A Study of Radiation Therapy and Cemiplimab for People With Skin Cancer
A Phase II, Multicenter, Single-Arm Clinical Trial of Radiotherapy and CeMiPlimAb: Rwlc ImmunoTherapy for Locally Advanced, Unresectable Cutaneous Squamous Cell Carcinoma: RAMPART
1 other identifier
interventional
34
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Oct 2022
Typical duration for phase_2
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 6, 2022
CompletedStudy Start
First participant enrolled
October 6, 2022
CompletedFirst Posted
Study publicly available on registry
October 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 6, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 6, 2026
August 8, 2025
August 1, 2025
4 years
October 6, 2022
August 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Participants with locally advanced, unresectable cutaneous squamous cell carcinoma/CSCC
EXPERIMENTALParticipants have locally advanced, unresectable cutaneous squamous cell carcinoma/CSCC
Interventions
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.
Participants will receive radiotherapy to 70 Gy in 35 fractions over 7 weeks concurrently with cemiplimab
Eligibility Criteria
You may qualify if:
- 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)
- +11 more criteria
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
University of Colorado (Data Collection Only)
Aurora, Colorado, 80045, United States
Moffitt Cancer Center (Data Collection Only)
Tampa, Florida, 33612, United States
Memorial Sloan Kettering Cancer Center at Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (All protocol activities)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (All protocol activities)
Rockville Centre, New York, 11553, United States
Cleveland Clinic (Data Collection Only)
Cleveland, Ohio, 44195, United States
Fox Chase Cancer Center (Data Collection Only)
Philadelphia, Pennsylvania, 19111, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
University of Washington (Data Collection Only)
Seattle, Washington, 98109, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher Barker, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2022
First Posted
October 10, 2022
Study Start
October 6, 2022
Primary Completion (Estimated)
October 6, 2026
Study Completion (Estimated)
October 6, 2026
Last Updated
August 8, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.