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Cutaneous Squamous Cell CarcinomaPhase 2CERPASSNCT04050436

Study Evaluating Cemiplimab Alone and Combined With RP1 in Treating Advanced Squamous Skin Cancer

A Phase 2 study testing Cemiplimab and RP1 in people with Cutaneous Squamous Cell Carcinoma and Advanced Cutaneous Squamous Cell Carcinoma, run by Replimune, Inc. at 56 sites in 10 countries.

Active, not recruiting

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

Official record
Search all trials

Trial summary

To estimate the clinical benefit of cemiplimab monotherapy versus cemiplimab in combination with RP1 for patients with locally advanced or metastatic CSCC, as assessed by overall response rate (ORR) and complete response rate (CRR) according to blinded independent review. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cemiplimab and RP1
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
231 participants
Where
56 sitesin 10 countries
Study dates
8 Oct 2019to Sep 2025
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

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

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

Who may be able to join

  • Histologically confirmed locally advanced or metastatic cutaneous squamous cell carcinoma
  • Patients with locally advanced disease who are not suitable candidates for surgical or radiological treatment of lesions or have refused those treatments
  • At least 1 lesion that is measurable and injectable by study criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤1. Patients with ECOG PS 2 at baseline may be allowed to enroll if PS 2 status is only related to the CSCC disease under study
  • Anticipated life expectancy >12 weeks
  • All patients must consent to provide archived or newly obtained tumor material for central pathology review for confirmation of diagnosis of CSCC.

Who cannot join

  • Prior treatment with an oncolytic therapy
  • Patients with active significant herpetic infections or prior complications of HSV-1 infection (e.g. herpetic keratitis or encephalitis)
  • Patients who require intermittent or chronic use of systemic (oral or intravenous) anti-virals with known anti-herpetic activity (e.g. acyclovir)
  • Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments
  • Prior treatment with an agent that blocks the PD-1/PD-L1 pathway.
  • Prior treatment with other immune modulating agents other than as adjuvant or neoadjuvant therapy within 3 years.
Show all 12Show fewer
  • Untreated brain metastasis(es) that may be considered active.
  • Acute or chronic active hepatitis B or known history of hepatitis B or hepatitis C or human immunodeficiency virus (HIV) infection
  • History of ILD/pneumonitis within the last 5 years or a history of ILD/pneumonitis requiring treatment with systemic steroids.
  • Any major or surgical procedure ≤ 28 days before randomization
  • Administration of live vaccines ≤ 28 days before randomization
  • Note: Other protocol defined Inclusion/Exclusion criteria apply.

Trial locations and contacts

56 sites in 10 countries.

56 sites in 10 countries

United States14 sites

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045

  • University Of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Prisma Health Cancer Institute

    Greenville, South Carolina, 29605

  • John Theurer Cancer Center at Hackensack Univeristy Medical Center

    Hackensack, New Jersey, 07601

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of California San Diego

    La Jolla, California, 92093

  • University of California Los Angeles

    Los Angeles, California, 90024

  • University of Miami Health System

    Miami, Florida, 33136

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Orlando Health UF Health Cancer Center

    Orlando, Florida, 32806

  • Stanford University

    Stanford, California, 94305

  • Moffitt McKinley Outpatient Center

    Tampa, Florida, 33612

Other trials in United States

France10 sites

  • CHU Besancon - Hopital Jean Minjoz

    Besançon, 25000

  • CHU Dijon Hopital F. Mitterrand Service de Dermatologie - UMAC

    Dijon

  • CHU de Grenoble - Hopital A Michallon

    La Tronche, 38700

  • CHRU de Lille

    Lille, 59037

  • Centre Léon Bérard

    Lyon, 69373

  • Service de Dermatologie et Cancerologie Cutanee Hopital de la Timone

    Marseille

  • CHU Nice - Hopital de l'Archet 2

    Nice, 06202

  • Hospital Saint Louis

    Paris

  • Hospices Civils de Lyon

    Pierre-Bénite, 69310

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Australia7 sites

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales

  • Monash Medical Centre

    Clayton, Victoria

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria

  • The Alfred Hospital

    Melbourne, Victoria

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia

  • Tasman Oncology Research Ltd

    Southport, Queensland

  • Cancer Care Wollongong Pty Limited

    Wollongong, New South Wales

Other trials in Australia

Spain7 sites

  • Hospital Clinic Barcelona

    Barcelona, 08036

  • Hospital Universitari Vall d'Hebron

    Barcelona

  • Hospital Universitario 12 de Octubre

    Madrid

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid

  • Hospital Universitario Virgen de la Arrixaca

    Murcia, 30120

  • Clinica Universitaria de Navarra

    Pamplona

  • Hospital General Universitario De Valencia

    Valencia, 46014

Other trials in Spain

Germany6 sites

  • Charite Universitatsmedizin Berlin

    Berlin, 10117

  • Universitatsklinikum Essen

    Essen, 45147

  • Universitätsklinikum Eppendorf

    Hamburg, 20251

  • Universitatsklinikum Heidelberg: National Centre for Tumour Diseases (NCT)

    Heidelberg, 69120

  • University Hospital Munchen (LMU)

