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Pembrolizumab and EDP1503 in Advanced Melanoma | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Pembrolizumab and EDP1503 in Advanced Melanoma

Phase II Dual-Cohort Study Evaluating the Effects of Pembrolizumab in the Presence of Gut Microbiota Modulation With EDP1503 in Advanced Melanoma Naïve or Refractory to Anti-PD1 Antibody

NCT03595683•University of Chicago

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Advanced, unresectable or metastatic melanoma
•Be willing and able to provide written informed consent/assent for the trial.
•Aged 18 years or older on day of signing informed consent.
•Have measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
•Be naïve to exposure in the metastatic setting to PD1/L1 antibody for cohort 1 but have had exposure to PD1/L1 (or PD1/L1 combination therapy) in cohort 2. Prior exposure to CTLA4 antibody in the metastatic setting is not allowed for cohort 1 though exposure in the adjuvant setting is allowed for either cohort. To be eligible for cohort 2, and considered refractory to PD1/L1, a patient must have had a restaging exam showing progressive disease at least 90 days following initiation of anti-PD1/L1 as prior therapy.
•* Adjuvant therapy with BRAF-MEK, PD1 or CTLA4 based therapy is allowed. Prior adjuvant BRAF-MEK therapy will fulfill treatment requirement in the metastatic setting. Patients who experience progression of disease during adjuvant PD1 therapy or within 6 months of completing adjuvant PD1 therapy will be considered refractory and thus eligible for cohort 1. Patients with progression to active metastatic disease more than 6 months following completion of adjuvant PD1 therapy will be eligible for cohort 1.
•Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
•Demonstrate adequate organ function as defined in Table 1, all screening labs should be performed within 14 days of study initiation.
•Adequate Organ Function Laboratory Values
•* Absolute neutrophil count (ANC) ≥1,500 /mcL
+9 more criteria

Exclusion Criteria

•For cohort 2: Has BRAF mutant disease but has not yet received treatment with RAF/MEK inhibitors. This criteria can be met via adjuvant treatment with BRAF-MEK inhibitors
•Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 2 weeks of the first dose.
•Is currently taking Bifidobacterium based probiotics or is taking pre/pro-biotics regularly.
•Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose.
•Has a known history of active Bacillus Tuberculosis (TB)
•Hypersensitivity to pembrolizumab or any of its excipients.
•Has had a prior anti-cancer monoclonal antibody (mAb) within 3 weeks prior to study Day 1 (excluding anti-PD1 antibodies such as pembrolizumab or nivolumab in cohort 2) or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
•Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
•* Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
•* Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
+11 more criteria

Locations (1)

University of Chicago Medical Center

Chicago, Illinois, United States

Key Dates

Start Date

October 2, 2018

Primary Completion Date

July 31, 2025

Completion Date

July 31, 2025

Last Updated

December 8, 2025

Enrollment

ACTUAL participants

Conditions

Melanoma (Skin)Melanoma

Interventions

Pembrolizumab

DRUG

EDP1503

BIOLOGICAL

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 8, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Pembrolizumab and EDP1503 in Advanced Melanoma

Inclusion Criteria

Exclusion Criteria

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

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