MelanomaNCT03771859
A Study of Patients Receiving Adjuvant Nivolumab Therapy for Melanoma That Has Been Removed
An observational study of Melanoma, run by Bristol-Myers Squibb at 14 sites in 2 countries.
Trial summary
An observational study of melanoma participants who are eligible for and who have initiated treatment with adjuvant nivolumab as part of routine clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- How many people
- 152 participants
- Where
- 14 sitesin 2 countries
- Study dates
- 16 Jan 2019to 9 Dec 2025
- 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 with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection, and who receive adjuvant nivolumab under real-world conditions in Belgium or Luxembourg. Patients will be enrolled after complete surgical resection and following a screen procedure (according to standard practice) that shows no evidence of disease. Patients currently enrolled in an interventional clinical trial will not be eligible.
Who may be able to join
- Patients with a primary diagnosis of melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection and have no evidence of disease.
- Decision to treat with adjuvant nivolumab therapy has already been taken
- At least 18 years of age at the time of treatment decision
- Patients who provide written informed consent to participate in the study (for retrospectively enrolled patients who are deceased at time of study start, a consent waiver will be sought)
Who cannot join
- Any patient with a diagnosis of persisting advanced melanoma prior to first administration of nivolumab
- Any patient currently enrolled in an interventional clinical trial for his/her melanoma treatment (note: patients who have completed their participation in an interventional trial or who are no longer receiving the study drug and are only followed up for Overall Survival (OS)/ Relapse Free Survival (RFS) can be enrolled. In case of a blinded study, the treatment arm needs to be known).
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
Belgium13 sites
Local Institution
Aalst, 9300
Local Institution
Antwerp, 2020
Local Institution
Bouge, 5004
Local Institution
Bruges, B-8000
Local Institution - 0001
Brussels, Brussels Capital, 1090
Local Institution
Brussels, 1000
Local Institution - 0014
Edegem, 2650
Local Institution
Ghent, 9000
Local Institution
Hasselt, 3500
Local Institution
La Louvière, 7100
Local Institution - 0008
Liège, 4000
Local Institution
Sint-Niklaas, 9100
Local Institution
Turnhout, 2300
About this study
Official title: An Observational Study in Patients Receiving Adjuvant Nivolumab Therapy for Resected Melanoma
An observational study of melanoma participants who are eligible for and who have initiated treatment with adjuvant nivolumab as part of routine clinical practice.
Read the detailed description
Participants receiving adjuvant nivolumab therapy could be enrolled prospectively and retrospectively.
- Conditions
- Melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants who initiate adjuvant treatment with nivolumab | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
RFS (relapse free survival)
Measured: 5 years
Secondary outcomes (10)
DMFS (distant metastasis free survival)
Measured: 5 years
OS (overall survival)
Measured: 5 years
Distribution of sociodemographic characteristics in participants initiating nivolumab
Measured: 5 years
Distribution of clinical characteristics in participants initiating nivolumab
Measured: 5 years
Distribution of treatment patterns in participants initiating nivolumab
Measured: 5 years
QOL (quality of life) of patients with resected melanoma receiving adjuvant nivolumab therapy by using the EuroQOL-5D (EQ-5D)
The EQ-5D is a standardized 3-level, 5-dimensional multi-attribute utility questionnaire that measures mobility, self-care, usual activities, pain/discomfort and anxiety/depression, where each dimension is rated by individuals as no problems, slight problems, moderate problems, severe problems, and extreme problems.
Measured: 5 years
The European Organization for Research and Treatment of Cancer (EORTC) QLQ C-30 questionnaire
The EORTC-QLQ-C30 questionnaire is a 30-item instrument that comprises 5 functional scales (physical functioning, cognitive functioning, emotional functioning, social functioning and global quality of life) as well as nine symptom scales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties).
Measured: 5 years
Functional Assessment of Cancer Therapy-Melanoma (FACT-M) questionnaires
The FACT-M is a frequently used melanoma specific questionnaire which has been validated to assess HRQOL for patients with all stages of melanoma. Besides general questions on Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being, it also contains specific questions related to melanoma, including a subscale on the melanoma surgery
Measured: 5 years
Incidence of AE's
Measured: 5 years
Incidence of SAE's
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start16 Jan 2019
- Primary completion9 Dec 2025
- Study completion9 Dec 2025
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
- Other
- Enrolment
- 152 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
- NCT03771859
- Sponsor's protocol ID
- CA209-8RX
- Status last verified
- Jun 2026
- First submitted
- 10 Dec 2018
- Last updated
- 2 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study in Patients Receiving Adjuvant Nivolumab Therapy for Resected Melanoma
- ClinicalTrials.gov ID
- NCT03771859
- Acronym / sponsor ID
- CA209-8RX
- Conditions
- Melanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 16 Jan 2019 (actual)
- Primary completion
- 9 Dec 2025 (actual)
- Study completion
- 9 Dec 2025 (actual)
- First posted
- 11 Dec 2018 (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.
An observational study of melanoma participants who are eligible for and who have initiated treatment with adjuvant nivolumab as part of routine clinical practice.
Detailed description
Participants receiving adjuvant nivolumab therapy could be enrolled prospectively and retrospectively.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants who initiate adjuvant treatment with nivolumab | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection, and who receive adjuvant nivolumab under real-world conditions in Belgium or Luxembourg. Patients will be enrolled after complete surgical resection and following a screen procedure (according to standard practice) that shows no evidence of disease. Patients currently enrolled in an interventional clinical trial will not be eligible.
Key inclusion criteria (4 listed)
- Patients with a primary diagnosis of melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection and have no evidence of disease.
- Decision to treat with adjuvant nivolumab therapy has already been taken
- At least 18 years of age at the time of treatment decision
- Patients who provide written informed consent to participate in the study (for retrospectively enrolled patients who are deceased at time of study start, a consent waiver will be sought)
Key exclusion criteria (3 listed)
- Any patient with a diagnosis of persisting advanced melanoma prior to first administration of nivolumab
- Any patient currently enrolled in an interventional clinical trial for his/her melanoma treatment (note: patients who have completed their participation in an interventional trial or who are no longer receiving the study drug and are only followed up for Overall Survival (OS)/ Relapse Free Survival (RFS) can be enrolled. In case of a blinded study, the treatment arm needs to be known).
- Other protocol defined inclusion/exclusion criteria could apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
RFS (relapse free survival)
Time frame: 5 years
10 secondary outcomes
DMFS (distant metastasis free survival)
Time frame: 5 years
OS (overall survival)
Time frame: 5 years
Distribution of sociodemographic characteristics in participants initiating nivolumab
Time frame: 5 years
Distribution of clinical characteristics in participants initiating nivolumab
Time frame: 5 years
Distribution of treatment patterns in participants initiating nivolumab
Time frame: 5 years
QOL (quality of life) of patients with resected melanoma receiving adjuvant nivolumab therapy by using the EuroQOL-5D (EQ-5D)
Time frame: 5 years
The European Organization for Research and Treatment of Cancer (EORTC) QLQ C-30 questionnaire
Time frame: 5 years
Functional Assessment of Cancer Therapy-Melanoma (FACT-M) questionnaires
Time frame: 5 years
Incidence of AE's
Time frame: 5 years
Incidence of SAE's
Time frame: 5 years
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 2 Jun 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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
14 sites in 2 countries: 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 14 sites in 2 countries.
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 4 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 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Belgium, Luxembourg. 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?
RFS (relapse free survival) (time frame: 5 years). 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 2 Jun 2026.