NCT04768504

Tofacitinib for the Treatment of Refractory Immune-related Colitis from Checkpoint Inhibitor Therapy- TRICK Study

An Open-label Study of Tofacitinib for the Treatment of Refractory Immune-related Colitis from ChecKpoint Inhibitor Therapy (TRICK)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Khashayar Esfahani · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm pilot study evaluating the efficacy and safety of tofacitinib in cancer patients with immune-related colitis from immune checkpoint inhibitor (ICI) therapy.

Detailed description

Primary objective and endpoint • Efficacy of tofacitinib in inducing clinical remission of immune related colitis, as measured by the proportion of patients who experience diarrhea resolution to grade ≤1 as per Common Terminology Criteria for Adverse Events \[CTCAE\] v5.0) without the requirement for additional immunosuppression (e.g., corticosteroids, biologics, or other immunosuppressors targeted for colitis) 8 weeks post-first dose of tofacitinib. Secondary objectives and endpoints: * Safety of tofacitinib in cancer patients with immune-related colitis, as defined by the occurrence of adverse events grade ≥3. * Efficacy of tofacitinib in cancer patients with immune colitis as defined by endoscopic remission of colitis (a total Mayo score of ≤2) at 8 weeks. * Efficacy of tofacitinib to induce a clinical remission of immune-related colitis as measured by the time, in days, necessary to achieve a diarrhea of grade ≤ 1 (as per CTCAE v 5.0). * Number of patients with tumor progression at 8 weeks per iRECIST and RECIST 1.1 criteria compared to baseline scans. Exploratory objective • The study will collect blood samples from participants seeking to characterize the inflammatory landscape of ICI-mediated colitis and biomarkers predictive of response to tofacitinib.

Conditions

• Immune-Mediated Colitis

Interventions

Type	Name	Description
DRUG	Tofacitinib 10 mg	Tofacitinib 10 mg PO BID for 30 days

Timeline

• Start date: 2022-03-22
• Primary completion: 2024-01-17
• Completion: 2024-01-17
• First posted: 2021-02-24
• Last updated: 2024-11-25

Locations

1 site across 1 country: Canada