Brief Title: Derazantinib and Atezolizumab in Patients With Urothelial Cancer

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

• Urothelial Carcinoma

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Manuel Häckl, MD

Role: Study Director

Affiliation: Basilea Pharmaceutica International Ltd, Allschwil

Overall Contact

Name: N/A

Phone: N/A

Email: N/A

LOCATION