AzTrials
AzTrials

Eyelid Squamous Cell CarcinomaPhase 3NCT06568172

Testing the Addition of an Immunotherapy Drug, Cemiplimab (REGN2810), Plus Surgery to the Usual Surgery Alone for Treating Advanced Skin Cancer

A Phase 3 study testing Biospecimen Collection, Cemiplimab and Computed Tomography in people with Eyelid Squamous Cell Carcinoma and Recurrent Eyelid Squamous Cell Carcinoma, run by National Cancer Institute (NCI) at 206 sites in 3 countries.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial summary

This phase III trial compares the effect of adding cemiplimab to standard therapy (surgery with or without radiation) versus standard therapy alone in treating patients with stage III/IV squamous cell skin cancer that is able to be removed by surgery (resectable) and that may have come back after a period of… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biospecimen Collection, Cemiplimab and Computed Tomography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
420 participants
Where
206 sitesin 3 countries
Study dates
18 Feb 2025to 14 Aug 2031
Phase
Phase 3
Are there results?
None posted in the registry

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

  • Pathologically (histologically or cytologically) proven diagnosis of invasive cutaneous squamous cell carcinoma (CSCC) or regional lymph node or in-transit metastasis of CSCC
  • The following CSCC subtypes are eligible according to World Health Organization (WHO) classification if the predominant histology is confirmed CSCC.
  • Spindle cell squamous cell carcinoma (SCC)
  • Squamous cell carcinoma with sarcomatoid differentiation
  • Acantholytic SCC
  • Clear cell SCC
Show all 54Show fewer
  • Lymphoepithelial carcinoma
  • Note: Keratoacanthoma SCC and Verrucous SCC subtypes are not eligible.
  • For patients with regional metastasis without a primary tumor at screening: a clinical history of CSCC that drains to the involved regional lymph nodes or in-transit metastases in question is required
  • For example, a parotid mass shown to be SCC by cytologic analysis of a fine needle aspirate in a patient with a clinical history of CSCC on the ipsilateral scalp would be eligible
  • For patients with regional metastases without a primary tumor and an ambiguous clinical history: tumor genomic sequencing suggesting a primary tumor of cutaneous origin would be acceptable evidence to establish eligibility
  • NOTE: Tumor genomic sequencing is not required to determine eligibility, but may be part of the routine evaluation of patients with cancers of unknown primary at some institutions. For example, a parotid mass shown to be SCC by cytologic analysis of fine needle aspirate without a primary tumor and an ambiguous clinical history, but with a tumor genomic sequencing assay demonstrating a high tumor mutation burden (≥ 10 mutations/Mb) and/or a high fraction of ultraviolet (UV) related mutations (> 50% of mutations [cytosine (C)/thymine (T)]C > T or CC > TT) and/or the presence of "signature 7" mutations would be eligible (Chang 2021)
  • Previously untreated or recurrent CSCC
  • Clinical American Joint Committee on Cancer (AJCC) 8th Edition (eyelid, head and neck sites) or Union for International Cancer Control (UICC) (non-head and neck sites) stage III or IV
  • Primary tumor site must be in the head and neck cutaneous region, other non-head and neck cutaneous regions, or eyelid cutaneous region
  • No mucosal squamous cell carcinoma (vermillion lip, nasal, oral, sinonasal, conjunctival, anogenital)
  • Tumor must be resectable with curative intent. Note: Tumor with bony skull base invasion and/or skull base foramen involvement (T4b) is not eligible. (Patients with T4b eyelid tumors using UICC Staging, and not involving the brain, are eligible.)
  • At least 1 lesion that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
  • No definitive clinical or radiologic evidence of distant metastatic disease (M1), visceral and/or distant nodal disease
  • Age ≥ 18
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Not pregnant and not nursing
  • Negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal
  • Absolute neutrophil count (ANC) ≥ 1,000 cells/mm^3
  • Platelets ≥ 75,000 cells/mm^3
  • Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin [Hgb] ≥ 8.0 g/dl is acceptable)
  • Creatinine clearance (CrCL) > 30mL/min by the Cockcroft-Gault formula
  • Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (NOTE: For patients with Gilbert's syndrome, total bilirubin ≤ 3 x ULN. Gilbert's syndrome must be documented appropriately as past medical history.)
  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 3 x institutional ULN
  • No prior systemic therapy for the study cancer (including patients currently receiving immunotherapy for a separate malignancy)
  • No prior radiotherapy to the region of the study cancer that would result in cumulative doses of radiation to organs at risk for radiation injury that exceed protocol limitations
  • No history of myocardial infarction/unstable angina within the last 6 months
  • New York Heart Association functional classification IIb or better (New York Heart Association [NYHA] functional classification III/IV are not eligible) (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association functional classification)
  • No active infection requiring systemic antibiotics, antiviral, or antifungal treatments
  • No history of allogeneic stem cell transplantation, or autologous stem cell transplantation
  • No history of a solid organ transplant (other than corneal transplant)
  • No active, known, or suspected autoimmune disease
  • Active or known disease is defined as:
  • Requiring higher than physiologic steroid levels (> 10mg prednisone/day or equivalent) or
  • Requiring disease-modifying agents or
  • Ongoing or recent (within 5 years prior to registration) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events (irAEs)
  • NOTES:
  • Patients meeting the following criteria are not considered immunosuppressed and are eligible to enroll:
  • Patients who require a brief course of steroids (eg, prophylaxis for imaging assessments due to hypersensitivity to contrast agents) are not excluded
  • Patients with type I diabetes mellitus, and endocrinopathies (including hypothyroidism due to autoimmune thyroiditis) only requiring hormone replacement, or skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
  • Physiologic replacement doses ≤ 10 mg prednisone/day or equivalent allowed, as long as they are not being administered for immunosuppressive intent. Inhaled or topical steroids are permitted
  • Patients with the following immunosuppressed conditions are eligible to enroll:
  • Patients with HIV infection on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible
  • Patients with chronic lymphocytic leukemia (CLL) with no history of anti-CLL therapy within 6 months prior to registration are eligible
  • No history of interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizing pneumonia)
  • No active, noninfectious pneumonitis requiring immune-suppressive therapy
  • No active tuberculosis
  • No live vaccines within 28 days prior to registration
  • No history of allergic reaction to the study agent, compounds of similar chemical or biologic composition to the study agent (or any of its excipients)

Who cannot join

None listed.

Trial locations and contacts

206 sites in 3 countries.

206 sites in 3 countries

United States196 sites

  • Atrium Health Stanly/LCI-Albemarle

    Albemarle, North Carolina, 28002

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106

  • Alton Memorial Hospital

    Alton, Illinois, 62002

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • UCHealth University of Colorado Hospital

    Aurora, Colorado, 80045

  • UM Sylvester Comprehensive Cancer Center at Aventura

    Aventura, Florida, 33180

  • UH Seidman Cancer Center at UH Avon Health Center

    Avon, Ohio, 44011

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920

  • LSU Health Baton Rouge-North Clinic

    Baton Rouge, Louisiana, 70805

  • Our Lady of the Lake Physician Group

    Baton Rouge, Louisiana, 70808

  • UHHS-Chagrin Highlands Medical Center

    Beachwood, Ohio, 44122

  • Nebraska Medicine-Bellevue

    Bellevue, Nebraska, 68123

  • Central Vermont Medical Center/National Life Cancer Treatment

    Berlin Corners, Vermont, 05602

  • Tower Cancer Research Foundation

    Beverly Hills, California, 90211

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233

  • University of Michigan - Brighton Center for Specialty Care

    Brighton, Michigan, 48116

  • University of Vermont Medical Center

    Burlington, Vermont, 05401

  • University of Vermont and State Agricultural College

    Burlington, Vermont, 05405

  • IU Health North Hospital

    Carmel, Indiana, 46032

  • Miami Valley Hospital South

    Centerville, Ohio, 45459

  • Christiana Care Health System-Concord Health Center

    Chadds Ford, Pennsylvania, 19317

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Carolinas Medical Center/Levine Cancer Institute

    Charlotte, North Carolina, 28203

  • Atrium Health Pineville/LCI-Pineville

    Charlotte, North Carolina, 28210

  • Atrium Health University City/LCI-University

    Charlotte, North Carolina, 28262

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

  • Northwestern University

    Chicago, Illinois, 60611

  • Rush MD Anderson Cancer Center

    Chicago, Illinois, 60612

  • University of Illinois

    Chicago, Illinois, 60612

  • University of Cincinnati Cancer Center-UC Medical Center

    Cincinnati, Ohio, 45219

  • Siteman Cancer Center at Saint Peters Hospital

    City of Saint Peters, Missouri, 63376

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • UCHealth Memorial Hospital Central

    Colorado Springs, Colorado, 80909

  • Memorial Hospital North

    Colorado Springs, Colorado, 80920

  • MU Health - University Hospital/Ellis Fischel Cancer Center

    Columbia, Missouri, 65212

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725

  • Atrium Health Cabarrus/LCI-Concord

    Concord, North Carolina, 28025

  • UT MD Anderson - The Woodlands

    Conroe, Texas, 77384

  • UM Sylvester Comprehensive Cancer Center at Coral Gables

    Coral Gables, Florida, 33146

  • Heartland Oncology and Hematology LLP

    Council Bluffs, Iowa, 51503

  • Methodist Jennie Edmundson Hospital

    Council Bluffs, Iowa, 51503

  • Siteman Cancer Center at West County Hospital

    Creve Coeur, Missouri, 63141

  • UT Southwestern Simmons Cancer Center - RedBird

    Dallas, Texas, 75237

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

  • Miami Valley Hospital North

    Dayton, Ohio, 45415

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach

    Deerfield Beach, Florida, 33442

  • Northwestern Medicine Cancer Center Kishwaukee

    DeKalb, Illinois, 60115

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • UM Sylvester Comprehensive Cancer Center at Doral

    Doral, Florida, 33166

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • UC San Diego Health System - Encinitas

    Encinitas, California, 92024

  • UPMC Hillman Cancer Center Erie

    Erie, Pennsylvania, 16505

  • Saint Vincent Hospital

    Erie, Pennsylvania, 16544

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031

  • UT Southwestern/Simmons Cancer Center-Fort Worth

    Fort Worth, Texas, 76104

  • Atrium Medical Center-Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • Levine Cancer Institute-Gaston

    Gastonia, North Carolina, 28054

  • Northwestern Medicine Cancer Center Delnor

    Geneva, Illinois, 60134

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

  • Goshen Center for Cancer Care

    Goshen, Indiana, 46526

  • Corewell Health Grand Rapids Hospitals - Butterworth Hospital

    Grand Rapids, Michigan, 49503

  • Miami Valley Cancer Care and Infusion

    Greenville, Ohio, 45331

  • Smilow Cancer Hospital Care Center at Greenwich

    Greenwich, Connecticut, 06830

  • Smilow Cancer Hospital Care Center - Guilford

    Guilford, Connecticut, 06437

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • UT MD Anderson Cancer Center

    Houston, Texas, 77030

  • UT MD Anderson - West Houston

    Houston, Texas, 77079

  • Indiana University/Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • Franciscan Health Indianapolis

    Indianapolis, Indiana, 46237

  • City of Hope at Irvine Lennar

    Irvine, California, 92618

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

  • UPMC-Johnstown/John P. Murtha Regional Cancer Center

    Johnstown, Pennsylvania, 15901

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160

  • University of Kansas Cancer Center - North

    Kansas City, Missouri, 64154

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

  • Northwell Health/Center for Advanced Medicine

    Lake Success, New York, 11042

  • City of Hope Antelope Valley

    Lancaster, California, 93534

  • UT MD Anderson - League City

    League City, Texas, 77573

  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

    Lebanon, New Hampshire, 03756

  • University of Kansas Cancer Center - Lee's Summit

    Lee's Summit, Missouri, 64064

  • University of Kentucky/Markey Cancer Center

    Lexington, Kentucky, 40536

  • The Angeles Clinic and Research Institute - West Los Angeles Office

    Los Angeles, California, 90025

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • The James Graham Brown Cancer Center at University of Louisville

    Louisville, Kentucky, 40202

  • UofL Health Medical Center Northeast

    Louisville, Kentucky, 40245

  • William S Middleton VA Medical Center

    Madison, Wisconsin, 53705

  • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

    Madison, Wisconsin, 53718

  • University of Wisconsin Carbone Cancer Center - University Hospital

    Madison, Wisconsin, 53792

  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin, 54449

  • Froedtert Menomonee Falls Hospital

    Menomonee Falls, Wisconsin, 53051

  • UH Seidman Cancer Center at Lake Health Mentor Campus

    Mentor, Ohio, 44060

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    Miami, Florida, 33136

  • Miami Cancer Institute

    Miami, Florida, 33176

  • UM Sylvester Comprehensive Cancer Center at Kendall

    Miami, Florida, 33176

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • NYU Langone Hospital - Long Island

