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

Phase 2

Active, not recruiting

• Conditions: Cutaneous Squamous Cell Carcinoma; Skin Cancer; Squamous Cell Carcinoma; Locally Advanced Squamous Cell Carcinoma; Locally Advanced Squamous Cell Carcinoma of the Skin; Locally Advanced Cutaneous Squamous Cell Carcinoma; Locally Advanced Skin Squamous Cell Carcinoma
• Interventions: Drug: Cemiplimab; Radiation: Radiotherapy

• Registration Number: NCT05574101
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-06
• Study First Submitted: 2022-10-06
• Study First Submitted QC: 2022-10-06
• Study First Posted: 2022-10-10
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-23
• Last Update Posted: 2025-05-25
• Primary Completion: 2026-10-06
• Study Completion: 2026-10-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• Biopsy proven cutaneous squamous cell carcinoma which is locally advanced

  • Mixed histology tumors that are predominantly squamous cell carcinoma are eligible
  • Locally advanced primary tumor is T3-T4 and/or N+ by AJCC and/or UICC 8th edition clinical criteria

• T3-T4 primary tumor characteristics noted below:

  • Non-eyelid tumor >4 cm in maximum dimension or with bone erosion or invasion, perineural invasion of nerve 0.1 mm or larger, or invasion beyond subcutaneous fat or >6 mm from granular layer of adjacent normal epidermis
  • Eyelid tumor >2 cm or invading adjacent ocular, orbital or facial structures

• ≥18 years old

• Unresectable or medically inoperable according to local multidisciplinary consensus for reasons such as:

  • Tumor or regional lymph node metastases that has recurred despite ≥2 prior surgical procedures, with another curative resection unlikely
  • Tumor or nodal disease with significant local invasion that precludes complete resection
  • Tumor or nodal disease in anatomically challenging area where surgery may result in significant disfigurement or dysfunction (amputation of nose, ear, eye, digit, limb, etc)
  • Medical contraindication to surgery
  • Patient refusal of surgery due to anticipate morbidity

• ECOG ≤2

• Adequate bone marrow and metabolic function (by blood tests)

  • Total bilirubin ≤1.5 x upper limit of normal
  • Aspirate aminotransferase (AST) ≤3 x upper limit of normal
  • Alanine aminotransferase (ALT) ≤3 x upper limit of normal
  • Alkaline phosphatase ≤2.5 x upper limit of normal
  • Serum creatinine ≤1.5 x upper limit of normal or estimated creatinine clearance >30 mL/min according to Cockcroft-Gault formula
  • Hemoglobin >9 g/dL
  • Absolute neutrophil count ≥1.5 x10^9/L
  • Platelet count ≥75 x10^9/L

• Able to provide informed consent

• Acceptable candidate for curative intent radiotherapy and Cemiplimab immunotherapy, in opinion of radiation and medical oncologist, respectively

• Life expectancy >18 months

Exclusion Criteria

• Primary tumor originating on the mucosal (non-hair bearing) lip or nose, anogenital (penis, scrotum, vulva, perianal) area

• Iatrogenic immunosuppression (>prednisone 10 mg/day or equivalent within 14 days of initiation of treatment)

• Women of child bearing potential unwilling or unable to use effective contraception while receiving treatment with cemiplimab and for 4 months thereafter

• Distant metastases

• Clinically significant autoimmune disease that requires iatrogenic immunosuppression

  o For example, severe rheumatoid arthritis requiring disease modifying antirheumatic drugs, such as methotrexate

• Current or previous hematopoietic malignancy (leukemia, lymphoma)

• Prior allogeneic transplant of solid organ or bone marrow

• Concurrent malignancies with >10% risk of metastasis or death within 2 years

• Prior aPD1 immunotherapy or PI3Kδ inhibitor use

• Prior radiotherapy for the cutaneous squamous cell carcinoma requiring treatment

• Other ongoing cancer therapy

  o Adjuvant endocrine therapy is permitted for patients with prostate or breast cancer

• Uncontrolled HIV or infectious hepatitis (viral load detectable in patient with known infection)

• Pregnancy or breastfeeding

• Comorbid or diagnostic abnormalities within the last year that would interfere with interpretation of study results

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Participants with locally advanced, unresectable cutaneous squamous cell carcinoma/CSCC	Radiotherapy	Participants have locally advanced, unresectable cutaneous squamous cell carcinoma/CSCC
Participants with locally advanced, unresectable cutaneous squamous cell carcinoma/CSCC	Cemiplimab	Participants have locally advanced, unresectable cutaneous squamous cell carcinoma/CSCC

Primary Outcome Measures

Name	Time	Method
Disease Free Survival	18 months	The primary endpoint for this study is disease free survival at 18 months (week 78 +/- 3 weeks) after starting cemiplimab.

Trial Locations

Locations (13)

University of Colorado (Data Collection Only); 🇺🇸 Aurora, Colorado, United States

Moffitt Cancer Center (Data Collection Only); 🇺🇸 Tampa, Florida, United States

Memorial Sloan Kettering Cancer Center at Basking Ridge (All Protocol Activities); 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (All Protocol Activities); 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (All protocol activities); 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Westchester (All Protocol Activities); 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities); 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Nassau (All protocol activities); 🇺🇸 Rockville Centre, New York, United States

Cleveland Clinic (Data Collection Only); 🇺🇸 Cleveland, Ohio, United States

Fox Chase Cancer Center (Data Collection Only); 🇺🇸 Philadelphia, Pennsylvania, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

University of Washington (Data Collection Only); 🇺🇸 Seattle, Washington, United States