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A Study of the Safety and Efficacy of Various Combinations of Avelumab as Therapy in Locally Advanced or Metastatic Urothelial Carcinoma (JAVELIN Bladder Medley)

Primary Purpose

Locally Advanced or Metastatic Urothelial Carcinoma

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Avelumab
Sacituzumab Govitecan
M6223
NKTR-255
Sponsored by
EMD Serono Research & Development Institute, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Locally Advanced or Metastatic Urothelial Carcinoma focused on measuring Avelumab, Avelumab in combination, Bladder cancer, M6223 (anti-TIGIT antibody), PD-L1, Sacituzumab govitecan (Trop-2 antibody drug conjugate), NKTR-255 (IL-15 agonist)

Eligibility Criteria

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

Inclusion Criteria:

  • Participants with histologically confirmed, unresectable locally advanced or metastatic urothelial carcinoma. Both transitional cell and mixed transitional/non- transitional cell histologies are allowed, but transitional cell carcinoma must be the predominant histology
  • Participants has documented Stage IIIA/IIIB with N1-N3, or Stage IV disease (per American Joint Committee on Cancer/International Union for Cancer Control Tumor Node Metastasis system, 8th edition) at the start of first line chemotherapy.
  • The last dose of first line chemotherapy must have been received no less than 4 weeks, and no more than 10 weeks, prior to randomization in the present study
  • Estimated life expectancy of at least 3 months
  • Participants without progressive disease as per RECIST v1.1 guidelines following completion of 4 to 6 cycles of 1L chemotherapy. Eligibility based on this criterion will be determined by Investigator review of pre chemotherapy and post chemotherapy radiological assessments (CT/MRI scans).
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
  • Adequate hematological, hepatic, and renal function as defined in the protocol
  • Other protocol defined inclusion criteria could apply

Exclusion Criteria:

  • Participants with prior immunotherapy with Interleukin-2 (IL-2), IL-15, interferon alfa (IFN-α), or an anti programmed death receptor-1 (PD-1), anti programmed death-ligand 1 (PD-L1), anti PD-L2, anti CD137, or cytotoxic T cell lymphocyte-4 (CTLA-4) antibody (including ipilimumab), anti TROP2, any other antibody or drug specifically targeting T cell costimulation or immune checkpoint pathways, or any of the investigational drugs used in combination with avelumab.
  • Participants with active infection 48 hours before randomization requiring systemic therapy
  • Participants with known prior or suspected hypersensitivity to study drugs or any component in their formulations
  • Participants with prior adjuvant or neoadjuvant systemic therapy within 12 months of randomization
  • Participants with vaccination within 4 weeks of the first dose of study treatment and while on trial is prohibited except for administration of inactivated vaccines (for example, inactivated influenza vaccines) and replication-deficient coronavirus vaccines approved or authorized by local Health Authorities
  • Other protocol defined exclusion criteria could apply

Sites / Locations

  • Beacon Cancer Care
  • Rush University Medical Center
  • University of Kansas Medical Center Research Institute, Inc. - 3901 Rainbow (MAIN)Recruiting
  • The Johns Hopkins Hospital
  • AMR Kansas City, Formerly Center for Pharmaceutical Research, an AMR company - Kansas City, MO at St. Joseph Medical CenterRecruiting
  • Washington University
  • Inova Schar Cancer Institute
  • Seattle Cancer Care AllianceRecruiting
  • Multicare Health System Tacoma General HospitalRecruiting
  • University of Wisconsin Cancer CenterRecruiting
  • Flinders Medical CentreRecruiting
  • Monash Medical Centre ClaytonRecruiting
  • Sunshine Hospital - PARENTRecruiting
  • Austin HealthRecruiting
  • Ashford Cancer Centre ResearchRecruiting
  • Liverpool Hospital - PARENTRecruiting
  • Calvary Mater Newcastle - PARENTRecruiting
  • Tasman Oncology Research Ltd - OncologyRecruiting
  • Royal North Shore Hospital - PARENTRecruiting
  • Macquarie University Hospital - PARENTRecruiting
  • St Vincent's Hospital Sydney - PARENTRecruiting
  • ZNA Middelheim - Middelheim - account 2Recruiting
  • AZ Klina - PARENTRecruiting
  • Institut Jules Bordet - Medical OncologyRecruiting
  • Universitair Ziekenhuis Gent - Medical OncologyRecruiting
  • AZ Groeninge - Campus Kennedylaan - account 2Recruiting
  • Centre Hospitalier de l'Ardenne - PARENTRecruiting
  • CHU de Liège - PARENTRecruiting
  • Universitaetsklinikum Wuerzburg - Klinik u. Poliklinik f. Urologie u. KinderurologieRecruiting
  • William Osler Health System - Brampton Civic HospitalRecruiting
  • CISSS de la Monteregie-Centre - Hospital Charles Le MoyneRecruiting
  • CHUM Centre de RechercheRecruiting
  • The Ottawa Hospital Cancer CentreRecruiting
  • Sjællands University Hospital - PARENT (Næstved)Recruiting
  • Ålborg Universitets Hospital - onkologisk afdRecruiting
  • ICO - Site Paul Papin - service d'oncologie medicaleRecruiting
  • Institut Bergonié - Service d'Oncologie MédicaleRecruiting
  • Centre François Baclesse - Pathologies GynecologiquesRecruiting
  • Hôpital Henri Mondor - Service d'Oncologie MédicaleRecruiting
  • Clinique Victor Hugo - Centre Jean Bernard - Service d'Oncologie MédicalRecruiting
  • Centre Leon Berard - Service d'Oncologie MedicaleRecruiting
  • Hôpital de la Timone - service d'urologieRecruiting
  • Hopital Caremeau - Service Hématologie Clinique/Oncologie MédicaleRecruiting
  • Hôpital Cochin - Hematologie et Oncologie MédicaleRecruiting
  • CHU Poitiers - Hôpital la Milétrie - service d'oncologie médicaleRecruiting
  • CRLCC Eugene Marquis - Service d'Oncologie médicaleRecruiting
  • ICO - Site René Gauducheau - Service d'Oncologie medicaleRecruiting
  • Clinique Sainte-Anne - Service d'Oncologie MédicaleRecruiting
  • Institut de Cancérologie de Strasbourg Europe - ICANS - Service d'oncologie médicaleRecruiting
  • Universitaetsklinikum Essen - Westdeutsches TumorzentrumRecruiting
  • Universitaetsklinikum Frankfurt Goethe-Universitaet - Urologie und Kinderurologie2Recruiting
  • Universitaetsklinikum Wuerzburg - Klinik u. Poliklinik f. Urologie u. KinderurologieRecruiting
  • Universitaetsklinikum Muenster - Klinik und Poliklinik fuer UrologieRecruiting
  • Kliniken Maria Hilf GmbH - Klinik fuer UrologieRecruiting
  • Universitaetsklinikum Tuebingen - Klinik fuer UrologieRecruiting
  • Athens Medical CenterRecruiting
  • General Hospital of Athens "Alexandra"Recruiting
  • University General Hospital "Attikon"Recruiting
  • Euromedica General Clinic of ThessalonikiRecruiting
  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS - Oncologia MedicaRecruiting
  • Azienda Ospedaliera Universitaria Careggi - S.O.D. di Oncologia MedicaRecruiting
  • IRCCS Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori "Dino Amadori" - IRST - OncologiaRecruiting
  • Fondazione IRCCS Istituto Nazionale dei Tumori - S.S. Oncologia Medica GenitourinariaRecruiting
  • Ospedale San Raffaele - U.O. di Oncologia MedicaRecruiting
  • Humanitas Istituto Clinico Catanese - Oncologia MedicaRecruiting
  • Istituto Nazionale Tumori Fondazione G. Pascale - Oncologia Medica ARecruiting
  • IOV - Istituto Oncologico Veneto IRCCS - U.O. Oncologia Medica 1Recruiting
  • Azienda Ospedaliero Universitaria Pisana - U.O. OncologiaRecruiting
  • Ospedale Santa Maria delle CrociRecruiting
  • Azienda Ospedaliera San Camillo Forlanini - Dipartimento di Oncologia MedicaRecruiting
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia MedicaRecruiting
  • IRCCS Ospedale Casa Sollievo della Sofferenza - Dipartimento di Oncologia MedicaRecruiting
  • Azienda Ospedaliera S. Maria Di Terni - S.C. Oncologia MedicaRecruiting
  • Chungnam National University Hospital - Department of Internal Medicine (Rheumatology)Recruiting
  • National Cancer CenterRecruiting
  • Seoul National University Bundang HospitalRecruiting
  • Asan Medical CenterRecruiting
  • Samsung Medical CenterRecruiting
  • Seoul National University HospitalRecruiting
  • Severance Hospital, Yonsei University Health SystemRecruiting
  • The Catholic University of Korea, Seoul St. Mary's HospitalRecruiting
  • Hospital Infanta Cristina - Unidad de Fase IRecruiting
  • Hospital Clinic de Barcelona - Servicio de OncologiaRecruiting
  • Hospital de la Santa Creu i Sant Pau - Dept of OncologyRecruiting
  • Hospital del Mar - Servicio de OncologiaRecruiting
  • Hospital Universitario Virgen del Rocio - Oncology ServiceRecruiting
  • Hospital Universitario Reina Sofia - Dept of OncologyRecruiting
  • Hospital General Universitario de Elche - Servicio de OncologiaRecruiting
  • Hospital Universitario Lucus Augusti - OncologyRecruiting
  • Hospital General Universitario Gregorio Marañon - Servicio de Oncologia MedicaRecruiting
  • ALTHAIA, Xarxa assistencial Universitaria de Manresa - Oncology DeptRecruiting
  • Hospital Clinico Universitario de Valencia - Servicio de Hematologia y Oncologia MedicaRecruiting
  • Kaohsiung Chang Gung Memorial HospitalRecruiting
  • Kaohsiung Medical University Chung-Ho Memorial HospitalRecruiting
  • China Medical University HospitalRecruiting
  • Chi Mei Hospital, LiouyingRecruiting
  • Taipei Veterans General HospitalRecruiting
  • National Taiwan University HospitalRecruiting
  • Chang Gung Memorial Hospital,LinkouRecruiting
  • Sarah Cannon Research Institute UKRecruiting
  • The Christie Hospital - Dept of OncologyRecruiting
  • Royal Preston Hospital - Rosemere Cancer CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Group A: Avelumab

Group B: Avelumab + Sacituzumab Govitecan

Group C: Avelumab + M6223

Group D: Avelumab + NKTR-255

Arm Description

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator
Number of Participants with Treatment Emergent Adverse Events (TEAEs), Treatment-Related Adverse Events, and AEs of Special Interest (AESIs) as per Qualitative Toxicity Scale [National Cancer Institute-Common Terminology Criteria for Adverse Events 5.0]

Secondary Outcome Measures

Overall Survival (OS)
Objective Response (OR) According to Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 Assessed by Investigator
Duration of Response (DoR) According to Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 Assessed by Investigator
Pharmacokinetic Serum Concentration of Avelumab, M6223, Sacituzumab govitecan and NKTR255
Number of Participants with Positive Anti-Drug Antibody (ADA) of Avelumab, M6223, Sacituzumab govitecan and NKTR-255
Change From Baseline in National Comprehensive Cancer Network- Functional Assessment of Cancer Therapy (NCCN-FACT) Bladder Symptom Index- 18 (FBlSI-18) Disease Related Symptoms-Physical Subscale (DRS-P) Scores

Full Information

First Posted
April 5, 2022
Last Updated
October 18, 2023
Sponsor
EMD Serono Research & Development Institute, Inc.
Collaborators
Merck KGaA, Darmstadt, Germany; Gilead Sciences; Nektar Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT05327530
Brief Title
A Study of the Safety and Efficacy of Various Combinations of Avelumab as Therapy in Locally Advanced or Metastatic Urothelial Carcinoma (JAVELIN Bladder Medley)
Official Title
A Phase II, Multicenter, Randomized, Open Label, Parallel-Arm, Umbrella Study of Avelumab (MSB0010718C) in Combination With Other AntiTumor Agents as a Maintenance Treatment in Participants With Locally Advanced or Metastatic Urothelial Carcinoma Whose Disease Did Not Progress With First Line Platinum-Containing Chemotherapy (JAVELIN Bladder Medley)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 17, 2022 (Actual)
Primary Completion Date
January 23, 2025 (Anticipated)
Study Completion Date
January 23, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EMD Serono Research & Development Institute, Inc.
Collaborators
Merck KGaA, Darmstadt, Germany; Gilead Sciences; Nektar Therapeutics

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 is to assess the safety and efficacy of avelumab in combination with other anti-tumor agents as a maintenance treatment in participants with bladder cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced or Metastatic Urothelial Carcinoma
Keywords
Avelumab, Avelumab in combination, Bladder cancer, M6223 (anti-TIGIT antibody), PD-L1, Sacituzumab govitecan (Trop-2 antibody drug conjugate), NKTR-255 (IL-15 agonist)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
252 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A: Avelumab
Arm Type
Experimental
Arm Title
Group B: Avelumab + Sacituzumab Govitecan
Arm Type
Experimental
Arm Title
Group C: Avelumab + M6223
Arm Type
Experimental
Arm Title
Group D: Avelumab + NKTR-255
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Avelumab
Other Intervention Name(s)
MSB0010718C
Intervention Description
Participants will receive avelumab intravenous infusion at a dose of 800 milligrams (mg) once every 2 weeks (Q2W) until unacceptable toxicity, withdraw consent or initiation of a new treatment.
Intervention Type
Drug
Intervention Name(s)
Sacituzumab Govitecan
Other Intervention Name(s)
IMMU-132, Trodelvy™, GS-0132
Intervention Description
Participants will receive sacituzumab govitecan intravenous infusion at dose of 10 milligrams per kilogram (mg/kg) of body weight once a week (Q1W) on Day 1 and 8 of 21-day treatment cycles, in combination with avelumab 800 mg Q2W, until unacceptable toxicity, withdraw consent or initiation of a new treatment.
Intervention Type
Drug
Intervention Name(s)
M6223
Intervention Description
Participants will receive M6223 (anti-T cell-immuno-receptor with Ig and ITM domains [anti-TIGIT]) intravenous infusion at dose of 1600 mg Q2W in combination with avelumab 800 mg Q2W, until unacceptable toxicity, withdraw consent or initiation of a new treatment.
Intervention Type
Drug
Intervention Name(s)
NKTR-255
Intervention Description
Participants will receive NKTR-255 intravenous infusion at a dose of 3 micrograms per kilogram body weight (mcg/kg) once every 4 weeks (Q4W) in combination with avelumab 800 mg Q2W, until unacceptable toxicity, withdraw consent or initiation of a new treatment.
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator
Time Frame
Time from randomization of study drug until first documentation of progressive disease (PD) or death, assessed approximately up to 51 months
Title
Number of Participants with Treatment Emergent Adverse Events (TEAEs), Treatment-Related Adverse Events, and AEs of Special Interest (AESIs) as per Qualitative Toxicity Scale [National Cancer Institute-Common Terminology Criteria for Adverse Events 5.0]
Time Frame
From Randomization up to the last safety follow-up visit at approximately up to 51 months
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Time Frame
Time from randomization of study drug until death, assessed approximately up to 51 months
Title
Objective Response (OR) According to Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 Assessed by Investigator
Time Frame
Time from randomization of study drug up to 51 months
Title
Duration of Response (DoR) According to Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 Assessed by Investigator
Time Frame
Time from first documented objective response to PD or death due to any cause, assessed approximately up to 51 months
Title
Pharmacokinetic Serum Concentration of Avelumab, M6223, Sacituzumab govitecan and NKTR255
Time Frame
Pre-dose up to safety follow up, assessed approximately up to maximum 51 months
Title
Number of Participants with Positive Anti-Drug Antibody (ADA) of Avelumab, M6223, Sacituzumab govitecan and NKTR-255
Time Frame
Baseline up to 51 months
Title
Change From Baseline in National Comprehensive Cancer Network- Functional Assessment of Cancer Therapy (NCCN-FACT) Bladder Symptom Index- 18 (FBlSI-18) Disease Related Symptoms-Physical Subscale (DRS-P) Scores
Time Frame
Baseline, Week 13

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants with histologically confirmed, unresectable locally advanced or metastatic urothelial carcinoma. Both transitional cell and mixed transitional/non- transitional cell histologies are allowed, but transitional cell carcinoma must be the predominant histology Participants has documented Stage IIIA/IIIB with N1-N3, or Stage IV disease (per American Joint Committee on Cancer/International Union for Cancer Control Tumor Node Metastasis system, 8th edition) at the start of first line chemotherapy. The last dose of first line chemotherapy must have been received no less than 4 weeks, and no more than 10 weeks, prior to randomization in the present study Estimated life expectancy of at least 3 months Participants without progressive disease as per RECIST v1.1 guidelines following completion of 4 to 6 cycles of 1L chemotherapy. Eligibility based on this criterion will be determined by Investigator review of pre chemotherapy and post chemotherapy radiological assessments (CT/MRI scans). Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 Adequate hematological, hepatic, and renal function as defined in the protocol Other protocol defined inclusion criteria could apply Exclusion Criteria: Participants with prior immunotherapy with Interleukin-2 (IL-2), IL-15, interferon alfa (IFN-α), or an anti programmed death receptor-1 (PD-1), anti programmed death-ligand 1 (PD-L1), anti PD-L2, anti CD137, or cytotoxic T cell lymphocyte-4 (CTLA-4) antibody (including ipilimumab), anti TROP2, anti-T-cell-immuno-receptor with Ig and ITM domains (anti-TIGIT) any other antibody or drug specifically targeting T cell costimulation or immune checkpoint pathways, agents targeting Nectin-4, or any of the investigational drugs used in combination with avelumab. Participants with active infection 48 hours before randomization requiring systemic therapy Participants with known prior or suspected hypersensitivity to study drugs or any component in their formulations Participants with prior adjuvant or neoadjuvant systemic therapy within 12 months of randomization Participants with vaccination within 4 weeks of the first dose of study treatment and while on trial is prohibited except for administration of inactivated vaccines (for example, inactivated influenza vaccines) administered >= 2 weeks prior first dose of study treatment. All severe acute respiratory syndrome coronavirus (SARS-CoV-2) vaccines approved or authorized by local Health Authorities are allowed Other protocol defined exclusion criteria could apply
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
US Medical Information
Phone
888-275-7376
Email
eMediUSA@emdserono.com
First Name & Middle Initial & Last Name or Official Title & Degree
Communication Center
Phone
+49 6151 72 5200
Email
service@emdgroup.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Responsible
Organizational Affiliation
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Official's Role
Study Director
Facility Information:
Facility Name
Beacon Cancer Care
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
Individual Site Status
Withdrawn
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University of Kansas Medical Center Research Institute, Inc. - 3901 Rainbow (MAIN)
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
sabbasi@kumc.edu
First Name & Middle Initial & Last Name & Degree
Saqib Abbasi
Facility Name
The Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
AMR Kansas City, Formerly Center for Pharmaceutical Research, an AMR company - Kansas City, MO at St. Joseph Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
66204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
drjsingh@mac.com
First Name & Middle Initial & Last Name & Degree
Jaswinder J Singh
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Inova Schar Cancer Institute
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
pgrivas@uw.edu
First Name & Middle Initial & Last Name & Degree
Petros Grivas
Facility Name
Multicare Health System Tacoma General Hospital
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
sunil.rangarajan@multicare.org
First Name & Middle Initial & Last Name & Degree
Sunil Rangarajan
Facility Name
University of Wisconsin Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53706
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
ckyriako@medicine.wisc.edu
First Name & Middle Initial & Last Name & Degree
Christos Kyriakopoulos
Facility Name
Flinders Medical Centre
City
Bedford Park
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
Email
ganessan.kichenadasse@sa.gov.au
First Name & Middle Initial & Last Name & Degree
Ganessan Kichenadasse
Facility Name
Monash Medical Centre Clayton
City
Clayton
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
Email
cameron.mclaren@monashhealth.org
First Name & Middle Initial & Last Name & Degree
Cameron McLaren
Facility Name
Sunshine Hospital - PARENT
City
Footscray
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
Email
shirley.wong@mh.org.au
First Name & Middle Initial & Last Name & Degree
Shirley Wong
Facility Name
Austin Health
City
Heidelberg
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
Email
andrew.weickhardt@austin.org.au
First Name & Middle Initial & Last Name & Degree
Andrew J Weickhardt
Facility Name
Ashford Cancer Centre Research
City
Kurralta Park
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
Email
annabel.smith@icon.team
First Name & Middle Initial & Last Name & Degree
Annabel Smith
Facility Name
Liverpool Hospital - PARENT
City
Liverpool
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
Email
wei.chua@health.nsw.gov.au
First Name & Middle Initial & Last Name & Degree
Wei Chua
Facility Name
Calvary Mater Newcastle - PARENT
City
Newcastle
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
Email
james.lynam@calvarymater.org.au
First Name & Middle Initial & Last Name & Degree
James Lynam
Facility Name
Tasman Oncology Research Ltd - Oncology
City
Southport
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
Email
andrew.hill@tasmanhealthcare.com.au
First Name & Middle Initial & Last Name & Degree
Andrew G Hill
Facility Name
Royal North Shore Hospital - PARENT
City
St Leonards
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
Email
alexander.guminski@health.nsw.gov.au
First Name & Middle Initial & Last Name & Degree
Alexander Guminski
Facility Name
Macquarie University Hospital - PARENT
City
Sydney
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
Email
alison.zhang@mqhealth.org.au
First Name & Middle Initial & Last Name & Degree
Alison Y Zhang
Facility Name
St Vincent's Hospital Sydney - PARENT
City
Westmead
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
Email
megan.crumbaker@svha.org.au
First Name & Middle Initial & Last Name & Degree
Megan Crumbaker
Facility Name
ZNA Middelheim - Middelheim - account 2
City
Antwerpen
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
Email
wesley.teurfs@zna.be
First Name & Middle Initial & Last Name & Degree
Wesley Teurfs
Facility Name
AZ Klina - PARENT
City
Brasschaat
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
Email
wim.demey@klina.be
First Name & Middle Initial & Last Name & Degree
Wim Demey
Facility Name
Institut Jules Bordet - Medical Oncology
City
Bruxelles
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
Email
nieves.martinez-chanza@bordet.be
First Name & Middle Initial & Last Name & Degree
Nieves Martinez Chanza
Facility Name
Universitair Ziekenhuis Gent - Medical Oncology
City
Gent
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
Email
sylvie.rottey@ugent.be
First Name & Middle Initial & Last Name & Degree
Sylvie Rottey
Facility Name
AZ Groeninge - Campus Kennedylaan - account 2
City
Kortrijk
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
Email
philip.debruyne@azgroeninge.be
First Name & Middle Initial & Last Name & Degree
Philip Debruyne
Facility Name
Centre Hospitalier de l'Ardenne - PARENT
City
Libramont-Chevigny
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
Email
frederic.forget@vivalia.be
First Name & Middle Initial & Last Name & Degree
Frederic Forget
Facility Name
CHU de Liège - PARENT
City
Liege
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
Email
pfreres@chuliege.be
First Name & Middle Initial & Last Name & Degree
Pierre Freres
Facility Name
Universitaetsklinikum Wuerzburg - Klinik u. Poliklinik f. Urologie u. Kinderurologie
City
Wuerzburg
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna K Seitz
Facility Name
William Osler Health System - Brampton Civic Hospital
City
Brampton
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marco Iafolla
Facility Name
CISSS de la Monteregie-Centre - Hospital Charles Le Moyne
City
Greenfield Park
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
Email
catherine.sperlich@gmail.com
First Name & Middle Initial & Last Name & Degree
Catherine Sperlich
Facility Name
CHUM Centre de Recherche
City
Montreal
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
Email
normand.blais.med@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name & Degree
Normand Blais
Facility Name
The Ottawa Hospital Cancer Centre
City
Ottawa
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
Email
ccanil@ottawahospital.on.ca
First Name & Middle Initial & Last Name & Degree
Christina M Canil
Facility Name
Sjællands University Hospital - PARENT (Næstved)
City
Naestved
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
Email
doy@regionsjaelland.dk
First Name & Middle Initial & Last Name & Degree
Dorthe Yakymenko
Facility Name
Ålborg Universitets Hospital - onkologisk afd
City
Åalborg
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
Email
andreascarus@rn.dk
First Name & Middle Initial & Last Name & Degree
Andreas Carus
Facility Name
ICO - Site Paul Papin - service d'oncologie medicale
City
Angers cedex 2
Country
France
Individual Site Status
Recruiting
Facility Contact:
Email
remy.delva@ico.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Remy Delva
Facility Name
Institut Bergonié - Service d'Oncologie Médicale
City
Bordeaux Cedex
Country
France
Individual Site Status
Recruiting
Facility Contact:
Email
g.roubaud@bordeaux.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Guilhem Roubaud
Facility Name
Centre François Baclesse - Pathologies Gynecologiques
City
Caen Decex
Country
France
Individual Site Status
Recruiting
Facility Contact:
Email
e.coquan@baclesse.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Elodie Coquan
Facility Name
Hôpital Henri Mondor - Service d'Oncologie Médicale
City
Creteil
Country
France
Individual Site Status
Recruiting
Facility Contact:
Email
christophe.tournigand@aphp.fr
First Name & Middle Initial & Last Name & Degree
Christophe Tournigand
Facility Name
Clinique Victor Hugo - Centre Jean Bernard - Service d'Oncologie Médical
City
Le Mans
Country
France
Individual Site Status
Recruiting
Facility Contact:
Email
essaisvoog@ilcgroupe.fr
First Name & Middle Initial & Last Name & Degree
Eric Voog
Facility Name
Centre Leon Berard - Service d'Oncologie Medicale
City
Lyon
Country
France
Individual Site Status
Recruiting
Facility Contact:
Email
aude.flechon@lyon.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Aude Flechon
Facility Name
Hôpital de la Timone - service d'urologie
City
Marseille Cedex 5
Country
France
Individual Site Status
Recruiting
Facility Contact:
Email
jean-laurent.deville@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
Jean Laurent Deville
Facility Name
Hopital Caremeau - Service Hématologie Clinique/Oncologie Médicale
City
Nîmes
Country
France
Individual Site Status
Recruiting
Facility Contact:
Email
nadine.houede@chu-nimes.fr
First Name & Middle Initial & Last Name & Degree
Nadine Houede
Facility Name
Hôpital Cochin - Hematologie et Oncologie Médicale
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
Email
olivier.huillard@aphp.fr
First Name & Middle Initial & Last Name & Degree
Olivier Huillard
Facility Name
CHU Poitiers - Hôpital la Milétrie - service d'oncologie médicale
City
Poitiers Cedex
Country
France
Individual Site Status
Recruiting
Facility Contact:
Email
nicolas.isambert@chu-poitiers.fr
First Name & Middle Initial & Last Name & Degree
Nicolas Isambert
Facility Name
CRLCC Eugene Marquis - Service d'Oncologie médicale
City
Rennes cedex
Country
France
Individual Site Status
Recruiting
Facility Contact:
Email
b.laguerre@rennes.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Brigitte Laguerre
Facility Name
ICO - Site René Gauducheau - Service d'Oncologie medicale
City
SAINT-HERBLAIN Cedex
Country
France
Individual Site Status
Recruiting
Facility Contact:
Email
frederic.rolland@ico.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Frederic Rolland
Facility Name
Clinique Sainte-Anne - Service d'Oncologie Médicale
City
Strasbourg
Country
France
Individual Site Status
Recruiting
Facility Contact:
Email
lmdourthe@solcrr.org
First Name & Middle Initial & Last Name & Degree
Louis Marie Dourthe
Facility Name
Institut de Cancérologie de Strasbourg Europe - ICANS - Service d'oncologie médicale
City
Strasbourg
Country
France
Individual Site Status
Recruiting
Facility Contact:
Email
p.barthelemy@icans.eu
First Name & Middle Initial & Last Name & Degree
Philippe Barthelemy
Facility Name
Universitaetsklinikum Essen - Westdeutsches Tumorzentrum
City
Essen
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
Email
viktor.gruenwald@uk-essen.de
First Name & Middle Initial & Last Name & Degree
Viktor Gruenwald
Facility Name
Universitaetsklinikum Frankfurt Goethe-Universitaet - Urologie und Kinderurologie2
City
Frankfurt
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
Email
severine.banek@kgu.de
First Name & Middle Initial & Last Name & Degree
Severine Banek
Facility Name
Universitaetsklinikum Wuerzburg - Klinik u. Poliklinik f. Urologie u. Kinderurologie
City
Halle
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
Email
direktor.urologie@uk-halle.de
First Name & Middle Initial & Last Name & Degree
Georgios Gakis
Facility Name
Universitaetsklinikum Muenster - Klinik und Poliklinik fuer Urologie
City
Muenster
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
Email
katrin.schlack@ukmuenster.de
First Name & Middle Initial & Last Name & Degree
Katrin Schlack
Facility Name
Kliniken Maria Hilf GmbH - Klinik fuer Urologie
City
Mönchengladbach
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
Email
herbert.sperling@mariahilf.de
First Name & Middle Initial & Last Name & Degree
Herbert Sperling
Facility Name
Universitaetsklinikum Tuebingen - Klinik fuer Urologie
City
Stuttgart
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
Email
j.bedke@klinikum-stuttgart.de
First Name & Middle Initial & Last Name & Degree
Jens Bedke
Facility Name
Athens Medical Center
City
Athens
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
Email
tsiatas@hotmail.com
First Name & Middle Initial & Last Name & Degree
Marinos Tsiatas
Facility Name
General Hospital of Athens "Alexandra"
City
Athens
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
Email
florazagouri@yahoo.co.uk
First Name & Middle Initial & Last Name & Degree
Flora Zagouri
Facility Name
University General Hospital "Attikon"
City
Haidari
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
Email
abamias@med.uoa.gr
First Name & Middle Initial & Last Name & Degree
Aristotelis Bamias
Facility Name
Euromedica General Clinic of Thessaloniki
City
Thessaloniki
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
Email
l.kontovinis@oncomedicare.com
First Name & Middle Initial & Last Name & Degree
Loukas Kontovinis
Facility Name
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS - Oncologia Medica
City
Bologna
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
Email
francesco.massari@aosp.bo.it
First Name & Middle Initial & Last Name & Degree
Francesco Massari
Facility Name
Azienda Ospedaliera Universitaria Careggi - S.O.D. di Oncologia Medica
City
Firenze
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
Email
antonuzzol@aou-careggi.toscana.it
First Name & Middle Initial & Last Name & Degree
Lorenzo Antonuzzo
Facility Name
IRCCS Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori "Dino Amadori" - IRST - Oncologia
City
Forli - Cesena
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
Email
ugo.degiorgi@irst.emr.it
First Name & Middle Initial & Last Name & Degree
Ugo De Giorgi
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori - S.S. Oncologia Medica Genitourinaria
City
Milano
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
Email
valentina.guadalupi@istitutotumori.mi.it
First Name & Middle Initial & Last Name & Degree
Valentina Guadalupi
Facility Name
Ospedale San Raffaele - U.O. di Oncologia Medica
City
Milano
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
Email
necchi.andrea@hsr.it
First Name & Middle Initial & Last Name & Degree
Andrea Necchi
Facility Name
Humanitas Istituto Clinico Catanese - Oncologia Medica
City
Misterbianco
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
Email
michele.caruso@ccocatania.it
First Name & Middle Initial & Last Name & Degree
Michele Caruso
Facility Name
Istituto Nazionale Tumori Fondazione G. Pascale - Oncologia Medica A
City
Napoli
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
Email
r.tambaro@istitutotumori.na.it
First Name & Middle Initial & Last Name & Degree
Rosa Tambaro
Facility Name
IOV - Istituto Oncologico Veneto IRCCS - U.O. Oncologia Medica 1
City
Padova
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
Email
marco.maruzzo@iov.veneto.it
First Name & Middle Initial & Last Name & Degree
Marco Maruzzo
Facility Name
Azienda Ospedaliero Universitaria Pisana - U.O. Oncologia
City
Pisa
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
Email
lugal71@yahoo.it
First Name & Middle Initial & Last Name & Degree
Luca Galli
Facility Name
Ospedale Santa Maria delle Croci
City
Ravenna
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
Email
francesco.carrozza@auslromagna.it
First Name & Middle Initial & Last Name & Degree
Francesco Carrozza
Facility Name
Azienda Ospedaliera San Camillo Forlanini - Dipartimento di Oncologia Medica
City
Roma
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
Email
studiclinicisc.fcalabro@gmail.com
First Name & Middle Initial & Last Name & Degree
Linda Cerbone
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica
City
Rome
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
Email
giampaolo.tortora@policlinicogemelli.it
First Name & Middle Initial & Last Name & Degree
Giampaolo Tortora
Facility Name
IRCCS Ospedale Casa Sollievo della Sofferenza - Dipartimento di Oncologia Medica
City
San Giovanni Rotondo
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
Email
e.maiello@operapadrepio.it
First Name & Middle Initial & Last Name & Degree
Evaristo Maiello
Facility Name
Azienda Ospedaliera S. Maria Di Terni - S.C. Oncologia Medica
City
Terni
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
Email
s.bracarda@aospterni.it
First Name & Middle Initial & Last Name & Degree
Sergio Bracarda
Facility Name
Chungnam National University Hospital - Department of Internal Medicine (Rheumatology)
City
Daejeon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
Email
cymed@cnuh.co.kr
First Name & Middle Initial & Last Name & Degree
Hyo Jin Lee
Facility Name
National Cancer Center
City
Gyeonggi-do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
Email
eohk@ncc.re.kr
First Name & Middle Initial & Last Name & Degree
Ho Kyung Seo
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
Email
sehyunkim@snubh.org
First Name & Middle Initial & Last Name & Degree
SE HYUN KIM
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
Email
jaelyun@amc.seoul.kr
First Name & Middle Initial & Last Name & Degree
Jae Lyun Lee
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
Email
sh1767.park@samsung.com
First Name & Middle Initial & Last Name & Degree
Se Hoon Park
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
Email
misokim@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Miso Kim
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
Email
ssj338@yuhs.ac
First Name & Middle Initial & Last Name & Degree
Sang Joon Shin
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
Email
ihkmd@catholic.ac.kr
First Name & Middle Initial & Last Name & Degree
In Ho Kim
Facility Name
