A Phase 1/2 Study of Ramucirumab Plus Nivolumab in Participants With Gastric or GEJ Cancer
Phase 1
Completed
- Conditions
- Gastric CancerGastroesophageal Junction Region (GEJ) Cancer
- Interventions
- Biological: RamucirumabBiological: Nivolumab
- Registration Number
- NCT02999295
- Lead Sponsor
- National Cancer Center, Japan
- Brief Summary
The main purpose of this study is to evaluate the safety and efficacy of the combination therapy of ramucirumab and nivolumab in participants with advanced or recurrent unresectable gastric or GEJ cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 46
Inclusion Criteria
- Advanced or recurrent unresectable gastric or GEJ cancer
- Histologically confirmed adenocarcinoma (papillary adenocarcinoma, tubular adenocarcinoma or poorly differentiated adenocarcinoma), signet-ring cell carcinoma, mucinous adenocarcinoma or hepatoid adnocarcinoma
- Patients with normal oral intake
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Patients who have measurable target lesion
- Patients has a refractory or intolerant pretreatment by pyrimidine fluoride anticancer agent and platinum-based anticancer agent
- Patients with adequate organ function
- Patients with no pretreatment history including ramucirumab, nivolumab or other therapies targeting control of T cells
- Patients with written informed consent
Exclusion Criteria
- Patients have double cancer
- Patients have infection required systemic therapy
- Known central vervous 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
- PARALLEL
- Arm && Interventions
Group Intervention Description Phase 1 Nivolumab Ramucirumab: 8 mg/kg, every two week Nivolumab: 3.0 mg/kg or 1.0 mg/kg (optional), every two weeks Phase 1 Ramucirumab Ramucirumab: 8 mg/kg, every two week Nivolumab: 3.0 mg/kg or 1.0 mg/kg (optional), every two weeks Phase 2 Ramucirumab Ramucirumab: 8 mg/kg, every two week Nivolumab: recommended dose established in the phase 1, every two weeks Phase 2 Nivolumab Ramucirumab: 8 mg/kg, every two week Nivolumab: recommended dose established in the phase 1, every two weeks
- Primary Outcome Measures
Name Time Method Number of participants with dose limiting toxicities (DLTs) Phase 1, course 1 (up to 28 days) Number of participants with dose limiting toxicities (DLTs)
Progression free survival rate after 6 months from baseline to 6 months Progression free survival rate after 6 months
- Secondary Outcome Measures
Name Time Method Objective response rate (ORR) from baseline to date of disease progression, approximately 24 months percentage of participants with with a best response of complete response (CR) or partial response (PR)
Number of participants with adverse events from baseline to date of treatment cessation, approximately 24 months Number of participants with adverse events
Overall survival (OS) from baseline to date of death, approximately 24 months Overall survival (OS)
Progression free survival (PFS) from baseline to date of disease progression or death, approximately 24 months Progression free survival (PFS)
Disease control rate (DCR) from baseline to date of disease progression, approximately 24 months percentage of participants with with a best response of CR, PR or stable disease (SD)
Trial Locations
- Locations (1)
National Cancer Center Hospital
🇯🇵Tokyo, Japan