Cemiplimab in Treating Patients With Recurrent and Resectable Stage II-IV Head and Neck Cutaneous Squamous Cell Cancer Before Surgery

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT03565783
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Recurrent Cutaneous Squamous Cell Carcinoma of the Head and Neck
  • Resectable Cutaneous Squamous Cell Carcinoma of the Head and Neck
  • Stage II Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8
  • Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8
  • Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8

Eligibility Criteria

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

Interventions

Study Details

This phase II trial studies how well cemiplimab works before surgery in treating patients with stage II-IV head and neck cutaneous squamous cell cancer that has come back (recurrent) and can be removed by surgery (resectable). Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Key Dates

Start date
Jul 3, 2018
Status verified
Feb 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

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

Arms

  • Experimental: Treatment (cemiplimab)
    Patients receive cemiplimab IV over 30 minutes every 3 weeks. Cycles repeat every 3 weeks for up to 6 weeks with or without radiation therapy at the discretion of the treating physician in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Overall response rate [ Time Frame: Up to 6 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By research site
M D Anderson Cancer Center· Houston, TX

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