Hospital Infanta Cristina - Unidad de Fase I
City
Badajoz
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Email
martagcordero@gmail.com
First Name & Middle Initial & Last Name & Degree
Marta Gonzalez Cordero
Facility Name
Hospital Clinic de Barcelona - Servicio de Oncologia
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oscar Reig Torras
Facility Name
Hospital de la Santa Creu i Sant Pau - Dept of Oncology
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Email
maroto@santpau.es
First Name & Middle Initial & Last Name & Degree
Jose Pablo Maroto Rey
Facility Name
Hospital del Mar - Servicio de Oncologia
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Email
arodriguezvida@parcdesalutmar.cat
First Name & Middle Initial & Last Name & Degree
Alejo Rodriguez-Vida
Facility Name
Hospital Universitario Virgen del Rocio - Oncology Service
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Email
oreig@clinic.cat
First Name & Middle Initial & Last Name & Degree
Begona Perez Valderrama
Facility Name
Hospital Universitario Reina Sofia - Dept of Oncology
City
Cordoba
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Email
mjosemv@yahoo.es
First Name & Middle Initial & Last Name & Degree
Maria Jose Mendez Vidal
Facility Name
Hospital General Universitario de Elche - Servicio de Oncologia
City
Elche
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Email
fvazquez.md@gmail.com
First Name & Middle Initial & Last Name & Degree
Federico Vazquez Mazon
Facility Name
Hospital Universitario Lucus Augusti - Oncology
City
Lugo
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Email
sergio.vazquez.estevez@sergas.es
First Name & Middle Initial & Last Name & Degree
Sergio Vazquez Estevez
Facility Name
Hospital General Universitario Gregorio Marañon - Servicio de Oncologia Medica
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Email
jaarranz@mdanderson.es
First Name & Middle Initial & Last Name & Degree
Jose Angel Arranz Arija
Facility Name
ALTHAIA, Xarxa assistencial Universitaria de Manresa - Oncology Dept
City
Manresa
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Email
mfigols@althaia.cat
First Name & Middle Initial & Last Name & Degree
Mariona Figols Gorina
Facility Name
Hospital Clinico Universitario de Valencia - Servicio de Hematologia y Oncologia Medica
City
Valencia
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Email
chirivella_isa@gva.es
First Name & Middle Initial & Last Name & Degree
Isabel Chirivella Gonzalez
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
Email
yolisu@mac.com
First Name & Middle Initial & Last Name & Degree
Yu Li Su
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
Email
shpihu@yahoo.com.tw
First Name & Middle Initial & Last Name & Degree
Shu-Pin Huang
Facility Name
China Medical University Hospital
City
Taichung
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
Email
wuhc@mail.cmuh.org.tw
First Name & Middle Initial & Last Name & Degree
Hsi-Chin Wu
Facility Name
Chi Mei Hospital, Liouying
City
Tainan
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
Email
kevin640209@yahoo.com.tw
First Name & Middle Initial & Last Name & Degree
Chien-Liang Li
Facility Name
Taipei Veterans General Hospital
City
Taipei City
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
Email
ptchang@vghtpe.gov.tw
First Name & Middle Initial & Last Name & Degree
Mu-Hsin Chang
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
Email
yctsai1@ntu.edu.tw
First Name & Middle Initial & Last Name & Degree
Yu- Chieh Tsai
Facility Name
Chang Gung Memorial Hospital,Linkou
City
Taoyuan
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
Email
su6826@gmail.com
First Name & Middle Initial & Last Name & Degree
Po-Jung Su
Facility Name
Sarah Cannon Research Institute UK
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
Email
elisa.fontana@hcahealthcare.co.uk
First Name & Middle Initial & Last Name & Degree
Elisa Fontana
Facility Name
The Christie Hospital - Dept of Oncology
City
Manchester
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
Email
yeepei.song1@nhs.net
First Name & Middle Initial & Last Name & Degree
Yee Pei Song
Facility Name
Royal Preston Hospital - Rosemere Cancer Centre
City
Preston
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
Email
alison.birtle@lthtr.nhs.uk
First Name & Middle Initial & Last Name & Degree
Alison Birtle

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21
IPD Sharing Time Frame
Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union
IPD Sharing Access Criteria
Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.
IPD Sharing URL
http://bit.ly/IPD21
Links:
URL
https://clinicaltrials.emdgroup.com/en/trial-details/?id=MS100070_0119
Description
Trial Awareness and Transparency website
URL
https://medical.emdserono.com/en_US/home.html
Description
US Medical Information website, Medical Resources

Learn more about this trial

A Study of the Safety and Efficacy of Various Combinations of Avelumab as Therapy in Locally Advanced or Metastatic Urothelial Carcinoma (JAVELIN Bladder Medley)

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