Nivolumab Combined With Ipilimumab Followed by Nivolumab Monotherapy as First-Line Treatment for Patients With Advanced Melanoma

Sponsor
Bristol-Myers Squibb
Study ID
NCT02599402
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

The purpose of this study is to determine the effects of combination treatment of Nivolumab with Ipilimumab followed by Nivolumab monotherapy in patients with previously untreated advanced Melanoma.

Key Dates

Start date
Dec 20, 2015
Status verified
May 2021
Primary completion
Feb 10, 2020
Completion
Feb 10, 2020

Study Design

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

Arms

  • Experimental: Combination therapy: Nivolumab + Ipilimumab
    Nivolumab + Ipilimumab specified dose on specified days
  • Experimental: Monotherapy: Nivolumab
    Nivolumab specified dose on specified days

Primary Outcome Measure

Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events [ Time Frame: From first dose to 30 days after last dose (up to approximately 37 months) ]

Related Studies