Clinical Trial

Gastric/Gastroesophageal Junction Adenocarcinoma

Study Description

Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859/KEYNOTE-859)

The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in combination with chemotherapy (Cisplatin combined with 5-Fluorouracil [FP regimen] or oxaliplatin combined with capecitabine [CAPOX regimen]) versus placebo in combination with chemotherapy (FP or CAPOX regimens) in the treatment of human epidermal growth factor receptor 2 (HER2) negative advanced gastric or GEJ adenocarcinoma in adult participants. The primary hypotheses of this study are that pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy in terms of overall survival (OS), and progression-free survival (PFS).

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Recruiting patients only Recruiting patients only

Drug - Pembrolizumab

Administered as an IV infusion on Day 1 Q3W

Drug - Cisplatin

Administered as an IV infusion on Day 1 Q3W

Drug - 5-fluorouracil

Administered as a continuous IV infusion on Days 1-5 Q3W

Drug - oxaliplatin

Administered as an IV infusion on Day 1 Q3W

Drug - capecitabine

Administered orally BID on Days 1 to 14 Q3W

Drug - Placebo for Pembrolizumab

Administered as an IV infusion on Day 1 Q3W

Additional Information

Official Study Title

A Phase 3, Randomized, Double-blind Clinical Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy as First-line Treatment in Participants With HER2 Negative, Previously Untreated, Unresectable or Metastatic Gastric Orgastroesophageal Junction Adenocarcinoma (KEYNOTE-859)

Clinical Trial ID

NCT03675737

ParticipAid ID

e0R8Kb