Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer.
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Phase
Phase 3
Status
Terminated
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
515actual
Sites
348
Countries
Argentina, Australia, Austria +26
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Why the sponsor stopped it
Study was terminated by sponsor
As filed on the registry record, in the sponsor's own words.
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-03-14 | actual | When the study began enrolling |
| Primary completion | 2025-10-14 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-10-29 | actual | The whole study's end, after follow-up |
| First posted | 2021-11-08 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-17 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Gastric Cancer
- Gastroesophageal Junction Adenocarcinoma
Interventions
- Drug: Bemarituzumab — also filed as AMG 552
- Drug: Nivolumab
- Drug: Chemotherapy
- Other: Placebo
Primary outcomes
what the primary-completion date above is the date OFPart 1: Number of Participants Who Experienced DLTs
measured 28 days
Part 1: Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAEs)
measured Up to 4.5 years
Part 1: Number of Participants Who Experienced One or More Related TEAEs
measured Up to 4.5 years
Part 1: Number of Participants With Clinically Significant Changes in Vital Signs
measured Up to 4.5 years
Part 1: Number of Participants With Clinically Significant Changes in Visual Acuity
measured Up to 4.5 years
Part 1: Number of Participants With Clinically Significant Changes in Physical Examinations
measured Up to 4.5 years
Part 1: Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests
measured Up to 4.5 years
Part 2: Overall Survival in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants
measured Up to 4.5 years
Publications
- PMID 40341124 — linked by the registry
- PMID 38308771 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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