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).
Additional locations may be listed on ClinicalTrials.gov for NCT03615326.
Locations matching your search criteria
United States
North Carolina
Durham
Duke University Medical CenterStatus: Active
Name Not Available
Pembrolizumab (200 mg) or placebo will be administered intravenously [IV] on day 1 of
each 3-week cycle. Trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance dose) will be
administered IV on day 1 of each 3-week cycle. SOC chemotherapy for the global cohort
will either be FP (80 mg/m^2 cisplatin administered IV on Day 1 of each 3-week cycle and
800 mg/m^2 5-fluorouracil [5-FU] administered IV on Days 1-5 of each 3-week cycle) or
CAPOX (1000 mg/m^2 capecitabine administered orally twice daily [BID] on days 1-14 of
each 3-week cycle and 130 mg/m^2 oxaliplatin administered IV on Day 1 of each 3-week
cycle). A Japan cohort will receive SOX chemotherapy consisting of S-1 (tegafur,
5-chloro-2,4-dihydroxypyridine [CDHP], and potassium oxonate [Oxo]) administered orally
BID according to Body Surface Area (BSA) on Days 1-14 of each 3-week cycle and
oxaliplatin (130 mg/m^2) administered IV on Day 1 each 3-week cycle.
Lead OrganizationMerck Sharp and Dohme LLC