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TroVax Renal Immunotherapy Survival Trial

Primary Purpose

Clear Cell Renal Carcinoma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Trovax
Placebo
Standard of care therapy
Sponsored by
Oxford BioMedica
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clear Cell Renal Carcinoma focused on measuring Renal, TroVax, survival, metastatic, Kidney, cancer, immunotherapy

Eligibility Criteria

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

Inclusion Criteria:

  • Signed informed consent. The patient must be competent to give written informed consent and comply with the protocol requirements.
  • Locally advanced or metastatic, histologically proven clear cell renal carcinoma.
  • Primary tumour surgically removed (some residual advanced primary tumour may remain).
  • At least four weeks post surgery or radiotherapy.
  • First-line. No prior therapy for renal cancer except surgery or radiotherapy.
  • Measurable disease.
  • Aged 18 years or more.
  • Patient expected to survive a minimum of 12 weeks (i.e. in the opinion of the investigator there is a >90% probability that the patient will survive >12 weeks if treated with the selected standard of care).
  • Free of clinically apparent autoimmune disease (including no prior confirmed diagnosis or treatment for autoimmune disease including Systemic Lupus Erythematosis, Grave's disease, Hashimoto's thyroiditis, multiple sclerosis, insulin dependant diabetes mellitus or systemic (non-joint) manifestations of rheumatoid disease).
  • Total white cell count ≥ 3 x 109/L and lymphocyte count ≥1 x 109/L.
  • Serum creatinine ≤1.5 times the upper limit of normal.
  • Bilirubin ≤ 2 times the upper limit of normal and an SGPT of ≤ 4 times the upper limit of normal.
  • Women must be either post menopausal, or rendered surgically sterile or, if of child bearing potential, must have been practising a reliable form of contraception (oral contraception + a barrier method) for at least three months prior to the first dose of TroVax® and must continue while they are being treated with TroVax®. Men must practise a reliable form of contraception (barrier or vasectomy) while they are being treated with TroVax®.
  • No acute changes on 12-lead ECG.
  • Ejection fraction documented as not less than 45% or no clinical suspicion that cardiac ejection fraction is less than 45%.(If clinical suspicion exists the ejection fraction should be measured according to local site procedures).
  • Karnofsky performance status of ≥ 80%.

Exclusion Criteria:

  • Cerebral metastases. (Known from previous investigations or clinically detectable).
  • Previous exposure to TroVax®.
  • Serious infections within the 28 days prior to entry to the trial.
  • Known to test positive for HIV or hepatitis B or C.
  • Life threatening illness unrelated to cancer.
  • History of allergic response to previous vaccinia vaccinations.
  • Known allergy to egg proteins.
  • Known hypersensitivity to neomycin.
  • Participation in any other clinical trial of a licensed or unlicensed drug within the previous 30 days or during the course of this trial.
  • Previous malignancies within the last 10 years other than successfully treated squamous carcinoma of the skin or in situ carcinoma of the cervix treated with cone biopsy.
  • Previous history of major psychiatric disorder requiring hospitalization or any current psychiatric disorder that would impede the patient's ability to provide informed consent or to comply with the protocol.
  • Oral corticosteroid use unless prescribed as replacement therapy in the case of adrenal insufficiency.
  • Ongoing use of agents listed in locally approved prescribing information as causing immunosuppression.
  • Prior history of organ transplantation.
  • Pregnancy or lactation.

