A Study of Patients Receiving Adjuvant Nivolumab Therapy for Melanoma That Has Been Removed

September 7, 2021 updated by: Bristol-Myers Squibb

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.

Study Overview

Status

Active, not recruiting

Conditions

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
      • Antwerpen, Belgium, 2020
        • Local Institution
      • Bouge, Belgium, 5004
        • Local Institution
      • Brugge, Belgium, B-8000
        • Local Institution
      • Brussel, Belgium, 1090
        • Local Institution
      • Brussels, Belgium, 1000
        • Local Institution
      • Edegem, Belgium, 2650
        • Local Institution
      • Gent, Belgium, 9000
        • Local Institution
      • Hasselt, Belgium, 3500
        • Local Institution
      • La Louviere, Belgium, 7100
        • Local Institution
      • Liege, Belgium, 4000
        • Local Institution
      • Sint-Niklaas, Belgium, 9100
        • Local Institution
      • Turnhout, Belgium, 2300
        • Local Institution
  • 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

Genders Eligible for Study

All

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

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

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

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 (Anticipated)

December 30, 2025

Study Completion (Anticipated)

December 30, 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)

September 14, 2021

Last Update Submitted That Met QC Criteria

September 7, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA209-8RX

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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