JOURNAL ONKOLOGIE – STUDIE

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

Studien-Informationen Einschlusskriterien Studien-Rationale

Rekrutierend

NCT-Nummer:
NCT02910557

Studienbeginn:
August 2017

Letztes Update:
08.02.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Communicable Diseases, Melanoma, Infections

Geschlecht:
Alle

Altersgruppe:
Alle

Phase:
-

Sponsor:
Amgen

Collaborator:
-

Studienleiter

MD
Study Director
Amgen

Kontakt

Amgen Call Center
Kontakt:
Phone: 866-572-6436
E-Mail: medinfo@amgen.com» Kontaktdaten anzeigen

Studienlocations
(3 von 21)

Mercy Medical Center
21202 Baltimore
United StatesRekrutierend» Google-Maps

Jefferson City Medical Group PC
65109 Jefferson City
United StatesAbgebrochen» Google-Maps

TriHealth Cancer Institute - Kenwood
45242 Cincinnati
United StatesRekrutierend» Google-Maps

University of Pittsburgh Medical Center Hillman Cancer Center
15213 Pittsburgh
United StatesAbgebrochen» Google-Maps

University of Tennessee Medical Center
37920 Knoxville
United StatesRekrutierend» Google-Maps

Intermountain Medical Center
84107 Murray
United StatesRekrutierend» Google-Maps

University of Wisconsin Hospital and Clinics
53792 Madison
United StatesAbgebrochen» Google-Maps

Medizinische Universitaet Graz
8036 Graz
AustriaRekrutierend» Google-Maps

Ordensklinikum Linz Elisabethinen
4020 Linz
AustriaRekrutierend» Google-Maps

Landeskrankenhaus Salzburg
5020 Salzburg
AustriaAbgebrochen» Google-Maps

Universitaetsklinikum Sankt Poelten
3100 Sankt Poelten
AustriaRekrutierend» Google-Maps

Rambam Medical Center
3109601 Haifa
IsraelAbgebrochen» Google-Maps

Sheba Medical Center
5262000 Ramat Gan
IsraelRekrutierend» Google-Maps

Universitaetsspital Basel
4052 Basel
SwitzerlandRekrutierend» Google-Maps

Kantonsspital Graubuenden
7000 Chur
SwitzerlandAbgebrochen» Google-Maps

Universitaetsspital Zuerich
8058 Zuerich Flughafen
SwitzerlandRekrutierend» Google-Maps

Cheltenham General Hospital
GL53 7AN Cheltenham
United KingdomRekrutierend» Google-Maps

Guys Hospital
SE1 9RT London
United KingdomRekrutierend» Google-Maps

Royal Marsden Hospital
SW3 6JJ London
United KingdomRekrutierend» Google-Maps

Churchill Hospital
OX3 7LJ Oxford
United KingdomRekrutierend» Google-Maps

Musgrove Park Hospital
TA1 5DA Taunton
United KingdomRekrutierend» Google-Maps

Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Incidence Rate (Time Frame - 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:

1. Herpectic Infection with T-VEC DNA for Close Contacts and Healthcare Providers (HCPs) (Time Frame - Through study completion, average of 5 years):
Count the number of herpetic infections with detection of T-VEC DNA among close contacts and HCPs.

2. Incidence of Herpetic Infection with T-VEC in Patients During Treatment (Time Frame - 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.

3. Incidence of Herpetic Infection with T-VEC in Patients After Treatment (Time Frame - 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.

4. Incidence of Herpes Simplex Virus 1 (HSV-1) DNA in Patients During Treatment (Time Frame - 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.

5. Incidence of HSV-1 DNA in Patients After Treatment (Time Frame - 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.

6. Patient Demographics (Time Frame - Through study completion, average of 5 years):
The following baseline variables will be recorded: sex, age, Eastern Cooperative Oncology Group (ECOG) performance status.

7. Use of Drug Therapies (Time Frame - Through study completion, average of 5 years):
Describe the use of IMLYGIC, other anti-cancer therapy, anti-herpetic therapy.

8. Incidence of Adverse Events and Serious Adverse Events in Patients (Time Frame - Through study completion, average of 5 years):
Incidence of adverse events and serious adverse events during and after treatment with IMLYGIC

9. Overall Survival (Time Frame - Through study completion, average of 5 years):
Survival is defined by the time to death from the date of the first use of IMLYGIC.

Quelle: ClinicalTrials.gov

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