Immune Resistance Interrogation Study

Official Title

Immune Resistance Interrogation Study

Summary:

This is a prospective research study which will include patients who have progressed on immunotherapy as their most recent line of therapy. This study aims to characterize whether patients who fail to respond to immunotherapy versus patients who respond initially but after a period of time progress demonstrate different genomic, transcriptomic, epigenetic, immunophenotyping profiles. Patients will have a one-time fresh tumour biopsy. Serial blood samples (total amount of blood drawn may not exceed the lesser of 50 mL or 3 mL/kg in an 8 week period), archival tissue (if available) and one stool sample will be collected.

Trial Description

Primary Outcome:

• Genomic changes associated with primary or acquired resistance to immunotherapy given alone or in combination in patients with advanced solid tumours
• Transcriptomic changes associated with primary or acquired resistance to immunotherapy given alone or in combination in patients with advanced solid tumours
• Immunophenotypic changes associated with primary or acquired resistance to immunotherapy given alone or in combination in patients with advanced solid tumours
• Epigenetic changes associated with primary or acquired resistance to immunotherapy given alone or in combination in patients with advanced solid tumours

Secondary Outcome:

• Genomic changes associated with subsequent anticancer therapies in patients with advanced solid tumours who have progressed on immunotherapy
• Transcriptomic changes associated with subsequent anticancer therapies in patients with advanced solid tumours who have progressed on immunotherapy
• Immunophenotyping changes associated with subsequent anticancer therapies in patients with advanced solid tumours who have progressed on immunotherapy
• Epigenetic changes associated with subsequent anticancer therapies in patients with advanced solid tumours who have progressed on immunotherapy

Although there has been some success with the use of immunotherapy treatments specifically antibodies that block the programmed death 1 receptor (PD1/L1), the majority of cancer patients either fail to respond (primary resistance) or respond initially but progress after a period of time (acquired resistance) when treated with immunotherapy agents. The hypothesis being tested is whether patients who have primary versus acquired resistance to immunotherapy demonstrate different genomic, transcriptomic, immunophenotypic and/or epigenetic profiles.

View this trial on ClinicalTrials.gov