Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

Advanced Cutaneous Squamous Cell Carcinoma Clinical Trial

Official title:

A Phase 2 Study of REGN2810, a Fully Human Monoclonal Antibody to Programmed Death-1 (PD-1), in Patients With Advanced Cutaneous Squamous Cell Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02760498
• Other study ID #: R2810-ONC-1540
• Secondary ID: 2016-000105-36
• Status: Completed
• Phase: Phase 2
• Start date: April 7, 2016
• Est. completion date: October 18, 2023

Study information

• Verified date: December 2023
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Groups 1 to 4 To estimate the clinical benefit of cemiplimab monotherapy for patients with:

metastatic (nodal or distant) cutaneous squamous cell carcinoma (CSCC), or unresectable locally advanced CSCC

Group 6 To provide additional efficacy and safety data for cemiplimab monotherapy in patients with advanced CSCC (metastatic [nodal or distant] or locally advanced treated with cemiplimab

Recruitment information / eligibility

• Status: Completed
• Enrollment: 432
• Est. completion date: October 18, 2023
• Est. primary completion date: October 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• At least 1 measurable lesion

• Eastern Cooperative Oncology Group (ECOG) performance status =1

• Adequate bone marrow function

• Adequate renal function

• Adequate hepatic function

• Archived or newly obtained tumor material

• Patients must consent to undergo biopsies of CSCC lesions (Groups 2, 4, and 6)

• Surgical or radiological treatment of lesions contraindicated

Key Exclusion Criteria:

• Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events

• Prior treatment with an agent that blocks the PD-1/PD-L1pathway

• Prior treatment with a BRAF inhibitor

• Prior treatment with other immune-modulating agents within fewer than 4 weeks prior to the first dose of cemiplimab, or associated with immune-mediated adverse events that were = grade 1 within 90 days prior to the first dose of cemiplimab, or associated with toxicity that resulted in discontinuation of the immune-modulating agent. Examples of immune-modulating agents include therapeutic vaccines, cytokine treatments, or agents that target cytotoxic T-lymphocyte antigen 4 (CTLA-4), 4-1BB (CD137), or OX-40.

• Untreated brain metastasis(es) that may be considered active

• Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of cemiplimab

• Infection with human immunodeficiency virus (HIV) and/or chronic/active infection with hepatitis B virus or hepatitis C virus

• History of non-infectious pneumonitis within the last 5 years

• Allergic reactions or acute hypersensitivity reaction attributed to antibody treatments

• Known allergy to doxycycline or tetracycline

• Patients with a history of solid organ transplant

• Any medical co-morbidity, physical examination finding, or metabolic dysfunction, or clinical laboratory abnormality that renders the patient unsuitable

Other protocol-defined inclusion/exclusion criteria apply

Related Conditions & MeSH terms

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

Intervention

Drug:
• cemiplimab

Locations

Country	Name	City	State
Australia	The Canberra Hospital	Garran	Australian Capital Territory
Australia	Gosford Hospital	Gosford	New South Wales
Australia	Royal Brisbane & Women's Hospital	Herston	Queensland
Australia	Adelaide Cancer Centre	Kurralta Park	South Australia
Australia	Peter MacCallum Cancer Centre	Melbourne	Victoria
Australia	Sir Charles Gairdner Hospital	Nedlands	Western Australia
Australia	Royal North Shore Hospital	St Leonards	New South Wales
Australia	Calvary Mater Newcastle	Waratah	New South Wales
Australia	Border Medical Oncology	Wodonga	Victoria
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland
Brazil	Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner	Curitiba
Brazil	Fundação São Francisco Xavier-Hospital Márcio Cunha	Ipatinga
Brazil	Animi	Lages
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul
Brazil	Instituto do Cancer do Estado de São Paulo ICESP	Sao Paulo
Brazil	Fundação Antônio Prudente - AC Camargo Câncer Center	São Paulo
France	Hopital Avicenne	Bobigny
France	Hôpital Saint-André	Bordeaux
France	CHU Dijon Bourgogne	Dijon
France	CHRU Grenoble	Grenoble
France	Hôpital Claude Huriez	Lille	Nord
France	Hopitaux de La Timone	Marseille
France	Centre Hospitalier Universitaire de Nantes	Nantes
France	Hopital Cochin	Paris
France	Hôpital Saint Louis	Paris
France	Centre Hospitalier Lyon Sud	Pierre Bénite
France	Institut Gustave Roussy	Villejuif
Germany	Charitè Campus Mitte	Berlin
Germany	Universitätsklinikum Carl Gustav Carus	Dresden	Sachsen
Germany	Universitätsklinikum Essen	Essen	Nordrhein-Westfalen
Germany	SRH Wald-Klinikum Gera	Gera
Germany	Medizinische Hochschule Hannover	Hannover	Niedersachsen
Germany	Universitatsklinikum Schleswig-Holstein	Kiel	Schleswig-Holstein
Germany	LMU Klinikum der Universität München	Munich	Bayern
Germany	Universitätsklinikum Tübingen	Tübingen	Baden-Württemberg
Greece	Andreas Sygros Hosptial-University of Athen	Athens
Italy	ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia	Brescia
Italy	Ospedale San Salvatore	L'Aquila
Italy	Istituto Europeo Di Oncologia	Milan
Italy	Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale	Napoli	Campania
Italy	Istituto Oncologico Veneto - I.R.C.C.S.	Padova	Veneto
Italy	Fondazione Policlinico Universitario A Gemelli	Roma
Spain	Hospital Clinic de Barcelona	Barcelona	Cataluna
Spain	Hospital Universitario Germans Trias i Pujol	Barcelona
Spain	Hospital Universitario Vall d'Hebron	Barcelona
Spain	C.H. Regional Reina Sofia - PPDS	Cordoba
Spain	ICO l'Hospitalet - Hospital Duran i Reynals	L'Hospitalet de Llobregat	Barelona
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Fundacion Jimenez Diaz	Madrid
Spain	Hospital Universitario Ramon y Cajal	Madrid
Spain	Hospital Universitario Marques de Valdecilla	Santander
Spain	Fundacion Instituto Valenciano de Oncología	Valencia
United States	University of Colorado, Denver	Aurora	Colorado
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Dermatology and Laser Center of Charleston	Charleston	South Carolina
United States	Northwestern University	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	City of Hope Hospital	Duarte	California
United States	St. Luke's Hematology Oncology Specialists	Easton	Pennsylvania
United States	Penn State Hershey Medical Center	Hershey	Pennsylvania
United States	MD Anderson Cancer Center	Houston	Texas
United States	University of California, Los Angeles	Los Angeles	California
United States	Norton Cancer Institute	Louisville	Kentucky
United States	Mount Sinai Comprehensive Cancer Center	Miami Beach	Florida
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	New York University	New York	New York
United States	Nebraska Methodist Hospital	Omaha	Nebraska
United States	Mayo Clinic	Phoenix	Arizona
United States	University of Arizona Cancer Center	Phoenix	Arizona
United States	Stanford University	Redwood City	California
United States	University of Rochester Medical Center	Rochester	New York
United States	St. Louis University	Saint Louis	Missouri
United States	Washington University in St. Louis	Saint Louis	Missouri
United States	Huntsman Cancer Institute	Salt Lake City	Utah
United States	University of California, San Diego	San Diego	California
United States	H. Lee Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  France,  Germany,  Greece,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate (ORR)	Groups 1, 3, 4, and 6: Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 will be used to determine ORR. Group 2: Clinical response criteria will be used to determine ORR	30 months
Secondary	Investigator Assessments of ORR	Groups 1-4, and 6	Up to 30 months
Secondary	Duration of response	Groups 1-4, and 6	Up to 30 months
Secondary	PFS (progression-free survival)	Groups 1-4, and 6	Up to 30 months
Secondary	Overall Survival	Groups 1-4, and 6	Up to 30 months
Secondary	Complete Response (CR) Rate	Groups 1-4, and 6	Up to 30 months
Secondary	Change in scores of patient reported outcomes on EORTC QLQ-C30	Except Group 6	Up to 30 months
Secondary	Incidence of Treatment Emergent Adverse Events (TEAEs)		Up to 30 months
Secondary	Cemiplimab PK: Concentration at end-of-infusion (Ceoi) (IV)		Up to 24 months
Secondary	Cemiplimab PK: Peak concentrations (Cmax) (SC)		Up to 24 months
Secondary	Cemiplimab PK: Pre-infusion concentration (Ctrough)		Up to 24 months
Secondary	Cemiplimab PK: Time of end-of-infusion (teoi)		Up to 24 months
Secondary	Cemiplimab PK: Time to peak concentration (tmax) (SC)		Up to 24 months
Secondary	Cemiplimab PK: Area under the plasma concentration-time curve after the first SC or IV dose		Up to 24 months
Secondary	Cemiplimab PK: Absolute bioavailability after SC administration		Up to 24 months
Secondary	Anti-cemiplimab antibodies		Up to 30 months
Secondary	Immunohistochemistry (IHC) assessment of correlation between PD-L1 status and ORR	Group 6	Up to 30 months
Secondary	IHC assessment of correlation between PD-L1 and DOR	Group 6	Up to 30 months
Secondary	IHC assessment of correlation between PD-L1 and PFS	Group 6	Up to 30 months