INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies
NCT ID: NCT03277352
Last Updated: 2021-07-22
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
10 participants
INTERVENTIONAL
2017-11-21
2020-07-01
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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INCAGN01876 + Pembrolizumab + Epacadostat
INCAGN01876 in combination with pembrolizumab and epacadostat
INCAGN01876
In Phase 1 subjects will receive INCAGN01876 administered intravenously (IV) at the protocol-defined dose and schedule according to cohort and treatment group enrollment. In Phase 2, subjects will be administered IV study drug at the recommended dose from Phase 1.
Epacadostat
Epacadostat will be self-administered orally at the protocol-defined dose.
Pembrolizumab
Pembrolizumab will be administered IV at the protocol-defined dose.
Interventions
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INCAGN01876
In Phase 1 subjects will receive INCAGN01876 administered intravenously (IV) at the protocol-defined dose and schedule according to cohort and treatment group enrollment. In Phase 2, subjects will be administered IV study drug at the recommended dose from Phase 1.
Epacadostat
Epacadostat will be self-administered orally at the protocol-defined dose.
Pembrolizumab
Pembrolizumab will be administered IV at the protocol-defined dose.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Phase 1: Subjects with advanced or metastatic solid tumors.
* Phase 1: Subjects who have disease progression after treatment with available therapies.
* Phase 2: Subjects with advanced or metastatic melanoma, RCC, and urothelial carcinoma.
* Presence of measurable disease based on RECIST v1.1.
* Eastern Cooperative Oncology Group performance status of 0 or 1.
Exclusion Criteria
* Prior treatment with any tumor necrosis factor super family agonist.
* Receipt of anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug.
* Has not recovered to ≤ Grade 1 from toxic effects of prior therapy.
* Active autoimmune disease.
* Known active central nervous system metastases and/or carcinomatous meningitis.
* Evidence of active, noninfectious pneumonitis or history of interstitial lung disease.
* Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.
* Known history of human immunodeficiency virus (HIV; HIV 1/2 antibodies).
18 Years
ALL
No
Sponsors
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Incyte Biosciences International Sàrl
INDUSTRY
Responsible Party
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Principal Investigators
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John N. Janik, MD
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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The Angeles Clinic and Research Institute
Los Angeles, California, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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INCAGN 1876-202
Identifier Type: -
Identifier Source: org_study_id
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