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Immune Resistance Interrogation Study (IRIS)

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ClinicalTrials.gov Identifier: NCT04243720
Recruitment Status : Recruiting
First Posted : January 28, 2020
Last Update Posted : October 20, 2020
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Tracking Information
First Submitted Date January 20, 2020
First Posted Date January 28, 2020
Last Update Posted Date October 20, 2020
Actual Study Start Date August 26, 2020
Estimated Primary Completion Date February 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 23, 2020)
  • Genomic changes associated with primary or acquired resistance to immunotherapy given alone or in combination in patients with advanced solid tumors [ Time Frame: Through study completion, up to 4 years ]
  • Transcriptomic changes associated with primary or acquired resistance to immunotherapy given alone or in combination in patients with advanced solid tumors [ Time Frame: Through study completion, up to 4 years ]
  • Immunophenotypic changes associated with primary or acquired resistance to immunotherapy given alone or in combination in patients with advanced solid tumors [ Time Frame: Through study completion, up to 4 years ]
  • Epigenetic changes associated with primary or acquired resistance to immunotherapy given alone or in combination in patients with advanced solid tumors [ Time Frame: Through study completion, up to 4 years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 23, 2020)
  • Genomic changes associated with subsequent anticancer therapies in patients with advanced solid tumors who have progressed on immunotherapy [ Time Frame: Through study completion, up to 4 years ]
  • Transcriptomic changes associated with subsequent anticancer therapies in patients with advanced solid tumors who have progressed on immunotherapy [ Time Frame: Through study completion, up to 4 years ]
  • Immunophenotyping changes associated with subsequent anticancer therapies in patients with advanced solid tumors who have progressed on immunotherapy [ Time Frame: Through study completion, up to 4 years ]
  • Epigenetic changes associated with subsequent anticancer therapies in patients with advanced solid tumors who have progressed on immunotherapy [ Time Frame: Through study completion, up to 4 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 23, 2020)
  • Radiomic changes associated with primary or acquired resistance to immunotherapy given alone or in combination in patients with advanced solid tumors [ Time Frame: Through study completion, up to 4 years ]
  • Radiomic changes associated with subsequent anticancer therapies in patients with advanced solid tumors who have progressed on immunotherapy [ Time Frame: Through study completion, up to 4 years ]
  • Fecal microbiome changes associated with primary or acquired resistance to immunotherapy given alone or in combination in patients with advanced solid tumors [ Time Frame: Through study completion, up to 4 years ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Immune Resistance Interrogation Study
Official Title Immune Resistance Interrogation Study
Brief 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:

Peripheral blood samples collected serially for DNA extraction under the LIBERATE protocol.

Archived tumor sample (if available) collected for DNA extraction. Fresh tumor biopsy sample (if available) collected for DNA extraction. Stool sample (if available) collected for DNA extraction.

Sampling Method Non-Probability Sample
Study Population Patients with a diagnosis of solid tumor malignancy who progressed on immunotherapy as their most recent line of therapy.
Condition
  • Cancer
  • Solid Tumor
  • Metastatic Cancer
  • Immune Resistance
Intervention Not Provided
Study Groups/Cohorts IRIS
Patients with a histological or cytological diagnosis of solid malignancies. Patients must have progressed on immunotherapy as their most recent line of therapy.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 23, 2020)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 2024
Estimated Primary Completion Date February 2024   (Final data collection date for primary outcome measure)
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) defined as > 6 months with subsequent progression (i.e. acquired resistance), 2) those whose disease is primary refractory to immunotherapy with disease progression on first on-treatment imaging.
  • 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Celeste Yu 416-946-4501 ext 5281 celeste.yu@uhn.ca
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT04243720
Other Study ID Numbers IRIS
CAPCR ID ( Other Identifier: 19-6224 )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party University Health Network, Toronto
Study Sponsor University Health Network, Toronto
Collaborators Not Provided
Investigators
Principal Investigator: Lillian Siu, MD Princess Margaret Cancer Centre
Principal Investigator: Anna Spreafico, MD Princess Margaret Cancer Centre
PRS Account University Health Network, Toronto
Verification Date October 2020