A Phase 1b Study of MEDI4736 in Combination With Tremelimumab in Subjects With Advanced Non-small Cell Lung Cancer
NCT ID: NCT02000947
Last Updated: 2019-10-31
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
459 participants
INTERVENTIONAL
2013-10-25
2019-09-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dose Escalation
MEDI4736 and tremelimumab received by intravenous infusion.
MEDI4736
MEDI4736 is an anti-PD-L1 monoclonal antibody (MAb).
Tremelimumab
Tremelimumab is an anti-CTLA4 monoclonal antibody (mAb).
Arm A
Medi4736 and tremelimumab received by intravenous infusion
MEDI4736
MEDI4736 is an anti-PD-L1 monoclonal antibody (MAb).
Tremelimumab
Tremelimumab is an anti-CTLA4 monoclonal antibody (mAb).
Arm B
MEDI4736 and tremelimumab received by intravenous infusion
MEDI4736
MEDI4736 is an anti-PD-L1 monoclonal antibody (MAb).
tremelimumab
Tremelimumab is an anti-CTLA4 monoclonal antibody (mAb).
Arm C
MEDI4736 and tremelimumab received by intravenous infursion
MEDI4736
MEDI4736 is an anti-PD-L1 monoclonal antibody (MAb).
tremelimumab
Tremelimumab is an anti-CTLA4 monoclonal antibody (mAb).
Interventions
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MEDI4736
MEDI4736 is an anti-PD-L1 monoclonal antibody (MAb).
Tremelimumab
Tremelimumab is an anti-CTLA4 monoclonal antibody (mAb).
tremelimumab
Tremelimumab is an anti-CTLA4 monoclonal antibody (mAb).
Eligibility Criteria
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Inclusion Criteria
2. Advanced non-small cell lung cancer
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
4. Adequate organ and marrow function
Exclusion Criteria
2. Current or prior use of immunosuppressive medication within 14 days before the first dose of study drugs
3. Active or prior documented autoimmune disease within the last 2 years.
18 Years
101 Years
ALL
No
Sponsors
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MedImmune LLC
INDUSTRY
Responsible Party
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Principal Investigators
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MedImmune LLC
Role: STUDY_DIRECTOR
MedImmune LLC
Locations
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Research Site
Birmingham, Alabama, United States
Research Site
Tucson, Arizona, United States
Research Site
Los Angeles, California, United States
Research Site
Los Angeles, California, United States
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San Francisco, California, United States
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Aurora, Colorado, United States
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New Haven, Connecticut, United States
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Newark, Delaware, United States
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Tampa, Florida, United States
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Indianapolis, Indiana, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Ann Arbor, Michigan, United States
Research Site
Detroit, Michigan, United States
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St Louis, Missouri, United States
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Lebanon, New Hampshire, United States
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New York, New York, United States
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New York, New York, United States
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Huntersville, North Carolina, United States
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Columbus, Ohio, United States
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Portland, Oregon, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Tyler, Texas, United States
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Fairfax, Virginia, United States
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Seattle, Washington, United States
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Morgantown, West Virginia, United States
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Darlinghurst, , Australia
Research Site
Gosford, , Australia
Research Site
Kogarah, , Australia
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Brussels, , Belgium
Research Site
Ghent, , Belgium
Research Site
Liège, , Belgium
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Bordeaux, , France
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Dijon, , France
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La Tronche, , France
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Lille, , France
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Lyon, , France
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Marseille, , France
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Montpellier, , France
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Saint-Herblain, , France
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Bologna, , Italy
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Milan, , Italy
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Rozzano, , Italy
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Saronno, , Italy
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Siena, , Italy
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Sondrio, , Italy
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Cheongju-si, , South Korea
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Incheon, , South Korea
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Seongnam-si, , South Korea
Research Site
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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Seoul, , South Korea
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Barcelona, , Spain
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Barcelona, , Spain
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Jaén, , Spain
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Madrid, , Spain
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Madrid, , Spain
Research Site
Málaga, , Spain
Research Site
Seville, , Spain
Research Site
Valencia, , Spain
Research Site
Tainan City, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
London, , United Kingdom
Research Site
Manchester, , United Kingdom
Countries
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References
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Garon EB, Spira AI, Goldberg SB, Chaft JE, Papadimitrakopoulou V, Cascone T, Antonia SJ, Brahmer JR, Camidge DR, Powderly JD, Wozniak AJ, Felip E, Wu S, Ascierto ML, Elgeioushi N, Awad MM. Brief Report: Safety and Antitumor Activity of Durvalumab Plus Tremelimumab in Programmed Cell Death-(Ligand)1-Monotherapy Pretreated, Advanced NSCLC: Results From a Phase 1b Clinical Trial. J Thorac Oncol. 2023 Aug;18(8):1094-1102. doi: 10.1016/j.jtho.2023.04.020. Epub 2023 May 4.
Antonia S, Goldberg SB, Balmanoukian A, Chaft JE, Sanborn RE, Gupta A, Narwal R, Steele K, Gu Y, Karakunnel JJ, Rizvi NA. Safety and antitumour activity of durvalumab plus tremelimumab in non-small cell lung cancer: a multicentre, phase 1b study. Lancet Oncol. 2016 Mar;17(3):299-308. doi: 10.1016/S1470-2045(15)00544-6. Epub 2016 Feb 6.
Other Identifiers
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2015-003715-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D4190C00006
Identifier Type: -
Identifier Source: org_study_id
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