A Study to Compare Nivolumab Administered Subcutaneously vs Intravenous in Melanoma Participants Following Complete Resection

Part of paid clinical trials in Fort Wayne, Indiana.

Sponsor
Bristol-Myers Squibb
Study ID
NCT05297565
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 assess the safety and tolerability of subcutaneous nivolumab vs intravenous nivolumab in participants with completely resected Stage IIIA/B/C/D or Stage IV melanoma.

Key Dates

Start date
Aug 2, 2022
Status verified
Feb 2025
Primary completion
Feb 8, 2024
Completion
Feb 8, 2024

Study Design

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

Arms

  • Experimental: Arm A: Subcutaneous Nivolumab
  • Active Comparator: Arm B: Intravenous Nivolumab

Primary Outcome Measure

Number of Participants With Adverse Events [ Time Frame: From first dose to 100 days post last dose (Approximately up to 14 Months) ]

Locations (2)

FacilityCityStateZIPSite coordinators
Local Institution - 0004Fort WayneIndiana46804-
Local Institution - 0044KnoxvilleTennessee37920-

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