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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)

NCT02494583 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 763

Last updated 2023-04-13

Study results available
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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.

Conditions

  • Gastric Adenocarcinoma

Interventions

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).

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2019-03-26
Completion
2022-06-06
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02494583 on ClinicalTrials.gov