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Anti-PD-1 with/without LAG-3 + Infliximab in Metastatic Melanoma
NCT05034536Phase 2
Key facts
- Status
- Active, not recruiting
- Start
- Feb 2022
- Primary completion
- Jun 2027
- Countries
- 1
- Sponsor
- Massachusetts General Hospital
- Modality
- Monoclonal Antibodies
- Drugs
- infliximab
- Conditions
- melanoma
01
Overview
Phase 2, randomised, double-blind trial in melanoma comparing Anti-PD-1 therapy + Infliximab with Anti-PD-1 therapy + Placebo (2 arms). Primary endpoint: Incidence of immune-related adverse events at 12 weeks. Started Feb 2022; status: active, not recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Anti-PD-1 therapy + Infliximab
Physician's choice of anti-PD-1 therapy (pembrolizumab or nivolumab+relatlimab) + Infliximab on weeks 0, 2, and 6
Anti-PD-1 therapy + Placebo
Physician's choice of anti-PD-1 therapy (pembrolizumab or nivolumab+relatlimab) + Placebo on weeks 0, 2, and 6
03
Who it enrols
Adults with Stage III unresectable or Stage IV metastatic melanoma, treatment-naive for advanced disease (prior adjuvant allowed if >6 months ago), with measurable disease, normal organ function, and ECOG 0-1. Excludes ocular/mucosal melanoma, active autoimmune disease, prior IBD, and active infections.
04
Endpoints
Primary
Incidence of immune-related adverse events
Secondary
Incidence of severe immune-related adverse events (grade 3-5)
Incidence of anti-PD-1 antibody cessation due to immune-related adverse events
Incidence of clinically apparent infections
Overall Survival
Progression-Free Survival
Objective Response Rate
Cumulative steroid exposure
Incidence of diarrhea
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