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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)

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
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE January 7, 2015
First Posted Date  ICMJE January 9, 2015
Last Update Posted Date May 21, 2020
Actual Study Start Date  ICMJE February 3, 2015
Estimated Primary Completion Date July 23, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 10, 2015)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 7, 2015)
  • 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 ]
  • Overall Response Rate (ORR) [ Time Frame: Up to 36 months ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Pembrolizumab (MK-3475) in Participants With Recurrent or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (MK-3475-059/KEYNOTE-059)
Official Title  ICMJE 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)
Brief Summary 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).
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Gastric Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma
Intervention  ICMJE
  • 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®
Study Arms  ICMJE
  • 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
    Intervention: Biological: pembrolizumab
  • 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
    Interventions:
    • Biological: pembrolizumab
    • Drug: cisplatin
    • Drug: 5-FU
    • Drug: capecitabine
  • 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
    Intervention: Biological: pembrolizumab
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 21, 2020)
315
Original Estimated Enrollment  ICMJE
 (submitted: January 7, 2015)
270
Estimated Study Completion Date  ICMJE July 23, 2021
Estimated Primary Completion Date July 23, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Australia,   Canada,   Chile,   Colombia,   Estonia,   France,   Israel,   Italy,   Japan,   Korea, Republic of,   Lithuania,   Peru,   Portugal,   Romania,   Russian Federation,   United Kingdom,   United States
 
Administrative Information
NCT Number  ICMJE NCT02335411
Other Study ID Numbers  ICMJE 3475-059
2014-003574-16 ( EudraCT Number )
MK-3475-059 ( Other Identifier: Merck )
KEYNOTE-059 ( Other Identifier: Merck )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP