SOGUG-NEOWIN TRIAL
Research type
Research Study
Full title
A Phase 2, open-label, multi-centre, multi-national interventional trial to evaluate the efficacy and safety of erdafitinib (ERDA) monotherapy and erdafitinib (ERDA) and cetrelimab (CET) combination as neoadjuvant treatment in cisplatin-ineligible patients with muscle-invasive bladder cancer (MIBC) whose tumours express FGFR gene alterations.
IRAS ID
1006918
Contact name
Silvia Martínez Cruz
Contact email
Sponsor organisation
Spanish Oncology Genito Urinary Group (SOGUG)
Eudract number
2022-002586-15
Research summary
Primary purpose of this clinical trial is to evaluate the safety and efficacy of erdafitinib (a Fibroblast Growth Factor Receptor (FGFR)- inhibitor) alone or in combination with cetrelimab (an anti-PD-1 monoclonal antibody) as neoadjuvant treatment in cisplatin-ineligible patients with MIBC whose tumours express FGFR gene alterations.
Erdafitinib (ERDA) is an experimental drug in this clinical trial and is being studied as a potential new treatment in the neoadjuvant setting of patients with nonmetastatic muscle-invasive bladder cancer which carry specific alterations in the Fibroblast Growth Factor Receptor (FGFR) family. Cetrelimab (CET) is an anti-PD-1 monoclonal antibody (an immune checkpoint inhibitor (ICI)) being studied in the treatment of several tumours, including bladder cancer. Combination of CET plus ERDA seems an interesting approach in FGFR-mutated bladder cancer due to different mechanisms of action and non-overlapping toxicities, as shown in a phase 2 clinical trial in metastatic UC.The SOGUG Group (Sponsor) is non-profit scientific association whose aim is to promote and develop specific programmes of study and research in the field of genito-urinary tumours.
Number of patients planned in this study are 90, 45 in each cohort. There will be 21 study centres in 4 countries will participates in main study. Treatment will be assigned through a centralized allocation by order of arrival.
In Erdafitinib group, patient will receive ERDA 8mg (two 4mg tablets) orally daily for 9 or 12weeks (3 or 4 cycles of 3weeks each).
In Erdafitinib and Cetrelimab combination group, you will receive ERDA 8mg (two 4mg tablets) orally daily, in combination with CET 360mg intravenously (IV) on Cycle 1Day1, then every 3weeks (21days), for 9 or 12weeks (3 or 4 cycles of 3weeks each).
When the treatment period ends, patient will have end of trial visit & an imaging & laboratory test before proceeding to surgery. The overall study duration is 60 months.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
23/NW/0081
Date of REC Opinion
20 Sep 2023
REC opinion
Further Information Favourable Opinion