Spots Global Cancer Trial Database for IRX-2 Regimen and Durvalumab, for Incurable H&N Squamous Cell Carcinoma
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Trial Identification
Brief Title: IRX-2 Regimen and Durvalumab, for Incurable H&N Squamous Cell Carcinoma
Official Title: A Phase 1b Trial of the IRX-2 Regimen and Durvalumab (MEDI4736), in Patients With Incurable Head and Neck Squamous Cell Carcinoma
Study ID: NCT03381183
Study Description
Brief Summary: The purpose of this study is to see if the IRX-2 regimen and Durvalumab, will have a tolerable safety profile and will increase the intratumoral immune profile compared with the pretreatment tumors.
Detailed Description: Study Population: Patients with histologically or cytologically confirmed recurrent or metastatic squamous cell carcinoma of oral cavity, oropharynx, paranasal sinuses, hypopharynx, or larynx that is not amenable to local therapy with curative intent. Squamous cell carcinoma of unknown primary in cervical lymph node can be included only if p16 status is positive.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
University of Michigan Health System, Ann Arbor, Michigan, United States
Contact Details
Name: Christine Chung, M.D.
Affiliation: H. Lee Moffitt Cancer Center and Research Institute
Role: PRINCIPAL_INVESTIGATOR
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