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NCT05574101 Clinical Trial

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

Squamous Cell Carcinoma Clinical Trial

Official title:
A Phase II, Multicenter, Single-Arm Clinical Trial of Radiotherapy and CeMiPlimAb: Rwlc ImmunoTherapy for Locally Advanced, Unresectable Cutaneous Squamous Cell Carcinoma: RAMPART

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05574101
Other study ID # 22-090
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date October 6, 2022
Est. completion date October 6, 2026

Study information
Verified date April 2024
Source Memorial Sloan Kettering Cancer Center
Contact Christopher Barker, MD
Phone 212-639-8168
Email LianM@mskcc.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 34
Est. completion date October 6, 2026
Est. primary completion date October 6, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 PI3Kd 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

Related Conditions & MeSH terms

Intervention

Drug:
• Cemiplimab
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.
Radiation:
• Radiotherapy
Participants will receive radiotherapy to 70 Gy in 35 fractions over 7 weeks concurrently with cemiplimab

Locations
Country Name City State
United States Emory University Atlanta Georgia
United States University of Colorado (Data Collection Only) Aurora Colorado
United States Memorial Sloan Kettering Cancer Center at Basking Ridge (All Protocol Activities) Basking Ridge New Jersey
United States Medical University of South Carolina Charleston South Carolina
United States Cleveland Clinic (Data Collection Only) Cleveland Ohio
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 Monmouth (All Protocol Activities) Middletown New Jersey
United States Memorial Sloan Kettering Bergen (All protocol activities) Montvale New Jersey
United States Memorial Sloan Kettering Cancer Center (All Protocol Activities) New York New York
United States Fox Chase Cancer Center (Data Collection Only) Philadelphia Pennsylvania
United States Memorial Sloan Kettering Nassau (All protocol activities) Rockville Centre New York
United States University of Washington (Data Collection Only) Seattle Washington
United States Moffitt Cancer Center (Data Collection Only) Tampa Florida

Sponsors (1)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Disease Free Survival The primary endpoint for this study is disease free survival at 18 months (week 78 +/- 3 weeks) after starting cemiplimab. 18 months
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