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NCT03691714 Clinical Trial

Durvalumab (MEDI4736) With Cetuximab in Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Head and Neck Cancer Clinical Trial

Official title:
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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03691714
Other study ID # UCCI-HN-17-02
Secondary ID EAR-17-12765
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date October 23, 2018
Est. completion date December 2024

Study information
Verified date December 2023
Source University of Cincinnati
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 36
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Durvalumab
Two hour infusion
• Cetuximab
Two hour infusion for loading dose followed by weekly one hour infusion

Locations
Country Name City State
United States UC Health Cincinnati Ohio

Sponsors (2)
Lead Sponsor Collaborator
Trisha Wise-Draper AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Objective response rate Imaging review using RECIST 1.1 24 months
Secondary Adverse events Percentage of adverse events using CTCAE v 5.0 24 months
Secondary Disease control rate Combined complete response, partial response, and stable disease 6 months
Secondary Progression-free survival Imaging review using RECIST 1.1 24 months
Secondary Overall survival Date of on treatment to date of death 24 months
Secondary Duration of response Date of initial response to progressive disease 24 months
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