Pembrolizumab Plus Ramucirumab in Metastatic Gastric Cancer

Summary

1. Objective 1) Primary Objective: To estimate preliminary overall response rate (ORR) of combination therapy of Ramucirumab and Pembrolizumab in patients with metastatic gastric or GEJ adenocarcinoma 2)Secondary Objectives: To assess secondary measures of clinical efficacy * Best Overall Response Rate: BORR * Disease Control Rate: DCR * Progression-Free Survival:PFS * Overall Survival: OS * Duration of Overall Response: DOR \& maximal tumor shrinkage 2. Subjects : Patients with metastatic gastric or GEJ adenocarcinoma 3. Study design(Dosage \& Treatment) Patients will continue to receive study treatment, until they demonstrate objective disease progression (determined by modified RECIST 1.1) or until they meet any other discontinuation criteria. * Ramucirumab 8mg/kg on q2W * Pembrolizumab 200mg on q3W (pembrolizumab first followed by ramucirumab when concurrently administered on the same day) * If ramucirumab had to be stopped due to intolerable toxicity, pembrolizumab will be continued until unacceptable toxicity, disease progression or upto 35 cycles.

Timeline

Start

2021-06-16

Primary completion

2025-01-09

Completion

2025-01-15

Drugs

Indications