Conditions: Melanoma
Keywords: gene transfer gene therapy oncolytic virus GM-CSF melanoma
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 50
Healthy volunteers: no

Brief summary:
The primary objective of the study was to assess the clinical efficacy of talimogene laherparepvec in terms of tumor response rates.

Detailed description:

Arms:
arm 1: Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks for up to 15 weeks. After the initial 8 doses, if indications of biological activity were observed, treatment could continue for up to 16 additional doses.

Interventions: intervention 1: Talimogene Laherparepvec
Intervention descriptions: intervention 1: Up to 4 mL of 10⁸ pfu/mL/per intratumoral injection

Protocol document: