Immune Resistance Interrogation Study

Last updated: June 9, 2026
Sponsor: University Health Network, Toronto
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neoplasms

Neuroblastoma

Cancer

Treatment

N/A

Clinical Study ID

NCT04243720
IRIS
CAPCR ID
  • Ages > 18
  • All Genders

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 tumor 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with a histological or cytological diagnosis of solid malignancies, with atleast one tumor lesion amenable to core needle biopsy and consent to such aprocedure.

  • Patients must have progressed on immunotherapy (defined as anti-PD1/PD-L1 antibodiesgiven as monotherapy or as part of a combination therapy) as their most recent lineof therapy. Patients will be classified into two groups: 1) those who benefittedfrom immunotherapy with either complete response (CR), partial response (PR) orprolonged stable disease (SD) lasting at least 6 months with subsequent progressionor who had disease progression after at least 12 weeks from the last dose ofimmunotherapy in the adjuvant setting (i.e. acquired resistance), 2) those whosedisease is primary refractory to immunotherapy with disease progression at theirfirst on-treatment imaging, those who benefitted from immunotherapy with stabledisease (SD) but progressed in <6 months or those that had progressive diseaseearlier 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 anticancertherapy, 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

Exclusion Criteria:

  • Any condition that could interfere with a patient's ability to provide informedconsent such as dementia or severe cognitive impairment.

  • Any contraindication to undergoing venipuncture.

  • Any condition that, in the opinion of the Investigator, would interfere with patientsafety, or evaluation of the collected specimens and interpretation of studyresults.

Study Design

Total Participants: 100
Study Start date:
August 26, 2020
Estimated Completion Date:
June 30, 2027

Study Description

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.

Connect with a study center

  • Princess Margaret Cancer Centre

    Toronto, Ontario M5G2M9
    Canada

    Active - Recruiting

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