Single-arm Trial to Evaluate the Role of the Immune Response to Talimogene Laherparepvec in Unresected Melanoma

Completed · Phase 2

Conditions studied: Unresected Stage IIIb to IVM1c Melanoma

In brief

The study is a phase 2, multi centered, single arm study designed to evaluate the correlation between cluster of differentiation 8-positive (CD8+) cell density and objective response rate in adults with unresected stage IIIB to IVM1c melanoma. This study will also evaluate the safety and tolerability profile of talimogene laherparepvec.

Key facts

Study ID

NCT02366195

Run by

Amgen

People needed

112

Starts

2015-04-07

Expected to finish

2020-12-25

Last updated by the study team

2021-11-30

Who can join

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

You may qualify if…

• Provided informed consent prior to initiation of any study-specific activities/procedures
• Subject with stage IIIB to IVM1c melanoma for whom surgery is not recommended
• Candidate for intralesional therapy
• Measurable disease with greatest diameter ≥ 10 mm
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Adequate organ function
• Other Inclusion Criteria May Apply

You may not qualify if…

• Clinically active cerebral metastases.
• Bone metastases
• Primary ocular or mucosal melanoma
• Active herpetic skin lesions or prior complications of herpes simplex virus type 1 (HSV-1) infection (eg, herpetic keratitis or encephalitis)
• Requires intermittent or chronic systemic (intravenous or oral) treatment with an antiherpetic drug (eg, acyclovir), other than intermittent topical use
• Female subject is pregnant or breast-feeding, or planning to become pregnant during study treatment and through 3 months after the last dose of talimogene laherparepvec
• Female subject of childbearing potential who is unwilling to use acceptable method(s) of effective contraception
• Other Exclusion Criteria May Apply

Where it is running

• Research Site — Salt Lake City, Utah, United States
• Research Site — Salzburg, Austria
• Research Site — Vienna, Austria
• Research Site — Brussels, Belgium
• Research Site — Brussels, Belgium
• Research Site — Liège, Belgium
• Research Site — Boulogne-Billancourt, France
• Research Site — Marseille, France
• Research Site — Nantes, France
• Research Site — Paris, France
• Research Site — Poitiers, France
• Research Site — Essen, Germany
• Research Site — Frankfurt am Main, Germany
• Research Site — Hanover, Germany
• Research Site — Heidelberg, Germany
• Research Site — Athens, Greece
• Research Site — Athens, Greece
• Research Site — Heraklion - Crete, Greece
• Research Site — Pátrai, Greece
• Research Site — Thessaloniki, Greece
• Research Site — Budapest, Hungary
• Research Site — Budapest, Hungary
• Research Site — Debrecen, Hungary
• Research Site — Pécs, Hungary
• Research Site — Szeged, Hungary

Full record on ClinicalTrials.gov

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