Prospective Analysis of Intestinal Microbiome and Autoimmune Panels as Predictors of Toxicity in ImmunOncology Patients

NCT04107311 | Recruiting

• 1 other identifier: INSPECT-IO-001
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, investigator-initiated, non-interventional study evaluating the role of the intestinal microbiome and autoimmune panels as a predictor for developing ≥ Grade 2 CTCAE v5.0 immune-related adverse event (irAE) and/or requiring systemic immunosuppression for irAEs in advanced solid tumor patients receiving immunooncology (IO) combinations at the Princess Margaret Cancer Centre. This is a minimal risk study involving the analysis of patient samples and does not involve therapeutic intervention. The study will involve a prospective cohort of up to 120 patients and it is anticipated that patient accrual will be completed within 18 months. Patients will receive IO combination as per their specific protocols from their other clinical trial or per their standard of care and samples will be collected at multiple time-points. No additional visits to the hospital will be needed for this study as safety assessments are already captured for all patients based on their participation in a clinical trial or per their standard of care.

Conditions

Solid Tumor

Keywords

solid tumor; immunooncology

Outcome Measures

Primary Outcomes (1)

• Feasibility of evaluating intestinal microbiome composition and autoimmune panels in patients treated with immunooncology combinations through the analysis of stool and blood samples at multiple time-points.

  To assess the feasibility, the endpoint will be deemed feasible if \>50% of patients have biospecimens collected in at least 2 time-points.

  18 months

Secondary Outcomes (7)

• Correlation between baseline intestinal microbiome composition to the development of ≥ Grade 2 CTCAE v5.0 irAEs and/or requiring systemic immunosuppression for irAEs.

  18 months

• Correlation between baseline autoimmune panels to the development of ≥ Grade 2 CTCAE v5.0 irAEs and/or requiring systemic immunosuppression for irAEs.

  18 month

• Correlation between baseline fecal calprotectin levels to the development of ≥ Grade 2 CTCAE v5.0 colitis and/or requiring systemic immunosuppression for colitis.

  18 months

• Correlation between the early changes in composition of intestinal microbiome and the development of ≥ Grade 2 CTCAE v5.0 irAEs and/or requiring systemic immunosuppression for irAEs.

  18 months

• Correlation between the early changes in composition of autoimmune panels and the development of ≥ Grade 2 CTCAE v5.0 irAEs and/or requiring systemic immunosuppression for irAEs.

  18 months

Other Outcomes (12)

• Evaluate the overall response rate (ORR) of the enrolled cohort measured by RECIST v1.1 and iRECIST.

  18 months

• Evaluate the median progression-free survival (PFS) of the enrolled cohort measured by RECIST v1.1 and iRECIST.

  18 months

• Correlation between the baseline composition of the intestinal microbiome with PFS.

  18 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Advanced solid tumor patients receiving immunooncology combinations

You may qualify if:

• Signed written and voluntary informed consent.
• Patient must be willing and able to provide collection for blood and stool specimen analysis at the pre-specified time-points.
• Age \> 18 years, male or female.
• Patient must be diagnosed with any advanced solid tumor deemed incurable and to be treated at Princess Margaret Cancer Centre.
• Patients must be eligible to treatment with an IO combination.

You may not qualify if:

• Any conditions that in the opinion of the Investigator would interfere with patient safety, or evaluation of the collected specimen and interpretation of study result.
• History of autoimmune disease with a flare episode within one year before study screening.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

Related Publications (1)

• Genta S, Lajkosz K, Yee NR, Spiliopoulou P, Heirali A, Hansen AR, Siu LL, Saibil S, Stayner LA, Yanekina M, Sauder MB, Keshavarzi S, Salawu A, Vornicova O, Butler MO, Bedard PL, Razak ARA, Rottapel R, Chruscinski A, Coburn B, Spreafico A. Autoimmune PaneLs as PrEdictors of Toxicity in Patients TReated with Immune Checkpoint InhibiTors (ALERT). J Exp Clin Cancer Res. 2023 Oct 21;42(1):276. doi: 10.1186/s13046-023-02851-6.

  PMID: 37865776 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Stool and blood samples at multiple time-points in patients undergoing treatment with immunooncology (IO) combination therapy.

Study Officials

• Anna Spreafico, MD

  Princess Margaret Cancer Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Spreafico, MD

CONTACT

416-946-4501; tip@uhn.ca

Aileen Trang

CONTACT

416-946-4501; aileen.trang@uhn.ca

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2019
• First Posted: September 27, 2019
• Study Start: September 5, 2019
• Primary Completion (Estimated): March 5, 2027
• Study Completion (Estimated): March 5, 2027
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)