Clinical trial NCT03205722: The Effectiveness of Nivolumab Monotherapy as First-Line Therapy in Adults With Advanced Melanoma in Germany
Official title: The Effectiveness of Nivolumab (OPDIVO®) Monotherapy as First-Line Therapy in Adults With Advanced (Unresectable or Metastatic) Melanoma: An Early Retrospective, Observational Study in Germany
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Melanoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2017-07-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients diagnosed with advanced melanoma who were initiated with nivolumab monotherapy as their first-line therapy in Germany between June 2015 and June 2016.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Approximately 23 months
Secondary outcomes:
measure: OS from date of advanced diagnosis
timeFrame: Approximately 23 months
measure: progression-free survival (PFS)
timeFrame: Approximately 23 months
measure: best overall response rate (BORR)
timeFrame: Approximately 23 months
measure: best overall response (BOR)
timeFrame: Approximately 23 months
measure: Distribution of Best Overall Response (BOR) by Severity of melanoma at initiation of treatment
timeFrame: Approximately 23 months
measure: Best Overall Response (BOR) in patients greater than or equal to 65 years old
timeFrame: Approximately 23 months
measure: Best Overall Response (BOR) in Eastern Cooperative Oncology Group (ECOG) performance status greater than or equal to 2
timeFrame: Approximately 23 months
measure: Distribution of Best Overall Response (BOR) by Mutational status
timeFrame: Approximately 23 months
measure: Best Overall Response (BOR) in Patients with brain metastases
timeFrame: Approximately 23 months
measure: Distribution of Best Overall Response (BOR) by Melanoma subtype
timeFrame: Approximately 23 months
measure: Distribution of incidence of Adverse Events (AEs)
timeFrame: Approximately 23 months
measure: Distribution of severity of Adverse Events (AEs)
timeFrame: Approximately 23 months
measure: Distribution of management of Adverse Events (AEs)
timeFrame: Approximately 23 months
measure: Distribution of socio-demographic characteristics in adult patients with advanced melanoma treated with nivolumab monotherapy as first-line therapy
timeFrame: Approximately 23 months
measure: Distribution of clinical characteristics in adult patients with advanced melanoma treated with nivolumab monotherapy as first-line therapy
timeFrame: Approximately 23 months
measure: Distribution of Treatment Patterns
timeFrame: Approximately 23 months
measure: Distribution of Healthcare Resource Utilization
timeFrame: Approximately 23 months
measure: Duration of nivolumab treatment
timeFrame: Approximately 23 months
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: