Neoadjuvant Plus Adjuvant Treatment With Cemiplimab in Cutaneaous Squamous Cell Carcinoma

Sponsor
Fondazione Melanoma Onlus
Study ID
NCT04632433
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

Study Details

Neoadjuvant plus adjuvant treatment with immunotherapy may have an anti-tumor activity and reduce the risk of relapse in patients with high risk surgically resectable stage III cutaneous squamous cell carcinoma.

Key Dates

Start date
Feb 10, 2021
Status verified
Mar 2025
Primary completion
Feb 6, 2023
Completion
Feb 1, 2026

Study Design

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

Arms

  • Experimental: single arm
    Patients will receive cemiplimab at a dosage of 350 mg every 3 weeks for two cycles prior surgery. Stage III stage must be documented at screening and re-assessed prior surgery by spiral or multidetector computed tomography (CT) scan (if clinically indicated) and Positron emission tomography (PET). Postoperatively, adjuvant immunotherapy with cemiplimab will be administered at a dosage of 350 mg every 3 weeks for one year.

Primary Outcome Measure

Major pathological response rate [ Time Frame: 43-71 days ]

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