Clinical trial · Interventional
A Phase 1/2 Study of Ramucirumab Plus Nivolumab in Participants With Gastric or GEJ Cancer
A Multicenter, Phase 1/2 Study of Ramucirumab Plus Nivolumab as Second-line Therapy in Participants With Gastric or GEJ Cancer
NCT02999295CI-TRIAL-00040178completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Gastroesophageal Junction Region (GEJ) Cancer | Gastric Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nivolumab | Biological | Nivolumab | ALIAS |
| Ramucirumab | Biological | Ramucirumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Phase 1
- description
- Ramucirumab: 8 mg/kg, every two week Nivolumab: 3.0 mg/kg or 1.0 mg/kg (optional), every two weeks
- interventionNames
- Biological: Ramucirumab
- Biological: Nivolumab
- type
- EXPERIMENTAL
- label
- Phase 2
- description
- Ramucirumab: 8 mg/kg, every two week Nivolumab: recommended dose established in the phase 1, every two weeks
- interventionNames
- Biological: Ramucirumab
- Biological: Nivolumab
Primary outcomes (2)
- measure
- Number of participants with dose limiting toxicities (DLTs)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.