Nivolumab + Chemotherapy for Gastric Cancer
(NIVOFGFR2 Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Kidney Cancer Research Bureau

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults with FGFR2-positive/PD-L1-positive/HER2-negative metastatic gastric cancer who haven't had treatment before. They should have measurable lesions, be in a decent physical state (ECOG PS 0-2), and have good organ function. People can't join if they've been in other trials recently, have brain metastases or meningeal carcinomas, other cancers within the last 5 years (except certain skin cancers or cervical cancer), are pregnant, or have HIV/hepatitis B/C.

Inclusion Criteria

Absence of any psychological, family, social or geographical circumstances that could potentially serve as obstacles to the implementation of the study

Measurable lesions according to the RECIST 1.1 criteria

Signed Informed Consent

+8 more

Exclusion Criteria

My cancer has spread to my brain or its coverings.

I have not had surgery within the last week.

I have signs of bleeding or a bleeding disorder.

+5 more

Participant Groups

The study tests how well Nivolumab works alongside chemotherapy drugs Oxaliplatin and Capecitabine (CapeOX) for advanced stomach cancer that's spread and has specific genetic markers. It's a phase 2 trial to see if this combo is effective.

1Treatment groups

Experimental Treatment

Group I: Nivolumab in combination with chemotherapyExperimental Treatment3 Interventions

Nivolumab 360 mg with CAPOX (capecitabine and oxaliplatin) every 3 weeks

Capecitabine is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Xeloda for: