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

Primary Purpose

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

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Cemiplimab
RP1
Sponsored by
Replimune Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cutaneous Squamous Cell Carcinoma focused on measuring Oncolytic Virus, Carcinoma, Carcinoma, Squamous Cell, Cemiplimab, Metastatic Cutaneous Squamous Cell Carcinoma, Oncolytic Immuno-gene therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California San Diego
  • University of California Los Angeles
  • Stanford University
  • University of Colorado Cancer Center
  • University of Miami Health System
  • Orlando Health UF Health Cancer Center
  • Moffitt McKinley Outpatient Center
  • Winship Cancer Institute of Emory University
  • John Theurer Cancer Center at Hackensack Univeristy Medical Center
  • Memorial Sloan Kettering Cancer Center
  • University Of North Carolina at Chapel Hill
  • Ohio State University Comprehensive Cancer Center
  • Prisma Health Cancer Institute
  • MD Anderson Cancer Center
  • Chris O'Brien Lifehouse
  • Southern Medical Day Care Centre
  • Tasman Oncology Research Ltd
  • Monash Medical Centre
  • Peter MacCallum Cancer Centre
  • The Alfred Hospital
  • Sir Charles Gairdner Hospital
  • Multiprofile Hospital for Active Treatment - Uni Hospital" OOD Department of Medical Oncology
  • "Complex Oncology Center - Plovdiv" EOOD Department of Medical Oncology and Cutaneous Cancer Diseases "
  • Sunnybrook Health Science Centre
  • CHU Besancon - Hopital Jean Minjoz
  • CHU Dijon Hopital F. Mitterrand Service de Dermatologie - UMAC
  • CHU de Grenoble - Hopital A Michallon
  • CHRU de Lille
  • Centre Léon Bérard
  • Service de Dermatologie et Cancerologie Cutanee Hopital de la Timone
  • CHU Nice - Hopital de l'Archet 2
  • Hospital Saint Louis
  • Hospices Civils de Lyon
  • Institut Gustave Roussy
  • Charite Universitatsmedizin Berlin
  • Universitatsklinikum Essen
  • Universitätsklinikum Eppendorf
  • Universitatsklinikum Heidelberg: National Centre for Tumour Diseases (NCT)
  • University Hospital Munchen (LMU)
  • Universitatsklinikum Tubingen Zentrum fur Dermatoonkologie
  • Hippocratio General Hospital of Athens
  • Attiko University Hospital
  • Andreas Syggros Hospital
  • General Hospital of Athens "Laiko", 1st Department of Medicine, University of Athens Medical School
  • Istituto Tumori "Giovanni Paolo II" IRCCS
  • Uniwersyteckie Centrum Kliniczne; Centrum Leczenia Czerniaka w Gdańsku
  • Narodowy Instytut Onkologii; Panstwowy Instytut Badawczy Oddzial w Krakowie
  • Narodowy Instytut Onkologii; Panstwowy Instytut Badawczy
  • Klinika Dermatologii, Wenerologii i Alergologii, USK im J. Mikulicza-Radeckiego we Wroclawiu
  • Hospital Clinic Barcelona
  • Hospital Universitari Vall d'Hebron
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario Fundación Jiménez Díaz
  • Hospital Universitario Virgen de la Arrixaca
  • Clinica Universitaria de Navarra
  • Hospital General Universitario De Valencia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cemiplimab in combination with RP1

Cemiplimab

Arm Description

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

Cemiplimab administered intravenously as a single therapy every 3 weeks

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR) according to blinded independent review
Complete Response Rate (CRR) according to blinded independent review

Secondary Outcome Measures

Progression Free Survival (PFS) by blinded independent review.
ORR/CRR by investigator assessment and blinded independent review
ORR/CRR for patients with metastatic or locally advanced disease according to investigator review and blinded independent review
ORR/CRR for patients who have and have not previously received systemic CSCC-directed therapy and blinded independent review
Duration of Response (DOR) per investigator review and blinded independent review
Progression-free Survival (PFS) per investigator review
Overall Survival (OS)
3-year survival
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)
Evaluation of the safety and tolerability of cemiplimab alone and combined with RP1 as assessed via adverse events (AEs)

Full Information

First Posted
August 2, 2019
Last Updated
February 1, 2023
Sponsor
Replimune Inc.
Collaborators
Regeneron Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT04050436
Brief Title
Study Evaluating Cemiplimab Alone and Combined With RP1 in Treating Advanced Squamous Skin Cancer
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 8, 2019 (Actual)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Replimune Inc.
Collaborators
Regeneron Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
231 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cemiplimab in combination with RP1
Arm Type
Experimental
Arm Description
Cemiplimab administered intravenously every 3 weeks in combination with RP1 administered as an intratumoral injection every 3 weeks
Arm Title
Cemiplimab
Arm Type
Active Comparator
Arm Description
Cemiplimab administered intravenously as a single therapy every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Cemiplimab
Other Intervention Name(s)
Libtayo
Intervention Description
Cemiplimab administered intravenously
Intervention Type
Biological
Intervention Name(s)
RP1
Other Intervention Name(s)
Genetically modified herpes simplex type 1 virus
Intervention Description
RP1 administered intratumorally
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR) according to blinded independent review
Time Frame
up to 5 years
Title
Complete Response Rate (CRR) according to blinded independent review
Time Frame
up to 5 years
Secondary Outcome Measure Information:
Title
Progression Free Survival (PFS) by blinded independent review.
Time Frame
up to 5 years
Title
ORR/CRR by investigator assessment and blinded independent review
Time Frame
up to 5 years
Title
ORR/CRR for patients with metastatic or locally advanced disease according to investigator review and blinded independent review
Time Frame
up to 5 years
Title
ORR/CRR for patients who have and have not previously received systemic CSCC-directed therapy and blinded independent review
Time Frame
up to 5 years
Title
Duration of Response (DOR) per investigator review and blinded independent review
Time Frame
up to 5 years
Title
Progression-free Survival (PFS) per investigator review
Time Frame
up to 5 years
Title
Overall Survival (OS)
Time Frame
up to 5 years
Title
3-year survival
Time Frame
3 years
Title
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)
Time Frame
approximately 30 months
Title
Evaluation of the safety and tolerability of cemiplimab alone and combined with RP1 as assessed via adverse events (AEs)
Time Frame
approximately 26 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sumera Raoof, MD
Organizational Affiliation
Lead Medical Monitor
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jeannie Hou, MD
Organizational Affiliation
Secondary Medical Monitor
Official's Role
Study Director
Facility Information:
Facility Name
University of California San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Colorado Cancer Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Miami Health System
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Orlando Health UF Health Cancer Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Moffitt McKinley Outpatient Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Winship Cancer Institute of Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
John Theurer Cancer Center at Hackensack Univeristy Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
University Of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Prisma Health Cancer Institute
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Chris O'Brien Lifehouse
City
Camperdown
State/Province
New South Wales
Country
Australia
Facility Name
Southern Medical Day Care Centre
City
Wollongong
State/Province
New South Wales
Country
Australia
Facility Name
Tasman Oncology Research Ltd
City
Southport
State/Province
Queensland
Country
Australia
Facility Name
Monash Medical Centre
City
Clayton
State/Province
Victoria
Country
Australia
Facility Name
Peter MacCallum Cancer Centre
City
Melbourne
State/Province
Victoria
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
State/Province
Western Australia
Country
Australia
Facility Name
Multiprofile Hospital for Active Treatment - Uni Hospital" OOD Department of Medical Oncology
City
Panagyurishte
Country
Bulgaria
Facility Name
"Complex Oncology Center - Plovdiv" EOOD Department of Medical Oncology and Cutaneous Cancer Diseases "
City
Plovdiv
Country
Bulgaria
Facility Name
Sunnybrook Health Science Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
CHU Besancon - Hopital Jean Minjoz
City
Besancon
ZIP/Postal Code
25000
Country
France
Facility Name
CHU Dijon Hopital F. Mitterrand Service de Dermatologie - UMAC
City
Dijon
Country
France
Facility Name
CHU de Grenoble - Hopital A Michallon
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
CHRU de Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Centre Léon Bérard
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Service de Dermatologie et Cancerologie Cutanee Hopital de la Timone
City
Marseille
Country
France
Facility Name
CHU Nice - Hopital de l'Archet 2
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
Hospital Saint Louis
City
Paris
Country
France
Facility Name
Hospices Civils de Lyon
City
Pierre-Bénite
ZIP/Postal Code
69310
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Charite Universitatsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Universitatsklinikum Essen
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Universitätsklinikum Eppendorf
City
Hamburg
ZIP/Postal Code
20251
Country
Germany
Facility Name
Universitatsklinikum Heidelberg: National Centre for Tumour Diseases (NCT)
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
University Hospital Munchen (LMU)
City
München
ZIP/Postal Code
80337
Country
Germany
Facility Name
Universitatsklinikum Tubingen Zentrum fur Dermatoonkologie
City
Tübingen
ZIP/Postal Code
72074
Country
Germany
Facility Name
Hippocratio General Hospital of Athens
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Attiko University Hospital
City
Athens
ZIP/Postal Code
12462
Country
Greece
Facility Name
Andreas Syggros Hospital
City
Athens
ZIP/Postal Code
16121
Country
Greece
Facility Name
General Hospital of Athens "Laiko", 1st Department of Medicine, University of Athens Medical School
City
Athens
Country
Greece
Facility Name
Istituto Tumori "Giovanni Paolo II" IRCCS
City
Bari
Country
Italy
Facility Name
Uniwersyteckie Centrum Kliniczne; Centrum Leczenia Czerniaka w Gdańsku
City
Gdańsk
ZIP/Postal Code
80-214
Country
Poland
Facility Name
Narodowy Instytut Onkologii; Panstwowy Instytut Badawczy Oddzial w Krakowie
City
Kraków
ZIP/Postal Code
31-115
Country
Poland
Facility Name
Narodowy Instytut Onkologii; Panstwowy Instytut Badawczy
City
Warsaw
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Klinika Dermatologii, Wenerologii i Alergologii, USK im J. Mikulicza-Radeckiego we Wroclawiu
City
Wrocław
Country
Poland
Facility Name
Hospital Clinic Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Fundación Jiménez Díaz
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Virgen de la Arrixaca
City
Murcia
ZIP/Postal Code
30120
Country
Spain
Facility Name
Clinica Universitaria de Navarra
City
Pamplona
Country
Spain
Facility Name
Hospital General Universitario De Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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

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