A PHASE II, OPEN LABEL, RANDOMIZED, NON-COMPARATIVE COHORTS STUDY OF ADJUVANT ATEZOLIZUMAB OR ATEZOLIZUMAB PLUS TIRAGOLUMAB IN SOLID TUMORS WITH RESECTABLE DISEASE WITH INTERMEDIATE-HIGH RISK OF RECURRENCE AND HIGH TUMOR MUTATIONAL BURDEN (TMB-H) OR MICROSATELLITE INSTABILITY (MSI-H) (IMperator) - ML43332

Roche Farma S.A.0 个研究点目标入组 40 人开始时间: 2024年5月8日最近更新: 2024年7月22日

试验速览

阶段: 1 期
状态: 招募中
发起方
入组人数: 40

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: 18 至 65+（—）
性别: All

入选标准

•Signed Informed Consent Form (ICF), For female patients of childbearing potential, agreement to use a highly effective form(s) of contraception that results in a low failure rate when used consistently and correctly, For male patients with female partners of childbearing potential, agreement to use a highly effective form(s) of contraception that results in a low failure rate when used consistently and correctly, Oral contraception should always be combined with an additional contraceptive method because of a potential interaction with the study drugs, Women not postmenopausal or surgically sterile must have a negative serum pregnancy test result. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy., Male or female, 18 years of age or older, ECOG performance status of 0 to 1, Solid tumors considered to be resectable with a curative intent with known high TMB/MSI-H, Patients must undergo standard treatment according to the stage of their disease, All patients must be disease free after standard therapy to be included in this study, TMB = 13 mut/MB or MSI-H in tumor tissue biopsy, Patients must be at intermediate/high risk of recurrence, Adequate hematologic and organ function

排除标准

•Previous malignancies within 3 years prior to enrollment, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome, History of idiopathic pulmonary fibrosis, organizing pneumonia, druginduced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan, Severe infections within 4 weeks prior to be included in the study, Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction, or cerebrovascular accident within 3 months prior to inclusion, unstable arrhythmias, or unstable angina, Treatment with systemic immunosuppressive medications within 2 weeks prior to inclusion, Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patient at high risk from treatment complications, Active tuberculosis, Major surgical procedure within 28 days prior to study treatment or anticipation of need for a major surgical procedure during the course of the study, Administration of a live, attenuated vaccine within 4 weeks prior to initiation of study treatment or anticipation that such a live attenuated vaccine will be required during the study, Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives of the drug, whichever is longer, prior to randomization, Patients with illnesses or conditions that interfere with their capacity to understand, follow, and/or comply with study procedures, Prior cancer immunotherapy, Any contraindication for surgery and/or systemic therapy and cancer immunotherapy, Known serine/threonine kinase 11 (STK-11) ligand alterations, mouse double minute 2 (MDM2) homolog amplifications, Women who are pregnant, lactating, or intending to become pregnant during the study, History of autoimmune disease, Positive test for human immunodeficiency virus, Patients with active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen test at screening) or hepatitis C

研究者

发起方

Roche Farma S.A.

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