At a glance
ClinicalIndex Comparison Record- ✓Previously untreated localized gastric or GEJ adenocarcinoma defined by T3 or greater primary lesion or presence of any positive nodes (N+) without metastatic disease
- ✓Plans to proceed to surgery following pre-operative chemotherapy based on standard staging studies
- ✓Willing to provide tumor tissue at baseline and at time of surgery
- ✓ECOG performance status 0-1
- ✕History of non-infectious pneumonitis requiring steroids or current pneumonitis
- ✕Active infection requiring systemic therapy
- ✕Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2 agents or other T-cell co-inhibitory agents (CTLA-4, OX-40, CD137) or prior MSD pembrolizumab studies
- ✕Prior systemic anti-cancer therapy for current malignancy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Randomized, Double-Blind, Clinical Trial of Pembrolizumab (MK-3475) Plus Chemotherapy (XP or FP) Versus Placebo Plus Chemotherapy (XP or FP) as Neoadjuvant/Adjuvant Treatment for Subjects With Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma (KEYNOTE-585)
In Brief
A Phase 3 clinical trial evaluating Pembrolizumab, Placebo, and 6 other interventions for Gastric Cancer and Gastroesophageal Junction Cancer. Completed, enrolled 1,007 participants across 171 sites in 24 countries.
Detailed Summary
The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in the neoadjuvant (prior to surgery) or adjuvant (after surgery) treatment of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma. The primary study hypotheses are that: * Neoadjuvant and adjuvant pembrolizumab plus chemotherapy, followed by adjuvant pembrolizumab is superior to neoadjuvant and adjuvant placebo plus chemotherapy, followed by adjuvant placebo in terms of Event-free Survival (EFS) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), and * Neoadjuvant pembrolizumab plus chemotherapy is superior to neoadjuvant placebo plus chemotherapy in terms of rate of Pathological Complete Response (pathCR) at the time of surgery. With Amendment 10, upon study completion, participants will be discontinued and may be enrolled in an extension study.
Study Details
Timeline
Interventions
IV infusion
IV infusion
IV infusion
Oral tablets
IV infusion
IV infusion
IV infusion
IV infusion