NCT04495010撤回2 期
A Phase 2, Randomized Study of Neoadjuvant Nivolumab Plus Ipilimumab Followed by Adjuvant Nivolumab or Neoadjuvant Nivolumab Plus Ipilimumab Followed by Either Adjuvant Nivolumab or Postsurgical Observation Depending on Pathologic Response Compared With Adjuvant Nivolumab in Treatment-Naive Patients With Resectable Clinically Detectable Stage III Melanoma
Bristol-Myers Squibb118 个研究点 分布在 5 个国家开始时间: 2021年3月31日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 118
- 主要终点
- Event-free survival (EFS)
研究概览
简要总结
The purpose of this study is to evaluate the role of neoadjuvant immunotherapy and to demonstrate high pathologic complete response (pCR) and near pCR rates in melanoma participants with clinically detectable nodal disease and a high risk of recurrence. Neoadjuvant immunotherapy aims to enhance the systemic T-cell response to tumor antigens while detectable tumor is still present, inducing a stronger and broader tumor-specific immune response. Of the neoadjuvant approaches studied within melanoma, the neoadjuvant combination of nivolumab and ipilimumab has demonstrated high pCR and near pCR rates that may translate to prolonged clinical benefit.
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
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
- •Inclusion Criteria:
- •Males and females, ≥ 12 years of age [Except: where local regulations and/or institutional policies do not allow for participants < 18 years of age (adolescent population) to participate. For those sites, the eligible participant population is 18 years of age or local age of majority, inclusive]
- •Diagnosed with cytologically or histologically confirmed Stage IIIB, IIIC, or IIID cutaneous melanoma as per American Joint Committee on Cancer (AJCC) staging system, with ≥ 1 clinically detectable lymph node metastases (N1b, N2b, N3b), which are measurable according to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1)
- •Adult participants and adolescents 16 to 18 years old must have an Eastern Cooperative Oncology Group (ECOG) scale performance status of 0 or
- •Adolescents < 16 years old must have Lanksky Play-Performance Status scale performance of ≥ 60
- •Must be treatment-naïve (ie, no prior systemic anticancer therapy as adjuvant therapy for melanoma or unresectable/metastatic melanoma)
- •Women and men must agree to follow specific methods of contraception, if applicable, while participating in the trial
排除标准
- •Women who are breastfeeding
- •Patients with serious or uncontrolled medical disorders
- •Prior treatment with an anti-programmed cell death protein 1 (PD-1), anti-programmed death-ligand 1 (PD-L1), anti-programmed death-ligand 2 (PD-L2), or anti cytotoxic T-lymphocyte antigen 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Adjuvant treatment
Experimental
干预措施: Nivolumab (Biological)
Neo treat with patho response-driven Adju treat or observation
Experimental
Neoadjuvant treatment with pathologic response-driven Adjuvant treatment or observation
干预措施: Nivolumab (Biological)
Neo treat with patho response-driven Adju treat or observation
Experimental
Neoadjuvant treatment with pathologic response-driven Adjuvant treatment or observation
干预措施: Ipilimumab (Biological)
Neoadjuvant treatment + Adjuvant treatment
Experimental
干预措施: Ipilimumab (Biological)
Neoadjuvant treatment + Adjuvant treatment
Experimental
干预措施: Nivolumab (Biological)
结局指标
主要结局
Event-free survival (EFS)
时间窗: Up to 4 years
次要结局
- Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests(Up to 5 years)
- RFS Time from Adjuvant Therapy(Up to 5 years)
- Incidence of Adverse Events (AEs)(Up to 5 years)
- Incidence of deaths(Up to 5 years)
- Incidence of clinically significant changes in clinical laboratory results: Hematology tests(Up to 5 years)
- RFS by MPR(Up to 5 years)
- Incidence of Serious Adverse Events (SAEs)(Up to 5 years)
- Recurrence-free survival (RFS) Time from Surgery(Up to 5 years)
- Pathologic response rate (pRR) by immune-related pathologic response (irPR)(Up to 5 years)
- Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests(Up to 5 years)
- Change from baseline in Health-related quality of life (HRQoL) by the Trial Outcome Index (TOI) and Melanoma Subscale (MS)(Up to 5 years)
- Concordance major pathologic response (MPR) by local and central pathology Review(Up to 5 years)
研究者
研究点 (118)
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