Clinical Trial on Melanoma - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Melanoma

Detailed Description

Participants receiving adjuvant nivolumab therapy could be enrolled prospectively and retrospectively.

Study Type

Observational

Enrollment (Actual)

152

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

Belgium
- - Aalst, Belgium, 9300
    - Local Institution
  - Antwerp, Belgium, 2020
    - Local Institution
  - Bouge, Belgium, 5004
    - Local Institution
  - Bruges, Belgium, B-8000
    - Local Institution
  - Brussels, Belgium, 1000
    - Local Institution
  - Edegem, Belgium, 2650
    - Local Institution - 0014
  - Ghent, Belgium, 9000
    - Local Institution
  - Hasselt, Belgium, 3500
    - Local Institution
  - La Louvière, Belgium, 7100
    - Local Institution
  - Liège, Belgium, 4000
    - Local Institution - 0008
  - Sint-Niklaas, Belgium, 9100
    - Local Institution
  - Turnhout, Belgium, 2300
    - Local Institution
- Brussels Capital
  - Brussels, Brussels Capital, Belgium, 1090
    - Local Institution - 0001
Luxembourg
- - Luxembourg, Luxembourg, 1210
    - 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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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.

Description

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

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

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Participants who initiate adjuvant treatment with nivolumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
RFS (relapse free survival) Time Frame: 5 years	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DMFS (distant metastasis free survival) Time Frame: 5 years		5 years
OS (overall survival) Time Frame: 5 years		5 years
Distribution of sociodemographic characteristics in participants initiating nivolumab Time Frame: 5 years		5 years
Distribution of clinical characteristics in participants initiating nivolumab Time Frame: 5 years		5 years
Distribution of treatment patterns in participants initiating nivolumab Time Frame: 5 years		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 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.	5 years
The European Organization for Research and Treatment of Cancer (EORTC) QLQ C-30 questionnaire Time Frame: 5 years	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).	5 years
Functional Assessment of Cancer Therapy-Melanoma (FACT-M) questionnaires Time Frame: 5 years	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	5 years
Incidence of AE's Time Frame: 5 years		5 years
Incidence of SAE's Time Frame: 5 years		5 years

Collaborators and Investigators

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

Sponsor

Bristol-Myers Squibb

Investigators

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

BMS Clinical Trial Information

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)

January 16, 2019

Primary Completion (Actual)

December 9, 2025

Study Completion (Actual)

December 9, 2025

Study Registration Dates

First Submitted

December 10, 2018

First Submitted That Met QC Criteria

December 10, 2018

First Posted (Actual)

December 11, 2018

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified