A Phase 1/2 Study Exploring the Safety, Tolerability, Effect on the Tumor Microenvironment, and Efficacy of Azacitidine in Combination With Pembrolizumab and Epacadostat in Subjects With Advanced Solid Tumors and Previously Treated Stage IIIB or Stage IV Non–Small Cell Lung Cancer and Stage IV Microsatellite Stable Colorectal Cancer - ECHO 206

Incyte Corporation0 个研究点目标入组 160 人开始时间: 2017年5月12日最近更新: 2020年7月20日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Incyte Corporation
入组人数: 160

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

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研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•Male or female subjects, age 18 years or older on day of signing consent.
•Willingness to provide written informed consent for the study.
•Part 1 Only
•Subjects with histologically or cytologically confirmed advanced or metastatic solid tumors that have failed prior standard therapy Note: there is no limit to the number of prior treatment regimens.
•Part 2 Only
•Note: Subjects must have failed available therapies that are known to confer clinical benefit as indicated below, unless they are ineligible, intolerant, or refused standard treatment.
•Subjects with histologically or cytologically confirmed NSCLC:
•Stage IIIB or metastatic (Stage IV) NSCLC (according to American Joint Committee on Cancer 7th edition guidelines) who have had disease progression after available therapies for advanced or metastatic disease that are known to confer clinical benefit, been intolerant to treatment, or refused standard treatment.
•Prior systemic regimens must include previously approved therapies, including a platinum-containing chemotherapy regimen; a tyrosine kinase inhibitor for tumors with driver mutations; and checkpoint inhibitors where approved.
•Must have disease progression on a prior PD-1–pathway targeted agent (Cohorts A-1, A-3, and A-4). The baseline scan for the purposes of this study may serve as the documentation of progression.
•Subjects with recurrent (unresectable) or metastatic CRC:
•Histologically or cytologically confirmed adenocarcinoma of the colon or rectum
•Confirmed MSS CRC as per local testing.
•Stage IV MSS CRC (according to American Joint Committee on Cancer 7th edition guidelines) who have had disease progression after available therapies for advanced or metastatic disease that are known to confer clinical benefit, been intolerant to treatment, or refused standard treatment.
•Prior systemic regimens must include previously approved therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy; an anti–VEGF therapy (if no contraindication); and if negative for KRAS, NRAS, and BRAF mutations and no contraindication, an anti-EGFR therapy; and progressed after the last administration of approved therapy
•Subjects with HNSCC:
•Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx.
•Note: Carcinomas of the nasopharynx, salivary gland, or nonsquamous cell histology are excluded.
•Must have received prior treatment with a platinum-based therapy. Subjects who relapsed within 6 months of adjuvant therapy, including a platinum-containing regimen, may enroll.
•Must have documented human papilloma virus status.
•Subjects with melanoma:
•Histologically or cytologically confirmed melanoma.
•Unresectable Stage III or Stage IV melanoma, as per American Joint Committee on Cancer staging system not amenable to local therapy.
•Documentation of V600-activating BRAF mutation status or consent to BRAF.
•V600 mutation testing during the screening period.
•Must not have ocular melanoma.
•Subjects with urothelial carcinoma:
•Histologically or cytologically confirmed urothelial carcinoma of the renal pelvis, ureter, urinary bladder, or urethra that is transitional cell or mixed transitional/nontransitional (predominantly transitional) cell type.
•Stage IV locally advanced or metastatic urothelial carcinoma (according to American Joint Committee on Cancer 7th edition guidelines) with disease progression during or after PD-1 pathway-tar

排除标准

•Laboratory and medical history parameters not within Protocol-defined range.
•- Absolute neutrophil count < 1.5 × 109/L.
•- Platelet count < 100 × 109/L.
•- Hemoglobin < 8 g/dL (transfusion is acceptable to meet this criterion).
•- Serum creatinine = 1.5 × institutional upper limit of normal (ULN) OR measured or calculated creatinine clearance (glomerular filtration rate can also be used in place of creatinine or CrCl) < 50 mL/min for subjects with creatinine levels > 1.5 × institutional ULN).
•- Aspartate aminotransferase, alanine aminotransferase, and alkaline phosphatase = 2.5 × ULN.
•- Total bilirubin = 1.2 × ULN are excluded unless direct bilirubin is = ULN.
•- International normalized ratio or prothrombin time > 1.5 × ULN.
•- Activated partial thromboplastin time > 1.5 × ULN.
•Receipt of anticancer medications or investigational drugs within the following interval before the first administration of study drug:
•- < 14 days for chemotherapy, targeted small-molecule therapy, or radiation therapy.
•- < 14 days for a prior PD-1 pathway–targeted agent.
•- < 28 days for prior monoclonal antibody used for anticancer therapy with the exception of PD-1 pathway–targeted agents.
•- < 14 days for an immune-suppressive–based treatment for any reason
•- < 28 days or 5 half-lives (whichever is longer) before the first dose for all other investigational study drugs or devices.
•Has not recovered from toxic effect(s) of prior therapy to = Grade 1.
•Subjects with prior ocular toxicity from prior immune therapy are excluded.
•Subjects who have not recovered adequately from toxicity and/or complications from surgical intervention before starting therapy.
•Subjects who have any active or inactive autoimmune disease or syndrome that has required systemic treatment in the past 2 years or who are receiving systemic therapy for an autoimmune or inflammatory disease
•Known active CNS metastases and/or carcinomatous meningitis.
•Has received a live vaccine within 30 days of planned start of study therapy.
•Evidence of interstitial lung disease or active, noninfectious pneumonitis.
•History or presence of an abnormal ECG that, in the investigator's opinion, is clinically meaningful.
•Clinically significant cardiac disease, including unstable angina, acute myocardial infarction within 6 months from Day 1 of study drug administration, New York Heart Association Class III or IV congestive heart failure, and arrhythmia requiring therapy.
•Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications.
•Subject has a known history of or is positive for hepatitis B or hepatitis C
•Known history of human immunodeficiency virus (HIV; HIV 1/2 antibodies).
•Active infection requiring systemic therapy.
•Known allergy or reaction to any component of the study drugs or formulation components.
•Women who are pregnant or breastfeeding.
•Known additional malignancy that is progressing
•Prior receipt of an IDO inhibitor.
•Receipt of MAOIs within the 21 days before the first dose of study treatment.
•History of serotonin syndrome after receiving 1 or more serotonergic drugs.
•Prior receipt of any formulation of azacitidine, decitabine, or any other hypomethylating agent.
•Known hypersensitivity to any of the active substances or any of their excipients
•Subjects with bleeding associated with tumors in proximity to major blood vessels are excluded except w

研究者

发起方

Incyte Corporation

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