Clinical trial NCT02910557: Postmarketing Prospective Study of Melanoma Patients Treated With IMLYGIC® to Characterize Risk of Herpetic Infection
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Melanoma
Herpetic Infection
Keywords: IMLYGIC
Talimogene Laherparepvec
Herpetic
Infection Melanoma
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2016-09-22
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This postmarketing prospective cohort study will follow melanoma patients for up to 5 years after the first IMLYGIC dose in clinical practice. There is no experimental intervention, and the study population will receive standard-of-care treatment as determined by their treating physician.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence Rate
timeFrame: Up to 5 years
Secondary outcomes:
measure: Herpectic Infection with T-VEC DNA for Close Contacts and Healthcare Providers (HCPs)
timeFrame: Through study completion, average of 5 years
measure: Incidence of Herpetic Infection with T-VEC in Patients During Treatment
timeFrame: Through treatment period, up to 1 year
measure: Incidence of Herpetic Infection with T-VEC in Patients After Treatment
timeFrame: Through study completion, average of 5 years
measure: Incidence of Herpes Simplex Virus 1 (HSV-1) DNA in Patients During Treatment
timeFrame: Through treatment period, up to 1 year
measure: Incidence of HSV-1 DNA in Patients After Treatment
timeFrame: Through study completion, average of 5 years
measure: Patient Demographics
timeFrame: Through study completion, average of 5 years
measure: Use of Drug Therapies
timeFrame: Through study completion, average of 5 years
measure: Incidence of Adverse Events and Serious Adverse Events in Patients
timeFrame: Through study completion, average of 5 years
measure: Overall Survival
timeFrame: Through study completion, average of 5 years
Other outcomes:
Locations:
city: Coral Springs
country: United States
facility: Corazon United States of America, LLC doing business as Life Clinical Trials
state: Florida
city: Baltimore
country: United States
facility: Mercy Medical Center
state: Maryland
city: Jefferson City
country: United States
facility: Jefferson City Medical Group PC
state: Missouri
city: Cincinnati
country: United States
facility: TriHealth Cancer Institute - Kenwood
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Health Network
state: Pennsylvania
city: Knoxville
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
city: Graz
country: Austria
facility: Medizinische Universitaet Graz
city: Linz
country: Austria
facility: Ordensklinikum Linz Elisabethinen
city: Salzburg
country: Austria
facility: Landeskrankenhaus Salzburg
city: Sankt Poelten
country: Austria
facility: Universitaetsklinikum Sankt Poelten
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Basel
country: Switzerland
facility: Universitaetsspital Basel
city: Chur
country: Switzerland
facility: Kantonsspital Graubuenden
city: Zuerich Flughafen
country: Switzerland
facility: Universitaetsspital Zuerich
city: Cheltenham
country: United Kingdom
facility: Cheltenham General Hospital
city: London
country: United Kingdom
facility: Guys Hospital
city: London
country: United Kingdom
facility: Royal Marsden Hospital
city: Oxford
country: United Kingdom
facility: Churchill Hospital
city: Taunton
country: United Kingdom
facility: Musgrove Park Hospital
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: