A Study of Patients Receiving Adjuvant Nivolumab Therapy for Melanoma That Has Been Removed
- Conditions
- Melanoma
- Registration Number
- NCT03771859
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 152
- 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)
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method RFS (relapse free survival) 5 years
- Secondary Outcome Measures
Name Time Method OS (overall survival) 5 years DMFS (distant metastasis free 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
Trial Locations
- Locations (1)
Local Institution
🇱🇺Luxembourg, Luxembourg