A Prospective Non-Interventional Study in Participants Receiving Nivolumab in Adjuvant Setting for Resected Melanoma in Real-World Conditions in France

Melanoma Clinical Trial

— AdjuMel  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04550247
• Other study ID #: CA209-7HU
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Melanoma

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

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls