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Derazantinib and Atezolizumab in Patients With Urothelial Cancer (FIDES-02)

Primary Purpose

Urothelial Carcinoma

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Derazantinib 300 mg once daily monotherapy
Derazantinib 200 mg once daily + atezolizumab 1200 mg
Derazantinib 300 mg once daily+ atezolizumab 1200 mg
Derazantinib 200 mg twice daily + atezolizumab 1200 mg
Derazantinib 300 mg once daily monotherapy (QD)
Derazantinib 300 mg once daily + atezolizumab 1200 mg
Derazantinib 200 mg twice daily monotherapy
Sponsored by
Basilea Pharmaceutica
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

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

Arm Description

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

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR) Based on RECIST 1.1 (Substudies 1,3,4 and 5)
ORR was defined as the proportion of patients who achieved a confirmed clinical response (CR) or partial response (PR) by blinded investigator central review (BICR) using the internationally recognized criteria for the radiological assessment in tumor response of solid tumors (RECIST) Version 1.1
Recommended Phase 2 Dose (RP2D) of Derazantinib-atezolizumab in Combination Based on DLT Criteria, Safety and Efficacy Data (Substudy 2)
The RP2D was determined by a joint decision taken by the Independent Data Monitoring Committee (IDMC), Investigators, and the Sponsor in reviewing the aggregate of DLT and AE data, and considering efficacy data
Number of Patients With Dose-limiting Toxicities (DLTs) in Substudy 2
In Substudy 2, the primary endpoint was the number of patients with DLTs. A DLT was defined as a clinically-significant adverse event (AE) or abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness, or concomitant medications. Any DLT had to be a toxicity considered at least possibly related to derazantinib or the combination of derazantinib and atezolizumab

Secondary Outcome Measures

Disease Control Rate (DCR) Per RECIST 1.1 in All Substudies
DCR was defined as the proportion of patients who achieved a confirmed clinical response (CR), partial response (PR) or stable disease (SD) by BICR using the internationally recognized criteria in accordance with RECIST Version 1.1
Duration of Response (DOR) Per RECIST 1.1
DOR was calculated from the first date of documented tumor response (confirmed CR or PR) to the date of disease progression as assessed by BICR or death per RECIST 1.1
ORR Based on RECIST 1.1 (Substudy 2)
ORR was defined as the proportion of patients who achieved a confirmed clinical response (CR) or partial response (PR) by blinded investigator central review (BICR) using the internationally recognized criteria for the radiological assessment in tumor response of solid tumors (RECIST) Version 1.1
Progression-free Survival (PFS) by RECIST in All Substudies
PFS was calculated as the time from cohort assignment until disease progression as assessed by BICR, or death from any cause, whichever came first
Overall Survival (OS) in All Substudies
OS was calculated from the date of cohort assignment until death from any cause
Number of Patients With at Least Grade 3 Adverse Events (AEs)
Common Terminology Criteria for Adverse Events (CTCAE) displayed by increasing severity grades 3 to 5 (CTCAE grade 3/4/5 )

Full Information

First Posted
July 26, 2019
Last Updated
September 21, 2023
Sponsor
Basilea Pharmaceutica
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1. Study Identification

Unique Protocol Identification Number
NCT04045613
Brief Title
Derazantinib and Atezolizumab in Patients With Urothelial Cancer
Acronym
FIDES-02
Official Title
An Open-label Multi-cohort Phase 1b/2 Study of Derazantinib and Atezolizumab in Patients With Urothelial Cancer Expressing Activating Molecular FGFR Aberrations
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
August 2, 2019 (Actual)
Primary Completion Date
October 4, 2022 (Actual)
Study Completion Date
October 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Basilea Pharmaceutica

