Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Adenocarcinoma

Stomach Neoplasms

Esophageal Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Head and Neck Neoplasms

Esophageal Diseases

Stomach Cancer

Esophageal Cancer

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Capecitabine

Leucovorin

Fluorouracil

Nivolumab

Oxaliplatin

Bemarituzumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Participants will be administered bemarituzumab at different doses with mFOLFOX6 and nivolumab to determine the recommended phase 3 dose (RP3D) based on occurrence of dose-limiting toxicities (DLTs), and on an evaluation of the overall safety, tolerability, and pharmacokinetics (PK).

Participants will be administered bemarituzumab at the RP3D determined from Part 1 in combination with mFOLFOX6 and nivolumab on a 14-day cycle.

Or participants will be administered bemarituzumab in combination with CAPOX and nivolumab on a 21-day cycle.

Participants will be administered placebo comparator in combination with mFOLFOX6 and nivolumab on a 14-day cycle.

Or participants will be administered placebo comparator in combination with CAPOX and nivolumab on a 21-day cycle.

Bemarituzumab will be administered as intravenous (IV) infusion.

Nivolumab will be administered as IV infusion.

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.

Chemotherapy

Placebo will be administered as IV infusion.

Placebo

Amgen Call Center

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.

This is a Phase 1b/3 study:

* Phase 1b (Part 1) is a single-arm open-label study, which will enroll about 20 participants
* Phase 3 (Part 2) is a randomized double-blind 2-arm study, which will enroll 508 participants

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

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Amgen

Crouzon Syndrome

Jackson-Weiss Syndrome

Pfeiffer Syndrome

Mitogens

mFOLFOX6 administered as a combination of oxaliplatin and leucovorin as IV infusions. 5-FU administered as bolus followed by additional administration as IV infusion.

mFOLFOX6

The main objective of this study is to compare efficacy of bemarituzumab combined with oxaliplatin, leucovorin, and 5-fluorouracil (5-FU) (mFOLFOX6) to placebo plus mFOLFOX6 as assessed by overall survival (OS) in participants with FGFR2b ≥10% 2+/3+ tumor cell staining (FGFR2b ≥10% 2+/3+TC)

Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression

A Randomized, Multi-center, Double-blind, Placebo-controlled Phase 3 Study of Bemarituzumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer With FGFR2b Overexpression

Overall survival in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants

PFS in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants

ORR in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants

Any clinically significant changes in vital signs, visual acuity, and clinical laboratory tests after first dose will be recorded as TEAEs.

Overall survival in all randomized participants

DOR in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants

Disease Control Rate in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants

Measured in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants

Zai Lab (China only)

CAPOX administered as a combination of oxaliplatin as an IV infusion and capecitabine orally as tablets.

CAPOX

SOX administered as a combination of oxaliplatin as an IV infusion and S-1 orally.

The main objectives of this study are to evaluate the safety and tolerability of bemarituzumab in combination with other anti-cancer therapies, and to evaluate the efficacy of bemarituzumab in combination with S-1 and oxaliplatin (SOX) and nivolumab as assessed by objective response.

A Study Evaluating Bemarituzumab in Combination With Other Anti-cancer Therapies in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer.

A Phase 1b/2 Study Evaluating the Safety, Tolerability, Efficacy, and Pharmacokinetics of Bemarituzumab in Combination With Other Anti-cancer Therapies in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer (FORTITUDE-103).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer	NCT05111626	Gastric Cancer Gastroesophagea...	Bemarituzumab Nivolumab Chemotherapy Placebo	18 Years - 100 Years	Amgen
Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression	NCT05052801	Gastric Cancer Gastroesophagea...	Bemarituzumab mFOLFOX6 Placebo	18 Years - 100 Years	Amgen
Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression	NCT05052801	Gastric Cancer Gastroesophagea...	Bemarituzumab mFOLFOX6 Placebo	18 Years - 100 Years	Amgen
Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression	NCT05052801	Gastric Cancer Gastroesophagea...	Bemarituzumab mFOLFOX6 Placebo	18 Years - 100 Years	Amgen
A Study Evaluating Bemarituzumab in Combination With Other Anti-cancer Therapies in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer.	NCT05322577	Gastric Cancer Gastroesophagea...	Bemarituzumab CAPOX SOX Nivolumab	18 Years - 100 Years	Amgen

Spots Global Cancer Trial Database for fgfr2b overexpression