A National, Prospective, Non- Interventional Study (NIS) in Patients Receiving Adjuvant Nivolumab Therapy for Resected Melanoma and Subsequent Treatments in Case of Relapse

Bristol-Myers Squibb1 site in 1 country362 target enrollmentSeptember 2, 2020

ConditionsMelanoma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Melanoma
Sponsor: Bristol-Myers Squibb
Enrollment: 362
Locations: 1
Primary Endpoint: Relapse-Free Survival (RFS)
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2, 2020

End Date

March 15, 2027

Last Updated

4 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Relapse-Free Survival (RFS)

Time Frame: up to 60 months

Secondary Outcomes

Assessment of sociodemographic characteristics(Up to 60 months)
Frequency of nivolumab therapy: number of dosing(Up to 60 months)
Relapse-Free Survival 2 (RFS2)(Up to 60 months)
Assessment of clinical characteristics(Up to 60 months)
Overall Survival (OS)(Up to 60 months)
Frequency of Nivolumab: pattern of use(Up to 60 months)
Safety profile of systemic therapies administered after relapse in terms of severe adverse events: Incidence(Up to 60 months)
Characteristics of nivolumab adjuvant safety profile: incidence(Up to 60 months)
Assessment of health related quality of life(Up to 60 Months)
Distant Metastatasis-Free Survival (DMFS)(Up to 60 months)
Progression Free Survival (PFS)(Up to 60 months)
Estimate of the effectiveness of systemic therapies administered after relapse following adjuvant nivolumab, in terms of time and duration of response(Up to 60 months)
Estimate the effectiveness of subsequents treatments administered after relapse in terms of PFS(Up to 60 months)
Safety profile of systemic therapies administered after relapse in terms of severe adverse events: Outcome(Up to 60 months)
Frequency of nivolumab therapy: number of infusions(Up to 60 months)
Characteristics of nivolumab adjuvant safety profile: time to onset of other immune- related AEs(Up to 60 months)
Characteristics of nivolumab adjuvant safety profile: time to resolution of other immune-related AEs(Up to 60 months)
Characteristics of nivolumab adjuvant safety profile: management(Up to 60 months)
Characteristics of nivolumab adjuvant safety profile: time to resolution of select AEs(Up to 60 months)
Describe the use of subsequent therapies after relapse following adjuvant nivolumab(Up to 60 months)
Estimate of the effectiveness of systemic therapies administered after relapse following adjuvant nivolumab, in terms of overall response rate(Up to 60 months)
Safety profile of systemic therapies administered after relapse in terms of severe adverse events incidence, type, management and outcome(Up to 60 months)
Characteristics of nivolumab adjuvant safety profile: grade(Up to 60 months)
Characteristics of nivolumab adjuvant safety profile: type(Up to 60 months)
Characteristics of nivolumab adjuvant safety profile: time to onset of select AEs(Up to 60 months)
Estimate the effectiveness of subsequents treatments administered after relapse in terms of RFS2(Up to 60 months)
Estimate the effectiveness of subsequents treatments administered after relapse in terms of OS(Up to 60 months)
Characteristics of nivolumab adjuvant safety profile: outcome(Up to 60 months)
Safety profile of systemic therapies administered after relapse in terms of severe adverse events: Type(Up to 60 months)
Safety profile of systemic therapies administered after relapse in terms of severe adverse events: Management(Up to 60 months)