A Study to Evaluate Treatment With Nivolumab Alone and Nivolumab Combined With Ipilimumab in Children With Melanoma

Part of paid clinical trials in Dublin, Ohio.

Sponsor
Bristol-Myers Squibb
Study ID
NCT06163170
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab +/- ipilimumab — DRUG
    Participants treated with nivolumab +/- ipilimumab for unresectable/metastatic melanoma
  • Nivolumab — DRUG
    Participants treated with nivolumab as adjuvant therapy for resected stage IIB-IV melanoma

Study Details

The purpose of this study is to describe real-world safety outcomes in children with melanoma who are treated with nivolumab alone or nivolumab in combination with ipilimumab for unresectable or metastatic melanoma, or treated with adjuvant nivolumab after resection of stage IIB-IV melanoma. Demographic and clinical characteristics, and treatment patterns, will also be described in this population.

Key Dates

Start date
Aug 14, 2023
Status verified
Apr 2024
Primary completion
Sep 25, 2023
Completion
Nov 10, 2023

Study Design

Enrollment
100 participants (actual)

Arms

  • Arm: Participants treated with nivolumab +/- ipilimumab for unresectable/metastatic melanoma
  • Arm: Participants treated with nivolumab as adjuvant therapy for resected stage IIB-IV melanoma

Primary Outcome Measure

Incidence of treatment-related adverse events [ Time Frame: Up to 100 days after treatment discontinuation ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cardinal HealthDublinOhio43017-

Find similar trials in Dublin, OH

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Cardinal Health· Dublin, OH

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