Clinical trial · Interventional
A Comparative Study in Chinese Subjects With Chemotherapy Naïve Stage IV Melanoma Receiving Ipilimumab (3 mg/kg) vs. Dacarbazine
A Randomized, Open-Label, Two-arm, Comparative Study in Chinese Subjects With Chemotherapy Naïve Stage IV Melanoma Receiving Ipilimumab (3 mg/kg) vs. Dacarbazine
NCT02545075CI-TRIAL-00045154completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dacarbazine | Drug | Dacarbazine | ALIAS |
| Ipilimumab | Drug | Ipilimumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Ipilimumab
- description
- Intravenously (IV) 3 mg/kg every 3 weeks (at week 1,4,7,10) and thereafter (q3w/4 doses) at the time of progression
- interventionNames
- Drug: Ipilimumab
- type
- EXPERIMENTAL
- label
- Dacarbazine
- description
- IV solution 250 mg/m2 (Day 1-5, every 3weeks/at week 1, 4, 7, 10,13,16,19,22)
- interventionNames
- Drug: Dacarbazine
Primary outcomes (1)
- measure
- Two-Years Survival Rate
- timeFrame
- 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.