- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03691714
Durvalumab (MEDI4736) With Cetuximab in Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
December 6, 2023 updated by: Trisha Wise-Draper
An Open-label, Phase II Study of Durvalumab (MEDI4736) in Combination With Cetuximab in Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)
The purpose of this research study is to test the combination of the anti-cancer drugs durvalumab, the study drug, and cetuximab as a treatment for metastatic or recurrent head and neck cancer.
Participants will receive both durvalumab and cetuximab.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
This research study is designed to see if the study drug, durvalumab, will work better with cetuximab than either medicine alone along with the evaluation of side effects of the drug combination.
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States, 45219
- UC Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Body weight > 30 kg
- 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:
- Nasopharyngeal and salivary gland tumors
- Prior exposure to both immunotherapy drugs and Cetuximab. Single exposure to either immunotherapy or cetuximab is allowed.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
|
Two hour infusion
Other Names:
Two hour infusion for loading dose followed by weekly one hour infusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective response rate
Time Frame: 24 months
|
Imaging review using RECIST 1.1
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse events
Time Frame: 24 months
|
Percentage of adverse events using CTCAE v 5.0
|
24 months
|
Disease control rate
Time Frame: 6 months
|
Combined complete response, partial response, and stable disease
|
6 months
|
Progression-free survival
Time Frame: 24 months
|
Imaging review using RECIST 1.1
|
24 months
|
Overall survival
Time Frame: 24 months
|
Date of on treatment to date of death
|
24 months
|
Duration of response
Time Frame: 24 months
|
Date of initial response to progressive disease
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Shuchi Gulati, MD, University of Cincinnati
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 23, 2018
Primary Completion (Estimated)
December 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
September 28, 2018
First Submitted That Met QC Criteria
September 28, 2018
First Posted (Actual)
October 2, 2018
Study Record Updates
Last Update Posted (Estimated)
December 8, 2023
Last Update Submitted That Met QC Criteria
December 6, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Disease Attributes
- Neoplasms, Squamous Cell
- Head and Neck Neoplasms
- Recurrence
- Carcinoma, Squamous Cell
- Squamous Cell Carcinoma of Head and Neck
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Durvalumab
- Cetuximab
Other Study ID Numbers
- UCCI-HN-17-02
- EAR-17-12765 (Other Grant/Funding Number: AstraZeneca Pharmaceuticals)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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