Derazantinib and atezolizumab in patients with urothelial cancer (FIDES-02)


The purpose of this study is to evaluate efficacy of derazantinib single-agent or derazantinib-atezolizumab in combination in patients with advanced urothelial cancer harboring fibroblast growth factor receptor (FGFR) genetic aberrations (GA) of various clinical stages of disease progression and prior treatments.


Accepting new patients

Primary Study Objective(s)

The objective of this study is to determine the overall response rate to this treatment.

Core eligibility

Note: This is only a partial list of eligibility criteria.

Accepting patients who meet the following criteria:

  • 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 alteration
  • Measurable disease per RECIST 1.1
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2
  • Adequate bone marrow, liver and renal function

Excluding patients who meet these criteria:

  • Receipt of chemotherapy, targeted therapies, immunotherapy, or treatment with an investigational anticancer agent within two weeks or at least five half-lives of the drug whichever is longer before the first dose of study drug.
  • Concurrent evidence of any clinically significant corneal or retinal disorder
  • Phosphatemia greater than institutional upper limit of normal (ULN) at screening
  • Uncontrolled tumor-related hypercalcemia

Accepting new patients


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