Cetuximab After Immunotherapy for the Treatment of Head and Neck Squamous Cell Cancer

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT04375384
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Cetuximab — DRUG
    A loading dose of Cetuximab will be administered intravenously in the first day of treatment. The dose is 400 mg/m2 and will be infused over 2h followed by 1h observation. The maintenance dose of Cetuximab is 250 mg/m2 and will be infused over 1h. No further observation time needed. The maintenance dose of cetuximab will be given every 7 days (+/- 2 days) starting 7 days (+/- 2 days) after the loading dose of cetuximab. Pre-medicate with 50 mg Diphenhydramine IV before the loading dose of Cetuximab and as per standard of care before the maintenance treatment.
  • Questionnaire administration — OTHER
    Ancillary studies
  • Quality of life assessment — OTHER
    Ancillary studies

Study Details

This is a Phase II treatment, non-randomized, open label clinical trial to study the efficacy of the Cetuximab when administered as single agent in recurrent/ metastatic head and neck squamous cell carcinoma after the failure or intolerance of immuno-oncology or immuno-oncology combined with chemotherapy.

Key Dates

Start date
Jul 1, 2020
Status verified
Feb 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
38 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cetuximab
    Patients receive cetuximab IV over 60-120 minutes once every week in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Change in Overall Response Rate To Treatment with Cetuximab [ Time Frame: 14 days before start of treatment, 7 weeks after start of treatment, and then every 6-8 weeks for the duration of treatment, up to approximately 2 years. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wake Forest Baptist Comprehensive Cancer CenterWinston-SalemNorth Carolina27157
Study Coordinator
[email protected]
Mercedes Porosnicu, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Winston-Salem, NC

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
Wake Forest Baptist Comprehensive Cancer Center· Winston-Salem, NC

Related Studies