A Randomized Phase 2 Trial of Nivolumab, Relatlimab Plus Ipilimumab vs. Nivolumab Plus Ipilimumab in First-line Advanced Renal Cell Carcinoma (RCC)
概览
- 阶段
- 2 期
- 干预措施
- Drugs Nivolumab
- 疾病 / 适应症
- Renal Cell Carcinoma, Clear Cell
- 发起方
- M.D. Anderson Cancer Center
- 入组人数
- 15
- 试验地点
- 6
- 主要终点
- Safety and Averse events (AEs)
- 状态
- 招募中
- 最后更新
- 上个月
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
研究者
入排标准
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
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)
研究组 & 干预措施
Treatment with Nivolumab + Ipilimumab
Participants will randonmized to study and treatment will be administered on an outpatient basis.
干预措施: Drugs Nivolumab
Treatment with Nivolumab + Ipilimumab
Participants will randonmized to study and treatment will be administered on an outpatient basis.
干预措施: Ipilimumab
Treatment with Nivolumab + Relatlimab + Ipilimumab
Participants will randonmized to study and treatment will be administered on an outpatient basis.
干预措施: Ipilimumab
Treatment with Nivolumab + Relatlimab + Ipilimumab
Participants will randonmized to study and treatment will be administered on an outpatient basis.
干预措施: BMS-986213 (Relatlimab-Nivolumab FDC)
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