Pembrolizumab/Placebo Plus Trastuzumab Plus Chemotherapy in Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-811/KEYNOTE-811)

Part of paid clinical trials in Los Angeles, California.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT03615326
Phase
PHASE3
Status
Completed

Conditions

  • Gastric Neoplasms
  • Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — BIOLOGICAL
    200 mg on Day 1 of each 3-week cycle as an IV infusion.
  • Placebo — BIOLOGICAL
    Solution for IV infusion on Day 1 of each 3-week cycle.
  • Cisplatin — DRUG
    80 mg/m\^2 on Day 1 of each 3-week cycle as an IV infusion, administered as part of FP chemotherapy regimen.
  • 5-FU — DRUG
    800 mg/m\^2/day continuous on Days 1-5 of each 3-week cycle (120 hours or per local standard), administered as part of FP chemotherapy regimen.
  • Oxaliplatin — DRUG
    130 mg/m\^2 on Day 1 of each 3-week cycle over 2 hours as an IV infusion, administered as part of CAPOX chemotherapy regimen and as part of SOX chemotherapy regimen.
  • Capecitabine — DRUG
    1000 mg/m\^2 as oral capsules BID on Days 1-14 of each 3-week cycle, administered as part of CAPOX chemotherapy regimen.
  • S-1 — DRUG
    Combination product of tegafur, CDHP, and Oxo. Oral capsules BID on Days 1-14 of each 3-week cycle based on body surface area (BSA): \<1.25 m\^2 BSA =40 mg, 1.25 to \<1.5 m\^2 BSA=50 mg, ≥1.5 m\^2 BSA=60 mg. Administered as part of SOX chemotherapy regimen.
  • Trastuzumab — BIOLOGICAL
    8 mg/kg loading dose and then 6 mg/kg maintenance dose administered IV on day 1 of each 3-week cycle.

Study Details

The study will compare the efficacy and safety of pembrolizumab plus trastuzumab in combination with standard of care (SOC) chemotherapy versus trastuzumab in combination with SOC chemotherapy in participants with HER2-positive gastric cancer. The primary hypotheses of the study are that pembrolizumab plus trastuzumab in combination with chemotherapy is superior to trastuzumab plus chemotherapy in terms of 1) progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR), and 2) overall survival (OS).

Key Dates

Start date
Oct 5, 2018
Status verified
Nov 2025
Primary completion
Mar 20, 2024
Completion
Nov 12, 2025

Study Design

Enrollment
738 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Global Pembrolizumab + Standard of Care First Course
    Participants received 200 mg pembrolizumab IV every 3 weeks (Q3W) plus trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance thereafter) IV Q3W in combination with investigator's choice of FP or CAPOX chemotherapy.
  • Active Comparator: Global Standard of Care
    Participants received matched placebo to pembrolizumab IV Q3W plus trastuzumab (8mg/kg loading dose, 6mg/kg maintenance thereafter) IV Q3W in combination with investigator's choice of FP or CAPOX chemotherapy.
  • Experimental: Japan Pembrolizumab + Trastuzumab + S-1 Plus Oxaliplatin
    Participants received 200 mg pembrolizumab IV every 3 weeks (Q3W) plus trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance thereafter) IV Q3W in combination with SOX chemotherapy.
  • Experimental: Japan Trastuzumab + S-1 Plus Oxaliplatin
    Participants received matched placebo to pembrolizumab IV Q3W plus trastuzumab (8mg/kg loading dose, 6mg/kg maintenance thereafter) IV Q3W in combination with SOX chemotherapy.

Primary Outcome Measure

Progression Free Survival (PFS) Per RECIST 1.1 Assessed by BICR [ Time Frame: Up to 46 months ]

Locations (23)

FacilityCityStateZIPSite coordinators
UCLA Hematology/Oncology - Westwood (Building 200 Suite 120) ( Site 0045)Los AngelesCalifornia90095-
Pacific Cancer Care ( Site 0063)MontereyCalifornia93940-
UC Irvine Medical Center/Chao Family Comprehensive Cancer Center ( Site 0050)OrangeCalifornia92868-
University of Miami Sylvester Comprehensive Cancer Center - Plantation ( Site 0026)MiamiFlorida33136-
Southeastern Regional Medical Center, Inc. ( Site 0058)NewnanGeorgia30265-
Midwestern Regional Medical Center, Inc. ( Site 0059)ZionIllinois60099-
Beth Israel Deaconess Medical Center ( Site 0070)BostonMassachusetts02215-
Dana-Farber Cancer Institute [Boston, MA] ( Site 0010)BostonMassachusetts02215-
Minnesota Oncology Hematology, PA ( Site 8001)MinneapolisMinnesota55404-
Washington University School of Medicine ( Site 0040)St LouisMissouri63110-
Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0071)MiddletownNew Jersey07748-
Memorial Sloan-Kettering Cancer Center at West Harrison ( Site 0065)HarrisonNew York10604-
Memorial Sloan-Kettering Cancer Center ( Site 0017)New YorkNew York10065-
University of Rochester ( Site 0041)RochesterNew York14642-
Levine Cancer Institute ( Site 0015)CharlotteNorth Carolina28204-
Duke Cancer Institute ( Site 0042)DurhamNorth Carolina27710-
CTCA Southwestern ( Site 0060)TulsaOklahoma74133-
Cancer Treatment Centers of America-Eastern Regional Medical Center ( Site 0025)PhiladelphiaPennsylvania19124-
Allegheny General Hospital ( Site 0053)PittsburghPennsylvania15212-
Sanford Hematology Oncology-Sioux Falls SD ( Site 0004)Sioux FallsSouth Dakota57104-
University of Texas MD Anderson Cancer Center ( Site 0001)HoustonTexas77030-
Oncology & Hematology Assoc. SW Virginia, Inc., DBA Blue Ridge Cancer Care ( Site 8000)RoanokeVirginia24014-
Seattle Cancer Care Alliance ( Site 0038)SeattleWashington98109-

Related coverage on Hipa.ai

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By research site
UCLA Hematology/Oncology - Westwood (Building 200 Suite 120)· Los Angeles, CAPacific Cancer Care· Monterey, CAUC Irvine Medical Center/Chao Family Comprehensive Cancer Center· Orange, CAUniversity of Miami Sylvester Comprehensive Cancer Center - Plantation· Miami, FLSoutheastern Regional Medical Center, Inc.· Newnan, GAMidwestern Regional Medical Center, Inc.· Zion, IL

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