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

January 22, 2025 updated by: Replimune Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
231

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia
        • Chris O'Brien Lifehouse
      • Wollongong, New South Wales, Australia
        • Cancer Care Wollongong Pty Limited
    • Queensland
      • Southport, Queensland, Australia
        • Tasman Oncology Research Ltd
    • Victoria
      • Clayton, Victoria, Australia
        • Monash Medical Centre
      • Melbourne, Victoria, Australia
        • The Alfred Hospital
      • Melbourne, Victoria, Australia
        • Peter MacCallum Cancer Centre
    • Western Australia
      • Nedlands, Western Australia, Australia
        • Sir Charles Gairdner Hospital
  • Bulgaria
      • Panagyurishte, Bulgaria
        • Multiprofile Hospital for Active Treatment - Uni Hospital" OOD Department of Medical Oncology
      • Plovdiv, Bulgaria
        • "Complex Oncology Center - Plovdiv" EOOD Department of Medical Oncology and Cutaneous Cancer Diseases "
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Science Centre
  • France
      • Besancon, France, 25000
        • CHU Besancon - Hôpital Jean Minjoz
      • Dijon, France
        • CHU Dijon Hopital F. Mitterrand Service de Dermatologie - UMAC
      • La Tronche, France, 38700
        • CHU de Grenoble - Hôpital A Michallon
      • Lille, France, 59037
        • CHRU de Lille
      • Lyon, France, 69373
        • Centre Leon Berard
      • Marseille, France
        • Service de Dermatologie et Cancerologie Cutanee Hopital de la Timone
      • Nice, France, 06202
        • CHU Nice - Hopital de l'Archet 2
      • Paris, France
        • Hospital Saint Louis
      • Pierre-Bénite, France, 69310
        • Hospices Civils de Lyon
      • Villejuif, France, 94805
        • Institut Gustave Roussy
  • Germany
      • Berlin, Germany, 10117
        • Charité Universitätsmedizin Berlin
      • Essen, Germany, 45147
        • Universitätsklinikum Essen
      • Hamburg, Germany, 20251
        • Universitätsklinikum Eppendorf
      • Heidelberg, Germany, 69120
        • Universitatsklinikum Heidelberg: National Centre for Tumour Diseases (NCT)
      • München, Germany, 80337
        • University Hospital München (LMU)
      • Tübingen, Germany, 72074
        • Universitatsklinikum Tubingen Zentrum fur Dermatoonkologie
  • Greece
      • Athens, Greece, 16121
        • Andreas Syggros Hospital
      • Athens, Greece, 11527
        • Hippocratio General Hospital of Athens
      • Athens, Greece, 12462
        • ATTIKO University Hospital
      • Athens, Greece
        • General Hospital of Athens "Laiko", 1st Department of Medicine, University of Athens Medical School
  • Italy
      • Bari, Italy
        • Istituto Tumori "Giovanni Paolo II" IRCCS
  • Poland
      • Gdańsk, Poland, 80-214
        • Uniwersyteckie Centrum Kliniczne; Centrum Leczenia Czerniaka w Gdańsku
      • Kraków, Poland, 31-115
        • Narodowy Instytut Onkologii; Panstwowy Instytut Badawczy Oddzial w Krakowie
      • Warsaw, Poland, 02-781
        • Narodowy Instytut Onkologii; Panstwowy Instytut Badawczy
      • Wrocław, Poland
        • Klinika Dermatologii, Wenerologii i Alergologii, USK im J. Mikulicza-Radeckiego we Wroclawiu
  • Spain
      • Barcelona, Spain
        • Hospital Universitari Vall d'Hebron
      • Barcelona, Spain, 08036
        • Hospital Clinic Barcelona
      • Madrid, Spain
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain
        • Hospital Universitario Fundacion Jimenez Diaz
      • Murcia, Spain, 30120
        • Hospital Universitario Virgen de la Arrixaca
      • Pamplona, Spain
        • Clinica Universitaria de Navarra
      • Valencia, Spain, 46014
        • Hospital General Universitario de Valencia
  • United States
    • California
      • La Jolla, California, United States, 92093
        • University of California San Diego
      • Los Angeles, California, United States, 90024
        • University of California Los Angeles
      • Stanford, California, United States, 94305
        • Stanford University
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Cancer Center
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami Health System
      • Orlando, Florida, United States, 32806
        • Orlando Health UF Health Cancer Center
      • Tampa, Florida, United States, 33612
        • Moffitt McKinley Outpatient Center
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Winship Cancer Institute of Emory University
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • John Theurer Cancer Center at Hackensack Univeristy Medical Center
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University Comprehensive Cancer Center
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Prisma Health Cancer Institute
    • Texas
      • Houston, Texas, United States, 77030
        • Md Anderson Cancer Center

Participation Criteria

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

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • 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.

Key Exclusion Criteria:

  • 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.
  • 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.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cemiplimab in combination with RP1
Cemiplimab administered intravenously every 3 weeks in combination with RP1 administered as an intratumoral injection every 3 weeks
Drug: Cemiplimab
Cemiplimab administered intravenously
Other Names:
  • Libtayo
Biological: RP1
RP1 administered intratumorally
Other Names:
  • Genetically modified herpes simplex type 1 virus
Active Comparator: Cemiplimab
Cemiplimab administered intravenously as a single therapy every 3 weeks
Drug: Cemiplimab
Cemiplimab administered intravenously
Other Names:
  • Libtayo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Objective Response Rate (ORR) according to blinded independent review
Time Frame: up to 5 years
up to 5 years
Complete Response Rate (CRR) according to blinded independent review
Time Frame: up to 5 years
up to 5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Progression Free Survival (PFS) by blinded independent review.
Time Frame: up to 5 years
up to 5 years
ORR/CRR by investigator assessment and blinded independent review
Time Frame: up to 5 years
up to 5 years
ORR/CRR for patients with metastatic or locally advanced disease according to investigator review and blinded independent review
Time Frame: up to 5 years
up to 5 years
ORR/CRR for patients who have and have not previously received systemic CSCC-directed therapy and blinded independent review
Time Frame: up to 5 years
up to 5 years
Duration of Response (DOR) per investigator review and blinded independent review
Time Frame: up to 5 years
up to 5 years
Progression-free Survival (PFS) per investigator review
Time Frame: up to 5 years
up to 5 years
Overall Survival (OS)
Time Frame: up to 5 years
up to 5 years
3-year survival
Time Frame: 3 years
3 years
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)
Time Frame: approximately 30 months
approximately 30 months
Evaluation of the safety and tolerability of cemiplimab alone and combined with RP1 as assessed via adverse events (AEs)
Time Frame: approximately 26 months
approximately 26 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Replimune Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Regeneron Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Jeannie Hou, MD, Secondary Medical Monitor
  • Study Director: Moran Mishal, MD, Lead Medical Monitor

Study record dates

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

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 8, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 2, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 8, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RPL-002-18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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

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