    Mineola, New York, 11501

  • University of Minnesota/Masonic Cancer Center

    Minneapolis, Minnesota, 55455

  • Atrium Health Union/LCI-Union

    Monroe, North Carolina, 28112

  • Forbes Hospital

    Monroeville, Pennsylvania, 15146

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645

  • Sarasota Memorial Hospital-Venice

    N. Venice, Florida, 34275

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee, 37232

  • Yale University

    New Haven, Connecticut, 06520

  • University Medical Center New Orleans

    New Orleans, Louisiana, 70112

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York, New York, 10016

  • Manhattan Eye Ear and Throat Hospital

    New York, New York, 10065

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Lenox Hill Hospital

    New York, New York, 10075

  • Helen F Graham Cancer Center

    Newark, Delaware, 19713

  • Medical Oncology Hematology Consultants PA

    Newark, Delaware, 19713

  • Drexel Town Square Health Center

    Oak Creek, Wisconsin, 53154

  • Kaiser Permanente-Oakland

    Oakland, California, 94611

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Nebraska Cancer Specialists/Oncology Hematology West PC - MECC

    Omaha, Nebraska, 68114

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • Nebraska Medicine-Village Pointe

    Omaha, Nebraska, 68118

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Northwestern Medicine Orland Park

    Orland Park, Illinois, 60462

  • University of Kansas Cancer Center-Overland Park

    Overland Park, Kansas, 66210

  • University of Kansas Hospital-Indian Creek Campus

    Overland Park, Kansas, 66211

  • Stanford Cancer Institute Palo Alto

    Palo Alto, California, 94304

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Mayo Clinic Hospital in Arizona

    Phoenix, Arizona, 85054

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • West Penn Hospital

    Pittsburgh, Pennsylvania, 15224

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • UM Sylvester Comprehensive Cancer Center at Plantation

    Plantation, Florida, 33324

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Duke Cancer Center Raleigh

    Raleigh, North Carolina, 27609

  • UT Southwestern Clinical Center at Richardson/Plano

    Richardson, Texas, 75080

  • VCU Massey Comprehensive Cancer Center

    Richmond, Virginia, 23298

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

  • University of Rochester

    Rochester, New York, 14642

  • Rock Hill Radiation Therapy Center

    Rock Hill, South Carolina, 29730

  • Levine Cancer Institute-Rock Hill

    Rock Hill, South Carolina, 29732

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817

  • Kaiser Permanente-South Sacramento

    Sacramento, California, 95823

  • Dartmouth Cancer Center - North

    Saint Johnsbury, Vermont, 05819

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • UC San Diego Medical Center - Hillcrest

    San Diego, California, 92103

  • Kaiser Permanente-San Francisco

    San Francisco, California, 94115

  • Florida Cancer Specialists - Sarasota

    Sarasota, Florida, 34232

  • First Physicians Group - Silverstein Institute at Floyd Street

    Sarasota, Florida, 34239

  • Florida Cancer Specialists - Sarasota Downtown

    Sarasota, Florida, 34239

  • Sarasota Memorial Hospital

    Sarasota, Florida, 34239

  • Sarasota Memorial Health Care Center at University Parkway

    Sarasota, Florida, 34243

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Atrium Health Cleveland/LCI-Cleveland

    Shelby, North Carolina, 28150

  • Memorial Hospital East

    Shiloh, Illinois, 62269

  • City of Hope South Pasadena

    South Pasadena, California, 91030

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Siteman Cancer Center-South County

    St Louis, Missouri, 63129

  • Siteman Cancer Center at Christian Hospital

    St Louis, Missouri, 63136

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

  • UT MD Anderson - Sugar Land

    Sugar Land, Texas, 77478

  • State University of New York Upstate Medical University

    Syracuse, New York, 13210

  • SUNY Upstate Medical Center-Community Campus

    Syracuse, New York, 13215

  • Moffitt Cancer Center-International Plaza

    Tampa, Florida, 33607

  • Moffitt Cancer Center - McKinley Campus

    Tampa, Florida, 33612

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Montefiore Medical Center-Einstein Campus

