Nivolumab Based Immunotherapy for Treatment of High Grade Cervical Dysplasia
2019年1月17日 更新者:University of Texas Southwestern Medical Center
Phase II Trial of Nivolumab Based Immunotherapy for the Treatment of High-Grade Cervical Dysplasia
The study design is a phase II interventional trial for women with biopsy proven high-grade cervical dysplasia.
The study is an open label study and randomized.
The study will have two arms.
Patients will be randomized to both arms.
研究概览
详细说明
High-grade cervical dysplasia (cervical intraepithelial neoplasia (CIN) II/III), is both detectable and quantifiable, which presents many opportunities for evaluation or early treatment, intervention and eventually, for cancer prevention.
High-grade dysplasia is typically detected during cervical cancer screening with a pap smear.
To determine the pathologic response rate of high grade cervical dysplasia with PD-1 checkpoint modulation with Nivolumab.This is a randomized phase II trial with two experimental arms (1 dose of nivolumab and 3 doses of nivolumab).
研究类型
介入性
阶段
- 阶段2
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
女性
描述
Inclusion Criteria:
- Adult female subjects (age 18 years or older)
- Performance status ECOG 0-1
- All patients must have cervical biopsies demonstrating high-grade cervical dysplasia.
- All patients must have a satisfactory colposcopy with visualization of the entire squamo-columnar junction
- All patients must be candidates for a cervical conization procedure or LEEP procedure
- The patient is able and willing to comply with study procedures, and signed and dated informed consent is obtained before any study-related procedure is performed
- Negative screening test results for hepatitis B, hepatitis C, and human immunodeficiency virus
- At least six weeks must have elapsed from any prior chemotherapy, radiation therapy or immunotherapy
Patients must have adequate:
- Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl. Platelets greater than or equal to100, 000/mcl. Hemoglobin > 9 gm/dL.
- Renal function: creatinine less than or equal to institutional upper limit normal (ULN) or calculated creatinine clearance (Cockcroft-Gault) ≥ 50 ml/min.
- Serum creatinine </= 1.5xULN or creatinine clearance (CrCl) >/=50 mL/min (using the Cockcroft-Gault formula)
- Female CrCl = (140-age in years) x weight in kg x 0.85 72 x serum creatinine in mg/dL
- Metabolic function: Calcium, Magnesium, Phosphate, and Potassium levels within institutional normal limits.
- Hepatic function: Bilirubin less than or equal to 1.5 x ULN. AST and ALT less than or equal to 3 ULN and alkaline phosphatase less than or equal to 2.5 x ULN.
- Patients must have signed an approved informed consent and authorization permitting release of personal health information.
- Patients of childbearing potential must have a negative serum pregnancy test prior to the study entry and be practicing an effective form of contraception. The effects of Nivolumab on the developing human fetus are unknown. For this reason and because other therapeutic agents or modalities used in this trial are known to be teratogenic, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, through the duration of study participation and for a period of 5 months after the last dose of nivolumab. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Exclusion Criteria:
- The patient is lactating or pregnant
- The colposcopy is inadequate; the entire transformation zone is not visualized and endocervical curettage is positive for high-grade dysplasia
- Clinical concern for invasive cervical cancer
- Patients must not have received any prior oncology vaccine therapy
- Intercurrent medical illnesses that would impair patient tolerance to participation
- Any concurrent medical condition requiring the use of systemic steroids is not permitted (the use of inhaled or topic steroids is permitted)
- Concurrent treatment with chemotherapy, radiation therapy or immunotherapy for intercurrent illnesses
- Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results;
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways;
- Subjects with an active, known or suspected autoimmune disease. Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll;
- Subjects with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity
- Subjects with history of life-threatening toxicity, including hypersensitivity reaction, related to prior immunoglobulin treatment for another condition or any other study drug component.
- History or evidence upon physical/neurological examination of other central nervous system condition (e.g., seizures, abscess) unrelated to cancer, unless adequately controlled by medication or considered not potentially interfering with protocol treatment;
- Surgical procedure <7 days prior to study treatment, vascular access device no restriction;
- Subjects unable (e.g., due to pacemaker or ICD device) or unwilling to have a contrast-enhanced MRI of the head;
- History of allergy or hypersensitivity to study drug components
- Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids, and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
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:随机化
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
有源比较器:Arm 1
Nivolumab, 3 mg/kg Iv, day 1
|
Protocol dose: 3mg/kg mg as a 30-minute IV infusion on Day 1 (Arm I) or Days 1, 15, 29 (Arm II).
其他名称:
|
有源比较器:Arm 2
Nivolumab, 3 mg/kg IV, days 1, 15, 29
|
Protocol dose: 3mg/kg mg as a 30-minute IV infusion on Day 1 (Arm I) or Days 1, 15, 29 (Arm II).
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 |
---|---|---|
Rate of regression on high grade dysplasia lesions
大体时间:15 weeks after the beginning of immunotherapy
|
The endpoints of the current study will be to determine the rate of spontaneous regression on high grade dysplasia lesions
|
15 weeks after the beginning of immunotherapy
|
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:Jayanthi Lea, MD、Univeristy of Texas Southwestern Medical Center
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 (预期的)
2019年1月15日
初级完成 (预期的)
2019年6月1日
研究完成 (预期的)
2020年6月1日
研究注册日期
首次提交
2019年1月15日
首先提交符合 QC 标准的
2019年1月15日
首次发布 (实际的)
2019年1月17日
研究记录更新
最后更新发布 (实际的)
2019年1月18日
上次提交的符合 QC 标准的更新
2019年1月17日
最后验证
2019年1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.
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