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ACTIVE NOT RECRUITING Phase 3

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

NCT05111626 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • OTHER Placebo
  • DRUG Nivolumab
  • DRUG Chemotherapy
  • DRUG Bemarituzumab

Study Locations (20)

California

  • The Oncology Institute Clinical Research — Cerritos
  • Cancer and Blood Specialty Clinic — Downey
  • City of Hope National Medical Center — Duarte
  • University of California Los Angeles — Los Angeles
  • University of California Irvine — Orange
  • Torrance Memorial Physician Network — Redondo Beach
  • Translational Research in Oncology - US Inc — Santa Monica
  • Translational Research in Oncology US Inc, Trio Central Pharmacy — Santa Monica
  • Olive View-University of California in Los Angeles Medical Center — Sylmar
  • Presbyterian Intercommunity Hospital Health Whitter Hospital — Whittier

Florida

  • Florida Cancer Specialists - Fort Myers — Fort Myers
  • Mayo Clinic — Jacksonville
  • Adventist Health System/Sunbelt, Inc d/b/a AdventHealth Orlando — Orlando
  • Orlando Health Cancer Institute — Orlando

Arizona

  • Mayo Clinic - Arizona — Phoenix

Connecticut

  • Yale New Haven Hospital Yale Cancer Center — New Haven

Illinois

  • University of Illinois Chicago — Chicago

Maryland

  • Greater Baltimore Medical Center — Baltimore

Michigan

  • Henry Ford Health System — Detroit

Minnesota

  • Mayo Clinic — Rochester

Trial Details

FieldValue
Enrollment Target 515 participants
Start Date 2022-03-14
Est. Completion 2027-01-29
Phase Phase 3

Sponsor

Amgen

266 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05111626

The ClinicalTrials.gov registry entry for NCT05111626 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 515 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 266 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Gastric Cancer appearing as the primary indexed condition, and to 4 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05111626 reports 20 study locations spanning 8 distinct geographic areas — top geographies include California, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05111626 about?

NCT05111626 is a clinical study titled "Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer.". 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...

What is the current status of trial NCT05111626?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 515 participants. The study started on 2022-03-14. Estimated completion is 2027-01-29.

What conditions does trial NCT05111626 study?

This clinical trial studies the following conditions: Gastric Cancer, Gastroesophageal Junction Adenocarcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05111626?

The interventions under investigation include: Placebo (OTHER), Nivolumab (DRUG), Chemotherapy (DRUG), Bemarituzumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05111626?

This trial is sponsored by Amgen, which has 266 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05111626 being conducted?

This trial has 20 study locations across Arizona, California, Connecticut, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial