Efficacy and safety of Talimogene Laherparepvec Neoadjuvant Treatment Plus Surgery versus Surgery alone for Melanoma

Phase 1

• Conditions: Resectable, Stage IIIB to IVM1a Melanoma; MedDRA version: 17.0Level: LLTClassification code 10053571Term: MelanomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-001146-13-ES
• Lead Sponsor: Amgen Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-10-20
• Study Completion: 2022-04-28
• Last Update Posted: 3 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Male or female >= 18 years of age with 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. Also, 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 76
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 74

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified