drugset / Trial / NCT05655715

Checkpoint Inhibitors and SBRT for MCRPC

NCT05655715 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

The goal of this investigator-initiated, single-center, and randomized phase II trial is to investigate the potential synergistic effect of combining stereotactic body radiotherapy of a single soft tissue- or bone metastasis with ipilimumab and nivolumab in patients with mCRPC and perform translational analyses on tissue and blood, searching for predictive biomarkers of efficacy and toxicity. Participants will be randomized to receive ipilimumab and nivolumab with or without stereotactic body radiotherapy (SBRT).

Timeline

Start
2019-11-25
Primary completion
2024-08-30
Completion
2024-08-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Ipilimumab Monoclonal antibody 1 mg/kg Intravenous
Subject Nivolumab Monoclonal antibody 480 mg Intravenous