A Real-World Study of Ipilimumab Treatment After Nivolumab Treatment in Melanoma in Japan

NCT03165422 | Completed

• 1 other identifier: CA209-9DA
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

This is a medical chart review of ipilimumab treatment after nivolumab treatment in melanoma in Japan

Conditions

Melanoma

Outcome Measures

Primary Outcomes (5)

• Incidence of ipilimumab treatment after nivolumab treatment

  Approximately 19 months

• Incidence of nivolumab treatment after ipilimumab treatment

  Approximately 19 months

• Duration of nivolumab treatment

  Approximately 19 months

• Duration of ipilimumab treatment

  Approximately 19 months

• Duration of interval between nivolumab treatment and ipilimumab treatment

  Approximately 19 months

Secondary Outcomes (6)

• overall response rate (ORR)

  Approximately 19 months

• best overall response rate (BORR)

  Approximately 19 months

• overall survival (OS)

  Approximately 19 months

• progression-free survival (PFS)

  Approximately 19 months

• incidence of treatment-related adverse events (AEs)

  Approximately 19 months

Study Arms (1)

Adult patients with melanoma

Adult patients with melanoma at participating centers in Japan

Other: Non-Interventional

Interventions

Non-Interventional OTHER

Non-Interventional

Adult patients with melanoma

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

Adult patients with melanoma who are patients at the participating centers in Japan will be enrolled.

You may qualify if:

• Adult patients \> 18 years of age or older
• Diagnosis of advanced melanoma (unresectable/metastatic), alive or deceased as of date of data collection
• Treated with ipilimumab between 31-Aug-2015 and 31-Mar-2017 before or after nivolumab treatment

You may not qualify if:

• Patients enrolled in any clinical trials at any time
• Overlapping use of nivolumab and ipilimumab

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• Ono Pharmaceutical Co. Ltd: collaborator

Study Sites (1)

Local Institution

Minato-ku, Tokyo, 1050001, Japan

Location

Related Links

• BMS Clinical Trial Information
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

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: May 16, 2017
• First Posted: May 24, 2017
• Study Start: March 1, 2017
• Primary Completion: December 29, 2018
• Study Completion: December 29, 2018
• Last Updated: October 23, 2019

Record last verified: 2019-10

Locations

JP (1)