Recruiting
Phase 2

Nivolumab & CAPOX

Sponsor:

Kidney Cancer Research Bureau

Code:

NCT05859477

Conditions

Metastatic Gastric Cancer

PD-L1 Gene Amplification

FGFR2 Amplification

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Nivolumab

Capecitabine

Oxaliplatin

Study Details

Brief summary:

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

Metastatic Gastric Cancer

PD-L1 Gene Amplification

FGFR2 Amplification

Study ID

NCT05859477

Start date

Jun 5, 2022

Status verified date

Dec, 2023

Completion date

Dec 1, 2024

Anticipated

Primary completion date

Dec 1, 2023

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

23 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Nivolumab in combination with chemotherapy

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

Interventions

Nivolumab

360 mg, i.v., every 3 weeks

Capecitabine

capecitabine 1000 mg/m², orally, twice a day, days 1-14 of each cycle

Oxaliplatin

130 mg/m², i.v., day 1, every 3 weeks

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Ilya Tsimafeyeu

+19178914943director@bucare.org

Locations

Bureau for Cancer Research

Recruiting

New York, New York, United States, 10032

Contacts

Magnolia Rouge

917-981-6485bucare@bucare.org

More Information

Sponsor

Kidney Cancer Research Bureau

Last update posted

Jan 2, 2024

Last verified

Dec, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Kidney Cancer Research Bureau on 2024-01-02.