Sites / Locations

  • AZ Cancer Center
  • Little Rock Hematology / Oncology Associates, P.A.
  • La Jolla, CA
  • The Angeles Clinic and Reseach Institute
  • 1300 N. Vermont Ave
  • UCLA Urology/Oncology
  • Scripps Cancer Center
  • Sharp Health Care
  • UCHSC
  • Washington Cancer Center
  • Broward Oncology Associates
  • SCORE Physician Alliance
  • SCORE Physician Alliance
  • H. Lee Moffitt Cancer Center & Research Institute
  • Augusta Oncology Associates
  • SMO-USA Inc.
  • North Idaho Cancer Centre
  • Patricia A. Joyce Cancer Institute
  • Edward H Kaplan and Associates
  • St Francis Hospital
  • Cancer Care Centre of Indiana
  • Ochsner Clinic Foundation
  • Henry Ford Health System / Josephine Ford Cancer Center
  • University Minnesota Fairview Medical Center
  • Haematology and Oncology Associates at Bridgeport
  • Charleston Hematology and Oncology Associates,
  • Billings Clinical Research Center
  • Freedman Urology
  • Norris Cotton Cancer Center / Dartmouth-Hitchcock Medical Center
  • The Cancer Center @ HUMC
  • Columbia Presbyterian Medical Center
  • Pluta Cancer Centre
  • Piedmont Hospital, Inc.
  • Riverside Cancer Centre
  • Heamatology and Oncology Associates Inc.
  • Flower Hospital/ Promedica Health System
  • Oregon Urology Institute
  • Cancer Centre of the Carolinas
  • Carolina Urologic Research Center
  • University of Texas Medical Branch
  • The Methodist Hospital
  • Urology Associates of South Texas
  • Cancer Outreach Associates PC
  • Virginia Oncology Associates
  • Seattle Cancer Care Alliance
  • Madigan Army Medical Centre
  • CHU Besançon Hôpital Minjoz
  • Centre Francois Baclesse
  • Centre François Baclesse-CLCC-Caen
  • Universitätsklinikum C.G. Carus TU Dresden
  • Oncology department, Assaf Harofeh Medical Center
  • Oncology institute , Rambam /health Care Campus
  • Meir Medical Center
  • Oncology department Rabin Medical center
  • Tel Aviv Sourasky Medical Center
  • Oncology institute , The Chaim Sheba Medical center
  • IIndependent Public Hospital #1- , Oncology and Radiotherapy Dept
  • Holycross Oncology Center in Kielce, Department of Urology
  • Maria Sklodowska-Curie Memorial Institute, Oncology Center Kraków Clinic Systemic and Generalized Neoplasms
  • Independent Public Health Care Institution University Hospital in Krakow, Department of Oncology
  • Lord's Transfiguration Independent Hospital Medical Academy Poznań
  • Independent Public Clinical Hospital #2 - Pomeranian Medical Academy in Szczecin, Urology Clinic
  • Military Institute of Medicine, Department of Oncology
  • Maria Sklodowska-Curie Memorial Institute, Oncology Center in Warsaw, Clinic of Neoplasms of Urinary System
  • Regional Specialistic Hospital in Wrocław, Department of Urology
  • Private Medical Centre
  • Fundeni Clinical Institute - Urology Department
  • Dinu Uromedica
  • "Prof. Dr. Th. Burghele" Clinical Hospital, Urology Clinic
  • "Prof. Dr. Th. Burghele" Clinical Hospital, Urology Clinic
  • E-URO Medical Center
  • "I. Chiricuta" Institute of Oncology
  • Provita Center SRL
  • Sibiu Clinical County Hospital - Urology Clinic
  • Oncomed SRL
  • Leningrad Regional Oncological Center, Surgical Department #3
  • Republican Oncology Center" under the Ministry of Healthcare,
  • State Medical Institution of Healthcare: Clinical Oncological Center under the Ministry of Healthcare of the Republic of Tatarstan, Chemotherapy Department
  • State Medical Institution: Arkhangelsk Regional Clinical Oncological Center, Surgery Department 7.
  • Chelyabinsk Regional Oncological Center, Chemotherapy Department
  • State Therapeutical and Prophylactic Institution: Chelyabinsk Regional Oncological Center,
  • Municipal Medical Institution: Oncological Center, Chemotherapy Department
  • State Institution: Russian Oncological Research Center n.a. N.N. Blokhin of the Russian Academy of Medical Sciences, Department of Urology
  • Russian Research Center of Roentgenology & Radiology , Surgery Department
  • Russian State Medical University under the Federal Agency for Healthcare and Social Development, Department of Radiology Daignostics and Radiology Therapy
  • Russian State Medical University under the Federal Agency for Healthcare and Social Development, Department of Urology and Surgical Nephrology
  • Moscow Research Oncological Institute n.a. P.A. Hertzen, Urology Departmen
