A Study of Cobimetinib Plus Atezolizumab Versus Pembrolizumab in Participants With Previously Untreated Advanced BRAFv600 Wild-Type Melanoma

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
• •Current or recent treatment with therapeutic antibiotics, live attenuated vaccines or systemic immunostimulatory/immunosuppresive medication
• •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 central nervous system (CNS) metastases Exclusions Related to Cardiovascular Disease
• •Unstable angina, new-onset angina within 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
• •Left ventricular ejection fraction (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 electrocardiogram (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
• •Any Grade \>=3 hemorrhage or bleeding event within 28 days of Day 1 of Cycle 1
• •History of stroke, reversible ischemic neurological defect, or transient ischemic attack within 6 months prior to Day 1
• •Proteinuria \>3.5 gm/24 hr
• •Consumption of foods, supplements, or drugs that are strong or moderate CYP3A4 enzyme inducers or inhibitors at least 7 days prior to Day 1 of Cycle 1 and during study treatment