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Checkpoint Inhibitor
Pembrolizumab + EDP1503 for Advanced Melanoma
Phase 2
Waitlist Available
Led By Jason Luke, MD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Advanced, unresectable or metastatic melanoma
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
This trial aims to see if taking EDP1503 by mouth will improve how well standard immunotherapy (pembrolizumab) works in people with advanced melanoma. Participants will first take
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects include immune-related reactions such as inflammation in various organs, infusion reactions from pembrolizumab, fatigue, digestive issues like nausea or diarrhea from EDP1503, skin rash or itching.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My melanoma cannot be removed by surgery and has spread.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
EDP1503
2018
Completed Phase 1
~70
Find a Location
Who is running the clinical trial?
University of ChicagoLead Sponsor
1,058 Previous Clinical Trials
765,588 Total Patients Enrolled
10 Trials studying Melanoma
422 Patients Enrolled for Melanoma
Merck Sharp & Dohme LLCIndustry Sponsor
4,027 Previous Clinical Trials
5,188,795 Total Patients Enrolled
126 Trials studying Melanoma
23,231 Patients Enrolled for Melanoma
Evelo Biosciences, Inc.Industry Sponsor
10 Previous Clinical Trials
1,498 Total Patients Enrolled
Evelo BiosciencesUNKNOWN
Jason Luke, MDPrincipal InvestigatorUniversity of Chicago
3 Previous Clinical Trials
763 Total Patients Enrolled
1 Trials studying Melanoma
578 Patients Enrolled for Melanoma