A Study of Epacadostat in Combination With Pembrolizumab and Chemotherapy in Participants With Advanced or Metastatic Solid Tumors (ECHO-207/KEYNOTE-723)
NCT ID: NCT03085914
Last Updated: 2022-09-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
70 participants
INTERVENTIONAL
2017-05-02
2020-07-13
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment Group A
Epacadostat + pembrolizumab + mFOLFOX6 (oxaliplatin, leucovorin, 5-fluorouracil)
Epacadostat
Epacadostat oral twice-daily continuous daily dosing at the protocol-defined dose.
Pembrolizumab
Pembrolizumab
Oxaliplatin
Oxaliplatin
Leucovorin
Leucovorin
5-Fluorouracil
5-Fluorouracil
Treatment Group B
Epacadostat + pembrolizumab + gemcitabine and nab-paclitaxel
Epacadostat
Epacadostat oral twice-daily continuous daily dosing at the protocol-defined dose.
Pembrolizumab
Pembrolizumab
Gemcitabine
Gemcitabine
nab-Paclitaxel
nab-Paclitaxel
Treatment Group C
Epacadostat + pembrolizumab + carboplatin and paclitaxel
Epacadostat
Epacadostat oral twice-daily continuous daily dosing at the protocol-defined dose.
Pembrolizumab
Pembrolizumab
Carboplatin
Carboplatin
Paclitaxel
Paclitaxel
Treatment Group D
Epacadostat + pembrolizumab + pemetrexed and investigators choice of platinum agent
Epacadostat
Epacadostat oral twice-daily continuous daily dosing at the protocol-defined dose.
Pembrolizumab
Pembrolizumab
Pemetrexed
Pemetrexed
Carboplatin
Carboplatin
Cisplatin
Cisplatin
Investigator's choice of platinum agent
Investigator's choice of platinum agent: carboplatin or cisplatin
Treatment Group E
Epacadostat + pembrolizumab + cyclophosphamide
Epacadostat
Epacadostat oral twice-daily continuous daily dosing at the protocol-defined dose.
Pembrolizumab
Pembrolizumab
Cyclophosphamide
Cyclophosphamide
Treatment Group F
Epacadostat + pembrolizumab + gemcitabine and investigators choice of platinum agent
Epacadostat
Epacadostat oral twice-daily continuous daily dosing at the protocol-defined dose.
Pembrolizumab
Pembrolizumab
Gemcitabine
Gemcitabine
Treatment Group G
Epacadostat + pembrolizumab + investigators choice of platinum agent and 5-fluorouracil
Epacadostat
Epacadostat oral twice-daily continuous daily dosing at the protocol-defined dose.
Pembrolizumab
Pembrolizumab
Carboplatin
Carboplatin
Cisplatin
Cisplatin
5-Fluorouracil
5-FU
Investigator's choice of platinum agent
Investigator's choice of platinum agent: carboplatin or cisplatin
Interventions
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Epacadostat
Epacadostat oral twice-daily continuous daily dosing at the protocol-defined dose.
Pembrolizumab
Pembrolizumab
Oxaliplatin
Oxaliplatin
Leucovorin
Leucovorin
5-Fluorouracil
5-Fluorouracil
Gemcitabine
Gemcitabine
nab-Paclitaxel
nab-Paclitaxel
Carboplatin
Carboplatin
Paclitaxel
Paclitaxel
Pemetrexed
Pemetrexed
Cyclophosphamide
Cyclophosphamide
Carboplatin
Carboplatin
Cisplatin
Cisplatin
5-Fluorouracil
5-FU
Investigator's choice of platinum agent
Investigator's choice of platinum agent: carboplatin or cisplatin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Presence of measurable disease per RECIST v1.1.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Fred Zheng, MD
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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Mayo Clinic Arizona
Phoenix, Arizona, United States
University of California San Diego Medical Center, Moores Cancer Center
La Jolla, California, United States
The Angeles Clinic and Research Institute
Los Angeles, California, United States
Mayo Clinic
Jacksonville, Florida, United States
University of Chicago
Chicago, Illinois, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Carolina Bio-Oncology Institute, PLLC
Huntersville, North Carolina, United States
Oregon Health and Science University
Portland, Oregon, United States
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
Tennessee Oncology - Nashville; The Sarah Cannon Research Institute
Nashville, Tennessee, United States
Vanderbilt University; Henry Joyce Cancer Clinic
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States
Countries
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References
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Powderly JD, Klempner SJ, Naing A, Bendell J, Garrido-Laguna I, Catenacci DVT, Taylor MH, Lee JJ, Zheng F, Zhou F, Gong X, Gowda H, Beatty GL. Epacadostat Plus Pembrolizumab and Chemotherapy for Advanced Solid Tumors: Results from the Phase I/II ECHO-207/KEYNOTE-723 Study. Oncologist. 2022 Nov 3;27(11):905-e848. doi: 10.1093/oncolo/oyac174.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-004678-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
INCB 24360-207 / ECHO-207
Identifier Type: -
Identifier Source: org_study_id
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