Pembrolizumab and EDP1503 in Advanced Melanoma

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT03595683
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    200 mg given by intravenous (IV) infusion once every 3 weeks.
  • EDP1503 — BIOLOGICAL
    Taken by mouth twice daily. Each capsule will contain ≥ 7.5x10\^10 colony-forming units (CFU).

Study Details

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.

Key Dates

Start date
Oct 2, 2018
Status verified
Dec 2025
Primary completion
Jul 31, 2025
Completion
Jul 31, 2025

Study Design

Enrollment
8 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: Anti-PD1 naive
    Participants that have not received prior anti-PD1 therapy for their cancer will be enrolled to this arm.
  • Experimental: Cohort 2: Anti-PD1 refractory
    Participants that have received prior anti-PD1 therapy for their cancer will be enrolled to this arm.

Primary Outcome Measure

Response Rate [ Time Frame: 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Chicago Medical CenterChicagoIllinois60637-

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Find similar trials in Chicago, IL

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
University of Chicago Medical Center· Chicago, IL

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