Nivolumab Plus Relatlimab or Ipilimumab in Metastatic Melanoma Stratified by MHC-II Expression

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Elizabeth Davis
Study ID
NCT03724968
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
    Nivolumab will be given by vein on day 1 of each cycle.
  • Relatlimab — DRUG
    Relatlimab will be given by vein on day 1 of each 28-day cycle
  • Ipilimumab — DRUG
    Ipilimumab will be given by vein on day 1 during cycles 1-4 (cycles are 21 days).

Study Details

This is an open-label, non-randomized two arm Phase 2 study of intravenous nivolumab plus intravenous ipilimumab or intravenous relatlimab in patients with metastatic melanoma stratified by MHC-II expression.

Key Dates

Start date
Jan 17, 2019
Status verified
Mar 2021
Primary completion
May 28, 2020
Completion
May 28, 2020

Study Design

Enrollment
2 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    Nivolumab and Relatlimab
  • Experimental: Arm B
    Nivolumab and Ipilimumab

Primary Outcome Measure

Change in Activated GZMB+ CD8+T-cell Density Intratumorally, of Two Immunotherapy Regimens [ Time Frame: Approximately 16 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232-

Find similar trials in Nashville, TN

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Vanderbilt-Ingram Cancer Center· Nashville, TN

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