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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)

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

INTRODUCTION

  • Org Study ID: 3475-966
  • Secondary ID: 2019-000944-82, MK-3475-966, KEYNOTE-966, 195007
  • NTC ID: NCT04003636
  • Sponsor: Merck Sharp & Dohme Corp.

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 study has 2 primary hypotheses: 1. Pembrolizumab plus
gemcitabine/cisplatin is superior to placebo plus gemcitabine/cisplatin with respect to
progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
by blinded independent central review (BICR) and 2. Pembrolizumab plus gemcitabine/cisplatin
is superior to placebo plus gemcitabine/cisplatin with respect to overall survival (OS).


  • Overall Status
    Recruiting
  • Start Date
    September 24, 2019
  • Phase
    Phase 3
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)

Primary Outcome 1 - Timeframe: Up to 48 months

Primary Outcome 2 - Measure: Overall Survival (OS)

Primary Outcome 2 - Timeframe: Up to 48 months

CONDITION

  • Biliary Tract Carcinoma

ELIGIBILITY


Inclusion Criteria

1. Has histologically confirmed diagnosis of advanced (metastatic) and/or unresectable
(locally advanced) biliary tract cancer (intra-or extrahepatic cholangiocarcinoma or
gallbladder cancer).

2. Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST
1.1), as determined by the site investigator.

3. Participants with a history of hepatitis B or hepatitis C can be enrolled if they meet
study criteria.

4. Provide archival tumor tissue sample or newly obtained core or excisional biopsy of a
tumor lesion.

5. Have a life expectancy of greater than 3 months.

6. Have adequate organ function.

Exclusion Criteria

1. Has had previous systemic therapy for advanced (metastatic) or unresectable (locally
advanced) biliary tract cancer (intra-or extra hepatic cholangiocarcinoma or
gallbladder cancer), with the exception of adjuvant therapy which is allowed.

2. Has ampullary cancer.

3. Has small cell cancer, neuroendocrine tumors, lymphoma, sarcoma and/or Mucinous cystic
neoplasms.

4. 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 co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40,
CD137).

5. Has a known history of, or any evidence of, central nervous system (CNS) metastases
and/or carcinomatous meningitis, as assessed by local site investigator.

6. Has had an allogenic tissue/solid organ transplant.

Gender: All

Minimum Age: N/A

Maximum Age: 18 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Medical Director

Role: Study Director

Affiliation: Merck Sharp & Dohme Corp.

Overall Contact

Name: Medical Director

Phone: 1-888-577-8839

Email: Trialsites@merck.com

LOCATION

Facility Status Contact
Facility: University of Colorado Hospital ( Site 0011)
Aurora, Colorado 80045
United States
Status: Recruiting Contact:
Study Coordinator
720-848-9457
Facility: Hartford Hospital ( Site 0057)
Hartford, Connecticut 06102
United States
Status: Recruiting Contact:
Study Coordinator
860-249-6291
Facility: Yale University ( Site 0053)
New Haven, Connecticut 06511
United States
Status: Recruiting Contact:
Study Coordinator
203-785-6308
Facility: Winship Cancer Institute of Emory University ( Site 0013)
Atlanta, Georgia 30322-1013
United States
Status: Recruiting Contact:
Study Coordinator
404-778-8025
Facility: Northwest Georgia Oncology Centers PC ( Site 0045)
Marietta, Georgia 30060
United States
Status: Recruiting Contact:
Study Coordinator
770-333-2161
Facility: Decatur Memorial Hospital ( Site 0056)
Decatur, Illinois 62526
United States
Status: Recruiting Contact:
Study Coordinator
217-876-4769
Facility: Columbia University/Herbert Irving Cancer Center ( Site 0009)
New York, New York 10032
United States
Status: Recruiting Contact:
Study Coordinator
212-342-5162
Facility: Charleston Oncology ( Site 0042)
Charleston, South Carolina 29414
United States
Status: Recruiting Contact:
Study Coordinator
843-577-6957
Facility: Saint Francis Health System ( Site 0051)
Greenville, South Carolina 29607
United States
Status: Recruiting Contact:
Study Coordinator
864-603-6213
Facility: Blue Ridge Cancer Care ( Site 0033)
Roanoke, Virginia 24014
United States
Status: Recruiting Contact:
Study Coordinator
540-982-0237
Facility: Gallipoli Medical Research Foundation ( Site 0705)
Brisbane, Queensland 4120
Australia
Status: Recruiting Contact:
Study Coordinator
+61733947284
Facility: UZ Leuven ( Site 0205)
Leuven, 3000
Belgium
Status: Recruiting Contact:
Study Coordinator
+3216344218
Facility: Hospital de Caridade de Ijui ( Site 0602)
Ijui, RS 98700-000
Brazil
Status: Recruiting Contact:
Study Coordinator
+555533319393
Facility: Hospital Paulistano - Amil Clinical Research ( Site 0603)
Sao Paulo, SP 01321-001
Brazil
Status: Recruiting Contact:
Study Coordinator
+551130161340
Facility: McGill University Health Centre ( Site 0179)
Montreal, Quebec H4A 3J1
Canada
Status: Recruiting Contact:
Study Coordinator
514934193435721
Facility: Sociedad Oncovida S.A. ( Site 0626)
Santiago, Metropolitan Region 7510032
Chile
Status: Recruiting Contact:
Study Coordinator
+56998634501
Facility: Servicios Medicos Urumed ( Site 0621)
Rancagua, 2852424
Chile
Status: Recruiting Contact:
Study Coordinator
+56989022206
Facility: Fundacion Arturo Lopez Perez FALP ( Site 0623)
Santiago, 7500921
Chile
Status: Recruiting Contact:
Study Coordinator
5698954524
Facility: Pontificia Universidad Catolica de Chile ( Site 0620)
Santiago, 8330024
Chile
Status: Recruiting Contact:
Study Coordinator
+56978073559
Facility: Sociedad de Investigaciones Medicas Limitadas ( Site 0622)
Temuco, 4810469
Chile
Status: Recruiting Contact:
Study Coordinator
5694443272
Facility: CHU de Montpellier - Hopital Saint-Eloi ( Site 0248)
Montpellier, 34295
France
Status: Recruiting Contact:
Study Coordinator
+33467330137
Facility: Krankenhaus Nordwest ( Site 0266)
Frankfurt, 60488
Germany
Status: Recruiting Contact:
Study Coordinator
+496976014187
Facility: Prince of Wales Hospital ( Site 0855)
Hong Kong,
Hong Kong
Status: Recruiting Contact:
Study Coordinator
+85235052166
Facility: Queen Mary Hospital ( Site 0851)
Hong Kong,
Hong Kong
Status: Recruiting Contact:
Study Coordinator
+85222551727
Facility: Rambam Medical Center ( Site 0308)
Haifa, 3109601
Israel
Status: Recruiting Contact:
Study Coordinator
+97247776750
Facility: Hadassah Ein Karem - Sharett Institute of Oncology ( Site 0309)
Jerusalem, 9112001
Israel
Status: Recruiting Contact:
Study Coordinator
+97226776760
Facility: Rabin Medical Center ( Site 0307)
Petah Tikva, 4941492
Israel
Status: Recruiting Contact:
Study Coordinator
+97239378076
Facility: Sourasky Medical Center ( Site 0306)
Tel Aviv, 6423906
Israel
Status: Recruiting Contact:
Study Coordinator
+97236973082
Facility: Aichi Cancer Center Hospital ( Site 0080)
Nagoya, Aichi 464-8681
Japan
Status: Recruiting Contact:
Study Coordinator
+81527626111
Facility: Kanagawa Cancer Center ( Site 0079)
Yokohama, Kanagawa 241-8515
Japan
Status: Recruiting Contact:
Study Coordinator
+81455202222
Facility: Osaka University Hospital ( Site 0085)
Suita, Osaka 565-0871
Japan
Status: Recruiting Contact:
Study Coordinator
+81668795111
Facility: Osaka International Cancer Institute ( Site 0084)
Osaka, 541-8567
Japan
Status: Recruiting Contact:
Study Coordinator
+81669451181
Facility: The Cancer Institute Hospital of JFCR ( Site 0082)
Tokyo, 135-8550
Japan
Status: Recruiting Contact:
Study Coordinator
+81335200111
Facility: Chungnam National University Hospital ( Site 0840)
Daejeon, Chungnam 35015
Korea, Republic of
Status: Recruiting Contact:
Study Coordinator
+82422808369
Facility: CHA Bundang Medical Center CHA University ( Site 0835)
Seongnam, Gyeonggi-do 13496
Korea, Republic of
Status: Recruiting Contact:
Study Coordinator
+82317803928
Facility: Ajou University Hospital, Clinical Research Center ( Site 0838)
