EUCTR2017-002038-21-GB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 145 人开始时间: 2018年2月27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
- 145
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 inoperable locally advanced, histologically documented TNBC
- •- For patients in the 1L PD-L1 positive cohort: no prior systemic treatment for metastatic or inoperable locally advanced TNBC
- •- For patients in the 2L CIT-naïve cohort: Eligible for capecitabine monotherapy
- •- For patients in the 2L CIT-naïve cohort: Radiologic/objective evidence of recurrence or disease progression after 1L treatment with chemotherapy (chemo) for a total of one line of therapy for inoperable locally advanced or 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
- •- For patients in the 1L PD-L1 positive cohort: positive PD-L1 expression, defined as >= 1%of the tumor area occupied by PD-L1- expressing tumor-infiltrating immune cells of any intensity
- •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
- •- Negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by quantitative hepatitis B virus (HBV) DNA < 500 IU/mL at screening
- •- For women of childbearing potential: agreement to remain abstinent or use treatment arm-specific contraceptive measures and agreement to refrain from breastfeeding and donating eggs
- •- 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 103
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 42
排除标准
- •- Prior treatment with T-cell co-stimulating or immune checkpoint blockade therapies
- •- Treatment with investigational therapy within 28 days prior to C1D1
- •- Biologic treatment or other systemic treatment within 2 weeks (wks) prior to C1D1
- •- Eligibility only for the control arm
- •Stage 1 (2L CIT naïve cohort only)
- •- Prior treatment with capecitabine
- •- 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 or tuberculosis on screening and malignancy other than breast cancer within 2 years prior to screening.
- •- History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
- •- History of autoimmune disease or immune deficiency
- •- Grade >= 3 hemorrhage or bleeding event within 28 days prior to C1D1
- •- Severe infection within 4 wks prior C1D1
- •- Major surgical procedure within 4wks
- •- Treatment with antibiotics or live, attenuated vaccine within 2 wks or 4wks prior to C1D1 respectively
- •- Treatment with systemic immunostimulatory agents within 4wks or 5 half-lives of the drug prior to C1D1
- •- Patients entering Stage 2: immunotherapy-related adverse events that have not resolved to Grade 1 or better or to baseline at the time of consent
- •Ipatasertib (Ipat) - Containing arm (Stage 1)
- •- Prior treatment with ipat or other Akt inhibitors
- •- Grade >= 2 uncontrolled or untreated hypercholesterolemia or hypertriglyceremia
- •- History of Type I or Type II diabetes mellitus requiring insulin
- •- Congenital long QT syndrome or screening QT interval corrected through use of Fridericia’s formula > 480ms
- •- Treatment with strong CYP3A4 inducers or inhibitors within 2wks or 5 drug-elimination half-lives prior to C1D1.
- •SGN-LIV1A - Containing arm (Stage 1)
- •- Prior treatment with SGN-LIV1A or MMAE -based biologic
- •- Grade>= 2 neuropathy
- •- Radiotherapy within 2wks prior to C1D1
- •- AST/ALT > 1.5 x ULN, or 3 x ULN if liver metastases present
- •- Documented history of a cerebrovascular event, unstable angina, myocardial infarction, or cardiac symptoms consistent with congestive heart failure, within 6 months prior to study enrollment.
- •Bevacizumab (Bev) - Containing arm (Stage 1)
- •- Inadequately controlled arterial hypertension
- •- History of hypertensive crisis or hypertensive encephalopathy
- •- Significant vascular disease within 6 months prior to C1D1
- •- History of hemoptysis within 1 month prior to C1D1 and abdominal or tracheoesophageal fistula, gastrointestinal (GI) perforation, or intra-abdominal abscess and intestinal obstruction and/or clinical signs or symptoms of GI obstruction and intra-abdominal inflammatory process within 6 months prior to C1D1.
- •- Radiotherapy within 28 days or abdominal/pelvic radiotherapy within 60 days prior to C1D1
- •- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to C1D1; or abdominal surgery, abdominal interventions or significant abdominal traumatic injury within 60 days prior to C1D1
- •Selicrelumab (Seli)– containing arm (Stage 1)
- •- Soluble CD25 > 2xULN
- •- Serum ferritin > 1000 ng/mL
- •- Known hereditary or acquired coagulopathy
- •- Concomitan
研究者
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