NCT04577807

LUMINOS-102: Lerapolturev With or Without Immune Checkpoint Blockade in Advanced PD-1 Refractory Melanoma

Lerapolturev (Formerly Known as PVSRIPO) With or Without Immune Checkpoint Blockade in Advanced PD-1 Refractory Melanoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Istari Oncology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Phase 2 study to investigate the efficacy and safety of lerapolturev alone or in combination with a programmed death receptor-1 (anti-PD-1) inhibitor.

Detailed description

This multi-center, open-label, randomized, Phase 2 will investigate the efficacy and safety of lerapolturev alone (Arm 1) or in combination with an anti-PD-1 inhibitor (Arm 2). Following a 6 participant safety run-in period, up to approximately 50 participants with cutaneous melanoma who previously failed anti-PD-1/L1-based therapy will be randomized 1:1 to receive either lerapolturev or lerapolturev plus an anti-PD-1.

Conditions

• Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	Lerapolturev	Lerapolturev administered via direct lesion injection
BIOLOGICAL	Anti-PD-1 Checkpoint Inhibitor	Anti-PD-1 Checkpoint Inhibitor administered per package insert instructions

Timeline

• Start date: 2020-11-17
• Primary completion: 2024-11-15
• Completion: 2024-11-15
• First posted: 2020-10-08
• Last updated: 2025-09-19
• Results posted: 2025-09-19

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study