A Study of Epacadostat in Combination With Pembrolizumab and Chemotherapy in Participants With Advanced or Metastatic Solid Tumors (ECHO-207/KEYNOTE-723)
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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 13 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Sep 23, 2022 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- Incyte Corporation
- Interventions being studied
- Drug: Epacadostat; Drug: Pembrolizumab; Drug: Oxaliplatin; Drug: Leucovorin; Drug: 5-Fluorouracil; Drug: Gemcitabine; Drug: nab-Paclitaxel; Drug: Carboplatin; Drug: Paclitaxel; Drug: Pemetrexed; Drug: Cyclophosphamide; Drug: Carboplatin; Drug: Cisplatin; Drug: 5-Fluorouracil; Drug: Investigator's choice of platinum agent
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Histologically or cytologically confirmed diagnosis of selected advanced or metastatic solid tumors.
- Presence of measurable disease per RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Laboratory and medical history parameters not within the Protocol-defined range.
- Receipt of anticancer medications or investigational drugs within the Protocol-defined intervals before the first administration of study drug.
- Previous radiotherapy within 2 weeks of starting study therapy.
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Has not recovered to ≤ Grade 1 from toxic effects of previous therapy and/or complications from previous surgical intervention before starting study therapy.
- Receipt of a live vaccine within 30 days of planned start of study therapy.
- Active infection requiring systemic therapy.
- Subjects who have any active or inactive autoimmune disease or syndrome.
- Women who are pregnant or breastfeeding.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Mayo Clinic ArizonaPhoenix, Arizona
- University of California San Diego Medical Center, Moores Cancer CenterLa Jolla, California
- The Angeles Clinic and Research InstituteLos Angeles, California
- Mayo ClinicJacksonville, Florida
- University of ChicagoChicago, Illinois
- Mayo ClinicRochester, Minnesota
- Washington University School of MedicineSt Louis, Missouri
- Memorial Sloan Kettering Cancer CenterNew York, New York
- Carolina Bio-Oncology Institute, PLLCHuntersville, North Carolina
- Oregon Health and Science UniversityPortland, Oregon
- University of Pennsylvania Health SystemPhiladelphia, Pennsylvania
- University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 23, 2022. Always confirm current availability with the study team.