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Cutaneous Squamous Cell CarcinomaPhase 2NCT05574101

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

A Phase 2 study testing Cemiplimab and Radiotherapy in people with Cutaneous Squamous Cell Carcinoma and Skin Cancer, run by Memorial Sloan Kettering Cancer Center at 13 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cemiplimab and Radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
13 sitesUnited States
Study dates
6 Oct 2022to 6 Oct 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 26Show fewer
  • ≥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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

United States13 sites

  • University of Colorado (Data Collection Only)

    Aurora, Colorado, 80045

  • Memorial Sloan Kettering Cancer Center at Basking Ridge (All Protocol Activities)

    Basking Ridge, New Jersey, 07920

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Cleveland Clinic (Data Collection Only)

    Cleveland, Ohio, 44195

  • Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities)

    Commack, New York, 11725

  • Memorial Sloan Kettering Westchester (All Protocol Activities)

    Harrison, New York, 10604

  • Memorial Sloan Kettering Monmouth (All Protocol Activities)

    Middletown, New Jersey, 07748

  • Memorial Sloan Kettering Bergen (All protocol activities)

    Montvale, New Jersey, 07645

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York, New York, 10065

  • Fox Chase Cancer Center (Data Collection Only)

    Philadelphia, Pennsylvania, 19111

  • Memorial Sloan Kettering Nassau (All protocol activities)

    Rockville Centre, New York, 11553

  • University of Washington (Data Collection Only)

    Seattle, Washington, 98109

  • Moffitt Cancer Center (Data Collection Only)

    Tampa, Florida, 33612

Other trials in United States

About this study

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

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.

Being tested
Cemiplimab, Radiotherapy
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
Medical subject headings
Skin Neoplasms, Carcinoma, Squamous Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CemiplimabDrug

    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.

  • RadiotherapyRadiation

    Participants will receive radiotherapy to 70 Gy in 35 fractions over 7 weeks concurrently with cemiplimab

Study groups in NCT05574101
Study groupRoleWhat they receive
Participants with locally advanced, unresectable cutaneous squamous cell carcinoma/CSCCExperimentalParticipants have locally advanced, unresectable cutaneous squamous cell carcinoma/CSCC
Receives: Drug: Cemiplimab; Radiation: Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Event Free Survival

    The primary endpoint for this study is event free survival at 18 months (week 78 +/- 3 weeks) after starting cemiplimab.

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2022
  2. Study start6 Oct 2022
  3. Primary completion6 Oct 2026 (estimated)
  4. Study completion6 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05574101
Sponsor's protocol ID
22-090
Status last verified
May 2026
First submitted
6 Oct 2022
Last updated
15 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cemiplimab and Radiotherapy in people with Cutaneous Squamous Cell Carcinoma and Skin Cancer, run by Memorial Sloan Kettering Cancer Center at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event Free Survival (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05574101.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.

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