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A Study of Erdafitinib in Participants With Metastatic or Locally Advanced Urothelial Cancer

Primary Purpose

Urothelial Carcinoma

Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Erdafitinib
Cetrelimab
Cisplatin
Carboplatin
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urothelial Carcinoma

Eligibility Criteria

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

Inclusion Criteria:

  • Histologic demonstration of transitional cell carcinoma of the urothelium. Variant urothelial carcinoma histologies such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable
  • Metastatic or locally advanced urothelial cancer
  • Must have measurable disease by radiological imaging according to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) at baseline
  • Prior systemic therapy for metastatic urothelial cancer: (a) For Phase 1b erdafitinib + cetrelimab cohort: Any number of lines of prior therapy; (b) For Phase 1b erdafitinib + cetrelimab + platinum chemotherapy cohort: No prior systemic therapy for metastatic disease; and renal function for participants must have a creatinine clearance (CrCl) greater than (>) 30 milliliter per minute (mL/min) to receive carboplatin and >60 mL/min to receive cisplatin as calculated by Cockcroft Gault and (c) Phase 2: No prior systemic therapy for metastatic disease and cisplatin-ineligible based on: ECOG PS 0-1 and at least one of the following criteria: Renal function defined as creatinine clearance (CrCl) less than (˂) 60 mL/min as calculated by Cockcroft-Gault; Grade 2 or higher peripheral neuropathy per NCI-CTCAE version 5.0; Grade 2 or higher hearing loss per NCI-CTCAE version 5.0 OR ECOG PS 2
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) grade of: (a) Phase 1b erdafitinib + cetrelimab cohort: ECOG 0-2; (b) Phase 1b erdafitinib + cetrelimab + platinum chemotherapy cohort: ECOG 0-1 for cisplatin and 0-2 for carboplatin (c) Phase 2: ECOG 0-2

Exclusion Criteria:

  • Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to Cycle 1 Day 1. For Phase 1b, participants who have received the following prior antitumor therapy: received nitrosoureas and mitomycin C within 6 weeks
  • Phase 1b erdafitinib + cetrelimab cohort: Chemotherapy within 3 weeks of Cycle 1 Day 1; Phase 1b erdafitinib + cetrelimab + platinum chemotherapy cohort and Phase 2: Prior neoadjuvant/adjuvant chemotherapy is allowed if the last dose was given >12 months prior to recurrent disease progression and did not result in drug-related toxicity leading to treatment discontinuation
  • Prior anti-programmed death receptor-1 (PD-1), anti-programmed death ligand-1 (PD-L1), or anti-programmed death ligand-2 (PD-L2) therapy. Prior neoadjuvant/adjuvant checkpoint inhibitor therapy is allowed if the last dose was given more than (>)12 months prior to recurrent disease progression and did not result in drug-related toxicity leading to treatment discontinuation. PD-1 for non-muscle invasive bladder cancer is also allowed
  • Active malignancies requiring concurrent therapy other than urothelial cancer
  • Symptomatic central nervous system metastases

