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Clear Cell Renal CarcinomaPhase 3NCT00397345

TroVax Renal Immunotherapy Survival Trial

A Phase 3 study testing Trovax in people with Clear Cell Renal Carcinoma, run by Oxford BioMedica at 152 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Clear Cell Renal Carcinoma
What is being tested?
Trovax
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
733 participants
Where
152 sitesin 10 countries
Study dates
Sep 2006to Dec 2009
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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%.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

152 sites in 10 countries.

152 sites in 10 countries

United States46 sites

  • Cancer Outreach Associates PC

    Abingdon, Virginia, 24211

  • Augusta Oncology Associates

    Augusta, Georgia, 30901

  • UCHSC

    Aurora, Colorado, 80045

  • Charleston Hematology and Oncology Associates,

    Billings, Montana, 59101

  • Billings Clinical Research Center

    Billings, Montana, 59107

  • SMO-USA Inc.

    Canton, Georgia, 301115

  • Piedmont Hospital, Inc.

    Canton, Ohio, 30309

  • North Idaho Cancer Centre

    Coeur d'Alene, Idaho, 83814

  • Riverside Cancer Centre

    Columbus, Ohio, 43214

  • Heamatology and Oncology Associates Inc.

    Columbus, Ohio, 43235

  • Henry Ford Health System / Josephine Ford Cancer Center

    Detroit, Michigan, 48202

  • Broward Oncology Associates

    Fort Lauderdale, Florida, 33308

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0565

  • Cancer Centre of the Carolinas

    Greenville, South Carolina, 29605

  • The Cancer Center @ HUMC

    Hackensack, New Jersey, 07601

  • The Methodist Hospital

    Houston, Texas, 77030

  • St Francis Hospital

    Indianapolis, Indiana, 46107

  • La Jolla, CA

    La Jolla, California, 92093

  • Freedman Urology

    Las Vegas, Nevada, 89109

  • Norris Cotton Cancer Center / Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Little Rock Hematology / Oncology Associates, P.A.

    Little Rock, Arkansas, 72205

  • The Angeles Clinic and Reseach Institute

    Los Angeles, California, 90025

  • 1300 N. Vermont Ave

    Los Angeles, California, 90027

  • UCLA Urology/Oncology

    Los Angeles, California, 90095

  • Urology Associates of South Texas

    McAllen, Texas, 78503

  • University Minnesota Fairview Medical Center

    Minneapolis, Minnesota, 55455

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

  • Cancer Care Centre of Indiana

    New Albany, Indiana, 47150

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Columbia Presbyterian Medical Center

    New York, New York, 10032

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Patricia A. Joyce Cancer Institute

    Olympia Fields, Illinois, 60461

  • Pluta Cancer Centre

    Rochester, New York, 14623

  • Scripps Cancer Center

    San Diego, California, 92121

  • Sharp Health Care

    San Diego, California, 92823

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • Edward H Kaplan and Associates

    Skokie, Illinois, 60076

  • Oregon Urology Institute

    Springfield, Oregon, 97477

  • SCORE Physician Alliance

    St. Petersburg, Florida, 33709

  • SCORE Physician Alliance

    St. Petersburg, Florida, 33710

  • Flower Hospital/ Promedica Health System

    Sylvania, Ohio, 43560

  • Madigan Army Medical Centre

    Tacoma, Washington, 98109

  • H. Lee Moffitt Cancer Center & Research Institute

    Tampa, Florida, 33612

  • AZ Cancer Center

    Tucson, Arizona, 85724

  • Haematology and Oncology Associates at Bridgeport

    Tupelo, Mississippi, 38801

  • Washington Cancer Center

    Washington D.C., District of Columbia, 20010

Other trials in United States

Russia40 sites

  • State Medical Institution: Arkhangelsk Regional Clinical Oncological Center, Surgery Department 7.

