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Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer. | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE3

Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer.

A Phase 1b/3 Study of Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab Alone in Subjects With Previously Untreated Advanced Gastric and Gastroesophageal Junction Cancer With FGFR2b Overexpression

NCT05111626•Amgen

View on ClinicalTrials.gov

Summary

The main objective of Part 1 is to evaluate the safety and tolerability of bemarituzumab plus 5-fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) and nivolumab. The main objective Part 2 is to compare efficacy of bemarituzumab plus chemotherapy (mFOLFOX6 or capecitabine combined with oxaliplatin (CAPOX)) and nivolumab to placebo plus chemotherapy (mFOLFOX6 or CAPOX) and nivolumab as assessed by overall survival.

Eligibility

Age

18 - 100 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Adult with unresectable, locally advanced or metastatic (not amenable to curative therapy) histologically documented gastric or gastroesophageal junction adenocarcinoma
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
•Measurable disease or non-measurable, but evaluable disease, according to Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1)
•Participant has no contraindications to nivolumab and either mFOLFOX6 or CAPOX chemotherapy as per local prescribing information. Participants in Part 1 must have no contraindications to mFOLFOX6. Participants in Part 2 with contraindications to mFOLFOX6 are permitted and may be administered the CAPOX regimen, if no contraindications for this regimen exist. Participants in Part 2 with contraindications to CAPOX are permitted and may be administered the mFOLFOX6 regimen, if no contraindications for this regimen exist
•Adequate organ function as follows:
•* Absolute neutrophil count ≥ 1.5 x 10\^9/L
•* Platelet count ≥ 100 x 10\^9/L
•* Hemoglobin ≥ 9 g/dL without red blood cell (RBC) transfusion within 7 days prior to the first dose of study treatment
•* Aspartate aminotransaminase (AST) and Alanine aminotransaminase (ALT) \<3 x upper limit of normal (ULN) (or \< 5 x ULN if liver involvement)
•* Total bilirubin \<1.5 x ULN (or \< 2 x ULN if liver involvement or Gilbert's disease)
+6 more criteria

Exclusion Criteria

•Prior treatment with any selective inhibitor of the fibroblast growth factor (FGF)-FGFR pathway
•Known positive human epidermal growth factor receptor 2 (HER2) status
•Untreated or symptomatic central nervous system disease metastases and leptomeningeal disease
•Peripheral sensory neuropathy grade 2 or higher
•Clinically significant cardiac disease
•Other malignancy within the last 2 years (exceptions for definitively treated disease)
•Chronic or systemic ophthalmologic disorders
•Major surgery or other investigational study within 28 days prior to randomization
•Palliative radiotherapy within 14 days prior to randomization
•Abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer
+1 more criteria

Locations (348)

Mayo Clinic - Arizona

Phoenix, Arizona, United States

The Oncology Institute Clinical Research

Cerritos, California, United States

Cancer and Blood Specialty Clinic

Downey, California, United States

City of Hope National Medical Center

Duarte, California, United States

University of California Los Angeles

Los Angeles, California, United States

University of California Irvine

Orange, California, United States

Torrance Memorial Physician Network

Redondo Beach, California, United States

Translational Research in Oncology - US Inc

Santa Monica, California, United States

Translational Research in Oncology US Inc, Trio Central Pharmacy

Santa Monica, California, United States

Olive View-University of California in Los Angeles Medical Center

Sylmar, California, United States

Key Dates

Start Date

March 14, 2022

Primary Completion Date

October 14, 2025

Completion Date

January 29, 2027

Last Updated

December 15, 2025

Enrollment

515

ACTUAL participants

Conditions

Gastric CancerGastroesophageal Junction Adenocarcinoma

Interventions

Bemarituzumab

DRUG

Nivolumab

DRUG

Chemotherapy

DRUG

Placebo

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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: December 15, 2025Data 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

Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer.

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Resilience and Equity in Aging, Cancer, and Health (REACH)

Novel Combinations in Participants With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Using 18F-FAPI PET to Detect Metastatic Disease in Patients That Have Gastric or Esophageal Cancer.