Sites / Locations

  • Rocky Mountain Cancer Centers
  • Norton Cancer Institute
  • Maryland Oncology Hematology, PA
  • Hackensack University Medical Center
  • Weill Cornell Medical College - NY Presbyterian Hospital
  • White Plains Hospital Center for Cancer Care
  • Levine Cancer Institute, Carolinas HealthCare System
  • Toledo Clinic Cancer Centers
  • Penn State Hershey Cancer Institute
  • Texas Oncology, P.A.
  • The University of Texas MD Anderson Cancer Center
  • Virginia Oncology Associates
  • Brest Regional Oncology Dispensary
  • Gomel Regional Clinical Oncology Dispensary
  • Grodno University Hospital
  • State Institution N.N. Alexandrov Republican Scientific and
  • Minsk city Clinical Oncological Dispensary
  • Mogilev Regional Hospital
  • Vitebsk Regional Clinical Hospital
  • Cliniques Universitaires Saint-Luc
  • ULB Hôpital Erasme
  • Jolimont
  • Az Groeninge
  • CHU de Liège - Domaine Universitaire du Sart Tilman
  • AZ Nikolaas - Campus Sint-Niklaas Moerland
  • GZA Ziekenhuizen- Campus St Augustinus
  • Fundacao Pio XII
  • Santa Casa de Misericordia de Belo Horizonte
  • Liga Paranaense de Combate ao Cancer
  • Oncocentro Servicos Medicos e Hospitalares Ltda - Oncocentro
  • Oncoclínicas Rio de Janeiro S.A.
  • Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
  • CEPHO - Centro de Estudos e Pesquisa de Hematologia e Oncologia
  • Institut de Cancerologie de Ouest (ICO) Site Paul Papin
  • Hopital Saint André
  • Centre Francois Baclesse
  • Centre hospitalier Saint Louis
  • Centre Leon Bérard
  • APHM Hopital Timone
  • Hôpital Européen Georges Pompidou
  • Clinique Sainte Anne
  • CHRU de Tours
  • Institut de Cancérologie de Lorraine
  • Institut Gustave Roussy
  • Cliniche Humanitas Gavazzeni
  • Istituto di Candiolo, IRCCS
  • Ospedale Di Zona B Ramazzini
  • UOS Oncologia Medica, A.O. Cannizzaro
  • Arcispedale S. Anna Ferrara
  • PO A.Manzoni di Lecco, ASST Lecco - Oncologia Medica - Lecco
  • Ospedale Civile Di Livorno
  • IRCCS Ospedale San Raffaele
  • ASST Grande Ospedale Metropolitano Niguarda
  • Ospedale S. Maria Della Misericordia Centro Operativo Studi Clinici SC Oncologia Medica
  • AUSL DI PIACENZA - Ospedale Guglielmo da Saliceto
  • Campus Bio-Medico di Roma
  • Azienda Socio Sanitaria Territoriale (ASST) della Valtellin
  • Azienda Ospedaliera S. Maria Terni
  • Azienda Ospedaliero Universitaria S.Maria Della Misericordia
  • Chungnam National University Hospital
  • Chonnam National University Hospital
  • The Catholic university of Korea, St. Vincent's Hospital
  • Pusan National University Yangsan Hospital
  • Seoul National University Hospital
  • Kangbuk Samsung Hospital
  • Severance Hospital, Yonsei University Health System
  • Asan Medical Center
  • The Catholic University of Korea Seoul St. Mary's Hospital
  • Seoul Metropolitan Government Seoul National University Boramae Medical Center
  • Przychodnia Lekarska KOMED Roman Karaszewski
  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
  • LUX MED Onkologia Sp. z o.o.
  • Centralny Szpital Kliniczny MSWiA w Warszawie
  • Altai Regional Oncology Dispensary
  • Ivanovo Regional Oncology Dispensary
  • GUZ Kursk Regional Oncology Dispensary
  • Leningrad Regional Oncology Dispensary
  • City Clinical Hospital n.a. D.D.Pletnev
  • Russian Scientific Center of Roentgenoradiology
  • Moscow City Clinical Hospital # 62
  • Clinical Diagnostic Centre of Nizhny Novgorod Region
  • Privolzhsky District Medical Centre
  • Clinical Oncology Dispensary
  • LLC Novaya Clinica
  • Private Medical Institution Euromedservice
  • Russian Scientific Center of Radiology and Surgical Technologies
  • Tambov Regional Oncology Clinical Dispansary
  • Multifunctional clinical medical center 'Medical city'
  • Hosp. Del Mar
  • Hosp. Clinic I Provincial de Barcelona
  • Hosp. Univ. Ramon Y Cajal
  • Hosp. Clinico San Carlos
  • Hosp. Univ. Fund. Jimenez Diaz
  • Hosp. Univ. Hm Sanchinarro
  • Hosp. Virgen de La Victoria
  • Complexo Hosp. Univ. de Ourense
  • Complejo Hospitalario de Vigo
  • Hosp. Quiron Madrid Pozuelo
  • Corporacio Sanitari Parc Tauli
  • Hosp. Univ. Marques de Valdecilla
  • H. Clinico Universitario de Santiago de Compostela
  • Hosp. Virgen Macarena
  • Hosp. Virgen Del Rocio
  • Instituto Valenciano de Oncologia
  • Hosp. Clinico Univ. de Valencia
  • Kaohsiung Chang Gung Memorial Hospital
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • China Medical University Hospital
  • National Cheng Kung University Hospital
  • National Taiwan University Hospital
  • Chang-Gung Memorial Hospital, LinKou Branch
  • Adana Acibadem Hospital
  • Memorial Ankara Hastanesi
  • Hacettepe University Medical Faculty
  • Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital
  • Adnan Menderes University Training and Research Hospital
  • Trakya University Medical Faculty
  • Istanbul University Cerrahpasa Medical Faculty
  • Istanbul Medeniyet University Goztepe Training and Research Hospital
  • Ege University
  • Kocaeli University Medical Faculty
  • Necmettin Erbakan University Meram Medical Faculty
  • Karadeniz Teknik University Medical Faculty
  • Royal Lancaster Infirmary
  • St Bartholomew's Hospital
  • University College London Hospitals Nhs Foundation Trust
  • Nottingham University Hospitals NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Phase 1b: Dose Escalation

