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

April 11, 2024 updated by: Memorial Sloan Kettering Cancer Center

A Phase II, Multicenter, Single-Arm Clinical Trial of 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

34

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Christopher Barker, MD
  • Phone Number: 212-639-8168
  • Email: LianM@mskcc.org

Study Contact Backup

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado (Data Collection Only)
        • Contact:
          • Ryan Lanning, MD, PhD
          • Phone Number: 720-516-0150
    • Florida
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center (Data Collection Only)
        • Contact:
          • Evan Wuthrick, MD
          • Phone Number: 813-745-4673
    • Georgia
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Recruiting
        • Memorial Sloan Kettering Cancer Center at Basking Ridge (All Protocol Activities)
        • Contact:
          • Christopher Barker, MD
          • Phone Number: 212-639-8168
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • Memorial Sloan Kettering Monmouth (All protocol activities)
        • Contact:
          • Christopher Barker, MD
          • Phone Number: 212-639-8168
      • Montvale, New Jersey, United States, 07645
        • Recruiting
        • Memorial Sloan Kettering Bergen (All Protocol Activities)
        • Contact:
          • Christopher Barker, MD
          • Phone Number: 212-639-8168
    • New York
      • Commack, New York, United States, 11725
        • Recruiting
        • Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities)
        • Contact:
          • Christopher Barker, MD
          • Phone Number: 212-639-8168
      • Harrison, New York, United States, 10604
        • Recruiting
        • Memorial Sloan Kettering Westchester (All Protocol Activities)
        • Contact:
          • Christopher Barker, MD
          • Phone Number: 212-639-8168
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
        • Contact:
          • Christopher Barker, MD
          • Phone Number: 212-639-8168
      • Rockville Centre, New York, United States, 11553
        • Recruiting
        • Memorial Sloan Kettering Nassau (All Protocol Activities)
        • Contact:
          • Christopher Barker, MD
          • Phone Number: 212-639-8168
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic (Data Collection Only)
        • Contact:
          • Shlomo Koyman, MD
          • Phone Number: 216-444-7552
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Recruiting
        • Fox Chase Cancer Center (Data Collection Only)
        • Contact:
          • Thomas Galloway, MD
          • Phone Number: 888-369-2427
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Not yet recruiting
        • Medical University of South Carolina
        • Contact:
          • Bhisham Chere, MD
          • Phone Number: 843-792-9300
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • University of Washington (Data Collection Only)
        • Contact:
          • Upendra Parvathaneni, MD
          • Phone Number: 206-228-1025

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Participants with locally advanced, unresectable cutaneous squamous cell carcinoma/CSCC
Participants have locally advanced, unresectable cutaneous squamous cell carcinoma/CSCC
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Christopher Barker, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 6, 2022

Primary Completion (Estimated)

October 6, 2026

Study Completion (Estimated)

October 6, 2026

Study Registration Dates

First Submitted

October 6, 2022

First Submitted That Met QC Criteria

October 6, 2022

First Posted (Actual)

October 10, 2022

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-090 (Icelandic Bioethics Committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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