Phase 2
Completed N=20
Phase 2 Study of Ipilimumab in Japanese Advanced Melanoma Patients
Source: ClinicalTrials.gov NCT01990859 ↗Enrolled (actual)
20
Serious AEs
55.0%
Results posted
May 2015
Primary outcomePrimary: Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation of Study Drug, Related AEs, Immune-related AEs (IrAEs) at Primary Endpoint - All Treated Participants — 6; 6; 10; 3 participants
Summary
The purpose of this study is to assess the safety of Ipilimumab monotherapy in Japanese subjects with advanced melanoma
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation of Study Drug, Related AEs, Immune-related AEs (IrAEs) at Primary Endpoint - All Treated Participants |
6; 6; 10; 3; 1; 7 | — |
| SECONDARY Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation of Study Drug, Related AEs, Immune-related AEs (IrAEs) - All Treated Participants |
8; 8; 11; 3; 1; 9 | — |
| SECONDARY Number of Participants Who Died - All Treated Participants |
5; 8 | — |
| SECONDARY Number of Participants With Hematology Laboratory Abnormalities |
1; 0; 1; 0; 4; 1 | — |
| SECONDARY Number of Participants With Liver Function Laboratory Abnormalities |
11; 1; 10; 3; 3; 1 | — |
| SECONDARY Number of Participants With Renal Laboratory Abnormalities |
5; 1 | — |
| SECONDARY Number of Participants With Complete Response, Partial Response, Stable Disease, or Progressive Disease as the Best Overall Response |
2; 2; 13; 3 | — |
| SECONDARY Percent of Participants With Best Overall Response (BOR) of Complete Response or Partial Response |
10.0 | — |
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
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
Data sourced from ClinicalTrials.gov (NCT01990859). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.