Registry Study for Talimogene Laherparepvec

Completed

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

• 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.

Study Timeline

• Study Start: 2010-04-27
• Study First Submitted: 2014-06-11
• Study First Submitted QC: 2014-06-23
• Study First Posted: 2014-06-24
• Status Verified: 2021-09
• Primary Completion: 2021-09-23
• Study Completion: 2021-09-23
• Last Update Submitted: 2021-09-29
• Last Update Posted: 2021-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 185

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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

Trial Locations

Locations (59)

University of South Alabama Mitchell Cancer Institute; 🇺🇸 Mobile, Alabama, United States

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

St Joseph Heritage Healthcare; 🇺🇸 Santa Rosa, California, United States

University of Colorado Cancer Center; 🇺🇸 Aurora, Colorado, United States

Florida Hospital Memorial Division; 🇺🇸 Daytona Beach, Florida, United States

Baptist MD Anderson Cancer Center; 🇺🇸 Jacksonville, Florida, United States

Mount Sinai Comprehensive Cancer Center; 🇺🇸 Miami Beach, Florida, United States

H Lee Moffitt Cancer Center and Research Institute; 🇺🇸 Tampa, Florida, United States

Oncology Specialists SC; 🇺🇸 Park Ridge, Illinois, United States

Investigative Clinical Research of Indiana, LLC; 🇺🇸 Indianapolis, Indiana, United States

Scroll for more (49 remaining)