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

Completed · Phase 1

Conditions studied: Neoplasms

In brief

This Phase Ib, open-label, dose-escalation study will evaluate the safety, tolerability, and pharmacokinetics of the combination of MOXR0916 and atezolizumab in participants with locally advanced, recurrent, or metastatic incurable solid malignancy that has progressed after available standard therapy; or for which standard therapy has proven to be ineffective or intolerable or is considered inappropriate; or for which a clinical trial of an investigational agent is a recognized standard of care. Participants will be enrolled in two stages: a dose-escalation stage and an expansion stage.

Key facts

Study ID

NCT02410512

Run by

Genentech, Inc.

People needed

610

Starts

2015-04-24

Expected to finish

2019-11-22

Last updated by the study team

2022-04-01

Who can join

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

You may qualify if…

• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• 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

You may not qualify if…

• Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to initiation of study treatment
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.