Efficacy and Safety of Talimogene Laherparepvec Neoadjuvant Treatment Plus Surgery Versus Surgery Alone for Melanoma

Completed · Phase 2

Conditions studied: Completely Resectable Stage IIIB, IIIC, or IVM1a Melanoma

In brief

This is a phase 2, multicenter, randomized, open-label study to estimate the efficacy of talimogene laherparepvec as a neoadjuvant treatment followed by surgery compared to surgery alone in subjects with completely resectable stage IIIB, IIIC, or IVM1a melanoma.

Key facts

Study ID: NCT02211131
Run by: Amgen
People needed: 150
Starts: 2015-02-03
Expected to finish: 2022-04-28
Last updated by the study team: 2023-06-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Histologically confirmed diagnosis of stage IIIB, IIIC or IVM1a melanoma eligible for complete surgical resection.
Prior systemic, regional and radiation anticancer therapies for melanoma must have been completed at least 3 months prior to randomization.
Subject must have measurable disease and must be a candidate for intralesional therapy with at least one injectable cutaneous, subcutaneous, or nodal melanoma lesion (≥ 10 mm in longest diameter) or with multiple injectable lesions that in aggregate have a longest diameter of ≥ 10 mm.
Subject must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and must have a serum lactate dehydrogenase (LDH) ≤ 1.0 X upper limit of normal and adequate hematologic, hepatic, renal, and coagulation organ function- Other criteria may apply

You may not qualify if…

Subject must not have primary ocular or mucosal melanoma, or history or evidence of melanoma associated with immunodeficiency states (eg, hereditary immune deficiency, organ transplant, or leukemia).
Subject must not have history or evidence of symptomatic autoimmune pneumonitis, glomerulonephritis, vasculitis, or other symptomatic autoimmune disease.
Subject must not have evidence of clinically significant immunosuppression or active herpetic skin lesions or prior complications of herpes simplex type 1 (HSV-1) infection (eg, herpetic keratitis or encephalitis) and must not require intermittent or chronic systemic treatment with an antiherpetic drug (eg, acyclovir), other than intermittent topical use.
Subject known to have acute or chronic active hepatitis B, hepatitis C, or human immunodeficiency virus infection will also be excluded.
Subject must not have been treated previously with talimogene laherparepvec or tumor vaccine.
Other criteria may apply

Where it is running

Research Site — Birmingham, Alabama, United States
Research Site — Duarte, California, United States
Research Site — Orange, California, United States
Research Site — San Francisco, California, United States
Research Site — Santa Monica, California, United States
Research Site — Daytona Beach, Florida, United States
Research Site — Gainesville, Florida, United States
Research Site — Tampa, Florida, United States
Research Site — Louisville, Kentucky, United States
Research Site — Worcester, Massachusetts, United States
Research Site — Omaha, Nebraska, United States
Research Site — New Brunswick, New Jersey, United States
Research Site — New York, New York, United States
Research Site — New York, New York, United States
Research Site — Chapel Hill, North Carolina, United States
Research Site — Columbus, Ohio, United States
Research Site — Philadelphia, Pennsylvania, United States
Research Site — Memphis, Tennessee, United States
Research Site — Dallas, Texas, United States
Research Site — Dallas, Texas, United States
Research Site — Houston, Texas, United States
Research Site — Salt Lake City, Utah, United States
Research Site — North Sydney, New South Wales, Australia
Research Site — Woodville South, South Australia, Australia
Research Site — Heidelberg, Victoria, Australia

Full record on ClinicalTrials.gov

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