical Fakultesi ( Site 0501)
  • Baskent University Adana Training Hospital ( Site 0499)
  • Hacettepe University Faculty of Medicine ( Site 0498)
  • Abdurrahman Yurtaslan Onkoloji Hastanesi ( Site 0494)
  • Gazi Universitesi Tip Fakultesi ( Site 0496)
  • Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0506)
  • Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 0495)
  • Izmir Medical Park Hospital Department of Medical Oncology ( Site 0502)
  • Erciyes Universitesi Tip Fakultesi ( Site 0500)
  • Aberdeen Royal Infirmary ( Site 0529)
  • Royal Free London NHS Foundation Trust ( Site 0520)
  • Royal Marsden Hospital ( Site 0536)
  • Imperial College Healthcare NHS Trust - Hammersmith Hospital ( Site 0525)
  • Royal Marsden NHS Foundation Trust ( Site 0535)
  • Belfast City Hospital ( Site 0517)
  • University Hospital Coventry and Warwickshire NHS Trust ( Site 0518)
  • The Christie NHS Foundation Trust ( Site 0537)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm A (Pembrolizumab+Gemcitabine+Cisplatin)

Arm B (Placebo+Gemcitabine+Cisplatin)

Arm Description

Pembrolizumab, 200 mg, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m^2, Q3W, Day 1 and Day 8 of each cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m^2, Q3W, Day 1 and Day 8 of each cycle for up to 8 cycles.

Placebo to Pembrolizumab, 200 mg, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m^2, Q3W, Day 1 and Day 8 of each cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m^2, Q3W, Day 1 and Day 8 of each cycle for up to 8 cycles.

Outcomes

Primary Outcome Measures

Overall Survival (OS)
Overall survival is defined as the time from randomization to death due to any cause.

Secondary Outcome Measures

Progression-free Survival (PFS) per RECIST 1.1 as Assessed by BICR
Progression-free survival is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first.
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 is 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 is adjusted for this study to allow a maximum of 10 target lesions in total and 5 per organ.
Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR
For participants who demonstrate a confirmed CR or PR, DOR is the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.
Number of Participants Who Experience One or More Adverse Events (AE)
An adverse event (AE) is 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 is 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 Adverse Event (AE)
An AE is 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 is considered related to the medical treatment or procedure, that occurs during the course of the study.

Full Information

First Posted
June 28, 2019
Last Updated
July 25, 2023
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04003636
Brief Title
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)
Acronym
KEYNOTE-966
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 24, 2019 (Actual)
Primary Completion Date
December 15, 2022 (Actual)
Study Completion Date
November 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. The primary hypothesis is pembrolizumab plus gemcitabine/cisplatin is superior to placebo plus gemcitabine/cisplatin with respect to overall survival (OS).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Tract Carcinoma
Keywords
Programmed cell death 1 (PD-1), Pembrolizumab, Cholangiocarcinoma, Gallbladder cancer, Checkpoint inhibitor, Immunotherapy, Biliary, Keytruda, Bile Duct Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1069 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A (Pembrolizumab+Gemcitabine+Cisplatin)
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm B (Placebo+Gemcitabine+Cisplatin)
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
MK-3475
Intervention Description
Pembrolizumab by intravenous (IV) infusion
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemzar
Intervention Description
Gemcitabine by IV infusion
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
Platinol®, Platinol®-AQ
Intervention Description
Cisplatin by IV infusion
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo to pembrolizumab
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
Overall survival is defined as the time from randomization to death due to any cause.
Time Frame
Up to approximately 38 months
Secondary Outcome Measure Information:
Title
Progression-free Survival (PFS) per RECIST 1.1 as Assessed by BICR
Description
Progression-free survival is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first.
Time Frame
Up to approximately 26 months
Title
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)
Description
ORR is 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 is adjusted for this study to allow a maximum of 10 target lesions in total and 5 per organ.
Time Frame
Up to approximately 26 months
Title
Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR
Description
For participants who demonstrate a confirmed CR or PR, DOR is the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.
Time Frame
Up to approximately 38 months
Title
Number of Participants Who Experience One or More Adverse Events (AE)
Description
An adverse event (AE) is 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 is considered related to the medical treatment or procedure, that occurs during the course of the study.
Time Frame
Up to approximately 38 months
Title
Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE)
Description
An AE is 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 is considered related to the medical treatment or procedure, that occurs during the course of the study.
Time Frame
Up to approximately 38 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Has histologically confirmed diagnosis of advanced (metastatic) and/or unresectable (locally advanced) biliary tract cancer (intra-or extrahepatic cholangiocarcinoma or gallbladder cancer) Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1), as determined by the site investigator Participants with a history of hepatitis B or hepatitis C can be enrolled if they meet study criteria Is able to provide archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion Has a life expectancy of greater than 3 months Has adequate organ function Exclusion Criteria Has had previous systemic therapy for advanced (metastatic) or unresectable (locally advanced) biliary tract cancer (intra-or extra hepatic cholangiocarcinoma or gallbladder cancer) Has ampullary cancer Has small cell cancer, neuroendocrine tumors, lymphoma, sarcoma, mixed tumor histology and/or mucinous cystic neoplasms Has received prior therapy with an anti-programmed cell death 1 (anti-PD-1), anti- programmed cell death ligand 1 or 2 (anti-PD-L1, anti-PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX-40, CD137) Has a known history of, or any evidence of, central nervous system (CNS) metastases and/or carcinomatous meningitis, as assessed by local site investigator Has had an allogenic tissue/solid organ transplant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham Comprehensive Cancer Ctr ( Site 0016)
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
University of California San Diego Moores Cancer Center ( Site 0008)
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0698
Country
United States
Facility Name
UCLA Hematology/Oncology - Santa Monica ( Site 0014)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
University of California - San Francisco ( Site 0030)
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
University of Colorado Hospital ( Site 0011)
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Hartford Hospital ( Site 0057)
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Facility Name
Yale University ( Site 0053)
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Winship Cancer Institute of Emory University ( Site 0013)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322-1013
Country
United States
Facility Name
Northwest Georgia Oncology Centers PC ( Site 0045)
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Decatur Memorial Hospital ( Site 0056)
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Winthrop University Hospital ( Site 0059)
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0038)
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Columbia University/Herbert Irving Cancer Center ( Site 0009)
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of Oklahoma- Stephenson Oklahoma Cancer Center ( Site 0055)
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
OHSU Center for Health & Healing ( Site 0044)
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Charleston Oncology ( Site 0042)
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Saint Francis Health System ( Site 0051)
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
Blue Ridge Cancer Care ( Site 0033)
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
CEMIC ( Site 0581)
City
Buenos Aires
State/Province
Caba
ZIP/Postal Code
C1431FWO
Country
Argentina
Facility Name
Fundacion Favaloro ( Site 0578)
City
Ciudad de Buenos Aires
State/Province
Caba
ZIP/Postal Code
C1093AAS
Country
Argentina
Facility Name
Centro Medico San Roque ( Site 0579)
City
San Miguel de Tucuman
State/Province
Tucuman
ZIP/Postal Code
T4000IAK
Country
Argentina
Facility Name
Hospital Municipal de Gastroenterologia Dr. Bonorino Udaondo ( Site 0580)
City
Caba
ZIP/Postal Code
C1264AAA
Country
Argentina
Facility Name
Centro Oncologico Riojano Integral ( Site 0584)
City
La Rioja
ZIP/Postal Code
F5300COE
Country
Argentina
Facility Name
Liverpool Hospital ( Site 0707)
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Mid North Coast Cancer Institute ( Site 0708)
City
Port Macquarie
State/Province
New South Wales
ZIP/Postal Code
2444
Country
Australia
Facility Name
Gallipoli Medical Research Foundation ( Site 0705)
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4120
Country
Australia
Facility Name
Eastern Health ( Site 0704)
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Western Health-Sunshine Hospital ( Site 0709)
City
St Albans
State/Province
Victoria
ZIP/Postal Code
3021
Country
Australia
Facility Name
UZA University Hospital Antwerp ( Site 0202)
City
Edegem
State/Province
Antwerpen
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Saint-Luc UCL ( Site 0200)
City
Brussels
State/Province
Bruxelles-Capitale, Region De
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Erasme Hospital ( Site 0204)
City
Bruxelles
State/Province
Bruxelles-Capitale, Region De
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Grand Hopital de Charleroi ( Site 0206)
City
Charleroi
State/Province
Hainaut
ZIP/Postal Code
6000
Country
Belgium
Facility Name
CHU de Liege ( Site 0201)
City
Liège
State/Province
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
UZ Gent ( Site 0203)
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Leuven ( Site 0205)
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Oncobio Servicos de Saude SA ( Site 0604)
City
Nova Lima
State/Province
Minas Gerais
ZIP/Postal Code
34000-000
Country
Brazil
Facility Name
Hospital de Caridade de Ijui ( Site 0602)
City
Ijui
State/Province
Rio Grande Do Sul
ZIP/Postal Code
98700-000
Country
Brazil
Facility Name
Associacao Hospitalar Moinhos de Vento ( Site 0599)
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-001
Country
Brazil
Facility Name
Hospital de Clinicas de Porto Alegre ( Site 0610)
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Hospital Nossa Senhora da Conceicao ( Site 0601)
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
91350-200
Country
Brazil
Facility Name
Instituto COI de Pesquisa Educacao e Gestao ( Site 0606)
City
Rio de Janeiro
ZIP/Postal Code
22793-080
Country
Brazil
Facility Name
Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0607)
City
Sao Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
Hospital Paulistano - Amil Clinical Research ( Site 0603)
City
Sao Paulo
ZIP/Postal Code
01321-001
Country
Brazil
Facility Name
Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0609)
City
Sao Paulo
ZIP/Postal Code
01321-001
Country
Brazil
Facility Name
A.C. Camargo Cancer Center ( Site 0600)
City
Sao Paulo
ZIP/Postal Code
01509-900
Country
Brazil
Facility Name
Tom Baker Cancer Centre ( Site 0184)
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Cross Cancer Institute ( Site 0183)
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0182)
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V5C2
Country
Canada
Facility Name
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0180)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 3E4
Country
Canada
Facility Name
McGill University Health Centre ( Site 0179)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Centro Investigación del Cáncer James Lind ( Site 0622)
City
Temuco
State/Province
Araucania
ZIP/Postal Code
4780000
Country
Chile
Facility Name
IC La Serena Research ( Site 0630)
City
La Serena
State/Province
Coquimbo
ZIP/Postal Code
1720430
Country
Chile
Facility Name
Servicios Medicos Urumed ( Site 0621)
City
Rancagua
State/Province
Lbtdr Gen Bernardo O Higgins
ZIP/Postal Code
2852424
Country
Chile
Facility Name
Fundacion Arturo Lopez Perez FALP ( Site 0623)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
7500921
Country
Chile
Facility Name
Sociedad Oncovida S.A. ( Site 0626)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
7510032
Country
Chile
Facility Name
Pontificia Universidad Catolica de Chile ( Site 0620)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8330032
Country
Chile
Facility Name
Anhui Provincial Hospital ( Site 0140)
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230001
Country
China
Facility Name
Beijing Cancer Hospital ( Site 0138)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100036
Country
China
Facility Name
Peking Union Medical College Hospital ( Site 0150)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
First Affiliated Hospital of The Third Military Medical University ( Site 0130)
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400038
Country
China
Facility Name
Fujian Provincial Cancer Hospital ( Site 0154)
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Facility Name
900 Hospital of the Joint ( Site 0137)
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350025
Country
China
Facility Name
Guangdong Provincial People s Hospital ( Site 0161)
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
The Third Xiangya Hospital of Central South University ( Site 0157)
City
Changsha
State/Province
Hainan
ZIP/Postal Code
410013
Country
China
Facility Name
Harbin Medical University Cancer Hospital ( Site 0133)
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
610000
Country
China
Facility Name
Hunan Provincial People Hospital ( Site 0142)
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410005
Country
China
Facility Name
Hunan Cancer Hospital ( Site 0132)
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Facility Name
The 81st Hospital of PLA ( Site 0128)
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210031
Country
China
Facility Name
The First Hospital of Jilin University ( Site 0131)
City
Chanchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
Zhongshan Hospital Fudan University ( Site 0129)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Renji Hospital Shanghai Jiaotong University School of Medicine ( Site 0158)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Facility Name
Fudan University Shanghai Cancer Center ( Site 0160)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201315
Country
China
Facility Name
Tangdu Hospital ( Site 0146)
City
XI An
State/Province
Shanxi
ZIP/Postal Code
710038
Country
China
Facility Name
The First Affiliated Hospital of Xi an Jiaotong University ( Site 0145)
City
XI An
State/Province
Shanxi
ZIP/Postal Code
710048
Country
China
Facility Name
West China Hospital of Sichuan University ( Site 0147)
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Tianjin Medical University Cancer Institute & Hospital ( Site 0155)
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Facility Name
The First Affiliated Hospital Zhejiang University ( Site 0136)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Facility Name
Zhejiang Cancer Hospital ( Site 0134)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Facility Name
CHU Bordeaux Haut-Leveque Centre Francois Magendie ( Site 0245)
City
Pessac Cedex
State/Province
Gironde
ZIP/Postal Code
33604
Country
France
Facility Name
A.P.H. Paris, Hopital Beaujon ( Site 0247)
City
Clichy
State/Province
Hauts-de-Seine
ZIP/Postal Code
92110
Country
France
Facility Name
CHU de Montpellier - Hopital Saint-Eloi ( Site 0248)
City
Montpellier
State/Province
Herault
ZIP/Postal Code
34295
Country
France
Facility Name
Centre Eugene Marquis ( Site 0242)
City
Rennes
State/Province
Ille-et-Vilaine
ZIP/Postal Code
35042
Country
France
Facility Name
CHU Clermont-Ferrand - Site Estaing ( Site 0249)
City
Clermont-Ferrand
State/Province
Puy-de-Dome
ZIP/Postal Code
63003
Country
France
Facility Name
Gustave Roussy ( Site 0244)
City
Villejuif
State/Province
Val-de-Marne
ZIP/Postal Code
94805
Country
France
Facility Name
Universitaetsklinikum Ulm ( Site 0267)
City
Ulm
State/Province
Baden-Wurttemberg
ZIP/Postal Code
89081
Country
Germany
Facility Name
Klinikum der Ludwig - Maximilian Universitat Munchen ( Site 0264)
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
81377
Country
Germany
Facility Name
Krankenhaus Nordwest ( Site 0266)
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60488
Country
Germany
Facility Name
Medizinische Hochschule Hannover ( Site 0265)
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitaetsklinikum Aachen AOER ( Site 0275)
City
Aachen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Universitaetsklinikum Essen ( Site 0273)
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Universitaetsklinikum Koeln ( Site 0274)
City
Koeln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50937
Country
Germany
Facility Name
Universitaetsklinikum Magdeburg A.o.R. ( Site 0271)
City
Magdeburg
State/Province
Sachsen-Anhalt
ZIP/Postal Code
39120
Country
Germany
Facility Name
Staedtisches Klinikum Dresden ( Site 0272)
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01067
Country
Germany
Facility Name
Charite - Universtitatsmedizin Berlin CCM ( Site 0269)
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Universitaetsklinikum Hamburg-Eppendorf ( Site 0268)
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Pamela Youde Nethersole Eastern Hospital ( Site 0857)
City
Hong Kong
Country
Hong Kong
Facility Name
Prince of Wales Hospital ( Site 0855)
City
Hong Kong
Country
Hong Kong
Facility Name
Princess Margaret Hospital. ( Site 0856)
City
Hong Kong
Country
Hong Kong
Facility Name
Queen Mary Hospital ( Site 0851)
City
Hong Kong
Country
Hong Kong
Facility Name
Queen Elizabeth Hospital. ( Site 0854)
City
Kowloon
Country
Hong Kong
Facility Name
Cork University Hospital ( Site 0538)
City
Cork
ZIP/Postal Code
T12 DC4A
Country
Ireland
Facility Name
Bon Secours Hospital ( Site 0526)
City
Cork
ZIP/Postal Code
T12 DV56
Country
Ireland
Facility Name
Tallaght University Hospital ( Site 0522)
City
Dublin
ZIP/Postal Code
D24 NROA
Country
Ireland
Facility Name
St Vincents University Hospital ( Site 0521)
City
Dublin
ZIP/Postal Code
DO4 YN63
Country
Ireland
Facility Name
Rambam Medical Center ( Site 0308)
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Hadassah Ein Karem - Sharett Institute of Oncology ( Site 0309)
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Rabin Medical Center ( Site 0307)
City
Petah Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Sourasky Medical Center ( Site 0306)
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Universita Cattolica del Sacro Cuore - Policlinico Gemelli ( Site 0329)
City
Rome
State/Province
Abruzzo
ZIP/Postal Code
00168
Country
Italy
Facility Name
Policlinico S. Orsola-Malpighi ( Site 0333)
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
A.O. di Rilievo Nazionale e di alta Specializzazione Garibaldi ( Site 0330)
City
Catania
ZIP/Postal Code
95124
Country
Italy
Facility Name
ASST Grande Ospedale Metropolitano Niguarda ( Site 0332)
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Pisana ( Site 0326)
City
Pisa
ZIP/Postal Code
56127
Country
Italy
Facility Name
Policlinico Universitario Campus Biomedico ( Site 0328)
City
Roma
ZIP/Postal Code
00128
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria di Verona ( Site 0334)
City
Verona
ZIP/Postal Code
37134
Country
Italy
Facility Name
Aichi Cancer Center Hospital ( Site 0080)
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
National Cancer Center Hospital East ( Site 0081)
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
Kobe City Medical Center General Hospital ( Site 0087)
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0047
Country
Japan
Facility Name
Kagawa University Hospital ( Site 0086)
City
Kita-gun
State/Province
Kagawa
ZIP/Postal Code
761-0793
Country
Japan
Facility Name
Kanagawa Cancer Center ( Site 0079)
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
Facility Name
Osaka University Hospital ( Site 0085)
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Kyorin University Hospital ( Site 0077)
City
Mitaka
State/Province
Tokyo
ZIP/Postal Code
181-8611
Country
Japan
Facility Name
National Hospital Organization Kyushu Cancer Center ( Site 0078)
City
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Facility Name
Kyoto University Hospital ( Site 0083)
City
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
Facility Name
Osaka International Cancer Institute ( Site 0084)
City
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Facility Name
The Cancer Institute Hospital of JFCR ( Site 0082)
City
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Chonnam National University Hwasun Hospital ( Site 0837)
City
Hwasun Gun
State/Province
Jeonranamdo
ZIP/Postal Code
58128
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital ( Site 0833)
City
Seongnam-si
State/Province
Kyonggi-do
ZIP/Postal Code
13605
Country
Korea, Republic of
Facility Name
CHA Bundang Medical Center CHA University ( Site 0835)
City
Seongnam
State/Province
Kyonggi-do
ZIP/Postal Code
13496
Country
Korea, Republic of
Facility Name
Ajou University Hospital, Clinical Research Center ( Site 0838)
City
Suwon-si
State/Province
Kyonggi-do
ZIP/Postal Code
16499
Country
Korea, Republic of
Facility Name
Kyungpook National University Chilgok Hospital ( Site 0834)
City
Daegu
State/Province
Taegu-Kwangyokshi
ZIP/Postal Code
41404
Country
Korea, Republic of
Facility Name
Chungnam National University Hospital ( Site 0840)
City
Daejeon
State/Province
Taejon-Kwangyokshi
ZIP/Postal Code
35015
Country
Korea, Republic of
Facility Name
Severance Hospital Yonsei University Health System ( Site 0836)
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center ( Site 0830)
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center ( Site 0831)
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 0839)
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital ( Site 0832)
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Facility Name
Hospital Sultan Ismail ( Site 0772)
City
Johor Bahru
State/Province
Johor
ZIP/Postal Code
81100
Country
Malaysia
Facility Name
University Malaya Medical Centre ( Site 0770)
City
Lembah Pantai
State/Province
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
Hospital Pulau Pinang ( Site 0773)
City
Georgetown
State/Province
Pulau Pinang
ZIP/Postal Code
10990
Country
Malaysia
Facility Name
Institut Kanser Negara - National Cancer Institute ( Site 0767)
City
Putrajaya
State/Province
Wilayah Persekutuan Putrajaya
ZIP/Postal Code
62250
Country
Malaysia
Facility Name
Hospital Kuala Lumpur ( Site 0768)
City