    Arkhangelsk, 163045

  • Chelyabinsk Regional Oncological Center, Chemotherapy Department

    Chelyabinsk, 454087

  • State Therapeutical and Prophylactic Institution: Chelyabinsk Regional Oncological Center,

    Chelyabinsk, 454087

  • State Medical Institution of Healthcare: Clinical Oncological Center under the Ministry of Healthcare of the Republic of Tatarstan, Chemotherapy Department

    Kazan', Tatarstan Republic, 420029

  • Municipal Medical Institution: Oncological Center, Chemotherapy Department

    Krasnodar, 350040

  • State Institution: Russian Oncological Research Center n.a. N.N. Blokhin of the Russian Academy of Medical Sciences, Department of Urology

    Moscow, 115478

  • Russian Research Center of Roentgenology & Radiology , Surgery Department

    Moscow, 117997

  • Russian State Medical University under the Federal Agency for Healthcare and Social Development, Department of Radiology Daignostics and Radiology Therapy

    Moscow, 117997

  • Russian State Medical University under the Federal Agency for Healthcare and Social Development, Department of Urology and Surgical Nephrology

    Moscow, 117997

  • Moscow Research Oncological Institute n.a. P.A. Hertzen, Urology Departmen

    Moscow, 125284

  • Regional Research Clinical Institute n.a M.F. Vladimirskiy, Urology Department #1

    Moscow, 129110

  • Non-State Medical Institution:Central Clinical Hospital

    Moscow, 129128

  • Murmansk Regional Oncological Center, Oncology Department #5

    Murmansk, 183047

  • Privolzhsky County Medical Center

    Nizhny Novgorod, 603001

  • State Institution of Nizhny Novgorod Region: "Nizhny Novgorod Oncology Center", Department of Oncology #5 (for chemotherapy treatment)

    Nizhny Novgorod, 603081

  • Medical Radiological Research Center under the Russian Academy of Medical Sciences, Department of Urology

    Obninsk, 249036

  • State Medical Institution: Omsk Regional Oncological Center, Chemotherapy Department

    Omsk, 644013

  • Orenburg Regional Clinical Oncological Center, Chemotherapy Department

    Orenburg, 460021

  • Regional State Medical Institution:"Orel Oncological Center", Oncology Department #5

    Oryol, 302020

  • Republican Oncology Center" under the Ministry of Healthcare,

    Petrozavodsk, Republic of Karelia, 185007

  • Pyatigorsk Branch of Stavropol Territorial Clinical Oncological Center (State Medical Institution), Outpatient Department

    Pyatigorsk, 357500

  • Rostov State Medical University under the Federal Agency for Healthcare and Social Development, Department of Urology

    Rostov-on-Don, 344022

  • Regional Clinical Oncological Center, Surgery Department

    Ryazan, 390011

  • Leningrad Regional Oncological Center, Surgical Department #3

    Saint Petersburg, Leningradskaya Oblast', 188663

  • St. Petersburg State Pediatric Medical Academy

    Saint Petersburg, 194100

  • Department of Urology

    Saint Petersburg, 194291

  • Municipal Multi-Speciality Hospital #2, Department of Urology

    Saint Petersburg, 194354

  • St. Petersburg State Medical Institution: Municipal Multi-Speciality Hospital #2, Department of Functional Diagnostics

    Saint Petersburg, 194354

  • Municipal Hospital #26, Department Of Urology

    Saint Petersburg, 196247

  • "Central Research Institute of Roentgenology & Radiology Federal Agency Healthcare Social Development"

    Saint Petersburg, 197758

  • Department of Biotherapy and Bone Marrow Transplantation

    Saint Petersburg, 197758

  • St. Petersburg State Medical Institution: Municipal Hospital #15, Urology Department

    Saint Petersburg, 198205

  • Samara Regional Oncology Center, Chemotherapy Department

    Samara, 443066

  • "Oncological Center", Department of Haematology and Chemotherapy

    Sochi, 354057

  • State Medical Institution: Stavropol Territorial Clinical Oncological Center, Department of Urology

    Stavropol, 355047

  • State Medical Institution: Tambov Regional Oncological Center, Surgery Department

    Tambov, 392013

  • State Higher Educational Institution: Siberian State Medical University, Department of Urology