Phase 2: Dose Expansion

Arm Description

Two dosing cohorts (erdafitinib and cetrelimab; and erdafitinib, cetrelimab and cisplatin/carboplatin) are explored in Phase 1b of the study. Participants will receive erdafitinib orally followed by cetrelimab intravenously (IV) and carboplatin/cisplatin IV as a part of platinum chemotherapy. The dose levels will be escalated sequentially based on the decisions of the Study Evaluation Team (SET) until the recommended Phase 2 Dose (RP2D) has been identified.

The participants will be randomized in a 1:1 manner to receive either erdafitinib alone (orally) or the identified RP2D of Phase 1b for erdafitinib (orally) in combination with cetrelimab (IV).

Outcomes

Primary Outcome Measures

Phase 1b: Number of Participants With Dose-Limiting Toxicity (DLTs)
Number of participants with DLTs were reported. The DLTs as per National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE version 5.0) are specific adverse events defined as grade 3 (severe), grade 4 (life-threatening), and grade 5 (death) non-hematological toxicity or hematological toxicity.
Phase 2: Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator Assessment
ORR is defined as the percentage of participants who achieved confirmed complete response (CR) or confirmed partial response (PR), according to response evaluation criteria in solid tumors (RECIST) version1.1. As per RECIST version 1.1, CR: disappearance of all lesions; all lymph nodes were non-pathological in size and normalization of tumor marker level; PR: greater than or equal to (>=) 30 percent (%) decrease in the sum of the diameters of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of nontarget lesions.
Phase 2: Number of Participants With Treatment-emergent Adverse Event (TEAEs)
Number of participants with TEAEs were reported. An adverse event is any untoward medical event that occurs in a participant administered an investigational product and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs were defined as adverse events with onset or worsening on or after date of first dose of study treatment.

Secondary Outcome Measures

Phase 1b and Phase 2: Plasma Concentration of Erdafitinib
Phase 1b and Phase 2: Serum Concentration of Cetrelimab
Phase 1b: Plasma Concentration of Platinum (Cisplatin and Carboplatin) Chemotherapy
Phase 1b and Phase 2: Number of Participants With Anti-Cetrelimab Antibodies
Phase 2: Number of Participants With Serious Adverse Events (SAEs)
Phase 2: Number of Participants With Abnormal Laboratory Values
Phase 2: Duration of Response (DoR)
Phase 2: Time to Response (TTR)
Phase 2: Progression-free Survival (PFS)
Phase 2: Overall Survival (OS)