  • Regional Research Clinical Institute n.a M.F. Vladimirskiy, Urology Department #1
  • Non-State Medical Institution:Central Clinical Hospital
  • Murmansk Regional Oncological Center, Oncology Department #5
  • Privolzhsky County Medical Center
  • State Institution of Nizhny Novgorod Region: "Nizhny Novgorod Oncology Center", Department of Oncology #5 (for chemotherapy treatment)
  • Medical Radiological Research Center under the Russian Academy of Medical Sciences, Department of Urology
  • State Medical Institution: Omsk Regional Oncological Center, Chemotherapy Department
  • Regional State Medical Institution:"Orel Oncological Center", Oncology Department #5
  • Orenburg Regional Clinical Oncological Center, Chemotherapy Department
  • Pyatigorsk Branch of Stavropol Territorial Clinical Oncological Center (State Medical Institution), Outpatient Department
  • Rostov State Medical University under the Federal Agency for Healthcare and Social Development, Department of Urology
  • Regional Clinical Oncological Center, Surgery Department
  • Samara Regional Oncology Center, Chemotherapy Department
  • "Oncological Center", Department of Haematology and Chemotherapy
  • Municipal Multi-Speciality Hospital #2, Department of Urology
  • Municipal Hospital #26, Department Of Urology
  • "Central Research Institute of Roentgenology & Radiology Federal Agency Healthcare Social Development"
  • Department of Biotherapy and Bone Marrow Transplantation
  • St. Petersburg State Pediatric Medical Academy
  • Department of Urology
  • St. Petersburg State Medical Institution: Municipal Hospital #15, Urology Department
  • St. Petersburg State Medical Institution: Municipal Multi-Speciality Hospital #2, Department of Functional Diagnostics
  • State Medical Institution: Stavropol Territorial Clinical Oncological Center, Department of Urology
  • State Medical Institution: Tambov Regional Oncological Center, Surgery Department
  • State Higher Educational Institution: Siberian State Medical University, Department of Urology
  • Bashkir State Medical University, Urology Department
  • State Medical Institution of Yaroslavl Region
  • State Institution of Mariy El Republic: "Republican Clinical Hospital", Department Of Urology
  • Hospital Severo Ochoa, Servicio de Oncologia - Primera planta
  • Hospital de Cruces
  • Hospital Santa Creu i Sant Pau Hospital Nuevo-Servicio de Oncologia Medica
  • Hospital Universitario Ramon y Cajal
  • Hospital Marques de Valdecilla Consultas de Oncologia 1st planta
  • Bukovyna State Medical University, Department of Oncology, Radiodiagnostics and Radiotherapy
  • Dnepropetrovsk State Medical Academy, Department of Urology
  • Dnepropetrovsk State Medical Academy, Oncology, Radiodiagnostics and Radiotherapy Department
  • Donetsk Regional Antitumor Center, Urology Department
  • Ivano-Frankovsk State Medical University; Oncology Department
  • Kharkov Regional Clinical Urology and Nephrology Center, Oncourology Department
  • Kharkov Medical Academy of Postgraduate Education, Oncology and Pediatric Oncology Department
  • Urology Institute under the Ukrainian Academy of Medical Sciences, Oncourology Department
  • Urology Institute under the Ukrainian Academy of Medical Sciences, Plastic and Reconstructive Urology Department
  • Regional Public Institution: Krivoy Rog Oncological Center, Chemotherapy Department
  • Lugansk Regional Clinical Oncological Center, Urology Department
  • Crimea State Medical University n.a. S.I. Georgievsky, Course in Urology at the Faculty Surgery#1 Department
  • Odessa State Medical University;
  • Crimean Republican Clinical Oncological Center, Chemotherapy Department
  • Uzhgorod National University,
  • Zaporozhye Medical Academy of Postgraduate Education, Oncology Department
  • Zaporozhye Medical Academy of Postgraduate Education, Urology Department
  • Mount Vernon Cancer Centre
  • Belfast City Hospital
  • Clatterbridge Centre for Oncology
  • The Royal Bournemouth Hospital
  • Bristol Haematology and Oncology Centre
  • Beatson Oncology Centre
  • St Luke's Cancer Centre, Royal Surrey County Hospital
  • St. James University Hospital
  • Christie Hospital NHS Trust
  • The James Cook University Hospital
  • University of Nottingham
  • The Churchill Hospital
  • Weston Park Hospital
  • The South West Wales Cancer Institute
  • New Cross Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Trovax

