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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04050436




Registration number
NCT04050436
Ethics application status
Date submitted
2/08/2019
Date registered
8/08/2019

Titles & IDs
Public title
Study Evaluating Cemiplimab Alone and Combined With RP1 in Treating Advanced Squamous Skin Cancer
Scientific 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
Secondary ID [1] 0 0
RPL-002-18
Universal Trial Number (UTN)
Trial acronym
CERPASS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cutaneous Squamous Cell Carcinoma 0 0
Advanced Cutaneous Squamous Cell Carcinoma 0 0
Metastatic Cutaneous Squamous Cell Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Cemiplimab
Treatment: Other - RP1

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

Active comparator: Cemiplimab - Cemiplimab administered intravenously as a single therapy every 3 weeks


Treatment: Drugs: Cemiplimab
Cemiplimab administered intravenously

Treatment: Other: RP1
RP1 administered intratumorally
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Response Rate (ORR) according to blinded independent review
Timepoint [1] 0 0
up to 5 years
Primary outcome [2] 0 0
Complete Response Rate (CRR) according to blinded independent review
Timepoint [2] 0 0
up to 5 years
Secondary outcome [1] 0 0
Progression Free Survival (PFS) by blinded independent review.
Timepoint [1] 0 0
up to 5 years
Secondary outcome [2] 0 0
ORR/CRR by investigator assessment and blinded independent review
Timepoint [2] 0 0
up to 5 years
Secondary outcome [3] 0 0
ORR/CRR for patients with metastatic or locally advanced disease according to investigator review and blinded independent review
Timepoint [3] 0 0
up to 5 years
Secondary outcome [4] 0 0
ORR/CRR for patients who have and have not previously received systemic CSCC-directed therapy and blinded independent review
Timepoint [4] 0 0
up to 5 years
Secondary outcome [5] 0 0
Duration of Response (DOR) per investigator review and blinded independent review
Timepoint [5] 0 0
up to 5 years
Secondary outcome [6] 0 0
Progression-free Survival (PFS) per investigator review
Timepoint [6] 0 0
up to 5 years
Secondary outcome [7] 0 0
Overall Survival (OS)
Timepoint [7] 0 0
up to 5 years
Secondary outcome [8] 0 0
3-year survival
Timepoint [8] 0 0
3 years
Secondary outcome [9] 0 0
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)
Timepoint [9] 0 0
approximately 30 months
Secondary outcome [10] 0 0
Evaluation of the safety and tolerability of cemiplimab alone and combined with RP1 as assessed via adverse events (AEs)
Timepoint [10] 0 0
approximately 26 months

Eligibility
Key inclusion criteria
Key

* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/10/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2025
Actual
Sample size
Target
Accrual to date
Final
231
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
Cancer Care Wollongong Pty Limited - Wollongong
Recruitment hospital [3] 0 0
Tasman Oncology Research Ltd - Southport
Recruitment hospital [4] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [5] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [6] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [7] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
- Camperdown
Recruitment postcode(s) [2] 0 0
- Wollongong
Recruitment postcode(s) [3] 0 0
- Southport
Recruitment postcode(s) [4] 0 0
- Clayton
Recruitment postcode(s) [5] 0 0
- Melbourne
Recruitment postcode(s) [6] 0 0
- Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
New Jersey
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
South Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
Bulgaria
State/province [11] 0 0
Panagyurishte
Country [12] 0 0
Bulgaria
State/province [12] 0 0
Plovdiv
Country [13] 0 0
Canada
State/province [13] 0 0
Ontario
Country [14] 0 0
France
State/province [14] 0 0
Besancon
Country [15] 0 0
France
State/province [15] 0 0
Dijon
Country [16] 0 0
France
State/province [16] 0 0
La Tronche
Country [17] 0 0
France
State/province [17] 0 0
Lille
Country [18] 0 0
France
State/province [18] 0 0
Lyon
Country [19] 0 0
France
State/province [19] 0 0
Marseille
Country [20] 0 0
France
State/province [20] 0 0
Nice
Country [21] 0 0
France
State/province [21] 0 0
Paris
Country [22] 0 0
France
State/province [22] 0 0
Pierre-Bénite
Country [23] 0 0
France
State/province [23] 0 0
Villejuif
Country [24] 0 0
Germany
State/province [24] 0 0
Berlin
Country [25] 0 0
Germany
State/province [25] 0 0
Essen
Country [26] 0 0
Germany
State/province [26] 0 0
Hamburg
Country [27] 0 0
Germany
State/province [27] 0 0
Heidelberg
Country [28] 0 0
Germany
State/province [28] 0 0
München
Country [29] 0 0
Germany
State/province [29] 0 0
Tübingen
Country [30] 0 0
Greece
State/province [30] 0 0
Athens
Country [31] 0 0
Italy
State/province [31] 0 0
Bari
Country [32] 0 0
Poland
State/province [32] 0 0
Gdansk
Country [33] 0 0
Poland
State/province [33] 0 0
Kraków
Country [34] 0 0
Poland
State/province [34] 0 0
Warsaw
Country [35] 0 0
Poland
State/province [35] 0 0
Wroclaw
Country [36] 0 0
Spain
State/province [36] 0 0
Barcelona
Country [37] 0 0
Spain
State/province [37] 0 0
Madrid
Country [38] 0 0
Spain
State/province [38] 0 0
Murcia
Country [39] 0 0
Spain
State/province [39] 0 0
Pamplona
Country [40] 0 0
Spain
State/province [40] 0 0
Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Replimune Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Regeneron Pharmaceuticals
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sumera Raoof, MD
Address 0 0
Lead Medical Monitor
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04050436