Postmarketing Prospective Study of Melanoma Patients Treated With IMLYGIC® to Characterize Risk of Herpetic Infection

Melanoma Clinical Trial

Official title:

A Postmarketing Prospective Cohort Study of Melanoma Patients Treated With IMLYGIC® in Clinical Practice to Characterize Risk of Herpetic Infection Among Patients, Close Contacts, Health Care Providers & Long-term Safety in Treated Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02910557
• Other study ID #: 20130193
• Status: Recruiting
• Start date: August 10, 2017
• Est. completion date: August 6, 2038

Study information

• Verified date: June 2024
• Source: Amgen
• Contact: Amgen Call Center
• Phone: 866-572-6436
• Email: medinfo[@]amgen.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A postmarketing Cohort study of Melanoma patients treated with IMLYGIC (Talimogene Laherparepvec) in clinical Practice to Characterize the risk of herpetic infection with detection of Talimogene Laherparepvec DNA among patients, close contacts, and health care providers; and long term safety in treated patients for up to 5 years after the first IMLYGIC dose.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: August 6, 2038
• Est. primary completion date: August 6, 2038
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patient has provided written informed consent

• Patient is an adult (= 18 years of age at the time of informed consent) with a diagnosis of melanoma

• Patient enrolled within 1 month of receiving the first dose of IMLYGIC for the treatment of melanoma

Exclusion Criteria:

• Patient has a prior history of being a subject in an interventional clinical trial for IMLYGIC

Related Conditions & MeSH terms

• Communicable Diseases
• Herpetic Infection
• Infections
• Melanoma

Locations

Country	Name	City	State
Austria	Medizinische Universitaet Graz	Graz
Austria	Ordensklinikum Linz Elisabethinen	Linz
Austria	Landeskrankenhaus Salzburg	Salzburg
Austria	Universitaetsklinikum Sankt Poelten	Sankt Poelten
Israel	Rambam Medical Center	Haifa
Israel	Sheba Medical Center	Ramat Gan
Switzerland	Universitaetsspital Basel	Basel
Switzerland	Kantonsspital Graubuenden	Chur
Switzerland	Universitaetsspital Zuerich	Zuerich Flughafen
United Kingdom	Cheltenham General Hospital	Cheltenham
United Kingdom	Guys Hospital	London
United Kingdom	Royal Marsden Hospital	London
United Kingdom	Churchill Hospital	Oxford
United Kingdom	Musgrove Park Hospital	Taunton
United States	Mercy Medical Center	Baltimore	Maryland
United States	TriHealth Cancer Institute - Kenwood	Cincinnati	Ohio
United States	Jefferson City Medical Group PC	Jefferson City	Missouri
United States	University of Tennessee Medical Center	Knoxville	Tennessee
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin
United States	Intermountain Medical Center	Murray	Utah
United States	University of Pittsburgh Medical Center Hillman Cancer Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Austria,  Israel,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence Rate	Estimate the incidence rate of herpetic infection with detection of talimogene laherparepvec (T-VEC) DNA among patients for up to 5 years after the first IMLYGIC dose.	Up to 5 years
Secondary	Herpectic Infection with T-VEC DNA for Close Contacts and Healthcare Providers (HCPs)	Count the number of herpetic infections with detection of T-VEC DNA among close contacts and HCPs.	Through study completion, average of 5 years
Secondary	Incidence of Herpetic Infection with T-VEC in Patients During Treatment	Estimate the incidence rate of herpetic infection with detection of T-VEC DNA among patients during treatment with IMLYGIC.	Through treatment period, up to 1 year
Secondary	Incidence of Herpetic Infection with T-VEC in Patients After Treatment	Estimate the incidence rate of herpetic infection with detection of T-VEC DNA among patients after discontinuation of IMLYGIC.	Through study completion, average of 5 years
Secondary	Incidence of Herpes Simplex Virus 1 (HSV-1) DNA in Patients During Treatment	Estimate the incidence rate of herpetic infection with detection of wild-type HSV-1 DNA among patients during treatment with IMLYGIC.	Through treatment period, up to 1 year
Secondary	Incidence of HSV-1 DNA in Patients After Treatment	Estimate the incidence rate of herpetic infection with detection of wild-type HSV-1 DNA among patients after discontinuation of IMLYGIC.	Through study completion, average of 5 years
Secondary	Patient Demographics	The following baseline variables will be recorded: sex, age, Eastern Cooperative Oncology Group (ECOG) performance status.	Through study completion, average of 5 years
Secondary	Use of Drug Therapies	Describe the use of IMLYGIC, other anti-cancer therapy, anti-herpetic therapy.	Through study completion, average of 5 years
Secondary	Incidence of Adverse Events and Serious Adverse Events in Patients	Incidence of adverse events and serious adverse events during and after treatment with IMLYGIC	Through study completion, average of 5 years
Secondary	Overall Survival	Survival is defined by the time to death from the date of the first use of IMLYGIC.	Through study completion, average of 5 years

External Links

•   AmgenTrials clinical trials website