MelanomaNCT04146324
An Observational Study of Adjuvant (Post-surgery) Therapy With Nivolumab for Resected (Completely Removed) Melanoma in Australia
An observational study of Melanoma, run by Bristol-Myers Squibb at 9 sites in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- nivolumab
- How many people
- 150 participants
- Where
- 9 sitesAustralia
- Study dates
- 12 Dec 2019to 31 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Australia9 sites
Local Institution
Birtinya, Queensland, 4575
Local Institution
Box Hill, Victoria, 3128
Local Institution
Cairns, Queensland, 4870
Local Institution
Garran, Australian Capital Territory, 2605
Local Institution
Greenslopes, Queensland, 4120
Local Institution
Herston, Queensland, 4031
Local Institution
Malvern, Victoria, 3144
Local Institution - 0006
Woodville South, South Australia, 5001
Local Institution
Woolloongabba, Queensland, 4012
About this study
Official title: 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nivolumabDrug
Administered as adjuvant therapy as per the market authorization in Australia
| Study group | Role | What they receive |
|---|---|---|
| Adjuvant nivolumab therapy | Participants receiving nivolumab as an adjuvant therapy according to the market authorization in Australia Receives: Drug: nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 5 years post treatment initiation with adjuvant nivolumab therapy
Secondary outcomes (13)
Percentage of Participants with Distant Metastasis-Free Survival (DMFS)
Measured: Up to 5 years post treatment initiation with adjuvant nivolumab therapy
Overall Survival (OS)
Measured: Up to 5 years post treatment initiation with adjuvant nivolumab therapy
Description of sociodemographic profile of participants
Measured: At treatment initiation with adjuvant nivolumab therapy
Description of clinical characteristics of participants
Measured: At treatment initiation with adjuvant nivolumab therapy
Prior medical history of participants
Measured: At treatment initiation with adjuvant nivolumab therapy
Description of nivolumab pattern of use
Measured: 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)
Measured: 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)
Measured: 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
Measured: Up to 5 years post treatment initiation with adjuvant nivolumab therapy
Participants' socioeconomic status as assessed by their highest education level
Measured: At treatment initiation with adjuvant nivolumab therapy
Description of care received as assessed by Healthcare Resource Utlization
Measured: During, and up to 5 years post discontinuation of nivolumab use
Number of participants experiencing immune-related Adverse Events (AEs)
Measured: Up to 5 years post treatment initiation with adjuvant nivolumab therapy
Number of participants experiencing non-immune-related AEs
Measured: Up to 5 years post treatment initiation with adjuvant nivolumab therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study start12 Dec 2019
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04146324
- Sponsor's protocol ID
- CA209-7CK
- Status last verified
- Jan 2025
- First submitted
- 29 Oct 2019
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study in Patients Receiving Adjuvant Nivolumab Therapy for Resected Melanoma in Australia
- ClinicalTrials.gov ID
- NCT04146324
- Acronym / sponsor ID
- CA209-7CK
- Conditions
- Melanoma
- Keywords
- Adjuvant, nivolumab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2019 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 31 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adjuvant nivolumab therapy | – | Drug: nivolumabParticipants receiving nivolumab as an adjuvant therapy according to the market authorization in Australia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nivolumabAdministered as adjuvant therapy as per the market authorization in Australia | Drug | Adjuvant nivolumab therapy |
Primary outcome
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.
13 secondary outcomes
Percentage of Participants with Distant Metastasis-Free Survival (DMFS)
Time frame: 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
Description of sociodemographic profile of participants
Time frame: At treatment initiation with adjuvant nivolumab therapy
Description of clinical characteristics of participants
Time frame: At treatment initiation with adjuvant nivolumab therapy
Prior medical history of participants
Time frame: At treatment initiation with adjuvant nivolumab therapy
Description of nivolumab pattern of use
Time frame: 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
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
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
Participants' socioeconomic status as assessed by their highest education level
Time frame: 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
Number of participants experiencing immune-related Adverse Events (AEs)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma, run by Bristol-Myers Squibb at 9 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants with Relapse-Free Survival (RFS) (time frame: Up to 5 years post treatment initiation with adjuvant nivolumab therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025.