A Study of Patients Receiving Adjuvant Nivolumab Therapy for Melanoma That Has Been Removed

Bristol-Myers Squibb (BMS)

Status: Active, not recruiting

Conditions: Melanoma

Study type: Observational

Funder types: Industry

Identifiers

NCT03771859

CA209-8RX

Details and patient eligibility

About

An observational study of melanoma participants who are eligible for and who have initiated treatment with adjuvant nivolumab as part of routine clinical practice.

Full description

Participants receiving adjuvant nivolumab therapy could be enrolled prospectively and retrospectively.

Enrollment: 152 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients 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
• At least 18 years of age at the time of treatment decision
• Patients who provide written informed consent to participate in the study (for retrospectively enrolled patients who are deceased at time of study start, a consent waiver will be sought)

Exclusion criteria

• Any patient with a diagnosis of persisting advanced melanoma prior to first administration of nivolumab
• Any patient 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 Overall Survival (OS)/ Relapse Free Survival (RFS) can be enrolled. In case of a blinded study, the treatment arm needs to be known).

Other protocol defined inclusion/exclusion criteria could apply

Trial design

152 participants in 1 patient group

Participants who initiate adjuvant treatment with nivolumab