A Phase I Study to Evaluate the Safety, Tolerability and Efficacy of MEDI4736 (Durvalumab) With Tremelimumab in Head and Neck Cancer
NCT ID: NCT02262741
Last Updated: 2017-10-23
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
71 participants
INTERVENTIONAL
2014-10-15
2017-09-21
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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MEDI4736 + tremelimumab
MEDI4736
MEDI4736 will be administered by IV infusion in combination with tremelimumab.
tremelimumab
Tremelimumab will be administered by IV infusion in combination with MEDI4736.
Interventions
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MEDI4736
MEDI4736 will be administered by IV infusion in combination with tremelimumab.
tremelimumab
Tremelimumab will be administered by IV infusion in combination with MEDI4736.
Eligibility Criteria
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Inclusion Criteria
2. 18 years and older
3. Histologically or cytologically confirmed recurrent or metastatic squamous cell carcinoma of the head and neck (oral cavity, oropharynx, hypopharynx or larynx) that is incurable by local therapy.
4. Subjects who are treatment-naive or pretreated (prior anti-PD-1 or anti-PD-L1 required) in the recurrent/metastatic setting.
5. Subject eligibility will be based on PD-L1 expression as determined by a specified IHC assay.
Exclusion Criteria
2. Concurrent or prior use of immunosuppressive medication within 14 days
3. Active or prior documented autoimmune or inflammatory disease within 3 years with some exceptions.
18 Years
99 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
Scottsdale, Arizona, United States
Research Site
La Jolla, California, United States
Research Site
Los Angeles, California, United States
Research Site
Los Angeles, California, United States
Research Site
San Francisco, California, United States
Research Site
Aurora, Colorado, United States
Research Site
New Haven, Connecticut, United States
Research Site
Orlando, Florida, United States
Research Site
Chicago, Illinois, United States
Research Site
Fairway, Kansas, United States
Research Site
New Orleans, Louisiana, United States
Research Site
Baltimore, Maryland, United States
Research Site
Detroit, Michigan, United States
Research Site
Minneapolis, Minnesota, United States
Research Site
New York, New York, United States
Research Site
New York, New York, United States
Research Site
Portland, Oregon, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Greenville, South Carolina, United States
Research Site
San Antonio, Texas, United States
Research Site
Fairfax, Virginia, United States
Research Site
London, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Countries
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References
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Algazi A, Papadopoulos KP, Tsai F, Hansen AR, Angra N, Das M, Sheth S, Siu LL. Safety and clinical activity of durvalumab combined with tremelimumab in recurrent/metastatic head and neck squamous cell carcinoma: a multicenter phase I study. ESMO Open. 2024 Aug;9(8):103646. doi: 10.1016/j.esmoop.2024.103646. Epub 2024 Jul 23.
Other Identifiers
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D4190C00011
Identifier Type: -
Identifier Source: org_study_id