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NCT04146324 Clinical Trial

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

Melanoma Clinical Trial

Official title:
A Prospective Observational Study in Patients Receiving Adjuvant Nivolumab Therapy for Resected Melanoma in Australia

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04146324
Other study ID # CA209-7CK
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date December 12, 2019
Est. completion date December 9, 2026

Study information
Verified date January 2022
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 150
Est. completion date December 9, 2026
Est. primary completion date September 30, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com 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 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• nivolumab
Administered as adjuvant therapy as per the market authorization in Australia

Locations
Country Name City State
Australia Local Institution Birtinya Queensland
Australia Local Institution Box Hill Victoria
Australia Local Institution Cairns Queensland
Australia Local Institution Garran Australian Capital Territory
Australia Local Institution Greenslopes Queensland
Australia Local Institution Herston Queensland
Australia Local Institution Malvern Victoria
Australia Local Institution Woodville South South Australia
Australia Local Institution Woolloongabba Queensland

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Australia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of Participants with Relapse-Free Survival (RFS) 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. Up to 5 years post treatment initiation with adjuvant nivolumab therapy
Secondary Percentage of Participants with Distant Metastasis-Free Survival (DMFS) Up to 5 years post treatment initiation with adjuvant nivolumab therapy
Secondary Overall Survival (OS) Up to 5 years post treatment initiation with adjuvant nivolumab therapy
Secondary Description of sociodemographic profile of participants At treatment initiation with adjuvant nivolumab therapy
Secondary Description of clinical characteristics of participants At treatment initiation with adjuvant nivolumab therapy
Secondary Prior medical history of participants At treatment initiation with adjuvant nivolumab therapy
Secondary Description of nivolumab pattern of use At treatment initiation with adjuvant nivolumab therapy
Secondary 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
Secondary 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
Secondary 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
Secondary Participants' socioeconomic status as assessed by their highest education level At treatment initiation with adjuvant nivolumab therapy
Secondary Description of care received as assessed by Healthcare Resource Utlization During, and up to 5 years post discontinuation of nivolumab use
Secondary Number of participants experiencing immune-related Adverse Events (AEs) Up to 5 years post treatment initiation with adjuvant nivolumab therapy
Secondary Number of participants experiencing non-immune-related AEs Up to 5 years post treatment initiation with adjuvant nivolumab therapy
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