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

PHASE1CompletedINTERVENTIONAL
Enrollment

37

Participants

Timeline

Start Date

May 15, 2018

Primary Completion Date

July 16, 2021

Study Completion Date

July 10, 2024

Conditions
Urothelial Carcinoma
Interventions
DRUG

Rogaratinib (BAY1163877)

Part A:Rogaratinib will be administered orally until disease progression, unacceptable toxicity or consent withdrawal. The starting dose of 800 mg b.i.d. will be confirmed using a dose selection design.

DRUG

Atezolizumab

Part A: A fixed dose of 1200 mg atezolizumab will be administered through intravenous (i.v.) infusion on Day 1 of each 21-day cycle until disease progression, unacceptable toxicity or consent withdrawal.

Trial Locations (30)

1020

Krankenhaus der Barmherzigen Brüder, Vienna

1090

Universitätsklinikum AKH Wien, Vienna

4020

Ordensklinikum Linz GmbH Elisabethinen, Linz

5020

Uniklinikum Salzburg - Landeskrankenhaus, Salzburg

8036

Hospital Clínic i Provincial de Barcelona, Barcelona

10065

Memorial Sloan-Kettering Cancer Center, New York

20133

Fondazione IRCCS Istituto Nazionale dei Tumori, Milan

20141

Istituto Europeo di Oncologia s.r.l - Sviluppo di nuovi farmaci per Terapie Innovative, Milan

33076

Institut Bergonie - Unicancer Nouvelle Aquitaine, Bordeaux

35128

Istituto Oncologico Veneto, Padua

37134

A.O.U.I. Verona, Verona

41100

Azienda Ospedaliero Universitaria di Modena, Modena

44800

Institut de Cancérologie de l'Ouest - Saint Herblain, Saint-Herblain

45147

Universitätsklinikum Essen, Essen

46014

Hospital General Universitario de Valencia, Valencia

48201

Barbara Ann Karmanos Cancer Institute - Detroit Headquarters, Detroit

50937

Universitätsklinikum Köln, Cologne

55101

Universitätsmedizin der Johannes Gutenberg Universität Mainz, Mainz

59020

Centre Oscar Lambret - Lille, Lille

60637

UChicago Medicine Comprehensive Cancer Center - Hyde Park, Chicago

85724

University of Arizona Cancer Center, Tucson

277-8577

National Cancer Center Hospital East, Kashiwa

791-0280

National Hospital Organization Shikoku Cancer Center, Matsuyama

305-8576

University of Tsukuba Hospital, Tsukuba

135-8550

The Cancer Institute Hospital of JFCR, Koto-ku

03722

Severance Hospital, Yonsei University Health System, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

08035

Ciutat Sanitaria i Universitaria de la Vall d'Hebron, Barcelona

Unknown

"Hospital Ramón y Cajal , Oncología"

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY

NCT03473756 - Phase 1b/2 Study of Rogaratinib (BAY1163877) in Combination With Atezolizumab in Urothelial Carcinoma | Biotech Hunter | Biotech Hunter