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Single-arm Trial to Evaluate the Biodistribution and Shedding of Talimogene Laherparepvec | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Single-arm Trial to Evaluate the Biodistribution and Shedding of Talimogene Laherparepvec

A Phase 2, Multicenter, Single-arm Trial to Evaluate the Biodistribution and Shedding of Talimogene Laherparepvec in Subjects With Unresected, Stage IIIB to IVM1c Melanoma

NCT02014441•Amgen

View on ClinicalTrials.gov

Summary

The primary objective was to estimate the proportion of participants with detectable talimogene laherparepvec deoxyribonucleic acid (DNA) in the blood and urine at any time after administration of talimogene laherparepvec within the first 3 cycles.

Eligibility

Age

18 - 100 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female age ≥ 18 years with histologically confirmed diagnosis of melanoma and unresected stage IIIB, IIIC, IVM1a, IVM1b, or IVM1c regardless of prior line of therapy. Subject is candidate for intralesional therapy administration into cutaneous, subcutaneous, or nodal disease and must also have measurable disease, serum lactate dehydrogenase ≤ 1.5 x upper limit of normal, and Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and adequate hematologic, hepatic, and renal organ function.

Exclusion Criteria

•Subject must not have clinically active cerebral metastases, greater than 3 visceral metastases (this does not include lung metastases or any nodal metastases associated with visceral organs) or any bone metastases melanoma, primary ocular or mucosal melanoma, history or evidence of symptomatic autoimmune pneumonitis, glomerulonephritis, vasculitis, or symptomatic autoimmune disease, or evidence of immunosuppression for any reason. Subject known to have acute or chronic active hepatitis B or hepatitis C infection, or human immunodeficiency virus infection will also be excluded. Subject who has active herpetic skin lesions or prior complications of herpes simplex virus type 1 ( HSV-1) infection (eg, herpetic keratitis or encephalitis), and/or requires intermittent or chronic systemic (intravenous or oral) treatment with an antiherpetic drug (eg, acyclovir), other than intermittent topical use will also be excuded. Subject must not have received previous treatment with talimogene laherparepvec.

Locations (14)

Research Site

Tampa, Florida, United States

Research Site

Indianapolis, Indiana, United States

Research Site

Louisville, Kentucky, United States

Research Site

Fridley, Minnesota, United States

Research Site

Minneapolis, Minnesota, United States

Research Site

New Brunswick, New Jersey, United States

Research Site

Albuquerque, New Mexico, United States

Research Site

Winston-Salem, North Carolina, United States

Research Site

Germantown, Tennessee, United States

Research Site

Dallas, Texas, United States

Key Dates

Start Date

April 7, 2014

Primary Completion Date

January 25, 2016

Completion Date

April 19, 2018

Last Updated

November 20, 2019

Enrollment

ACTUAL participants

Conditions

Melanoma

Interventions

Talimogene laherparepvec

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 20, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Single-arm Trial to Evaluate the Biodistribution and Shedding of Talimogene Laherparepvec

Inclusion Criteria

Exclusion Criteria

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