PD-1 Antibody Therapy + Infliximab for Metastatic Melanoma

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT05034536
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    Intravenous infusion
  • Infliximab — DRUG
    Intravenous infusion
  • Placebo — DRUG
    Intravenous infusion
  • Relatlimab — DRUG
    Intravenous infusion
  • Nivolumab — DRUG
    Intravenous infusion

Study Details

The purpose of this research is to test the safety and effectiveness of the investigational combination of anti-Programmed Death (PD)-1 antibody therapy with or without LAG-3 inhibition (pembrolizumab or nivolumab+relatlimab) and infliximab in treating metastatic melanoma.

Key Dates

Start date
Feb 7, 2022
Status verified
May 2026
Primary completion
Jun 30, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Anti-PD-1 therapy + Infliximab
    Participants will be randomly assigned to receive physician's choice of anti-PD-1 therapy (pembrolizumab or nivolumab+relatlimab) and infliximab. * Pembrolizumab will be administered every 3 weeks for up to 2 years * Nivolumab+relatlimab will be administered every 4 weeks for up to 2 years * Infliximab will be administered on weeks 0, 2, and 6 (+/- 3 days) for a total of 3 doses
  • Experimental: Anti-PD-1 therapy + Placebo
    Participants will be randomly assigned to receive physician's choice of anti-PD-1 therapy (pembrolizumab or nivolumab+relatlimab) and placebo. * Pembrolizumab will be administered every 3 weeks for up to 2 years * Nivolumab+relatlimab will be administered every 4 weeks for up to 2 years * Placebo. will be administered on weeks 0, 2, and 6 (+/- 3 days) for a total of 3 doses

Primary Outcome Measure

Incidence of immune-related adverse events (irAE) in patients treated with anti-PD-1 plus infliximab compared to pembrolizumab plus placebo [ Time Frame: 12 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General Hospital Cancer CenterBostonMassachusetts02114-

Find similar trials in Boston, MA

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Massachusetts General Hospital Cancer Center· Boston, MA

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