Full Information

First Posted
March 14, 2018
Last Updated
September 29, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03473743
Brief Title
A Study of Erdafitinib in Participants With Metastatic or Locally Advanced Urothelial Cancer
Official Title
A Phase 1b-2 Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Various Regimens of Erdafitinib in Subjects With Metastatic or Locally Advanced Urothelial Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 5, 2018 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this study is to: (a) characterize the safety and tolerability of and to identify the recommended Phase 2 dose (RP2D) and schedule for erdafitinib in combination with cetrelimab, and for erdafitinib in combination with cetrelimab and platinum (cisplatin and carboplatin) chemotherapy and; (b) to evaluate the safety and clinical activity of erdafitinib alone and in combination with cetrelimab in cisplatin-ineligible participants with metastatic or locally advanced urothelial cancer (UC) with select fibroblast growth factor receptor (FGFR) gene alterations and no prior systemic therapy for metastatic disease.
Detailed Description
This open-label (all people know identity of intervention) and multicenter (when more than one hospital or medical school team work on a medical research study) study to establish the recommended phase 2 dose (RP2D) for erdafitinib and cetrelimab and/or platinum (cisplatin or carboplatin) chemotherapy, and to evaluate the safety of erdafitinib in combination with cetrelimab and platinum chemotherapy in Phase 1b and to evaluate the safety and efficacy of the RP2D of erdafitinib plus cetrelimab versus erdafitinib in Phase 2 in participants with advanced urothelial cancer with select fibroblast growth factor receptor (FGFR) gene alterations. Participants enrolled in Phase 1b erdafitinib + cetrelimab cohort may have received any number of lines of prior therapy, and participants enrolled in Phase 1b erdafitinib + cetrelimab + platinum chemotherapy cohort will have had no prior systemic therapy for metastatic disease and participants enrolled in Phase 2 will have had no prior systemic therapy for metastatic disease and will be cis-ineligible. Part 1 (Phase 1b: Dose Escalation) will identify safety and RP2Ds of erdafitinib + cetrelimab and erdafitinib + cetrelimab + platinum (cisplatin or carboplatin) chemotherapy, and Part 2 (Phase 2: Dose Expansion) will evaluate erdafitinib monotherapy and the RP2D regimen of the erdafitinib + cetrelimab combination to further characterize safety and clinical activity. The study will be conducted in 3 phases: screening phase, treatment phase, and follow-up phase. Study evaluations include efficacy, pharmacokinetics, pharmacodynamics, immunogenicity, biomarkers, and safety.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urothelial Carcinoma

