A Safety and Efficacy Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Melanoma

Sponsor
Bristol-Myers Squibb
Study ID
NCT02905266
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab — BIOLOGICAL
    -Specified dose on specified days
  • Ipilimumab — BIOLOGICAL
    -Specified dose on specified days

Study Details

This is a safety and efficacy study of different administration regimens of nivolumab plus Ipilimumab in subjects with previously untreated, unresectable or metastatic melanoma.

Key Dates

Start date
Oct 27, 2016
Status verified
Nov 2020
Primary completion
Oct 23, 2017
Completion
Oct 25, 2019

Study Design

Enrollment
106 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab and Ipilimumab Concomitant Administration
    Followed by Nivolumab monotherapy
  • Experimental: Nivolumab and Ipilimumab Sequential Administration
    Followed by Nivolumab monotherapy

Primary Outcome Measure

Percentage of Participants Affected by Adverse Events (AEs) in the Broad Scope MedDRA Anaphylactic Reaction Standardized MedDRA Queries (SMQ) [ Time Frame: Within 2 days from administration of any of the 4 doses in part 1 period (approximately 12 weeks) ]

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