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

Cutaneous Squamous Cell Carcinoma Clinical Trial

— CERPASS  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04050436
• Other study ID #: RPL-002-18
• Status: Active, not recruiting
• Phase: Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Advanced Cutaneous Squamous Cell Carcinoma
• Carcinoma
• Carcinoma, Squamous Cell
• Cutaneous Squamous Cell Carcinoma
• Metastatic Cutaneous Squamous Cell Carcinoma

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