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NCT Number: NCT03771859

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

An observational study of melanoma participants who are eligible for and who have initiated treatment with adjuvant nivolumab as part of routine clinical practice.

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Key information

Conditions

Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution - 0001, Brussels, Brussels Capital, Belgium

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. RFS (relapse free survival)

    Time frame: 5 years

Secondary outcomes

  1. DMFS (distant metastasis free survival)

    Time frame: 5 years

  2. OS (overall survival)

    Time frame: 5 years

  3. Distribution of sociodemographic characteristics in participants initiating nivolumab

    Time frame: 5 years

  4. Distribution of clinical characteristics in participants initiating nivolumab

    Time frame: 5 years

  5. Distribution of treatment patterns in participants initiating nivolumab

    Time frame: 5 years

  6. 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.

  7. 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).

  8. 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

  9. Incidence of AE's

    Time frame: 5 years

  10. Incidence of SAE's

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

An Observational Study in Patients Receiving Adjuvant Nivolumab Therapy for Resected Melanoma

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Dec 11, 2018
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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