A multicenter, phase 1/2 study of Ramucirumab plus Nivolumab as second-line therapy in participants with gastric or GEJ cancer
- Conditions
- Advanced or recurrent unresectable gastric or GEJ cancer
- Registration Number
- JPRN-UMIN000025560
- Lead Sponsor
- Department of Head and Neck Oncology, National Cancer Center Japan Hospital
- Brief Summary
46 advanced gastric cancer patients (median age 66 years) were enrolled. No dose limiting toxicities were observed in the phase 1 part. With median follow up time of 10.2 month, 6-month progression free survival rate was 37.4% (90% confidential intervals: 25.7-49.2%), which met the primary endpoint of the phase 2 part. objective responce rate/disease responce rate were 26.7%/62.2%. Median progression free survival/overall survival were 2.9/9.0 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 46
Not provided
- Patients have double cancer - Patients have infection required systemic therapy - Known central nervous system (CNS) metastasis - Patients with history of pneumonitis or pulmonary fibrosis - Patients with history of serious anaphylaxis induced by antibody preparation - Patients who have known active autoimmune disease or history of chronic recurrent autoimmune disease - Female who is pregnant, lactating or suspected pregnancy - Patients with psychosis or dementia to interfere to obtain informed consent appropriately
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase 1 Number of participants with dose limiting toxicities (DLTs) for 28 days from first administration Phase 2 Progression free survival rate after 6 months
- Secondary Outcome Measures
Name Time Method Phase 1 Number of participants with adverse events Phase 2 Overall response rate (ORR) Disease control rate (DCR) Progression-free survival (PFS) Overall survival (OS) Number of participants with adverse events