Study of Atezolizumab in Combination With Cobimetinib in Participants With Locally Advanced or Metastatic Solid Tumors
NCT ID: NCT01988896
Last Updated: 2019-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
153 participants
INTERVENTIONAL
2013-12-27
2019-11-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dose-Escalation: Cobimetinib, Atezolizumab
Participants will receive single dose of 800 milligrams (mg) of atezolizumab IV infusion on Day 1, 15 and 29 of Cycle 1 (cycle length=42 days \[14-day run-in period + 28-day concomitant dosing period\]), thereafter with atezolizumab IV dosing every 2 weeks (q2w) in all subsequent treatment cycles (28 days each). Combination with cobimetinib will begin on Cycle 1 Day 15 and will be given at increasing dose levels during Stage 1. During Stage 1, cobimetinib will be administered once daily (QD) orally for 21 consecutive days out of 28 days (21/7 dosing schedule) at a starting dose of 20 mg with escalation of 20 mg until the maximum tolerated dose (MTD; not more than 60 mg) for the two-drug combination.
Atezolizumab
Atezolizumab will be administered at a fixed dose as specified via IV infusion.
Cobimetinib
Cobimetinib will be administered orally at an escalating dose during Stage 1 and at RP2D during Stage 2.
Dose-Expansion: Cobimetinib, Atezolizumab
Participants will receive single dose of 800 mg of atezolizumab IV infusion q2w in all subsequent treatment cycles (28 days each). Participants will receive cobimetinib at the selected recommended RP2D on Days 1-14 of each 28-day cycle during Stage 2.
Atezolizumab
Atezolizumab will be administered at a fixed dose as specified via IV infusion.
Cobimetinib
Cobimetinib will be administered orally at an escalating dose during Stage 1 and at RP2D during Stage 2.
Interventions
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Atezolizumab
Atezolizumab will be administered at a fixed dose as specified via IV infusion.
Cobimetinib
Cobimetinib will be administered orally at an escalating dose during Stage 1 and at RP2D during Stage 2.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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
* 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 degeneration
* History of malabsorption syndrome or other condition that would interfere with enteral absorption
* Prior treatment with clusters of differentiation (CD) 137 agonists or immune checkpoint blockade therapies, systemic immunostimulatory agents, or systemic immunosuppressive medications
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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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
Countries
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References
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Hellmann MD, Kim TW, Lee CB, Goh BC, Miller WH Jr, Oh DY, Jamal R, Chee CE, Chow LQM, Gainor JF, Desai J, Solomon BJ, Das Thakur M, Pitcher B, Foster P, Hernandez G, Wongchenko MJ, Cha E, Bang YJ, Siu LL, Bendell J. Phase Ib study of atezolizumab combined with cobimetinib in patients with solid tumors. Ann Oncol. 2019 Jul 1;30(7):1134-1142. doi: 10.1093/annonc/mdz113.
Other Identifiers
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2013-003329-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GP28363
Identifier Type: -
Identifier Source: org_study_id