A Study of Epacadostat in Combination With Pembrolizumab and Chemotherapy in Participants With Advanced or Metastatic Solid Tumors (ECHO-207/KEYNOTE-723)
Public ClinicalTrials.gov record NCT03085914. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1/2, Open-Label, Safety, Tolerability, and Efficacy Study of Epacadostat in Combination With Pembrolizumab and Chemotherapy in Subjects With Advanced or Metastatic Solid Tumors (ECHO-207/KEYNOTE-723)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This was an open-label, nonrandomized, Phase 1/2 study designed to determine the safety, tolerability, and efficacy of epacadostat when given in combination with pembrolizumab and 7 different chemotherapy regimens described as Treatment Groups A through G below (see Study Drug and Background Therapies, Dose, and Mode of Administration). Phase 1 consisted of a 3 + 3 + 3 design intended to determine the MTD or PAD of epacadostat when given in combination with pembrolizumab and chemotherapy; efficacy was also explored. Phase 2 was designed to enroll efficacy expansion cohorts to further evaluate the safety, tolerability, and efficacy of epacadostat at the MTD or PAD (as selected in Phase 1) when given in combination with pembrolizumab and chemotherapy. Each efficacy expansion cohort was to enroll participants with 1 specific type of advanced or metastatic solid tumor. Additional cohorts (ie, the mandatory biopsy cohorts) were designed to evaluate changes in the tumor microenvironment in participants with any advanced or metastatic solid tumor who had progressed on previous therapy with a PD-1 or a PD-L1 inhibitor. No participants were enrolled in any Phase 2 efficacy expansion cohort, or in any Phase 2 mandatory biopsy cohort receiving Treatment A, B, F, or G. Phase 2 mandatory biopsy cohort participants received Treatments C, D, or E (ie, were included in Treatment Groups C, D, or E). Participants were assigned to a treatment group based on the chemotherapy regimen most appropriate for their tumor type.
Study identification
- NCT ID
- NCT03085914
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 70 participants
Conditions and interventions
Conditions
Interventions
- Epacadostat Drug
- Pembrolizumab Drug
- Oxaliplatin Drug
- Leucovorin Drug
- 5-Fluorouracil Drug
- Gemcitabine Drug
- nab-Paclitaxel Drug
- Carboplatin Drug
- Paclitaxel Drug
- Pemetrexed Drug
- Cyclophosphamide Drug
- Cisplatin Drug
- Investigator's choice of platinum agent Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 1, 2017
- Primary completion
- Jan 24, 2019
- Completion
- Jul 12, 2020
- Last update posted
- Sep 22, 2022
2017 – 2020
United States locations
- U.S. sites
- 16
- U.S. states
- 13
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic Arizona | Phoenix | Arizona | 85054 | — |
| University of California San Diego Medical Center, Moores Cancer Center | La Jolla | California | 92093 | — |
| The Angeles Clinic and Research Institute | Los Angeles | California | 90025 | — |
| Mayo Clinic | Jacksonville | Florida | 32224 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| Carolina Bio-Oncology Institute, PLLC | Huntersville | North Carolina | 28078 | — |
| Oregon Health and Science University | Portland | Oregon | 97239 | — |
| University of Pennsylvania Health System | Philadelphia | Pennsylvania | 19104 | — |
| University of Pittsburgh Cancer Institute | Pittsburgh | Pennsylvania | 15237 | — |
| Tennessee Oncology - Nashville; The Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | — |
| Vanderbilt University; Henry Joyce Cancer Clinic | Nashville | Tennessee | 37232 | — |
| MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Huntsman Cancer Institute at University of Utah | Salt Lake City | Utah | 84112 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
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About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03085914, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 22, 2022 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03085914 live on ClinicalTrials.gov.