A Study to Assess the Safety and Pharmacokinetics of MOXR0916 and Atezolizumab (Also Known as MPDL3280A or Anti-PD-L1) in Participants With Locally Advanced or Metastatic Solid Tumors
NCT ID: NCT02410512
Last Updated: 2022-04-01
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
610 participants
INTERVENTIONAL
2015-04-24
2019-11-22
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
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation: MOXR0916 + Atezolizumab
Cohorts of at least 3 participants each will be treated at escalating doses of MOXR0916 in combination with a fixed dose of atezolizumab to determine the MTD or maximum administered dose (MAD).
Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 [PD-L1] antibody
Atezolizumab will be administered intravenously.
MOXR0916, a humanized agonist anti-OX40 monoclonal antibody
MOXR0916 will be administered intravenously.
Expansion: MOXR0916 + Atezolizumab
Approximately 250-580 participants will be enrolled in the expansion stage to better characterize the safety, tolerability, pharmacokinetic variability, biomarkers of anti-tumor activity, and preliminary efficacy of MOXR0916 + atezolizumab in different cancer types.
Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 [PD-L1] antibody
Atezolizumab will be administered intravenously.
MOXR0916, a humanized agonist anti-OX40 monoclonal antibody
MOXR0916 will be administered intravenously.
Interventions
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Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 [PD-L1] antibody
Atezolizumab will be administered intravenously.
MOXR0916, a humanized agonist anti-OX40 monoclonal antibody
MOXR0916 will be administered intravenously.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Life expectancy of at least 12 weeks
* Adequate hematologic and end organ function
* Histologic documentation of locally advanced, recurrent, or metastatic incurable solid malignancy that has progressed after available standard therapy; or for which standard therapy is ineffective, intolerable, or considered inappropriate; or for which a clinical trial of an investigational agent is recognized standard of care
* Tumor specimen availability
* Measurable disease according to RECIST v1.1
Exclusion Criteria
* Malignancies other than disease under study within 5 years prior to D1 of C1
* Primary central nervous system (CNS) malignancy, or untreated/active CNS metastases
* History of leptomeningeal disease
* History of idiopathic pulmonary fibrosis, pneumonitis (including drug-induced), organizing pneumonia, or evidence of active pneumonitis on screening chest computed tomography scan; history of radiation pneumonitis in the radiation field (fibrosis) is permitted
* History of autoimmune disease
* Positive human immunodeficiency virus test result
* Active hepatitis B, hepatitis C, or tuberculosis
* Severe infection within 4 weeks prior to D1 of C1
* Prior allogeneic bone marrow or solid organ transplantation
* Significant cardiovascular disease
* Known clinically significant liver disease
18 Years
ALL
No
Sponsors
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Genentech, Inc.
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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HonorHealth Research Institute - Bisgrove
Scottsdale, Arizona, United States
University of Colorado
Aurora, Colorado, United States
Yale School of Medicine
New Haven, Connecticut, United States
Georgetown University Medical Center Lombardi Cancer Center
Washington D.C., District of Columbia, United States
University Of Chicago Medical Center; Section Of Hematology/Oncology
Chicago, Illinois, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana Farber Can Ins
Boston, Massachusetts, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia
Austin Hospital
Heidelberg, Victoria, Australia
Peter Maccallum Cancer Centre
Melbourne, Victoria, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Institut Jules Bordet
Anderlecht, , Belgium
UZ Gent
Ghent, , Belgium
Sint Augustinus Wilrijk
Wilrijk, , Belgium
British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre
Vancouver, British Columbia, Canada
University Health Network; Princess Margaret Hospital; Medical Oncology Dept
Toronto, Ontario, Canada
McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
Montreal, Quebec, Canada
Gustave Roussy
Villejuif, , France
Seoul National University Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Yonsei University Health System/Severance Hospital
Seoul, , South Korea
Clinica Universitaria de Navarra
Pamplona, Navarre, Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hosp de Madrid Norte Sanchinarro; Centro Integral; Onco Clara Campal
Madrid, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Countries
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Other Identifiers
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2015-000516-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GO29674
Identifier Type: -
Identifier Source: org_study_id
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