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

March 29, 2024 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

Active, not recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

231

Phase

  • 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 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 Besançon - Hôpital Jean Minjoz
      • Dijon, France
        • CHU Dijon Hopital F. Mitterrand Service de Dermatologie - UMAC
      • La Tronche, France, 38700
        • CHU de Grenoble - Hopital A Michallon
      • Lille, France, 59037
        • CHRU de Lille
      • Lyon, France, 69373
        • Centre Léon Bérard
      • Marseille, France
        • Service de Dermatologie et Cancerologie Cutanee Hopital de la Timone
      • Nice, France, 06202
        • CHU Nice - Hôpital 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
        • Charite Universitatsmedizin 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 Munchen (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

Ages Eligible for Study

16 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
Intervention / Treatment
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

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

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

Replimune Inc.

Collaborators

Regeneron Pharmaceuticals

Investigators

  • Study Director: Sumera Raoof, MD, Lead Medical Monitor
  • Study Director: Jeannie Hou, MD, Secondary 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)

October 8, 2019

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

August 2, 2019

First Submitted That Met QC Criteria

August 7, 2019

First Posted (Actual)

August 8, 2019

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

March 29, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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