Suwon-si, Gyeonnggi-do 16499
Korea, Republic of
Status: Recruiting Contact:
Study Coordinator
+82312195989
Facility: Chonnam National University Hwasun Hospital ( Site 0837)
Hwasun Gun, Jeollanam Do 58128
Korea, Republic of
Status: Recruiting Contact:
Study Coordinator
+82613797622
Facility: Kyungpook National University Chilgok Hospital ( Site 0834)
Daegu, 41404
Korea, Republic of
Status: Recruiting Contact:
Study Coordinator
+82532002623
Facility: Seoul National University Bundang Hospital ( Site 0833)
Seongnam-si, 13605
Korea, Republic of
Status: Recruiting Contact:
Study Coordinator
+82317877053
Facility: Severance Hospital Yonsei University Health System ( Site 0836)
Seoul, 03722
Korea, Republic of
Status: Recruiting Contact:
Study Coordinator
+82222288133
Facility: Asan Medical Center ( Site 0830)
Seoul, 05505
Korea, Republic of
Status: Recruiting Contact:
Study Coordinator
+82230101720
Facility: Samsung Medical Center ( Site 0831)
Seoul, 06351
Korea, Republic of
Status: Recruiting Contact:
Study Coordinator
+82234103459
Facility: The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 0839)
Seoul, 06591
Korea, Republic of
Status: Recruiting Contact:
Study Coordinator
+82222586044
Facility: Korea University Guro Hospital ( Site 0832)
Seoul, 08308
Korea, Republic of
Status: Recruiting Contact:
Study Coordinator
+82226263060
Facility: Hospital Pulau Pinang ( Site 0773)
Georgetown, Pulau Pinang 10990
Malaysia
Status: Recruiting Contact:
Study Coordinator
+60164156926
Facility: Institut Kanser Negara - National Cancer Institute ( Site 0767)
Putrajaya, Wilayah Persekutuan 62250
Malaysia
Status: Recruiting Contact:
Study Coordinator
+60388925555
Facility: Hospital Sultan Ismail ( Site 0772)
Johor Bahru, 81100
Malaysia
Status: Recruiting Contact:
Study Coordinator
+60126128545
Facility: Hospital Kuala Lumpur ( Site 0768)
Kuala Lumpur, 50586
Malaysia
Status: Recruiting Contact:
Study Coordinator
+60126061210
Facility: University Malaya Medical Centre ( Site 0770)
Kuala Lumpur, 59100
Malaysia
Status: Recruiting Contact:
Study Coordinator
+60379492120
Facility: Maastricht University Medical Centre ( Site 0347)
Maastricht, 6229 HX
Netherlands
Status: Recruiting Contact:
Study Coordinator
+0000000000
Facility: Erasmus University Medical Center ( Site 0352)
Rotterdam, 3015 GD
Netherlands
Status: Recruiting Contact:
Study Coordinator
+31107034897
Facility: Hospital Universitario General de Asturias ( Site 0434)
Oviedo, Asturias 33011
Spain
Status: Recruiting Contact:
Study Coordinator
+34985106100Ext36281
Facility: Hospital General Universitari Vall d Hebron ( Site 0432)
Barcelona, 08035
Spain
Status: Recruiting Contact:
Study Coordinator
+34934894158
Facility: Hospital General Universitario Gregorio Maranon ( Site 0433)
Madrid, 28009
Spain
Status: Recruiting Contact:
Study Coordinator
+34914269393
Facility: Hospital Universitario HM Sanchinarro ( Site 0435)
Madrid, 28050
Spain
Status: Recruiting Contact:
Study Coordinator
+34917567825
Facility: Hospital Regional Universitario Carlos Haya ( Site 0431)
Malaga, 29010
Spain
Status: Recruiting Contact:
Study Coordinator
+34951291425
Facility: China Medical University Hospital ( Site 0862)
Taichung, 40447
Taiwan
Status: Recruiting Contact:
Study Coordinator
886422052121#5057
Facility: National Cheng Kung University Hospital ( Site 0864)
Tainan, 704
Taiwan
Status: Recruiting Contact:
Study Coordinator
+886623535354559
Facility: Taipei Veterans General Hospital ( Site 0861)
Taipei,, 112
Taiwan
Status: Recruiting Contact:
Study Coordinator
+886228712121
Facility: National Taiwan University Hospital ( Site 0860)
Taipei, 10048
Taiwan
Status: Recruiting Contact:
Study Coordinator
+886223123456
Facility: Koo Foundation Sun Yat-Sen Cancer Center ( Site 0863)
Taipei, 112
Taiwan
Status: Recruiting Contact:
Study Coordinator
886935303335
Facility: Chang Gung Medical Foundation. Linkou ( Site 0853)
Taoyuan, 333
Taiwan
Status: Recruiting Contact:
Study Coordinator
+886332812008825
Facility: Baskent University Adana Training Hospital ( Site 0499)
Adana, 01250
Turkey
Status: Recruiting Contact:
Study Coordinator
+905353067506
Facility: Hacettepe University Faculty of Medicine ( Site 0498)
Ankara, 06100
Turkey
Status: Recruiting Contact:
Study Coordinator
+903123052910
Facility: Abdurrahman Yurtaslan Onkoloji Hastanesi ( Site 0494)
Ankara, 06200
Turkey
Status: Recruiting Contact:
Study Coordinator
+905055718475
Facility: Gazi Universitesi Tip Fakultesi ( Site 0496)
Ankara, 06500
Turkey
Status: Recruiting Contact:
Study Coordinator
+905055873568
Facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0506)
Istanbul, 34098
Turkey
Status: Recruiting Contact:
Study Coordinator
+905324167355
Facility: Istanbul Medeniyet Universitesi Goztepe EAH ( Site 0495)
Istanbul, 34732
Turkey
Status: Recruiting Contact:
Study Coordinator
+905063509061
Facility: Izmir Medical Park Hospital Department of Medical Oncology ( Site 0502)
Izmir, 35520
Turkey
Status: Recruiting Contact:
Study Coordinator
+905052642353
Facility: Erciyes Universitesi Tip Fakultesi ( Site 0500)
Kayseri, 38039
Turkey
Status: Recruiting Contact:
Study Coordinator
+905053883441
Facility: Inonu Universitesi Medical Fakultesi ( Site 0501)
Malatya, 44280
Turkey
Status: Recruiting Contact:
Study Coordinator
+905385003562