Trials / Terminated
TerminatedNCT03595683
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
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 8 (actual)
- Sponsor
- University of Chicago · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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). |
Timeline
- Start date
- 2018-10-02
- Primary completion
- 2025-07-31
- Completion
- 2025-07-31
- First posted
- 2018-07-23
- Last updated
- 2025-12-08
- Results posted
- 2025-12-08
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03595683. Inclusion in this directory is not an endorsement.