Study of Atezolizumab in Combination With Cobimetinib in Participants With Locally Advanced or Metastatic Solid Tumors
Trial ID or NCT#
This is a Phase Ib, open-label, multicenter study designed to assess the safety, tolerability, and pharmacokinetics of coadministration of intravenous (IV) dosing of atezolizumab (an engineered anti-programmed death-ligand 1 [anti-PD-L1] antibody) and oral dosing of cobimetinib in participants with metastatic or locally advanced cancer for which no standard therapy exists.
A Phase Ib Study of the Safety and Pharmacology of Atezolizumab Administered With Cobimetinib in Patients With Locally Advanced or Metastatic Solid Tumors
- - Solid tumor that is metastatic, locally advanced or recurrent - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Life expectancy greater than or equal to (>/=) 12 weeks - Measurable disease, as defined by RECIST v 1.1 - Adequate hematologic and end organ function - Use of highly effective contraception - Histological tumor tissue specimen - Participants enrolling in the indication-specific expansion cohorts in Stage 2 must consent to tumor biopsies and must have one of the following types of cancer: - Metatastic colorectal cancer - Non-small cell lung cancer - Melanoma
- Cancer-Specific Exclusion Criteria: - Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment - Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment - Known active or untreated central nervous system (CNS) metastases - Leptomeningeal disease - Uncontrolled tumor-related pain or uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent (once monthly or more frequently) drainage procedures - Uncontrolled hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab General Medical Exclusion Criteria: - Pregnant and lactating women - History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins - Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cell or any component of the atezolizumab formulation - History of autoimmune disease - Participants with prior allogeneic stem cell or solid organ transplantation - Positive test for human immunodeficiency virus (HIV) - Participants with active hepatitis B, hepatitis C, or tuberculosis - Severe infections within 4 weeks prior to Cycle 1 Day 1 - Signs or symptoms of infection within 2 weeks prior to Cycle 1 Day 1 - Received therapeutic oral or IV antibiotics within 2 weeks prior to Cycle 1 Day 1 - Significant cardiovascular disease - Major surgical procedure other than for diagnosis within 28 days prior to Cycle 1 Day 1 or anticipation of need for a major surgical procedure during the course of the study - Administration of a live, attenuated vaccine within 4 weeks before Cycle 1 Day 1 Exclusion Criteria Unique to Cobimetinib: - History of prior significant toxicity from another mitogen-activated protein kinase (MEK) pathway inhibitor requiring discontinuation of treatment - Allergy or hypersensitivity to components of the cobimetinib formulations - History of congenital long QT syndrome or corrected QT interval (QTc) greater than (>) 450 milliseconds at screening - Left ventricular ejection fraction (LVEF) below institutional lower limit of normal (LLN) or below 50%, whichever is lower, as determined by echocardiogram or Multi Gated Acquisition Scan (MUGA) scan - History of or evidence of retinal pathology on ophthalmologic examination that is considered a risk factor for neurosensory retinal detachment, central serous chorioretinopathy (CSCR), retinal vein occlusion (RVO), or neovascular macular degeneration - History of malabsorption syndrome or other condition that would interfere with enteral absorption Exclusion Criteria Related to Medications: - Prior treatment with clusters of differentiation (CD) 137 agonists or immune checkpoint blockade therapies, systemic immunostimulatory agents, or systemic immunosuppressive medications
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