TroVax Renal Immunotherapy Survival Trial
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.
1 other identifier
interventional
733
10 countries
152
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2006
Typical duration for phase_3
152 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 8, 2006
CompletedFirst Posted
Study publicly available on registry
November 9, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedOctober 19, 2020
October 1, 2020
3.3 years
November 8, 2006
October 9, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
overall survival
18 months
Study Arms (2)
Trovax
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
subcutaneous low dose IL-2, interferon-α or sunitinib
Eligibility Criteria
You may qualify if:
- 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).
- +1 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oxford BioMedicalead
- Sanoficollaborator
Study Sites (152)
AZ Cancer Center
Tucson, Arizona, 85724, United States
Little Rock Hematology / Oncology Associates, P.A.
Little Rock, Arkansas, 72205, United States
La Jolla, CA
La Jolla, California, 92093, United States
The Angeles Clinic and Reseach Institute
Los Angeles, California, 90025, United States
1300 N. Vermont Ave
Los Angeles, California, 90027, United States
UCLA Urology/Oncology
Los Angeles, California, 90095, United States
Scripps Cancer Center
San Diego, California, 92121, United States
Sharp Health Care
San Diego, California, 92823, United States
UCHSC
Aurora, Colorado, 80045, United States
Washington Cancer Center
Washington D.C., District of Columbia, 20010, United States
Broward Oncology Associates
Fort Lauderdale, Florida, 33308, United States
SCORE Physician Alliance
St. Petersburg, Florida, 33709, United States
SCORE Physician Alliance
St. Petersburg, Florida, 33710, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612, United States
Augusta Oncology Associates
Augusta, Georgia, 30901, United States
SMO-USA Inc.
Canton, Georgia, 301115, United States
North Idaho Cancer Centre
Coeur d'Alene, Idaho, 83814, United States
Patricia A. Joyce Cancer Institute
Olympia Fields, Illinois, 60461, United States
Edward H Kaplan and Associates
Skokie, Illinois, 60076, United States
St Francis Hospital
Indianapolis, Indiana, 46107, United States
Cancer Care Centre of Indiana
New Albany, Indiana, 47150, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Henry Ford Health System / Josephine Ford Cancer Center
Detroit, Michigan, 48202, United States
University Minnesota Fairview Medical Center
Minneapolis, Minnesota, 55455, United States
Haematology and Oncology Associates at Bridgeport
Tupelo, Mississippi, 38801, United States
Charleston Hematology and Oncology Associates,
Billings, Montana, 59101, United States
Billings Clinical Research Center
Billings, Montana, 59107, United States
Freedman Urology
Las Vegas, Nevada, 89109, United States
Norris Cotton Cancer Center / Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
The Cancer Center @ HUMC
Hackensack, New Jersey, 07601, United States
Columbia Presbyterian Medical Center
New York, New York, 10032, United States
Pluta Cancer Centre
Rochester, New York, 14623, United States
Piedmont Hospital, Inc.
Canton, Ohio, 30309, United States
Riverside Cancer Centre
Columbus, Ohio, 43214, United States
Heamatology and Oncology Associates Inc.
Columbus, Ohio, 43235, United States
Flower Hospital/ Promedica Health System
Sylvania, Ohio, 43560, United States
Oregon Urology Institute
Springfield, Oregon, 97477, United States
Cancer Centre of the Carolinas
Greenville, South Carolina, 29605, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572, United States
University of Texas Medical Branch
Galveston, Texas, 77555-0565, United States
The Methodist Hospital
Houston, Texas, 77030, United States
Urology Associates of South Texas
McAllen, Texas, 78503, United States
Cancer Outreach Associates PC
Abingdon, Virginia, 24211, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
Madigan Army Medical Centre
Tacoma, Washington, 98109, United States
CHU Besançon Hôpital Minjoz
Besançon, 25030, France
Centre Francois Baclesse
Caen, 14076, France
Centre François Baclesse-CLCC-Caen
Caen, 14076, France
Universitätsklinikum C.G. Carus TU Dresden
Dresden, 01307, Germany
Oncology department, Assaf Harofeh Medical Center
Be’er Ya‘aqov, Zerifin, 70300, Israel
Oncology institute , Rambam /health Care Campus
Haifa, 31096, Israel
Meir Medical Center
Kfar Saba, 44281, Israel
Oncology department Rabin Medical center
Petah Tikva, 49100, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
Oncology institute , The Chaim Sheba Medical center
Tel Litwinsky, 52621, Israel
IIndependent Public Hospital #1- , Oncology and Radiotherapy Dept
Gdansk, 80-952, Poland
Holycross Oncology Center in Kielce, Department of Urology
Kielce, 25-734, Poland
Maria Sklodowska-Curie Memorial Institute, Oncology Center KrakĂ³w Clinic Systemic and Generalized Neoplasms
Krakow, 31-115, Poland
Independent Public Health Care Institution University Hospital in Krakow, Department of Oncology
Krakow, 31-501, Poland
Lord's Transfiguration Independent Hospital Medical Academy Poznań
Poznan, 61-848, Poland
Independent Public Clinical Hospital #2 - Pomeranian Medical Academy in Szczecin, Urology Clinic
Szczecin, 70-111, Poland
Military Institute of Medicine, Department of Oncology
Warsaw, 00-909, Poland
Maria Sklodowska-Curie Memorial Institute, Oncology Center in Warsaw, Clinic of Neoplasms of Urinary System
Warsaw, 02-781, Poland
Regional Specialistic Hospital in Wrocław, Department of Urology
Wroclaw, 51-124, Poland
Private Medical Centre
Arad, 310175, Romania
Fundeni Clinical Institute - Urology Department
Bucharest, 022328, Romania
Dinu Uromedica
Bucharest, 041345, Romania
"Prof. Dr. Th. Burghele" Clinical Hospital, Urology Clinic
Bucharest, 050659,, Romania
"Prof. Dr. Th. Burghele" Clinical Hospital, Urology Clinic
Bucharest, Romania
"I. Chiricuta" Institute of Oncology
Cluj-Napoca, 400015,, Romania
E-URO Medical Center
Cluj-Napoca, 400420, Romania
Provita Center SRL
Constanța, 900635, Romania
Sibiu Clinical County Hospital - Urology Clinic
Sibiu, 550245, Romania
Oncomed SRL
Timișoara, 300239, Romania
Leningrad Regional Oncological Center, Surgical Department #3
Saint Petersburg, Leningradskaya Oblast', 188663, Russia
Republican Oncology Center" under the Ministry of Healthcare,
Petrozavodsk, Republic of Karelia, 185007, Russia
State Medical Institution of Healthcare: Clinical Oncological Center under the Ministry of Healthcare of the Republic of Tatarstan, Chemotherapy Department
Kazan', Tatarstan Republic, 420029, Russia
State Medical Institution: Arkhangelsk Regional Clinical Oncological Center, Surgery Department 7.
Arkhangelsk, 163045, Russia
Chelyabinsk Regional Oncological Center, Chemotherapy Department
Chelyabinsk, 454087, Russia
State Therapeutical and Prophylactic Institution: Chelyabinsk Regional Oncological Center,
Chelyabinsk, 454087, Russia
Municipal Medical Institution: Oncological Center, Chemotherapy Department
Krasnodar, 350040, Russia
State Institution: Russian Oncological Research Center n.a. N.N. Blokhin of the Russian Academy of Medical Sciences, Department of Urology
Moscow, 115478, Russia
Russian Research Center of Roentgenology & Radiology , Surgery Department
Moscow, 117997, Russia
Russian State Medical University under the Federal Agency for Healthcare and Social Development, Department of Radiology Daignostics and Radiology Therapy
Moscow, 117997, Russia
Russian State Medical University under the Federal Agency for Healthcare and Social Development, Department of Urology and Surgical Nephrology
Moscow, 117997, Russia
Moscow Research Oncological Institute n.a. P.A. Hertzen, Urology Departmen
Moscow, 125284, Russia
Regional Research Clinical Institute n.a M.F. Vladimirskiy, Urology Department #1
Moscow, 129110, Russia
Non-State Medical Institution:Central Clinical Hospital
Moscow, 129128, Russia
Murmansk Regional Oncological Center, Oncology Department #5
Murmansk, 183047, Russia
Privolzhsky County Medical Center
Nizhny Novgorod, 603001, Russia
State Institution of Nizhny Novgorod Region: "Nizhny Novgorod Oncology Center", Department of Oncology #5 (for chemotherapy treatment)
Nizhny Novgorod, 603081, Russia
Medical Radiological Research Center under the Russian Academy of Medical Sciences, Department of Urology
Obninsk, 249036, Russia
State Medical Institution: Omsk Regional Oncological Center, Chemotherapy Department
Omsk, 644013, Russia
Orenburg Regional Clinical Oncological Center, Chemotherapy Department
Orenburg, 460021, Russia
Regional State Medical Institution:"Orel Oncological Center", Oncology Department #5
Oryol, 302020, Russia
Pyatigorsk Branch of Stavropol Territorial Clinical Oncological Center (State Medical Institution), Outpatient Department
Pyatigorsk, 357500, Russia
Rostov State Medical University under the Federal Agency for Healthcare and Social Development, Department of Urology
Rostov-on-Don, 344022, Russia
Regional Clinical Oncological Center, Surgery Department
Ryazan, 390011, Russia
St. Petersburg State Pediatric Medical Academy
Saint Petersburg, 194100, Russia
Department of Urology
Saint Petersburg, 194291, Russia
Municipal Multi-Speciality Hospital #2, Department of Urology
Saint Petersburg, 194354, Russia
St. Petersburg State Medical Institution: Municipal Multi-Speciality Hospital #2, Department of Functional Diagnostics
Saint Petersburg, 194354, Russia
Municipal Hospital #26, Department Of Urology
Saint Petersburg, 196247, Russia
"Central Research Institute of Roentgenology & Radiology Federal Agency Healthcare Social Development"
Saint Petersburg, 197758, Russia
Department of Biotherapy and Bone Marrow Transplantation
Saint Petersburg, 197758, Russia
St. Petersburg State Medical Institution: Municipal Hospital #15, Urology Department
Saint Petersburg, 198205, Russia
Samara Regional Oncology Center, Chemotherapy Department
Samara, 443066, Russia
"Oncological Center", Department of Haematology and Chemotherapy
Sochi, 354057, Russia
State Medical Institution: Stavropol Territorial Clinical Oncological Center, Department of Urology
Stavropol, 355047, Russia
State Medical Institution: Tambov Regional Oncological Center, Surgery Department
Tambov, 392013, Russia
State Higher Educational Institution: Siberian State Medical University, Department of Urology
Tomsk, 634050, Russia
Bashkir State Medical University, Urology Department
Ufa, 634050, Russia
State Medical Institution of Yaroslavl Region
Yaroslavl, 150054, Russia
State Institution of Mariy El Republic: "Republican Clinical Hospital", Department Of Urology
Yoshkar-Ola, 424037, Russia
Hospital Severo Ochoa, Servicio de Oncologia - Primera planta
Leganés, Madrid, S, Spain
Hospital de Cruces
Barakaldo, 48903, Spain
Hospital Santa Creu i Sant Pau Hospital Nuevo-Servicio de Oncologia Medica
Barcelona, 080025, Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
Hospital Marques de Valdecilla Consultas de Oncologia 1st planta
Santander, 39008, Spain
Bukovyna State Medical University, Department of Oncology, Radiodiagnostics and Radiotherapy
Chernivtsi, 58000,, Ukraine
Dnepropetrovsk State Medical Academy, Department of Urology
Dnipro, 49005, Ukraine
Dnepropetrovsk State Medical Academy, Oncology, Radiodiagnostics and Radiotherapy Department
Dnipro, 49044, Ukraine
Donetsk Regional Antitumor Center, Urology Department
Donetsk, 83092, Ukraine
Ivano-Frankovsk State Medical University; Oncology Department
Ivano-Frankivsk, 76000, Ukraine
Kharkov Regional Clinical Urology and Nephrology Center, Oncourology Department
Kharkiv, 61037, Ukraine
Kharkov Medical Academy of Postgraduate Education, Oncology and Pediatric Oncology Department
Kharkiv, 61176, Ukraine
Urology Institute under the Ukrainian Academy of Medical Sciences, Oncourology Department
Kiev, 04053, Ukraine
Urology Institute under the Ukrainian Academy of Medical Sciences, Plastic and Reconstructive Urology Department
Kiev, 04053, Ukraine
Regional Public Institution: Krivoy Rog Oncological Center, Chemotherapy Department
Krivoi Rog, 50048, Ukraine
Lugansk Regional Clinical Oncological Center, Urology Department
Luhansk, 91047, Ukraine
Crimea State Medical University n.a. S.I. Georgievsky, Course in Urology at the Faculty Surgery#1 Department
Lviv, 79010, Ukraine
Odessa State Medical University;
Odesa, 65074, Ukraine
Crimean Republican Clinical Oncological Center, Chemotherapy Department
Simferopol, 95023, Ukraine
Uzhgorod National University,
Uzhhorod, 88000, Ukraine
Zaporozhye Medical Academy of Postgraduate Education, Oncology Department
Zaporizhzhya, 69096, Ukraine
Zaporozhye Medical Academy of Postgraduate Education, Urology Department
Zaporizhzhya, 69600, Ukraine
Mount Vernon Cancer Centre
Northwood, Middlesex, HA6 2RN, United Kingdom
Belfast City Hospital
Belfast, Northern Ireland, United Kingdom
Clatterbridge Centre for Oncology
Bebington, Wirral, CH63 4JY., United Kingdom
The Royal Bournemouth Hospital
Bournemouth, BH7 7DW, United Kingdom
Bristol Haematology and Oncology Centre
Bristol, BS2 8ED, United Kingdom
Beatson Oncology Centre
Glasgow, G11 6NT, United Kingdom
St Luke's Cancer Centre, Royal Surrey County Hospital
Guildford, GU2 7XX, United Kingdom
St. James University Hospital
Leeds, LS9 7TF, United Kingdom
Christie Hospital NHS Trust
Manchester, M20 4BX, United Kingdom
The James Cook University Hospital
Middlesbrough, TS4 3BW, United Kingdom
University of Nottingham
Nottingham, NG5 1PB, United Kingdom
The Churchill Hospital
Oxford, OX3 7LJ, United Kingdom
Weston Park Hospital
Sheffield, S10 2SJ, United Kingdom
The South West Wales Cancer Institute
Swansea, SA2 8QA, United Kingdom
New Cross Hospital
Wolverhampton, WV10 0QP, United Kingdom
Related Publications (1)
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.
PMID: 20881001RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 8, 2006
First Posted
November 9, 2006
Study Start
September 1, 2006
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
October 19, 2020
Record last verified: 2020-10