A Study of Pembrolizumab (MK-3475) in Participants With Recurrent or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (MK-3475-059/KEYNOTE-059)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02335411 |
Recruitment Status :
Active, not recruiting
First Posted : January 9, 2015
Last Update Posted : May 21, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gastric Adenocarcinoma Gastroesophageal Junction Adenocarcinoma | Biological: pembrolizumab Drug: cisplatin Drug: 5-FU Drug: capecitabine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 315 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II Clinical Trial of Pembrolizumab as Monotherapy and in Combination With Cisplatin+5-Fluorouracil in Subjects With Recurrent or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (KEYNOTE-059) |
Actual Study Start Date : | February 3, 2015 |
Estimated Primary Completion Date : | July 23, 2021 |
Estimated Study Completion Date : | July 23, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Cohort 1: Pembro monotherapy, previously treated
Participants receive pembrolizumab (Pembro) 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for up to 24 months
|
Biological: pembrolizumab
IV infusion
Other Name: MK-3475 |
Experimental: Cohort 2: Pembro combination therapy, treatment naive
Participants receive pembrolizumab 200 mg IV Q3W for up to 24 months + cisplatin 80 mg/m^2 IV Q3W for up to 6 cycles + 5-FU 800 mg/m^2 IV on Days 1-5 every 3 weeks or (Japan only) capecitabine 1000 mg/m^2 orally, twice per day (BID) on Days 1-14 of each 3-week cycle
|
Biological: pembrolizumab
IV infusion
Other Name: MK-3475 Drug: cisplatin IV infusion
Other Name: PLATINOL® Drug: 5-FU IV infusion
Other Name: ADRUCIL® Drug: capecitabine oral tablets
Other Name: XELODA® |
Experimental: Cohort 3: Pembro monotherapy, treatment naive
Participants receive pembrolizumab 200 mg IV on Day 1 of each 3-week cycle (Q3W) for up to 24 months
|
Biological: pembrolizumab
IV infusion
Other Name: MK-3475 |
- Number of Participants Experiencing Adverse Events (AEs) [ Time Frame: Up to 25 months ]
- Number of Participants Discontinuing Study Drug Due to AEs [ Time Frame: Up to 24 months ]
- Objective Response Rate (ORR) [ Time Frame: Up to 36 months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02335411
Study Director: | Medical Director | Merck Sharp & Dohme Corp. |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Merck Sharp & Dohme Corp. |
ClinicalTrials.gov Identifier: | NCT02335411 |
Other Study ID Numbers: |
3475-059 2014-003574-16 ( EudraCT Number ) MK-3475-059 ( Other Identifier: Merck ) KEYNOTE-059 ( Other Identifier: Merck ) |
First Posted: | January 9, 2015 Key Record Dates |
Last Update Posted: | May 21, 2020 |
Last Verified: | May 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf |
URL: | http://engagezone.msd.com/ds_documentation.php |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Gastric cancer Gastroesophageal junction cancer PD1 |
PD-1 PDL1 PD-L1 |
Adenocarcinoma Esophageal Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Head and Neck Neoplasms |
Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Capecitabine Pembrolizumab Antineoplastic Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Immunological |