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NeoAdjuvant Pembrolizumab and STEreotactic Radiotherapy Prior to Nephrectomy for Renal Cell Carcinoma: Investigating Induced Immune Context Changes
Other Non-Commercial Sponsor
Peter MacCallum Cancer Centre
Eligible participants will be randomly allocated to either the Active Comparator Arm or the Experimental Arm. In the Active Comparator Arm, participants will receive Stereotactic Ablative Radiotherapy (SABR) plus nephrectomy (surgical removal of the kidney). SABR will be prescribed at a dose of 42Gy in 3 fractions. All radiation therapy treatment will be completed within 3 weeks. Participants will then undergo nephrectomy within 9-12 weeks after the first dose of treatment. In the Experimental Arm, participants will receive pembrolizumab followed by SABR plus nephrectomy. Pembrolizumab (200mg, flat dose) will be administered as a 30 minute intravenous infusion every 21 days for 3 cycles. Participants will receive 1 cycle of pembrolizumab prior to SABR followed by an additional 2 cycles of pembrolizumab (1 cycle is 21 days). Participants will then undergo nephrectomy 9-12 weeks after beginning treatment.