Pembrolizumab Plus Ramucirumab in Metastatic Gastric Cancer
Status:
Not yet recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
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.