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

Bristol-Myers Squibb (BMS)

Status: Active, not recruiting

Conditions: Melanoma

Study type: Observational

Funder types: Industry

Identifiers

NCT04550247

CA209-7HU

Details and patient eligibility

About

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.

Enrollment: 362 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

362 participants in 1 patient group

Nivolumab treatment

Description:

Administered according to the market authorization in France