Safety Testing of Adding Nivolumab to Chemotherapy in Patients With Intermediate and High-Risk Local-Regionally Advanced Head and Neck Cancer
2022年11月22日 更新者：RTOG Foundation, Inc.
Safety Evaluations of Nivolumab (Anti-PD-1) Added To Chemotherapy (CRT) Platforms In Patients With Intermediate And High-Risk Local-Regionally Advanced Head and Neck Squamous Cell Carcinoma
This study will evaluate the safety of adding nivolumab to several chemotherapy platforms with weekly cisplatin, high-dose cisplatin, cetuximab or radiation therapy alone.
研究概览
研究类型
介入性
注册 (实际的)
40
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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California
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Palo Alto、California、美国、94304
- Stanford Cancer Institute
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Florida
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Orlando、Florida、美国、32806
- University of Florida Cancer Center at Orlando Health
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Georgia
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Atlanta、Georgia、美国、30322
- Emory University/Winship Cancer Institute
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Kentucky
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Louisville、Kentucky、美国、40202
- University of Louisville
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Ohio
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Cleveland、Ohio、美国、44106
- University Hospitals Cleveland Medical Center
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Columbus、Ohio、美国、43210
- Ohio State University
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Oregon
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Portland、Oregon、美国、97213
- Providence Portland Medical Center
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Pennsylvania
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Pittsburgh、Pennsylvania、美国、15232
- UPMC - Shadyside Hospital
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Texas
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Houston、Texas、美国、77030
- MD Anderson Cancer Center
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Virginia
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Falls Church、Virginia、美国、22042
- INOVA Fairfax Hospital
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Wisconsin
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Madison、Wisconsin、美国、53792
- University of Wisconsin Hospital and Clinics
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Histologically or cytologically-confirmed diagnosis of HNSCC of the oral cavity, oropharynx, larynx, or hypopharynx.
- Intermediate-risk group: Oropharynx cancer that is p16-positive by immunohistochemistry with smoking status > 10 Pack-years, stage T1-2N2b-N3 OR ≤ 10 pack-years, stage T4N0-N3 or T1-3N3.
High-risk group: Oral cavity, larynx, hypopharynx, or p16-negative oropharynx cancer, stage T1-2N2a-N3 or T3-4-N0-3 based on the following diagnostic workup:
- Mandatory submission of H&E and p16 stained slides for central review of p16 staining is required for oropharyngeal patients and H&E stained slide block (or punch biopsy of paraffin block) for PD-L1 expression analysis for all patients
- History/physical examination within 28 days prior to registration
- Examination by Radiation Oncologist, Medical Oncologist, and Ear, Nose, Throat (ENT) or Head & Neck Surgeon within 28 days prior to registration
- Fiberoptic exam with laryngopharyngoscopy within 28 days prior to registration
- Diagnostic quality, cross sectional imaging of the thorax within 28 days prior to registration; 18-F-FDG-PET/CT or conventional CT are acceptable.
- Diagnostic quality CT or MRI of neck, with contrast, within 28 days prior to registration; a 18-F-FDG-PET/CT of the neck only is acceptable as a substitute if the CT is of diagnostic quality and with IV contrast.
- Age ≥ 18 years
- The trial is open to both genders
Exclusion Criteria:
- Definitive clinical or radiologic evidence of distant (beyond cervical lymph node and neck tissue) metastatic disease.
- Patients with oral cavity cancer are excluded from participation if resection of the primary tumor is considered technically feasible by an oral or head and neck cancers surgical subspecialist.
- Carcinoma of the neck of unknown primary site origin (even if p16-positive).
- Absence of RECIST, v. 1.1 defined measurable disease.
- Gross total excision of both primary and nodal disease; this includes tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease. Patients with RECIST, v. 1.1 evaluable remaining cancer either in the neck or primary site remain eligible.
- Simultaneous primary cancers or separate bilateral primary tumor sites.
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible).
- Prior systemic chemotherapy for the study cancer.
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.
- Patients with active autoimmune disease, with exceptions of vitiligo, type I diabetes mellitus, hypothyroidism and psoriasis.
- Use of systemic corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of study drug administration, with exception of inhaled or topical steroids.
- Known immunosuppressive disease, for example HIV infection or history of bone marrow transplant or chronic lymphocytic leukemia (CLL).
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
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：顺序分配
- 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：Arm 1 (Nivolumab + Cisplatin)
Patients will receive Nivolumab via IV administration every 14 days for 10 doses starting 14 days prior to IMRT.
Cisplatin will be given weekly.
IMRT will be given at 5 fractions per week for 7 weeks for a dose of 70 Gy.
Adjuvant nivolumab every 28 days for 7 doses will be administered starting 3 months after end of chemoradiation.
Adjuvant administration of nivolumab may be discontinued if more than 4 of first 8 patients receive less than 7 doses.
|
Anti-PD-1 targeted immunotherapy
其他名称：
Anti-cancer alkylating agent
其他名称：
High-precision radiotherapy
其他名称：
|
|
实验性的：Arm 2 (Nivolumab + High-dose Cisplatin)
Patients will receive Nivolumab via IV administration starting 14 days prior to IMRT, then Day 1 of IMRT and then every 21 days for 6 doses.
Cisplatin will be given every 21 days for 3 doses.
IMRT will be given at 5 fractions per week for 7 weeks for a dose of 70 Gy.
Adjuvant nivolumab every 28 days for 7 doses will be administered starting 3 months after end of chemoradiation.
Adjuvant administration of nivolumab may be discontinued if more than 4 of first 8 patients receive less than 7 doses.
|
Anti-PD-1 targeted immunotherapy
其他名称：
Anti-cancer alkylating agent
其他名称：
High-precision radiotherapy
其他名称：
|
|
实验性的：Arm 3 (Nivolumab + Cetuximab)
Patients will receive Nivolumab via IV administration every 14 days for 10 doses starting 14 days prior to IMRT.
Cetuximab will be given for 7 doses.
IMRT will be given at 5 fractions per week for 7 weeks for a dose of 70 Gy.
Adjuvant nivolumab every 28 days for 7 doses will be administered starting 3 months after end of chemoradiation.
Adjuvant administration of nivolumab may be discontinued if more than 4 of first 8 patients receive less than 7 doses.
|
Anti-PD-1 targeted immunotherapy
其他名称：
High-precision radiotherapy
其他名称：
Epidermal Growth Factor Receptor (EGFR) antagonist
其他名称：
|
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实验性的：Arm 4 (Nivolumab + IMRT)
Patients will receive Nivolumab via IV administration every 14 days for 10 doses starting 14 days prior to IMRT.
IMRT will be given at 5 fractions per week for 7 weeks for a dose of 70 Gy.
Adjuvant nivolumab every 28 days for 7 doses will be administered starting 3 months after end of chemoradiation.
Adjuvant administration of nivolumab may be discontinued if more than 4 of first 8 patients receive less than 7 doses.
|
Anti-PD-1 targeted immunotherapy
其他名称：
High-precision radiotherapy
其他名称：
|
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 |
|---|---|---|
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Dose Limiting Toxicity (DLT)
大体时间：From the first dose of nivolumab to 28 days after the completion of radiation therapy.
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A nivolumab attributable, dose-limiting toxicity (DLT) will be defined as follows: 1) Any ≥ grade 3 adverse event (CTCAE, v. 4) that is related to nivolumab that does not resolve to grade 1 or less within 28 days; 2) A delay in radiotherapy of > 2 weeks due to toxicity related to nivolumab; 3) Inability to complete radiotherapy due to toxicity related to nivolumab; 4) Inability to receive an adequate dose (≥ 70%) of cisplatin (Arm 1 and 2) or cetuximab (Arm 3) due to toxicity definitely related to nivolumab. |
From the first dose of nivolumab to 28 days after the completion of radiation therapy.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Maura Gillison, MD, PhD、RTOG Foundation
- 首席研究员：Robert Ferris, MD, PhD、RTOG Foundation
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2016年6月1日
初级完成 (实际的)
2018年9月25日
研究完成 (实际的)
2022年2月21日
研究注册日期
首次提交
2016年5月4日
首先提交符合 QC 标准的
2016年5月4日
首次发布 (估计)
2016年5月6日
研究记录更新
最后更新发布 (实际的)
2022年11月29日
上次提交的符合 QC 标准的更新
2022年11月22日
最后验证
2022年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.