drugset / Trial / NCT03469713

Nivolumab Plus Stereotactic Body Radiotherapy in II and III Line of Patients With Metastatic Renal Cell Carcinoma

NCT03469713 ↗

Phase 2 Completed 69 enrolled Italian Oncology Group for Clinical Research
NaSingle-groupOpen-labelTreatment

Summary

NIVES study is an ongoing phase II, single arm, multicenter study. In this trial pts received SBRT to one non-brain measurable lesion and concomitant NIVOLUMAB, an anti-programmed cell death (PD-1). Combining SBRT with NIVO may enhance the antitumor immune responses and improve clinical outcomes, how it was demonstrated for other solid tumors with a phenomenon known as the abscopal effect . It was planned to enrolled a total of 68 pts within 12 months. The objective of the current analysis is to describe the first report of safety profile of NIVO in combination with SBRT.

Timeline

Start
2017-07-14
Primary completion
2019-03-04
Completion
2021-07-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Nivolumab Monoclonal antibody 240 mg Intravenous
Subject Nivolumab Monoclonal antibody 480 mg Intravenous

Indications