Study of Combination of Ipilimumab and Nivolumab in Patients With Melanoma

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT02970981
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

The purpose of this study is to assess the safety and tolerability of treatment with Nivolumab in combination with Ipilimumab in subjects with resected Stages IIIB/IIIC/ IV melanoma.

Key Dates

Start date
Nov 29, 2016
Status verified
Apr 2024
Primary completion
Nov 30, 2018
Completion
May 2, 2022

Study Design

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

Arms

  • Experimental: Nivolumab and Ipilimumab
    Dosing during cycle 1 will consist of: 3 mg/kg of Nivolumab+ Ipilimumab at 1 mg/kg. Each induction treatment cycle is comprised of 4 doses of Nivolumab and 4 doses of Ipilimumab given every three weeks for a total of 12 weeks (cycle 1) Dosing during cycles 2-5 will consist of flat dose Nivolumab at 480 mg every 4 weeks (Q4W) for 48 weeks.

Primary Outcome Measure

Relapse-Free Survival [ Time Frame: Month 48 Post-Treatment Initiation ]

Locations (1)

FacilityCityStateZIPSite coordinators
Laura and Isaac Perlmutter Cancer CenterNew YorkNew York10016-

Find similar trials in New York, NY

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Laura and Isaac Perlmutter Cancer Center· New York, NY

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