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

January 23, 2025 updated by: Bristol-Myers Squibb

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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 - 0006
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Local Institution
      • Malvern, Victoria, Australia, 3144
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Up to 5 years post treatment initiation with adjuvant nivolumab therapy

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Percentage of Participants with Distant Metastasis-Free Survival (DMFS)
Time Frame: Up to 5 years post treatment initiation with adjuvant nivolumab therapy
Up to 5 years post treatment initiation with adjuvant nivolumab therapy
Overall Survival (OS)
Time Frame: Up to 5 years post treatment initiation with adjuvant nivolumab therapy
Up to 5 years post treatment initiation with adjuvant nivolumab therapy
Description of sociodemographic profile of participants
Time Frame: At treatment initiation with adjuvant nivolumab therapy
At treatment initiation with adjuvant nivolumab therapy
Description of clinical characteristics of participants
Time Frame: At treatment initiation with adjuvant nivolumab therapy
At treatment initiation with adjuvant nivolumab therapy
Prior medical history of participants
Time Frame: At treatment initiation with adjuvant nivolumab therapy
At treatment initiation with adjuvant nivolumab therapy
Description of nivolumab pattern of use
Time Frame: At treatment initiation with adjuvant nivolumab therapy
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)
Time Frame: Up to 5 years post treatment initiation with adjuvant nivolumab therapy
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)
Time Frame: Up to 5 years post treatment initiation with adjuvant nivolumab therapy
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
Time Frame: Up to 5 years post treatment initiation with adjuvant nivolumab therapy
Up to 5 years post treatment initiation with adjuvant nivolumab therapy
Participants' socioeconomic status as assessed by their highest education level
Time Frame: At treatment initiation with adjuvant nivolumab therapy
At treatment initiation with adjuvant nivolumab therapy
Description of care received as assessed by Healthcare Resource Utlization
Time Frame: During, and up to 5 years post discontinuation of nivolumab use
During, and up to 5 years post discontinuation of nivolumab use
Number of participants experiencing immune-related Adverse Events (AEs)
Time Frame: Up to 5 years post treatment initiation with adjuvant nivolumab therapy
Up to 5 years post treatment initiation with adjuvant nivolumab therapy
Number of participants experiencing non-immune-related AEs
Time Frame: Up to 5 years post treatment initiation with adjuvant nivolumab therapy
Up to 5 years post treatment initiation with adjuvant nivolumab therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 12, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 29, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 31, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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