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Cutaneous Squamous Cell CarcinomaPhase 3NCT03969004

Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma

A Phase 3 study testing Cemiplimab in people with Cutaneous Squamous Cell Carcinoma, run by Regeneron Pharmaceuticals at 166 sites in 16 countries.

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 primary objective of the study is to compare disease-free survival (DFS) of patients with high-risk cutaneous squamous cell carcinoma (CSCC) treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and radiation therapy (RT). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cutaneous Squamous Cell Carcinoma
What is being tested?
Cemiplimab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
415 participants
Where
166 sitesin 16 countries
Study dates
4 Jun 2019to 7 Jan 2028
Phase
Phase 3
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

  • For Japan only, men and women ≥21 years old
  • Patient with resection of pathologically confirmed CSCC (primary CSCC lesion only, or primary CSCC with nodal involvement, or CSCC nodal metastasis with known primary CSCC lesion previously treated within the draining lymph node echelon), with macroscopic gross resection of all disease
  • High risk CSCC, as defined in the protocol
  • Completion of curative intent post-operative radiation therapy (RT) within 2 to 10 weeks of randomization
  • Eastern Cooperative Oncology Group performance status (ECOG PS) ≤1
  • Adequate hepatic, renal, and bone marrow function as defined in the protocol

Who cannot join

  • Squamous cell carcinomas (SCCs) arising in non-cutaneous sites as defined in the protocol
  • Concurrent malignancy other than localized CSCC and/or history of malignancy other than localized CSCC within 3 years of date of randomization as defined in the protocol
  • Patients with hematologic malignancies (note: patients with chronic lymphocytic leukemia (CLL) are not excluded if they have not required systemic therapy for CLL within 6 months of enrollment)
  • Patients with history of distantly metastatic CSCC (visceral or distant nodal), unless the disease-free interval is at least 3 years (regional nodal involvement of disease in draining lymph node basin that was resected and radiated prior to enrollment will not be exclusionary)
  • Ongoing or recent (within 5 years of randomization date) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events (irAEs). The following are not exclusionary: vitiligo, childhood asthma that has resolved, type 1 diabetes, residual hypothyroidism that required only hormone replacement, or psoriasis that does not require systemic treatment.
  • Has had prior systemic anti-cancer immunotherapy for CSCC
  • Note: Other protocol defined Inclusion/Exclusion criteria apply

Trial locations and contacts

166 sites in 16 countries.

166 sites in 16 countries

United States40 sites

  • Michigan Medicine- University of Michigan

    Ann Arbor, Michigan, 48109

  • Regeneron Study Site

    Atlanta, Georgia, 30342

  • Regeneron Study Site

    Baltimore, Maryland, 21287

  • Memorial Sloan Kettering

    Basking Ridge, New Jersey, 07920

  • Massachusetts General Cancer Center

    Boston, Massachusetts, 02114

  • Dana Farber/Harvard Cancer Center

    Boston, Massachusetts, 02215

  • University Of Virginia Health System

    Charlottesville, Virginia, 22908

  • Regeneron Study Site

    Chicago, Illinois, 60611

  • Regeneron Research Site

    Cincinnati, Ohio, 45267

  • University of Missouri Health Care - University Physicians - Medicine Specialty Clinic

    Columbia, Missouri, 65212

  • Memorial Sloan Kettering

    Commack, New York, 11725

  • Texas Oncology - Baylor Charles A. Simmons Cancer Center

    Dallas, Texas, 75246

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • The Ohio State University

    Gahanna, Ohio, 43230

  • University of Florida Health

    Gainesville, Florida, 032608

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

  • Memorial Sloan Kettering

    Harrison, New York, 10604

  • Penn State Hershey Children's Hospital

    Hershey, Pennsylvania, 17025

  • The Angeles Clinic

    Los Angeles, California, 90025

  • University of Southern California (USC)

    Los Angeles, California, 90033

  • Regeneron Study Site

    Louisville, Kentucky, 40202

  • Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

  • Miami Cancer Institute at Baptist Health, Inc.

    Miami, Florida, 33176

  • Memorial Sloan Kettering

    Middletown, New Jersey, 07748

  • Memorial Sloan Kettering

    Montvale, New Jersey, 07645

  • Sarah Cannon Research Institute - Tennessee Oncology

    Nashville, Tennessee, 37203

  • Memorial Sloan Kettering

    New Brunswick, New Jersey, 08903

  • NYU Langone Health

    New York, New York, 10016

  • Columbia University

    New York, New York, 10032

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • Stanford Cancer Institute, Stanford Medicine at Stanford University

    Palo Alto, California, 94304

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Mayo Clinic Hospital

    Phoenix, Arizona, 85054

  • University Of California San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94143-0981

  • Washington University in Saint Louis

    St Louis, Missouri, 63110

  • University of South Florida (USF) - H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612

  • Regeneron Study Site

    Tucson, Arizona, 85724-5024

  • Memorial Sloan Kettering

    Uniondale, New York, 11553

  • George Washington University School of Medicine and Health Sciences

    Washington D.C., District of Columbia, 20037

Other trials in United States

Australia30 sites

  • Royal Adelaide Hospital

    Adelaide, 5000

  • The Border Cancer Hospital Dispensary - Albury Wodonga Regional Cancer Centre

    Albury, New South Wales, 2640

  • Bendigo Health

    Bendigo, Victoria, 3550

  • Wide Bay Hospital and Health Service - Cancer Care Services

    Bundaberg, Queensland, 4670

  • Cairns Hospital

    Cairns, Queensland, 4870

  • Coffs Harbour Health Campus

    Coffs Harbour, New South Wales, 2450

  • St. Vincent's Hospital

    Fitzroy, Victoria, 3065

  • Central Coast Cancer Centre-Gosford and Wyong Hospitals

    Gosford, New South Wales, 2250

  • Olivia Newton -John Cancer Wellness & Research Centre

    Heidelberg, Victoria, 3084

  • The Royal Brisbane and Women's Hospital

    Herston, Queensland, 4029

  • Royal Hobart Hospital-Hobart Hospital

    Hobart, Tasmania, 7000

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000

  • St George Hospital

    Kogarah, New South Wales, 2217

  • Ashford Cancer Centre Research-Adelaide Cancer Centre

    Kurralta Park, South Australia, 5037

  • Liverpool Cancer Therapy Center

    Liverpool, 2170

  • University of New South Wales (UNSW) - Liverpool Hospital - Liverpool Cancer Therapy Centre

    Liverpool, 2170

  • Peter Maccallum Cancer Centre (PMCC)

    Melbourne, Victoria, 3000

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009

  • ICON Cancer Care

    Southport, Queensland, 4215

  • North Shore Private Hospital

    St Leonards, New South Wales, 2065

  • Melanoma Institute

    Sydney, North South Wales, 2060

  • Toowoomba Hospital

    Toowoomba, Queensland, 4350

  • The Townsville Hospital and Health Service

    Townsville, 4814

  • Genesis Care Tugun - John Flynn Private Hospital

    Tugun, Queensland, 4224

  • Wide Bay Hospital and Health Service - Cancer Care Services - Hervey Bay

    Urraween, Queensland, 4655

  • Cancer Care Associates (CCA) Riverina Cancer Care Centre (RCCC)

    Wagga Wagga, New South Wales, 2650

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298

  • Westmead Hospital

    Westmead, New South Wales, 2145

  • Illawarra Cancer Care Centre (ICCC)

    Wollongong, New South Wales, 2500

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Spain14 sites

  • Hospital Universitario Fundacion Alcorcon

    Alcorcón, Madrid, 28922

  • Catalan institute of Oncology Badalona

    Badalona, 8916

  • Hospital Universitari Vall d'Hebron

    Barcelona, Catalonia, 08035

  • Hospital Clinic de Barcelona - Institut Clinic de Malalties Hematologiques i Oncologiques (ICMHO)

    Barcelona, 08036

  • Genesis Care hospital San Francisco de Asis

    Madrid, 28002

  • Hospital General Universitario Gregorio Maranon (HGUGM)

    Madrid, 28007

  • Clinica Universidad de Navarra

    Madrid, 28027

  • Hospital Universitario 12 de Octubre-Centro de Actividades Ambulatorias

    Madrid, 28041

  • Hospital Universitario Puerta de Hierro de Majadahonda

    Majadahonda, 28222

  • Hospital Clinico Universitario de Salamanca

    Salamanca, 37007

  • Hospital Universitario Virgen Macarena-merge

    Seville, 41009

  • Hospital Universitario de Torrejon

    Torrejón de Ardoz, Madrid, 28850

  • Instituto Valenciano de Oncología

    Valencia, 46009

  • Hospital Universitario y Politecnico La Fe-merge

    Valencia, 46026

Other trials in Spain

France13 sites

  • Hopital Saint Andre - CHU de Bordeaux

    Bordeaux, 33604

  • Hopital Ambroise Pare

    Boulogne-Billancourt, 92100

  • Centre Hospitalier Universitaire (CHU) de Dijon - Hopital du Bocage

    Dijon, Dijon Cedex, 21079

  • Centre Hospitalier Universitaire De Grenoble- Hopital Albert Michallon

    La Tronche, 38700

  • Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez

    Lille, 59037

  • Centre Leon-Berard (CLB) - Centre de Recherche en Cancerologie Lyon-Est (CRCL)

    Lyon, 69008

  • Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hopital Hotel Dieu

    Nantes, 44093

  • Centre Hospitalier Universitaire de Nice,Hopital l Archet

    Nice, 06202

  • CIC Cochin Pasteur, Hopital Cochin

    Paris, 7504

  • Hospital Saint-Louis - APHP

    Paris, 75475

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • Centre Hospitalier Universitaire de Rouen-Hopital Charles Nicolle

    Rouen, 76031

  • Institut Gustave Roussy-Gustave Roussy Cancer Center -DITEP

    Villejuif, 94805

Other trials in France

Germany12 sites

  • Charite- Universitaetsmedizin Berlin

    Berlin, 10117

  • Universitaetsklinikum der Ruhr Universitaet Bochum (UKRUB), St. Josef Hospital

    Bochum, 44791

  • Elbekliniken Buxtehude

    Buxtehude, 21614

  • Klinikum der Universitaet zu Koeln

    Cologne, 50937

  • University Hospital Dresden

    Dresden, 01307

  • Universitaetsklinikum Essen (AoR)

    Essen, 45147

  • NCT Dermatoonkologie -Hautklinik Heidelberg

    Heidelberg, Baden-Wurttemberg, 69120

  • SLK-Kliniken Heilbronn GmbH

    Heilbronn, 74078

  • Universitaetsklinikum Schleswig-Holstein, Campus Kiel

    Kiel, 24105

  • Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR

    Mainz, Rhineland-Palatinate, 55131

  • LMU Munchen

    München, 80337

  • University Hospital Tuebingen

    Tübingen, 72076

Other trials in Germany

Italy12 sites

  • ASST Papa Giovanni XXIII

    Bergamo, 24128

  • Policlinico S.Orsola-Malpighi U.O. Dermatologia - University of Bologna

    Bologna, 40138

  • ASST Spedali Civili Brescia

    Brescia, 089263

  • University of Brescia

    Brescia, 25121

  • Universita di Firenze - Azienda Sanitaria Firenze

    Florence, 50125

  • University L'Aquila

    L’Aquila, 67100

  • IRCCS-Istituto Europeo di Oncologia

    Milan, 20141

  • U.O.S.C Di Oncologia Medica E Terapie Innovative

    Naples, 43100

  • UOC Oncoematologia AOU Luigi Vanvitelli

    Naples, 80131

  • A. Gemelli University Hospital, Catholic University of the Sacred Heart

    Rome, 00168

  • IRCCS Istituto Clinico Humanitas

    Rozzano, 20089

  • AOU Citta della Salute e della Scienza di Torino

    Torino, 10126

Other trials in Italy

Brazil11 sites

  • Fundacao Pio XII - Hospital de Cancer de Barretos

    Barretos, Porte Alegre, 90610-000

  • Ynova pesquisa clinica

    Florianópolis, 88020-210

  • Fundacao Sao Francisco Xavier - Hospital Marcio Cunha (HMC) - Unidade I

    Ipatinga, Minas Gerais, 35160-158

  • Centro De Novos Tratamentos Itajai

    Itajaí, Santa Catarina, 88301-220

  • ANIMI

    Lages, Santa Catarina, 88501-001

  • Centro Oncologico Mogi das Cruzes

    Mogi das Cruzes, São Paulo, 08730-500

  • Hospital Sao Vicente de Paulo (HSVP)

    Passo Fundo, Rio Grande do Sul, 99010-080

  • Centro de Pesquisa em Oncologia - Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Hospital das Clinicas da Faculdade de Medician de Ribeirao Preto FMRP USP

    Ribeirão Preto, São Paulo, 14049-900

  • Instituto Nacional de Cancer Jose Alencar Gomes da Silva ¿ INCA

    Santo Cristo, Rio de Janiero, 20220-410

  • Instituto do Cancer do Estado de Sao Paulo - ICESP

    São Paulo, 05403-000

Other trials in Brazil

Russia7 sites

  • Regeneron Study Site

    Magnitogorsk, 455001

  • N.N.Blokhin Cancer Research Center

    Moscow, 33756

  • Regeneron Research Site

    Omsk, 644013

  • SBHI of Stavropol Region Pyatigorsk Interdistrict Oncology Dispensary

    Pyatigorsk, Stavropol Kray, 357502

  • Federal State Budgetary Institution Rostov Research Institute of Oncology of the Ministry of Healthcare of the Russian Federation

    Rostov-on-Don, 344037

  • Regeneron Study Site

    Saint Petersburg, 198255

  • State Healthcare Institution Oncology Dispensary 2 Ministry of Healthcare of Krasnodar Region

    Sochi, Krasnodarskiy Kray, 354057

Other trials in Russia

United Kingdom7 sites

  • University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre (BHOC) - Bristol Cancer Institute

    Bristol, Somerset, BS2 8ED

  • Velindre NHS Trust, Velindre Cancer Centre

    Cardiff, CF14 2TL

  • The Lothian University Hospitals NHS Lothian - Western General Hospital (WGH)

    Edinburgh, EH4 2XU

  • Beatson West of Scotland Cancer Centre - Greater Glasgow Health Board

    Glasgow, G12 0YN

  • St George's Hospital - St George's University Hospitals NHS Foundation Trust

    London, SW17 0QT

  • The Christie - The Christie NHS Foundation Trust

    Manchester, M20 4QL

  • Derriford Hospital

    Plymouth, Devon, PL6 8DH

Other trials in United Kingdom

Japan5 sites

  • National Cancer Center Hospital - Gastrointestinal Oncology

    Chuo-ku, Tokyo, 104-0045

  • Shizuoka Cancer Center - Oncology

    Nagaizumi-Cho, Shizuoka, 411-8777

  • Niigata Cancer Center Hospital

    Niigata, 951-8566

  • Osaka International Cancer Institute - Clinical Oncology

    Osaka, 541-8567

  • Sapporo Medical University Hospital

    Sapporo, Hokkaido, 060-8543

Other trials in Japan

Poland5 sites

  • Narodowy Instytut Onkologii im. Marii Sk¿odowskiej-Curie - Panstwowy Instytut Badawczy, Oddzial w Gliwicach

