EUCTR2016-005119-42-FI进行中（未招募）1 期
A PHASE III, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTRE STUDY OF THE EFFICACY AND SAFETY OF ATEZOLIZUMAB PLUS CHEMOTHERAPY FOR PATIENTS WITH EARLY RELAPSING RECURRENT (INOPERABLE LOCALLY ADVANCED OR METASTATIC) 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
- 597
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
- •- Male or female >= 18 years of age
- •- Histologically confirmed TNBC that is either locally recurrent, inoperable and cannot be treated with curative intent or is metastatic
- •- Prior treatment with an anthracycline and taxane
- •- Documented disease progression occurring within 12 months (<12 months) from the last treatment with curative intent
- •- Have not received prior chemotherapy or targeted systemic therapy for their locally advanced inoperable or metastatic recurrence. China Population only: Chinese traditional medicines with an approved indication for cancer treatment are permitted as long as the last administration occurred at least 2 weeks prior to randomisation
- •- Measurable or non-measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- •- Availability of a representative formalin-fixed paraffin-embedded
- •(FFPE) tumour block (preferred) or at least 17 unstained slides, obtained
- •from relapsed metastatic or locally advanced diseases may be submitted,
- •if clinically feasible, with an associated pathology report, if available If a
- •fresh tumour is not clinically feasible, either the diagnosis sample, the
- •primary surgical resection sample or the most recent FFPE tumour
- •biopsy sample should be used
- •- Eastern Cooperative Oncology Group performance status 0-1
- •- Life expectancy >= 12 weeks
- •- Adequate haematologic and end-organ function, Negative human immunodeficiency virus (HIV) test at screening
- •- Negative hepatitis B surface antigen (HBsAg) test at screening
- •- Negative total hepatitis B core antibody (HBcAb) test at screening, or positive HBcAb test followed by a negative hepatitis B virus (HBV) DNA test 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
- •- The HCV RNA test will be performed only for patients who have a negative HBsAg test and a positive HCV antibody test
- •- For women of childbearing potential: agreement to remain abstinent
- •(refrain from heterosexual intercourse) or use a contraceptive method
- •with a failure rate of <=1% per year during the treatment period and for
- •5 months after the final dose of atezo or 6 months after the last dose of
- •capecitabine. Women must refrain from donating eggs during the same
- •time period
- •- For men: agreement to remain abstinent (refrain from heterosexual
- •intercourse) or use a condom, and agreement to refrain from donating
- •sperm, with female partners of childbearing potential or pregnant female
- •partners, men must remain abstinent or use a condom during the
- •treatment period and for at least 3 months after last dose of
- •capecitabine or 6 months after the last dose of carboplatin/gemcitabine
- •to avoid exposing the embryo.
- •-For patients enrolled after the recruitment of all-comers is complete: PD-L1-positive tumour status (assessed centrally prior to randomisation), defined as PD-L1 expression on tumour-infiltrating immune cells of 1% or greater.
- •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 508
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 89
排除标准
- •- Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for > 2 weeks prior to randomisation
- •- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
- •- Symptomatic or rapid visceral progression
- •- History of leptomeningeal disease
- •- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
- •- Uncontrolled tumour-related pain
- •- Uncontrolled or symptomatic hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy
- •- Malignancies other than TNBC within 5 years prior to randomisation, with the exception of those with a negligible risk of metastasis or death (e.g., 5-year OS rate > 90%) and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, non melanoma skin carcinoma, localised prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer)
- •- Significant cardiovascular disease
- •- Presence of an abnormal ECG that is clinically significant in the investigator’s opinion
- •- Severe infection requiring oral or IV antibiotics within 4 weeks prior to randomisation, including but not limited to hospitalization for complications of infection, bacteraemia, or severe pneumonia
- •- Current treatment with anti-viral therapy for HBV
- •- Major surgical procedure within 4 weeks prior to randomisation or anticipation of the need for a major surgical procedure during the course of the study other than for diagnosis
- •- Treatment with investigational therapy within 28 days prior to randomisation
- •- Pregnant or lactating, or intending to become pregnant during or within 5 months after the last dose of study treatment atezo, or within 6 months after the last dose of capecitabine, whichever is later
- •- History of autoimmune disease
- •- History of idiopathic pulmonary fibrosis (including pneumonitis), druginduced
- •pneumonitis, organizing pneumonia (i.e., bronchiolitis
- •obliterans, cryptogenic organizing pneumonia), or evidence of active
- •pneumonitis on screening chest computerised tomography (CT) scan
- •-Receipt of a live, attenuated vaccine within 4 weeks prior to
- •randomisation or anticipation that a live, attenuated vaccine will be
- •required during atezolizumab/placebo treatment or within 5 months
- •after the last dose of atezolizumab/placebo
- •-Prior treatment with CD137 agonists, anti-PD-1, or anti-PD-L1
- •therapeutic antibody or pathway targeting agents
- •-Treatment with systemic immunostimulatory agents (including but not
- •limited to interferons or interleukin [IL]-2) within 4 weeks or five halflives
- •of the drug (whichever is longer) prior to randomisation
- •-Treatment with systemic corticosteroids or other systemic
- •immunosuppressive medications (including but not limited to
- •prednisone, dexamethasone, cyclophosphamide, azathioprine,
- •methotrexate, thalidomide, mycophenolate, and anti tumour necrosis
- •factor [TNF] agents) within 2 weeks prior to initiation of study
- •treatment, or anticipated requirement for systemic immunosuppressive
- •medications during the trial.
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A PHASE III, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTRE,INTERNATIONAL STUDY OF MEDI4736 AS SEQUENTIAL THERAPY IN PATIENTS WITHLOCALLY ADVANCED, UNRESECTABLE NON-SMALL CELL LUNG CANCER (STAGE III)WHO HAVE NOT PROGRESSED FOLLOWING DEFINITIVE, PLATINUM-BASED,CONCURRENT CHEMORADIATION THERAPY (PACIFIC)-C34 Malignant neoplasm of bronchus and lungMalignant neoplasm of bronchus and lungC34PER-054-14AstraZeneca AB,3