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

Recruiting

• Conditions: Herpetic Infection; Melanoma

• Registration Number: NCT02910557
• Lead Sponsor: Amgen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-07
• Study First Submitted QC: 2016-09-20
• Study First Posted: 2016-09-22
• Study Start: 2017-08-10
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-04
• Last Update Posted: 2024-10-07
• Primary Completion: 2038-01-07
• Study Completion: 2038-01-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence Rate	Up to 5 years	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.

Secondary Outcome Measures

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

Trial Locations

Locations (23)

Allegheny Health Network; 🇺🇸 Pittsburgh, Pennsylvania, United States

Corazon United States of America, LLC doing business as Life Clinical Trials; 🇺🇸 Coral Springs, Florida, United States

Mercy Medical Center; 🇺🇸 Baltimore, Maryland, United States

Jefferson City Medical Group PC; 🇺🇸 Jefferson City, Missouri, United States

TriHealth Cancer Institute - Kenwood; 🇺🇸 Cincinnati, Ohio, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

University of Tennessee Medical Center; 🇺🇸 Knoxville, Tennessee, United States

Intermountain Medical Center; 🇺🇸 Murray, Utah, United States

University of Wisconsin Hospital and Clinics; 🇺🇸 Madison, Wisconsin, United States

Medizinische Universitaet Graz; 🇦🇹 Graz, Austria

Ordensklinikum Linz Elisabethinen; 🇦🇹 Linz, Austria

Landeskrankenhaus Salzburg; 🇦🇹 Salzburg, Austria

Universitaetsklinikum Sankt Poelten; 🇦🇹 Sankt Poelten, Austria

Rambam Medical Center; 🇮🇱 Haifa, Israel

Sheba Medical Center; 🇮🇱 Ramat Gan, Israel

Universitaetsspital Basel; 🇨🇭 Basel, Switzerland

Kantonsspital Graubuenden; 🇨🇭 Chur, Switzerland

Universitaetsspital Zuerich; 🇨🇭 Zuerich Flughafen, Switzerland

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 Kingdom