Derazantinib and Atezolizumab in Patients With Urothelial Cancer (FIDES-02)
Urothelial Carcinoma
About this trial
This is an interventional treatment trial for Urothelial Carcinoma focused on measuring metastatic urothelial cancer, bladder cancer, Fibroblast Growth Factor Receptor, FGFR genetic aberration, targeted therapy, derazantinib, checkpoint inhibitor, immune checkpoint blockade, atezolizumab, Tecentriq, solid tumor
Eligibility Criteria
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)
- Measurable disease per RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2
- Adequate bone marrow, liver and renal function
Exclusion Criteria:
- Receipt of chemotherapy, targeted therapies, immunotherapy, or treatment with an investigational anticancer agent within 2 weeks or at least 5 half-lives of the drug whichever is longer before the first dose of study drug.
- Concurrent evidence of any clinically significant corneal or retinal disorder
- Phosphatemia greater than institutional upper limit of normal (ULN) at screening
- Uncontrolled tumor-related hypercalcemia
Sites / Locations
- CTCA Clinical Research Inc., Atlanta
- Englander Institute Weill Cornell Medicine
- New York Cancer and Blood Specialists
- University of Texas Southwestern Medical Center (UTSWMC)
- MD Anderson
- NEXT Oncology
- Medical Oncology Associates PS (dba Summit Cancer Centers)
- Coastal Cancer Care
- Canberra Hospital and Health Services
- John Flynn Private Hospital
- Ballarat Oncology & Haematology Services
- Westmead Hospital
- Medizinische Universitaet Wien - Allgemeines Krankenhaus der Stadt Wien (AKH) - Universitaetsklinik fuer Urologie
- Princess Margaret Hospital
- Juravinski Cancer Center
- Fakultni nemocnice u sv. Anny v Brne
- Fakultni Nemocnice Olomouc
- Institut Bergonie
- Centre François Baclesse
- CHU Timone / CEPCM
- Medical Oncology - Pitié-Salpêtrière Hopital
- IUCT-Oncopole de Toulouse
- Institut Gustave Roussy
- Campus Charite Mitte
- Universitaetsklinikum Duesseldorf
- University Clinic Erlangen
- Universitaetsklinikum Magdeburg A.oe.R
- Studienpraxis Urologie
- National Institute of Oncology
- Bacs- Kiskun Megyei Korhaz
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
- IRCCS Ospedale San Raffaele
- Fondazione IRCCS Istituto Nazionale dei Tumori
- IRCCS - Istituto Europeo di Oncologia IEO
- Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte
- ASST Valtellina e Alto Lario - UOC Oncologia Medica Ospedale di Sondrio
- Inje University Haeundae Paik Hospital
- Pusan National University Hospital
- Chungnam National University Hospital
- National Cancer Center
- Gachon University Gil Medical Center
- Seoul National University Bundang Hospital
- Korea University Anam Hospital
- Seoul National University Hospital
- Yonsei University Health System
- Asan Medical Center
- Seoul St. Marys Hospital Catholic University of Korea
- Wojewodzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego
- Med-Polonia Sp. z o. o.
- Szpital Grochowski im. dr med. Rafała Masztaka Sp. z o.o., 04-073, Warszawa, Poland
- Mazowiecki Szpital Onkologiczny
- Vall d Hebron Hospital
- Hospital del Mar
- IOB - Hospital Quiron Salud
- ICO Hospitalet
- Hospital Universitario HM Sanchinarro CIOCC
- Marques de Valdecilla University Hospital
- Hospital Universitario Virgen Macarena
- Hospital Universitario Virgen del Rocio
- Kantonsspital Graubünden
- Lausanne University Hospital
- UniversitaetsSpital Zuerich
- Barts and The London School of Medicine and Dentistry - Barts Cancer Institute (BCI)
- The Sarah Cannon Research Institute
- University College London Hospitals
- The Royal Marsden NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Substudy 1: Derazantinib 300 mg once daily
Substudy 2 (Dose-Level 1): Derazantinib 200 mg once daily + atezolizumab 1200 mg
Substudy 2 (Dose-Level 2): Derazantinib 300 mg once daily + atezolizumab 1200 mg
Substudy 3: Derazantinib 200 mg twice daily + atezolizumab 1200 mg
Substudy 4 (Cohort 4a):Derazantinib 300 mg once daily
Substudy 4 (Cohort 4b):Derazantinib 300 mg once daily + atezolizumab 1200 mg
Substudy 5: Derazantinib 200 mg twice daily
Patients with urothelial cancer were treated with derazantinib 300 mg once daily
Patients with any solid tumors were treated with derazantinib 200 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as intravenous (IV) infusion
Patients with any solid tumors were treated with derazantinib 300 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion
Patients with urothelial cancer were treated with derazantinib 200 mg twice daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion
Patients with FGFR inhibitor resistant urothelial cancer were treated with derazantinib 300 mg once daily
Patients with urothelial cancer were treated with derazantinib 300 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion
Patients with urothelial cancer were treated with derazantinib 200 mg twice daily