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

Primary Purpose

Cutaneous Squamous Cell Carcinoma, Skin Cancer, Squamous Cell Carcinoma

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cemiplimab
Radiotherapy
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cutaneous Squamous Cell Carcinoma focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
  • 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

Sites / Locations

  • University of Colorado (Data Collection Only)Recruiting
  • Moffitt Cancer Center (Data Collection Only)Recruiting
  • Emory University
  • Memorial Sloan Kettering Cancer Center at Basking Ridge (All Protocol Activities)Recruiting
  • Memorial Sloan Kettering Monmouth (All Protocol Activities)Recruiting
  • Memorial Sloan Kettering Bergen (All protocol activities)Recruiting
  • Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities)Recruiting
  • Memorial Sloan Kettering Westchester (All Protocol Activities)Recruiting
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)Recruiting
  • Memorial Sloan Kettering Nassau (All protocol activities)Recruiting
  • Cleveland Clinic (Data Collection Only)
  • Fox Chase Cancer Center (Data Collection Only)
  • Medical University of South Carolina
  • University of Washington (Data Collection Only)Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Participants with locally advanced, unresectable cutaneous squamous cell carcinoma/CSCC

Arm Description

Participants have locally advanced, unresectable cutaneous squamous cell carcinoma/CSCC

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 6, 2022
Last Updated
August 1, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT05574101
Brief Title
A Study of Radiation Therapy and Cemiplimab for People With Skin Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 6, 2022 (Actual)
Primary Completion Date
October 6, 2026 (Anticipated)
Study Completion Date
October 6, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Participants with locally advanced, unresectable cutaneous squamous cell carcinoma/CSCC
Arm Type
Experimental
Arm Description
Participants have locally advanced, unresectable cutaneous squamous cell carcinoma/CSCC
Intervention Type
Drug
Intervention Name(s)
Cemiplimab
Intervention 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.
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
Participants will receive radiotherapy to 70 Gy in 35 fractions over 7 weeks concurrently with cemiplimab
Primary Outcome Measure Information:
Title
Disease Free Survival
Description
The primary endpoint for this study is disease free survival at 18 months (week 78 +/- 3 weeks) after starting cemiplimab.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher Barker, MD
Phone
212-639-8168
Email
LianM@mskcc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Lara Dunn, MD
Phone
646-608-3787
Email
dunnl1@mskcc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Barker, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado (Data Collection Only)
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryan Lanning, MD, PhD
Phone
720-516-0150
Facility Name
Moffitt Cancer Center (Data Collection Only)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evan Wuthrick, MD
Phone
813-745-4673
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zachary Buchwald, MD, PhD
Email
zachary.scott.buchwald@emory.edu
Facility Name
Memorial Sloan Kettering Cancer Center at Basking Ridge (All Protocol Activities)
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Barker, MD
Phone
212-639-8168
Facility Name
Memorial Sloan Kettering Monmouth (All Protocol Activities)
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Barker, MD
Phone
212-639-8168
Facility Name
Memorial Sloan Kettering Bergen (All protocol activities)
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Barker, MD
Phone
212-639-8168
Facility Name
Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities)
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Barker, MD
Phone
212-639-8168
Facility Name
Memorial Sloan Kettering Westchester (All Protocol Activities)
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Barker, MD
Phone
212-639-8168
Facility Name
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Barker, MD
Phone
212-639-8168
Facility Name
Memorial Sloan Kettering Nassau (All protocol activities)
City
Rockville Centre
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Barker, MD
Phone
212-639-8168
Facility Name
Cleveland Clinic (Data Collection Only)
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shlomo Koyman, MD
Phone
216-444-7552
Facility Name
Fox Chase Cancer Center (Data Collection Only)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Galloway, MD
Phone
888-369-2427
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bhisham Chere, MD
Phone
843-792-9300
Facility Name
University of Washington (Data Collection Only)
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Upendra Parvathaneni, MD
Phone
206-228-1025

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

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

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