NCT07011719招募中3 期
A Randomized, Double-Blind, Active-Control, Multicenter Phase 3 Trial of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 720
- 试验地点
- 184
- 主要终点
- Progression-free Survival (PFS) as assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1
研究概览
简要总结
The purpose of the study is to evaluate the progression-free survival (PFS) of casdatifan versus placebo when each is given in combination with cabozantinib in adult patients with confirmed advanced or metastatic clear cell Renal Cell Carcinoma who have experienced progression on or after prior anti-PD-1 or anti-PD-L1 immunotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unresectable and measurable locally advanced or metastatic renal cell carcinoma with a primary clear cell component.
- •A Karnofsky Performance Status (KPS) score ≥ 80%
- •At least 1 target lesion measurable by computed tomography/magnetic resonance imaging per RECIST 1.1, not within a field of prior radiation therapy.
- •Adequate organ and marrow function, ≤ 1 week prior to randomization.
- •Women of childbearing potential (WOCBP) must have a negative serum pregnancy test.
排除标准
- •Received prior treatment with a HIF-2α inhibitor or cabozantinib.
- •Other prior malignancy active within the previous year except for locally curable cancers that have been apparently cured.
- •Ongoing clinically significant toxicities related to any prior anticancer treatment, or toxicities Grade ≥ 3 per National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0) regardless of relatedness to prior anticancer therapies.
- •Uncontrolled or poorly controlled hypertension, defined as a sustained blood pressure > 150 mmHg systolic or > 90 mmHg diastolic despite optimal antihypertensive treatment.
- •History of leptomeningeal disease or spinal cord compression.
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Arm A (Experimental Arm)
Experimental
Casdatifan and cabozantinib taken orally
干预措施: Cabozantinib (Drug)
Arm B (Comparator Arm)
Placebo Comparator
Placebo and cabozantinib taken orally
干预措施: Cabozantinib (Drug)
Arm B (Comparator Arm)
Placebo Comparator
Placebo and cabozantinib taken orally
干预措施: Placebo (Drug)
Arm A (Experimental Arm)
Experimental
Casdatifan and cabozantinib taken orally
干预措施: Casdatifan (Drug)
结局指标
主要结局
Progression-free Survival (PFS) as assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1
时间窗: up to approximately 33 months
次要结局
- Overall Survival (OS)(up to approximately 64 months)
- Objective Response Rate (ORR) as assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1(up to approximately 33 months)
- Duration of Response (DOR) as assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1(up to approximately 33 months)
- Disease Control Rate (DCR) by Blinded Independent Central Review (BICR)(up to approximately 33 months)
- The incidence and severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (SAEs)(up to approximately 33 months)
- Time to first symptom deterioration in National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Kidney Symptom Index - Disease Related Symptoms (NFKSI-DRS) Items 1-9 sub-scale score.(up to approximately 33 months)
研究者
研究点 (184)
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