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Phase 1b: Dose Escalation
Arm Type
Experimental
Arm Description
Two dosing cohorts (erdafitinib and cetrelimab; and erdafitinib, cetrelimab and cisplatin/carboplatin) are explored in Phase 1b of the study. Participants will receive erdafitinib orally followed by cetrelimab intravenously (IV) and carboplatin/cisplatin IV as a part of platinum chemotherapy. The dose levels will be escalated sequentially based on the decisions of the Study Evaluation Team (SET) until the recommended Phase 2 Dose (RP2D) has been identified.
Arm Title
Phase 2: Dose Expansion
Arm Type
Experimental
Arm Description
The participants will be randomized in a 1:1 manner to receive either erdafitinib alone (orally) or the identified RP2D of Phase 1b for erdafitinib (orally) in combination with cetrelimab (IV).
Intervention Type
Drug
Intervention Name(s)
Erdafitinib
Other Intervention Name(s)
JNJ-42756493
Intervention Description
Participants will receive erdafitinib orally.
Intervention Type
Drug
Intervention Name(s)
Cetrelimab
Other Intervention Name(s)
JNJ-63723283
Intervention Description
Participants will receive cetrelimab by intravenous infusion.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Participants will receive cisplatin by intravenous infusion as a part of platinum chemotherapy.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Participants will receive carboplatin by intravenous infusion as a part of platinum chemotherapy.
Primary Outcome Measure Information:
Title
Phase 1b: Number of Participants With Dose-Limiting Toxicity (DLTs)
Description
Number of participants with DLTs were reported. The DLTs as per National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE version 5.0) are specific adverse events defined as grade 3 (severe), grade 4 (life-threatening), and grade 5 (death) non-hematological toxicity or hematological toxicity.
Time Frame
Up to 8 weeks
Title
Phase 2: Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator Assessment
Description
ORR is defined as the percentage of participants who achieved confirmed complete response (CR) or confirmed partial response (PR), according to response evaluation criteria in solid tumors (RECIST) version1.1. As per RECIST version 1.1, CR: disappearance of all lesions; all lymph nodes were non-pathological in size and normalization of tumor marker level; PR: greater than or equal to (>=) 30 percent (%) decrease in the sum of the diameters of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of nontarget lesions.
Time Frame
From Day 1 up to 36 months
Title
Phase 2: Number of Participants With Treatment-emergent Adverse Event (TEAEs)
Description
Number of participants with TEAEs were reported. An adverse event is any untoward medical event that occurs in a participant administered an investigational product and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs were defined as adverse events with onset or worsening on or after date of first dose of study treatment.
Time Frame
From Day 1 up to 36 months
Secondary Outcome Measure Information:
Title
Phase 1b and Phase 2: Plasma Concentration of Erdafitinib
Time Frame
Up to 6 years 1 month
Title
Phase 1b and Phase 2: Serum Concentration of Cetrelimab
Time Frame
Up to 6 years 1 month
Title
Phase 1b: Plasma Concentration of Platinum (Cisplatin and Carboplatin) Chemotherapy
Time Frame
Up to 6 years 1 month
Title
Phase 1b and Phase 2: Number of Participants With Anti-Cetrelimab Antibodies
Time Frame
Up to 6 years 1 month
Title
Phase 2: Number of Participants With Serious Adverse Events (SAEs)
Time Frame
Up to 6 years 1 month
Title
Phase 2: Number of Participants With Abnormal Laboratory Values
Time Frame
Up to 6 years 1 month
Title
Phase 2: Duration of Response (DoR)
Time Frame
Up to 6 years 1 month
Title
Phase 2: Time to Response (TTR)
Time Frame
Up to 6 years 1 month
Title
Phase 2: Progression-free Survival (PFS)
Time Frame
Up to 6 years 1 month
Title
Phase 2: Overall Survival (OS)
Time Frame
