Bemarituzumab plus Chemotherapy and Nivolumab versus Chemotherapy and Nivolumab Alone(FORTITUDE-102)
Research type
Research Study
Full 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 (FORTITUDE-102)
IRAS ID
1004338
Contact name
Matthew Rodaway
Contact email
Sponsor organisation
Amgen Inc.
Eudract number
2021-003477-61
Clinicaltrials.gov Identifier
Research summary
Gastric cancer is the fifth most common cancer in the world and the third most common cause of cancer deaths globally. Gastric cancer is often not diagnosed until the disease is advanced and the 5 year overall survival rate is less than 5%.
Fibroblast growth factor 2b (FGFR2b) is a receptor on the surface of cancer tumour cells that plays an important role in tumour cell growth and survival. In a substantial number of people the tumour produces more than normal amounts of this receptor (overexpression) and this has been linked to significantly worse survival compared with tumours that do not overexpress.
Bemarituzumab is an antibody that acts specifically on the FGFR2b receptor and works in two ways. First, it binds to the FGFR2b receptors in place of the fibroblast growth factors to prevent tumour growth. Second, it attracts natural killer cells, a type of white blood cell which is part of the body’s immune system, to help kill the tumour cell.
Part 1 of the study is to assess the safety of Bemarituzumab and how well it is tolerated. This part of the study will determine the best dose of bemarituzumab to use in Part 2. This will be assessed by the number and severity of events reported by subjects that are linked to the treatment. Part 1 will also look at how the body absorbs, moves around and gets rid of Bemarituzumab. Approximately 20 subjects will be enrolled in part 1 and all of them will get active Bemarituzumab along with mFOLFOX6 and Nivolumab.
The primary objective of Part 2 of the study is to compare effectiveness of bemarituzumab when given with chemotherapy (mFOLFOX6 and nivolumab) to placebo with chemotherapy (mFOLFOX6 and nivolumab). The placebo will look exactly like bemarituzumab and be administered in the same way, but will have no active medicinal properties. Please see the submission cover letter for further details relating to this question.REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
22/EE/0030
Date of REC Opinion
8 Apr 2022
REC opinion
Further Information Favourable Opinion