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study was to evaluate efficacy of derazantinib monotherapy or derazantinib-atezolizumab in combination in patients with advanced urothelial cancer harboring fibroblast growth factor receptor (FGFR) genetic aberrations (GA) of various clinical stages of disease progression and prior treatments.
Detailed Description
The study comprised five open-label substudies (1-5) in patients with advanced urothelial cancer harboring FGFR GA (with the exception of substudy 2 which did not require a FGFR GA) who were treated by derazantinib monotherapy or derazantinib in combination with atezolizumab. The study enrolled patients with cisplatin-ineligible status, or patients whose disease progressed after either first-line treatment or prior treatment with FGFR inhibitors.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urothelial Carcinoma
Keywords
metastatic urothelial cancer, bladder cancer, Fibroblast Growth Factor Receptor, FGFR genetic aberration, targeted therapy, derazantinib, checkpoint inhibitor, immune checkpoint blockade, atezolizumab, Tecentriq, solid tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
95 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Substudy 1: Derazantinib 300 mg once daily
Arm Type
Experimental
Arm Description
Patients with urothelial cancer were treated with derazantinib 300 mg once daily
Arm Title
Substudy 2 (Dose-Level 1): Derazantinib 200 mg once daily + atezolizumab 1200 mg
Arm Type
Experimental
Arm Description
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
Arm Title
Substudy 2 (Dose-Level 2): Derazantinib 300 mg once daily + atezolizumab 1200 mg
Arm Type
Experimental
Arm Description
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
Arm Title
Substudy 3: Derazantinib 200 mg twice daily + atezolizumab 1200 mg
Arm Type
Experimental
Arm Description
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
Arm Title
Substudy 4 (Cohort 4a):Derazantinib 300 mg once daily
Arm Type
Experimental
Arm Description
Patients with FGFR inhibitor resistant urothelial cancer were treated with derazantinib 300 mg once daily
Arm Title
Substudy 4 (Cohort 4b):Derazantinib 300 mg once daily + atezolizumab 1200 mg
Arm Type
Experimental
Arm Description
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
Arm Title
Substudy 5: Derazantinib 200 mg twice daily
Arm Type
Experimental
Arm Description
Patients with urothelial cancer were treated with derazantinib 200 mg twice daily
Intervention Type
Drug
Intervention Name(s)
Derazantinib 300 mg once daily monotherapy
Intervention Description
Derazantinib was administered orally at a dose of 300 mg once daily
Intervention Type
Drug
Intervention Name(s)
Derazantinib 200 mg once daily + atezolizumab 1200 mg
Intervention Description
Derazantinib was administered orally at a dose of 200 mg once daily in combination with atezolizumab 1200 mg every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Derazantinib 300 mg once daily+ atezolizumab 1200 mg
Intervention Description
Derazantinib was administered orally at a dose of 300 mg once daily in combination with atezolizumab 1200 mg every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Derazantinib 200 mg twice daily + atezolizumab 1200 mg
Intervention Description
Derazantinib was administered orally at a dose of 200 mg twice daily in combination with atezolizumab 1200 mg every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Derazantinib 300 mg once daily monotherapy (QD)
Intervention Description
Derazantinib was administered orally at a dose of 300 mg once daily
Intervention Type
Drug
Intervention Name(s)
Derazantinib 300 mg once daily + atezolizumab 1200 mg
Intervention Description
Derazantinib was administered orally at a dose of 300 mg once daily in combination with atezolizumab 1200 mg every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Derazantinib 200 mg twice daily monotherapy
Intervention Description
Derazantinib was administered orally at a dose of 200 mg twice daily
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR) Based on RECIST 1.1 (Substudies 1,3,4 and 5)
Description
ORR was defined as the proportion of patients who achieved a confirmed clinical response (CR) or partial response (PR) by blinded investigator central review (BICR) using the internationally recognized criteria for the radiological assessment in tumor response of solid tumors (RECIST) Version 1.1
