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

Sponsor

Amgen (Industry)

Overall Status

Recruiting

CT.gov ID

NCT02910557

Collaborator

(none)

920

Enrollment

Locations

120.7

Anticipated Duration (Months)

54.1

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A Postmarketing Prospective Cohort Study of Melanoma Patients Treated With IMLYGIC® (Talimogene Laherparepvec) in Clinical Practice to Characterize the Risk of Herpetic Infection Among Patients, Close Contacts, and Health Care Providers; and Long-term Safety in Treated Patients. This data analysis for this study will also include data from 9 Amgen-sponsored clinical studies in adult participants with stage IIIB-IVM1c melanoma.

Condition or Disease	Intervention/Treatment	Phase
Melanoma Herpetic Infection

Study Design

Study Type:

Observational

Anticipated Enrollment :

920 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Aug 10, 2017

Anticipated Primary Completion Date :

Sep 1, 2027

Anticipated Study Completion Date :

Sep 1, 2027

Outcome Measures

Primary Outcome Measures

Incidence Rate [Up to 5 years]
Estimate the incidence rate of herpetic infection with detection of talimogene laherparepvec DNA among patients for up to 5 years after the first IMLYGIC dose.

Secondary Outcome Measures

Herpectic Infection with T-VEC for Close Contacts and HCPs [Through study completion, average of 5yrs.]
Count the number of herpetic infections with detection of talimogene laherparepvec DNA among close contacts and HCPs.
Incidence of Herpetic Infection with TVEC in Patients during treatment [Through treatment period, upto 1yr]
Estimate the incidence rate of herpetic infection with detection of talimogene laherparepvec DNA among patients during treatment with IMLYGIC.
Incidence of Herpetic Infection with TVEC in Patients after treatment [Through study completion, average of 5yrs.]
Estimate the incidence rate of herpetic infection with detection of talimogene laherparepvec DNA among patients after discontinuation of IMLYGIC.
Incidence of HSV-1 DNA in Patients during Treatment [Through treatment period, upto 1yr]
Estimate the incidence rate of herpetic infection with detection of wild-type HSV-1 DNA among patients during treatment with IMLYGIC.
Incidence of HSV-1 DNA in Patients after Treatment [Through study completion, average of 5yrs.]
Estimate the incidence rate of herpetic infection with detection of wild-type HSV-1 DNA among patients after discontinuation of IMLYGIC.
Patient Demographics [Through study completion, average of 5yrs.]
The following baseline variables will be recorded: sex, age, Eastern Cooperative Oncology Group (ECOG) performance status.
Use of drug therapies [Through study completion, average of 5yrs.]
Describe the use of IMLYGIC, other anti-cancer therapy, anti-herpetic therapy.
Incidence of Adverse Events and Serious Adverse Events in Patients [Through study completion, average of 5yrs.]
Incidence of adverse events and serious adverse events during and after treatment with IMLYGIC
Overall Survival [Through study completion, average of 5yrs.]
Survival is defined by the time to death from the date of the first use of IMLYGIC.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jefferson City Medical Group PC	Jefferson City	Missouri	United States	65109
2	TriHealth Cancer Institute - Kenwood	Cincinnati	Ohio	United States	45242
3	University of Pittsburgh Medical Center Hillman Cancer Center	Pittsburgh	Pennsylvania	United States	15213
4	University of Tennessee Medical Center	Knoxville	Tennessee	United States	37920
5	Intermountain Medical Center	Murray	Utah	United States	84107
6	University of Wisconsin Hospital and Clinics	Madison	Wisconsin	United States	53792
7	Medizinische Universitaet Graz	Graz		Austria	8036
8	Ordensklinikum Linz Elisabethinen	Linz		Austria	4020
9	Landeskrankenhaus Salzburg	Salzburg		Austria	5020
10	Universitaetsklinikum Sankt Poelten	Sankt Poelten		Austria	3100
11	Rambam Medical Center	Haifa		Israel	3109601
12	Sheba Medical Center	Ramat Gan		Israel	5262000
13	Universitaetsspital Basel	Basel		Switzerland	4052
14	Kantonsspital Graubuenden	Chur		Switzerland	7000
15	Universitaetsspital Zuerich	Zuerich Flughafen		Switzerland	8058
16	Cheltenham General Hospital	Cheltenham		United Kingdom	GL53 7AN
17	Churchill Hospital	Oxford		United Kingdom	OX3 7LJ