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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04550247
Other study ID # CA209-7HU
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date September 2, 2020
Est. completion date March 15, 2027

Study information

Verified date March 2022
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 362
Est. completion date March 15, 2027
Est. primary completion date March 15, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Local Institution Lille

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

France, 

Outcome

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