This is a phase 2 study whose main purpose is to evaluate gene changes and immune biomarkers in patients with solid tumors 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.
This study will involve treatment with pembrolizumab, tests and procedures done for safety, and the collection of archival tumor tissue, fresh tumor biopsies, and blood samples for biomarker research (including genetic testing).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Pembrolizumab is a potent and highly selective humanized monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2.
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Changes in genomic and immune biomarkers that will be measured in blood and tumor 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)
T-test or Wilcoxon's test
Time frame: 5 years
Overall response rate
summary statistics
Time frame: 5 years
Changes in circulating tumor DNA genomic biomarkers
T-test or Wilcoxon's test
Time frame: 5 years
Changes in radiomic imaging parameters
T-test or Wilcoxon's test
Time frame: 5 years
Correlation between tumor genomic profiles and radiomic imaging signatures
Pearson correlation coefficients, chi-square tests, one- or two-sample t-tests or logistic regression analyses as appropriate. Non-parametric tests such as Spearman correlation coefficients, Fisher's exact tests and Wilcoxon rank sum tests may be substituted if necessary.
Time frame: 5 years
Changes in immune cell subsets in the blood and tumor microenvironment
T-test or Wilcoxon's test
Time frame: 5 years
Positive predictive value and negative predictive value of in vitro predictive assay for Pembrolizumab response
Positive predictive value and negative predictive value
Time frame: 5 years
Distribution of drug tumor penetration using a mass spectrometry assay
summary statistics
Time frame: 5 years
Baseline tumor RNA expression profile for immune inhibitory genes
summary statistics
Time frame: 5 years
Comparison of baseline tumor RNA expression profile for immune inhibitory genes with clinical outcome (response)
T-test or Wilcoxon's test
Time frame: 5 years
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