Registry Study for Talimogene Laherparepvec

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

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02173171
• Other study ID #: 20120139
• Status: Completed
• Start date: April 27, 2010
• Est. completion date: September 23, 2021

Study information

• Verified date: September 2021
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: September 23, 2021
• Est. primary completion date: September 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Other:
• Information collection
Q3M Information collection

Locations

Country	Name	City	State
Austria	Landeskrankenhaus Salzburg	Salzburg
Austria	Universitaetsklinikum Allgemeines Krankenhaus Wien	Wien
Canada	Tom Baker Cancer Centre	Calgary	Alberta
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	Princess Margaret Cancer Centre	Toronto	Ontario
France	Hopital Ambroise Pare	Boulogne Billancourt
France	Centre Hospitalier Universitaire de Nantes, Hôpital Hôtel Dieu	Nantes Cedex 1
Germany	University Hospital	Heidelberg
Germany	Universitätsklinikum Tübingen	Tübingen
Greece	General Hospital of Athens Laiko	Athens
Greece	Metropolitan Hospital	Athens
Greece	Bioclinic of Thessaloniki	Thessaloniki
Hungary	Pecsi Tudomanyegyetem Klinikai Kozpont	Pecs
Hungary	Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar	Szeged
Italy	Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII	Bergamo
Italy	IRCCS Istituto Europeo di Oncologia	Milano
Italy	Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte	Siena
Korea, Republic of	Yonsei University Health System Severance Hospital	Seoul
Poland	Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy	Warszawa
Russian Federation	FSBI N N Blokhin Russian Oncology Research Center Ministry of Health of Russian Federation	Moscow
Russian Federation	FSBI Scientific and Research Oncology Institute named after N N Petrov	Saint-Petersburg
South Africa	Wilgers Oncology Centre	Pretoria
Spain	Hospital Clinic i Provincial de Barcelona	Barcelona	Cataluña
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Onkologikoa	San Sebastian	País Vasco
Spain	Hospital General Universitario de Valencia	Valencia	Comunidad Valenciana
Switzerland	Kantonsspital Graubuenden	Chur
Switzerland	Hopitaux Universitaires de Geneve	Geneve
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne
Switzerland	Universitaetsspital Zuerich	Zuerich Flughafen
United Kingdom	Guys and St Thomas Hospital	London
United Kingdom	Royal Marsden Hospital	London
United Kingdom	The Clatterbridge Cancer Centre NHS Foundation Trust	Wirral
United States	University of Colorado Cancer Center	Aurora	Colorado
United States	Gabrail Cancer Center, LLC	Canton	Ohio
United States	University of North Carolina Chapel Hill	Chapel Hill	North Carolina
United States	Mary Crowley Cancer Research	Dallas	Texas
United States	Florida Hospital Memorial Division	Daytona Beach	Florida
United States	Wheaton Franciscan Healthcare	Franklin	Wisconsin
United States	The West Clinic PC dba West Cancer Center	Germantown	Tennessee
United States	Greenville Health System Institute for Translational Oncology Research	Greenville	South Carolina
United States	University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Investigative Clinical Research of Indiana, LLC	Indianapolis	Indiana
United States	Baptist MD Anderson Cancer Center	Jacksonville	Florida
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Mount Sinai Comprehensive Cancer Center	Miami Beach	Florida
United States	Allina Health System dba Virginia Piper Cancer Institute	Minneapolis	Minnesota
United States	University of South Alabama Mitchell Cancer Institute	Mobile	Alabama
United States	Morristown Medical Center	Morristown	New Jersey
United States	Intermountain Medical Center	Murray	Utah
United States	Henry Joyce Cancer Center	Nashville	Tennessee
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	Oncology Specialists SC	Park Ridge	Illinois
United States	Providence Oncology and Hematology Care Eastside	Portland	Oregon
United States	Saint Louis University Hospital	Saint Louis	Missouri
United States	University of Utah Huntsman Cancer Institute	Salt Lake City	Utah
United States	St Joseph Heritage Healthcare	Santa Rosa	California
United States	H Lee Moffitt Cancer Center and Research Institute	Tampa	Florida
United States	Wake Forest Baptist Health Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Austria,  Canada,  France,  Germany,  Greece,  Hungary,  Italy,  Korea, Republic of,  Poland,  Russian Federation,  South Africa,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Talimogene Laherparepvec Related Adverse Events	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.	7 years
Primary	Subject overall survival	Overall survival status will be reported every 3 months	7 years
Primary	Use of subsequent anti-cancer therapy	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	7 years

External Links

•   AmgenTrials clinical trials website