Placebo

Arm Description

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

Full Information

First Posted
November 8, 2006
Last Updated
October 9, 2020
Sponsor
Oxford BioMedica
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00397345
Brief Title
TroVax Renal Immunotherapy Survival Trial
Official Title
Randomised,Double-blind,Placebo-controlled,Parallel Group Study TroVax, Added to First-line Standard of Care, Prolongs Survival of Patients With Locally Advanced or Metastatic Clear Cell Renal Adenocarcinoma.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oxford BioMedica
Collaborators
Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to investigate whether TroVax, when added to first line standard of care therapy, improves survival for patients with locally advanced or metastatic clear cell renal adenocarcinoma.
Detailed Description
This is an international, randomised, double blind, placebo controlled, parallel group study to investigate whether a minimum of three doses of TroVax® added to first-line standard of care therapy, prolongs the survival of patients with locally advanced or metastatic renal clear cell adenocarcinoma. The primary endpoint is survival. The study is designed to be pragmatic, limiting additional study related investigations to a minimum. Protocol mandated scans and X-rays are limited to two time points (baseline and week 26) to permit comparison of the percentage of patients with progressive disease at 6 months as a secondary efficacy endpoint. Six months was selected based on review of published literature indicating that progressive disease was commonly observed by 26 weeks in patients with renal cancer. Endpoints such as tumour response by RECIST are considered of secondary importance to survival and will be determined by radiological examinations ordered at the discretion of the investigator based on the clinical status of the patient and will be based the interpretation of the patient's care-team (investigator and local radiologist). After signing the study informed consent form and meeting the baseline enrolment criteria patients will be assigned by the investigator (their physician) to one of the following defined first-line standard of care regimens based on what is best for the patient and consistent with local practice: subcutaneous low dose IL-2 interferon-α (excluding pegylated IFNα) sunitinib TroVax® is administered at a dose of 1E9TCID50/ml in 1ml by injection into the deltoid muscle of the upper arm at regular intervals up to 8 weeks apart up to a maximum of 13 doses.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clear Cell Renal Carcinoma
Keywords
Renal, TroVax, survival, metastatic, Kidney, cancer, immunotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
733 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trovax
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
Trovax
Intervention Description
1ml IM injection 2-8 weeks apart.
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Placebo
Intervention Type
Biological
Intervention Name(s)
Standard of care therapy
Intervention Description
subcutaneous low dose IL-2, interferon-α or sunitinib
Primary Outcome Measure Information:
Title
overall survival
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed informed consent. The patient must be competent to give written informed consent and comply with the protocol requirements. Locally advanced or metastatic, histologically proven clear cell renal carcinoma. Primary tumour surgically removed (some residual advanced primary tumour may remain). At least four weeks post surgery or radiotherapy. First-line. No prior therapy for renal cancer except surgery or radiotherapy. Measurable disease. Aged 18 years or more. Patient expected to survive a minimum of 12 weeks (i.e. in the opinion of the investigator there is a >90% probability that the patient will survive >12 weeks if treated with the selected standard of care). Free of clinically apparent autoimmune disease (including no prior confirmed diagnosis or treatment for autoimmune disease including Systemic Lupus Erythematosis, Grave's disease, Hashimoto's thyroiditis, multiple sclerosis, insulin dependant diabetes mellitus or systemic (non-joint) manifestations of rheumatoid disease). Total white cell count ≥ 3 x 109/L and lymphocyte count ≥1 x 109/L. Serum creatinine ≤1.5 times the upper limit of normal. Bilirubin ≤ 2 times the upper limit of normal and an SGPT of ≤ 4 times the upper limit of normal. Women must be either post menopausal, or rendered surgically sterile or, if of child bearing potential, must have been practising a reliable form of contraception (oral contraception + a barrier method) for at least three months prior to the first dose of TroVax® and must continue while they are being treated with TroVax®. Men must practise a reliable form of contraception (barrier or vasectomy) while they are being treated with TroVax®. No acute changes on 12-lead ECG. Ejection fraction documented as not less than 45% or no clinical suspicion that cardiac ejection fraction is less than 45%.