EUCTR2017-000794-37-ES进行中（未招募）1 期
A PHASE II, OPEN-LABEL, MULTICENTER, MULTI-COHORT STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF COBIMETINIB PLUS ATEZOLIZUMAB IN PATIENTS WITH SOLID TUMORS
F. Hoffman-La Roche Ltd.0 个研究点目标入组 250 人开始时间: 2019年9月4日最近更新:
适应症
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
- 250
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
入选标准
- •General Inclusion Criteria:
- •- Age >=18 years
- •- Ability to comply with the study protocol, in the investigator's judgment
- •- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- •- Life expectancy >=3 months, as determined by the investigator
- •- Adequate hematologic and end-organ function
- •Cancer-Related Inclusion Criteria:
- •- Patients must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) scan per RECIST v1.1.
- •- Availability to provide a representative tumor specimen biopsy. For patients with SCCHN or RCC, histologic samples are required. For patients with UC, cytological or histologic samples are acceptable.
- •- Evidence of tumor progression on or after the last treatment regimen received and within 6 months prior to study enrollment
- •- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a non-hormonal contraceptive method with a failure rate of < 1% per year during the treatment period and for at least 5 months after the last dose of atezolizumab and within 3 months after the last dose of cobimetinib. Women must refrain from donating eggs during this same period.
- •- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm during the treatment period and for at least 3 months after the last dose of cobimetinib
- •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 166
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 84
排除标准
- •General Exclusion Criteria:
- •- Inability to swallow medications
- •- Malabsorption condition that would alter the absorption of orally administered medications
- •- Poor peripheral venous access
- •- Prior treatment with cobimetinib or a MEK inhibitor
- •- For patients in Cohorts 1, 2, and 3 only: prior treatment with T-cell co-stimulating or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
- •- Treatment with investigational therapy within 14 days prior to initiation of study treatment
- •- Any anti-cancer therapy, including chemotherapy or hormonal therapy, within 2 weeks prior to initiation of study treatment
- •- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- •- Known hypersensitivity to biopharmaceutical agents produced in Chinese hamster ovary cells or any component of the atezolizumab formulation, or any component of the cobimetinib formulation or hypersensitivity to any anti–PD-1/PD-L1 therapy
- •- History of serous retinopathy, retinal vein occlusion (RVO), or evidence of ongoing serous retinopathy or RVO at baseline
- •- Major surgical procedure other than for diagnosis within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
- •- Uncontrolled tumor-related pain
- •- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage more than once every 28 days
- •- Uncontrolled hypercalcemia (ionized calcium > 1.5 mmol/L, calcium > 12 mg/dL, or corrected calcium greater than the ULN) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy
- •- Active or untreated CNS metastases
- •- Pregnancy or breastfeeding, or intending to become pregnant during the study
- •Exclusion Criteria based on Organ Function or Medical History Cardiovascular
- •Patients who meet the following cardiovascular exclusion criterion will be excluded from study entry:
- •Left ventricular ejection fraction (LVEF) below the institutional lower limit of normal or < 50%, whichever is lower Infections
- •Patients who meet any of the following infection exclusion criteria will be excluded from study entry:
- •Positive HIV test at screening
- •Active hepatitis B virus (HBV) infection (chronic or acute)
- •Active hepatitis C virus (HCV) infection
- •Active tuberculosis
- •Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
- •Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment
研究者
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