18 and older, any sex, with Melanoma (Skin) or Melanoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Response RatePrimary· 2 years
For Cohort 1, based on deep response (\>80% tumor reduction). Assessed by standard RECIST criteria for Cohort 2 (complete + partial response).
Group
Value
95% CI
Cohort 1: Anti-PD1 Naive
0
Cohort 2: Anti-PD1 Refractory
0
Number of Participants With EPD1503 Related Adverse Events During the Run in PeriodPrimary· 2 weeks
Assessed by CTCAE v4.0, grade 3 or higher
Group
Value
95% CI
Cohort 1: Anti-PD1 Naive
0
Cohort 2: Anti-PD1 Refractory
0
Progression Free Survival (PFS)Secondary· 2 years
Time from first dose of either drug until disease progression or death from any cause. Surviving subjects without progression will be censored as of the date of the last negative examination. Estimated using the Kaplan-Meier method
Group
Value
95% CI
Cohort 1: Anti-PD1 Naive
8.6
± 0.5
Cohort 2: Anti-PD1 Refractory
2.7
± 0.7
Number of Participants With Treatment Related Adverse Events During Combination TherapySecondary· 2 years
Assessed by CTCAE v4.0, grade 3 or higher
Group
Value
95% CI
Cohort 1: Anti-PD1 Naive
1
Cohort 2: Anti-PD1 Refractory
0
Adverse events — posted to ClinicalTrials.gov
Time frame: 2 years.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem
· Phase 2, PHASE3
· not yet recruiting
NCT07275216 — Pembrolizumab in Combination With Chemotherapy for the Treatment of Frail Hodgkin Lymphoma Patients Ineligible for Stand
· Phase 2
· not yet recruiting
NCT07302347 — A Study of Pembrolizumab in Japanese Pediatric Participants With Solid Tumors or Lymphomas and Japanese Adult Participan
· Phase 1, PHASE2
· recruiting
NCT06724042 — Study of ISM5939 in Patients With Advanced and/or Metastatic Solid Tumors
· Phase 1
· not yet recruiting
NCT07383441 — Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer
· Phase 3
· not yet recruiting
Other recruiting trials for Melanoma (Skin)
Currently open trials in the same condition.
NCT06643286 — Evaluation of a Personalised Survivorship Care Plan App for Patients With Melanoma
· NA
· recruiting
NCT06298734 — High-Intensity Exercise and High-Fiber Diet for Immunotherapy Outcomes in Melanoma Patients: The DUO Trial
· NA
· recruiting
NCT05704647 — Phase II Study of Nivolumab in Combination With Relatlimab in Patients With Active Melanoma Brain Metastases
· Phase 2
· recruiting
NCT05492682 — START: Safety and Anti-Tumor Activity of PeptiCRAd-1 in Treatment of Cancer
· Phase 1
· active not recruiting
NCT05649683 — Immunological Functionnal Test Validation to Predict Melanoma Metastatic Patient Response to Checkpoint Inhibitors
· NA
· recruiting
Other University of Chicago trials
Trials by the same sponsor.
NCT07346196 — A Trial of Locoregionally Advanced Squamous Cell Carcinoma of The Head and Neck
· Phase 2
· not yet recruiting
NCT07354100 — Lactulose to Improve Gut Health in Cancer Patients Receiving Immunotherapy
· Phase 1, PHASE2
· not yet recruiting
NCT06446661 — Using Text Messages to Improve Oral Chemotherapy for Adolescents and Adults With Acute Lymphoblastic Leukemia
· NA
· not yet recruiting
NCT07179315 — A Study Comparing Two Immunotherapy Options for Human Papillomavirus Positive HPV-Positive Head and Neck Cancer After Tr
· Phase 2
· not yet recruiting
NCT07126561 — Trastuzumab Deruxtecan to Treat HER2 + Newly Diagnosed Metastatic GI Cancers
· Phase 2
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Chicago
Last refreshed: 8 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03595683.