Phase II Study of Neoadjuvant Cetuximab and Cemiplimab in Patients Undergoing Surgery for HNSCC

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT06855212
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Cemiplimab — DRUG
    Given by IV infusion.
  • Cetuximab — DRUG
    Given by IV infusion.

Study Details

The purpose of the study is to determine if cemiplimab in combination with cetuximab given before their surgery are beneficial and safe in participants with head and neck squamous cell carcinoma (HNSCC).

Key Dates

Start date
Feb 26, 2025
Status verified
May 2026
Primary completion
Mar 31, 2028
Completion
Mar 31, 2028

Study Design

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

Arms

  • Experimental: Neoadjuvant Cetuximab and Cemiplimab Treatment
    Cemiplimab: 350 mg IV dose on C1D1 and C2D1 Cetuximab: 400mg/m2 loading dose on C1D1 followed by 250 mg/m2 IV weekly doses on C1D8, C1D15, and C2D1 (total 4 doses including the loading dose).

Primary Outcome Measure

Major and Complete Pathologic Response Rate [ Time Frame: Day of Surgery ]

Locations (1)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612-

Find similar trials in Tampa, FL

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
Moffitt Cancer Center· Tampa, FL

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