InformationClinical trials have complex eligibility criteria.
Always talk to your clinician about you’re interest in participating in a trial.
Learn why

Optimise reading forHealth ProfessionalsPatients

RecruitingLast updated: 5 February 2024

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

Clinical summary

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.

Conditions

This trial is treating patients with urothelial cancer

Cancer

Urinary System Cancers Genitourinary

Age

People18+

Phase

I/II

Trial Acronym

FIDES-02

More information

Trial Identifiers

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

Trial sponsor

Basilea Pharmaceutica

Scientific Title

An Open-label Multi-cohort Phase 1b/2 Study of Derazantinib and Atezolizumab in Patients With Urothelial Cancer Expressing Activating Molecular FGFR Aberrations

Eligibility

Inclusion

  • Histologically-confirmed transitional cell carcinoma of the urothelium of the upper or lower urinary tract
  • Recurrent or progressing stage IV disease, or surgically unresectable, recurrent or progressing disease
  • Documented central FGFR genetic aberration (FGFR1, FGFR2, or FGFR3 mutations / short variants and rearrangements / fusions) (Note; Substudy 2 started with patients requiring an FGFR GA, but this requirement was removed from the protocol later on)
  • Measurable disease, as defined by the Investigator using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2
  • Adequate organ functions as indicated by Screening visit local laboratory values

Exclusion

  • Receipt of prior cancer treatment within specific interval periods
  • Concurrent evidence of any clinically significant corneal or retinal disorder
  • History of clinically significant cardiac disorders
  • Known CNS metastases
  • Concurrent uncontrolled or active infection with human immunodeficiency virus
  • Active hepatitis B or chronic hepatitis B without current antiviral therapy
  • Active hepatitis C
  • Active tuberculosis
  • Severe bacterial, fungal, viral and/or parasitic infections on therapeutic oral or IV medication at the time of first dose of study drug administration

Inclusion

  • You are able to swallow medication by mouth.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

Participating hospitals

Recruiting hospitals

InformationTell us if you find this trial availability is not accurate.Report inaccuracy

Get Support

Example

Cancer Connect

You might find it helpful to speak to someone who has 'been there before'. Our Cancer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.

Learn more

Example

Cancer Council’s cancer nurses

If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council’s experienced cancer nurses on 131120.

Learn more

Example

Information for family, friends and carers

When you are considering a cancer clinical trial, it is a good idea to discuss it with your family, friends or carers.

Learn more

Victorian Cancer Registry Victorian Government

The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

RAP

Cancer Council Victoria would like to acknowledge the traditional custodians of the land on which we live and work. We would also like to pay respect to the elders past and present and extend that respect to all other Aboriginal people.