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)
Overview
- Phase
- Phase 2
- Intervention
- Durvalumab
- Conditions
- Recurrent Head and Neck Cancer
- Sponsor
- Trisha Wise-Draper
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Objective response rate
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Trisha Wise-Draper
Investigator
University of Cincinnati
Eligibility Criteria
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.
Arms & Interventions
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
Intervention: Durvalumab
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
Intervention: Cetuximab
Outcomes
Primary Outcomes
Objective response rate
Time Frame: 24 months
Imaging review using RECIST 1.1
Secondary Outcomes
- Overall survival(24 months)
- Duration of response(24 months)
- Progression-free survival(24 months)
- Adverse events(24 months)
- Disease control rate(6 months)