Gastric Cancer, Gastroesophageal Junction Region (GEJ) Cancer
Conditions
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.
Interventions
BIOLOGICALRamucirumab
Ramucirumab (8 mg/kg) is administered.
BIOLOGICALNivolumab
Nivolumab (3.0 mg/kg or 1.0 mg/kg) is administered.
Sponsors
Ono Pharmaceutical Co. Ltd
Fiverings Co., Ltd.
National Cancer Center, Japan
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Number of participants with adverse events | from baseline to date of treatment cessation, approximately 24 months | Number of participants with adverse events |
| Progression free survival (PFS) | from baseline to date of disease progression or death, approximately 24 months | Progression free survival (PFS) |
| Overall survival (OS) | from baseline to date of death, approximately 24 months | Overall survival (OS) |
| 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) |
Countries
Japan
Outcome results
None listed