OncoMatch/Clinical Trials/NCT05024318
NeoAdjuvant Pembrolizumab and STEreotactic Radiotherapy Prior to Nephrectomy for Renal Cell Carcinoma
Is NCT05024318 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Pembrolizumab for renal cell carcinoma, clear cell, somatic.
Treatment: Pembrolizumab — This is a prospective, open label, phase II, randomised, non-comparative clinical trial, evaluating changes in tumour-responsive T-cells following neoadjuvant stereotactic ablative body radiotherapy (SABR) with or without pembrolizumab, prior to nephrectomy, in patients with localised primary clear cell renal cell carcinoma (ccRCC).
Check if I qualifyExtracted eligibility criteria
Cancer type
Renal Cell Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-PD-1/PD-L1/PD-L2 or immune-regulatory antibody
Had prior treatment with any anti-PD-1, or anti-PD-L1, or PD-L2 agent or with an antibody targeting any other immune-regulatory receptors or mechanisms. Examples of such antibodies include antibodies against IDO, PD-L1, IL-2R, and GITR
Cannot have received: radiotherapy
Exception: previous radiotherapy to the upper abdomen with radiation dose overlap to the involved kidney
Previous radiotherapy to the upper abdomen with radiation dose overlap to the involved kidney
Cannot have received: investigational agent/device
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to randomisation
Lab requirements
Blood counts
WBC ≥ 3 X 10^9/L; ANC ≥1.5 X 10^9/L; Platelets ≥ 100 X 10^9/L; Haemoglobin ≥ 100 g/L independent of transfusion
Kidney function
Serum Creatinine ≤1.5 X ULN or measured or calculated CrCl ≥ 30 ml/min; GFR can also be used in place of serum creatinine or CrCl
Liver function
Total bilirubin ≤1.5 X ULN except for patients with known Gilbert's Syndrome; AST and ALT ≤1.5 X ULN; Albumin > 30 g/L
Patients must have adequate bone marrow, hepatic and renal function documented within 28 days prior to randomisation
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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