Phase 1b/2 Study of Rogaratinib (BAY1163877) in Combination With Atezolizumab in Urothelial Carcinoma

Phase 1

Completed

Brief Summary: FORT-2 is designed to evaluate safety, efficacy, RP2D and PK of rogaratinib in combination with atezolizumab in patients with untreated FGFR-positive urothelial carcinoma. The study originally comprised two separate parts: Phase 1b (Part A) and Phase 2 (Part B). The study parts differ in design, objectives, and treatment.

The primary objectives of this Phase 1b study (Part A) are to determine the safety, tolerability, RP2D and pharmacokinetics of rogaratinib in combination with atezolizumab in these patients.

The primary objective of the Part B is to compare progression-free survival (PFS) according to RECIST v1.1 of rogaratinib in combination with atezolizumab over placebo in combination with atezolizumab in untreated patients with FGFR-positive locally advanced or metastatic urothelial carcinoma.

Of note, patients who participate in Part A are not allowed to participate in Part B.

Part B will be initiated once the data from Part A supports continuation of the study, even if this occurs prior to primary completion of Part A. The sponsor may decide not to continue the study as a whole after completion of Part A if the data do not support further development.

Part B of the study will no longer be conducted.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Rogaratinib + Atezolizumab in Part A	Rogaratinib (BAY1163877)	Part A: Part A is conducted in patients who are cisplatin-ineligible and have had no prior systemic treatment for locally advanced or metastatic disease. Patients will receive rogaratinib plus atezolizumab combination treatment.
Rogaratinib + Atezolizumab in Part A	Atezolizumab	Part A: Part A is conducted in patients who are cisplatin-ineligible and have had no prior systemic treatment for locally advanced or metastatic disease. Patients will receive rogaratinib plus atezolizumab combination treatment.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Drug-related TEAEs	up to 90 days after the last study medication intake, an average of 60 days
Number of Participants With Treatment-emergent Serious Adverse Events(TESAEs)	up to 90 days after the last study medication intake, an average of 60 days
Number of Participants With Dose-limiting Toxicities(DLTs)	Up to 21 days
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	up to 90 days after the last study medication intake, an average of 60 days

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate(ORR)	Up to 5 months	Objective response rate (ORR) was defined as the percentage of patients with complete response (CR) or partial response (PR). Patients for whom best overall tumor response was not CR or PR, as well as patients without any post-baseline tumor assessment were considered non-responders. For all patients, the best overall tumor response was determined locally by investigators using the RECIST (Response Evaluation Criteria In Solid Tumors) criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Area Under the Rogaratinib Concentration Versus Time Curve (AUC)	At cycle 1 Day 1, 0-t(last)
Maximal Plasma Concentration (Cmax) of Rogaratinib	At cycle 1 Day 1

Locations (30): UChicago Medicine Comprehensive Cancer Center - Hyde Park
🇺🇸
Chicago, Illinois, United States
Barbara Ann Karmanos Cancer Institute - Detroit Headquarters
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Detroit, Michigan, United States
Institut Bergonie - Unicancer Nouvelle Aquitaine
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Bordeaux Cedex, France
Azienda Ospedaliero Universitaria di Modena
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Modena, Emilia-Romagna, Italy
University of Arizona Cancer Center
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Tucson, Arizona, United States
Memorial Sloan-Kettering Cancer Center
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New York, New York, United States
Ordensklinikum Linz GmbH Elisabethinen
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Linz, Oberösterreich, Austria
Krankenhaus der Barmherzigen Brüder
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Vienna, Wien, Austria
Uniklinikum Salzburg - Landeskrankenhaus
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Salzburg, Austria
Universitätsklinikum AKH Wien
🇦🇹
Wien, Austria
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UChicago Medicine Comprehensive Cancer Center - Hyde Park
🇺🇸Chicago, Illinois, United States