Nivolumab and Ipilimumab in Mucinous Colorectal and Appendiceal Tumors
赞助:
Abramson Cancer Center of the University of Pennsylvania
合作者:
信息的提供 (责任方):
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| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | October 1, 2018 | ||
| 首次发布日期e ICMJE | October 3, 2018 | ||
| 最后更新发布日期 | October 3, 2018 | ||
| 预计研究开始日期 ICMJE | November 2018 | ||
| 预计主要完成日期 | November 2020 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Six-month progression-free survival[ Time Frame: 6 months ] To determine six-month progression-free survival by iRECIST |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Nivolumab and Ipilimumab in Mucinous Colorectal and Appendiceal Tumors | ||
| 正式标题 ICMJE | A Phase II Study of Nivolumab and Ipilimumab in Mucinous Colorectal and Appendiceal Tumors | ||
| 简要概况 | This is a single-arm phase II study of twenty-one subjects with mucinous adenocarcinoma of the colon, rectum, or appendix with prior systemic therapy with a fluoropyrimidine, oxaliplatin, and irinotecan. Treatment will consist of nivolumab 480mg every 4 weeks and ipilimumab 1mg/kg every 8 weeks until disease progression, unacceptable toxicity, or 2 years of therapy. |
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| 详细说明 | |||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | Phase 2 | ||
| 研究设计 ICMJE | 分配: 干预模型: Single Group Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Treatment |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Not yet recruiting | ||
| 预计入组 ICMJE |
21 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | November 2023 | ||
| 预计主要完成日期 | November 2020 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - Subjects must have signed and dated an IRB-approved written informed consent form prior to the performance of any protocol-related procedures that are not part of standard care. - Colorectal or appendiceal mucinous adenocarcinoma with peritoneal-only metastatic disease. It is recognized that in some patients, peritoneal disease will predominate without distinction of the site of origin, and such patients will be eligible. - Microsatellite stable by PCR and/or mismatch repair proficient by immunohistochemistry - ECOG performance status of 0 or 1 - Prior therapy with a fluoropyrimidine, oxaliplatin, and irinotecan unless contraindicated or refused. Prior treatment with antiangiogenic and/or anti-EGFR antibody therapy is permitted but not required - Measurable disease by RECIST v. 1.1 - Laboratory parameters: - Absolute neutrophil count > 1500/μL - Platelets > 100,000/μL - Hemoglobin > 9.0 g/dL - PT/INR or PTT < 1.5xULN - Creatinine < 1.5xULN OR creatinine clearance > 50 mL/min by Cockcroft-Gault formula - Total bilirubin < 1.5xULN - Subjects with Gilbert's Syndrome must have a total bilirubin level of < 3.0xULN - Albumin > 3.0 g/dL - AST and/or ALT: < 3.0×ULN - Subjects with HIV are permitted provided they meet the following criteria: - CD4+ cell count > 250 cells/mm3 - No history of AIDS-defining conditions other than low CD4+ count - If subject is on antiretroviral therapy, there must not be expected significant drug-drug interactions with study treatment Exclusion Criteria: - Bowel obstruction within the past 60 days - Subjects who are currently pregnant, planning to become pregnant, or breast-feeding. - Females participants of child-bearing potential are required to use an effective contraception method or abstain from intercourse during treatment and for at least 5 months following the last dose - Males participants with partners of child-bearing potential are required to use an effective contraception method or abstain from intercourse during treatment and for at least 7 months following the last dose - Subjects who, in the opinion of the physician, would not be clinically appropriate for receipt of the therapy regimen associated with participation - Subjects with contraindications to immune checkpoint therapy, as follows: - Interstitial lung disease that is symptomatic or may interfere with the detection and management of suspected drug-related pulmonary toxicity - Prior organ allograft or allogeneic bone marrow transplantation - Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication - Active autoimmune disease, except for vitiligo, type 1 diabetes mellitus, asthma, atopic dermatitis, or endocrinopathies manageable by hormone replacement; other autoimmune conditions may be allowable at the discretion of the principal investigator - Condition requiring systemic treatment with corticosteroids - Systemic steroids at physiologic doses (equivalent to dose of oral prednisone 10 mg) are permitted. - Intranasal, inhaled, topical, intra-articular, and ocular corticosteroids with minimal systemic absorption are permitted. - Established non-peritoneal metastatic disease, including but not limited to metastases to the liver, lung, brain, extra-abdominal lymph nodes, and bone - A second primary malignancy that, in the judgment of the investigator, may affect interpretation of results - Prior treatment with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody - Toxicities attributed to prior anti-cancer therapy other than alopecia, fatigue, and peripheral neuropathy must have resolved to Grade 1 or baseline before administration of study drug. In addition, a washout period will be required for prior therapies as specified: - No chemotherapy within 14 days prior to first dose - No investigational product(s) (IPs) and/or biologic therapy within 28 days or 5 half-lives, whichever is longer, prior to first dose - No major surgery within 28 days prior to first dose. Any surgery-related AE(s) must have resolved at least 14 days prior to first dose. - No radiation therapy with curative intent within 28 days prior to first dose. Prior focal palliative radiotherapy must have been completed at least 14 days prior to first dose. - Active hepatitis B or hepatitis C, defined as the following: - Hepatitis B surface antigen positive or HBV DNA PCR >100 IU/mL - Hepatitis C antibody positive unless HCV RNA PCR is negative (i.e. undetectable viral load) - Prisoners or participants who are involuntarily incarcerated. (Note: under specific circumstances a person who has been imprisoned may be included as a participant. Strict conditions apply and BMS approval is required.) - Participants who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness | ||
| 性别 |
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| 年龄 | 最小年龄：18 Years ，最大年龄：N/A | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | United States | ||
| 管理信息 | 数据检测委员会 | Yes | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: Yes 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | ， | ||
| 研究赞助商 ICMJE | Abramson Cancer Center of the University of Pennsylvania | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | |||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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