Tofacitinib for the Treatment of Refractory Immune-related Colitis from Checkpoint Inhibitor Ther… (NCT04768504) | Clinical Trial Compass
TerminatedPhase 2
Tofacitinib for the Treatment of Refractory Immune-related Colitis from Checkpoint Inhibitor Therapy- TRICK Study
Stopped: sponsor decision, due to low recruitment rate
Canada2 participantsStarted 2022-03-22
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 18 years of age or older.
✓. Able to provide informed consent.
✓. Diagnosis of a solid tumor treated with an immune checkpoint inhibitor (ICI), with the exception of colorectal cancer.
✓. Exposure to an ICI (CTLA-4, PD-1, PDL-1) as part of a cancer treatment regimen within 6 months of the onset of colitis symptoms. The ICI may be used as a single agent, or in combination with other ICIs, or with chemotherapy.
✓. Current diagnosis of immune-related colitis characterized by grade ≥ 2 diarrhea as per CTCAE v5.0.
✓. Patients should have failed corticosteroids (at least 1mg/kg equivalent of prednisone for a minimum of 72 hours), and at least one dose of a biologic agent (i.e. either a TNFα inhibitor or an anti-integrin). Failure is defined as having ongoing grade ≥ 2 diarrhea per CTCAE v5.0.
✓. Adequate hematological function, defined by:
✓. hemoglobin ≥ 90 g/L
Exclusion criteria
✕. Diagnosis of a thromboembolic event (deep vein thrombosis, pulmonary embolism, embolic stroke, myocardial infarction, or peripheral arterial insufficiency) within 3 months of enrollment.
✕. Diagnosis of concomitant infectious colitis (e.g. C. difficile or other bacterial source), unless the patient has finished an appropriate length of treatment with antibiotics as indicated for each diagnosis at the time of enrollment.
. Any other grade ≥ 3 infection at the time of enrollment.
✕. Prior therapy with a JAK inhibitor within 3 months preceding enrollment.
✕. Use of strong inducers of CYP3A4 within 7 days of starting treatment with tofacitinib (see appendix 3).
✕. Known allergy or hypersensitivity to tofacitinib, its excipients or any of the drugs used in this study (valacyclovir, heparin, trimethoprim and sulfonamides).
✕. Active pregnancy or breastfeeding.
✕. Patients on intravenous biologic agents for other baseline autoimmune conditions.