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

NCT05859477 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: NIVOFGFR2
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 1-year progression-free survival (PFS)

  Proportion of patients who will be progression-free at 1 year

  12 months

Secondary Outcomes (4)

• Median PFS

  18 months

• Median overall survival (OS)

  24 months

• Objective response rate (ORR)

  18 months

• Toxicity Summary

  Up to 30 days post treatment

Study Arms (1)

Nivolumab in combination with chemotherapy

EXPERIMENTAL

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

Drug: Nivolumab; Drug: Capecitabine; Drug: Oxaliplatin

Interventions

Nivolumab DRUG

360 mg, i.v., every 3 weeks

Also known as: Opdivo

Nivolumab in combination with chemotherapy

Capecitabine DRUG

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

Also known as: Xeloda

Nivolumab in combination with chemotherapy

Oxaliplatin DRUG

130 mg/m², i.v., day 1, every 3 weeks

Nivolumab in combination with chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kidney Cancer Research Bureau: lead

Study Sites (1)

Bureau for Cancer Research

New York, New York, 10032, United States

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Nivolumab; Capecitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals

Study Officials

• Ilya Tsimafeyeu

  Bureau for Cancer Research

  STUDY CHAIR

Central Study Contacts

Ilya Tsimafeyeu

CONTACT

+19178914943; director@bucare.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Nivolumab in combination with chemotherapy

Study Record Dates

• First Submitted: May 1, 2023
• First Posted: May 16, 2023
• Study Start: June 5, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: January 2, 2024

Record last verified: 2023-12

Locations

US (1)