(If clinical suspicion exists the ejection fraction should be measured according to local site procedures). Karnofsky performance status of ≥ 80%. Exclusion Criteria: Cerebral metastases. (Known from previous investigations or clinically detectable). Previous exposure to TroVax®. Serious infections within the 28 days prior to entry to the trial. Known to test positive for HIV or hepatitis B or C. Life threatening illness unrelated to cancer. History of allergic response to previous vaccinia vaccinations. Known allergy to egg proteins. Known hypersensitivity to neomycin. Participation in any other clinical trial of a licensed or unlicensed drug within the previous 30 days or during the course of this trial. Previous malignancies within the last 10 years other than successfully treated squamous carcinoma of the skin or in situ carcinoma of the cervix treated with cone biopsy. Previous history of major psychiatric disorder requiring hospitalization or any current psychiatric disorder that would impede the patient's ability to provide informed consent or to comply with the protocol. Oral corticosteroid use unless prescribed as replacement therapy in the case of adrenal insufficiency. Ongoing use of agents listed in locally approved prescribing information as causing immunosuppression. Prior history of organ transplantation. Pregnancy or lactation.
Facility Information:
Facility Name
AZ Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Little Rock Hematology / Oncology Associates, P.A.
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
La Jolla, CA
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
The Angeles Clinic and Reseach Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
1300 N. Vermont Ave
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
UCLA Urology/Oncology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Scripps Cancer Center
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
Facility Name
Sharp Health Care
City
San Diego
State/Province
California
ZIP/Postal Code
92823
Country
United States
Facility Name
UCHSC
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Washington Cancer Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Broward Oncology Associates
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
SCORE Physician Alliance
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
SCORE Physician Alliance
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33710
Country
United States
Facility Name
H. Lee Moffitt Cancer Center & Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Augusta Oncology Associates
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30901
Country
United States
Facility Name
SMO-USA Inc.
City
Canton
State/Province
Georgia
ZIP/Postal Code
301115
Country
United States
Facility Name
North Idaho Cancer Centre
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
Facility Name
Patricia A. Joyce Cancer Institute
City
Olympia Fields
State/Province
Illinois
ZIP/Postal Code
60461
Country
United States
Facility Name
Edward H Kaplan and Associates
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Facility Name
St Francis Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46107
Country
United States
Facility Name
Cancer Care Centre of Indiana
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Henry Ford Health System / Josephine Ford Cancer Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
University Minnesota Fairview Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Haematology and Oncology Associates at Bridgeport
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
Charleston Hematology and Oncology Associates,
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Billings Clinical Research Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59107
Country
United States
Facility Name
Freedman Urology
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Norris Cotton Cancer Center / Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
The Cancer Center @ HUMC
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Columbia Presbyterian Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Pluta Cancer Centre
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
Piedmont Hospital, Inc.
City
Canton
State/Province
Ohio
ZIP/Postal Code
30309
Country
United States
Facility Name
Riverside Cancer Centre
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Heamatology and Oncology Associates Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Facility Name
Flower Hospital/ Promedica Health System
City
Sylvania
State/Province
Ohio
ZIP/Postal Code
43560
Country
United States
Facility Name
Oregon Urology Institute
City
Springfield
State/Province
Oregon
ZIP/Postal Code
97477
Country
United States
Facility Name
Cancer Centre of the Carolinas
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Carolina Urologic Research Center
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555-0565
