Clinical trial · Interventional
Nivolumab in Combination With Chemotherapy for FGFR2-positive Metastatic Gastric Cancer
Nivolumab and CAPOX in Patients With FGFR2/PD-L1-positive Metastatic Gastric Adenocarcinoma: a Single-arm, Phase 2 Study
NCT05859477CI-TRIAL-00072670NIVOFGFR2unknownPhase 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 goal of this phase 2 clinical trial is to evaluate the efficacy of nivolumab in combination with CAPOX in patients with FGFR2-positive/PD-L1-positive/HER2-negative metastatic gastric cancer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| FGFR2 Amplification | — | UNRESOLVED | — |
| Metastatic Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| PD-L1 Gene Amplification | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Nivolumab | Drug | Nivolumab | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Nivolumab in combination with chemotherapy
- description
- Nivolumab 360 mg with CAPOX (capecitabine and oxaliplatin) every 3 weeks
- interventionNames
- Drug: Nivolumab
- Drug: Capecitabine
- Drug: Oxaliplatin
Primary outcomes (1)
- measure
- 1-year progression-free survival (PFS)
- timeFrame
- 12 months
- description
- Proportion of patients who will be progression-free at 1 year
Secondary outcomes (4)
- measure
- Median PFS
- timeFrame
- 18 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Previously untreated, unresectable advanced or metastatic gastric adenocarcinoma * Measurable lesions according to the RECIST 1.1 criteria * PD-L1 Combined Positive Score (CPS) of five or more assessed by Dako PD-L1 immunohistochemistry 28-8 pharmDx assay * Positive FGFR2 overexpression status by immunohistochemistry defined as exhibiting any moderate (2+) to strong (3+) membranous staining in more than 1% of tumor cells * Possibility to assess the amplification of FGFR2 * HER2-negative status * ECOG PS 0-2 * Age \>= 18 years old * Adequate function of organs * Absence of any psychological, family, social or geographical circumstances that could potentially serve as obstacles to the implementation of the study * Signed Informed Consent Exclusion Criteria: * Participation in another clinical study and concomitant treatment with any research drug or any study of antitumor therapy, including radiation, within 28 days before inclusion in this study * Presence of metastases in the central nervous system and / or carcinoma of the meninges at the time of inclusion in the study * Presence or history of present signs of any condition, therapy or laboratory abnormalities that could limit the interpretation of the results of this study * Any malignant tumor within the previous 5 years, with the exception of adequately cured cervical cancer in situ or squamous cell skin cancer, or basal cell skin cancer with limited growth, subject to adequate control over the course of this disease * Pregnancy * Known positive status for human immunodeficiency virus (HIV) or active hapatitis B and C * Surgery within 7 days before the first dose of the study drug * Signs of bleeding or hemorrhagic diathesis
References
Publications (0)
Data not yet available
No reference posted for this study.