    Tomsk, 634050

  • Bashkir State Medical University, Urology Department

    Ufa, 634050

  • State Medical Institution of Yaroslavl Region

    Yaroslavl, 150054

  • State Institution of Mariy El Republic: "Republican Clinical Hospital", Department Of Urology

    Yoshkar-Ola, 424037

Other trials in Russia

Ukraine17 sites

  • Bukovyna State Medical University, Department of Oncology, Radiodiagnostics and Radiotherapy

    Chernivtsi, 58000,

  • Dnepropetrovsk State Medical Academy, Department of Urology

    Dnipro, 49005

  • Dnepropetrovsk State Medical Academy, Oncology, Radiodiagnostics and Radiotherapy Department

    Dnipro, 49044

  • Donetsk Regional Antitumor Center, Urology Department

    Donetsk, 83092

  • Ivano-Frankovsk State Medical University; Oncology Department

    Ivano-Frankivsk, 76000

  • Kharkov Regional Clinical Urology and Nephrology Center, Oncourology Department

    Kharkiv, 61037

  • Kharkov Medical Academy of Postgraduate Education, Oncology and Pediatric Oncology Department

    Kharkiv, 61176

  • Urology Institute under the Ukrainian Academy of Medical Sciences, Oncourology Department

    Kiev, 04053

  • Urology Institute under the Ukrainian Academy of Medical Sciences, Plastic and Reconstructive Urology Department

    Kiev, 04053

  • Regional Public Institution: Krivoy Rog Oncological Center, Chemotherapy Department

    Krivoi Rog, 50048

  • Lugansk Regional Clinical Oncological Center, Urology Department

    Luhansk, 91047

  • Crimea State Medical University n.a. S.I. Georgievsky, Course in Urology at the Faculty Surgery#1 Department

    Lviv, 79010

  • Odessa State Medical University;

    Odesa, 65074

  • Crimean Republican Clinical Oncological Center, Chemotherapy Department

    Simferopol, 95023

  • Uzhgorod National University,

    Uzhhorod, 88000

  • Zaporozhye Medical Academy of Postgraduate Education, Oncology Department

    Zaporizhzhya, 69096

  • Zaporozhye Medical Academy of Postgraduate Education, Urology Department

    Zaporizhzhya, 69600

Other trials in Ukraine

United Kingdom15 sites

  • Clatterbridge Centre for Oncology

    Bebington, Wirral, CH63 4JY.

  • Belfast City Hospital

    Belfast, Northern Ireland

  • The Royal Bournemouth Hospital

    Bournemouth, BH7 7DW

  • Bristol Haematology and Oncology Centre

    Bristol, BS2 8ED

  • Beatson Oncology Centre

    Glasgow, G11 6NT

  • St Luke's Cancer Centre, Royal Surrey County Hospital

    Guildford, GU2 7XX

  • St. James University Hospital

    Leeds, LS9 7TF

  • Christie Hospital NHS Trust

    Manchester, M20 4BX

  • The James Cook University Hospital

    Middlesbrough, TS4 3BW

  • Mount Vernon Cancer Centre

    Northwood, Middlesex, HA6 2RN

  • University of Nottingham

    Nottingham, NG5 1PB

  • The Churchill Hospital

    Oxford, OX3 7LJ

  • Weston Park Hospital

    Sheffield, S10 2SJ

  • The South West Wales Cancer Institute

    Swansea, SA2 8QA

  • New Cross Hospital

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Romania10 sites

  • Private Medical Centre

    Arad, 310175

  • Fundeni Clinical Institute - Urology Department

    Bucharest, 022328

  • Dinu Uromedica

    Bucharest, 041345

  • "Prof. Dr. Th. Burghele" Clinical Hospital, Urology Clinic

    Bucharest, 050659,

  • "Prof. Dr. Th. Burghele" Clinical Hospital, Urology Clinic

    Bucharest

  • "I. Chiricuta" Institute of Oncology

    Cluj-Napoca, 400015,

  • E-URO Medical Center

    Cluj-Napoca, 400420

  • Provita Center SRL

    Constanța, 900635

  • Sibiu Clinical County Hospital - Urology Clinic

    Sibiu, 550245

  • Oncomed SRL

    Timișoara, 300239

Other trials in Romania

Poland9 sites

  • IIndependent Public Hospital #1- , Oncology and Radiotherapy Dept

    Gdansk, 80-952

  • Holycross Oncology Center in Kielce, Department of Urology

    Kielce, 25-734

  • Maria Sklodowska-Curie Memorial Institute, Oncology Center Kraków Clinic Systemic and Generalized Neoplasms

