Clinical trial NCT02173171: Registry Study for Talimogene Laherparepvec
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Any Tumor Type Eligible for Treatment With Talimogene Laherparepvec in Amgen or BioVEX-sponsored Clinical Trial
Keywords: Melanoma
talimogene laherparepvec
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2014-06-24
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who have received at least one dose of talimogene laherparepvec in an Amgen or BioVEX-sponsored clinical trial.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Talimogene Laherparepvec Related Adverse Events
timeFrame: 7 years
measure: Subject overall survival
timeFrame: 7 years
measure: Use of subsequent anti-cancer therapy
timeFrame: 7 years
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama Mitchell Cancer Institute
state: Alabama
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Santa Rosa
country: United States
facility: St Joseph Heritage Healthcare
state: California
city: Aurora
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: Daytona Beach
country: United States
facility: Florida Hospital Memorial Division
state: Florida
city: Jacksonville
country: United States
facility: Baptist MD Anderson Cancer Center
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Comprehensive Cancer Center
state: Florida
city: Tampa
country: United States
facility: H Lee Moffitt Cancer Center and Research Institute
state: Florida
city: Park Ridge
country: United States
facility: Oncology Specialists SC
state: Illinois
city: Indianapolis
country: United States
facility: Investigative Clinical Research of Indiana, LLC
state: Indiana
city: Minneapolis
country: United States
facility: Allina Health System dba Virginia Piper Cancer Institute
state: Minnesota
city: Saint Louis
country: United States
facility: Saint Louis University Hospital
state: Missouri
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: Chapel Hill
country: United States
facility: University of North Carolina Chapel Hill
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health Medical Center
state: North Carolina
city: Canton
country: United States
facility: Gabrail Cancer Center, LLC
state: Ohio
city: Portland
country: United States
facility: Providence Oncology and Hematology Care Eastside
state: Oregon
city: Greenville
country: United States
facility: Greenville Health System Institute for Translational Oncology Research
state: South Carolina
city: Germantown
country: United States
facility: The West Clinic PC dba West Cancer Center
state: Tennessee
city: Nashville
country: United States
facility: Henry Joyce Cancer Center
state: Tennessee
city: Dallas
country: United States
facility: Mary Crowley Cancer Research
state: Texas
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah Huntsman Cancer Institute
state: Utah
city: Franklin
country: United States
facility: Wheaton Franciscan Healthcare
state: Wisconsin
city: Salzburg
country: Austria
facility: Landeskrankenhaus Salzburg
city: Wien
country: Austria
facility: Universitaetsklinikum Allgemeines Krankenhaus Wien
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Boulogne Billancourt
country: France
facility: Hopital Ambroise Pare
city: Nantes Cedex 1
country: France
facility: Centre Hospitalier Universitaire de Nantes, Hôpital Hôtel Dieu
city: Heidelberg
country: Germany
facility: University Hospital
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Athens
country: Greece
facility: General Hospital of Athens Laiko
city: Athens
country: Greece
facility: Metropolitan Hospital
city: Thessaloniki
country: Greece
facility: Bioclinic of Thessaloniki
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem Klinikai Kozpont
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar
city: Bergamo
country: Italy
facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
city: Milano
country: Italy
facility: IRCCS Istituto Europeo di Oncologia
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System Severance Hospital
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
city: Moscow
country: Russian Federation
facility: FSBI N N Blokhin Russian Oncology Research Center Ministry of Health of Russian Federation
city: Saint-Petersburg
country: Russian Federation
facility: FSBI Scientific and Research Oncology Institute named after N N Petrov
city: Pretoria
country: South Africa
facility: Wilgers Oncology Centre
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial de Barcelona
state: Cataluña
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
state: Comunidad Valenciana
city: San Sebastian
country: Spain
facility: Onkologikoa
state: País Vasco
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Chur
country: Switzerland
facility: Kantonsspital Graubuenden
city: Geneve
country: Switzerland
facility: Hopitaux Universitaires de Geneve
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
city: Zuerich Flughafen
country: Switzerland
facility: Universitaetsspital Zuerich
city: London
country: United Kingdom
facility: Guys and St Thomas Hospital
city: London
country: United Kingdom
facility: Royal Marsden Hospital
city: Wirral
country: United Kingdom
facility: The Clatterbridge Cancer Centre NHS Foundation Trust
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: