NCT02494583

Study of Pembrolizumab (MK-3475) as First-Line Monotherapy and Combination Therapy for Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (MK-3475-062/KEYNOTE-062)

A Randomized, Active-Controlled, Partially Blinded, Biomarker Select, Phase III Clinical Trial of Pembrolizumab as Monotherapy and in Combination With Cisplatin+5-Fluorouracil Versus Placebo+Cisplatin+5-Fluorouracil as First-Line Treatment in Subjects With Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 763 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a study of pembrolizumab (MK-3475) as first-line treatment for participants with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. Participants whose tumors express programmed death-ligand 1 (PD-L1) will be randomly assigned to one of the three treatment arms of the study: pembrolizumab as monotherapy \[pembro mono\], pembrolizumab plus standard of care (SOC) chemotherapy with cisplatin plus 5-fluorouracil (5-FU) or capecitabine \[pembro combo\], or placebo plus SOC chemotherapy with cisplatin plus 5-fluorouracil (5-FU) or capecitabine \[SOC\]. The primary study hypotheses are that pembrolizumab in combination with SOC chemotherapy is superior to SOC chemotherapy alone in terms of Progression-free Survival (PFS) and Overall Survival (OS) in participants with PD-L1 Combined Positive Score (CPS) ≥1, pembrolizumab in combination with SOC chemotherapy is superior to SOC chemotherapy alone in terms of OS in participants with PD-L1 CPS ≥10, pembrolizumab monotherapy is non-inferior to SOC chemotherapy alone in terms of OS in participants with PD-L1 CPS ≥1, and pembrolizumab monotherapy is superior to SOC chemotherapy alone in terms of OS in participants with PD-L1 CPS ≥1 and in participants with PD-L1 CPS ≥10.

Detailed description

As specified by the protocol, primary and secondary efficacy analyses will be evaluated in gastric cancer participants with PD-L1 CPS ≥1 (all participants) and PD-L1 CPS ≥10 (OS) by comparing the pembro mono arm or pembro combo arm separately to the SOC arm.

Conditions

• Gastric Adenocarcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Pembrolizumab	Pembrolizumab 200 mg IV on Day 1 of each week in 3-week cycles for up to 35 cycles (approximately 2 years).
DRUG	Cisplatin	Cisplatin 80 mg/m\^2 IV on Day 1 of each week in 3-week cycles (6 cycle maximum per local country guidelines).
DRUG	5-FU	5-FU 800 mg/m\^2/day IV continuous from Day 1-5 of each 3-week cycle.
DRUG	Capecitabine	Capecitabine 1000 mg/m\^2 twice daily by oral tablet on Day 1-14 of each 3-week cycle.
DRUG	Placebo	Normal saline IV on Day 1 of each week in 3-week cycles for up to 35 cycles (approximately 2 years).

Timeline

• Start date: 2015-07-31
• Primary completion: 2019-03-26
• Completion: 2022-06-06
• First posted: 2015-07-10
• Last updated: 2023-04-13
• Results posted: 2020-03-13

Regulatory

• FDA-regulated drug study