EUCTR2016-004387-18-HU进行中（未招募）1 期
A PHASE III, OPEN-LABEL, MULTICENTER, TWO ARM, RANDOMIZED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF COBIMETINIB PLUS ATEZOLIZUMAB VERSUS PEMBROLIZUMAB IN PATIENTS WITH PREVIOUSLY UNTREATED ADVANCED BRAF V600 WILD-TYPE MELANOMA
F. Hoffman-La Roche Ltd.0 个研究点目标入组 446 人开始时间: 2017年9月8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
- 446
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
- •Disease-Specific Inclusion Criteria
- •- Histologically confirmed locally advanced and unresectable or metastatic melanoma
- •- Naive to prior systemic anti-cancer therapy for melanoma
- •- Documentation of BRAFV600 wild-type status in melanoma tumor tissue through use of a clinical mutation test approved by the local health authority
- •- A representative, formalin-fixed, paraffin-embedded (FFPE) tumor specimen in a paraffin block (preferred) or 20 slides containing unstained, freshly cut, serial sections must be submitted along with an associated pathology report prior to study entry. If 20 slides are not available or the tissue block is not of sufficient size, the patient may still be eligible for the study, after discussion with and approval by the Medical Monitor.
- •- Measureable disease according to RECIST v1.1
- •General Inclusion Criteria
- •- Age >=18 years at time of signing Informed Consent Form
- •- Ability to comply with the study protocol, in the investigator’s judgment
- •- Histologically or cytologically confirmed BRAFV600 wild-type melanoma
- •- ECOG Performance Status of 0 or 1
- •- Life expectancy >=3 months
- •- Adequate hematologic and end-organ function
- •- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use at least two forms of effective contraceptive with a failure rate of < 1% per year during the treatment period and for at least 3 months after the last dose of cobimetinib and at least 5 months after the last dose of atezolizumab or pembrolizumab after the last dose of cobimetinib and atezolizumab, respectively
- •- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures (e.g. condom), and agreement to refrain from donating sperm, for at least 3 months after the last dose of cobimetinib
- •- Willingness and ability of patients to report selected study outcomes using an electronic device or paper backup questionnaires
- •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 280
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 170
排除标准
- •General Exclusion Criteria
- •- Inability to swallow medications
- •- Malabsorption condition that would alter the absorption of orally administered medications
- •- Pregnancy, breastfeeding, or intention of becoming pregnant during the study
- •- History of severe hypersensitivity reactions to components of the cobimetinib, atezolizumab or pembrolizumab formulations
- •- Administration of a live, attenuated vaccine within 4 weeks before randomization or anticipation of need for such a vaccine during the study
- •- Any anti-cancer therapy, including chemotherapy or hormonal therapy, within 2 weeks prior to initiation of study treatment
- •- Treatment with systemic immunostimulatory agents within 28 days or 5 half-lives of the drug, whichever is shorter, prior to Day 1 of Cycle 1
- •- Treatment with systemic immunosuppressive medications within 2 weeks prior to Day 1 of Cycle 1
- •- Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator’s judgment, precludes the patient’s safe participation in and completion of the study
- •Cancer-Related Exclusion Criteria
- •- Ocular melanoma
- •- Major surgery or radiotherapy within 21 days prior to Day 1 of Cycle 1 or anticipation of needing such procedure while receiving study treatment
- •- Uncontrolled tumor-related pain
- •- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage more than once every 28 days
- •- Active or untreated CNS metastases
- •Exclusions Related to Cardiovascular Disease
- •- Unstable angina, new-onset angina within the last 3 months, myocardial infarction within the last 6 months prior to Day 1 of Cycle 1, or current congestive heart failure classified as New York Heart Association Class II or higher
- •- LVEF below institutional lower limit of normal or <50%, whichever is lower
- •- Poorly controlled hypertension, defined as sustained, uncontrolled, non-episodic baseline hypertension consistently above 159/99 mmHg despite optimal medical management
- •- History or presence of an abnormal ECG that is clinically significant in the investigator’s opinion, including complete left bundle branch block, second- or third degree heart block, or evidence of prior myocardial infarction
- •Exclusions Related to Infections
- •- HIV infection
- •- Active tuberculosis infection
- •- Severe infections within 4 weeks prior to Day 1 of Cycle 1, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
- •- Signs or symptoms of clinically relevant infection within 2 weeks prior to Day 1 of Cycle 1
- •- Treatment with oral or IV antibiotics within 2 weeks prior to Day 1 of Cycle 1
- •- Active or chronic viral hepatitis B or C infection
- •Exclusions Related to Ocular Disease
- •- Known risk factors for ocular toxicity
- •Exclusions Related to Autoimmune Conditions and Immunomodulatory Drugs
- •- Active or history of autoimmune disease or immune deficiency
- •- Prior allogeneic stem cell or solid organ transplantation
- •- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
- •- Treatment with systemic immunosuppressive medications within 2 weeks prior to Day 1, Cycle 1
- •Exclusions Related to Other Medical Conditions or Medications
- •- Active malignancy (other than melanoma) or a prior malignancy within the past 3 years
研究者
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