Brief Summary

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).

Conditions

• Renal Cell Carcinoma, Clear Cell, Somatic

Intervention / Treatment

• Drug: Pembrolizumab
• Radiation: Stereotactic Ablative Radiotherapy
• Procedure: Nephrectomy

Primary Outcome Measures

• mPR post-SABR with or without pembrolizumab (At nephrectomy performed 9-12 weeks after first dose of pembrolizumab)
  The mPR rate is defined as \<10% residual tumour at post-nephrectomy specimens
• CD8+ TRM in baseline biopsy and post-nephrectomy specimen, all measured as a continuous variable. (Baseline and at nephrectomy performed 9-12 weeks after first dose of pembrolizumab)
  To describe changes in tumour-responsive T-cells, TRM CD8+ T-cells from baseline to post-nephrectomy in patients treated with SABR with or without pembrolizumab treatment followed by nephrectomy
• TCF-1 + tumour infiltrating lymphocytes (TILs) in baseline biopsy and post-nephrectomy specimen, measured as a continuous variable (Baseline and at nephrectomy performed 9-12 weeks after first dose of pembrolizumab)
  To describe changes in TCF-1+ T-cells from baseline to post-nephrectomy in patients treated with SABR with or without pembrolizumab treatment followed by nephrectomy

Countries

Australia

Locations and Investigators

• Princess Alexandra Hospital, Woolloongabba, Australia (Recruiting)
  • David Pryor
• Peter MacCallum Cancer Centre, Melbourne, Australia (Recruiting)
  • Shankar Siva, A/Prof
  • Arun Azad, A/Prof

Study Officials

• Shankar Siva, A/Prof (Study Chair) — Peter MacCallum Cancer Centre, Australia