A Study of Radiation Therapy and Cemiplimab for People With Skin Cancer

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT05574101
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Cemiplimab — DRUG
    Participants will undergo baseline imaging, followed by two doses of neoadjuvant cemiplimab at a dose of 350 mg intravenously over 30 minutes every 3 weeks (+/-3 days). Then, participants will receive concurrent cemiplimab 350 mg intravenously over 30 minutes every 3 weeks (+/-3 days) concurrently with RT to 70 Gy in 35 fractions over 7 weeks. Thereafter, participants will receive 38 weeks of cemiplimab 350 mg intravenously over 30 minutes every 3 weeks (+/-3 days) for a cumulative total of 12 months of cemiplimab.
  • Radiotherapy — RADIATION
    Participants will receive radiotherapy to 70 Gy in 35 fractions over 7 weeks concurrently with cemiplimab

Study Details

The purpose of the study is to see if the combination of radiation therapy and cemiplimab immunotherapy is an effective treatment for people with locally advanced, unresectable CSCC.

Key Dates

Start date
Oct 6, 2022
Status verified
May 2026
Primary completion
Oct 6, 2026
Completion
Oct 6, 2026

Study Design

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

Arms

  • Experimental: Participants with locally advanced, unresectable cutaneous squamous cell carcinoma/CSCC
    Participants have locally advanced, unresectable cutaneous squamous cell carcinoma/CSCC

Primary Outcome Measure

Event Free Survival [ Time Frame: 18 months ]

Locations (13)

FacilityCityStateZIPSite coordinators
University of Colorado (Data Collection Only)AuroraColorado80045-
Moffitt Cancer Center (Data Collection Only)TampaFlorida33612-
Memorial Sloan Kettering Cancer Center at Basking Ridge (All Protocol Activities)Basking RidgeNew Jersey07920-
Memorial Sloan Kettering Monmouth (All Protocol Activities)MiddletownNew Jersey07748-
Memorial Sloan Kettering Bergen (All protocol activities)MontvaleNew Jersey07645-
Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities)CommackNew York11725-
Memorial Sloan Kettering Westchester (All Protocol Activities)HarrisonNew York10604-
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065-
Memorial Sloan Kettering Nassau (All protocol activities)Rockville CentreNew York11553-
Cleveland Clinic (Data Collection Only)ClevelandOhio44195-
Fox Chase Cancer Center (Data Collection Only)PhiladelphiaPennsylvania19111-
Medical University of South CarolinaCharlestonSouth Carolina29425-
University of Washington (Data Collection Only)SeattleWashington98109-

Find similar trials in Aurora, CO

By condition
Skin cancer
By specialty
OncologySkin cancerDermatology
By research site
University of Colorado (Data Collection Only)· Aurora, COMoffitt Cancer Center (Data Collection Only)· Tampa, FLMemorial Sloan Kettering Cancer Center at Basking Ridge (All Protocol Activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (All Protocol Activities)· Middletown, NJMemorial Sloan Kettering Bergen (All protocol activities)· Montvale, NJMemorial Sloan Kettering Suffolk-Commack (All Protocol Activities)· Commack, NY

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