EUCTR2016-002423-29-GB进行中（未招募）1 期
A Phase 1/2 Study of the Safety, Tolerability, and Efficacy of Epacadostat Administered in Combination With Nivolumab in Select Advanced Cancers
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 291
研究概览
简要总结
暂无简介。
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.
- •Subjects with histologically or cytologically confirmed NSCLC, MEL, CRC, SCCHN, ovarian cancer, recurrent B cell NHL or HL, or glioblastoma.
- •Subjects with Stage IIIB, Stage IV, or recurrent NSCLC; unresectable or Stage IV MEL; recurrent (unresectable) or metastatic CRC; recurrent (unresectable) or metastatic SCCHN; FIGO Stage Ic, II, III, or IV recurrent ovarian cancer (unresectable), relapsed or refractory B cell NHL or HL (including relapsed or refractory DLBCL), or glioblastoma and meet the tumor specific criteria
- •Presence of measurable disease by RECIST v1.1 for solid tumors or Cheson criteria for B cell NHL (including DLBCL) or HL. For subjects with glioblastoma, presence of measurable disease is not required.
- •ECOG performance status 0 to 1.
- •Fresh baseline tumor biopsies (defined as a biopsy specimen taken since completion of the most recent prior chemotherapy regimen) are required for all cohorts except glioblastoma.
- •Female subjects of childbearing potential (defined as women who have not undergone surgical sterilization with a hysterectomy and/or bilateral oophorectomy, and are not postmenopausal (defined as =12 months of amenorrhea) must have a negative serum pregnancy test at screening. All female (and male as appropriate for Protocol) subjects of childbearing potential must agree to take appropriate precautions to avoid pregnancy (or fathering children), with at least 99% certainty, from screening through 150 days after the last dose of study treatment.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 140
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 151
排除标准
- •Laboratory and medical history parameters not within Protocol-defined range unless directly resulting from the bone marrow infiltration of the underlying malignancy. All screening laboratory tests should be performed within 7 days of treatment initiation and must be independent of hematopoietic growth factor support:
- •Absolute neutrophil count < 1.5 × 109/L (in no case < 1.0 × 109/L).
- •Platelets < 100 × 109/L (in no case < 50 × 109/L).
- •Hemoglobin < 9 g/dL or = 5.6 mmol/L (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, alkaline phosphatase > 2.5 × ULN.
- •Total bilirubin above the institutional ULN or conjugated bilirubin = 1.2 × ULN (need only be tested if total bilirubin exceeds ULN). If an institutional ULN for conjugated bilirubin is not available, then conjugated bilirubin should be < 40% of total bilirubin to be considered eligible.
- •International normalized ratio (INR) or prothrombin time (PT) > 1.5 × ULN unless subject is receiving anticoagulant therapy as long as PT or INR is within therapeutic range of intended use of anticoagulants.
- •Activated partial thromboplastin time (aPTT) > 1.5 × ULN unless subject is receiving anticoagulant therapy, as long as PTT is within therapeutic range of intended use of anticoagulants.
- •Current pregnancy or breastfeeding.
- •Participation in any other study in which receipt of an investigational study drug occurred within 28 days or 5 half-lives (whichever is longer) before first dose.
- •Subjects who have received prior immune checkpoint inhibitors (eg, anti–CTLA-4, anti–programmed death receptor 1, anti–PD-L1, and any other antibody or drug specifically targeting T-cell costimulation) or an IDO inhibitor. Anti-CTLA-4 given as first-line treatment for metastatic melanoma will be permitted. These subjects must have discontinued anti-CTLA-4 therapy at least 12 weeks prior to first dose of study treatment.
- •Any prior = Grade 3 immune-related adverse event (irAE) while receiving immunotherapy, including anti-CTLA-4 treatment, or any unresolved irAE>Grade 1.
- •Subjects who are receiving an immunologically based treatment for any reason, including chronic use of systemic steroid or prednisone equivalent at doses = 10 mg/day prednisone equivalent within 7 days prior to the first dose of study treatment. Use of inhaled or topical steroids or systemic corticosteroids < 10 mg is permitted.
- •Subjects who have received any anticancer medication in the 21 days prior to receiving their first dose of study medication or has any unresolved toxicity greater than Grade 1 from previous anticancer therapy, except for stable chronic toxicities not expected to resolve, such as peripheral neurotoxicity, alopecia, and fatigue.
- •Prior monoclonal antibody within 4 weeks before study Day 1 or not recovered (= Grade 1 or at baseline) from AEs due to agents administered more than 4 weeks earlier.
- •Untreated central nervous system (CNS) metastases or CNS metastases that have progressed.
- •Subjects with any active or inactive autoimmune process (eg, rheumatoid arthritis, moderate or severe psoriasis, multiple sclerosis, etc.) or who are receiving systemic therapy for an autoimmune or inflam
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