drugset / Trial / NCT01689974

Phase II Randomized Trial of Ipilimumab Versus Ipilimumab and Radiotherapy in Metastatic Melanoma

NCT01689974 ↗

Phase 2 Terminated 10 enrolled NYU Langone Health
RandomizedSingle-groupOpen-labelTreatment

Summary

An attractive area of research regards immune manipulations to recover some of the patient's immune response to his/her tumor, a strategy that has the advantages of being both natural and potentially long-lasting.\[1\] We propose to combine immunotherapy with radiotherapy directed to a metastatic site, to create a "hub" for in vivo immunization to the tumor, to enable "tumor rejection" at the other metastatic sites. This "in vivo immunization" is explored as a viable alternative to an individualized vaccine approach. Preclinical data generated by us and others support a "proof of principle" clinical trial that may open the field to an alternative use of radiotherapy in a novel partnership with cancer immunotherapy.\[2\]

Timeline

Start
2013-01
Primary completion
2015-03
Completion
2015-03

Outcome

Outcome not reported

Stopped: “Study terminated because PI left institution. Planned Statistical analysis not available”

Drugs

EvaluationDrugModalityDoseRoute
Subject Ipilimumab Monoclonal antibody 3 mg/kg Intravenous

Indications