Bemarituzumab plus chemotherapy and nivolumab compared to chemotherapy and nivolumab alone (FORTITUDE-102)
Aim of the study
This study is being conducted to find out if bemarituzumab is effective, safe and well tolerated when used in patients with advanced gastric or gastroesophageal junction cancer overexpressing FGFR2b, along with other treatment options such as chemotherapy, either the chemotherapy regimen mFOLFOX6 (a combination of 5-fluorouracil [5-FU], oxaliplatin and leucovorin) OR the chemotherapy regimen capecitabine in combination with oxaliplatin (CAPOX), and nivolumab (a drug that stimulates the immune system to kill cancer cells), compared to placebo in combination with chemotherapy and nivolumab. Your investigator will decide which chemotherapy regimen you will receive (either mFOLFOX6 or CAPOX).
Who can take part?
Patients with untreated advanced gastric or gastroesophageal junction carcinoma with FGFR2b overexpression.
Procedure
You will have to attend around 40 appointments at the clinic during the study. The appointments last several hours each and are spread over a period of around 20 months. Including the long-term follow-up, your participation in the study could last up to 40 months in total.
If you decide to take part in the study, a number of tests will be carried out to determine whether you are suitable. In the pre-examination phase (day -28 to day 0) you will have up to 2 appointments. If, according to the results of the preliminary examinations, you do not meet the requirements for participation in the study, you cannot take part in the study.
During the treatment visits (starting from day 1), a cycle comprises 2 weeks (mFOLFOX6) OR 3 weeks (CAPOX). In cycles 1 and 2 you will be hospitalized up to 3 times.
From cycle 3 and onwards you will have an appointment or as instructed by your investigator.
At the visit at the end of treatment with the study drug, you will come up to 2 times (approximately 28 days after the last dose of the study drug).
You will attend the safety follow-up visit once (approximately 28 days after the last dose of all study treatments).
During the long-term follow-up visit, you will receive a telephone call every ~12 weeks for about 15 months after the last participant has been admitted.
If you suffer from persistent eye problems, you will be asked to have eye examinations until these have subsided or no further improvement is possible.
Compensation
Original study name
Protocol number 20210098: A phase 1b/3 study of bemarituzumab plus chemotherapy and nivolumab versus chemotherapy and nivolumab alone in patients with untreated advanced gastric or gastroesophageal junction carcinoma with
BASEC number
2021-02466
Sponsors
Unicancer