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

Active, not recruiting

• Conditions: Melanoma
• Interventions: Drug: nivolumab

• Registration Number: NCT04146324
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-10-29
• Study First Submitted QC: 2019-10-29
• Study First Posted: 2019-10-31
• Study Start: 2019-12-12
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-25
• Last Update Posted: 2022-01-26
• Primary Completion: 2026-09-30
• Study Completion: 2026-12-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Adults with a primary diagnosis of melanoma with involvement of lymph nodes or metastatic disease who have undergone complete surgical removal and have no evidence of disease
• Decision to treat with adjuvant nivolumab therapy has already been taken
• Ability to provide written informed consent to participate in the study

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Exclusion Criteria

• Adults with a current diagnosis of persisting advanced melanoma
• Adults currently enrolled in an interventional clinical trial for his/her melanoma treatment

Other protocol-defined inclusion/exclusion criteria apply

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adjuvant nivolumab therapy	nivolumab	Participants receiving nivolumab as an adjuvant therapy according to the market authorization in Australia

Primary Outcome Measures

Name	Time	Method
Percentage of Participants with Relapse-Free Survival (RFS)	Up to 5 years post treatment initiation with adjuvant nivolumab therapy	The time between the date of randomisation and the date of first recurrence, new primary melanoma, or death due to any cause, whichever occurred first.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants with Distant Metastasis-Free Survival (DMFS)	Up to 5 years post treatment initiation with adjuvant nivolumab therapy
Description of sociodemographic profile of participants	At treatment initiation with adjuvant nivolumab therapy
HRQOL of participants as assessed by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ C-30)	Up to 5 years post treatment initiation with adjuvant nivolumab therapy
Overall Survival (OS)	Up to 5 years post treatment initiation with adjuvant nivolumab therapy
HRQOL of participants as assessed by Functional Assessment of Cancer Therapy-Melanoma (FACT-M) questionnaire	Up to 5 years post treatment initiation with adjuvant nivolumab therapy
Description of clinical characteristics of participants	At treatment initiation with adjuvant nivolumab therapy
Description of nivolumab pattern of use	At treatment initiation with adjuvant nivolumab therapy
Health-related quality of life (HRQOL) of participants as assessed by European Quality of Life Five Dimensional Scale (EuroQOL-5D/EQ-5D)	Up to 5 years post treatment initiation with adjuvant nivolumab therapy
Number of participants experiencing non-immune-related AEs	Up to 5 years post treatment initiation with adjuvant nivolumab therapy
Prior medical history of participants	At treatment initiation with adjuvant nivolumab therapy
Participants' socioeconomic status as assessed by their highest education level	At treatment initiation with adjuvant nivolumab therapy
Description of care received as assessed by Healthcare Resource Utlization	During, and up to 5 years post discontinuation of nivolumab use
Number of participants experiencing immune-related Adverse Events (AEs)	Up to 5 years post treatment initiation with adjuvant nivolumab therapy

Trial Locations

Locations (1)

Local Institution; 🇦🇺 Malvern, Victoria, Australia