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

NCT03205722 | Withdrawn

• 1 other identifier: CA209-939
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (18)

• OS from date of advanced diagnosis

  Approximately 23 months

• progression-free survival (PFS)

  Approximately 23 months

• best overall response rate (BORR)

  Approximately 23 months

• best overall response (BOR)

  Approximately 23 months

• Distribution of Best Overall Response (BOR) by Severity of melanoma at initiation of treatment

  Approximately 23 months

Study Arms (1)

Melanoma patients with 1st-line Nivo treatment

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

Other: Non-Interventional

Interventions

Non-Interventional OTHER

Non-Interventional

Melanoma patients with 1st-line Nivo treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Related Links

• Investigator Inquiry Form

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2017
• First Posted: July 2, 2017
• Study Start: January 5, 2018
• Primary Completion: July 30, 2018
• Study Completion: July 30, 2018
• Last Updated: April 9, 2018

Record last verified: 2018-04