A Phase II Proof of Principle Study of the Activity of Pembrolizumab (MK-3475) in Combination With SBRT in Primary Tyrosine Kinase Inhibitor (TKI) Refractory Metastatic Kidney Cancer (mRCC) Patients
This study is designed as a phase-II proof of concept trial to investigate if a treatment
strategy where stereotactic body radiation therapy (SBRT) is given with pembrolizumab is
sufficiently active to warrant further investigation in randomized phase II or III studies.
Metastatic renal cell cancer (mRCC) patients with PD-1 expressing immune cells are more
likely to have larger more aggressive tumours and reduced survival and renal tumours that
express PD-L1 are more aggressive with poorer outcome. Blocking this receptor/ligand
interaction with monoclonal antibodies can restore the activity of tumour specific T-cells
within the tumour with durable responses documented in early clinical trials in several
tumour types including renal cell carcinoma. The study drug pembrolizumab is designed to
directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. SBRT will be
given to the 1-3 most clinically significant lesions at the time of progression on
pembrolizumab or at the 2nd course of pembrolizumab treatment in an effort to improve the
activity of pembrolizumab. A total of 35 patients refractory to the approved first line
therapy with a targeted drug (Sunitinib or Pazopanib) will be enrolled on study. This group
of patient has a poor outcome on any other 2nd line therapy and urgently need novel therapy.
View this trial on ClinicalTrials.gov
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