Immune Resistance Interrogation Study

Launched by UNIVERSITY HEALTH NETWORK, TORONTO · Jan 23, 2020

Keywords

ClinConnect Summary

**Summary of the Immune Resistance Interrogation Study**

The Immune Resistance Interrogation Study is a research project looking at why some cancer patients do not respond to immunotherapy, which is a treatment that helps the body's immune system fight cancer. This study focuses on patients who have shown signs that their cancer is getting worse after receiving immunotherapy. Researchers want to understand the differences in the genetic and immune profiles of patients who do not respond at all compared to those who initially respond but later see their cancer progress. To do this, participants will provide a fresh tumor biopsy, blood samples, and a stool sample, helping scientists learn more about the reasons behind immune resistance in cancer treatment.

To be eligible for this study, participants must be at least 18 years old and diagnosed with solid tumors. They should have had immunotherapy as their most recent treatment and must meet specific criteria about their response to that treatment. Participants will also need to give informed consent, meaning they agree to join the study after understanding what it involves. Those who take part can expect to undergo a one-time biopsy and provide some blood samples over an eight-week period. It’s important to note that this study is currently recruiting participants, and it aims to gather valuable information that could improve future cancer treatments.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with a histological or cytological diagnosis of solid malignancies, with at least one tumor lesion amenable to core needle biopsy and consent to such a procedure.
• • Patients must have progressed on immunotherapy (defined as anti-PD1/PD-L1 antibodies given as monotherapy or as part of a combination therapy) as their most recent line of therapy. Patients will be classified into two groups: 1) those who benefitted from immunotherapy with either complete response (CR), partial response (PR) or prolonged stable disease (SD) lasting at least 6 months with subsequent progression or who had disease progression after at least 12 weeks from the last dose of immunotherapy in the adjuvant setting (i.e. acquired resistance), 2) those whose disease is primary refractory to immunotherapy with disease progression at their first on-treatment imaging, those who benefitted from immunotherapy with stable disease (SD) but progressed in \<6 months or those that had progressive disease earlier than 12 weeks from the last dose of immunotherapy in the adjuvant setting.
• • Patients must be of good performance status, ECOG 0-1, for subsequent anticancer therapy, with either standard treatment or within the context of a clinical trial.
• • Patients must be ≥ 18 years old.
• • Patients must have provided voluntary written informed consent.
• Exclusion Criteria:
• • Any condition that could interfere with a patient's ability to provide informed consent such as dementia or severe cognitive impairment.
• • Any contraindication to undergoing venipuncture.
• • Any condition that, in the opinion of the Investigator, would interfere with patient safety, or evaluation of the collected specimens and interpretation of study results.