Up to 6 years 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologic demonstration of transitional cell carcinoma of the urothelium. Variant urothelial carcinoma histologies such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable Metastatic or locally advanced urothelial cancer Must have measurable disease by radiological imaging according to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) at baseline Prior systemic therapy for metastatic urothelial cancer: (a) For Phase 1b erdafitinib + cetrelimab cohort: Any number of lines of prior therapy; (b) For Phase 1b erdafitinib + cetrelimab + platinum chemotherapy cohort: No prior systemic therapy for metastatic disease; and renal function for participants must have a creatinine clearance (CrCl) greater than (>) 30 milliliter per minute (mL/min) to receive carboplatin and >60 mL/min to receive cisplatin as calculated by Cockcroft Gault and (c) Phase 2: No prior systemic therapy for metastatic disease and cisplatin-ineligible based on: ECOG PS 0-1 and at least one of the following criteria: Renal function defined as creatinine clearance (CrCl) less than (˂) 60 mL/min as calculated by Cockcroft-Gault; Grade 2 or higher peripheral neuropathy per NCI-CTCAE version 5.0; Grade 2 or higher hearing loss per NCI-CTCAE version 5.0 OR ECOG PS 2 Eastern Cooperative Oncology Group (ECOG) performance status (PS) grade of: (a) Phase 1b erdafitinib + cetrelimab cohort: ECOG 0-2; (b) Phase 1b erdafitinib + cetrelimab + platinum chemotherapy cohort: ECOG 0-1 for cisplatin and 0-2 for carboplatin (c) Phase 2: ECOG 0-2 Exclusion Criteria: Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to Cycle 1 Day 1. For Phase 1b, participants who have received the following prior antitumor therapy: received nitrosoureas and mitomycin C within 6 weeks Phase 1b erdafitinib + cetrelimab cohort: Chemotherapy within 3 weeks of Cycle 1 Day 1; Phase 1b erdafitinib + cetrelimab + platinum chemotherapy cohort and Phase 2: Prior neoadjuvant/adjuvant chemotherapy is allowed if the last dose was given >12 months prior to recurrent disease progression and did not result in drug-related toxicity leading to treatment discontinuation Prior anti-programmed death receptor-1 (PD-1), anti-programmed death ligand-1 (PD-L1), or anti-programmed death ligand-2 (PD-L2) therapy. Prior neoadjuvant/adjuvant checkpoint inhibitor therapy is allowed if the last dose was given more than (>)12 months prior to recurrent disease progression and did not result in drug-related toxicity leading to treatment discontinuation. PD-1 for non-muscle invasive bladder cancer is also allowed Active malignancies requiring concurrent therapy other than urothelial cancer Symptomatic central nervous system metastases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Rocky Mountain Cancer Centers
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Norton Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Maryland Oncology Hematology, PA
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Weill Cornell Medical College - NY Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
White Plains Hospital Center for Cancer Care
City
White Plains
State/Province
New York
ZIP/Postal Code
10601
Country
United States
Facility Name
Levine Cancer Institute, Carolinas HealthCare System
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Toledo Clinic Cancer Centers
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623-3536
Country
United States
Facility Name
Penn State Hershey Cancer Institute
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Texas Oncology, P.A.
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Virginia Oncology Associates
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Brest Regional Oncology Dispensary
City
Brest
ZIP/Postal Code
224027
Country
Belarus
Facility Name
Gomel Regional Clinical Oncology Dispensary
City
Gomel
ZIP/Postal Code
246012
Country
Belarus
Facility Name
Grodno University Hospital
City
Grodno
ZIP/Postal Code
230017
Country
Belarus
Facility Name
State Institution N.N. Alexandrov Republican Scientific and
City
Lesnoy
ZIP/Postal Code
223040
Country
Belarus
Facility Name
Minsk city Clinical Oncological Dispensary
City
Minsk
ZIP/Postal Code
220013
Country
Belarus
Facility Name
Mogilev Regional Hospital
City
Mogilev
ZIP/Postal Code
212018
Country
Belarus
Facility Name
Vitebsk Regional Clinical Hospital
City
Vitebsk
ZIP/Postal Code
210603
Country
Belarus
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussel
ZIP/Postal Code
1200
Country
Belgium
Facility Name
ULB Hôpital Erasme
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Jolimont
City
Haine-Saint-Paul, La Louviere
ZIP/Postal Code
7100
Country
Belgium
Facility Name
Az Groeninge
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
CHU de Liège - Domaine Universitaire du Sart Tilman
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
AZ Nikolaas - Campus Sint-Niklaas Moerland
City
Sint-Niklaas
ZIP/Postal Code
9100
Country
Belgium
Facility Name
GZA Ziekenhuizen- Campus St Augustinus
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
Facility Name
Fundacao Pio XII
City
Barretos
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Santa Casa de Misericordia de Belo Horizonte
City
Belo Horizonte
ZIP/Postal Code
30150-221
Country
Brazil
Facility Name
Liga Paranaense de Combate ao Cancer
City
Curitiba
ZIP/Postal Code
