Clinical trial · no report yet · Phase 3
FORTITUDE-102
Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer.
- NCT05111626 ↗
- Terminated
- Amgen
- 19 commentary sources found
- Standard
We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Commentary we found
Podcasts, YouTube videos and X posts in our index that name this trial. A report screens them, searches for more and cites what clinicians said when it is built.
| Channel | Found | |
|---|---|---|
| YouTube | 7 | |
| Podcasts | 6 | |
| X threads | 6 |
The trial
ClinicalTrials.gov- Official title
- 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
- Phase
- Phase 3
- Status
- Terminated
- Conditions
- Gastric Cancer; Gastroesophageal Junction Adenocarcinoma
- Interventions
- Bemarituzumab; Nivolumab; Chemotherapy; Placebo
- Arms
- Part 1 Safety Lead-in: Bemarituzumab with mFOLFOX6 and Nivolumab · Experimental
- Part 2: Bemarituzumab with chemotherapy (mFOLFOX6 or CAPOX) and Nivolumab · Experimental
- Part 2: Placebo with chemotherapy (mFOLFOX6 or CAPOX) and Nivolumab · Placebo comparator
- Enrollment
- 515
- Primary outcomes
- Part 1: Number of Participants Who Experienced DLTs
- Part 1: Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAEs)
- Part 1: Number of Participants Who Experienced One or More Related TEAEs
- Part 1: Number of Participants With Clinically Significant Changes in Vital Signs
- Part 1: Number of Participants With Clinically Significant Changes in Visual Acuity
- Part 1: Number of Participants With Clinically Significant Changes in Physical Examinations
- Part 1: Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests
- Part 2: Overall Survival in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants
- Sponsor
- Amgen
- Start
- Mar 14, 2022
- Primary completion
- Oct 14, 2025
- Results posted
- No
- Registry record
- NCT05111626 · updated Sep 10, 2026
Publications
linked from the registry- Maron SB, Xu RH, Wainberg ZA, Rha SY, Zhang Y, Pietrantonio F, Oliveira SCS, Li Y, Chen MH, Korphaisarn K, Elimova E, Calderon CA, Herpe FV, Yong WP, Dos Santos TM, Tan M, Isse K, Yanes RE, Shitara K. Global prevalence of FGFR2b protein overexpression in advanced gastric cancer and gastroesophageal junction cancers: pooled analysis of two bemarituzumab phase III studies. ESMO Open. 2026 Jun;11(6):107698. doi: 10.1016/j.esmoop.2026.107698. Epub 2026 May 26. PubMed 42190313
- Yu J, Mehta R. Biomarker-Driven Approach to the Treatment of Metastatic Gastric or Gastroesophageal Adenocarcinoma. J Natl Compr Canc Netw. 2025 May;23(5):e257036. doi: 10.6004/jnccn.2025.7036. PubMed 40341124
- Wainberg ZA, Kang YK, Lee KW, Qin S, Yamaguchi K, Kim IH, Saeed A, Oh SC, Li J, Turk HM, Teixeira A, Hitre E, Udrea AA, Cardellino GG, Sanchez RG, Zahlten-Kumeli A, Taylor K, Enzinger PC. Bemarituzumab as first-line treatment for locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma: final analysis of the randomized phase 2 FIGHT trial. Gastric Cancer. 2024 May;27(3):558-570. doi: 10.1007/s10120-024-01466-w. Epub 2024 Feb 3. PubMed 38308771