    München, 80337

  • Universitatsklinikum Tubingen Zentrum fur Dermatoonkologie

    Tübingen, 72074

Other trials in Germany

Greece4 sites

  • Hippocratio General Hospital of Athens

    Athens, 11527

  • Attiko University Hospital

    Athens, 12462

  • Andreas Syggros Hospital

    Athens, 16121

  • General Hospital of Athens "Laiko", 1st Department of Medicine, University of Athens Medical School

    Athens

Other trials in Greece

Poland4 sites

  • Uniwersyteckie Centrum Kliniczne; Centrum Leczenia Czerniaka w Gdańsku

    Gdansk, 80-214

  • Narodowy Instytut Onkologii; Panstwowy Instytut Badawczy Oddzial w Krakowie

    Krakow, 31-115

  • Narodowy Instytut Onkologii; Panstwowy Instytut Badawczy

    Warsaw, 02-781

  • Klinika Dermatologii, Wenerologii i Alergologii, USK im J. Mikulicza-Radeckiego we Wroclawiu

    Wroclaw

Other trials in Poland

Bulgaria2 sites

  • Multiprofile Hospital for Active Treatment - Uni Hospital" OOD Department of Medical Oncology

    Panagyurishte

  • "Complex Oncology Center - Plovdiv" EOOD Department of Medical Oncology and Cutaneous Cancer Diseases "

    Plovdiv

Other trials in Bulgaria

Canada1 site

  • Sunnybrook Health Science Centre

    Toronto, Ontario, M4N 3M5

Other trials in Canada

Italy1 site

  • Istituto Tumori "Giovanni Paolo II" IRCCS

    Bari

Other trials in Italy

About this study

Official title: A Randomized, Controlled, Open-Label, Phase 2 Study of Cemiplimab as a Single Agent and in Combination With RP1 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

To estimate the clinical benefit of cemiplimab monotherapy versus cemiplimab in combination with RP1 for patients with locally advanced or metastatic CSCC, as assessed by overall response rate (ORR) and complete response rate (CRR) according to blinded independent review.

Read the detailed description

RP1 is a selectively replication competent herpes simplex virus type 1(HSV-1). This is a Phase 1/2, open-label, multicenter repeat-dosing study of RP1 alone and in combination with nivolumab in patients with advanced malignancies, and contains both single agent dose escalation, dose expansion to include nivolumab, and the combination in multiple Phase 2 cohorts in individual tumor types.

Being tested
Cemiplimab, RP1
Keywords
Oncolytic Virus, Carcinoma, Carcinoma, Squamous Cell, Cemiplimab, Metastatic Cutaneous Squamous Cell Carcinoma, Oncolytic Immuno-gene therapy
Medical subject headings
Carcinoma, Carcinoma, Squamous Cell

What participants receive

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

  • CemiplimabDrug

    Also called Libtayo

    Cemiplimab administered intravenously

  • RP1Biological

    Also called Genetically modified herpes simplex type 1 virus

    RP1 administered intratumorally

Study groups in NCT04050436
Study groupRoleWhat they receive
Cemiplimab in combination with RP1ExperimentalCemiplimab administered intravenously every 3 weeks in combination with RP1 administered as an intratumoral injection every 3 weeks
Receives: Drug: Cemiplimab; Biological: RP1
CemiplimabActive comparatorCemiplimab administered intravenously as a single therapy every 3 weeks
Receives: Drug: Cemiplimab

What is being measured

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

  1. Objective Response Rate (ORR) according to blinded independent review

    Measured: up to 5 years

  2. Complete Response Rate (CRR) according to blinded independent review

    Measured: up to 5 years

Secondary outcomes (10)

  1. Progression Free Survival (PFS) by blinded independent review.

    Measured: up to 5 years

  2. ORR/CRR by investigator assessment and blinded independent review

    Measured: up to 5 years

  3. ORR/CRR for patients with metastatic or locally advanced disease according to investigator review and blinded independent review

    Measured: up to 5 years

  4. ORR/CRR for patients who have and have not previously received systemic CSCC-directed therapy and blinded independent review

    Measured: up to 5 years

  5. Duration of Response (DOR) per investigator review and blinded independent review

    Measured: up to 5 years

  6. Progression-free Survival (PFS) per investigator review

    Measured: up to 5 years

  7. Overall Survival (OS)

    Measured: up to 5 years

  8. 3-year survival

    Measured: 3 years

  9. Change in overall scores of patient-reported outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)

    Measured: approximately 30 months

  10. Evaluation of the safety and tolerability of cemiplimab alone and combined with RP1 as assessed via adverse events (AEs)

    Measured: approximately 26 months

Timeline

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

  1. First posted8 Aug 2019
  2. Study start8 Oct 2019
  3. Primary completionSep 2025 (estimated)
  4. Study completionSep 2025 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
231 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04050436
Sponsor's protocol ID
RPL-002-18
Acronym
CERPASS
Status last verified
Jan 2025
First submitted
2 Aug 2019
Last updated
27 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cemiplimab and RP1 in people with Cutaneous Squamous Cell Carcinoma and Advanced Cutaneous Squamous Cell Carcinoma, run by Replimune, Inc. at 56 sites in 10 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 12 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 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in United States, France, Australia, Spain, Germany and 5 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

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

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

Are results available for this study?

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

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

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

What does the primary outcome measure?

Objective Response Rate (ORR) according to blinded independent review (time frame: up to 5 years). The study lists 2 primary outcomes in all. 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 NCT04050436.

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 Jan 2025.

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