Nivolumab in Combination With Chemotherapy for FGFR2-positive Metastatic Gastric Cancer

Part of paid clinical trials in New York, New York.

Sponsor
Kidney Cancer Research Bureau
Study ID
NCT05859477
Phase
PHASE2
Status
Unknown

Conditions

  • FGFR2 Amplification
  • Metastatic Gastric Cancer
  • PD-L1 Gene Amplification

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    360 mg, i.v., every 3 weeks
  • Capecitabine — DRUG
    capecitabine 1000 mg/m², orally, twice a day, days 1-14 of each cycle
  • Oxaliplatin — DRUG
    130 mg/m², i.v., day 1, every 3 weeks

Study Details

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.

Key Dates

Start date
Jun 5, 2022
Status verified
Dec 2023
Primary completion
Dec 1, 2023
Completion
Dec 1, 2024

Study Design

Enrollment
23 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab in combination with chemotherapy
    Nivolumab 360 mg with CAPOX (capecitabine and oxaliplatin) every 3 weeks

Primary Outcome Measure

1-year progression-free survival (PFS) [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Bureau for Cancer ResearchNew YorkNew York10032
Magnolia Rouge
917-981-6485

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