Durvalumab (MEDI4736) With Cetuximab in Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
NCT ID: NCT03691714
Last Updated: 2023-12-08
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE2
36 participants
INTERVENTIONAL
2018-10-23
2024-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Durvalumab and Cetuximab
Durvalumab 500mg as a 120-minute intravenous infusion every two weeks. Cetuximab 400mg/m2 IV loading dose followed by weekly Cetuximab 250mg/m2 IV Treatment with Durvalumab continues until progression and Cetuximab may continue as maintenance
Durvalumab
Two hour infusion
Cetuximab
Two hour infusion for loading dose followed by weekly one hour infusion
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Durvalumab
Two hour infusion
Cetuximab
Two hour infusion for loading dose followed by weekly one hour infusion
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Histologically or cytologically confirmed recurrent or metastatic HNSCC
* Not considered a candidate for other curative therapy (i.e. surgery/RT)
* Documented progression of disease after receiving platinum based regimen
* ECOG performance status 0-2
Exclusion Criteria
* Prior exposure to both immunotherapy drugs and Cetuximab. Single exposure to either immunotherapy or cetuximab is allowed.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AstraZeneca
INDUSTRY
Trisha Wise-Draper
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Trisha Wise-Draper
Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Shuchi Gulati, MD
Role: PRINCIPAL_INVESTIGATOR
University of Cincinnati
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UC Health
Cincinnati, Ohio, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EAR-17-12765
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
UCCI-HN-17-02
Identifier Type: -
Identifier Source: org_study_id