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Real-world nivolumab use in melanoma: what happens after surgery?

NCT ID NCT03771859

Knowledge-focused Sponsor: Bristol-Myers Squibb Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study watched 152 melanoma patients who had their tumors surgically removed and then started nivolumab as part of their normal care. Researchers tracked how long patients stayed cancer-free, whether the cancer spread, and overall survival. The goal was to see how well the drug works in everyday practice, not to test a new treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

152 people

The number who actually took part.

Started

Jan 2019

Finished

Dec 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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) Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

cutaneous melanoma melanoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Melanoma

Contacts and locations

Locations

  • Local Institution

    Aalst, 9300, Belgium

  • Local Institution

    Antwerp, 2020, Belgium

  • Local Institution

    Bouge, 5004, Belgium

  • Local Institution

    Bruges, B-8000, Belgium

  • Local Institution

    Brussels, 1000, Belgium

  • Local Institution

    Ghent, 9000, Belgium

  • Local Institution

    Hasselt, 3500, Belgium

  • Local Institution

    La Louvière, 7100, Belgium

  • Local Institution

    Sint-Niklaas, 9100, Belgium

  • Local Institution

    Turnhout, 2300, Belgium

  • Local Institution

    Luxembourg, 1210, Luxembourg

  • Local Institution - 0001

    Brussels, Brussels Capital, 1090, Belgium

  • Local Institution - 0008

    Liège, 4000, Belgium

  • Local Institution - 0014

    Edegem, 2650, Belgium

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