Country
United States
Facility Name
The Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Urology Associates of South Texas
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Cancer Outreach Associates PC
City
Abingdon
State/Province
Virginia
ZIP/Postal Code
24211
Country
United States
Facility Name
Virginia Oncology Associates
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Madigan Army Medical Centre
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
CHU Besançon Hôpital Minjoz
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Centre Francois Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Centre François Baclesse-CLCC-Caen
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Universitätsklinikum C.G. Carus TU Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Oncology department, Assaf Harofeh Medical Center
City
Be'er Ya'aqov
State/Province
Zerifin
ZIP/Postal Code
70300
Country
Israel
Facility Name
Oncology institute , Rambam /health Care Campus
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Meir Medical Center
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
Oncology department Rabin Medical center
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Oncology institute , The Chaim Sheba Medical center
City
Tel- Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
IIndependent Public Hospital #1- , Oncology and Radiotherapy Dept
City
Gdańsk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Holycross Oncology Center in Kielce, Department of Urology
City
Kielce
ZIP/Postal Code
25-734
Country
Poland
Facility Name
Maria Sklodowska-Curie Memorial Institute, Oncology Center Kraków Clinic Systemic and Generalized Neoplasms
City
Krakow
ZIP/Postal Code
31-115
Country
Poland
Facility Name
Independent Public Health Care Institution University Hospital in Krakow, Department of Oncology
City
Kraków
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Lord's Transfiguration Independent Hospital Medical Academy Poznań
City
Poznan
ZIP/Postal Code
61-848
Country
Poland
Facility Name
Independent Public Clinical Hospital #2 - Pomeranian Medical Academy in Szczecin, Urology Clinic
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
Facility Name
Military Institute of Medicine, Department of Oncology
City
Warsaw,
ZIP/Postal Code
00-909
Country
Poland
Facility Name
Maria Sklodowska-Curie Memorial Institute, Oncology Center in Warsaw, Clinic of Neoplasms of Urinary System
City
Warsaw
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Regional Specialistic Hospital in Wrocław, Department of Urology
City
Wrocław
ZIP/Postal Code
51-124
Country
Poland
Facility Name
Private Medical Centre
City
Arad,
ZIP/Postal Code
310175
Country
Romania
Facility Name
Fundeni Clinical Institute - Urology Department
City
Bucharest,
ZIP/Postal Code
022328
Country
Romania
Facility Name
Dinu Uromedica
City
Bucharest,
ZIP/Postal Code
041345
Country
Romania
Facility Name
"Prof. Dr. Th. Burghele" Clinical Hospital, Urology Clinic
City
Bucharest,
ZIP/Postal Code
050659,
Country
Romania
Facility Name
"Prof. Dr. Th. Burghele" Clinical Hospital, Urology Clinic
City
Bucharest
Country
Romania
Facility Name
E-URO Medical Center
City
Cluj-Napoca,
ZIP/Postal Code
400420
Country
Romania
Facility Name
"I. Chiricuta" Institute of Oncology
City
Cluj-Napoca
ZIP/Postal Code
400015,
Country
Romania
Facility Name
Provita Center SRL
City
Constanţa
ZIP/Postal Code
900635
Country
Romania
Facility Name
Sibiu Clinical County Hospital - Urology Clinic
City
Sibiu,
ZIP/Postal Code
550245
Country
Romania
Facility Name
Oncomed SRL
City
Timisoara,
ZIP/Postal Code
300239
Country
Romania
Facility Name
Leningrad Regional Oncological Center, Surgical Department #3
City
St Petersburg
State/Province
Leningrad Region
ZIP/Postal Code
188663
Country
Russian Federation
Facility Name
Republican Oncology Center" under the Ministry of Healthcare,
City
Petrozavodsk
State/Province
Republic Of Karelia
ZIP/Postal Code
185007
Country
Russian Federation
Facility Name
State Medical Institution of Healthcare: Clinical Oncological Center under the Ministry of Healthcare of the Republic of Tatarstan, Chemotherapy Department
City
Kazan
State/Province
Republic Of Tatarstan
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
State Medical Institution: Arkhangelsk Regional Clinical Oncological Center, Surgery Department 7.
City
Arkhangelsk
ZIP/Postal Code
163045
Country
Russian Federation
Facility Name
Chelyabinsk Regional Oncological Center, Chemotherapy Department
City
Chelyabinsk
ZIP/Postal Code
454087
Country
Russian Federation
Facility Name
State Therapeutical and Prophylactic Institution: Chelyabinsk Regional Oncological Center,
City
Chelyabinsk
ZIP/Postal Code
454087
Country
Russian Federation
Facility Name
Municipal Medical Institution: Oncological Center, Chemotherapy Department
City
Krasnodar
ZIP/Postal Code
350040
Country
Russian Federation
Facility Name
State Institution: Russian Oncological Research Center n.a. N.N. Blokhin of the Russian Academy of Medical Sciences, Department of Urology
