Registry Study for Talimogene Laherparepvec

NCT ID: NCT02173171

Last Updated: 2021-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

185 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-04-27

Study Completion Date

2021-09-23

Brief Summary

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A Registry Study to Evaluate the Survival and Long-Term Safety of Subjects Who Previously Received Talimogene Laherparepvec in Amgen or BioVEX-Sponsored Clinical Trials

Detailed Description

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A registry study is to evaluate the overall survival, use of subsequent anti-cancer therapy, and the long-term safety of subjects who have received at least one dose of talimogene laherparepvec on an Amgen or BioVEX-sponsored clinical trial for any tumor type. Follow-Up will occur every 3 months.

Conditions

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Any Tumor Type Eligible for Treatment With Talimogene Laherparepvec in Amgen or BioVEX-sponsored Clinical Trial

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Previously treated with T-VEC

Received at least 1 dose of talimogene laherparepvec on Amgen or BioVEX-sponsored clinical trial

Information collection

Intervention Type OTHER

Q3M Information collection

Interventions

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Information collection

Q3M Information collection

Intervention Type OTHER

Other Intervention Names

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Q3M Information collection

Eligibility Criteria

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Inclusion Criteria

All subjects must provide informed consent prior to initiation of any study activities.

All subjects must have received at least one dose of talimogene laherparepvec on an Amgen or BioVEX-sponsored clinical trial for any tumor type and must have discontinued treatment and participation, including long-term follow-up (if applicable) in that trial.

Exclusion Criteria

Subjects currently receiving talimogene laherparepvec in Amgen or BioVEX-sponsored clinical trial.

Subject currently participating, including for long-term follow-up (if applicable), in other Amgen-sponsored talimogene laherparepvec clinical trial.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Locations

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University of South Alabama Mitchell Cancer Institute

Mobile, Alabama, United States

Site Status

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

St Joseph Heritage Healthcare

Santa Rosa, California, United States

Site Status

University of Colorado Cancer Center

Aurora, Colorado, United States

Site Status

Florida Hospital Memorial Division

Daytona Beach, Florida, United States

Site Status

Baptist MD Anderson Cancer Center

Jacksonville, Florida, United States

Site Status

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, United States

Site Status

H Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Site Status

Oncology Specialists SC

Park Ridge, Illinois, United States

Site Status

Investigative Clinical Research of Indiana, LLC

Indianapolis, Indiana, United States

Site Status

Allina Health System dba Virginia Piper Cancer Institute

Minneapolis, Minnesota, United States

Site Status

Saint Louis University Hospital

St Louis, Missouri, United States

Site Status

Morristown Medical Center

Morristown, New Jersey, United States

Site Status

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Site Status

University of North Carolina Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Wake Forest Baptist Health Medical Center

Winston-Salem, North Carolina, United States

Site Status

Gabrail Cancer Center, LLC

Canton, Ohio, United States

Site Status

Providence Oncology and Hematology Care Eastside

Portland, Oregon, United States

Site Status

Greenville Health System Institute for Translational Oncology Research

Greenville, South Carolina, United States

Site Status

The West Clinic PC dba West Cancer Center

Germantown, Tennessee, United States

Site Status

Henry Joyce Cancer Center

Nashville, Tennessee, United States

Site Status

Mary Crowley Cancer Research

Dallas, Texas, United States

Site Status

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Intermountain Medical Center

Murray, Utah, United States

Site Status

University of Utah Huntsman Cancer Institute

Salt Lake City, Utah, United States

Site Status

Wheaton Franciscan Healthcare

Franklin, Wisconsin, United States

Site Status

Landeskrankenhaus Salzburg

Salzburg, , Austria

Site Status

Universitaetsklinikum Allgemeines Krankenhaus Wien

Vienna, , Austria

Site Status

Tom Baker Cancer Centre

Calgary, Alberta, Canada

Site Status

Cross Cancer Institute

Edmonton, Alberta, Canada

Site Status

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Site Status

Hopital Ambroise Pare

Boulogne-Billancourt, , France

Site Status

Centre Hospitalier Universitaire de Nantes, Hôpital Hôtel Dieu

Nantes, , France

Site Status

University Hospital

Heidelberg, , Germany

Site Status

Universitätsklinikum Tübingen

Tübingen, , Germany

Site Status

General Hospital of Athens Laiko

Athens, , Greece

Site Status

Metropolitan Hospital

Athens, , Greece

Site Status

Bioclinic of Thessaloniki

Thessaloniki, , Greece

Site Status

Pecsi Tudomanyegyetem Klinikai Kozpont

Pécs, , Hungary

Site Status

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar

Szeged, , Hungary

Site Status

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

Bergamo, , Italy

Site Status

IRCCS Istituto Europeo di Oncologia

Milan, , Italy

Site Status

Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte

Siena, , Italy

Site Status

Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy

Warsaw, , Poland

Site Status

FSBI N N Blokhin Russian Oncology Research Center Ministry of Health of Russian Federation

Moscow, , Russia

Site Status

FSBI Scientific and Research Oncology Institute named after N N Petrov

Saint Petersburg, , Russia

Site Status

Wilgers Oncology Centre

Pretoria, , South Africa

Site Status

Yonsei University Health System Severance Hospital

Seoul, , South Korea

Site Status

Onkologikoa

Donostia / San Sebastian, Basque Country, Spain

Site Status

Hospital Clinic i Provincial de Barcelona

Barcelona, Catalonia, Spain

Site Status

Hospital General Universitario de Valencia

Valencia, Valencia, Spain

Site Status

Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status

Kantonsspital Graubuenden

Chur, , Switzerland

Site Status

Hopitaux Universitaires de Geneve

Geneva, , Switzerland

Site Status

Centre Hospitalier Universitaire Vaudois

Lausanne, , Switzerland

Site Status

Universitaetsspital Zuerich

Zuerich Flughafen, , Switzerland

Site Status

Guys and St Thomas Hospital

London, , United Kingdom

Site Status

Royal Marsden Hospital

London, , United Kingdom

Site Status

The Clatterbridge Cancer Centre NHS Foundation Trust

Metropolitan Borough of Wirral, , United Kingdom

Site Status

Countries

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United States Austria Canada France Germany Greece Hungary Italy Poland Russia South Africa South Korea Spain Switzerland United Kingdom

Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

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20120139

Identifier Type: -

Identifier Source: org_study_id

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