Melanoma
Conditions
Brief summary
An observational study of melanoma participants who are eligible for and who have initiated treatment with adjuvant nivolumab as part of routine clinical practice.
Detailed description
Participants receiving adjuvant nivolumab therapy could be enrolled prospectively and retrospectively.
Interventions
None listed
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| RFS (relapse free survival) | 5 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DMFS (distant metastasis free survival) | 5 years | — |
| OS (overall survival) | 5 years | — |
| Distribution of sociodemographic characteristics in participants initiating nivolumab | 5 years | — |
| Distribution of clinical characteristics in participants initiating nivolumab | 5 years | — |
| Distribution of treatment patterns in participants initiating nivolumab | 5 years | — |
| QOL (quality of life) of patients with resected melanoma receiving adjuvant nivolumab therapy by using the EuroQOL-5D (EQ-5D) | 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. |
| The European Organization for Research and Treatment of Cancer (EORTC) QLQ C-30 questionnaire | 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). |
| Functional Assessment of Cancer Therapy-Melanoma (FACT-M) questionnaires | 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 |
| Incidence of AE's | 5 years | — |
| Incidence of SAE's | 5 years | — |
Countries
Belgium, Luxembourg
Contacts
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed