Pilot Study of the Safety/Efficacy of Combination Checkpoint Blockade + External Beam Radiotherapy in Stage IV Melanoma
Status:
Completed
Trial end date:
2020-07-27
Target enrollment:
Participant gender:
Summary
This is an ongoing, Phase 1, open-label, multicenter, pilot study of the checkpoint
antibodies ipilimumab and nivolumab in combination with radiotherapy (RT) in 18 subjects with
unresectable Stage IV melanoma. The primary study objective is to evaluate the safety of
study treatment. Secondary objectives are to evaluate objective response rate (ORR) and
disease control rate (DCR) at Weeks 12 and 18, duration of response, progression-free
survival (PFS), and overall survival (OS).