Efficacy and Safety Study of Pembrolizumab (MK-3475) Versus Paclitaxel in Asian Participants With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Who Progressed After First-line Therapy With Platinum and Fluoropyrimidine (MK-3475-063/KEYNOTE-063)
Summary
The study will compare the efficacy and safety of treatment with pembrolizumab (MK-3475) versus paclitaxel in Asian, programmed death-ligand 1 (PD-L1) positive participants with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma who have progressed after failure of any combination chemotherapy containing a platinum and a fluoropyrimidine agent. The primary study hypotheses are that pembrolizumab prolongs Overall Survival (OS) compared to paclitaxel and that pembrolizumab prolongs Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) assessed by blinded central radiologists' review compared to paclitaxel.
Timeline
- Start
- 2017-02-16
- Primary completion
- 2021-06-29
- Completion
- 2021-06-29
Outcome
Missed primary endpoint
Stopped (Business): “Business Reasons”
registry analysis (superiority test); Pembrolizumab 200 mg vs Paclitaxel 80 mg/m^2; p = 0.2900; Hazard Ratio (HR) 0.89 (95% CI 0.58 to 1.36); Log Rank NCT03019588 ↗
registry analysis (superiority test); Pembrolizumab 200 mg vs Paclitaxel 80 mg/m^2; p = 0.9954; Hazard Ratio (HR) 1.77 (95% CI 1.14 to 2.74); Log Rank NCT03019588 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Paclitaxel | Small molecule | 80 mg/m2 | Intravenous |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |