Kidney Cancer Clinical Trial
A Study to Investigate the Efficacy and Safety of Cobimetinib Plus Atezolizumab in Participants With Solid Tumors
Summary
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).
Eligibility Criteria
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
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There are 18 Locations for this study
Washington District of Columbia, 20007, United States
Kansas City Kansas, 66209, United States
Commack New York, 11725, United States
New York New York, 10065, United States
New York New York, 10065, United States
Nashville Tennessee, 37203, United States
Kortrijk , 8500, Belgium
Heidelberg , 69120, Germany
Tübingen , 72076, Germany
Budapest , 1122, Hungary
Debrecen , 4032, Hungary
Nyíregyháza , 4400, Hungary
Seoul , (0)63, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 120-7, Korea, Republic of
London , EC1A , United Kingdom
London , SW3 6, United Kingdom
London , SW7 3, United Kingdom
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