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

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
Trisha Wise-Draper
Study ID
NCT03691714
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    Two hour infusion
  • Cetuximab — DRUG
    Two hour infusion for loading dose followed by weekly one hour infusion

Study Details

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.

Key Dates

Start date
Oct 23, 2018
Status verified
May 2026
Primary completion
Dec 1, 2024
Completion
Dec 1, 2024

Study Design

Enrollment
35 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Objective Response Rate [ Time Frame: RECIST 1.1 was assessed for each participant every 8 weeks from study initiation until the end of study treatment. The time from first RECIST 1.1 assessment to the final at the end of study was 8.5 months. ]

Locations (1)

FacilityCityStateZIPSite coordinators
UC HealthCincinnatiOhio45219-

Find similar trials in Cincinnati, OH

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
UC Health· Cincinnati, OH

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