    Krakow, 31-115

  • Independent Public Health Care Institution University Hospital in Krakow, Department of Oncology

    Krakow, 31-501

  • Lord's Transfiguration Independent Hospital Medical Academy Poznań

    Poznan, 61-848

  • Independent Public Clinical Hospital #2 - Pomeranian Medical Academy in Szczecin, Urology Clinic

    Szczecin, 70-111

  • Military Institute of Medicine, Department of Oncology

    Warsaw, 00-909

  • Maria Sklodowska-Curie Memorial Institute, Oncology Center in Warsaw, Clinic of Neoplasms of Urinary System

    Warsaw, 02-781

  • Regional Specialistic Hospital in Wrocław, Department of Urology

    Wroclaw, 51-124

Other trials in Poland

Israel6 sites

  • Oncology department, Assaf Harofeh Medical Center

    Be’er Ya‘aqov, Zerifin, 70300

  • Oncology institute , Rambam /health Care Campus

    Haifa, 31096

  • Meir Medical Center

    Kfar Saba, 44281

  • Oncology department Rabin Medical center

    Petah Tikva, 49100

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

  • Oncology institute , The Chaim Sheba Medical center

    Tel HaShomer, 52621

Other trials in Israel

Spain5 sites

  • Hospital de Cruces

    Barakaldo, 48903

  • Hospital Santa Creu i Sant Pau Hospital Nuevo-Servicio de Oncologia Medica

    Barcelona, 080025

  • Hospital Severo Ochoa, Servicio de Oncologia - Primera planta

    Leganés, Madrid, S

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Marques de Valdecilla Consultas de Oncologia 1st planta

    Santander, 39008

Other trials in Spain

France3 sites

  • CHU Besançon Hôpital Minjoz

    Besançon, 25030

  • Centre Francois Baclesse

    Caen, 14076

  • Centre François Baclesse-CLCC-Caen

    Caen, 14076

Other trials in France

Germany1 site

  • Universitätsklinikum C.G. Carus TU Dresden

    Dresden, 01307

Other trials in Germany

About this study

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.

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.

Read the 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:

  1. subcutaneous low dose IL-2
  2. interferon-α (excluding pegylated IFNα)
  3. 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.

Being tested
Trovax, Placebo, Standard of care therapy
Keywords
Renal, TroVax, survival, metastatic, Kidney, cancer, immunotherapy
Medical subject headings
Carcinoma, Renal Cell, Neoplasm Metastasis, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TrovaxBiological

    1ml IM injection 2-8 weeks apart.

  • PlaceboBiological

    Placebo

  • Standard of care therapyBiological

    subcutaneous low dose IL-2, interferon-α or sunitinib

Study groups in NCT00397345
Study groupRoleWhat they receive
TrovaxExperimentalNot described
Receives: Biological: Trovax; Biological: Standard of care therapy
PlaceboPlacebo comparatorNot described
Receives: Biological: Placebo; Biological: Standard of care therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. overall survival

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2006 (estimated)
  2. Study startSep 2006
  3. Primary completionDec 2009
  4. Study completionDec 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
733 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00397345
Sponsor's protocol ID
TV3/001/06
Status last verified
Oct 2020
First submitted
8 Nov 2006
Last updated
19 Oct 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 20881001

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Trovax in people with Clear Cell Renal Carcinoma, run by Oxford BioMedica at 152 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 152 sites in United States, Russia, Ukraine, United Kingdom, Romania and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

overall survival (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00397345, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.

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