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

Phase 2

Active, not recruiting

• Conditions: Recurrent Head and Neck Cancer; Head and Neck Cancer; Head and Neck Neoplasms; Metastatic Cancer
• Interventions: Drug: Durvalumab; Drug: Cetuximab

• Registration Number: NCT03691714
• Lead Sponsor: Trisha Wise-Draper

Brief 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.

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 Timeline

• Study First Submitted: 2018-09-28
• Study First Submitted QC: 2018-09-28
• Study First Posted: 2018-10-02
• Study Start: 2018-10-23
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-06
• Last Update Posted: 2023-12-08
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 36

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Durvalumab and Cetuximab	Durvalumab	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 and Cetuximab	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 Measures

Name	Time	Method
Objective response rate	24 months	Imaging review using RECIST 1.1

Secondary Outcome Measures

Name	Time	Method
Adverse events	24 months	Percentage of adverse events using CTCAE v 5.0
Disease control rate	6 months	Combined complete response, partial response, and stable disease
Overall survival	24 months	Date of on treatment to date of death
Duration of response	24 months	Date of initial response to progressive disease
Progression-free survival	24 months	Imaging review using RECIST 1.1

Trial Locations

Locations (1)

UC Health; 🇺🇸 Cincinnati, Ohio, United States