Etrasimod + Corticosteroids for Colitis

Recruiting in Palo Alto (17 mi)

Overseen byHarriet Kluger, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Yale University

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This is a randomized, double-blind, placebo-controlled, two-arm phase 2 study of etrasimod plus corticosteroids versus placebo plus corticosteroids for the treatment of IMDC CTCAE v5.0 grade ≥ 2 due to ICI therapy alone (α-PD-(L)1 monotherapy or combined with another ICI, such as α-CTLA-4 or α-LAG-3) or ICI plus an oral tyrosine kinase inhibitor that in the opinion of the treating physician requires treatment with corticosteroid-based immunosuppression and does not require immediate secondary immune suppression, such as vedolizumab or infliximab (or equivalent). IMDC is one of the most common Immune Related Adverse Events (irAEs) from treatment with ICI. Current guidelines recommend steroid treatment for IMDC CTCAE grade ≥ 2, which requires temporary or permanent cessation of ICI therapy. Corticosteroids may interfere with the anti-tumor activity of ICIs and are therefore not co-administered. Strategies are needed to both reduce the dose and duration of corticosteroids needed for IMDC treatment and minimize the duration off ICI therapy before re-administering ICI (for those patients in whom it is deemed safe to rechallenge).

Research Team

Harriet Kluger, MD

Principal Investigator

Yale University

Eligibility Criteria

This trial is for patients with grade ≥2 diarrhea and colitis caused by immune checkpoint inhibitors, used alone or with other treatments. Participants must need corticosteroid treatment but not immediate intense immunosuppression.

Inclusion Criteria

My cancer cannot be removed by surgery and has spread.

I need steroids for severe diarrhea and colitis.

I am willing and able to follow the study's medication and requirements.

See 9 more

Exclusion Criteria

I have a confirmed gut infection from a stool test.

I have had serious infections or widespread herpes.

Active psychiatric problems that could interfere with compliance with the study procedures

See 20 more

Treatment Details

Interventions

Etrasimod (Sphingosine-1-phosphate receptor modulator)

Trial OverviewThe study tests if etrasimod plus corticosteroids can better manage Immune Checkpoint Inhibitor Diarrhea and Colitis than a placebo plus corticosteroids, potentially reducing the total steroids needed.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Etrasimod plus corticosteroidsExperimental Treatment2 Interventions

Participants will receive Etrasimod plus corticosteroids, to be given up to 120 days, to treat IMDC.

Group II: Placebo plus corticosteroidsPlacebo Group2 Interventions

Participants will receive Placebo plus corticosteroids, to be given up to 120 days, to treat IMDC.