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.

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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-003196-29-ES

Enrollment

200

Registered

2017-11-07

Start date

2017-12-04

Completion date

Unknown

Last updated

2018-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Any tumor type eligible for treatment with talimogene laherparepvec in Amgen or BioVEX-sponsored clinical trial

Interventions

Trade Name: IMLYGIC Product Name: Talimogene Laherparepvec Product Code: AMG 678 Pharmaceutical Form: Solution for injection INN or Proposed INN: Talimogene laherparepvec CAS Number: 1187560-31-1 Curr

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: • To evaluate the long-term safety of talimogene laherparepvec • To monitor subject overall survival • To monitor 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 in subjects previously enrolled in Amgen or BioVEX-sponsored clinical trials;Secondary Objective: There are no secondary objectives;Primary end point(s): • Long-term safety as assessed by subject incidence of all talimogene laherparepvec treatment-related adverse events of any grade, grade = 3 adverse events, serious adverse events, fatal adverse events, and adverse events of interest that begin after the defined reporting period has ended on the previous Amgen or BioVEX-sponsored talimogene laherparepvec clinical trial will be summarized. Treatment-related adverse events during the retreatment period with marketed talimogene laherparepvec and up to 30 days after the discontinuation of treatment will be reported separately. • Survival status: Time to death will be calculated from the first dose of talimogene laherparepvec from the earliest parent study. • Use of subsequent anti-cancer therapy for indicated tumor type in prior Amgen or BioVEX-sponsored talimogene laherparepvec clinical trial will be summarized.;Timepoint(s) of evaluation of this end point: The primary analysis will be performed at the end of study. The registry study will end when the sponsor (in consultation with the regulatory authorities) has determined that the collection of long-term safety and survival data are no longer necessary.	—

Measure

Time frame

Main Objective: • To evaluate the long-term safety of talimogene laherparepvec • To monitor subject overall survival • To monitor 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 in subjects previously enrolled in Amgen or BioVEX-sponsored clinical trials;Secondary Objective: There are no secondary objectives;Primary end point(s): • Long-term safety as assessed by subject incidence of all talimogene laherparepvec treatment-related adverse events of any grade, grade = 3 adverse events, serious adverse events, fatal adverse events, and adverse events of interest that begin after the defined reporting period has ended on the previous Amgen or BioVEX-sponsored talimogene laherparepvec clinical trial will be summarized. Treatment-related adverse events during the retreatment period with marketed talimogene laherparepvec and up to 30 days after the discontinuation of treatment will be reported separately. • Survival status: Time to death will be calculated from the first dose of talimogene laherparepvec from the earliest parent study. • Use of subsequent anti-cancer therapy for indicated tumor type in prior Amgen or BioVEX-sponsored talimogene laherparepvec clinical trial will be summarized.;Timepoint(s) of evaluation of this end point: The primary analysis will be performed at the end of study. The registry study will end when the sponsor (in consultation with the regulatory authorities) has determined that the collection of long-term safety and survival data are no longer necessary.

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Secondary

Measure	Time frame
Secondary end point(s): There are no secondary endpoints;Timepoint(s) of evaluation of this end point: N/A	—

Countries

Austria, Canada, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Russian Federation, Spain, Switzerland, United Kingdom, United States

Contacts

Public ContactIHQ medical Info-Clinical Trials

Amgen (EUROPE) GmbH

MedinfoInternational@amgen.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026