2024-518173-34-00招募中2 期
LAPTOP: PHASE 1/2 STUDY IN BORDELINE RESECTABLE, LOCALLY ADVANCED OR METASTATIC PANCREATIC CANCER TO ASSESS SAFETY AND POTENTIAL EFFICACY OF DUAL CHECKPOINT INHIBITION IN COMBINATION WITH GEMCITABINE AND NAB-PACLITAXEL FOLLOWED BY IMMUNE-CHEMORADIATION.
Region Hovedstaden1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年10月8日最近更新:
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Incidence of treatment-related AEs, SAEs, AEs leading to discontinuation, death, and laboratory abnormalities
研究概览
简要总结
To evaluate the safety and toxicity profile of nivolumab with ipilimumab in combination with standard chemotherapy and followed by nivolumab in combination with gemcitabine and nab-paclitaxel and magnetic resonance imaging (MRI) and/or computed tomography (CT)-guided adaptive SBRT for the treatment of BRPC, LAPC or mPC.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent o Subjects must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care o Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study
- •Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. The investigator shall review contraception methods and the time period that contraception must be followed. Men that are sexually active with WOCBP must follow instructions for birth control when the half-life of the investigational drug is greater than 24 hours, contraception should be continued for a period of 90 days plus the time required for the investigational drug to undergo five half-lives. Men who are sexually active with WOCBP must continue contraception for 31 weeks (90 days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug. Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile) as well as azoospermic men do not require contraception
- •Subjects must have signed and dated a BIOPAC approved written informed consent form in accordance with regulatory and institutional guidelines
- •Histological or cytological confirmation of BRPC, LAPC or mPC prior to entering this study
- •No prior chemotherapy regimens received for PC
- •Age 18 years or older
- •Life expectancy greater than 6 months
- •ECOG/WHO Performance Status (PS) 0-1
- •All participants will be required to undergo mandatory pre- and on-treatment biopsies at acceptable clinical risk as judged by the investigator. An archival pre-treatment sample is acceptable
- •Patients must have normal organ and marrow function as defined below: o Absolute neutrophil count (ANC) ≥ 1.5 x 10⁹/L o Platelet count ≥ 100 x 10⁹/L o Serum bilirubin ≤ 1.5 x upper limit of normal (ULN) (patients with Gilbert's Syndrome must have a total bilirubin ≤ 50 mmol/L) o Aspartate transaminase (AST)/Alanine transaminase (ALT) ≤ 5 x ULN o Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL/min (using the Cockcroft-Gault formula)
- •Women of childbearing potential (WOCBP) must use method(s) of contraception as indicated in Appendix
- •For a teratogenic study drug and/or when there is insufficient information to assess teratogenicity (preclinical studies have not beendone), a highly effective method(s) of contraception (failure rate of less than 1% per year) is required. The individual methods of contraception and duration should be determined in consultation with the investigator. WOCBP must follow instructions for birth control when the half-life of the investigational drug is greater than 24 hours, contraception should be continued for a period of 30 days plus the time required for the investigational drug to undergo five half-lives. The half-life of nivolumab and ipilimumab is up to 25 days and 18 days, respectively. WOCBP should therefore use an adequate method to avoid pregnancy for 23 weeks (30 days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug
排除标准
- •Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
- •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
- •Participants with active, known or suspected autoimmune disease. Participants with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- •Participants with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
- •Patients should be excluded if they have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
- •Allergies and Adverse Drug Reaction o History of allergy to study drug components o History of severe hypersensitivity reaction to any monoclonal antibody
- •WOCBP who are pregnant or breastfeeding
结局指标
主要结局
Incidence of treatment-related AEs, SAEs, AEs leading to discontinuation, death, and laboratory abnormalities
Incidence of treatment-related AEs, SAEs, AEs leading to discontinuation, death, and laboratory abnormalities
次要结局
- Median PFS using RECIST v1.1 and PFSR at 6, 9, and 12 months
- Median OS and OSR at 6 months, 1 year, and 2 years
- Objective Response Rate (ORR) and median duration of response (DOR) by RECIST v1.1
- Rate of downstaging to surgical resection
研究者
Sponsor Investigator Inna Chen
Scientific
Region Hovedstaden
研究点 (1)
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