Derazantinib and Atezolizumab in Patients With Urothelial Cancer

Inclusion 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 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 Criteria

• 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