Kuala Lumpur
ZIP/Postal Code
50586
Country
Malaysia
Facility Name
Pantai Hospital Kuala Lumpur ( Site 0771)
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
Maastricht University Medical Centre ( Site 0347)
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
AMC ( Site 0348)
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Erasmus University Medical Center ( Site 0352)
City
Rotterdam
State/Province
Zuid-Holland
ZIP/Postal Code
3015 GD
Country
Netherlands
Facility Name
UMCG ( Site 0349)
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Universitair Medisch Centrum Utrecht ( Site 0351)
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Auckland City Hospital ( Site 0725)
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Hospital Universitario General de Asturias ( Site 0434)
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33011
Country
Spain
Facility Name
Hospital General Universitari Vall d Hebron ( Site 0432)
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon ( Site 0433)
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Hospital Universitario HM Sanchinarro ( Site 0435)
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital Regional Universitario Carlos Haya ( Site 0431)
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Taipei Veterans General Hospital ( Site 0861)
City
Taipei,
State/Province
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0865)
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Facility Name
China Medical University Hospital ( Site 0862)
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
National Cheng Kung University Hospital ( Site 0864)
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
National Taiwan University Hospital ( Site 0860)
City
Taipei
ZIP/Postal Code
10048
Country
Taiwan
Facility Name
Koo Foundation Sun Yat-Sen Cancer Center ( Site 0863)
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Chang Gung Medical Foundation. Linkou ( Site 0853)
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
King Chulalongkorn Memorial Hospital ( Site 0884)
City
Bangkok
State/Province
Krung Thep Maha Nakhon
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Ramathibodi Hospital. ( Site 0889)
City
Bangkok
State/Province
Krung Thep Maha Nakhon
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Siriraj Hospital ( Site 0888)
City
Bangkok
State/Province
Krung Thep Maha Nakhon
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Sunpasithiprasong Hospital ( Site 0883)
City
Ubonratchathani
State/Province
Ubon Ratchathani
ZIP/Postal Code
34000
Country
Thailand
Facility Name
Maharaj Nakorn Chiang Mai Hospital ( Site 0887)
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Srinagarind Hospital ( Site 0885)
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Udon Thani Cancer Hospital ( Site 0886)
City
Udon Thani
ZIP/Postal Code
41330
Country
Thailand
Facility Name
Inonu Universitesi Medical Fakultesi ( Site 0501)
City
Malatya
State/Province
Adana
ZIP/Postal Code
44280
Country
Turkey
Facility Name
Baskent University Adana Training Hospital ( Site 0499)
City
Adana
ZIP/Postal Code
01250
Country
Turkey
Facility Name
Hacettepe University Faculty of Medicine ( Site 0498)
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Abdurrahman Yurtaslan Onkoloji Hastanesi ( Site 0494)
City
Ankara
ZIP/Postal Code
06200
Country
Turkey
Facility Name
Gazi Universitesi Tip Fakultesi ( Site 0496)
City
Ankara
ZIP/Postal Code
06500
Country
Turkey
Facility Name
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0506)
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 0495)
City
Istanbul
ZIP/Postal Code
34722
Country
Turkey
Facility Name
Izmir Medical Park Hospital Department of Medical Oncology ( Site 0502)
City
Izmir
ZIP/Postal Code
35520
Country
Turkey
Facility Name
Erciyes Universitesi Tip Fakultesi ( Site 0500)
City
Kayseri
ZIP/Postal Code
38039
Country
Turkey
Facility Name
Aberdeen Royal Infirmary ( Site 0529)
City
Aberdeen
State/Province
Aberdeen City
ZIP/Postal Code
AB252ZN
Country
United Kingdom
Facility Name
Royal Free London NHS Foundation Trust ( Site 0520)
City
London
State/Province
London, City Of
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Royal Marsden Hospital ( Site 0536)
City
London
State/Province
London, City Of
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Imperial College Healthcare NHS Trust - Hammersmith Hospital ( Site 0525)
City
London
State/Province
London, City Of
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Facility Name
Royal Marsden NHS Foundation Trust ( Site 0535)
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Belfast City Hospital ( Site 0517)
City
Belfast
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
Facility Name
University Hospital Coventry and Warwickshire NHS Trust ( Site 0518)
City
Coventry
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust ( Site 0537)
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
37075781
Citation
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. Erratum In: Lancet. 2023 Sep 16;402(10406):964.
Results Reference
result
Links:
URL
https://www.merckclinicaltrials.com
Description
Merck Clinical Trials Information

Learn more about this trial

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)

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