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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Melanoma
• Intervention / Treatment: Drug: nivolumab

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Australia
  • Australian Capital Territory
    • Garran, Australian Capital Territory, Australia, 2605
      • Local Institution
  • Queensland
    • Birtinya, Queensland, Australia, 4575
      • Local Institution
    • Cairns, Queensland, Australia, 4870
      • Local Institution
    • Greenslopes, Queensland, Australia, 4120
      • Local Institution
    • Herston, Queensland, Australia, 4031
      • Local Institution
    • Woolloongabba, Queensland, Australia, 4012
      • Local Institution
  • South Australia
    • Woodville South, South Australia, Australia, 5001
      • Local Institution
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Local Institution
    • Malvern, Victoria, Australia, 3144
      • Local Institution

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adults whose melanoma had spread to the lymph nodes or other parts of the body and was surgically removed, and who are receiving post-surgery treatment with nivolumab to decrease the risk of cancer coming back.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adjuvant nivolumab therapy; Participants receiving nivolumab as an adjuvant therapy according to the market authorization in Australia	Drug: nivolumab; Administered as adjuvant therapy as per the market authorization in Australia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants with Distant Metastasis-Free Survival (DMFS)	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
Description of sociodemographic profile of participants	At treatment initiation with adjuvant nivolumab therapy
Description of clinical characteristics of participants	At treatment initiation with adjuvant nivolumab therapy
Prior medical history 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
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
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
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
Number of participants experiencing non-immune-related AEs	Up to 5 years post treatment initiation with adjuvant nivolumab therapy

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2019
• Primary Completion (Anticipated): September 30, 2026
• Study Completion (Anticipated): December 9, 2026

Study Registration Dates

• First Submitted: October 29, 2019
• First Submitted That Met QC Criteria: October 29, 2019
• First Posted (Actual): October 31, 2019

Study Record Updates

• Last Update Posted (Actual): January 26, 2022
• Last Update Submitted That Met QC Criteria: January 25, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: nivolumab; Adjuvant
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Nivolumab
• Other Study ID Numbers: CA209-7CK

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No