Time Frame
From first dose up to 2 years
Title
Recommended Phase 2 Dose (RP2D) of Derazantinib-atezolizumab in Combination Based on DLT Criteria, Safety and Efficacy Data (Substudy 2)
Description
The RP2D was determined by a joint decision taken by the Independent Data Monitoring Committee (IDMC), Investigators, and the Sponsor in reviewing the aggregate of DLT and AE data, and considering efficacy data
Time Frame
From first dose up to 2 years
Title
Number of Patients With Dose-limiting Toxicities (DLTs) in Substudy 2
Description
In Substudy 2, the primary endpoint was the number of patients with DLTs. A DLT was defined as a clinically-significant adverse event (AE) or abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness, or concomitant medications. Any DLT had to be a toxicity considered at least possibly related to derazantinib or the combination of derazantinib and atezolizumab
Time Frame
From first dose up to 2 years
Secondary Outcome Measure Information:
Title
Disease Control Rate (DCR) Per RECIST 1.1 in All Substudies
Description
DCR was defined as the proportion of patients who achieved a confirmed clinical response (CR), partial response (PR) or stable disease (SD) by BICR using the internationally recognized criteria in accordance with RECIST Version 1.1
Time Frame
From first dose up to 2 years
Title
Duration of Response (DOR) Per RECIST 1.1
Description
DOR was calculated from the first date of documented tumor response (confirmed CR or PR) to the date of disease progression as assessed by BICR or death per RECIST 1.1
Time Frame
From first dose up to 2 years
Title
ORR Based on RECIST 1.1 (Substudy 2)
Description
ORR was defined as the proportion of patients who achieved a confirmed clinical response (CR) or partial response (PR) by blinded investigator central review (BICR) using the internationally recognized criteria for the radiological assessment in tumor response of solid tumors (RECIST) Version 1.1
Time Frame
From first dose up to 2 years
Title
Progression-free Survival (PFS) by RECIST in All Substudies
Description
PFS was calculated as the time from cohort assignment until disease progression as assessed by BICR, or death from any cause, whichever came first
Time Frame
From first dose up to 2 years
Title
Overall Survival (OS) in All Substudies
Description
OS was calculated from the date of cohort assignment until death from any cause
Time Frame
From first dose up to 2 years
Title
Number of Patients With at Least Grade 3 Adverse Events (AEs)
Description
Common Terminology Criteria for Adverse Events (CTCAE) displayed by increasing severity grades 3 to 5 (CTCAE grade 3/4/5 )
Time Frame
From first dose and until 90 days following the last dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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) (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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manuel Häckl, MD
Organizational Affiliation
Basilea Pharmaceutica International Ltd, Allschwil
Official's Role
Study Director
Facility Information:
Facility Name
CTCA Clinical Research Inc., Atlanta
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30265
Country
United States
Facility Name
Englander Institute Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
New York Cancer and Blood Specialists
City
Port Jefferson Station
State/Province
New York
ZIP/Postal Code
11776
Country
United States
Facility Name
University of Texas Southwestern Medical Center (UTSWMC)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8852
Country
United States
Facility Name
MD Anderson
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
NEXT Oncology
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Medical Oncology Associates PS (dba Summit Cancer Centers)
City
Spokane
State/Province
Washington
ZIP/Postal Code
99208
Country
United States
Facility Name
Coastal Cancer Care
City
Birtinya
ZIP/Postal Code
4575
Country
Australia
Facility Name
Canberra Hospital and Health Services
City
Canberra
ZIP/Postal Code
2065
Country
Australia
Facility Name
John Flynn Private Hospital
City
Tugun
ZIP/Postal Code
4224
Country
Australia
Facility Name
Ballarat Oncology & Haematology Services
City
Wendouree
ZIP/Postal Code
3355
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
ZIP/Postal Code
2145
Country
Australia
Facility Name
