Clinical trial NCT04550247: A Prospective Non-Interventional Study in Participants Receiving Nivolumab in Adjuvant Setting for Resected Melanoma in Real-World Conditions in France
Official title: A National, Prospective, Non- Interventional Study (NIS) in Patients Receiving Adjuvant Nivolumab Therapy for Resected Melanoma and Subsequent Treatments in Case of Relapse
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Melanoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2020-09-16
Enrollment: 362
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will collect data primarily from hospital based dermatology and oncology care facilities

Brief summary: This is an observational prospective study to estimate in real world conditions the effectiveness, the safety profile and the pattern of use of adjuvant nivolumab in adults participants with stage III/IV resected melanoma, and subsequent treatments administered in case of relapse.


Eligibility criteria: For more information regarding Bristol-Myers Squibb Clinical Trial participation,please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* Participants 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
* Participants who provide oral informed consent to participate in the study

Exclusion Criteria:

* Any participant with a current diagnosis of persisting advanced melanoma
* Participants with a current primary diagnosis of a cancer other than advanced melanoma, ie, a cancer other than melanoma that requires systemic or other treatment or has not been treated curatively (as per discretion of the investigator)
* Any participants 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 OS/RFS can be enrolled. In case of a blinded study, the treatment arm needs to be known).
* Pregnant women
* Person under guardianship

Other protocol defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Relapse-Free Survival (RFS)
timeFrame: up to 60 months
Secondary outcomes:
measure: Distant Metastatasis-Free Survival (DMFS)
timeFrame: Up to 60 months
measure: Overall Survival (OS)
timeFrame: Up to 60 months
measure: Relapse-Free Survival 2 (RFS2)
timeFrame: Up to 60 months
measure: Progression Free Survival (PFS)
timeFrame: Up to 60 months
measure: Assessment of health related quality of life
timeFrame: Up to 60 Months
measure: Assessment of sociodemographic characteristics
timeFrame: Up to 60 months
measure: Assessment of clinical characteristics
timeFrame: Up to 60 months
measure: Frequency of nivolumab therapy: number of infusions
timeFrame: Up to 60 months
measure: Frequency of nivolumab therapy: number of dosing
timeFrame: Up to 60 months
measure: Frequency of Nivolumab: pattern of use
timeFrame: Up to 60 months
measure: Characteristics of nivolumab adjuvant safety profile: incidence
timeFrame: Up to 60 months
measure: Characteristics of nivolumab adjuvant safety profile: grade
timeFrame: Up to 60 months
measure: Characteristics of nivolumab adjuvant safety profile: type
timeFrame: Up to 60 months
measure: Characteristics of nivolumab adjuvant safety profile: time to onset of select AEs
timeFrame: Up to 60 months
measure: Characteristics of nivolumab adjuvant safety profile: time to onset of other immune- related AEs
timeFrame: Up to 60 months
measure: Characteristics of nivolumab adjuvant safety profile: time to resolution of select AEs
timeFrame: Up to 60 months
measure: Characteristics of nivolumab adjuvant safety profile: time to resolution of other immune-related AEs
timeFrame: Up to 60 months
measure: Describe the use of subsequent therapies after relapse following adjuvant nivolumab
timeFrame: Up to 60 months
measure: Estimate of the effectiveness of systemic therapies administered after relapse following adjuvant nivolumab, in terms of time and duration of response
timeFrame: Up to 60 months
measure: Estimate of the effectiveness of systemic therapies administered after relapse following adjuvant nivolumab, in terms of overall response rate
timeFrame: Up to 60 months
measure: Safety profile of systemic therapies administered after relapse in terms of severe adverse events incidence, type, management and outcome
timeFrame: Up to 60 months
measure: Estimate the effectiveness of subsequents treatments administered after relapse in terms of PFS
timeFrame: Up to 60 months
measure: Estimate the effectiveness of subsequents treatments administered after relapse in terms of RFS2
timeFrame: Up to 60 months
measure: Estimate the effectiveness of subsequents treatments administered after relapse in terms of OS
timeFrame: Up to 60 months
measure: Characteristics of nivolumab adjuvant safety profile: management
timeFrame: Up to 60 months
measure: Characteristics of nivolumab adjuvant safety profile: outcome
timeFrame: Up to 60 months
measure: Safety profile of systemic therapies administered after relapse in terms of severe adverse events: Incidence
timeFrame: Up to 60 months
measure: Safety profile of systemic therapies administered after relapse in terms of severe adverse events: Type
timeFrame: Up to 60 months
measure: Safety profile of systemic therapies administered after relapse in terms of severe adverse events: Management
timeFrame: Up to 60 months
measure: Safety profile of systemic therapies administered after relapse in terms of severe adverse events: Outcome
timeFrame: Up to 60 months
Other outcomes:
Locations:
city: Lille
country: France
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: