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

N/AWithdrawnNCT03205722

Bristol-Myers Squibb

Overview

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.

Study Type

OBSERVATIONAL

Conditions

Melanoma

Interventions

Non-InterventionalOTHER

Non-Interventional

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Overall Survival (OS)

OS for adult patients with advanced (unresectable or metastatic) melanoma treated with nivolumab monotherapy as first-line therapy from date of advanced diagnosis, and from the start of treatment with nivolumab over the first 23 months after treatment initiation, overall.