Adjuvant/Neoadjuvant Immunotherapy in Melanoma Based on Serial Plasma ctDNA Monitoring
The purpose of the study is to see if periodic (serial) blood-based testing of ctDNA (circulating tumor DNA) while receiving study treatment with study drug therapy for advanced melanoma (skin cancer) can be used to decide the best plan for care during and after initial study drug treatment.
研究概览
研究类型
注册 (估计的)
阶段
- 阶段2
联系人和位置
学习联系方式
- 姓名：Anjana Menon
- 电话号码：813-745-5537
- 邮箱：Anjana.Menon@moffitt.org
学习地点
-
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Florida
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Tampa、Florida、美国、33612
- 招聘中
- Moffitt Cancer Center
-
副研究员：
- Ahmad Tarhini, MD
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副研究员：
- Nikhil Khushalani, MD
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副研究员：
- Andrew Brohl, MD
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首席研究员：
- Zeynep Eroglu, MD
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副研究员：
- Edith Abraham, MD
-
副研究员：
- Lilit Karapetyan, MD
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副研究员：
- Joseph Markowitz, MD
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age ≥18 years
- Histologically confirmed melanoma (excluding uveal melanoma)
- Neoadjuvant Cohort: Surgically resectable AJCC 8th edition Stage III or Stage IV melanoma
- Adjuvant Cohort: Completely resected AJCC 8th edition Stage IIB, IIC, III, or IV melanoma
- ECOG Performance Status ≤2
- Adequate organ function: AST and ALT ≤5 × upper limit of normal (ULN) and Creatinine ≤2 × ULN.
- Baseline imaging obtained within 28 days prior to treatment initiation
- Negative pregnancy test for women of childbearing potential
- Ability to understand and sign informed consent
Exclusion Criteria:
- Prior anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 therapy within 1 year before enrollment
- Contraindication to nivolumab and/or ipilimumab
- Active autoimmune disease requiring systemic immunosuppressive therapy
- Concurrent malignancy requiring active treatment that could interfere with study treatment or assessments
- Unresectable disease
- Uveal melanoma
- Any medical, psychiatric, or social condition that would interfere with protocol compliance or study participation
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Neoadjuvant cohort
Patients with resectable stage III/IV melanoma eligible for neoadjuvant treatment will be enrolled. Patient cases will be reviewed with the surgery team to confirm surgical resectability prior to enrollment and CT imaging will be obtained at baseline, as per standard of care. |
Administered intravenously as neoadjuvant and/or adjuvant therapy for melanoma according to protocol-defined dosing schedules. Administered intravenously in combination with nivolumab in participants meeting ctDNA-defined criteria for treatment escalation. Tumor-informed circulating tumor DNA assay performed on serial plasma samples to evaluate molecular residual disease and guide treatment adaptation. |
|
实验性的：Adjuvant cohort
Patients who already underwent complete surgical resection of stage IIB/IIC/III/IV melanoma (and did not receive prior neoadjuvant treatment.) All patients in this cohort must be within 10 weeks of surgery and have CT scans post-surgery prior to study enrollment to confirm they are radiographically disease-free. Following study enrollment, all patients will have the first ctDNA analyses done within 12 weeks of date of surgery. |
Administered intravenously as neoadjuvant and/or adjuvant therapy for melanoma according to protocol-defined dosing schedules. Administered intravenously in combination with nivolumab in participants meeting ctDNA-defined criteria for treatment escalation. Tumor-informed circulating tumor DNA assay performed on serial plasma samples to evaluate molecular residual disease and guide treatment adaptation. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Event-Free Survival (EFS) in the Neoadjuvant Cohort
大体时间：Up to 5 Years
|
Defined as the time from initiation of study treatment to disease progression precluding surgery, melanoma recurrence, progression, or death from any cause. |
Up to 5 Years
|
|
Relapse-Free Survival (RFS) in the Adjuvant Cohort
大体时间：Up to 5 years
|
Defined as the time from initiation of adjuvant treatment to melanoma recurrence or death from any cause. |
Up to 5 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pathologic Response Rate (Neoadjuvant Cohort)
大体时间：Up to 12 weeks
|
Proportion of participants achieving pathologic response in the surgical specimen following neoadjuvant treatment, including pathologic complete response (pCR) and major pathologic response (MPR). |
Up to 12 weeks
|
|
Objective Response Rate (ORR) by RECIST v1.1 (Neoadjuvant Cohort)
大体时间：Up to 12 weeks
|
Proportion of participants achieving a complete response or partial response according to RECIST version 1.1 based on radiographic assessments performed during neoadjuvant treatment. |
Up to 12 weeks
|
|
Relapse With Undetectable ctDNA
大体时间：Up to 5 years
|
Frequency of participants who maintain undetectable circulating tumor DNA (ctDNA) during serial monitoring and subsequently experience clinical and/or radiographic melanoma relapse. |
Up to 5 years
|
合作者和调查者
调查人员
- 首席研究员：Zeynep Eroglu, MD、Moffitt Cancer Center
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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