Cemiplimab and Quad Shot Radiation for Cutaneous Squamous Cell Carcinoma in the Head and Neck

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Vanderbilt-Ingram Cancer Center
Study ID
NCT07869823
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Cemiplimab — DRUG
    Cemiplimab 350mg (IV) will be administered every 3 weeks for a total of eight doses or until progression or treatment related toxicity requiring discontinuation of therapy. Cemiplimab may be continued at the treating physician's discretion beyond six months for up to one year (cycle 9 to 16) for patients who achieve a partial or complete objective response and are tolerating treatment.
  • Radiation Therapy — RADIATION
    Radiation therapy will be delivered using a Quad Shot technique (two treatments per day for two days). Quad Shots will be repeated every three weeks for up to four consecutive cycles. The total planned radiation dose is 59.2 Gy. Patients achieving a complete clinical and radiographic response following the third Quad Shot may discontinue radiation after the third Quad Shot (44.4 Gy).

Study Details

The goal of this clinical trial is to learn if the combination of the drug cemiplimab along with a short course of radiation therapy called Quad Shot can be successfully given in several rounds to elderly or frail patients with head and neck skin cancers. The main question it aims to answer is: \- Can care providers successfully deliver at least 6 rounds of cemiplimab and 3 rounds of Quad Shot radiation to patients? Patients will: * Be given cemiplimab every 3 weeks for a total of up to 8 doses * Be given Quad Shot radiation (four treatments over two days) every 3 weeks for a total of up to 4 rounds

Key Dates

First listed
Oct 13, 2026
Start date
Sep 30, 2026
Status verified
Oct 2026
Primary completion
Sep 30, 2028
Completion
Sep 30, 2029

Study Design

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

Arms

  • Experimental: Cemiplimab and radiation

Primary Outcome Measure

Feasibility, as measured by the percentage of subjects receiving at least 6 planned doses of cemiplimab and at least 3 "Quad Shots" [ Time Frame: through study completion, an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University Medical CenterSt LouisMissouri63110
Jennifer De Los Santos, M.D.
[email protected]
314-747-7236
Alice Y Zhou, M.D., Ph.D.
[email protected]
314-454-8318

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Skin cancer
By specialty
OncologySkin cancerDermatology
By research site
Washington University Medical Center· St Louis, MO

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