Trials / Active Not Recruiting
Active Not RecruitingNCT05111626
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
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 515 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Bemarituzumab | Bemarituzumab will be administered as intravenous (IV) infusion. |
| DRUG | Nivolumab | Nivolumab will be administered as IV infusion. |
| DRUG | Chemotherapy | mFOLFOX6: 5-fluorouracil, leucovorin, and oxaliplatin will be administered as IV infusion. OR CAPOX: oxaliplatin will be administered as IV infusion and capecitabine will be administered orally. |
| OTHER | Placebo | Placebo will be administered as IV infusion. |
Timeline
- Start date
- 2022-03-14
- Primary completion
- 2025-10-14
- Completion
- 2027-01-29
- First posted
- 2021-11-08
- Last updated
- 2025-12-15
Locations
348 sites across 29 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czechia, France, Germany, Hong Kong, Hungary, Israel, Italy, Japan, Poland, Portugal, Romania, Singapore, South Korea, Spain, Switzerland, Taiwan, Thailand, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05111626. Inclusion in this directory is not an endorsement.