    The Bronx, New York, 10461

  • Montefiore Medical Center-Weiler Hospital

    The Bronx, New York, 10461

  • Montefiore Medical Center - Moses Campus

    The Bronx, New York, 10467

  • Torrance Memorial Physician Network - Cancer Care

    Torrance, California, 90505

  • Upper Valley Medical Center

    Troy, Ohio, 45373

  • Smilow Cancer Hospital Care Center-Trumbull

    Trumbull, Connecticut, 06611

  • Memorial Sloan Kettering Nassau

    Uniondale, New York, 11553

  • City of Hope Upland

    Upland, California, 91786

  • Florida Cancer Specialists - Venice Pinebrook

    Venice, Florida, 34275

  • Florida Cancer Specialists - Venice Island

    Venice, Florida, 34285

  • Kaiser Permanente-Walnut Creek

    Walnut Creek, California, 94596

  • Northwestern Medicine Cancer Center Warrenville

    Warrenville, Illinois, 60555

  • Smilow Cancer Hospital-Waterbury Care Center

    Waterbury, Connecticut, 06708

  • Smilow Cancer Hospital Care Center - Waterford

    Waterford, Connecticut, 06385

  • Wilmot Cancer Institute at Webster

    Webster, New York, 14580

  • Froedtert West Bend Hospital/Kraemer Cancer Center

    West Bend, Wisconsin, 53095

  • Henry Ford West Bloomfield Hospital

    West Bloomfield, Michigan, 48322

  • University of Cincinnati Cancer Center-West Chester

    West Chester, Ohio, 45069

  • Marshfield Medical Center - Weston

    Weston, Wisconsin, 54476

  • University of Kansas Hospital-Westwood Cancer Center

    Westwood, Kansas, 66205

  • Wexford Health and Wellness Pavilion

    Wexford, Pennsylvania, 15090

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

  • University of Michigan Health - West

    Wyoming, Michigan, 49519

Other trials in United States

Australia7 sites

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales, 2050

  • Saint Vincent's Hospital

    Fitzroy, Victoria, 3065

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150

  • Townsville General Hospital

    Townsville, Queensland, 4814

  • Wollongong Hospital

    Wollongong, New South Wales, 2500

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Canada3 sites

  • Odette Cancer Centre- Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • University Health Network-Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • BCCA-Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

About this study

Official title: Randomized Phase III Trial of Neoadjuvant Immunotherapy With Response-Adapted Treatment Versus Standard-of-Care Treatment for Resectable Stage III/IV Cutaneous Squamous Cell Carcinoma (C-PRE)

This phase III trial compares the effect of adding cemiplimab to standard therapy (surgery with or without radiation) versus standard therapy alone in treating patients with stage III/IV squamous cell skin cancer that is able to be removed by surgery (resectable) and that may have come back after a period of improvement (recurrent). The usual treatment for patients with resectable squamous cell skin cancer is the removal of the cancerous tissue (surgery) with or without radiation, which uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cemiplimab has been approved for the treatment of skin cancer that has spread or that cannot be removed by surgery, but it has not been approved for the treatment of skin cancer than can be removed by surgery. Adding cemiplimab to the usual treatment of surgery with or without radiation may be more effective in treating patients with stage III/IV resectable squamous cell skin cancer than the usual treatment alone.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To determine if neoadjuvant immunotherapy combined with response-adapted oncologic surgery improves site-reported event-free survival (EFS) compared to standard-of-care surgery in resectable stage III/IV cutaneous squamous cell carcinoma (CSCC).

SECONDARY OBJECTIVES:

  1. To compare utilization of adjuvant radiation between arms. II. To compare disease-free survival (DFS) between arms. III. To compare overall survival (OS) between arms. IV. To compare adverse events (Common Terminology Criteria for Adverse Events [CTCAE] version [v]5.0) between arms.
  2. To assess pathologic complete response in arm 2.

PATIENT-REPORTED OUTCOMES:

  1. Compare changes in patient reported quality of life as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) at 1, 6, and 12 months after surgery between treatment arms. (Primary objective) II. To compare patient reported symptoms functioning, and quality of life, as measured by the Cutaneous Squamous Cell Carcinoma NeoAdjuvant, Adjuvant and Perioperative 32 question scale (CSCC NAAP-32), Patient Reported Outcomes Measurement Information System (PROMIS)-Short Form (SF)-Anxiety, PROMIS-SF-Fatigue, and EuroQol-5D (EQ-5D), between arms at 1, 6, and 12 months after surgery.

III. Develop a scoring algorithm and validate the CSCC-NAAP-32 for use in this patient population.

EXPLORATORY OBJECTIVES:

  1. To compare disease-specific survival (DSS) between arms. II. To correlate pathologic response with DFS in arm 2. III. To assess overall response rate (ORR) in arm 2. IV. To compare patterns of failure between arms. V. To compare pathologic measurements of lymph node yield between arms. VI. To compare primary tumor specimen dimensions and volume between arms.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM 1: Patients undergo surgery per standard of care within 6 weeks of randomization. Starting within 6-12 weeks of surgery, patients may undergo image-guided radiation therapy (IGRT) with intensity modulated radiation therapy (IMRT) for 5 fractions per week for 6 weeks as clinically indicated. Patients also undergo computed tomography (CT), magnetic resonance imaging (MRI), and/or positron emission tomography (PET)/CT prior to treatment, and CT and/or MRI during follow up. Patients may also undergo optional collection of tissue, whole blood, and plasma on study.

ARM 2: Patients receive cemiplimab intravenously (IV) over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo response-adaptive surgery 21 days after last dose of cemiplimab. Starting within 12 weeks of surgery, patients may undergo IGRT with IMRT for 5 fractions per week for 6 weeks as clinically indicated. Starting within 6 weeks of completion of surgery or radiation therapy (if indicated), patients without pathologic complete response (pCR) receive cemiplimab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 42 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and/or PET/CT prior to treatment, and CT and/or MRI on study and during follow up. Patients may also undergo optional collection of tissue, whole blood, and plasma on study.

After completion of study treatment, patients are followed up at 1, 6, and 12 months post-surgery then every 3 months for 2 years, every 6 months in year 3, and then annually thereafter.

Being tested
Biospecimen Collection, Cemiplimab, Computed Tomography, Image Guided Radiation Therapy, Intensity-Modulated Radiation Therapy

What participants receive

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

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

    Undergo collection of blood and/or plasma

  • CemiplimabBiological

    Also called Cemiplimab RWLC, Cemiplimab-rwlc, Libtayo, REGN 2810

    Given IV

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT and/or PET/CT

  • Image Guided Radiation TherapyRadiation

    Also called IGRT, Image Guided Radiotherapy, image-guided radiation therapy, Image-Guided Radiotherapy

    Undergo IGRT

  • Intensity-Modulated Radiation TherapyRadiation

    Also called IMRT, Intensity modulated radiation therapy (procedure), Intensity Modulated RT, Intensity-Modulated Radiotherapy

    Undergo IMRT

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET/CT

  • Questionnaire AdministrationOther

    Ancillary studies

  • Surgical ProcedureProcedure or surgery

    Also called Operation, Surgery, Surgery Type, Surgery, NOS

    Undergo surgery per SOC

  • Surgical ProcedureProcedure or surgery

    Also called Operation, Surgery, Surgery Type, Surgery, NOS

    Undergo response-adaptive surgery

Study groups in NCT06568172
Study groupRoleWhat they receive
Arm 1 (surgery, radiation)Active comparatorPatients undergo surgery per standard of care within 6 weeks of randomization. Starting within 6-12 weeks of surgery, patients may undergo IGRT with IMRT for 5 fractions per week for 6 weeks as clinically indicated. Patients also undergo CT, MRI, and/or PET/CT prior to treatment, and CT and/or MRI during follow up. Patients may also undergo optional collection of tissue, whole blood, and plasma on study.
Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Radiation: Image Guided Radiation Therapy; Radiation: Intensity-Modulated Radiation Therapy; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Other: Questionnaire Administration; Procedure: Surgical Procedure
Arm 2 (cemiplimab, surgery, radiation)ExperimentalPatients receive cemiplimab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo response-adaptive surgery 21 days after last dose of cemiplimab. Starting within 12 weeks of surgery, patients may undergo IGRT with IMRT for 5 fractions per week for 6 weeks as clinically indicated. Starting within 6 weeks of completion of surgery or radiation therapy (if indicated), patients without pCR receive cemiplimab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 42 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and/or PET/CT prior to treatment, and CT and/or MRI on study and during follow up. Patients may also undergo optional collection of tissue, whole blood, and plasma on study.
Receives: Procedure: Biospecimen Collection; Biological: Cemiplimab; Procedure: Computed Tomography; Radiation: Image Guided Radiation Therapy; Radiation: Intensity-Modulated Radiation Therapy; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Other: Questionnaire Administration; Procedure: Surgical Procedure

What is being measured

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

  1. Event-free survival (EFS)

    Defined as the time from randomization to any of the following events: progression of disease that precludes surgery, toxic effects related to treatment that preclude surgery, inability to resect all gross disease), disease recurrence (local, regional, or distant) after surgery (or after radiographic complete response), disease progression after radiographic partial response or stable disease without surgery (or biopsy, as applicable), or death due to any cause, whichever occurs first. EFS rates will be estimated using the Kaplan-Meier method, and the stratified log-rank test will be used to assess whether perioperative immunotherapy (neoadjuvant/adjuvant) with response-adapted oncologic surgery improves EFS as recorded by the site compared to standard-of-care surgery in resectable stage III/IV cutaneous squamous cell carcinoma (CSCC).

    Measured: Up to 6 years

Secondary outcomes (5)

  1. Utilization of adjuvant radiation

    Rates of utilization of adjuvant radiation for each arm will be computed using a binomial distribution assumption. A 95% confidence interval (CI) for the rate difference between arms will be calculated using the stratified Newcombe (Wilson) method (Yan 2010).

    Measured: Up to 6 years

  2. Disease-free survival (DFS)

    DFS will use the same analytic methods as EFS.

    Measured: From randomization to recurrent or death, assessed up to 6 years

  3. Overall survival (OS)

    OS will use the same analytic methods as EFS.

    Measured: From randomization to death, assessed up to 6 years

  4. Incidence of adverse events

    Adverse events (AEs) will be graded using Common Terminology Criteria for Adverse Events version (v) 5.0. Counts and frequencies of all AEs by grade will be provided by each treatment arm. For the experimental arm, AEs will be summarized for each treatment phase (neoadjuvant, adjuvant, and post-treatment [after adjuvant]). Counts and frequencies will be provided for the worst grade AE experienced by the patient by treatment arm. The proportion of patients with at least one grade 3 or higher AE, serious AEs, AEs leading to discontinuation or death will be reported for each treatment arm. These analyses will be descriptive.

    Measured: At 30 days and then up to 6 years

  5. Pathologic complete response

    Site-reported pathologic response will be assessed using the following categories: pathological complete, major, and partial response, no pathological response (i.e., no complete, major, or partial response), and no pathological evaluation. Pathological responses at 1 and 2 years will be summarized using frequencies and percentages and tested using a chi-square test at a two-sided 5% significance level.

    Measured: At 1 and 2 years

Timeline

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

  1. First posted23 Aug 2024
  2. Study start18 Feb 2025
  3. Primary completion14 Aug 2031 (estimated)
  4. Study completion14 Aug 2031 (estimated)

Why it stopped: Other - Other

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
420 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06568172
Sponsor's protocol ID
NCI-2024-03425
Other IDs
NCI-2024-03425, NRG-HN014, NRG-HN014, U10CA180868
Status last verified
Oct 2026
First submitted
22 Aug 2024
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Publications

  • Allen DZ, Gross N, Nader ME, Ferrarotto R, Amit M, Nagarajan P, Gidley P. Neoadjuvant Immunotherapy for Periauricular Cutaneous Squamous Cell Carcinoma. Head Neck. 2026 Mar;48(3):837-842. doi: 10.1002/hed.70080. Epub 2025 Oct 25.

    PubMed 41137728

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Biospecimen Collection, Cemiplimab and Computed Tomography in people with Eyelid Squamous Cell Carcinoma and Recurrent Eyelid Squamous Cell Carcinoma, run by National Cancer Institute (NCI) at 206 sites in 3 countries.

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 54 inclusion and 0 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: paused, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 206 sites in United States, Australia, Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Results are not available in the source record.

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 (EFS) (time frame: Up to 6 years). 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 NCT06568172, which also lists 1 linked publication.

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 3 Nov 2026.

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