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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04050436
Other study ID # RPL-002-18
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date October 8, 2019
Est. completion date September 2025

Study information

Verified date February 2024
Source Replimune Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 231
Est. completion date September 2025
Est. primary completion date September 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Cemiplimab
Cemiplimab administered intravenously
Biological:
RP1
RP1 administered intratumorally

Locations

Country Name City State
Australia Chris O'Brien Lifehouse Camperdown New South Wales
Australia Monash Medical Centre Clayton Victoria
Australia Peter MacCallum Cancer Centre Melbourne Victoria
Australia The Alfred Hospital Melbourne Victoria
Australia Sir Charles Gairdner Hospital Nedlands Western Australia
Australia Tasman Oncology Research Ltd Southport Queensland
Australia Cancer Care Wollongong Pty Limited Wollongong New South Wales
Bulgaria Multiprofile Hospital for Active Treatment - Uni Hospital" OOD Department of Medical Oncology Panagyurishte
Bulgaria "Complex Oncology Center - Plovdiv" EOOD Department of Medical Oncology and Cutaneous Cancer Diseases " Plovdiv
Canada Sunnybrook Health Science Centre Toronto Ontario
France CHU Besancon - Hopital Jean Minjoz Besancon
France CHU Dijon Hopital F. Mitterrand Service de Dermatologie - UMAC Dijon
France CHU de Grenoble - Hopital A Michallon La Tronche
France CHRU de Lille Lille
France Centre Léon Bérard Lyon
France Service de Dermatologie et Cancerologie Cutanee Hopital de la Timone Marseille
France CHU Nice - Hopital de l'Archet 2 Nice
France Hospital Saint Louis Paris
France Hospices Civils de Lyon Pierre-Bénite
France Institut Gustave Roussy Villejuif
Germany Charite Universitatsmedizin Berlin Berlin
Germany Universitatsklinikum Essen Essen
Germany Universitätsklinikum Eppendorf Hamburg
Germany Universitatsklinikum Heidelberg: National Centre for Tumour Diseases (NCT) Heidelberg
Germany University Hospital Munchen (LMU) München
Germany Universitatsklinikum Tubingen Zentrum fur Dermatoonkologie Tübingen
Greece Andreas Syggros Hospital Athens
Greece Attiko University Hospital Athens
Greece General Hospital of Athens "Laiko", 1st Department of Medicine, University of Athens Medical School Athens
Greece Hippocratio General Hospital of Athens Athens
Italy Istituto Tumori "Giovanni Paolo II" IRCCS Bari
Poland Uniwersyteckie Centrum Kliniczne; Centrum Leczenia Czerniaka w Gdansku Gdansk
Poland Narodowy Instytut Onkologii; Panstwowy Instytut Badawczy Oddzial w Krakowie Kraków
Poland Narodowy Instytut Onkologii; Panstwowy Instytut Badawczy Warsaw
Poland Klinika Dermatologii, Wenerologii i Alergologii, USK im J. Mikulicza-Radeckiego we Wroclawiu Wroclaw
Spain Hospital Clinic Barcelona Barcelona
Spain Hospital Universitari Vall d'Hebron Barcelona
Spain Hospital Universitario 12 de Octubre Madrid
Spain Hospital Universitario Fundación Jiménez Díaz Madrid
Spain Hospital Universitario Virgen de la Arrixaca Murcia
Spain Clinica Universitaria de Navarra Pamplona
Spain Hospital General Universitario De Valencia Valencia
United States Winship Cancer Institute of Emory University Atlanta Georgia
United States University of Colorado Cancer Center Aurora Colorado
United States University Of North Carolina at Chapel Hill Chapel Hill North Carolina
United States Ohio State University Comprehensive Cancer Center Columbus Ohio
United States Prisma Health Cancer Institute Greenville South Carolina
United States John Theurer Cancer Center at Hackensack Univeristy Medical Center Hackensack New Jersey
United States MD Anderson Cancer Center Houston Texas
United States University of California San Diego La Jolla California
United States University of California Los Angeles Los Angeles California
United States University of Miami Health System Miami Florida
United States Memorial Sloan Kettering Cancer Center New York New York
United States Orlando Health UF Health Cancer Center Orlando Florida
United States Stanford University Stanford California
United States Moffitt McKinley Outpatient Center Tampa Florida

Sponsors (2)

Lead Sponsor Collaborator
Replimune Inc. Regeneron Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Bulgaria,  Canada,  France,  Germany,  Greece,  Italy,  Poland,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Objective Response Rate (ORR) according to blinded independent review up to 5 years
Primary Complete Response Rate (CRR) according to blinded independent review up to 5 years
Secondary Progression Free Survival (PFS) by blinded independent review. up to 5 years
Secondary ORR/CRR by investigator assessment and blinded independent review up to 5 years
Secondary ORR/CRR for patients with metastatic or locally advanced disease according to investigator review and blinded independent review up to 5 years
Secondary ORR/CRR for patients who have and have not previously received systemic CSCC-directed therapy and blinded independent review up to 5 years
Secondary Duration of Response (DOR) per investigator review and blinded independent review up to 5 years
Secondary Progression-free Survival (PFS) per investigator review up to 5 years
Secondary Overall Survival (OS) up to 5 years
Secondary 3-year survival 3 years
Secondary 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) approximately 30 months
Secondary Evaluation of the safety and tolerability of cemiplimab alone and combined with RP1 as assessed via adverse events (AEs) approximately 26 months
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