An Observational Study of Adjuvant (Post-surgery) Therapy With Nivolumab for Resected (Completely Removed) Melanoma in Australia

Sponsor
Bristol-Myers Squibb
Study ID
NCT04146324
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • nivolumab — DRUG
    Administered as adjuvant therapy as per the market authorization in Australia

Study Details

This study is designed to estimate the effectiveness of nivolumab when given to participants after removing their cancer with surgery, over a 5-year follow-up, in real-world conditions in Australia.

Key Dates

Start date
Dec 12, 2019
Status verified
Jan 2025
Primary completion
May 31, 2024
Completion
May 31, 2024

Study Design

Enrollment
150 participants (actual)

Arms

  • Arm: Adjuvant nivolumab therapy
    Participants receiving nivolumab as an adjuvant therapy according to the market authorization in Australia

Primary Outcome Measure

Percentage of Participants with Relapse-Free Survival (RFS) [ Time Frame: Up to 5 years post treatment initiation with adjuvant nivolumab therapy ]

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