LUMINOS-102: PVSRIPO With or Without Immune Checkpoint Blockade in Patients With Advanced PD-1 Refractory Melanoma
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 50
Summary
- Conditions
- Melanoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This multi-center, open-label, randomized, Phase 2 will investigate the efficacy and safety of PVSRIPO 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 or mucosal melanoma who previ...
This multi-center, open-label, randomized, Phase 2 will investigate the efficacy and safety of PVSRIPO 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 or mucosal melanoma who previously failed anti-PD-1/L1-based therapy will be randomized 1:1 to receive either PVSRIPO or PVSRIPO plus an anti-PD-1.
Tracking Information
- NCT #
- NCT04577807
- Collaborators
- Not Provided
- Investigators
- Not Provided
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