An observational study in Melanoma, sponsored by Bristol-Myers Squibb. Completed at 14 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-02.
Sponsored by Bristol-Myers Squibb · Observational
An observational study of melanoma participants who are eligible for and who have initiated treatment with adjuvant nivolumab as part of routine clinical practice.
Participants receiving adjuvant nivolumab therapy could be enrolled prospectively and retrospectively.
3,370 studies on the registry are indexed under Melanoma; 578 are open to participants now.
This study's enrollment of 152 is below the median of 187 across 488 observational studies indexed under Melanoma.
Browse Melanoma studies →Bristol-Myers Squibb is the lead sponsor of 1,561 studies on the registry; 117 are open to participants now.
Of its 436 completed or terminated interventional studies of FDA-regulated products, 228 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This study also gives Nivolumab. No intervention listed here names it: that was found by reading the record.
RFS (relapse free survival)
Time frame: 5 years
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)
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.
Time frame: 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).
Time frame: 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
Time frame: 5 years
Incidence of AE's
Time frame: 5 years
Incidence of SAE's
Time frame: 5 years
Plan to share: No
Ran from Jan 2019 to primary completion in Dec 2025, 82 months.
Of 59 industry-sponsored observational studies under Melanoma, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 80. This study's 82 months is above that.
Counting every sponsor, half of 236 studies reached it within 71 months; a quarter within 35 and three quarters within 223.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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