The Effectiveness of Nivolumab Monotherapy as First-Line Therapy in Adults With Advanced Melanoma in Germany

Bristol-Myers Squibb (BMS)

Status: Withdrawn

Conditions: Melanoma

Treatments: Other: Non-Interventional

Study type: Observational

Funder types: Industry

Identifiers

NCT03205722

CA209-939

Details and patient eligibility

About

A retrospective, observational study based on chart reviews for patients with advanced melanoma treated with nivolumab monotherapy prescribed as first-line therapy between June 2015 and June 2016, conducted in a representative sample of sites in Germany.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients with a primary diagnosis of advanced melanoma (histologically confirmed stage III [unresectable] or stage IV skin, ocular, or mucosal melanoma)
• Newly initiated with nivolumab monotherapy as their first-line therapy for previously untreated advanced melanoma between June 2015 and June 2016
• At least 18 years of age at time of treatment decision

Exclusion criteria

• Patients with a current primary diagnosis of a cancer other than advanced melanoma ie, a cancer other than melanoma that requires systemic or other treatment
• Patients currently included in an interventional clinical trial for his/her locally advanced or metastatic melanoma. Patients who have completed their participation in an interventional trial; or who are not receiving study drug anymore and who are only followed-up for overall survival can be enrolled. In case of a blinded study, the treatment arm (ie, type of administered treatment) needs to be known.
• Patients < 18 years of age at time of treatment initiation

Other protocol defined inclusion/exclusion criteria could apply

Trial design

0 participants in 1 patient group

Melanoma patients with 1st-line Nivo treatment

Description:

Non-Interventional. Patients with advanced melanoma treated with nivolumab monotherapy prescribed as first-line therapy between June 2015 and June 2016.

Treatment:

Other: Non-Interventional