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

Completed · Phase 2

Conditions studied: Solid Tumors

In brief

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).

Key facts

Study ID

NCT03264066

Run by

Hoffmann-La Roche

People needed

87

Starts

2017-11-23

Expected to finish

2020-06-25

Last updated by the study team

2021-05-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Georgetown University Medical Center — Washington D.C., District of Columbia, United States
• Kansas City - Menorah Medical Center — Kansas City, Kansas, United States
• Memorial Sloan-Kettering Cancer Center — Commack, New York, United States
• Memorial Sloan Kettering - Basking Ridge — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Sarah Cannon Research Institute — Nashville, Tennessee, United States
• AZ Groeninge — Kortrijk, Belgium
• Universitatsklinik Heidelberg; Universitätshautklinik und Nationales Centrum für Tumorerkrankungen — Heidelberg, Germany
• Universitätsklinikum Tübingen; Klinik für Urologie — Tübingen, Germany
• Orszagos Onkologiai Intezet — Budapest, Hungary
• Debreceni Egyetem Klinikai Kozpont — Debrecen, Hungary
• Jósa András Oktatókórház — Nyíregyháza, Hungary
• Samsung Medical Center — Seoul, South Korea
• Seoul National University Hospital — Seoul, South Korea
• Asan Medical Center — Seoul, South Korea
• Yonsei Cancer Center — Seoul, South Korea
• Barts & London School of Med; Medical Oncology — London, United Kingdom
• Royal Marsden Hospital - Fulham — London, United Kingdom
• The Royal Marsden — London, United Kingdom

Full record on ClinicalTrials.gov

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