NCT06708949进行中（未招募）2 期
A Randomized Phase 2 Trial of Nivolumab, Relatlimab Plus Ipilimumab vs. Nivolumab Plus Ipilimumab in First-line Advanced Renal Cell Carcinoma (RCC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 52
- 试验地点
- 13
- 主要终点
- Safety and Averse events (AEs)
研究概览
简要总结
This is a phase 2 stratified, randomized, multicenter, study investigating the efficacy of a triplet arm treating with nivolumab 480 mg every 4 weeks (Q4W), relatlimab 160 mg Q4W and ipilimumab 1 mg/kg every 8 weeks (Q8W) intravenous (IV) versus a doublet arm treating with nivolumab 480 mg Q3W and ipilimumab 1mg/kg Q3W IV in first-line advanced RCC.
详细描述
Primary Objectives:
To determine the safety and tolerability of nivolumab, relatlimab and ipilimumab in patients with untreated advanced RCC
• To assess the ORR of nivolumab, relatlimab and ipilimumab in patients with untreated advanced RCC
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Willing and able to provide a signed and dated written informed consent.
- •≥ 18 years of age
- •Confirmed diagnosis of RCC with a clear cell component
- •Stage IV metastatic renal cell carcinoma per American Joint Committee on Cancer
- •No prior systemic therapy for RCC. Prior neo/adjuvant systemic therapy is not allowed.
- •Karnofsky performance status ≥ 70%.
- •At least one measurable lesion as defined by RECIST 1.1 (Appendix 3)
- •A tumor lesion situated in a previously irradiated area is considered a measurable/target lesion only if subsequent disease progression has been documented in the lesion
- •Adequate organ function within 28 days prior to first dose of protocol-indicated treatment, including:
- •White blood cell (WBC) ≥ 2,000 /µL
- •Absolute neutrophil count (ANC) ≥ 1,500/µL
- •Platelets ≥ 100,000/µL
- •Serum creatinine < 1.5 x upper limit of normal (ULN) or creatinine clearance > 30 mL/min (measured or calculated by Cockroft-Gault formula)
- •Total bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who must have total bilirubin < 3.0 mg/dL)
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN
- •Women must not be breastfeeding while taking the study drug and for up to five months after the last dose of study drug
- •Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 24 hours prior to receiving first dose of protocol-indicated treatment. An extension up to 72 hours prior to the start of study treatment is permissible in situations where results cannot be obtained within the standard 24-hour window.
- •"Women of childbearing potential" (WOCBP) is defined as any female who has experienced menarche who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or is not postmenopausal.
- •Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 years of age in the absence of other biological or physiological causes.
- •If menopausal status is considered for the purpose of evaluating childbearing potential, women < 62 years of age must have a documented serum follicle stimulating hormone (FSH) level within laboratory reference range for postmenopausal women, in order to be considered postmenopausal and not of childbearing potential.
- •Women of childbearing potential (WOCBP) must agree to follow instructions for acceptable contraception Appendix 5 from the time of signing consent, and for 23 weeks after their last dose of protocol-indicated treatment.
排除标准
- •Prior systemic treatment for RCC of any type including neoadjuvant or adjuvant therapy is not allowed.
- •≤ 28 days before first dose of protocol-indicated treatment:
- •Major surgery requiring general anesthesia.
- •≤ 14 days before first dose of protocol-indicated treatment:
- •Radiosurgery or radiotherapy
- •Minor surgery. (Note: Placement of a vascular access device is not considered minor or major surgery)
- •Active infection requiring infusion treatment.
- •Any history of or current CNS metastases
- •Any condition requiring systemic treatment with either corticosteroids (> 10 mg/day prednisone or equivalent daily) or other immunosuppressive medications within 14 days prior to initiating protocol-indicated treatment.
- •In the absence of active autoimmune disease, subjects are permitted the use of corticosteroids with minimal systemic absorption (e.g. topical, ocular, intra-articular, intranasal, and inhalational) ≤ 10 mg/day prednisone or equivalent daily; and physiologic replacement doses of systemic corticosteroids ≤ 10 mg/day prednisone or equivalent daily (e.g. hormone replacement therapy needed in patients with hypophysitis)
- •Active, known or suspected autoimmune disease (see Appendix 1 for a comprehensive list of autoimmune diseases and immune deficiencies).
- •Subjects with type I diabetes mellitus; endocrine organ dysfunction (e.g., hypothyroidism) that are controlled and only requiring only hormone replacement; skin disorders such as vitiligo, psoriasis or alopecia not requiring systemic treatment; or conditions not expected by the investigator to recur in the absence of an external trigger are permitted to enroll.
- •Known psychiatric condition, social circumstance, or other medical condition reasonably judged by the investigator to unacceptably increase the risk of study participation; or to prohibit the understanding or rendering of informed consent or anticipated compliance with and interpretation of scheduled visits, treatment schedule, laboratory tests and other study requirements.
- •History of myocarditis, regardless of etiology
- •Troponin T (TnT) or I (TnI) > 2× institutional upper limit of normal (ULN)
- •Participants with TnT or TnI levels between > 1× to 2× ULN will be permitted if repeat levels within 24 hours are ≤ 1× ULN. If TnT or TnI levels are between > 1× to 2× ULN within 24 hours, the participant may undergo a cardiac evaluation and be considered for treatment, based on a favorable benefit/risk assessment by the Investigator.
- •When repeat levels within 24 hours are not available, a repeat test should be conducted as soon as possible. If TnT or TnI repeat levels beyond 24 hours are < 2× ULN, the participant may undergo a cardiac evaluation and be considered for treatment, based on a favorable benefit/risk assessment by the Investigator.
- •Treatment with any live/attenuated vaccine within 30 days of first study treatment
研究组 & 干预措施
Treatment with Nivolumab + Ipilimumab
Experimental
Participants will randonmized to study and treatment will be administered on an outpatient basis.
干预措施: Drugs Nivolumab (Drug)
Treatment with Nivolumab + Relatlimab + Ipilimumab
Experimental
Participants will randonmized to study and treatment will be administered on an outpatient basis.
干预措施: Ipilimumab (Drug)
Treatment with Nivolumab + Relatlimab + Ipilimumab
Experimental
Participants will randonmized to study and treatment will be administered on an outpatient basis.
干预措施: BMS-986213 (Relatlimab-Nivolumab FDC) (Drug)
Treatment with Nivolumab + Ipilimumab
Experimental
Participants will randonmized to study and treatment will be administered on an outpatient basis.
干预措施: Ipilimumab (Drug)
结局指标
主要结局
Safety and Averse events (AEs)
时间窗: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
次要结局
未报告次要终点
研究者
研究点 (13)
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