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

Completed · Phase 1

Conditions studied: Solid Tumors

In brief

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.

Key facts

Study ID

NCT01988896

Run by

Hoffmann-La Roche

People needed

153

Starts

2013-12-27

Expected to finish

2019-11-04

Last updated by the study team

2019-12-17

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Stanford University Medical Center — Palo Alto, California, United States
• Rocky Mountain Cancer Center - Denver — Denver, Colorado, United States
• Yale University School Of Medicine — New Haven, Connecticut, United States
• Massachusets General Hospital Clinical Trial Network and Institute — Boston, Massachusetts, United States
• Beth Israel Deaconess Med Ctr; Neurology/MS Center — Boston, Massachusetts, United States
• Sloan Kettering Cancer Center; Pediatric Hematology/Oncology — New York, New York, United States
• UNC Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States
• Compass Oncology — Portland, Oregon, United States
• SCRI-Tennessee Oncology — Nashville, Tennessee, United States
• Texas Oncology, P.A. — Arlington, Texas, United States
• University of Washington Seattle Cancer Care Alliance — Seattle, Washington, United States
• Peter MacCallum Cancer Centre-East Melbourne — Melbourne, Victoria, Australia
• Royal Melbourne Hospital — Parkville, Victoria, Australia
• Princess Margaret Hospital; Department of Med Oncology — Toronto, Ontario, Canada
• CHUM Hôpital Notre-Dame — Montreal, Quebec, Canada
• Jewish General Hospital — Montreal, Quebec, Canada
• Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden — Dresden, Germany
• Universitaetsklinikum Freiburg — Freiburg im Breisgau, Germany
• National University Hospital; Cancer Center — Singapore, Singapore
• Seoul National University Hospital — Seoul, South Korea
• Asan Medical Center - Oncology — Seoul, South Korea

Full record on ClinicalTrials.gov

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