A Study of Epacadostat (INCB024360) in Combination With Durvalumab (MEDI4736) in Subjects With Selected Advanced Solid Tumors (ECHO-203)
NCT ID: NCT02318277
Last Updated: 2022-01-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
176 participants
INTERVENTIONAL
2015-01-05
2020-10-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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MEDI4736 + INCB024360
MEDI4736 at selected dose levels every 2 weeks + INCB024360 25 mg BID as starting dose, followed by dose escalations until MTD or PAD is identified
MEDI4736
MEDI4736 administered intravenously (IV) every two weeks (q2w)
INCB024360
INCB024360: Oral daily dosing
Interventions
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MEDI4736
MEDI4736 administered intravenously (IV) every two weeks (q2w)
INCB024360
INCB024360: Oral daily dosing
Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed diagnosis of selected locally advanced or metastatic solid tumors
* Must have failed at least 1 prior treatment regimen for locally advanced or metastatic disease or be intolerant to treatment or refuse standard treatment
Exclusion Criteria
* Participation in any other study in which receipt of an investigational study drug occurred within 28 days or 5 half-lives (whichever is longer) prior to first dose
* Prior treatment with immune checkpoint inhibitors (eg, anti-CTLA-4, anti-PD-1, anti-PD-L1, and any other antibody or drug specifically targeting T-cell co-stimulation) or an IDO inhibitor (exception is tumor types in which a PD-1 pathway targeted agent is approved, e.g. melanoma, non-small cell lung cancer.)
* Receipt of any anticancer medication in the 21 days prior to receiving the first dose of study medication
* Has an active or inactive autoimmune process
* Evidence of interstitial lung disease or active, non-infectious pneumonitis
* Prior radiotherapy within 2 weeks of initiating treatment; Must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis
* Untreated central nervous system (CNS) metastases or CNS metastases that have progressed
* Currently pregnant or breastfeeding
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Lance Leopold, MD
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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San Francisco, California, United States
Denver, Colorado, United States
Miami, Florida, United States
Port Saint Lucie, Florida, United States
Sarasota, Florida, United States
Tampa, Florida, United States
Chicago, Illinois, United States
Louisville, Kentucky, United States
Durham, North Carolina, United States
Huntersville, North Carolina, United States
Winston-Salem, North Carolina, United States
Dallas, Texas, United States
Houston, Texas, United States
Countries
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References
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Naing A, Algazi AP, Falchook GS, Creelan BC, Powderly J, Rosen S, Barve M, Mettu NB, Triozzi PL, Hamm J, Zhou G, Walker C, Dong Z, Patel MR. Phase 1/2 study of epacadostat in combination with durvalumab in patients with metastatic solid tumors. Cancer. 2023 Jan 1;129(1):71-81. doi: 10.1002/cncr.34512. Epub 2022 Oct 30.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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INCB 24360-203 / ECHO-203
Identifier Type: -
Identifier Source: org_study_id
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