NCT02494583View on ClinicalTrials.gov

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)

PHASE3CompletedINTERVENTIONAL
Enrollment

763

Participants

Timeline

Start Date

July 31, 2015

Primary Completion Date

March 26, 2019

Study Completion Date

June 6, 2022

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).

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

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) | Biotech Hunter | Biotech Hunter