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Clinical Trials in Germany / NCT04050436
Active, not recruiting Phase 2

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

NCT04050436 · tracked via the Priya Life Science Germany tracker
Phase
Phase 2
Started
2019-10-08
Last updated
2025-01-27

Condition(s) studied

Cutaneous Squamous Cell CarcinomaAdvanced Cutaneous Squamous Cell CarcinomaMetastatic Cutaneous Squamous Cell Carcinoma

Investigational drug(s) / intervention(s)

Cemiplimab →RP1 →

Cemiplimab: Cemiplimab administered intravenously

RP1: RP1 administered intratumorally

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (56)

FacilityCityRegionStatus
University of California San Diego La Jolla California
University of California Los Angeles Los Angeles California
Stanford University Stanford California
University of Colorado Cancer Center Aurora Colorado
University of Miami Health System Miami Florida
Orlando Health UF Health Cancer Center Orlando Florida
Moffitt McKinley Outpatient Center Tampa Florida
Winship Cancer Institute of Emory University Atlanta Georgia
John Theurer Cancer Center at Hackensack Univeristy Medical Center Hackensack New Jersey
Memorial Sloan Kettering Cancer Center New York New York
University Of North Carolina at Chapel Hill Chapel Hill North Carolina
Ohio State University Comprehensive Cancer Center Columbus Ohio
Prisma Health Cancer Institute Greenville South Carolina
MD Anderson Cancer Center Houston Texas
Chris O'Brien Lifehouse Camperdown New South Wales
Cancer Care Wollongong Pty Limited Wollongong New South Wales
Tasman Oncology Research Ltd Southport Queensland
Monash Medical Centre Clayton Victoria
Peter MacCallum Cancer Centre Melbourne Victoria
The Alfred Hospital Melbourne Victoria
Sir Charles Gairdner Hospital Nedlands Western Australia
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 Bulgaria
Sunnybrook Health Science Centre Toronto Ontario
CHU Besancon - Hopital Jean Minjoz Besançon 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 France
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 Germany

+ 16 more sites — see the full list on the official registry below.

On this site

📄 Libtayo (cemiplimab) drug profile →

More Replimune, Inc. trials in Germany

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04050436 on ClinicalTrials.gov ↗ ← All trials in Germany