Phase 3
Completed N=182
A Comparative Study in Chinese Subjects With Chemotherapy Naïve Stage IV Melanoma Receiving Ipilimumab (3 mg/kg) vs. Dacarbazine
Source: ClinicalTrials.gov NCT02545075 ↗Enrolled (actual)
182
Serious AEs
26.3%
Results posted
May 2020
Primary outcomePrimary: Two-Years Survival Rate — 33.98; 34.09 Percentage of Participants — p=0.5059
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to determine whether Ipilimumab will extend the life of chinese patients with Chemotherapy Naive Stage IV Melanoma more than Dacarbazine as well as to examine safety in this patient population.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Two-Years Survival Rate |
33.98; 34.09 | 0.5059 |
| SECONDARY One-Year Survival Rate |
61.68; 64.11 | 0.6202 |
| SECONDARY Overall Survival (OS) |
15.08; 14.55 | 0.7267 |
| SECONDARY Progression Free Survival ( PFS) |
2.60; 1.84 | 0.2503 |
| SECONDARY Disease Control Rate ( DCR ) |
32; 31.7 | 0.9932 |
| SECONDARY Best Overall Response Rate ( BORR ) |
8.2; 8.3 | 0.9738 |
| SECONDARY Duration of Response ( DoR) |
8.99; 7.98 | — |
| SECONDARY Duration of Stable Disease ( DoSD ) |
6.83; 9.40 | — |
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria
- Chinese males and females ≥ 18 years of age
- Histologic diagnosis of malignant melanoma
- Chemotherapy naive Stage IV melanoma (AJCC 2010)
- Life expectancy of ≥ 16 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria
- Evidence of brain metastases on brain imaging
- Primary ocular or mucosal melanoma
- Any other malignancy from which the patient has been disease-free for less than 5 years
- BRAF status cannot be determined by Screening test
- Human Immunodeficiency Virus (HIV) positive or hepatitis B surface antigen (HBsAg) positive, or active Hepatitis C infection
Data sourced from ClinicalTrials.gov (NCT02545075). 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.