A Study to Investigate the Efficacy and Safety of Cobimetinib Plus Atezolizumab in Participants With Solid Tumors



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/6/2019
Start Date:November 23, 2017
End Date:September 10, 2020
Contact:Reference Study ID Number: WO39760 www.roche.com/about_roche/roche_worldwide.htm
Email:global-roche-genentech-trials@gene.com
Phone:888-662-6728 (U.S. only)

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A Phase II, Open-Label, Multicenter, Multicohort Study to Investigate the Efficacy and Safety of Cobimetinib Plus Atezolizumab in Patients With Solid Tumors

This is a study to evaluate the efficacy, safety, and pharmacokinetics of cobimetinib plus
atezolizumab in participants with advanced solid tumors including the following cohorts:
squamous cell carcinoma of the head and neck (SCCHN), urothelial carcinoma (UC), and renal
cell carcinoma (RCC).


Inclusion Criteria:

General Inclusion Criteria:

- Age ≥18 years

- Ability to comply with the study protocol, in the investigator's judgment

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

- Life expectancy ≥3 months, as determined by the investigator

- Adequate hematologic and end-organ function

Cancer-Related Inclusion Criteria:

- Patients must have measurable disease by computed tomography (CT) or magnetic
resonance imaging (MRI) scan per RECIST v1.1.

- Availability to provide a representative tumor specimen biopsy

- Evidence of tumor progression on or after the last treatment regimen received and
within 6 months prior to study enrollment

- For women of childbearing potential: agreement to remain abstinent (refrain from
heterosexual intercourse) or use a non-hormonal contraceptive method with a failure
rate of <1% per year during the treatment period and for at least 5 months after the
last dose of atezolizumab and within 3 months after the last dose of cobimetinib

- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use
contraceptive measures, and agreement to refrain from donating sperm during the
treatment period and for at least 3 months after the last dose of cobimetinib

Exclusion Criteria:

General Exclusion Criteria:

- Inability to swallow medications

- Malabsorption condition that would alter the absorption of orally administered
medications

- Poor peripheral venous access

- Prior treatment with cobimetinib or a MEK inhibitor

- Prior treatment with T-cell co-stimulating or immune checkpoint blockade therapies,
including anti−CTLA-4, anti−PD-1, and anti−PD-L1 therapeutic antibodies

- Treatment with investigational therapy within 14 days prior to initiation of study
treatment

- Any anti-cancer therapy, including chemotherapy or hormonal therapy, within 2 weeks
prior to initiation of study treatment

- History of severe allergic, anaphylactic, or other hypersensitivity reactions to
chimeric or humanized antibodies or fusion proteins

- Known hypersensitivity to biopharmaceutical agents produced in Chinese hamster ovary
cells or any component of the atezolizumab formulation, or any component of the
cobimetinib formulation

- History of serous retinopathy, retinal vein occlusion (RVO), or evidence of ongoing
serous retinopathy or RVO at baseline

- Major surgical procedure other than for diagnosis within 4 weeks prior to initiation
of study treatment, or anticipation of need for a major surgical procedure during the
study

- Uncontrolled tumor-related pain

- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated
drainage more than once every 28 days

- Uncontrolled hypercalcemia (ionized calcium >1.5 millimoles per liter [mmol/L],
calcium >12 milligrams per deciliter [mg/dL], or corrected calcium greater than the
upper limit of normal [ULN]) or symptomatic hypercalcemia requiring continued use of
bisphosphonate therapy

- Active or untreated central nervous system (CNS) metastases

- Pregnancy or breastfeeding, or intending to become pregnant during the study

Exclusion Criteria based on Organ Function or Medical History

Cardiovascular

Patients who meet the following cardiovascular exclusion criterion will be excluded from
study entry:

- Left ventricular ejection fraction (LVEF) below the institutional lower limit of
normal or <50%, whichever is lower

Infections Patients who meet any of the following infection exclusion criteria will be
excluded from study entry:

- Positive human immunodeficiency virus (HIV) test at screening

- Active hepatitis B virus (HBV) infection (chronic or acute)

- Active hepatitis C virus (HCV) infection

- Active tuberculosis

- Severe infection within 4 weeks prior to initiation of study treatment, including, but
not limited to, hospitalization for complications of infection, bacteremia, or severe
pneumonia

- Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation
of study treatment
We found this trial at
8
sites
3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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Commack, New York 11725
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Commack, NY
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Iowa City, IA
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5721 West 119th Street
Kansas City, Kansas 66209
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Kansas City, KS
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Kortrijk, 8510
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Kortrijk,
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1275 York Avenue
New York, New York 10065
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New York, NY
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 687-7695
Georgetown University Medical Center Georgetown University Medical Center is committed to excellence in research, education...
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Washington,
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