A Study to Investigate Efficacy and Safety of Cobimetinib Plus Atezolizumab and Atezolizumab Monotherapy Versus Regorafenib in Participants With Metastatic Colorectal Adenocarcinoma (COTEZO IMblaze370)

Exclusion Criteria

• •After the approximate 5% cap for microsatellite (MSI)-high participants is reached, only MSI-stable participants will be eligible
• •Once the 50% cap for wild-type RAS has been reached, only extended RAS-mutant participants will be eligible
• •Major surgery or radiotherapy within 21 days prior to Cycle 1 Day 1 or anticipation of needing such procedure while receiving study treatment
• •Treatment with any anti-cancer agent within 14 days prior to Cycle 1 Day 1
• •Uncontrolled tumor-related pain. Participants requiring narcotic pain medication must be on a stable regimen at study entry
• •Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage more than once every 28 days. Indwelling drainage catheters (e.g., PleurX®) are allowed
• •Active or untreated central nervous system (CNS) metastases are excluded
• •Prior therapy with any cancer immunotherapy, MEK inhibitor, or regorafenib
• •Participants with active malignancy (other than CRC) or a prior malignancy within the past 3 years are excluded. Participants with completely resected cutaneous melanoma (early stage), basal cell carcinoma, cutaneous squamous cell carcinoma, cervical carcinoma in-situ, breast carcinoma in-situ, and localized prostate cancer are eligible
• •Unstable angina, new onset angina within last 3 months, myocardial infarction within last 6 months and current congestive heart failure New York Heart Association Class II or higher
• •Left ventricular ejection fraction (LVEF) below institutional lower limit of normal or below 50%, whichever is lower
• •Poorly controlled hypertension, defined as a blood pressure consistently above 150/90 millimeters of Mercury (mmHg) despite optimal medical management
• •Human immunodeficiency virus (HIV) infection
• •Active tuberculosis infection
• •Severe infections within 2 weeks prior to Cycle 1 Day 1
• •Active or chronic viral hepatitis B or C infection
• •History of or evidence of retinal pathology on ophthalmologic examination that is considered a risk factor for central serous retinopathy, retinal vein occlusion, or neovascular macular degeneration
• •Participants will be excluded if they currently have any of the risk factors as defined in the study protocol for retinal vein occlusion
• •History of autoimmune disease
• •History of idiopathic pulmonary fibrosis, organizing pneumonia, bronchiolitis obliterans, drug-induced pneumonitis, or idiopathic pneumonitis
• •History of organ transplantation including allogeneic bone marrow transplantation
• •Inability to swallow medications
• •Malabsorption condition that would alter the absorption of orally administered medications
• •Pregnant, lactating, breastfeeding, or intending to become pregnant during the study
• •Administration of a live, attenuated vaccine within 4 weeks before randomization or anticipation of a live attenuated vaccine will be required during the study