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Anti-metabolites

Nivolumab + Chemotherapy for Gastric Cancer (NIVOFGFR2 Trial)

Phase 2
Recruiting
Research Sponsored by Kidney Cancer Research Bureau
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trial tests if a drug combo can help people with a specific type of stomach cancer.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Nivolumab may cause immune-related side effects like inflammation of organs, skin problems, hormone gland issues, infusion reactions; Oxaliplatin can lead to nerve damage and allergic reactions; Capecitabine might cause hand-foot syndrome, diarrhea, nausea.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
1-year progression-free survival (PFS)
Secondary study objectives
Median PFS
Median overall survival (OS)
Objective response rate (ORR)
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Nivolumab in combination with chemotherapyExperimental Treatment3 Interventions
Nivolumab 360 mg with CAPOX (capecitabine and oxaliplatin) every 3 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2015
Completed Phase 3
~4010
Capecitabine
2013
Completed Phase 3
~4280
Oxaliplatin
2011
Completed Phase 4
~2890

Find a Location

Who is running the clinical trial?

Kidney Cancer Research BureauLead Sponsor
11 Previous Clinical Trials
478 Total Patients Enrolled
Ilya TsimafeyeuStudy ChairBureau for Cancer Research

Media Library

Capecitabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT05859477 — Phase 2
No disease or condition mentioned. Research Study Groups: Nivolumab in combination with chemotherapy
No disease or condition mentioned. Clinical Trial 2023: Capecitabine Highlights & Side Effects. Trial Name: NCT05859477 — Phase 2
Capecitabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05859477 — Phase 2
~7 spots leftby Nov 2025
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