drugset / Trial / NCT00261365
Phase II Study to Determine Predictive Markers of Response to BMS-734016 (MDX-010)
RandomizedFactorialDouble-blindTreatment
Summary
The purpose of this study is to identify candidate markers predictive of response and/or serious toxicity to BMS-734016 (MDX-010).
Timeline
- Start
- 2005-11
- Primary completion
- 2007-10
- Completion
- 2007-10
Publications
- Schadendorf D, Hodi FS, Robert C, Weber JS, Margolin K, Hamid O, Patt D, Chen TT, Berman DM, Wolchok JD. Pooled Analysis of Long-Term Survival Data From Phase II and Phase III Trials of Ipilimumab in Unresectable or Metastatic Melanoma. J Clin Oncol. 2015 Jun 10;33(17):1889-94. doi: 10.1200/JCO.2014.56.2736. Epub 2015 Feb 9.
- Hamid O, Schmidt H, Nissan A, Ridolfi L, Aamdal S, Hansson J, Guida M, Hyams DM, Gomez H, Bastholt L, Chasalow SD, Berman D. A prospective phase II trial exploring the association between tumor microenvironment biomarkers and clinical activity of ipilimumab in advanced melanoma. J Transl Med. 2011 Nov 28;9:204. doi: 10.1186/1479-5876-9-204.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ipilimumab | Monoclonal antibody | 3 mg/kg | Intravenous |
| Comparator | Ipilimumab | Monoclonal antibody | 10 mg/kg | Intravenous |