Registry Study for Talimogene Laherparepvec

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

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 Overview

• Status: Completed
• Conditions: Any Tumor Type Eligible for Treatment With Talimogene Laherparepvec in Amgen or BioVEX-sponsored Clinical Trial
• Intervention / Treatment: Other: Information collection

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.

• Study Type: Observational
• Enrollment (Actual): 185

Contacts and Locations

Study Locations

• Austria
  • Salzburg, Austria, 5020
    • Landeskrankenhaus Salzburg
  • Wien, Austria, 1090
    • Universitaetsklinikum Allgemeines Krankenhaus Wien
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
      • Tom Baker Cancer Centre
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Cancer Centre
• France
  • Boulogne Billancourt, France, 92100
    • Hopital Ambroise Pare
  • Nantes Cedex 1, France, 44093
    • Centre Hospitalier Universitaire de Nantes, Hôpital Hôtel Dieu
• Germany
  • Heidelberg, Germany, 69120
    • university Hospital
  • Tübingen, Germany, 72076
    • Universitätsklinikum Tübingen
• Greece
  • Athens, Greece, 11527
    • General Hospital of Athens Laiko
  • Athens, Greece, 18547
    • Metropolitan Hospital
  • Thessaloniki, Greece, 54622
    • Bioclinic of Thessaloniki
• Hungary
  • Pecs, Hungary, 7632
    • Pécsi Tudományegyetem Klinikai Központ
  • Szeged, Hungary, 6720
    • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar
• Italy
  • Bergamo, Italy, 24127
    • Azienda Socio Sanitaria Territoriale Papa Giovanni xxiii
  • Milano, Italy, 20141
    • IRCCS Istituto Europeo di Oncologia
  • Siena, Italy, 53100
    • Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte
• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Yonsei University Health System Severance Hospital
• Poland
  • Warszawa, Poland, 02-781
    • Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
• Russian Federation
  • Moscow, Russian Federation, 115478
    • FSBI N N Blokhin Russian Oncology Research Center Ministry of Health of Russian Federation
  • Saint-Petersburg, Russian Federation, 197758
    • FSBI Scientific and Research Oncology Institute named after N N Petrov
• South Africa
  • Pretoria, South Africa, 0081
    • Wilgers Oncology Centre
• Spain
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Cataluña
    • Barcelona, Cataluña, Spain, 08036
      • Hospital Clinic i Provincial de Barcelona
  • Comunidad Valenciana
    • Valencia, Comunidad Valenciana, Spain, 46014
      • Hospital General Universitario de Valencia
  • País Vasco
    • San Sebastian, País Vasco, Spain, 20014
      • Onkologikoa
• Switzerland
  • Chur, Switzerland, 7000
    • Kantonsspital Graubuenden
  • Geneve, Switzerland, 1205
    • Hôpitaux Universitaires de Genève
  • Lausanne, Switzerland, 1011
    • Centre Hospitalier Universitaire Vaudois
  • Zuerich Flughafen, Switzerland, 8058
    • Universitaetsspital Zuerich
• United Kingdom
  • London, United Kingdom, SE1 9RT
    • Guys and St Thomas Hospital
  • London, United Kingdom, SW3 6JJ
    • Royal Marsden Hospital
  • Wirral, United Kingdom, CH63 4JY
    • The Clatterbridge Cancer Centre NHS Foundation Trust
• United States
  • Alabama
    • Mobile, Alabama, United States, 36604
      • University of South Alabama Mitchell Cancer Institute
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences
  • California
    • Santa Rosa, California, United States, 95403
      • St Joseph Heritage Healthcare
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Cancer Center
  • Florida
    • Daytona Beach, Florida, United States, 32117
      • Florida Hospital Memorial Division
    • Jacksonville, Florida, United States, 32207
      • Baptist MD Anderson Cancer Center
    • Miami Beach, Florida, United States, 33140
      • Mount Sinai Comprehensive Cancer Center
    • Tampa, Florida, United States, 33612
      • H Lee Moffitt Cancer Center and Research Institute
  • Illinois
    • Park Ridge, Illinois, United States, 60068
      • Oncology Specialists SC
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Investigative Clinical Research of Indiana, LLC
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Allina Health System DBA Virginia Piper Cancer Institute
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Saint Louis University Hospital
  • New Jersey
    • Morristown, New Jersey, United States, 07962
      • Morristown Medical Center
    • New Brunswick, New Jersey, United States, 08903
      • Rutgers Cancer Institute of New Jersey
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina Chapel Hill
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Health Medical Center
  • Ohio
    • Canton, Ohio, United States, 44718
      • Gabrail Cancer Center, LLC
  • Oregon
    • Portland, Oregon, United States, 97213
      • Providence Oncology and Hematology Care Eastside
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Greenville Health System Institute for Translational Oncology Research
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • The West Clinic PC dba West Cancer Center
    • Nashville, Tennessee, United States, 37232
      • Henry Joyce Cancer Center
  • Texas
    • Dallas, Texas, United States, 75230
      • Mary Crowley Cancer Research
    • Houston, Texas, United States, 77030
      • University of Texas MD Anderson Cancer Center
  • Utah
    • Murray, Utah, United States, 84107
      • Intermountain Medical Center
    • Salt Lake City, Utah, United States, 84112
      • University of Utah Huntsman Cancer Institute
  • Wisconsin
    • Franklin, Wisconsin, United States, 53132
      • Wheaton Franciscan Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Previously treated with T-VEC; Received at least 1 dose of talimogene laherparepvec on Amgen or BioVEX-sponsored clinical trial	Other: Information collection; Q3M Information collection; Other Names: Q3M Information collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Subject overall survival	Overall survival status will be reported every 3 months	7 years
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

Collaborators and Investigators

• Sponsor: Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2010
• Primary Completion (Actual): September 23, 2021
• Study Completion (Actual): September 23, 2021

Study Registration Dates

• First Submitted: June 11, 2014
• First Submitted That Met QC Criteria: June 23, 2014
• First Posted (Estimate): June 24, 2014

Study Record Updates

• Last Update Posted (Actual): September 30, 2021
• Last Update Submitted That Met QC Criteria: September 29, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Melanoma; talimogene laherparepvec
• Other Study ID Numbers: 20120139

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
• IPD Sharing Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.

IPD Sharing Access Criteria

Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.

Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be

• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No