A Registry study to evaluate the survival and long-term safety of subjects who have received at least one dose of talimogene laherparepvec in Amgen or BioVEX-sponsored clinical trial.
- Conditions
- Any tumor type eligible for treatment with talimogene laherparepvec in Amgen or BioVEX-sponsored clinical trialMedDRA version: 21.1Level: LLTClassification code 10053571Term: MelanomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-003196-29-DE
- Lead Sponsor
- Amgen Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
1. All subjects must provide informed consent prior to initiation of any study activities. When the subject is legally too young to provide informed consent/assent, subject’s legally acceptable representative must provide informed consent/assent based on local regulations and/or guidelines prior to initiation of any study activities
2. 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 140
1. Subjects currently receiving talimogene laherparepvec in Amgen or BioVEX-sponsored clinical trial
2. Subject currently participating, including for long-term follow-up (if applicable), in other Amgen-sponsored talimogene laherparepvec clinical trial.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method