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