An Observational Study of Adjuvant (Post-surgery) Therapy With Nivolumab for Resected (Completely Removed) Melanoma in Australia

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: Melanoma

Treatments: Drug: nivolumab

Study type: Observational

Funder types: Industry

Identifiers

NCT04146324

CA209-7CK

Details and patient eligibility

About

This study is designed to estimate the effectiveness of nivolumab when given to participants after removing their cancer with surgery, over a 5-year follow-up, in real-world conditions in Australia.

Enrollment: 150 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:

• Adults with a primary diagnosis of melanoma with involvement of lymph nodes or metastatic disease who have undergone complete surgical removal and have no evidence of disease
• Decision to treat with adjuvant nivolumab therapy has already been taken
• Ability to provide written informed consent to participate in the study

Exclusion Criteria:

• Adults with a current diagnosis of persisting advanced melanoma
• Adults currently enrolled in an interventional clinical trial for his/her melanoma treatment

Other protocol-defined inclusion/exclusion criteria apply

Trial design

150 participants in 1 patient group

Adjuvant nivolumab therapy

Description:

Participants receiving nivolumab as an adjuvant therapy according to the market authorization in Australia

Treatment:

Drug: nivolumab