2023-504963-17-00已完成2 期
A Multicenter, Open-label, Randomized, Phase 1/2 Study of Belzutifan in Combination with Palbociclib Versus Belzutifan Monotherapy in Participants with Advanced Renal Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 19
- 主要终点
- Part 1 - Number of Participants Who Experience at Least One Dose-limiting Toxicity (DLT)
研究概览
简要总结
- Part 1: To assess the safety and tolerability, and to establish the recommended Phase 2 dose (RP2D) of belzutifan plus palbociclib
- Part 2: To evaluate the objective response rate (ORR) as assessed by investigator using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 in each arm
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Has a histologically confirmed diagnosis of unresectable Stage IV (per American Joint Committee on Cancer [AJCC], 8th Edition) RCC with clear-cell component
- •Has had disease progression on or after having received at least 2 systemic treatments for unresectable Stage IV RCC with prior anti-programmed cell death 1 ligand 1 (PD-1/L1) and a vascular endothelial growth factor-tyrosine kinase inhibitor (VEGF-TKI) in sequence or in combination
- •Has measurable disease per RECIST 1.1 as assessed by the investigator and verified by blinded independent central review (BICR)
- •Has recovered from all AEs due to previous therapies
排除标准
- •Has hypoxia, requires intermittent supplemental oxygen, or requires chronic supplemental oxygen
- •Has had major surgery ≤3 weeks prior to first dose of study intervention
- •Has received colony-stimulating factors (eg, granulocyte colony-stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor [GM-CSF], or recombinant erythropoietin [EPO]) ≤28 days prior to the first dose of study intervention
- •Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
- •Has known central nervous system (CNS) metastases and/or carcinomatous meningitis
- •Has clinically significant cardiac disease
- •Has moderate to severe hepatic impairment
- •Has a known history of human immunodeficiency virus (HIV) infection
- •Has a history of hepatitis B (HBV) or known active hepatitis C (HCV) infection
- •Has received prior treatment of belzutifan or palbociclib
- •Has received prior radiotherapy ≤2 weeks prior to first dose of study intervention. Participants must have recovered from all radiation-related toxicities and not require corticosteroids
结局指标
主要结局
Part 1 - Number of Participants Who Experience at Least One Dose-limiting Toxicity (DLT)
Part 1 - Number of Participants Who Experience at Least One Dose-limiting Toxicity (DLT)
Part 1 - Number of Participants Who Experience at Least One Adverse Event (AE)
Part 1 - Number of Participants Who Experience at Least One Adverse Event (AE)
Part 1 - Number of Participants Who Discontinue Study Treatment Due to an AE
Part 1 - Number of Participants Who Discontinue Study Treatment Due to an AE
Part 2 - Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator
Part 2 - Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator
次要结局
- Part 2 - Clinical Benefit Rate (CBR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator
- Part 2 - Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator
- Part 2 - Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator
- Part 2 - Overall Survival (OS)
- Part 2 - Number of Participants Who Experience at Least One Adverse Event (AE)
- Part 2 - Number of Participants Who Discontinue Study Treatment Due to an AE
研究者
Yanfang Liu
Scientific
Merck Sharp & Dohme LLC
研究点 (19)
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