study of atezolizumab in combination with cobimetinib in participants with locally advanced or metastatic solid tumors

Conditions: Solid Tumors

Summary: 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.


Eligibility criteria:
inclusion criteria: * 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 exclusion criteria: 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