FIDES-02: This Phase I/II trial is evaluating the efficacy of targeted therapy (derazantinib) alone, or in combination with immunotherapy (atezolizumab) in people with advanced bladder (urothelial) cancerAn Open-label Multi-cohort Phase 1b/2 Study of Derazantinib and Atezolizumab in Patients With Urothelial Cancer Expressing Activating Molecular FGFR Aberrations

Summary

This randomised, open-label trial consists of five sub-studies in patients with advanced urotheial cancer harbouring FGFR genetic aberrations of various clinical stages of disease progression and prior treatments. The trial has five experimental arms, also called substudies. In Substudy 1, participants with urothelial cancer who have progressed on at least one line of standard treatment will be treated with derazantinib monotherapy, at dose level one (orally, 300mg once per day). In Substudy 2, participants with solid tumours will receive derazantinib + atezolizumab. Derazantinib will be administered orally at various dose levels, atezolizumab will be administered at 1200mg every three weeks. In Substudy 3, participants with urothelial cancer will be treated with derazantinib and atezolizumab. Derazantinib will be administered orally at a dose of 200 mg twice daily in combination with atezolizumab 1200 mg every three weeks. In Substudy 4, participants with urothelial cancer progressing after prior FGFR inhibitor treatment will be randomised to receive either derazantinib alone or a combination of derazantinib and atezolizumab. Derazantinib will be administered orally (300mg, once per day), and atezolizumab will be administered as 1200mg every three weeks. In Substudy 5, participants with urothelial cancer who have progressed on at least one line of standard treatment will be treated with derazantinib monotherapy at a dose of 200mg twice daily, taken orally.