EUCTR2017-002038-21-ES进行中（未招募）1 期
A PHASE Ib/II, OPEN-LABEL, MULTICENTER, RANDOMIZED UMBRELLA STUDY EVALUATING THE EFFICACY AND SAFETY OF MULTIPLEIMMUNOTHERAPY-BASED TREATMENT COMBINATIONS IN PATIENTS WITH METASTATIC TRIPLE-NEGATIVE BREAST CANCER (MORPHEUS-TNBC)
F. Hoffman-La Roche Ltd.0 个研究点目标入组 110 人开始时间: 2018年6月15日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 110
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
- •- Age >= 18 years
- •- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •- Metastatic or locally advanced, histologically documented TNBC
- •- Eligible for capecitabine monotherapy
- •- Radiologic/objective evidence of recurrence or disease progression after one line of chemotherapy (chemo) for metastatic breast cancer
- •- Life expectancy>= 3 months
- •- Availability of a representative tumor specimen that is suitable for determination of Programmed death-ligand 1and/or additional biomarker status via central testing
- •Stage 1 and Stage 2
- •- Measurable disease according to Response Evaluation Criteria in Solid Tumors 1.1
- •- Tumor accessible for biopsy
- •- Adequate hematologic and end-organ function
- •- For patients receiving therapeutic anticoagulation: stable anticoagulant regimen during the 14 days prior to initiation of study treatment
- •- Negative HIV test, hepatitis B surface antigen at screening, and hepatitis C virus (HCV) antibody test 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 treatment arm-specific contraceptive measures
- •- For men: agreement to remain abstinent or use treatment arm-specific contraceptive measures, and agreement to refrain from donating sperm for a treatment arm-specific time period
- •- ECOG Performance Status of 0, 1, or 2
- •- Patients randomly allocated to the control arm during Stage 1: ability to initiate Stage 2 treatment within 3 months after experiencing unacceptable toxicity, provided that Medical Monitor approval for entry into Stage 2 is obtained, or disease progression per RECIST v1.1 while receiving control treatment
- •- Patients randomly allocated to an experimental arm during Stage 1: ability to initiate Stage 2 treatment within 3 months after experiencing unacceptable toxicity not related to atezolizumab (Atezo), disease progression per RECIST v1.1, or loss of clinical benefit as determined by the investigator while receiving Stage 1 treatment
- •- Availability of a tumor specimen from a biopsy performed upon discontinuation of Stage 1
- •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 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •-Prior treatment with T-cell co-stimulating or immune checkpoint blockade therapies, including anti- cytotoxic T lymphocyte-associated molecule-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
- •-Treatment with investigational therapy within 28 days prior to initiation of study treatment , sorivudine or its chemically related analogues and systemic treatment for TNBC within 2 weeks (wks) of Cycle (C)1, Day(D)1 or 5 half-lives of the drug prior to C1,D1
- •-Adverse events from prior anti-cancer therapy that have not resolved to Grade<=1 or better with the exception of alopecia of any grade,Grade <= 2 peripheral neuropathy
- •-History of severe and unexpected reactions to fluoropyrimidine therapy
- •-Known complete absence of dihydropyrimidine dehydrogenase activity
- •Stage 1 and 2
- •-Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures, tumor-related pain and uncontrolled or symptomatic hypercalcemia
- •-Symptomatic, untreated, or actively progressing central nervous system metastases
- •-History of leptomeningeal disease, idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan and malignancy other than breast cancer within 2 years prior to screening and history of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins and active or history of autoimmune disease or immune deficiency
- •-Active tuberculosis and significant cardiovascular disease
- •-Grade >= 3 hemorrhage or bleeding event within 28 days prior to initiation of study treatment
- •-Prior allogeneic stem cell or solid organ transplantation
- •-Treatment with a live, attenuated vaccine within 4wks prior to initiation of study treatment, or anticipation of need for such a vaccine during treatment with atezo or within 5 months after the last dose of atezo
- •-Known hypersensitivity to Chinese hamster ovary cell products or recombinant human antibodies
- •-Treatment with systemic immunostimulatory agents and immunosuppressive medication within 4wks or 5 half-lives of the drug prior to initiation of study treatment and within 2wks prior to initiation of study treatment respectively
- •Atezo+Ipatasertib (Ipat) (Stage 1)
- •-Grade >= 2 uncontrolled or untreated hypercholesterolemia or hypertriglyceremia
- •-History of Type I or II diabetes mellitus requiring insulin and history or presence of an abnormal electrocardiogram
- •-Congenital long QT syndrome or screening QT interval corrected through use of Fridericia’s formula > 480ms
- •-Treatment with strong CYP3A4 inducers within 4wks or 5 drug-elimination half-lives prior to initiation of study drug
- •Atezo+SGN-LIV1A (Stage 1)
- •-Prior treatment with SGN-LIV1A or prior treatment with a monomethyl auristatin E -based biologic
- •-Grade>= 2 neuropathy
- •-Known hypersensitivity to any excipient contained in the drug formulation of SGN-LIV1A
- •-Radiotherapy within 2wks prior to first dose of study drug
- •-Documented history of a cerebrovascular event, unstable angina, myocardial infarction, or cardiac symptoms consistent with congestive heart failure, Class III-IV, by New York Heart Association criteria within 6 months prior to study enrollment
- •Atezo+ Bevacizumab (Bev) (Stage 1)
- •-Inadequately controlled arterial hypertension based on an average of >= 3BP readings on >=2 sessions
- •-Prior history of hypertensive crisis or hypertensive encephalopathy
- •-Significant vascular disease
研究者
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