Medizinische Universitaet Wien - Allgemeines Krankenhaus der Stadt Wien (AKH) - Universitaetsklinik fuer Urologie
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Juravinski Cancer Center
City
Hamilton
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Fakultni nemocnice u sv. Anny v Brne
City
Brno
ZIP/Postal Code
61700
Country
Czechia
Facility Name
Fakultni Nemocnice Olomouc
City
Olomouc
ZIP/Postal Code
77900
Country
Czechia
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076 CEDEX
Country
France
Facility Name
Centre François Baclesse
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
CHU Timone / CEPCM
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Name
Medical Oncology - Pitié-Salpêtrière Hopital
City
Paris
ZIP/Postal Code
75030
Country
France
Facility Name
IUCT-Oncopole de Toulouse
City
Toulouse
ZIP/Postal Code
31100
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Campus Charite Mitte
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Universitaetsklinikum Duesseldorf
City
Duesseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
University Clinic Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Universitaetsklinikum Magdeburg A.oe.R
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Studienpraxis Urologie
City
Nürtingen
ZIP/Postal Code
72622
Country
Germany
Facility Name
National Institute of Oncology
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Bacs- Kiskun Megyei Korhaz
City
Kecskemét
ZIP/Postal Code
6000
Country
Hungary
Facility Name
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
IRCCS Ospedale San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
IRCCS - Istituto Europeo di Oncologia IEO
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
ASST Valtellina e Alto Lario - UOC Oncologia Medica Ospedale di Sondrio
City
Sondrio
ZIP/Postal Code
23100
Country
Italy
Facility Name
Inje University Haeundae Paik Hospital
City
Busan
ZIP/Postal Code
48108
Country
Korea, Republic of
Facility Name
Pusan National University Hospital
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Chungnam National University Hospital
City
Daejeon
ZIP/Postal Code
35105
Country
Korea, Republic of
Facility Name
National Cancer Center
City
Goyang-si
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Yonsei University Health System
City
Seoul
ZIP/Postal Code
3722
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
5505
Country
Korea, Republic of
Facility Name
Seoul St. Marys Hospital Catholic University of Korea
City
Seoul
ZIP/Postal Code
6591
Country
Korea, Republic of
Facility Name
Wojewodzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego
City
Lublin
ZIP/Postal Code
20-718
Country
Poland
Facility Name
Med-Polonia Sp. z o. o.
City
Poznań
ZIP/Postal Code
60-693
Country
Poland
Facility Name
Szpital Grochowski im. dr med. Rafała Masztaka Sp. z o.o., 04-073, Warszawa, Poland
City
Warszawa
ZIP/Postal Code
04-073
Country
Poland
Facility Name
Mazowiecki Szpital Onkologiczny
City
Wieliszew
ZIP/Postal Code
05-135
Country
Poland
Facility Name
Vall d Hebron Hospital
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
8003
Country
Spain
Facility Name
IOB - Hospital Quiron Salud
City
Barcelona
ZIP/Postal Code
8023
Country
Spain
Facility Name
ICO Hospitalet
City
Barcelona
ZIP/Postal Code
8908
Country
Spain
Facility Name
Hospital Universitario HM Sanchinarro CIOCC
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Marques de Valdecilla University Hospital
City
Santander
ZIP/Postal Code
39011
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
14009
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Kantonsspital Graubünden
City
Chur
ZIP/Postal Code
7000
Country
Switzerland
Facility Name
Lausanne University Hospital
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
UniversitaetsSpital Zuerich
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Barts and The London School of Medicine and Dentistry - Barts Cancer Institute (BCI)
City
London
ZIP/Postal Code
EC1M 6BQ
Country
United Kingdom
Facility Name
The Sarah Cannon Research Institute
City
London
ZIP/Postal Code
W1G 6AD
Country
United Kingdom
Facility Name
University College London Hospitals
City
London
ZIP/Postal Code
W1T7HA
Country
United Kingdom
Facility Name
The Royal Marsden NHS Foundation Trust
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Derazantinib and Atezolizumab in Patients With Urothelial Cancer

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