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A Study of Pembrolizumab (MK-3475) in Participants With Recurrent or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (MK-3475-059 / KEYNOTE-059)

Trial Status: Closed to Accrual

This is a study of pembrolizumab (MK-3475) for advanced gastric or gastroesophageal junction adenocarcinoma; pembrolizumab will be given as monotherapy to participants who have had previous treatment or who are treatment-naïve; pembrolizumab will also be evaluated as combination therapy with cisplatin and 5-Fluorouracil (5-FU) or (Japan only) capecitabine in treatment-naïve participants. The primary study hypothesis is that pembrolizumab will provide a clinically meaningful Overall Response Rate (ORR).

Inclusion Criteria

  • Inclusion Criteria - Cohort 1: - Received and progressed on ≥2 prior chemotherapy regimens for their advanced disease; prior regimen must have included a cisplatin and a fluoropyridine - Human epidermal growth factor receptor 2 (HER-2/neu) negative, or, if HER2/neu positive, must have previously received treatment with trastuzumab Inclusion Criteria - Cohort 2 or 3: - HER2/neu negative - Has not received prior systemic anti-cancer therapy for their advanced carcinoma (systemic therapy received in the neoadjuvant and adjuvant setting does not count) Inclusion Criteria - All Participants: - Histologically- or cytologically-confirmed recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma that is considered incurable by local therapies - Willing to provide tissue for PD-L1 biomarker analysis from newly-obtained and/or archival tissue - Measurable disease based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 3 days prior to first dose of study drug - Life expectancy of >=3 months - Female participants of childbearing potential should have a negative pregnancy test and be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study drug (180 days for participants receiving cisplatin + 5FU) - Male participants should agree to use an adequate method of contraception starting with the first dose through 120 days after the last dose of study drug (180 days for participants receiving cisplatin + 5FU) - Adequate organ function Exclusion Criteria - All Participants: - Currently participating and receiving study therapy or participated in a study of an investigational agent and received study therapy or used an investigation device within 4 weeks of the first dose of study drug - Active autoimmune disease that has required systemic treatment in past 2 years - Immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug - Weight loss >10% over 2 months prior to first dose of study drug - Clinical evidence of ascites by physical exam - Prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or not recovered from AEs due to agents administered more than 4 weeks earlier - Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered from AEs due to a previously administered agent - Known additional malignancy that is progressing or requires active treatment excepting basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer - Known active central nervous system (CNS) metastases and/or carcinomatous meningitis - Known history of, or any evidence of active, non-infectious pneumonitis - Active infection requiring systemic therapy - Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study - Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study drug (180 days for participants receiving cisplatin + 5FU) - Prior therapy with an anti-programmed death-1 (PD-1), anti-PD-L1, or anti-PD-L2 agent - Human immunodeficiency virus (HIV) - Hepatitis B or C - Received live vaccine within 30 days of planned start of study drug

Arizona

Scottsdale
Mayo Clinic in Arizona
Status: CLOSED_TO_ACCRUAL

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Dorreth King-Rucker
Phone: 310-794-5782
San Francisco
UCSF Medical Center-Mount Zion
Status: CLOSED_TO_ACCRUAL

Illinois

Chicago
University of Chicago Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL

Indiana

Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Susan Hunter
Phone: 317-278-5614

Massachusetts

Boston
Dana-Farber Cancer Institute
Status: CLOSED_TO_ACCRUAL
Massachusetts General Hospital Cancer Center
Status: COMPLETED

Michigan

Detroit
Wayne State University / Karmanos Cancer Institute
Status: ADMINISTRATIVELY_COMPLETE

Minnesota

Rochester
Mayo Clinic in Rochester
Status: CLOSED_TO_ACCRUAL

New York

New York
Memorial Sloan Kettering Cancer Center
Status: CLOSED_TO_ACCRUAL
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: COMPLETED

North Carolina

Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL

Pennsylvania

Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: CLOSED_TO_ACCRUAL

Texas

Houston
M D Anderson Cancer Center
Status: WITHDRAWN

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION

Wisconsin

Madison
University of Wisconsin Hospital and Clinics
Status: CLOSED_TO_ACCRUAL

This study will have 3 cohorts. Cohorts 1 and 2 will run simultaneously; Cohort 3 will start when biomarker assay validation is complete. In Cohort 1, participants who have received at least two prior therapies for their advanced disease will receive monotherapy with pembrolizumab. In Cohort 2, participants who have not received any previous therapy for their disease will receive pembrolizumab in combination with cisplatin and 5-FU or (Japan only) capecitabine. In Cohort 3, participants who have not received any previous therapy and who have programmed death ligand 1 (PD-L1)-positive tumors will receive pembrolizumab monotherapy.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Merck and Company Inc

  • Primary ID 3475-059
  • Secondary IDs NCI-2015-00402, KEYNOTE-059, MK-3475-059, 2014-003574-16
  • Clinicaltrials.gov ID NCT02335411