Study of Atezolizumab in Combination With Cobimetinib in Participants With Locally Advanced or Metastatic Solid Tumors

Not Recruiting

Trial ID: NCT01988896


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.

Official Title

A Phase Ib Study of the Safety and Pharmacology of Atezolizumab Administered With Cobimetinib in Patients With Locally Advanced or Metastatic Solid Tumors

Stanford Investigator(s)

Heather Wakelee
Heather Wakelee

Winston Chen and Phyllis Huang Professor

George A. Fisher Jr.
George A. Fisher Jr.

Colleen Haas Chair in the School of Medicine


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

   - 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

   - 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

   - History of malabsorption syndrome or other condition that would interfere with enteral

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


drug: Cobimetinib

drug: Cobimetinib

drug: Atezolizumab

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Lisa Zhou

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