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

NCT04146324 | Completed DMC FDA Drug

• 1 other identifier: CA209-7CK
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 9

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.

Conditions

Melanoma

Keywords

Adjuvant; nivolumab

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• 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

Study Arms (1)

Adjuvant nivolumab therapy

Participants receiving nivolumab as an adjuvant therapy according to the market authorization in Australia

Drug: nivolumab

Interventions

nivolumab DRUG

Administered as adjuvant therapy as per the market authorization in Australia

Adjuvant nivolumab therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (9)

Local Institution

Garran, Australian Capital Territory, 2605, Australia

Location

Local Institution

Birtinya, Queensland, 4575, Australia

Location

Local Institution

Cairns, Queensland, 4870, Australia

Location

Local Institution

Greenslopes, Queensland, 4120, Australia

Location

Local Institution

Herston, Queensland, 4031, Australia

Location

Local Institution

Woolloongabba, Queensland, 4012, Australia

Location

Local Institution - 0006

Woodville South, South Australia, 5001, Australia

Location

Local Institution

Box Hill, Victoria, 3128, Australia

Location

Local Institution

Malvern, Victoria, 3144, Australia

Location

Related Links

• BMS Clinical Trial Information
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Melanoma

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: October 31, 2019
• Study Start: December 12, 2019
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: January 24, 2025

Record last verified: 2025-01

Locations

AU (9)