Interrogation of Biomarkers in Patient Samples from a Phase Ib Trial of the Immune Checkpoint Inhibitor, Avelumab, in Combination with SMAC Mimetic Debio1143
Key Information
Who may qualify?
- Patients with advanced solid malignancies who are not eligible for standard therapy or for whom standard therapy has failed
- Patients with histologically or cytologically confirmed NSCLC of stage IIIB or IV (per 7th International Association for the Study of Lung Cancer classification) that has progressed after one line of platinum containing doublet chemotherapy
- For full inclusion criteria, please click the link at the bottom of the page
Recruitment status
- Active; recruiting
Key words
- solid tumours, Debio1143, Avelumab, nonsmall cell lung cancer, NSCLC, immune checkpoint inhibitors
About the Trial
Recently, immunotherapy with immune checkpoint inhibitors (ICI) has profoundly impacted the management of many different cancers. While there is substantial clinical data to support ICI’s usefulness in extending survival, this is variable across and within tumor types. Combination immunotherapy is an accepted future direction for improving outcomes but without appropriate predictive biomarkers, testing combinations of agents remains theoretical with little chance of success. Furthermore, given the very high cost of approved ICIs, tailoring them to patients who will benefit is of utmost importance; especially in the context of a Canadian public health care system. Therefore, research characterizing the molecular and immunological profiles of tumors to identify the relevant indicators of efficacy will be clinically, scientifically, and economically beneficial.
To execute the above strategy, the investigators have initiated a Canada-wide collaboration of scientists and clinicians, who each contribute expertise to the focus areas of immunology, genetics and programmed cell death. Collaborators include network investigators in three BioCanRx core facilities dedicated to genomic sequencing and immune cell characterization. Within these three fields of interest, we intend to characterize tumours, interrogate efficacy biomarkers and evaluate changes in biology upon exposure to drug in tumour samples from an ongoing Phase I clinical trial of SMAC mimetic Debio1143 with ICI Avelumab in patients with solid tumors and non-small cell lung cancer (NSCLC). Our assembled team of internationally renowned researchers have the experience and drive to guarantee this project’s success.
(https://bit.ly/2OsfEVq)
Clinical Trial #: NCT03270176
