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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Ramucirumab (8 mg/kg) is administered.
Nivolumab (3.0 mg/kg or 1.0 mg/kg) is administered.
National Cancer Center Hospital
Tokyo, Japan
Number of participants with dose limiting toxicities (DLTs)
Number of participants with dose limiting toxicities (DLTs)
Time frame: Phase 1, course 1 (up to 28 days)
Progression free survival rate after 6 months
Progression free survival rate after 6 months
Time frame: from baseline to 6 months
Number of participants with adverse events
Number of participants with adverse events
Time frame: from baseline to date of treatment cessation, approximately 24 months
Objective response rate (ORR)
percentage of participants with with a best response of complete response (CR) or partial response (PR)
Time frame: from baseline to date of disease progression, approximately 24 months
Disease control rate (DCR)
percentage of participants with with a best response of CR, PR or stable disease (SD)
Time frame: from baseline to date of disease progression, approximately 24 months
Overall survival (OS)
Overall survival (OS)
Time frame: from baseline to date of death, approximately 24 months
Progression free survival (PFS)
Progression free survival (PFS)
Time frame: from baseline to date of disease progression or death, approximately 24 months
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