81520-060
Country
Brazil
Facility Name
Oncocentro Servicos Medicos e Hospitalares Ltda - Oncocentro
City
Fortaleza
ZIP/Postal Code
60170-170
Country
Brazil
Facility Name
Oncoclínicas Rio de Janeiro S.A.
City
Rio de Janeiro
ZIP/Postal Code
22250-905
Country
Brazil
Facility Name
Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
City
Rio de Janeiro
ZIP/Postal Code
22775-001
Country
Brazil
Facility Name
CEPHO - Centro de Estudos e Pesquisa de Hematologia e Oncologia
City
Santo Andre
ZIP/Postal Code
09060-650
Country
Brazil
Facility Name
Institut de Cancerologie de Ouest (ICO) Site Paul Papin
City
Angers Cedex 02
ZIP/Postal Code
49055
Country
France
Facility Name
Hopital Saint André
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Centre Francois Baclesse
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
Centre hospitalier Saint Louis
City
La Rochelle Cedex 1
ZIP/Postal Code
17019
Country
France
Facility Name
Centre Leon Bérard
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
APHM Hopital Timone
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Name
Hôpital Européen Georges Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Clinique Sainte Anne
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
CHRU de Tours
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Institut de Cancérologie de Lorraine
City
Vandoeuvre lès Nancy
ZIP/Postal Code
54519
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94800
Country
France
Facility Name
Cliniche Humanitas Gavazzeni
City
Bergamo
ZIP/Postal Code
24125
Country
Italy
Facility Name
Istituto di Candiolo, IRCCS
City
Candiolo
ZIP/Postal Code
10060
Country
Italy
Facility Name
Ospedale Di Zona B Ramazzini
City
Carpi
ZIP/Postal Code
41012
Country
Italy
Facility Name
UOS Oncologia Medica, A.O. Cannizzaro
City
Catania
ZIP/Postal Code
95126
Country
Italy
Facility Name
Arcispedale S. Anna Ferrara
City
Ferrara
ZIP/Postal Code
44124
Country
Italy
Facility Name
PO A.Manzoni di Lecco, ASST Lecco - Oncologia Medica - Lecco
City
Lecco
ZIP/Postal Code
23900
Country
Italy
Facility Name
Ospedale Civile Di Livorno
City
Livorno
ZIP/Postal Code
57122
Country
Italy
Facility Name
IRCCS Ospedale San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
ASST Grande Ospedale Metropolitano Niguarda
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Ospedale S. Maria Della Misericordia Centro Operativo Studi Clinici SC Oncologia Medica
City
Perugia
ZIP/Postal Code
06132
Country
Italy
Facility Name
AUSL DI PIACENZA - Ospedale Guglielmo da Saliceto
City
Piacenza
ZIP/Postal Code
29121
Country
Italy
Facility Name
Campus Bio-Medico di Roma
City
Roma
ZIP/Postal Code
00128
Country
Italy
Facility Name
Azienda Socio Sanitaria Territoriale (ASST) della Valtellin
City
Sondrio
ZIP/Postal Code
23100
Country
Italy
Facility Name
Azienda Ospedaliera S. Maria Terni
City
Terni
ZIP/Postal Code
05100
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria S.Maria Della Misericordia
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
Chungnam National University Hospital
City
Daejeon
ZIP/Postal Code
35015
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital
City
Gwangju
ZIP/Postal Code
61469
Country
Korea, Republic of
Facility Name
The Catholic university of Korea, St. Vincent's Hospital
City
Gyeonggi-do
ZIP/Postal Code
16247
Country
Korea, Republic of
Facility Name
Pusan National University Yangsan Hospital
City
Gyeongsangnam-do
ZIP/Postal Code
50612
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Kangbuk Samsung Hospital
City
Seoul
ZIP/Postal Code
03181
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
The Catholic University of Korea Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Seoul Metropolitan Government Seoul National University Boramae Medical Center
City
Seoul
ZIP/Postal Code
07061
Country
Korea, Republic of
Facility Name
Przychodnia Lekarska KOMED Roman Karaszewski
City
Konin
ZIP/Postal Code
62-500
Country
Poland
Facility Name
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
City
Lodz
ZIP/Postal Code
93-513
Country
Poland
Facility Name
LUX MED Onkologia Sp. z o.o.
City
Warszawa
ZIP/Postal Code
01-748
Country
Poland
Facility Name
Centralny Szpital Kliniczny MSWiA w Warszawie
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Altai Regional Oncology Dispensary
City
Barnaul
ZIP/Postal Code
656049
Country
Russian Federation
Facility Name
Ivanovo Regional Oncology Dispensary
City
Ivanovo
ZIP/Postal Code
153040
Country
Russian Federation
Facility Name
GUZ Kursk Regional Oncology Dispensary
City
Kislino Village, Ryshkovsky Ru
ZIP/Postal Code
305524
Country
Russian Federation
Facility Name
Leningrad Regional Oncology Dispensary
City
Kuzmolovsky
ZIP/Postal Code
188663
Country
