Pembrolizumab + EDP1503 for Advanced Melanoma

Recruiting in Palo Alto (17 mi)

Overseen byJason Luke, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Chicago

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?This study is being done to determine if orally administered EDP1503 will enhance the response to standard immunotherapy treatment (pembrolizumab) in participants with advanced melanoma. The study will involve initial administration of EDP1503 for a run-in period (2 weeks) followed by administration of both EDP1503 (twice daily) and pembrolizumab (every 3 weeks). Mandatory biopsies are required before starting study treatment and after 2 weeks of EDP1503 dosing.

Eligibility Criteria

This trial is for adults with advanced melanoma that can't be surgically removed or has spread. Participants must have measurable disease, may or may not have had prior PD1/L1 antibody treatment depending on the cohort, and should not have received CTLA4 antibodies in a metastatic setting. They need to function well daily (ECOG 0-1) and show good organ function.

Inclusion Criteria

My melanoma cannot be removed by surgery and has spread.

Be willing and able to provide written informed consent/assent for the trial.

I've had specific immune or targeted therapy for my cancer and it has progressed.

+7 more

Participant Groups

The study tests if EDP1503 taken orally enhances the effect of pembrolizumab, an immunotherapy drug. Initially, only EDP1503 is given for two weeks; then both drugs are administered together—EDP1503 twice daily and pembrolizumab every three weeks—with required biopsies before and after the run-in period.

2Treatment groups

Experimental Treatment

Group I: Cohort 2: Anti-PD1 refractoryExperimental Treatment2 Interventions

Participants that have received prior anti-PD1 therapy for their cancer will be enrolled to this arm.

Group II: Cohort 1: Anti-PD1 naiveExperimental Treatment2 Interventions

Participants that have not received prior anti-PD1 therapy for their cancer will be enrolled to this arm.

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

🇺🇸 Approved in United States as KEYTRUDA for: