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

Bristol-Myers Squibb152 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

152

Conditions

Melanoma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (14)

Local Institution - 0001

Brussels, Brussels Capital, Belgium

Local Institution

Aalst, Belgium

Local Institution

Antwerp, Belgium

Outcomes

Primary Outcomes

RFS (relapse free survival)

Time frame: 5 years

Secondary Outcomes

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

Data from ClinicalTrials.gov

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