Phase 2 Study of Ipilimumab in Japanese Advanced Melanoma Patients

Phase 2

• Conditions: Melanoma

• Registration Number: JPRN-jRCT2080222335
• Lead Sponsor: Bristol-Myers K.K.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12-19
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Histologically or cytologically confirmed diagnosis of malignant melanoma
Previously-treated or untreated unresectable Stage III or Stage IV melanoma
Measurable/evaluable disease per modified World Health Organization (mWHO) criteria, within 28 days of first dose of study drug
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria

Active brain metastases
Primary ocular or mucosal melanoma
History of or current active autoimmune disease

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety<br>Safety of Ipilimumab monotherapy based on serious and non-serious adverse events, laboratory evaluations, dose exposure and modifications. In addition, abnormal vital signs and physical examination findings are also included

Secondary Outcome Measures

Name	Time	Method
Best overall response rate (BORR)<br>Best Overall Response Rate, defined as the total number of subjects whose Best Overall Response is Complete Response (CR) or Partial Response (PR) divided by the total number of treated subjects.