EUCTR2016-004387-18-IT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 - A large, international study in advanced wild-type melanoma looking at the efficacy and safety with
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
- 446
研究概览
简要总结
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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
- •Histologically or cytologically confirmed BRAFV600 wild-type
- •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. Women must refrain from donating eggs during this same
- •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
- •- History of severe hypersensitivity reactions to components of the cobimetinib, atezolizumab or pembrolizumab, or ipilimumab 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
- •- 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
- •- LVEF below institutional lower limit of normal or <50%, whichever is
- •- 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
- •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
- •- 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
- •- Active or history of autoimmune disease or immune deficiency
- •- Prior allogeneic stem cell or solid organ transplantation
- •- History of idiopathic pulmonary fibrosis, organizing pneumonia, druginduced
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