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A Study of Durvalumab (MEDI4736) and Monalizumab in Solid Tumors
Sponsor: MedImmune LLC
Summary
This is a multicenter, open-label, dose-escalation, dose-exploration and dose-expansion study to evaluate the safety, tolerability, antitumor activity, pharmacokinetic (PK), pharmacodynamics, and immunogenicity of durvalumab (MEDI4736) in combination with monalizumab (IPH2201) in adult participants with selected advanced solid tumors and the combination of durvalumab and monalizumab (IPH2201) standard of care systemic therapy with or without biological agent and monalizumab (IPH2201) with biological agent administered to participants with recurrent or metastatic colorectal cancer (CRC).
Official title: A Phase 1/2 Study of Durvalumab and Monalizumab in Adult Subjects With Select Advanced Solid Tumors
Key Details
Gender
All
Age Range
18 Years - 99 Years
Study Type
INTERVENTIONAL
Enrollment
383
Start Date
2016-02-22
Completion Date
2025-09-01
Last Updated
2025-07-22
Healthy Volunteers
No
Conditions
Interventions
Monalizumab
Participants will receive IV infusion of monalizumab as stated in arm description.
Durvalumab
Participants will receive IV infusion of durvalumab as stated in arm description.
Cetuximab
Participants will receive IV infusion of cetuximab as stated in arm description.
mFOLFOX6
Participants will receive IV infusion of mFOLFOX as stated in arm description.
Bevacizumab
Participants will receive IV infusion of bevacizumab as stated in arm description.
Locations (49)
Research Site
Birmingham, Alabama, United States
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Scottsdale, Arizona, United States
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Duarte, California, United States
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La Jolla, California, United States
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Los Angeles, California, United States
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Sacramento, California, United States
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Santa Monica, California, United States
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Aurora, Colorado, United States
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Tampa, Florida, United States
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Chicago, Illinois, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Detroit, Michigan, United States
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New Brunswick, New Jersey, United States
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New Hyde Park, New York, United States
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New York, New York, United States
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The Bronx, New York, United States
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Providence, Rhode Island, United States
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Nashville, Tennessee, United States
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Dallas, Texas, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
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Blacktown, Australia
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Clayton, Australia
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Waratah, Australia
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Brussels, Belgium
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Edegem, Belgium
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Leuven, Belgium
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Vancouver, British Columbia, Canada
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Toronto, Ontario, Canada
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Marseille, France
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Nantes, France
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Debrecen, Hungary
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Milan, Italy
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Milan, Italy
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Grafton, New Zealand
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Barcelona, Spain
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Madrid, Spain
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Madrid, Spain
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Málaga, Spain
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Pamplona, Spain
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Seville, Spain
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London, United Kingdom
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Sutton, United Kingdom