招募中 NCT07227402

Belzutifan和Zanzalintinib在辅助治疗后复发性肾癌患者中的临床研究( MK-6482-033 )

肾癌肉瘤Phase IIIIII 期IV 期

研究人员正在寻找更多方法来治疗复发的晚期肾细胞癌( RCC )。 研究人员希望了解与cabozantinib相比, Belzutifan ( MK-6482 )和zanzalintinib治疗后复发性晚期肾细胞癌( RCC )是否有反应(变小或消失)。 本研究的目的是了解: 服用Belzutifan和Zanzalintinib的人总体寿命更长,而且癌症不会比服用Belzutifan和Zanzalintinib的人更糟。

适应症:Renal Cell Carcinoma

入组条件

纳入标准

  • Has a histologically confirmed diagnosis of unresectable, advanced renal cell cancer (RCC) with clear cell component (with or without sarcomatoid features) i.e., Stage IV renal cell cancer per American Joint Committee on Cancer (AJCC) (8th Edition)
  • Has measurable disease per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)
  • Has disease recurrence during adjuvant anti-programmed cell death 1/programmed cell death ligand 1 (PD-1/L1) therapy or recurrence ≤24 months following the last dose of adjuvant anti-PD-1/L1 therapy
  • Has received no other prior systemic therapy for their RCC except for their adjuvant anti-PD-1/L1 therapy

排除标准

  • Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, new-onset angina, pulmonary embolism, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability
  • Had deep vein thrombosis within 3 months before randomization unless stable, asymptomatic, and treated with therapeutic anticoagulation for at least 4 weeks before randomization
  • Has a left ventricular ejection fraction ≤50% or below the institutional (or local laboratory) normal range as determined by multigated acquisition or echocardiogram
  • Has had major surgery within 8 weeks before randomization or has not adequately recovered from major surgery or has ongoing surgical complications
  • Has current pneumonitis/interstitial lung disease
  • Has symptomatic pleural effusion (for example cough, dyspnea, pleuritic chest pain), ascites, or pericardial fluid requiring drainage within 4 weeks prior to randomization
  • Has a gastrointestinal disorder including those associated with a high risk of perforation or fistula formation
  • Has a serious active nonhealing wound/ulcer/bone fracture
  • Has a requirement for hemodialysis or peritoneal dialysis
  • Has history of human immunodeficiency virus infection
  • Has hepatitis B or hepatitis C virus
  • Has pharmacologically uncompensated, symptomatic hypothyroidism
  • Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention

入组条件维持 ClinicalTrials.gov 原始英文登记资料,实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源:ClinicalTrials.gov,每两周自动更新,最后同步:2026年10月8日。