Phase II Study of MEDI4736 Monotherapy or in Combinations With Tremelimumab in Metastatic Pancreatic Ductal Carcinoma
NCT ID: NCT02558894
Last Updated: 2018-08-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
65 participants
INTERVENTIONAL
2015-11-16
2017-06-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MEDI4736 monotherapy
MEDI4736 via IV infusion.
MEDI4736 monotherapy
MEDI4736 via IV infusion.
tremelimumab+MEDI4736
MEDI4736+tremelimumab via IV infusion.
tremelimumab+MEDI4736
tremelimumab+MEDI4736 via IV infusion.
Interventions
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MEDI4736 monotherapy
MEDI4736 via IV infusion.
tremelimumab+MEDI4736
tremelimumab+MEDI4736 via IV infusion.
Eligibility Criteria
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Inclusion Criteria
2. Eastern Cooperative Oncology Group 0 or 1
3. At least 1 lesion, not previously irradiated, that can be accurately measured at baseline as ≥10 mm in the longest diameter (except lymph nodes, which must have short axis ≥15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) scan and that is suitable for accurate repeated measurements
Exclusion Criteria
2. History of leptomeningeal carcinomatosis
3. Ascites requiring intervention
4. Brain metastases or spinal cord compression.
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Eileen M O'Reilly, M.D
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center, 300 East 66th Street,New York,NY 10065
Locations
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Research Site
Tampa, Florida, United States
Research Site
New York, New York, United States
Research Site
Vancouver, British Columbia, Canada
Research Site
Oshawa, Ontario, Canada
Research Site
Ottawa, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Friedrichshafen, , Germany
Research Site
München, , Germany
Research Site
Tübingen, , Germany
Research Site
Amsterdam, , Netherlands
Research Site
Groningen, , Netherlands
Research Site
Nijmegen, , Netherlands
Research Site
Seongnam-si, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Barcelona, , Spain
Research Site
Madrid, , Spain
Countries
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References
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O'Reilly EM, Oh DY, Dhani N, Renouf DJ, Lee MA, Sun W, Fisher G, Hezel A, Chang SC, Vlahovic G, Takahashi O, Yang Y, Fitts D, Philip PA. Durvalumab With or Without Tremelimumab for Patients With Metastatic Pancreatic Ductal Adenocarcinoma: A Phase 2 Randomized Clinical Trial. JAMA Oncol. 2019 Oct 1;5(10):1431-1438. doi: 10.1001/jamaoncol.2019.1588.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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D4198C00001
Identifier Type: -
Identifier Source: org_study_id
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