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Nivolumab in Combination With Chemotherapy for FGFR2-positive Metastatic Gastric Cancer | Clinical Trials | Clareo Health

UNKNOWNPHASE2

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

NCT05859477•Kidney Cancer Research Bureau

View on ClinicalTrials.gov

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.

Detailed Description

On April 16, 2021, the Food and Drug Administration approved first-line therapy with nivolumab and fluoropyrimidine-platinum-containing chemotherapy for metastatic gastric adenocarcinoma. Patients with PD-L1 expression benefit the most from this treatment. Fibroblast growth factor receptor 2 (FGFR2) is a predictor of poor overall survival and a potential target for targeted therapy. However, there is no data of nivolumab efficacy in patients with combined expression of PD-L1 and FGFR2. The aim of this study is to evaluate the preliminary efficacy of nivolumab in this patient population.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+1 more criteria

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

Locations (1)

Bureau for Cancer Research

New York, New York, United States

Key Dates

Start Date

June 5, 2022

Primary Completion Date

December 1, 2023

Completion Date

December 1, 2024

Last Updated

January 2, 2024

Enrollment

ESTIMATED participants

Conditions

Metastatic Gastric CancerPD-L1 Gene AmplificationFGFR2 Amplification

Interventions

Nivolumab

DRUG

Capecitabine

DRUG

Oxaliplatin

DRUG

Contacts

Ilya Tsimafeyeu

CONTACT

+19178914943 director@bucare.org

Safety and Efficacy of SHR2554 Combined With Other Antitumor Therapies in Gastric or Gastro-oesophageal Junction Adenocarcinoma

NCT07102901

Advanced Gastric CancerMetastatic Gastric Cancer+1 more

View study

RECRUITINGPHASE3

M108 Plus CAPOX Versus Placebo Plus CAPOX as First-line Treatment for Claudin (CLDN) 18.2-Positive, HER2-Negative, PD-L1 CPS<5, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma.

NCT06177041

Locally Advanced Unresectable or Metastatic Gastric CancerLocally Advanced Unresectable or Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 2, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Safety and Efficacy of SHR2554 Combined With Other Antitumor Therapies in Gastric or Gastro-oesophageal Junction Adenocarcinoma

M108 Plus CAPOX Versus Placebo Plus CAPOX as First-line Treatment for Claudin (CLDN) 18.2-Positive, HER2-Negative, PD-L1 CPS<5, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma.

REFOCUS: A First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients With ICC and Other Advanced Solid Tumors

Study of M7824 and Paclitaxel Combination as a Second-line Treatment in Patients With Recurrent/Metastatic Gastric Cancer

89Zr-DFO*-Trastuzumab PET in Patients With Gastric or Breast Cancer - a Pilot Study

Biomarker Research Study for Patients With FGFR-Mutant Bladder Cancer Receiving Erdafitinib