An investigator-initiated phase II trial of IMmune checkpoint inhibitor And niraparib for patients with homologous recombination repair GENE-mutated unresectable/recurrent advanced solid tumor - IMAGENE-01

Kato Taigo0 个研究点目标入组 57 人开始时间: 2021年11月9日最近更新: 2023年11月20日

适应症

试验速览

阶段: 2 期
状态: 招募中
发起方
入组人数: 57

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: >= 18age old 至 ot applicable（—）
性别: All

入选标准

•1) Malignant progression after one or more standard therapy by PD-1/PD-L1 inhibitors, and completion of standard therapy in principle
•2) Diagnosed with the target disease (Unresectable advanced or recurrent urothelial cancer, renal cancer, gastric cancer, esophageal cancer, head and neck cancer, malignant melanoma) with HRR gene mutation in the germline or somatic cells which were detected by the specified tests
•3) Measurable lesions
•4) Participating in or planning to participate in MONSTAR-SCREEN-2 study
•5) Legal adult on informed consent
•6) ECOG PS: 0 or 1
•7) Appropriate physical function confirmed by laboratory values within 14 days before enrollment
•8) (Female of childbearing potential) Agreed to contraception and not to donate oocytes from the consent to 180 days after the last dose of Niraparib
•9) (Male) Agreed to contraception from the start of study treatment to 180 days after the last dose of Niraparib, and agreed not to donate sperms from the start of study treatment to 90 days after the last dose of Niraparib or 120 days after the last dose of a PD-1 inhibitor, whichever is later.
•10) Written consent to participate in the clinical trial

排除标准

•1) Active double and more cancer
•2) History of treatment with PARP inhibitors
•3) Moderate or severe ascites observed by CT or MRI performed within 28 days prior to the enrollment
•4) Diagnosed with carcinomatous meningitis, symptomatic brain metastases, or spinal metastases requiring surgical intervention at the enrollment,
•5) Received systemic steroid therapy (10 mg/day or more dose equivalent to prednisolone) or immunosuppressants within 14 days before enrollment
•6) Received any cytotoxic anticancer drugs, molecular-targeted drugs or antibodies for aimed at treating cancer within a certain period of time before enrollment
•7) Performed surgery with systemic anesthesia within 21 days before enrollment, or unrecovered fully from the complications of the surgery
•8) Performed radiation therapy within 14 days before enrollment, or requiring corticosteroids (10 mg/day or more dose equivalent to prednisolone) without recovery from radiation therapy-related toxicity
•9) Historic or coexisting symptomatic congestive heart failure (NYHA Classes 2-4) within 6 months before enrollment, or arrhythmia requiring treatment
•10) Historic or coexisting myocardial infarction or unstable angina within 6 months before enrollment
•11) Uncontrolled hypertension at the enrollment
•12) Lymphatic malignancy at the enrollment.
•13) History of myelodysplastic syndrome or acute myeloid leukemia
•14) History of bone marrow transplantation or organ transplantation
•15) Historic or coexisting noninfectious interstitial lung disease or pneumonitis requiring steroid therapy at the enrollment
•16) Active autoimmune disease requiring systemic therapy within 2 years before enrollment
•17) Received live vaccines within 30 days before the scheduled start of protocol treatment
•18) Infections requiring intravenous antibiotics, antivirals or antifungals at the enrollment
•19) Active hepatitis B at the enrollment
•20) Positive HIV antibody, HTLV -1 antibody or HCV antibody at the enrollment
•21) Unrecovered adverse events to Grade 1 or less
•22) Serious hypersensitivity to components of drugs used in protocol therapy identified at the enrollment
•23) Rare genetic disorders of lactose intolerance, Lapp lactase deficiency or glucose/galactose malabsorption
•24) (Female) Pregnant (including suspected pregnancy) or breastfeeding
•25) Psychosis or psychiatric symptoms judged as difficult to participate in the study by the investigator
•26) Permanently discontinuation of PD-1/PD-L1 inhibitors in the prior therapy due to immune-mediated adverse events

研究者

发起方

Kato Taigo

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