RECRUITING

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

Conditions

Metastatic Gastric Cancer PD-L1 Gene Amplification FGFR2 Amplification

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Nivolumab and CAPOX in Patients With FGFR2/PD-L1-positive Metastatic Gastric Adenocarcinoma: a Single-arm, Phase 2 Study

Quick Facts

Study Start:2022-06-05

Study Completion:2024-12-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05859477

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Ilya Tsimafeyeu

CONTACT

+19178914943

director@bucare.org

Principal Investigator

Ilya Tsimafeyeu

STUDY_CHAIR

Bureau for Cancer Research

Study Locations (Sites)

Bureau for Cancer Research

New York, New York, 10032

United States

Collaborators and Investigators

Sponsor: Kidney Cancer Research Bureau

Ilya Tsimafeyeu, STUDY_CHAIR, Bureau for Cancer Research

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-05

Study Completion Date2024-12-01

Study Record Updates

Study Start Date2022-06-05

Study Completion Date2024-12-01

Terms related to this study

Additional Relevant MeSH Terms

Metastatic Gastric Cancer
PD-L1 Gene Amplification
FGFR2 Amplification