EUCTR2020-000531-47-DE进行中（未招募）1 期
A PHASE Ib, OPEN-LABEL, MULTICOHORT STUDY OF THE SAFETY, EFFICACY, AND PHARMACOKINETICS OF TIRAGOLUMAB IN COMBINATION WITH ATEZOLIZUMAB AND CHEMOTHERAPY IN PATIENTS WITH TRIPLE-NEGATIVE BREAST CANCER.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •General Inclusion Criteria (Cohort A and Cohort B):
- •Age >= 18 years
- •Eastern Cooperative Oncology Group Performance Status of 0 or 1
- •Adequate hematologic and end-organ function
- •Negative HIV test at screening
- •Negative hepatitis B surface antigen (HBsAg) test at screening
- •Positive hepatitis B surface antibody (HBsAb) test at screening, or negative HBsAb at screening
- •Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening
- •For women of childbearing potential: agreement to remain abstinent or use contraceptive methods, and agreement to refrain from donating eggs for at least 5 months after the final dose of atezolizumab, 90 days after the final dose of tiragolumab, 1 month after the final dose of nab-paclitaxel, 6 months after the final dose of carboplatin or doxorubicin, or 12 months after the final dose of cyclophosphamide
- •For men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm for 90 days after the final dose of tiragolumab, or 6 months after the final dose of nab-paclitaxel, carboplatin, doxorubicin, or cyclophosphamide
- •For women who are not postmenopausal or have undergone a sterilization procedure, a negative serum pregnancy test result is required within 14 days prior to initiation of study treatment.
- •Cancer-Specific Inclusion Criteria for Cohort A (Metastatic TNBC):
- •Life expectancy >= 12 weeks
- •Metastatic or locally advanced unresectable, histologically documented TNBC
- •Only patients with metastatic TNBC tumors that are centrally tested and found to be PD-L1 positive will be enrolled
- •No prior chemotherapy or targeted systemic therapy for inoperable, locally advanced, or metastatic TNBC
- •Measurable disease, as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors(RECIST), Version 1.1.
- •Cancer-Specific Inclusion Criteria for Cohort B (Early TNBC):
- •Histologically documented TNBC
- •Confirmed tumor PD-L1 evaluation as documented through central testing of a representative formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimen in paraffin blocks or at least 20 unstained slides
- •Primary breast tumor size of > 2 cm on at least one radiographic or clinical measurement
- •Stage at presentation: cT2-cT4, cN0-cN3, and cM0
- •Patient agreement to undergo appropriate surgical management after completion of neoadjuvant treatment
- •Baseline left ventricular ejection fraction (LVEF) >= 53%, as measured on echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scan.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 47
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 13
排除标准
- •General Medical Exclusion Criteria (Cohort A and Cohort B):
- •Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment, within 90 days after tiragolumab treatment, within 5 months after atezolizumab treatment, within 6 months after nab-paclitaxel, carboplatin, or doxorubicin treatment, or within 12 months after cyclophosphamide treatment, whichever is longer
- •Evidence of significant uncontrolled concurrent disease that could affect compliance with the protocol or interpretation of results
- •Significant cardiovascular disease
- •Severe infection within 4 weeks prior to initiation of study treatment
- •Treatment with oral or IV antibiotics within 2 weeks prior to initiation of study treatment
- •Major surgical procedure within 28 days prior to initiation of study treatment or anticipation of the need for a major surgical procedure during the study other than for diagnosis.
- •General Exclusion Criteria Related to Study Treatment (Cohort A and Cohort B):
- •History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- •Known hypersensitivity or allergy to biopharmaceuticals produced in CHO cells or any component of the tiragolumab or atezolizumab formulation
- •Active or history of autoimmune disease
- •Prior allogeneic stem cell or solid organ transplantation
- •History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on the chest computed tomography (CT) scan at screening
- •Positive EBV viral capsid antigen (VCA) IgM test at screening
- •Active tuberculosis
- •Receipt 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
- •Prior treatment with CD137 agonists or immune checkpoint blockade therapies, with an exception of anti-PD-1, or anti-PD-L1 therapeutic antibodies
- •Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives of the drug prior to initiation of study treatment
- •Treatment with systemic immunosuppressive medications within 2 weeks prior to initiation of study treatment, or anticipated requirement for systemic immunosuppressive medications during the study.
- •Cancer-Specific Exclusion Criteria for Cohort A (Metastatic TNBC):
- •FFPE tumor tissue that is PD-L1 negative
- •Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence thatdisease has been clinically stable for >2 weeks prior to initiation of study treatment
- •Known central nervous system (CNS) disease, except for treated asymptomatic CNS metastases
- •Leptomeningeal disease
- •Uncontrolled pleural effusion, pericardial effusion, or ascites
- •Uncontrolled tumor-related pain and hypercalcemia
- •Malignancies other than TNBC within 5 years prior to initiation of study treatment, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome
- •Known hypersensitivity to nab-paclitaxel or to any of its excipients.
- •Exclusion Criteria Specific to Cohort B (Early TNBC):
- •History of invasive breast cancer
- •Stage IV (metastatic) breast cancer
- •Prior systemic therapy for treatment and prevention of breast cancer
- •Previous therapy with anthracyclines, platinum, or taxanes for any malignancy
- •History of ductal carcinoma
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