Phase II Trial of Stereotactic Body Radiotherapy Followed by Ipilimumab in Treating Patients With Stage IV Melanoma

Summary

This phase II trial studies how well stereotactic body radiotherapy and ipilimumab work in treating patients with stage IV melanoma. Stereotactic body radiotherapy (SBRT) may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Monoclonal antibodies, such as ipilimumab, target certain cells to interfere with the ability of tumor cells to grow and spread. Giving SBRT with ipilimumab may kill more tumor cells.

Timeline

Start

2014-03

Primary completion

2018-11-03

Completion

2019-06-21

Outcome

Missed primary endpoint

Stopped: “Change in standard of care”

registry analysis (superiority test); Immune Naive vs Immune Resistant; p = 0.67; Log Rank NCT01970527 ↗

registry analysis (superiority test); Immune Naive vs Immune Resistant; p = 0.71; Log Rank NCT01970527 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ipilimumab	Monoclonal antibody	—	Intravenous

Indications