NCT06941857招募中2 期
A Phase 2 Study of NC410 and FOLFIRINOX in Combination With Nivolumab With or Without Ipilimumab in Patients With Treatment-naïve, Metastatic Pancreatic Cancer
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年9月4日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Number of participants experiencing unexpected toxicities. Unexpected toxicities are toxicities related to the study drug required treatment discontinuation.
研究概览
简要总结
The purpose of this study is to evaluate safety of the treatment regimen and identify any novel toxicities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 -
- •Metastatic histologically or cytologically confirmed pancreatic ductal adenocarcinoma.
- •Have metastatic disease
- •Must not have received prior systemic treatment for pancreatic cancer.
- •Have measurable disease based on RECIST 1.
- •Patients must have adequate organ and marrow function defined by study-specified laboratory tests and procedures.
- •Women of childbearing potential (WOCBP) must have a negative serum pregnancy test.
- •For both Women and Men, must use acceptable form of birth control while on study.
- •Must understand the study regimen, its requirements, risks and discomforts and is able and willing to sign the informed consent form in accordance with regulatory and institutional guidelines.
排除标准
- •Have had prior chemotherapy for pancreatic cancer or prior chemotherapy within 5 years of enrollment for other cancer diagnoses.
- •Has received radiotherapy for pancreatic cancer.
- •Are receiving or have received any investigational agent or used an investigational device within 28 days prior to Day 1 of treatment in this study.
- •Has undergone major surgery, other than diagnostic surgery (i.e. surgery done to obtain a biopsy for diagnosis or an aborted Whipple), within 28 days prior to Day 1 of treatment in this study.
- •Is expected to require any other form of systemic or localized antineoplastic therapy while on study.
- •Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, or anti-Lag-3 antibodies.
- •Has received a live vaccine or live-attenuated vaccine within 28 days prior to the first dose of study drug.
- •Prior tissue or organ allograft regardless of need for immunosuppression, including corneal allograft.
- •Has uncontrolled acute or chronic medical illness.
- •Has history of central nervous system (CNS) metastases and/or carcinomatous meningitis.
- •Has known additional malignancy that is progressing and requires active treatment.
- •Has active autoimmune disease.
- •Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent).
- •Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- •Requirement for daily supplemental oxygen.
- •History of interstitial lung disease, non-infectious pneumonitis or uncontrolled lung diseases including pulmonary fibrosis, acute lung diseases, chronic obstructive pulmonary disease (COPD), asthma requiring medication, etc.
- •Known history of human immunodeficiency virus (HIV).
- •Active or chronic hepatitis B or hepatitis C.
- •Unable to undergo venipuncture and/or tolerate venous access.
- •Has known psychiatric or substance use disorder that would interfere with cooperation with the requirements of the trial.
- •Pregnant or breastfeeding
- •A WOCBP who has a positive urine pregnancy test within 72 hours prior to study drug initiation.
研究组 & 干预措施
Arm 1 - FOLFIRINOX/NC410/Nivolumab
Experimental
干预措施: Irinotecan (Drug)
Arm 2 - FOLFIRINOX/NC410/Nivolumab/Ipilimumab
Experimental
干预措施: Ipilimumab (Drug)
Arm 2 - FOLFIRINOX/NC410/Nivolumab/Ipilimumab
Experimental
干预措施: Oxaliplatin (Drug)
Arm 1 - FOLFIRINOX/NC410/Nivolumab
Experimental
干预措施: Nivolumab (Drug)
Arm 1 - FOLFIRINOX/NC410/Nivolumab
Experimental
干预措施: 5-Fluorouracil (5-FU) (Drug)
Arm 2 - FOLFIRINOX/NC410/Nivolumab/Ipilimumab
Experimental
干预措施: Nivolumab (Drug)
Arm 2 - FOLFIRINOX/NC410/Nivolumab/Ipilimumab
Experimental
干预措施: NC410 (Drug)
Arm 2 - FOLFIRINOX/NC410/Nivolumab/Ipilimumab
Experimental
干预措施: 5-Fluorouracil (5-FU) (Drug)
Arm 2 - FOLFIRINOX/NC410/Nivolumab/Ipilimumab
Experimental
干预措施: Folinic Acid (Drug)
Arm 2 - FOLFIRINOX/NC410/Nivolumab/Ipilimumab
Experimental
干预措施: Irinotecan (Drug)
Arm 1 - FOLFIRINOX/NC410/Nivolumab
Experimental
干预措施: NC410 (Drug)
Arm 1 - FOLFIRINOX/NC410/Nivolumab
Experimental
干预措施: Folinic Acid (Drug)
Arm 1 - FOLFIRINOX/NC410/Nivolumab
Experimental
干预措施: Oxaliplatin (Drug)
结局指标
主要结局
Number of participants experiencing unexpected toxicities. Unexpected toxicities are toxicities related to the study drug required treatment discontinuation.
时间窗: 4 years
When calculating the incidence of Adverse Events (AEs), each AE (as defined by NCI CTCAE v5.0) will be counted only once for a given subject.
次要结局
- Progression- Free Survival (PFS)(4 years)
- Response Rate (ORR)(4 years)
- Disease Control Rate (DCR)(4 years)
- Overall Survival (OS)(4 years)
研究者
研究点 (2)
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