MedTrace Logo

Pembrolizumab and EDP1503 in Advanced Melanoma

NCT03595683 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2025-12-08

Study results available
· View outcomes & findings →

Summary

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.

Conditions

Interventions

DRUG

Pembrolizumab

200 mg given by intravenous (IV) infusion once every 3 weeks.

BIOLOGICAL

EDP1503

Taken by mouth twice daily. Each capsule will contain ≥ 7.5x10\^10 colony-forming units (CFU).

Sponsors & Collaborators

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Evelo Biosciences, Inc.

    collaborator INDUSTRY

  • University of Chicago

    lead OTHER

Principal Investigators

  • Jason Luke, MD · University of Chicago

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-02
Primary Completion
2025-07-31
Completion
2025-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03595683 on ClinicalTrials.gov