Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05111626 · ClinicalTrials.gov registry record · Phase 3
Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer.
A Phase 3 study of Gastric Cancer and Gastroesophageal Junction Adenocarcinoma, sponsored by Amgen.
- Active
- Registry status
- Phase 3
- Development phase
- 515
- Enrollment target
- 20
- Study locations
NCT05111626 is a Phase 3 study of Gastric Cancer and Gastroesophageal Junction Adenocarcinoma that is active but no longer recruiting, run by Amgen. The registered enrollment target is 515 participants, above the 316-participant average among 153 other Gastric Cancer trials with a reported enrollment target (63% higher). The trial reports 20 study locations across 8 states.
The verdict
NCT05111626, a Phase 3 study of Gastric Cancer and Gastroesophageal Junction Adenocarcinoma, is active but no longer recruiting, sponsored by Amgen.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 515 participants
- Enrollment target
- 20
- Study locations
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 515 participants |
| Start Date | 2022-03-14 |
| Est. Completion | 2027-01-29 |
| Phase | Phase 3 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 515 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 316-participant average among 153 other Gastric Cancer trials with a reported enrollment target (63% higher). The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.
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.
NCT05111626 reports 20 study locations spanning 8 distinct geographic areas - top geographies include California, Florida, Arizona.
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.
What interventions are being tested in trial NCT05111626?
The interventions under investigation include: Placebo (OTHER), Nivolumab (DRUG), Chemotherapy (DRUG), Bemarituzumab (DRUG).
Who is sponsoring clinical trial NCT05111626?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Gastric Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer
RECRUITING · Phase 3
-
AZD0901 Compared With Investigator's Choice of Therapy in Participants With Second- or Later-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2
RECRUITING · Phase 3
-
Study of TDXd, Chemotherapy, Pembrolizumab, and Trastuzumab in First-Line Metastatic HER2-Positive Gastric or Gastroesophageal Junction Cancer
RECRUITING · Phase 3
-
Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma Expressing Claudin18.2
RECRUITING · Phase 3
-
Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression
ACTIVE NOT RECRUITING · Phase 3
-
Early Palliative Care With Standard Care or Standard Care Alone in Improving Quality of Life of Patients With Incurable Lung or Non-colorectal Gastrointestinal Cancer and Their Family Caregivers
COMPLETED · Phase 3
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.