Trial Title:
A Study of Radiation Therapy and Cemiplimab for People With Skin Cancer
NCT ID:
NCT05574101
Condition:
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
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Skin Neoplasms
Cemiplimab
Conditions: Keywords:
Skin cancer
squamous cell carcinoma
locally advanced squamous cell carcinoma
Cutaneous Squamous Cell Carcinoma
Locally Advanced Squamous Cell Carcinoma of the Skin
Locally Advanced Cutaneous Squamous Cell Carcinoma
Locally Advanced Skin Squamous Cell Carcinoma
cemiplimab
RAMPART
22-090
Memorial Sloan Kettering Cancer Center
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Cemiplimab
Description:
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.
Arm group label:
Participants with locally advanced, unresectable cutaneous squamous cell carcinoma/CSCC
Intervention type:
Radiation
Intervention name:
Radiotherapy
Description:
Participants will receive radiotherapy to 70 Gy in 35 fractions over 7 weeks concurrently
with cemiplimab
Arm group label:
Participants with locally advanced, unresectable cutaneous squamous cell carcinoma/CSCC
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Colorado (Data Collection Only)
Address:
City:
Aurora
Zip:
80045
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ryan Lanning, MD, PhD
Phone:
720-516-0150
Facility:
Name:
Moffitt Cancer Center (Data Collection Only)
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Recruiting
Contact:
Last name:
Evan Wuthrick, MD
Phone:
813-745-4673
Facility:
Name:
Memorial Sloan Kettering Cancer Center at Basking Ridge (All Protocol Activities)
Address:
City:
Basking Ridge
Zip:
07920
Country:
United States
Status:
Recruiting
Contact:
Last name:
Christopher Barker, MD
Phone:
212-639-8168
Facility:
Name:
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Address:
City:
Middletown
Zip:
07748
Country:
United States
Status:
Recruiting
Contact:
Last name:
Christopher Barker, MD
Phone:
212-639-8168
Facility:
Name:
Memorial Sloan Kettering Bergen (All protocol activities)
Address:
City:
Montvale
Zip:
07645
Country:
United States
Status:
Recruiting
Contact:
Last name:
Christopher Barker, MD
Phone:
212-639-8168
Facility:
Name:
Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities)
Address:
City:
Commack
Zip:
11725
Country:
United States
Status:
Recruiting
Contact:
Last name:
Christopher Barker, MD
Phone:
212-639-8168
Facility:
Name:
Memorial Sloan Kettering Westchester (All Protocol Activities)
Address:
City:
Harrison
Zip:
10604
Country:
United States
Status:
Recruiting
Contact:
Last name:
Christopher Barker, MD
Phone:
212-639-8168
Facility:
Name:
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Christopher Barker, MD
Phone:
212-639-8168
Facility:
Name:
Memorial Sloan Kettering Nassau (All protocol activities)
Address:
City:
Rockville Centre
Zip:
11553
Country:
United States
Status:
Recruiting
Contact:
Last name:
Christopher Barker, MD
Phone:
212-639-8168
Facility:
Name:
Cleveland Clinic (Data Collection Only)
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Recruiting
Contact:
Last name:
Shlomo Koyman, MD
Phone:
216-444-7552
Facility:
Name:
Fox Chase Cancer Center (Data Collection Only)
Address:
City:
Philadelphia
Zip:
19111
Country:
United States
Status:
Recruiting
Contact:
Last name:
Thomas Galloway, MD
Phone:
888-369-2427
Facility:
Name:
Medical University of South Carolina
Address:
City:
Charleston
Zip:
29425
Country:
United States
Status:
Recruiting
Contact:
Last name:
Bhisham Chere, MD
Phone:
843-792-9300
Facility:
Name:
University of Washington (Data Collection Only)
Address:
City:
Seattle
Zip:
98109
Country:
United States
Status:
Recruiting
Contact:
Last name:
Upendra Parvathaneni, MD
Phone:
206-228-1025
Start date:
October 6, 2022
Completion date:
October 6, 2026
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05574101
http://www.mskcc.org
