drugset / Trial / NCT01740401
CTLA-4 Blockade and Low Dose Cyclophosphamide in Patients With Advanced Malignant Melanoma
Phase 2
Terminated
10 enrolled
Icahn School of Medicine at Mount Sinai
Bristol-Myers Squibb · collab
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to see whether the combination of low-dose Cyclophosphamide and Anti-CTLA4 (Ipilimumab) will stop tumor growth in patients with advanced skin cancer. The investigators expect to see an increase in response rate of the combination over Anti-CTLA-4 alone and estimate a response rate of approximately 20 % in the proposed population.
Timeline
- Start
- 2012-10
- Primary completion
- 2013-12
- Completion
- 2014-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclophosphamide | Other / unclassified | 300 mg/m2 | Oral |
| Subject | Ipilimumab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Background | Ondansetron | Other / unclassified | 8 mg | Oral |