NCT02781506

Trial name or title	Nivolumab and Stereotactic Ablative Radiation Therapy versus Nivolumab Alone for Metastatic Renal Cancer.
Methods	Study design: parallel‐arm, open‐label RCT. Setting: national, phase II. Countries: US.
Participants	Main inclusion criteria: aged 18 to 100 years, either gender, pathological diagnosis of metastatic RCC with clear‐cell component, measurable disease in at least 2 non‐radiated sites, progression or intolerance to ≥ 1 prior systemic antiangiogenic therapy, ECOG Performance Status 0, 1, 2 or 3, adequate organ and marrow function. Main exclusion criteria: major surgery within 2 weeks prior to first dose; prior treatment with any anti‐PD‐1, anti‐PD‐L1, anti‐PD‐L2, anti‐CD137 or anti‐CTLA‐4 antibody or any other antibody or drug specifically targeting T‐cell costimulation or checkpoint pathways; active known or suspected autoimmune disease; history of hypersensitivity to monoclonal antibodies. Sample size planned: 87.
Interventions	Group 1: nivolumab. Group 0: nivolumab with radiation.
Outcomes	Primary outcome: ORR. Secondary outcomes: OS, PFS, safety, other.
Starting date	June 2016.
Contact information	Raquibu Hannan, MD, PhD, tel: +1 214‐645‐8525.
Notes	Contact: Jean Wu, RN, MSN, OCN.