    Gliwice, 44-102

  • Regeneron Study Site

    Krakow, 30-820

  • Regeneron Study Site

    Poznan, 61-306

  • Regeneron Study Site

    Warsaw, 04-141

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

    Warsaw, 20-090

Other trials in Poland

Ireland3 sites

  • University College Cork-Cork University Maternity Hospital

    Cork

  • St. Vincent's University Hospital

    Dublin, Leinster, DO4 YN63

  • University Hospital Galway

    Galway, H91 YR71

Other trials in Ireland

Belgium2 sites

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Universitair Ziekenhuis Leuven Gasthuisberg Campus

    Leuven, Vlaams-Brabant, 3000

Other trials in Belgium

Greece2 sites

  • University of Athens - Hospital of Venereology Dermatology Diseases Andreas Syggros

    Athens, Attica, 16121

  • Office of Dr. Aimilios Lallas MD

    Thessaloniki, 546 23

Other trials in Greece

New Zealand2 sites

  • Regeneron Study Site

    Auckland, 1023

  • Palmerston North Hospital

    Palmerston North, 4410

Other trials in New Zealand

Canada1 site

  • University Health Network- Princess Margaret Cancer Center

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: A Randomized, Placebo-Controlled, Double-Blind Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma

The primary objective of the study is to compare disease-free survival (DFS) of patients with high-risk cutaneous squamous cell carcinoma (CSCC) treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and radiation therapy (RT).

The secondary objectives of the study are:

  • To compare the overall survival (OS) of high-risk CSCC patients treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and RT
  • To compare the effect of adjuvant cemiplimab with that of placebo on patients' freedom from locoregional recurrence (FFLRR) after surgery and RT
  • To compare the effect of adjuvant cemiplimab with that of placebo on patients' freedom from distant recurrence (FFDR) after surgery and RT
  • To compare the effect of adjuvant cemiplimab with that of placebo on the cumulative incidence of second primary CSCC tumors (SPTs) after surgery and RT
  • To evaluate the safety of adjuvant cemiplimab and that of placebo in high-risk CSCC patients after surgery and RT
  • To assess cemiplimab pharmacokinetics and immunogenicity in human serum
Read the detailed description

Cemiplimab is a monoclonal antibody. Antibodies are proteins naturally found in the blood. A monoclonal antibody is a special antibody that is manufactured as a medication to target specific proteins in the body that may be involved in cancer. Cemiplimab works by blocking programmed death-1 (PD-1), a cell receptor on immune cells. By blocking PD-1, it is expected that the immune cells will attack cancer cells.

The study is being conducted in participants that have had surgery and radiation therapy for a type of skin cancer called cutaneous squamous cell cancer, and who have a risk that this cancer may come back.

The main purpose of the study is to determine if cemiplimab will prevent cutaneous squamous cell cancer (CSCC) from returning after surgery and radiation. Currently, we know that certain types of CSCC have a high chance of coming back after surgery and radiation. At this time, there is no approved treatment to give patients after surgery and radiation to prevent high-risk CSCC from coming back. We are investigating if the addition of cemiplimab will decrease the chance of these high-risk cancers coming back.

The study will also investigate if cemiplimab may help participants live for longer.

The study has two parts. Part 1: participants will receive every 3 weeks via intravenous infusion (drip into a vein) either cemiplimab (study drug) or placebo (similar to the study drug but without active medicine). After 12 weeks of treatment, cemiplimab or placebo will be given every 6 weeks. Part 1 of the study includes a screening period (up to 28 days), a treatment period (approximately 48 weeks), an end of treatment visit (approximately 30 days after completion of study drug treatment period) and a post-treatment follow-up period (approximately up to 5 years or until skin cancer returns or the study ends).

Part 2 of the study is optional and provides the participant with the option to receive cemiplimab if the cancer comes back if the participant was initially receiving placebo. There is no placebo in Part 2 of the study. If the cancer comes back, the study doctor will discuss with participants if they are eligible to participate in the optional part 2 of the study.

Part 2 of the study includes a brief screening period, a treatment period (approximately 96 weeks) and an end of treatment visit (approximately 30 days after the completion of the study drug treatment period).

Being tested
Cemiplimab, Placebo
Keywords
High risk

What participants receive

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

  • CemiplimabDrug

    Also called REGN2810, Libtayo

    Intravenous (IV) infusion over 30 minutes

  • PlaceboDrug

    Intravenous (IV) infusion over 30 minutes

Study groups in NCT03969004
Study groupRoleWhat they receive
CemiplimabExperimentalNot described
Receives: Drug: Cemiplimab
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. DFS defined as time from randomization to the first documented disease recurrence (local, regional and/or distant); or death due to any cause.

    For patients who do not have a tumor recurrence or death, DFS will be censored on the date of last disease assessment.

    Measured: Up to 54 months

Secondary outcomes (9)

  1. Overall survival (OS), defined as time from randomization to the date of death. A patient who has not died will be censored on the last known date as alive.

    Measured: Up to 78 months

  2. FFLRR defined as time from randomization to the date of first locoregional recurrence (LRR). Patients who died without a preceding LRR will be censored on the date of death.

    For patients who do not have a LRR or death, FFLRR will be censored on the date of last disease assessment.

    Measured: Up to 54 months

  3. Freedom from distant recurrence (FFDR), defined as time from randomization to the date of first distant recurrence (DR). Patients who died without a preceding DR will be censored on the date of death.

    For patients who do not have a DR or death, FFDR will be censored on the date of last disease assessment.

    Measured: Up to 54 months

  4. Cumulative occurrence of second primary cutaneous squamous cell carcinoma tumor (SPTs) for each patient from randomization to occurrence of first primary endpoint event or end of study.

    Measured: Up to 54 months

  5. Incidence and severity of treatment-emergent adverse events (TEAE)

    Measured: Up to 78 months

  6. Incidence of deaths

    Measured: Up to 78 months

  7. Incidence of laboratory abnormalities

    Measured: Up to 78 months

  8. Cemiplimab concentrations in serum

    Measured: Up to 78 months

  9. Anti-drug antibodies (ADA) in serum

    Measured: Up to 78 months

Timeline

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

  1. First posted31 May 2019
  2. Study start4 Jun 2019
  3. Primary completion7 Jan 2028 (estimated)
  4. Study completion7 Jan 2028 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
415 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03969004
Sponsor's protocol ID
R2810-ONC-1788
Other IDs
2019-000566-38, 2024-511653-22-00, 2019
Status last verified
Mar 2026
First submitted
6 May 2019
Last updated
27 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

Publications

  • Rischin D, Porceddu S, Day F, Brungs DP, Christie H, Jackson JE, Stein BN, Su YB, Ladwa R, Adams G, Bowyer SE, Otty Z, Yamazaki N, Bossi P, Challapalli A, Hauschild A, Lim AM, Patel VA, Walker JL, De Liz Vassen Schurmann M, Queirolo P, Canueto J, Ferreira da Silva FA, Stratigos A, Guminski A, Lin C, Damian F, Flatz L, Taylor AE, Carr DR, Harris S, Kirtbaya D, Quereux G, Rutkowski P, Basset-Seguin N, Khushalani NI, Robert C, Ju H, Joseph C, Bansal S, Chen CI, Seebach F, Yoo SY, Lowy I, Goncalves P, Fury MG; C-POST Trial Investigators. Adjuvant Cemiplimab or Placebo in High-Risk Cutaneous Squamous-Cell Carcinoma. N Engl J Med. 2025 Aug 21;393(8):774-785. doi: 10.1056/NEJMoa2502449. Epub 2025 May 31.

    PubMed 40454639

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cemiplimab in people with Cutaneous Squamous Cell Carcinoma, run by Regeneron Pharmaceuticals at 166 sites in 16 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 6 inclusion and 7 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 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 166 sites in United States, Australia, Spain, France, Germany and 11 more countries. 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. Some participants in this study may receive a placebo. 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?

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?

DFS defined as time from randomization to the first documented disease recurrence (local, regional and/or distant); or death due to any cause. (time frame: Up to 54 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 NCT03969004, 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 27 Mar 2026.

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