CTIS2023-506823-28-00进行中（未招募）1 期
EMPIRE : Targeting MDM2 and PD1 in tumors with tertiary lymphoid structures - IB 2023-02
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
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
- •Histologically or cytologically confirmed diagnosis: - For cohort A: soft-tissue sarcoma. As recommended by the French NCI, diagnosis must be reviewed or confirmed by the RRePS Network (Réseau de référence en pathologie des sarcomes et des viscères) as recommended by the French NCI (Institut National du Cancer, Inca). - For cohort B: non-small cell lung cancer (NSCLC) or triple negative breast cancer (TNBC) or MMS colorectal cancer (MSS-CCR) or biliary tract cancer (BTC), Life expectancy = 8 weeks, Adequate hematologic and end-organ function as defined below: a) Abolute neutrophil count (ANC) = 1.5 G/l b) Platelet count = 100 G/l c) Hemoglobin = 8.5 g/dL (if applicable, previous transfusion at least 4 weeks before screening laboratory assessment) d) Total bilirubin = 1.5 x upper limit of normal (ULN), with the following exception: patients with known Gilbert’s syndrome who have a serum bilirubin = 3 x ULN may be enrolled. e) AST and ALT = 2.5 x ULN, with the following exception: patients with liver metastases who have an AST or ALT = 5 x ULN may be enrolled. f) Uncontrolled or symptomatic hypercalcemia (ionized calcium = 1.5 mmol/L, calcium = 12 mg/dL, or corrected calcium = ULN) g) INR or PT and aPTT = 1.5 x ULN, Disease progression on prior treatment, or previously untreated disease with no available acceptable treatment, Recovery to grade = 1 from any adverse event (AE) derived from previous treatment (excluding alopecia and vitiligo of any grade and non-painful peripheral neuropathy grade = 2) according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, version 5.0), Ability to comply with the study protocol, in the investigator's judgment, Female subjects of childbearing potential must have a negative serum pregnancy test within 14 days prior to the first dose of study treatment. Serum or urine pregnancy test must be repeated within 72 hours prior to receiving the first dose of study medication, Both women of childbearing potential and men must agree to use two medically acceptable methods of contraception throughout the treatment period and for: - Women: 6 months and 12 days after end of BI 907828; 6 months after end of ezabenlimab. - Men: 102 days after end of BI 907828; 11 months after end of ezabenlimab, No prior or concurrent malignant disease diagnosed or treated in the last 2 years except for: a. superficial/non-invasive bladder cancer, or basal or squamous cell carcinoma in situ treated with curative intent; b. endoscopically resected GI cancers limited to the mucosal layer without recurrence in > 1 year, Voluntarily signed and dated written informed consent prior to any study specific procedure, Patients with a social security in compliance with the French law, Age = 18 years, Advanced/unresectable and/or metastatic disease, Mature TLS positive status: tumors will be considered mature TLS-positive when containing either a visible germinal center on HES or a meshwork of CD23+ follicular dendritic cells or isolated CD23+ dendritic cell if the cell harbored a morphology fitting with dendritic differentiation (i.e., cytoplasmic dendritic extensions). Mature TLS displaying germinal centers visible on HES are confirmed with a double CD20/CD23 staining. Note that for TLS status, ensure the availability of archived FFPE (Formalin-Fixed Paraffin-Embedded) tumor tissue sample or tumor material newly obtained by biopsy. Except if TLS analysis have been already performed by Biopathological plat
排除标准
- •Prior treatment with ezabenlimab and/or BI 907828,, Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of ezabenlimab combined with BI 907828. Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study., Prior allogeneic stem cell or solid organ transplantation, History of leptomeningeal disease, Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of ezabenlimab combined with BI 907828, or anticipation of need for such a vaccine during treatment or within 6 months after the final dose ezabenlimab combined with BI 907828. Seasonal flu vaccines that do not contain a live virus are permitted,, Current treatment with anti-viral therapy for HBV, Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 [IL-2]) within 4 weeks or 5 drug elimination half-lives (whichever is longer) prior to initiation of ezabenlimab combined with BI 907828, Participation to a study involving a medical or therapeutic intervention in the last 30 days,, Treatment with systemic immunosuppressive medication (including, but not limited to corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-a agents) within 2 weeks prior to initiation of ezabenlimab combined with BI 907828, or anticipation of need for systemic immunosuppressive medication during ezabenlimabcombined with BI 907828, with the following exceptions: - Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy, a one-time dose of dexamethasone for nausea or chronic use of =10 mg/day of prednisone or dose-equivalent corticosteroid) are eligible for the study. The use of inhaled corticosteroids is allowed. - Patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study, Patients with oral anticoagulation based on Vitamin K antagonist., Previous enrolment in the present study,, Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or higher), myocardial infarction, or cerebrovascular accident within 3 months prior to enrollment, unstable arrhythmias, or unstable angina, Patient unable to follow and comply with the study procedures because of any geographical, social or psychological reasons,, Inability to swallow,, History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins,, Primary CNS tumors with any of the following characteristics: - History of intracranial hemorrhage or spinal cord hemorrhage - Neurosurgical resection or brain biopsy to the primary brain tumor within 28 days of Cycle 1 Day 1, Known hypersensitivity to Chinese hamster ovary cell products or to any component of the ezabenlimabor BI 907828 formulation,, Symptomatic or actively progressing central nervous system (CNS) metastases. Note that asymptomatic patients with treated or untreated CNS metastases are eligible, provided that all of the following criteria are met: - No ongoing requirement for corticosteroids as therapy for CNS metastases - No evidence of interim progression b
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