Trial of Nivolumab in Combination With Ipilimumab in Subjects With Previously Untreated Metastatic Uveal Melanoma

Sponsor
Grupo Español Multidisciplinar de Melanoma
Study ID
NCT02626962
Phase
PHASE2
Status
Completed

Conditions

  • Uveal Melanoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • ipilimumab — DRUG
    Ipilimumab every 3 weeks for a total of four doses (Cycles 1 and 2)
  • Nivolumab — DRUG
    Nivolumab every 3 weeks for a total of four doses (Cycles 1 and 2) followed by Nivolumab every 2 weeks

Study Details

This is a Phase 2, single-arm study of nivolumab combined with ipilimumab in subjects with previously untreated, unresectable or metastatic uveal melanoma. Previous studies with immunotherapy have shown promising results and this synergistic combination was very effective in other tumors. This study will allow for further characterization of the safety and clinical activity of nivolumab combined with ipilimumab in subjects with uveal melanoma.

Key Dates

Start date
Apr 30, 2016
Status verified
Mar 2022
Primary completion
May 31, 2017
Completion
Jul 22, 2021

Study Design

Enrollment
52 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab and Ipilimumab
    Nivolumab and Ipilimumab every 3 weeks for a total of four doses (Cycles 1 and 2) followed by Nivolumab every 2 weeks

Primary Outcome Measure

Overall Survival at 12 months [ Time Frame: 12 months after treatment start ]

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