Bemarituzumab + Chemotherapy + Nivolumab for Stomach Cancer
(FORTITUDE-102 Trial)

Recruiting in Palo Alto (17 mi)

+410 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Amgen

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults with advanced gastric or gastroesophageal junction adenocarcinoma that can't be removed by surgery. Participants must have an ECOG performance status of 0-1, indicating they are fully active or restricted in physically strenuous activity but ambulatory and able to carry out work of a light nature. They should not have had prior treatments for their metastatic disease, except possibly one dose of mFOLFOX6 with or without nivolumab.

Inclusion Criteria

Aspartate aminotransaminase (AST) and Alanine aminotransaminase (ALT) <3 x upper limit of normal (ULN) (or < 5 x ULN if liver involvement)

My blood clotting time is normal or near normal, or I've been on a stable blood thinner dose for 6 weeks.

I am fully active or restricted in physically strenuous activity but can do light work.

+10 more

Exclusion Criteria

My cancer is HER2 positive.

I have a serious heart condition.

I have moderate to severe numbness or pain in my hands or feet.

+8 more

Participant Groups

The study tests the safety and effectiveness of bemarituzumab combined with chemotherapy (mFOLFOX6 or CAPOX) and nivolumab versus placebo plus the same chemotherapies and nivolumab. The goal is to see if adding bemarituzumab improves survival compared to the standard treatment without it.

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Part 2: Bemarituzumab with chemotherapy (mFOLFOX6 or CAPOX) and NivolumabExperimental Treatment3 Interventions

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.

Group II: Part 1 Safety Lead-in: Bemarituzumab with mFOLFOX6 and NivolumabExperimental Treatment3 Interventions

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).

Group III: Part 2: Placebo with chemotherapy (mFOLFOX6 or CAPOX) and NivolumabPlacebo Group3 Interventions

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.

5-fluorouracil is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as 5-FU for: