Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

FORTITUDE-102 : 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

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

18-100Age 18-100

Stomach<br/>CancersCancer LocationStomach
Cancers

Systemic therapy | Stomach and upper gastrointestinal tractGastro-oesophageal junction ,Stomach

Trial Overview Read MoreRead more

This phase Ib/III study is evaluating the safety and effectiveness of targeted therapy (bemarituzumab), compared to a placebo, when combined with chemotherapy (mFOLFOX6) and immunotherapy (nivolumab) in people with previously untreated, advanced stomach and gastro-oesophageal junction cancer with FGFR2b overexpression.
 

This trial is treating patients with stomach cancer and cancer of the gastro-oesophagael junction.

This is a systemic therapy trial.

You may be able to join this trial if:

  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific 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

Commercial Sponsor

AMGEN

Summary

This study is being conducted in two parts. Part 1 (the phase Ib part) is evaluating how safe and tolerable bemarituzumab plus 5-fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) and nivolumab are when combined. Participants in this part will receive bemarituzumab at different doses (via intravenous [IV] infusion), with mFOLFOX6 (administered via IV) and nivolumab (via IV) to determine the recommended phase 3 dose (RP3D). Part 2 of the study (the Phase III section) is evaluating the efficacy of bemarituzumab plus mFOLFOX6 and nivolumab to placebo plus mFOLFOX6 and nivolumab. Eligible participants will be randomly allocated to either the experimental arm or placebo control arm. In the Experimental Arm, participants will receive bemarituzumab (administered via IV at the RP3D), in combination with mFOLFOX6 (via IV) and nivolumab (via IV). In the Placebo Comparator arm, participants will receive a placebo (via IV) in combination with mFOLFOX6 (via IV) and nivolumab (via IV).

Recruiting Hospitals Read MoreRead more

Austin Health
Heidelberg
Ms Samantha Chakar
samantha.chakar@austin.org.au
03 9496 3088

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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