Trials / Withdrawn
WithdrawnNCT04859582
Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859/KEYNOTE-859)-China Extension
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)
- Status
- Withdrawn
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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 Chinese participants. The primary hypotheses of this study are that pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy in terms of overall survival (OS).
Detailed description
The China extension study will include participants previously enrolled in China in the global study for MK-3475-859 (NCT03675737) plus those enrolled during the China extension enrollment period. A total of approximately 231 Chinese participants will be enrolled.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | 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 |
Timeline
- Start date
- 2018-11-08
- Primary completion
- 2024-11-29
- Completion
- 2024-11-29
- First posted
- 2021-04-26
- Last updated
- 2021-12-16
Locations
28 sites across 1 country: China
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04859582. Inclusion in this directory is not an endorsement.