Registry Study for Talimogene Laherparepvec
- Conditions
- Any Tumor Type Eligible for Treatment With Talimogene Laherparepvec in Amgen or BioVEX-sponsored Clinical Trial
- Interventions
- Other: Information collection
- Registration Number
- NCT02173171
- Lead Sponsor
- Amgen
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 185
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.
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Previously treated with T-VEC Information collection Received at least 1 dose of talimogene laherparepvec on Amgen or BioVEX-sponsored clinical trial
- Primary Outcome Measures
Name Time Method Talimogene Laherparepvec Related Adverse Events 7 years Long-term safety of talimogene laherparepvec will be assessed by reporting of related adverse events every 3 months. Related serious adverse events will be reported within 24 hours following investigator's knowledge of the event.
Subject overall survival 7 years Overall survival status will be reported every 3 months
Use of subsequent anti-cancer therapy 7 years The use of subsequent anti-cancer therapy, for the tumor indication in the prior Amgen or BioVEX-sponsored clinical trial, including retreatment with marketed talimogene laherparepvec for approved indication in subjects previously enrolled in Amgen or BioVEX-sponsored talimogene laherparepvec clinical trials, will be monitored
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (59)
Mary Crowley Cancer Research
🇺🇸Dallas, Texas, United States
Rutgers Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
Princess Margaret Cancer Centre
🇨🇦Toronto, Ontario, Canada
Gabrail Cancer Center, LLC
🇺🇸Canton, Ohio, United States
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Investigative Clinical Research of Indiana, LLC
🇺🇸Indianapolis, Indiana, United States
University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Centre Hospitalier Universitaire Vaudois
🇨🇭Lausanne, Switzerland
Universitaetsklinikum Allgemeines Krankenhaus Wien
🇦🇹Wien, Austria
Kantonsspital Graubuenden
🇨🇭Chur, Switzerland
Baptist MD Anderson Cancer Center
🇺🇸Jacksonville, Florida, United States
Florida Hospital Memorial Division
🇺🇸Daytona Beach, Florida, United States
Landeskrankenhaus Salzburg
🇦🇹Salzburg, Austria
Yonsei University Health System Severance Hospital
🇰🇷Seoul, Korea, Republic of
Mount Sinai Comprehensive Cancer Center
🇺🇸Miami Beach, Florida, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
University of Colorado Cancer Center
🇺🇸Aurora, Colorado, United States
University of South Alabama Mitchell Cancer Institute
🇺🇸Mobile, Alabama, United States
Oncology Specialists SC
🇺🇸Park Ridge, Illinois, United States
St Joseph Heritage Healthcare
🇺🇸Santa Rosa, California, United States
Morristown Medical Center
🇺🇸Morristown, New Jersey, United States
Allina Health System dba Virginia Piper Cancer Institute
🇺🇸Minneapolis, Minnesota, United States
Saint Louis University Hospital
🇺🇸Saint Louis, Missouri, United States
Wake Forest Baptist Health Medical Center
🇺🇸Winston-Salem, North Carolina, United States
University of North Carolina Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Greenville Health System Institute for Translational Oncology Research
🇺🇸Greenville, South Carolina, United States
Providence Oncology and Hematology Care Eastside
🇺🇸Portland, Oregon, United States
The West Clinic PC dba West Cancer Center
🇺🇸Germantown, Tennessee, United States
Henry Joyce Cancer Center
🇺🇸Nashville, Tennessee, United States
Intermountain Medical Center
🇺🇸Murray, Utah, United States
University of Utah Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
Wheaton Franciscan Healthcare
🇺🇸Franklin, Wisconsin, United States
Tom Baker Cancer Centre
🇨🇦Calgary, Alberta, Canada
Hopital Ambroise Pare
🇫🇷Boulogne Billancourt, France
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
Centre Hospitalier Universitaire de Nantes, Hôpital Hôtel Dieu
🇫🇷Nantes Cedex 1, France
University Hospital
🇩🇪Heidelberg, Germany
General Hospital of Athens Laiko
🇬🇷Athens, Greece
Pecsi Tudomanyegyetem Klinikai Kozpont
🇭🇺Pecs, Hungary
Universitätsklinikum Tübingen
🇩🇪Tübingen, Germany
Metropolitan Hospital
🇬🇷Athens, Greece
Bioclinic of Thessaloniki
🇬🇷Thessaloniki, Greece
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
🇮🇹Bergamo, Italy
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar
🇭🇺Szeged, Hungary
IRCCS Istituto Europeo di Oncologia
🇮🇹Milano, Italy
Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
🇵🇱Warszawa, Poland
Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte
🇮🇹Siena, Italy
Hospital General Universitario de Valencia
🇪🇸Valencia, Comunidad Valenciana, Spain
FSBI N N Blokhin Russian Oncology Research Center Ministry of Health of Russian Federation
🇷🇺Moscow, Russian Federation
Hospital Clinic i Provincial de Barcelona
🇪🇸Barcelona, Cataluña, Spain
Wilgers Oncology Centre
🇿🇦Pretoria, South Africa
FSBI Scientific and Research Oncology Institute named after N N Petrov
🇷🇺Saint-Petersburg, Russian Federation
Universitaetsspital Zuerich
🇨🇭Zuerich Flughafen, Switzerland
Guys and St Thomas Hospital
🇬🇧London, United Kingdom
Onkologikoa
🇪🇸San Sebastian, País Vasco, Spain
Hopitaux Universitaires de Geneve
🇨🇭Geneve, Switzerland
Royal Marsden Hospital
🇬🇧London, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
🇬🇧Wirral, United Kingdom
H Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States