drugset / Trial / NCT01565837

Concurrent Ipilimumab and Stereotactic Ablative Radiation Therapy (SART) for Oligometastatic But Unresectable Melanoma

NCT01565837 ↗

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate if precisely-targeted radiation therapy, known as stereotactic ablative radiotherapy (SART), given during treatment with the drug ipilimumab (Yervoy) will improve survival for patients with melanoma that has spread to five or fewer sites (oligometastatic). Blood samples will be collected for research purposes. Planned studies include exploration of certain gene mutations and serum markers as predictors of response to ipilimumab treatment. Research lab studies will also evaluate if circulating tumor cells (CTC) can be accurately detected and isolated from the blood using novel laboratory techniques and if they are a prognostic/predictive marker for treatment response. Test results will not be given to participants or their physicians. In some cases, CTC may be grown for long-term cell lines for further research.

Timeline

Start
2012-08
Primary completion
2016-11
Completion
2017-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Ipilimumab Monoclonal antibody 10 mg/kg Intravenous

Indications