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

NCT04050436 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: RPL-002-18
• Study Type: interventional
• Target: 231
• Locations: 10 countries
• Sites: 56

Brief 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.

Conditions

Cutaneous Squamous Cell Carcinoma; Advanced Cutaneous Squamous Cell Carcinoma; Metastatic Cutaneous Squamous Cell Carcinoma

Keywords

Oncolytic Virus; Carcinoma; Carcinoma, Squamous Cell; Cemiplimab; Metastatic Cutaneous Squamous Cell Carcinoma; Oncolytic Immuno-gene therapy

Outcome Measures

Primary Outcomes (2)

• Objective Response Rate (ORR) according to blinded independent review

  up to 5 years

• Complete Response Rate (CRR) according to blinded independent review

  up to 5 years

Secondary Outcomes (10)

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

  up to 5 years

• ORR/CRR by investigator assessment and blinded independent review

  up to 5 years

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

  up to 5 years

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

  up to 5 years

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

  up to 5 years

Study Arms (2)

Cemiplimab in combination with RP1

EXPERIMENTAL

Cemiplimab administered intravenously every 3 weeks in combination with RP1 administered as an intratumoral injection every 3 weeks

Drug: Cemiplimab; Biological: RP1

Cemiplimab

ACTIVE COMPARATOR

Cemiplimab administered intravenously as a single therapy every 3 weeks

Drug: Cemiplimab

Interventions

Cemiplimab DRUG

Cemiplimab administered intravenously

Also known as: Libtayo

Cemiplimab; Cemiplimab in combination with RP1

RP1 BIOLOGICAL

RP1 administered intratumorally

Also known as: Genetically modified herpes simplex type 1 virus

Cemiplimab in combination with RP1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Replimune Inc.: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (56)

University of California San Diego

La Jolla, California, 92093, United States

Location

University of California Los Angeles

Los Angeles, California, 90024, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

Location

University of Miami Health System

Miami, Florida, 33136, United States

Location

Orlando Health UF Health Cancer Center

Orlando, Florida, 32806, United States

Location

Moffitt McKinley Outpatient Center

Tampa, Florida, 33612, United States

Location

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322, United States

Location

John Theurer Cancer Center at Hackensack Univeristy Medical Center

Hackensack, New Jersey, 07601, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

University Of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Prisma Health Cancer Institute

Greenville, South Carolina, 29605, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Chris O'Brien Lifehouse

Camperdown, New South Wales, Australia

Location

Cancer Care Wollongong Pty Limited

Wollongong, New South Wales, Australia

Location

Tasman Oncology Research Ltd

Southport, Queensland, Australia

Location

Monash Medical Centre

Clayton, Victoria, Australia

Location

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Location

The Alfred Hospital

Melbourne, Victoria, Australia

Location

Sir Charles Gairdner Hospital

Nedlands, Western Australia, Australia

Location

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

Panagyurishte, Bulgaria

Location

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

Plovdiv, Bulgaria

Location

Sunnybrook Health Science Centre

Toronto, Ontario, M4N 3M5, Canada

Location

CHU Besancon - Hopital Jean Minjoz

Besançon, 25000, France

Location

CHU Dijon Hopital F. Mitterrand Service de Dermatologie - UMAC

Dijon, France

Location

CHU de Grenoble - Hopital A Michallon

La Tronche, 38700, France

Location

CHRU de Lille

Lille, 59037, France

Location

Centre Léon Bérard

Lyon, 69373, France

Location

Service de Dermatologie et Cancerologie Cutanee Hopital de la Timone

Marseille, France

Location

CHU Nice - Hopital de l'Archet 2

Nice, 06202, France

Location

Hospital Saint Louis

Paris, France

Location

Hospices Civils de Lyon

Pierre-Bénite, 69310, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

Charite Universitatsmedizin Berlin

Berlin, 10117, Germany

Location

Universitatsklinikum Essen

Essen, 45147, Germany

Location

Universitätsklinikum Eppendorf

Hamburg, 20251, Germany

Location

Universitatsklinikum Heidelberg: National Centre for Tumour Diseases (NCT)

Heidelberg, 69120, Germany

Location

University Hospital Munchen (LMU)

München, 80337, Germany

Location

Universitatsklinikum Tubingen Zentrum fur Dermatoonkologie

Tübingen, 72074, Germany

Location

Hippocratio General Hospital of Athens

Athens, 11527, Greece

Location

Attiko University Hospital

Athens, 12462, Greece

Location

Andreas Syggros Hospital

Athens, 16121, Greece

Location

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

Athens, Greece

Location

Istituto Tumori "Giovanni Paolo II" IRCCS

Bari, Italy

Location

Uniwersyteckie Centrum Kliniczne; Centrum Leczenia Czerniaka w Gdańsku

Gdansk, 80-214, Poland

Location

Narodowy Instytut Onkologii; Panstwowy Instytut Badawczy Oddzial w Krakowie

Krakow, 31-115, Poland

Location

Narodowy Instytut Onkologii; Panstwowy Instytut Badawczy

Warsaw, 02-781, Poland

Location

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

Wroclaw, Poland

Location

Hospital Clinic Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Spain

Location

Hospital Universitario Fundación Jiménez Díaz

Madrid, Spain

Location

Hospital Universitario Virgen de la Arrixaca

Murcia, 30120, Spain

Location

Clinica Universitaria de Navarra

Pamplona, Spain

Location

Hospital General Universitario De Valencia

Valencia, 46014, Spain

Location

MeSH Terms

Conditions

Carcinoma; Carcinoma, Squamous Cell

Interventions

cemiplimab

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell

Study Officials

• Moran Mishal, MD

  Lead Medical Monitor

  STUDY DIRECTOR

• Jeannie Hou, MD

  Secondary Medical Monitor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2019
• First Posted: August 8, 2019
• Study Start: October 8, 2019
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (7); ES (7); CA (1); FR (10); PL (4); GR (4); DE (6); BU (2); US (14); IT (1)