Conditions: Melanoma
Keywords: Melanoma Stage IIIb, IIIc and IV Disease oncolytic OncoVex OncoVEX^GM-CSF
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 31
Healthy volunteers: no

Brief summary:
The purpose of this study is to learn about the safety and the risks of using talimogene laherparepvec in patients who already received treatment with talimogene laherparepvec in study 005/05 (NCT00769704), and to see if extended treatment with talimogene laherparepvec can destroy melanoma tumors.

Detailed description:

Arms:
arm 1: Granulocyte macrophage colony-stimulating factor (GM-CSF) was administered at a dose of 125 μg/m²/day subcutaneously for 14 consecutive days followed by 14 days of rest, in 28-day treatment cycles for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met. arm 2: Talimogene laherparepvec was administered at a concentration of 10⁸ plaque forming units (PFU)/mL injected into 1 or more skin or subcutaneous tumors on Days 1 and 15 of each 28-day cycle for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.

Interventions: intervention 1: Talimogene Laherparepvec intervention 2: Granulocyte Macrophage Colony-Stimulating Factor (GM-CSF)
Intervention descriptions: intervention 1: Up to 4 mL of 10⁸ pfu/mL/per intratumoral injection intervention 2: 125 µg/m² subcutaneous injection

Protocol document: