At a glance
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Phase II Study of Pembrolizumab Plus Ramucirumab in Metastatic Gastric or GEJ Adenocarcinoma as Salvage Treatment
In Brief
A Phase 2 clinical trial evaluating pembrolizumab plus ramucirumab for Gastric Cancer. Completed, enrolled 26 participants across 2 sites.
Signals
Detailed 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.
Study Details
Timeline
Arms & Interventions
* 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
Interventions
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.