Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ono Pharmaceutical Co., Ltd. | INDUSTRY |
| Fiverings Co., Ltd. | OTHER |
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1 | Experimental | Ramucirumab: 8 mg/kg, every two week Nivolumab: 3.0 mg/kg or 1.0 mg/kg (optional), every two weeks |
|
| Phase 2 | Experimental | Ramucirumab: 8 mg/kg, every two week Nivolumab: recommended dose established in the phase 1, every two weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ramucirumab | Biological | Ramucirumab (8 mg/kg) is administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with dose limiting toxicities (DLTs) | Number of participants with dose limiting toxicities (DLTs) | Phase 1, course 1 (up to 28 days) |
| Progression free survival rate after 6 months | Progression free survival rate after 6 months | from baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | Number of participants with adverse events | 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ken Kato, M.D. / Ph.D. | Department of Gastrointestinal Medical Oncology, National cancer center hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center Hospital | Tokyo | Japan |
Not provided
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000096662 | Ramucirumab |
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Nivolumab | Biological | Nivolumab (3.0 mg/kg or 1.0 mg/kg) is administered. |
|
|
| 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) | from baseline to date of disease progression, approximately 24 months |
| Overall survival (OS) | Overall survival (OS) | from baseline to date of death, approximately 24 months |
| Progression free survival (PFS) | Progression free survival (PFS) | from baseline to date of disease progression or death, approximately 24 months |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |