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Completed

NCT Number: NCT04146324

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution, Garran, Australian Capital Territory, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nivolumab

Drug

Administered as adjuvant therapy as per the market authorization in Australia

Primary outcomes

  1. Percentage of Participants with Relapse-Free Survival (RFS)

    Time frame: 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 outcomes

  1. Percentage of Participants with Distant Metastasis-Free Survival (DMFS)

    Time frame: Up to 5 years post treatment initiation with adjuvant nivolumab therapy

  2. Overall Survival (OS)

    Time frame: Up to 5 years post treatment initiation with adjuvant nivolumab therapy

  3. Description of sociodemographic profile of participants

    Time frame: At treatment initiation with adjuvant nivolumab therapy

  4. Description of clinical characteristics of participants

    Time frame: At treatment initiation with adjuvant nivolumab therapy

  5. Prior medical history of participants

    Time frame: At treatment initiation with adjuvant nivolumab therapy

  6. Description of nivolumab pattern of use

    Time frame: At treatment initiation with adjuvant nivolumab therapy

  7. Health-related quality of life (HRQOL) of participants as assessed by European Quality of Life Five Dimensional Scale (EuroQOL-5D/EQ-5D)

    Time frame: Up to 5 years post treatment initiation with adjuvant nivolumab therapy

  8. HRQOL of participants as assessed by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ C-30)

    Time frame: Up to 5 years post treatment initiation with adjuvant nivolumab therapy

  9. HRQOL of participants as assessed by Functional Assessment of Cancer Therapy-Melanoma (FACT-M) questionnaire

    Time frame: Up to 5 years post treatment initiation with adjuvant nivolumab therapy

  10. Participants' socioeconomic status as assessed by their highest education level

    Time frame: At treatment initiation with adjuvant nivolumab therapy

  11. Description of care received as assessed by Healthcare Resource Utlization

    Time frame: During, and up to 5 years post discontinuation of nivolumab use

  12. Number of participants experiencing immune-related Adverse Events (AEs)

    Time frame: Up to 5 years post treatment initiation with adjuvant nivolumab therapy

  13. Number of participants experiencing non-immune-related AEs

    Time frame: Up to 5 years post treatment initiation with adjuvant nivolumab therapy

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Oct 31, 2019
Registry last updated
Jan 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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