A Registry study to evaluate the survival and long-term safety of subjectswho have received at least one dose of talimogene laherparepvec in Amgenor BioVEX-sponsored clinical trial.

Phase 1

• Conditions: Any tumor type eligible for treatment with talimogene laherparepvec in Amgen or BioVEX-sponsored clinical trial; MedDRA version: 21.1Level: LLTClassification code 10053571Term: MelanomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-003196-29-IT
• Lead Sponsor: AMGEN INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-15
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

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