Study of the Effects of Pembrolizumab in Patients With Advanced Solid Tumours

Official Title

Investigator-initiated Phase II Study of Pembrolizumab Immunological Response Evaluation


This is a phase 2 study whose main purpose is to evaluate gene changes and immune biomarkers in patients with solid tumours during treatment with pembrolizumab and in relation to response to treatment. Pembrolizumab is a monoclonal antibody that is designed to block a protein called programmed cell death 1 ligand 1 (PD-L1) which will allow the body's immune system to kill the cancer cells.

Trial Description

Primary Outcome:

  • Changes in genomic and immune biomarkers that will be measured in blood and tumour pre-treatment, on-treatment and at progression (progression biopsies only done for those who have complete or partial responses, or stable disease for more than 4 months)
Secondary Outcome:
  • Overall response rate
  • Changes in circulating tumour DNA genomic biomarkers
  • Changes in radiomic imaging parameters
  • Correlation between tumour genomic profiles and radiomic imaging signatures
  • Changes in immune cell subsets in the blood and tumour microenvironment
  • Positive predictive value and negative predictive value of in vitro predictive assay for Pembrolizumab response
  • Distribution of drug tumour penetration using a mass spectrometry assay
  • Baseline tumour RNA expression profile for immune inhibitory genes
  • Comparison of baseline tumour RNA expression profile for immune inhibitory genes with clinical outcome (response)
This study will involve treatment with pembrolizumab, tests and procedures done for safety, and the collection of archival tumour tissue, fresh tumour biopsies, and blood samples for biomarker research (including genetic testing).

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Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society