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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03969004




Registration number
NCT03969004
Ethics application status
Date submitted
6/05/2019
Date registered
31/05/2019

Titles & IDs
Public title
Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma
Scientific title
A Randomized, Placebo-Controlled, Double-Blind Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma
Secondary ID [1] 0 0
2019-000566-38
Secondary ID [2] 0 0
R2810-ONC-1788
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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: Drugs - Placebo

Experimental: Cemiplimab -

Placebo comparator: Placebo -


Treatment: Drugs: Cemiplimab
Intravenous (IV) infusion over 30 minutes

Treatment: Drugs: Placebo
Intravenous (IV) infusion over 30 minutes
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
DFS defined as time from randomization to the first documented disease recurrence (local, regional and/or distant); or death due to any cause.
Timepoint [1] 0 0
Up to 54 months
Secondary outcome [1] 0 0
Overall survival (OS), defined as time from randomization to the date of death. A patient who has not died will be censored on the last known date as alive.
Timepoint [1] 0 0
Up to 78 months
Secondary outcome [2] 0 0
FFLRR defined as time from randomization to the date of first locoregional recurrence (LRR). Patients who died without a preceding LRR will be censored on the date of death.
Timepoint [2] 0 0
Up to 54 months
Secondary outcome [3] 0 0
Freedom from distant recurrence (FFDR), defined as time from randomization to the date of first distant recurrence (DR). Patients who died without a preceding DR will be censored on the date of death.
Timepoint [3] 0 0
Up to 54 months
Secondary outcome [4] 0 0
Cumulative occurrence of second primary cutaneous squamous cell carcinoma tumor (SPTs) for each patient from randomization to occurrence of first primary endpoint event or end of study.
Timepoint [4] 0 0
Up to 54 months
Secondary outcome [5] 0 0
Incidence and severity of treatment-emergent adverse events (TEAE)
Timepoint [5] 0 0
Up to 78 months
Secondary outcome [6] 0 0
Incidence of deaths
Timepoint [6] 0 0
Up to 78 months
Secondary outcome [7] 0 0
Incidence of laboratory abnormalities
Timepoint [7] 0 0
Up to 78 months
Secondary outcome [8] 0 0
Cemiplimab concentrations in serum
Timepoint [8] 0 0
Up to 78 months
Secondary outcome [9] 0 0
Anti-drug antibodies (ADA) in serum
Timepoint [9] 0 0
Up to 78 months

Eligibility
Key inclusion criteria
Key

* For Japan only, men and women =21 years old
* Patient with resection of pathologically confirmed CSCC (primary CSCC lesion only, or primary CSCC with nodal involvement, or CSCC nodal metastasis with known primary CSCC lesion previously treated within the draining lymph node echelon), with macroscopic gross resection of all disease
* High risk CSCC, as defined in the protocol
* Completion of curative intent post-operative radiation therapy (RT) within 2 to 10 weeks of randomization
* Eastern Cooperative Oncology Group performance status (ECOG PS) =1
* Adequate hepatic, renal, and bone marrow function as defined in the protocol

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Squamous cell carcinomas (SCCs) arising in non-cutaneous sites as defined in the protocol
* Concurrent malignancy other than localized CSCC and/or history of malignancy other than localized CSCC within 3 years of date of randomization as defined in the protocol
* Patients with hematologic malignancies (note: patients with chronic lymphocytic leukemia (CLL) are not excluded if they have not required systemic therapy for CLL within 6 months of enrollment)
* Patients with history of distantly metastatic CSCC (visceral or distant nodal), unless the disease-free interval is at least 3 years (regional nodal involvement of disease in draining lymph node basin that was resected and radiated prior to enrollment will not be exclusionary)
* Ongoing or recent (within 5 years of randomization date) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events (irAEs). The following are not exclusionary: vitiligo, childhood asthma that has resolved, type 1 diabetes, residual hypothyroidism that required only hormone replacement, or psoriasis that does not require systemic treatment.
* Has had prior systemic anti-cancer immunotherapy for CSCC