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Russian Research Center of Roentgenology & Radiology , Surgery Department
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation
Facility Name
Russian State Medical University under the Federal Agency for Healthcare and Social Development, Department of Radiology Daignostics and Radiology Therapy
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation
Facility Name
Russian State Medical University under the Federal Agency for Healthcare and Social Development, Department of Urology and Surgical Nephrology
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation
Facility Name
Moscow Research Oncological Institute n.a. P.A. Hertzen, Urology Departmen
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
Regional Research Clinical Institute n.a M.F. Vladimirskiy, Urology Department #1
City
Moscow
ZIP/Postal Code
129110
Country
Russian Federation
Facility Name
Non-State Medical Institution:Central Clinical Hospital
City
Moscow
ZIP/Postal Code
129128
Country
Russian Federation
Facility Name
Murmansk Regional Oncological Center, Oncology Department #5
City
Murmansk
ZIP/Postal Code
183047
Country
Russian Federation
Facility Name
Privolzhsky County Medical Center
City
Nizhny Novgorod
ZIP/Postal Code
603001
Country
Russian Federation
Facility Name
State Institution of Nizhny Novgorod Region: "Nizhny Novgorod Oncology Center", Department of Oncology #5 (for chemotherapy treatment)
City
Nizhny Novgorod
ZIP/Postal Code
603081
Country
Russian Federation
Facility Name
Medical Radiological Research Center under the Russian Academy of Medical Sciences, Department of Urology
City
Obninsk
ZIP/Postal Code
249036
Country
Russian Federation
Facility Name
State Medical Institution: Omsk Regional Oncological Center, Chemotherapy Department
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
Regional State Medical Institution:"Orel Oncological Center", Oncology Department #5
City
Orel
ZIP/Postal Code
302020
Country
Russian Federation
Facility Name
Orenburg Regional Clinical Oncological Center, Chemotherapy Department
City
Orenburg
ZIP/Postal Code
460021
Country
Russian Federation
Facility Name
Pyatigorsk Branch of Stavropol Territorial Clinical Oncological Center (State Medical Institution), Outpatient Department
City
Pyatigorsk
ZIP/Postal Code
357500
Country
Russian Federation
Facility Name
Rostov State Medical University under the Federal Agency for Healthcare and Social Development, Department of Urology
City
Rostov-on-Don
ZIP/Postal Code
344022
Country
Russian Federation
Facility Name
Regional Clinical Oncological Center, Surgery Department
City
Ryazan
ZIP/Postal Code
390011
Country
Russian Federation
Facility Name
Samara Regional Oncology Center, Chemotherapy Department
City
Samara
ZIP/Postal Code
443066
Country
Russian Federation
Facility Name
"Oncological Center", Department of Haematology and Chemotherapy
City
Sochi
ZIP/Postal Code
354057
Country
Russian Federation
Facility Name
Municipal Multi-Speciality Hospital #2, Department of Urology
City
St Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
Municipal Hospital #26, Department Of Urology
City
St Petersburg
ZIP/Postal Code
196247
Country
Russian Federation
Facility Name
"Central Research Institute of Roentgenology & Radiology Federal Agency Healthcare Social Development"
City
St Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Department of Biotherapy and Bone Marrow Transplantation
City
St Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
St. Petersburg State Pediatric Medical Academy
City
St. Petersburg
ZIP/Postal Code
194100
Country
Russian Federation
Facility Name
Department of Urology
City
St. Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
St. Petersburg State Medical Institution: Municipal Hospital #15, Urology Department
City
St. Petersburg
ZIP/Postal Code
198205
Country
Russian Federation
Facility Name
St. Petersburg State Medical Institution: Municipal Multi-Speciality Hospital #2, Department of Functional Diagnostics
City
St.Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
State Medical Institution: Stavropol Territorial Clinical Oncological Center, Department of Urology
City
Stavropol
ZIP/Postal Code
355047
Country
Russian Federation
Facility Name
State Medical Institution: Tambov Regional Oncological Center, Surgery Department
City
Tambov
ZIP/Postal Code
392013
Country
Russian Federation
Facility Name
State Higher Educational Institution: Siberian State Medical University, Department of Urology
City
Tomsk, ,
ZIP/Postal Code
634050
Country
Russian Federation
Facility Name
Bashkir State Medical University, Urology Department
City
Ufa
ZIP/Postal Code
634050
Country
Russian Federation
Facility Name
State Medical Institution of Yaroslavl Region
City
Yaroslavl
ZIP/Postal Code
150054
Country
Russian Federation
Facility Name
State Institution of Mariy El Republic: "Republican Clinical Hospital", Department Of Urology
City
Yoshkar-Ola
ZIP/Postal Code
424037
Country
Russian Federation
Facility Name
Hospital Severo Ochoa, Servicio de Oncologia - Primera planta
City
Leganes
State/Province
Madrid
ZIP/Postal Code
S
Country
Spain
Facility Name
Hospital de Cruces
City
Barakaldo
ZIP/Postal Code
48903
Country
Spain
Facility Name
Hospital Santa Creu i Sant Pau Hospital Nuevo-Servicio de Oncologia Medica
City
Barcelona
ZIP/Postal Code
080025
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Marques de Valdecilla Consultas de Oncologia 1st planta
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Bukovyna State Medical University, Department of Oncology, Radiodiagnostics and Radiotherapy
City
Chernivtsi
ZIP/Postal Code
58000,
Country
Ukraine
Facility Name
Dnepropetrovsk State Medical Academy, Department of Urology
City
Dnepropetrovsk
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
Dnepropetrovsk State Medical Academy, Oncology, Radiodiagnostics and Radiotherapy Department
City
Dnepropetrovsk
ZIP/Postal Code
49044
Country
Ukraine
Facility Name
Donetsk Regional Antitumor Center, Urology Department
City
Donetsk
ZIP/Postal Code
83092
Country
Ukraine
Facility Name
Ivano-Frankovsk State Medical University; Oncology Department
City
Ivano-Frankivs'k
ZIP/Postal Code
76000
Country
Ukraine
Facility Name
Kharkov Regional Clinical Urology and Nephrology Center, Oncourology Department
City
Kharkov
ZIP/Postal Code
61037
Country
Ukraine
Facility Name
Kharkov Medical Academy of Postgraduate Education, Oncology and Pediatric Oncology Department
City
Kharkov
ZIP/Postal Code
61176
Country
Ukraine
Facility Name
Urology Institute under the Ukrainian Academy of Medical Sciences, Oncourology Department
City
Kiev
ZIP/Postal Code
04053
Country
Ukraine
Facility Name
Urology Institute under the Ukrainian Academy of Medical Sciences, Plastic and Reconstructive Urology Department
City
Kiev
ZIP/Postal Code
04053
Country
Ukraine
Facility Name
Regional Public Institution: Krivoy Rog Oncological Center, Chemotherapy Department
City
Krivoi Rog
ZIP/Postal Code
50048
Country
Ukraine
Facility Name
Lugansk Regional Clinical Oncological Center, Urology Department
City
Lugansk
ZIP/Postal Code
91047
Country
Ukraine
Facility Name
Crimea State Medical University n.a. S.I. Georgievsky, Course in Urology at the Faculty Surgery#1 Department
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
Facility Name
Odessa State Medical University;
City
Odessa
ZIP/Postal Code
65074
Country
Ukraine
Facility Name
Crimean Republican Clinical Oncological Center, Chemotherapy Department
City
Simferopol
ZIP/Postal Code
95023
Country
Ukraine
Facility Name
Uzhgorod National University,
City
Uzhorod
ZIP/Postal Code
88000
Country
Ukraine
Facility Name
Zaporozhye Medical Academy of Postgraduate Education, Oncology Department
City
Zaporozhye
ZIP/Postal Code
69096
Country
Ukraine
Facility Name
Zaporozhye Medical Academy of Postgraduate Education, Urology Department
City
Zaporozhye
ZIP/Postal Code
69600
Country
Ukraine
Facility Name
Mount Vernon Cancer Centre
City
Northwood
State/Province
Middlesex
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Belfast City Hospital
City
Belfast
State/Province
N. Ireland
Country
United Kingdom
Facility Name
Clatterbridge Centre for Oncology
City
Bebington
State/Province
Wirral
ZIP/Postal Code
CH63 4JY.
Country
United Kingdom
Facility Name
The Royal Bournemouth Hospital
City
Bournemouth
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
Bristol Haematology and Oncology Centre
City
Bristol
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Beatson Oncology Centre
City
Glasgow
ZIP/Postal Code
G11 6NT
Country
United Kingdom
Facility Name
St Luke's Cancer Centre, Royal Surrey County Hospital
City
Guildford
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
Facility Name
St. James University Hospital
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Christie Hospital NHS Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
The James Cook University Hospital
City
Middlesbrough
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
Facility Name
University of Nottingham
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
The Churchill Hospital
City
Oxford
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom
Facility Name
Weston Park Hospital
City
Sheffield
ZIP/Postal Code
S10 2SJ
Country
United Kingdom
Facility Name
The South West Wales Cancer Institute
City
Swansea
ZIP/Postal Code
SA2 8QA
Country
United Kingdom
Facility Name
New Cross Hospital
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
20881001
Citation
Amato RJ, Hawkins RE, Kaufman HL, Thompson JA, Tomczak P, Szczylik C, McDonald M, Eastty S, Shingler WH, de Belin J, Goonewardena M, Naylor S, Harrop R. Vaccination of metastatic renal cancer patients with MVA-5T4: a randomized, double-blind, placebo-controlled phase III study. Clin Cancer Res. 2010 Nov 15;16(22):5539-47. doi: 10.1158/1078-0432.CCR-10-2082. Epub 2010 Sep 29.
Results Reference
result

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