Russian Federation
Facility Name
City Clinical Hospital n.a. D.D.Pletnev
City
Moscow
ZIP/Postal Code
105077
Country
Russian Federation
Facility Name
Russian Scientific Center of Roentgenoradiology
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation
Facility Name
Moscow City Clinical Hospital # 62
City
Moscow
ZIP/Postal Code
125130
Country
Russian Federation
Facility Name
Clinical Diagnostic Centre of Nizhny Novgorod Region
City
Nizhny Novgorod
ZIP/Postal Code
603000
Country
Russian Federation
Facility Name
Privolzhsky District Medical Centre
City
Nizhny Novgorod
ZIP/Postal Code
603074
Country
Russian Federation
Facility Name
Clinical Oncology Dispensary
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
LLC Novaya Clinica
City
Pyatigorsk
ZIP/Postal Code
357500
Country
Russian Federation
Facility Name
Private Medical Institution Euromedservice
City
Saint Petersburg
ZIP/Postal Code
196603
Country
Russian Federation
Facility Name
Russian Scientific Center of Radiology and Surgical Technologies
City
Sankt-Peterburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Tambov Regional Oncology Clinical Dispansary
City
Tambov
ZIP/Postal Code
392013
Country
Russian Federation
Facility Name
Multifunctional clinical medical center 'Medical city'
City
Tyumen
ZIP/Postal Code
625041
Country
Russian Federation
Facility Name
Hosp. Del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hosp. Clinic I Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hosp. Univ. Ramon Y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hosp. Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hosp. Univ. Fund. Jimenez Diaz
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hosp. Univ. Hm Sanchinarro
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hosp. Virgen de La Victoria
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Complexo Hosp. Univ. de Ourense
City
Ourense
ZIP/Postal Code
32005
Country
Spain
Facility Name
Complejo Hospitalario de Vigo
City
Pontevedra
ZIP/Postal Code
36204
Country
Spain
Facility Name
Hosp. Quiron Madrid Pozuelo
City
Pozuelo de Alarcon
ZIP/Postal Code
28223
Country
Spain
Facility Name
Corporacio Sanitari Parc Tauli
City
Sabadell
ZIP/Postal Code
08208
Country
Spain
Facility Name
Hosp. Univ. Marques de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
H. Clinico Universitario de Santiago de Compostela
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hosp. Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hosp. Virgen Del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Instituto Valenciano de Oncologia
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Hosp. Clinico Univ. de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung City
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung City
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
70403
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei City
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Chang-Gung Memorial Hospital, LinKou Branch
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Adana Acibadem Hospital
City
Adana
ZIP/Postal Code
1130
Country
Turkey
Facility Name
Memorial Ankara Hastanesi
City
Ankara
ZIP/Postal Code
06520
Country
Turkey
Facility Name
Hacettepe University Medical Faculty
City
Ankara
ZIP/Postal Code
6100
Country
Turkey
Facility Name
Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital
City
Ankara
ZIP/Postal Code
6200
Country
Turkey
Facility Name
Adnan Menderes University Training and Research Hospital
City
Aydin
ZIP/Postal Code
09100
Country
Turkey
Facility Name
Trakya University Medical Faculty
City
Edirne
ZIP/Postal Code
22030
Country
Turkey
Facility Name
Istanbul University Cerrahpasa Medical Faculty
City
Istanbul
ZIP/Postal Code
34096
Country
Turkey
Facility Name
Istanbul Medeniyet University Goztepe Training and Research Hospital
City
Istanbul
ZIP/Postal Code
34732
Country
Turkey
Facility Name
Ege University
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Kocaeli University Medical Faculty
City
Kocaeli
Country
Turkey
Facility Name
Necmettin Erbakan University Meram Medical Faculty
City
Konya
ZIP/Postal Code
42080
Country
Turkey
Facility Name
Karadeniz Teknik University Medical Faculty
City
Trabzon
ZIP/Postal Code
61080
Country
Turkey
Facility Name
Royal Lancaster Infirmary
City
Lancaster
ZIP/Postal Code
LA1 4rp
Country
United Kingdom
Facility Name
St Bartholomew's Hospital
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
University College London Hospitals Nhs Foundation Trust
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

A Study of Erdafitinib in Participants With Metastatic or Locally Advanced Urothelial Cancer

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