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
• Status: Recruiting
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Cutaneous Squamous Cell Carcinoma
• Locally Advanced Cutaneous Squamous Cell Carcinoma
• Locally Advanced Skin Squamous Cell Carcinoma
• Skin Cancer
• Skin Neoplasms
• Squamous Cell Carcinoma

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

External Links

•   Memorial Sloan Kettering Cancer Center