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/06/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/01/2028
Actual
Sample size
Target
412
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,North South WalesQLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
The Border Cancer Hospital Dispensary - Albury Wodonga Regional Cancer Centre - Albury
Recruitment hospital [2] 0 0
Coffs Harbour Health Campus - Coffs Harbour
Recruitment hospital [3] 0 0
Central Coast Cancer Centre-Gosford and Wyong Hospitals - Gosford
Recruitment hospital [4] 0 0
St George Hospital - Kogarah
Recruitment hospital [5] 0 0
North Shore Private Hospital - St Leonards
Recruitment hospital [6] 0 0
Cancer Care Associates (CCA) Riverina Cancer Care Centre (RCCC) - Wagga Wagga
Recruitment hospital [7] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [8] 0 0
Westmead Hospital - Westmead
Recruitment hospital [9] 0 0
Illawarra Cancer Care Centre (ICCC) - Wollongong
Recruitment hospital [10] 0 0
Melanoma Institute - Sydney
Recruitment hospital [11] 0 0
Wide Bay Hospital and Health Service - Cancer Care Services - Bundaberg
Recruitment hospital [12] 0 0
Cairns Hospital - Cairns
Recruitment hospital [13] 0 0
The Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [14] 0 0
ICON Cancer Care - Southport
Recruitment hospital [15] 0 0
Toowoomba Hospital - Toowoomba
Recruitment hospital [16] 0 0
Genesis Care Tugun - John Flynn Private Hospital - Tugun
Recruitment hospital [17] 0 0
Wide Bay Hospital and Health Service - Cancer Care Services - Hervey Bay - Urraween
Recruitment hospital [18] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [19] 0 0
Ashford Cancer Centre Research-Adelaide Cancer Centre - Kurralta Park
Recruitment hospital [20] 0 0
Royal Hobart Hospital-Hobart Hospital - Hobart
Recruitment hospital [21] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [22] 0 0
Bendigo Health - Bendigo
Recruitment hospital [23] 0 0
St. Vincent's Hospital - Fitzroy
Recruitment hospital [24] 0 0
Olivia Newton -John Cancer Wellness & Research Centre - Heidelberg
Recruitment hospital [25] 0 0
Peter Maccallum Cancer Centre (PMCC) - Melbourne
Recruitment hospital [26] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [27] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [28] 0 0
Liverpool Cancer Therapy Center - Liverpool
Recruitment hospital [29] 0 0
University of New South Wales (UNSW) - Liverpool Hospital - Liverpool Cancer Therapy Centre - Liverpool
Recruitment hospital [30] 0 0
The Townsville Hospital and Health Service - Townsville
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [3] 0 0
2250 - Gosford
Recruitment postcode(s) [4] 0 0
2217 - Kogarah
Recruitment postcode(s) [5] 0 0
2065 - St Leonards
Recruitment postcode(s) [6] 0 0
2650 - Wagga Wagga
Recruitment postcode(s) [7] 0 0
2298 - Waratah
Recruitment postcode(s) [8] 0 0
2145 - Westmead
Recruitment postcode(s) [9] 0 0
2500 - Wollongong
Recruitment postcode(s) [10] 0 0
2060 - Sydney
Recruitment postcode(s) [11] 0 0
4670 - Bundaberg
Recruitment postcode(s) [12] 0 0
4870 - Cairns
Recruitment postcode(s) [13] 0 0
4029 - Herston
Recruitment postcode(s) [14] 0 0
4215 - Southport
Recruitment postcode(s) [15] 0 0
4350 - Toowoomba
Recruitment postcode(s) [16] 0 0
4224 - Tugun
Recruitment postcode(s) [17] 0 0
4655 - Urraween
Recruitment postcode(s) [18] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [19] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [20] 0 0
7000 - Hobart
Recruitment postcode(s) [21] 0 0
3550 - Bendigo
Recruitment postcode(s) [22] 0 0
3065 - Fitzroy
Recruitment postcode(s) [23] 0 0
3084 - Heidelberg
Recruitment postcode(s) [24] 0 0
3000 - Melbourne
Recruitment postcode(s) [25] 0 0
6009 - Nedlands
Recruitment postcode(s) [26] 0 0
5000 - Adelaide
Recruitment postcode(s) [27] 0 0
2170 - Liverpool
Recruitment postcode(s) [28] 0 0
4814 - Townsville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
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California
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United States of America
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District of Columbia
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United States of America
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Florida
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United States of America
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Georgia
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Illinois
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Kentucky
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Maryland
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Massachusetts
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Michigan
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Missouri
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Nebraska
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New Jersey
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New York
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United States of America
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Ohio
Country [16] 0 0
United States of America
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Pennsylvania
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United States of America
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Tennessee
Country [18] 0 0
United States of America
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Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Virginia
Country [20] 0 0
Belgium
State/province [20] 0 0
Vlaams-Brabant
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Belgium
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Bruxelles
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Brazil
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Minas Gerais
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Brazil
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Porte Alegre
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Rio De Janiero
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Santa Catarina
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Sao Paulo
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Brazil
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Florianopolis
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Canada
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Ontario
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Dijon Cedex
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Bordeaux
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Paris
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Pierre Benite Cedex
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Rouen cedex
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Villejuif Cedex
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Germany
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Baden-Württemberg
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Rheinland-Pfalz
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Berlin
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Buxtehude
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Dresden
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Koeln
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Muenchen
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Tuebingen
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Greece
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Attiki
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Leinster
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Cork
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Bologna
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Firenze
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L'Aquila
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Milan
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Napoli
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Rome
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Rozzano
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Torino
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Osaka
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Auckland
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New Zealand
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Palmerston North
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Poland
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Gliwice
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Krakow
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Poznan
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Warsaw
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Warszawa
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Russian Federation
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Krasnodar Krai
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Russian Federation
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Stavropol Region
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Russian Federation
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Magnitogorsk
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Russian Federation
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Moscow
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Russian Federation
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Omsk
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Russian Federation
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Rostov-Na-Donu
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Russian Federation
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Saint Petersburg
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Spain
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Cataluna
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Madrid
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Badalona
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Barcelona
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Majadahonda
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Salamanca
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Sevilla
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Spain
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Valencia
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United Kingdom
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Devon
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Somerset
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Cardiff
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Edinburgh
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Glasgow
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London
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United Kingdom
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Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Regeneron Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Clinical Trial Management
Address 0 0
Regeneron Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Clinical Trials Administrator
Address 0 0
Country 0 0
Phone 0 0
844-734-6643
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR), Analytic code
When will data be available (start and end dates)?
Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.
Available to whom?
Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency \[EMA\], Pharmaceuticals and Medical Devices Agency \[PMDA\], etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


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/NCT03969004