Study of the Effects of Pembrolizumab in Patients With Advanced Solid Tumors (INSPIRE)
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|ClinicalTrials.gov Identifier: NCT02644369|
Recruitment Status : Active, not recruiting
First Posted : December 31, 2015
Last Update Posted : November 26, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Squamous Cell Cancer of Head and Neck Triple Negative Breast Cancer Epithelial Ovarian Cancer Malignant Melanoma Advanced Solid Tumors||Biological: Pembrolizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Investigator-initiated Phase II Study of Pembrolizumab Immunological Response Evaluation|
|Actual Study Start Date :||March 21, 2016|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||June 2021|
Pembrolizumab will be given by intravenous infusion (IV, given by vein) at a dose of 200 mg, once every 3 weeks.
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.
- 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) [ Time Frame: 5 years ]T-test or Wilcoxon's test
- Overall response rate [ Time Frame: 5 years ]
- Changes in circulating tumor DNA genomic biomarkers [ Time Frame: 5 years ]
- Changes in radiomic imaging parameters [ Time Frame: 5 years ]
- Correlation between tumor genomic profiles and radiomic imaging signatures [ Time Frame: 5 years ]
- Changes in immune cell subsets in the blood and tumor microenvironment [ Time Frame: 5 years ]
- Positive predictive value and negative predictive value of in vitro predictive assay for Pembrolizumab response [ Time Frame: 5 years ]
- Distribution of drug tumor penetration using a mass spectrometry assay [ Time Frame: 5 years ]
- Baseline tumor RNA expression profile for immune inhibitory genes [ Time Frame: 5 years ]
- Comparison of baseline tumor RNA expression profile for immune inhibitory genes with clinical outcome (response) [ Time Frame: 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02644369
|Princess Margaret Cancer Centre|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||Lillian Siu, M.D.||Princess Margaret Cancer Centre|