NL-OMON54767招募中3 期
A Multicenter, Open-label, Randomized, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib in Combination with Everolimus or Pembrolizumab Versus Sunitinib Alone in First-Line Treatment of Subjects with Advanced Renal Cell Carcinoma (CLEAR). - CLEAR - E7080-G000-307
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Eisai
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Histological or cytological confirmation of RCC with a clear-cell component
- •(original tissue diagnosis of RCC is acceptable).
- •2. Documented evidence of advanced RCC.
- •3. At least 1 measurable target lesion according to RECIST 1.1 meeting the
- •following criteria:
- •Lymph node (LN) lesion that measures at least 1 dimension as >=1.5 cm in the
- •Non-nodal lesion that measures >=1.0 cm in the longest diameter
- •The lesion is suitable for repeat measurement using computerized
- •tomography/magnetic resonance imaging (CT/MRI). Lesions that have had external
- •beam radiotherapy (EBRT) or locoregional therapy must show radiographic
- •evidence of disease progression based on RECIST 1.1 to be deemed a target
- •4. Male or female subjects age >=18 years (or any age greater than 18 years of
- •age if that age is considered to be an adult per the local jurisdiction) at the
- •time of informed consent
- •5. Karnofsky Performance Status (KPS) of >=70.
- •6. Adequately controlled blood pressure (BP) with or without antihypertensive
- •medications, defined as BP <=150/90 mmHg at Screening and no change in
- •antihypertensive medications within 1 week before the Cycle 1/Day 1.
- •7. Adequate renal function as creatinine <=1.5× upper limit of normal (ULN); or
- •for subjects with creatinine >1.5×ULN, the calculated creatinine clearance >=30
- •mL/min (per the Cockcroft-Gault formula) is acceptable.
- •8. Adequate bone marrow function defined by:
- •Absolute neutrophil count (ANC) >=1500/mm3
- •Platelets >=100,000/mm3
- •Hemoglobin >=9 g/dL.
- •9. Adequate blood coagulation function defined by International Normalized
- •ratio (INR) <=1.5 unless participant is receiving anticoagulant therapy, as long
- •as INR is within therapeutic range of intended use of anticoagulants
- •10. Adequate liver function defined by:
- •Total bilirubin <=1.5 x ULN except for unconjugated hyperbilirubinemia of
- •Gilbert's syndrome.
- •Alkaline phosphatase (ALP), alanine aminotransferase (ALT), and aspartate
- •aminotransferase (AST) <=3×ULN (in the case of liver metastases <=5×ULN), unless
- •there are bone metastases. Subjects with ALP values >3xULN and known to have
- •bone metastases can be included.
- •11. Provide written informed consent.
- •12. Willing and able to comply with all aspects of the protocol.
排除标准
- •1. Subjects who have received any systemic anticancer therapy for RCC,
- •including anti-VEGF therapy, or any systemic investigational anticancer agent.
- •Prior adjuvant treatment with an investigational anticancer agent is not
- •allowed unless the investigator can provide evidence of subject's randomization
- •to placebo arm.
- •2. Subjects with CNS metastases are not eligible, unless they have completed
- •local therapy (eg, whole brain radiation therapy [WBRT], surgery or
- •radiosurgery) and have discontinued the use of corticosteroids for this
- •indication for at least 4 weeks before starting treatment in this study. Any
- •signs (eg, radiologic) or symptoms of brain
- •metastases must be stable for at least 4 weeks before starting study treatment.
- •3. Active malignancy (except for RCC, definitively treated basal or squamous
- •cell carcinoma of the skin, and carcinoma in-situ of the cervix or bladder)
- •within the past 24 months. Subjects with history of localized & low risk
- •prostate cancer are allowed in the study if they were treated with curative
- •intent and there is no PSA recurrence within the past 5 years.
- •4. Prior radiation therapy within 21 days prior to start of study treatment
- •with the exception of palliative radiotherapy to bone lesions, which is allowed
- •if completed 2 weeks prior to study treatment start.
- •5. Subjects who are using other investigational agents or who had received
- •investigational drugs <=4 weeks prior to study treatment start.
- •6. Received a live vaccine within 30 days of planned start of study treatment
- •(Cycle 1/Day 1). Examples of live vaccines include, measles,
- •mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies,
- •Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza
- •vaccines for injection are generally killed virus vaccines and are allowed;
- •however intranasal influenza vaccines (eg, FluMist®) are live attenuated
- •vaccines and are not allowed within 30 days of C1D1.
- •7. Subjects with proteinuria >1+ on urine dipstick testing will undergo 24-h
- •urine collection for quantitative assessment of proteinuria.
- •Subjects with urine protein >=1 g/24 h will be ineligible
- •8. Fasting total cholesterol >300 mg/dL (or >7.75 mmol/L) and/or fasting
- •triglycerides level >2.5 x ULN. NOTE: these subjects can be included after
- •initiation or adjustment of lipid-lowering medication.
- •9. Uncontrolled diabetes as defined by fasting glucose >1.5 times the ULN.
- •Note: these subjects can be included after initiation or adjustment of
- •glucose-lowering medication.
- •10. Prolongation of QTc interval to >480 ms.
- •11. Subjects who have not recovered adequately from any toxicity and/or
- •complications from major surgery prior to starting therapy.
- •12. Gastrointestinal malabsorption, gastrointestinal anastomosis, or any other
- •condition that might affect the absorption of lenvatinib, everolimus, and/or
- •13. Bleeding or thrombotic disorders or subjects at risk for severe hemorrhage.
- •The degree of tumor invasion/infiltration of major blood vessels (eg, carotid
- •artery) should be considered because of the potential risk of severe hemorrhage
- •associated with tumor
- •shrinkage/necrosis following lenvatinib therapy.
- •14. Clinically significant hemoptysis or tumor bleeding within 2 weeks prior to
- •the first dose of study drug.
- •15. Significant cardiovascular impairment wi
研究者
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