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

Melanoma Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03205722
• Other study ID #: CA209-939
• Status: Withdrawn
• First received: June 29, 2017
• Last updated: April 5, 2018
• Start date: January 5, 2018
• Est. completion date: July 30, 2018

Study information

• Verified date: April 2018
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 30, 2018
• Est. primary completion date: July 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma

Intervention

Other:
• Non-Interventional
Non-Interventional

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Approximately 23 months
Secondary	OS from date of advanced diagnosis		Approximately 23 months
Secondary	progression-free survival (PFS)		Approximately 23 months
Secondary	best overall response rate (BORR)		Approximately 23 months
Secondary	best overall response (BOR)		Approximately 23 months
Secondary	Distribution of Best Overall Response (BOR) by Severity of melanoma at initiation of treatment		Approximately 23 months
Secondary	Best Overall Response (BOR) in patients greater than or equal to 65 years old		Approximately 23 months
Secondary	Best Overall Response (BOR) in Eastern Cooperative Oncology Group (ECOG) performance status greater than or equal to 2		Approximately 23 months
Secondary	Distribution of Best Overall Response (BOR) by Mutational status		Approximately 23 months
Secondary	Best Overall Response (BOR) in Patients with brain metastases		Approximately 23 months
Secondary	Distribution of Best Overall Response (BOR) by Melanoma subtype		Approximately 23 months
Secondary	Distribution of incidence of Adverse Events (AEs)		Approximately 23 months
Secondary	Distribution of severity of Adverse Events (AEs)		Approximately 23 months
Secondary	Distribution of management of Adverse Events (AEs)		Approximately 23 months
Secondary	Distribution of socio-demographic characteristics in adult patients with advanced melanoma treated with nivolumab monotherapy as first-line therapy	Socio-demographic characteristics (Gender, Height, Weight, Age) will be summarized using descriptive statistics	Approximately 23 months
Secondary	Distribution of clinical characteristics in adult patients with advanced melanoma treated with nivolumab monotherapy as first-line therapy	Clinical characteristics (Initial Diagnosis of melanoma, Histological subtypes, Performance status, Comorbidities, history of cancer) will be summarized using descriptive statistics	Approximately 23 months
Secondary	Distribution of Treatment Patterns	Details on Prior and Evolution of Current Treatment Patterns will be summarized using descriptive statistics.	Approximately 23 months
Secondary	Distribution of Healthcare Resource Utilization	Healthcare Resource Utilization will be summarized using descriptive statistics	Approximately 23 months
Secondary	Duration of nivolumab treatment		Approximately 23 months

External Links

•   BMS Clinical Trial Information
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