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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03969004
Ethics application status
Date submitted
6/05/2019
Date registered
31/05/2019
Date last updated
22/04/2020

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. - For patients who do not have a tumor recurrence or death, DFS will be censored on the date of last disease assessment.
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. - For patients who do not have a LRR or death, FFLRR will be censored on the date of last disease assessment.
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. - For patients who do not have a DR or death, FFDR will be censored on the date of last disease assessment.
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

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 6
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
Gender
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 (eg, chronic lymphocytic leukemia (CLL))

- 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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC,WA
Recruitment hospital [1] 0 0
Regeneron Research Site - Albury
Recruitment hospital [2] 0 0
Regeneron Research Site - Kogarah
Recruitment hospital [3] 0 0
Regeneron Research Sites - Wagga Wagga
Recruitment hospital [4] 0 0
Regeneron Research Facility - Waratah
Recruitment hospital [5] 0 0
Regeneron Research Site - Westmead
Recruitment hospital [6] 0 0
Regeneron Research Site - Wollongong
Recruitment hospital [7] 0 0
Regeneron Research Facility - Herston
Recruitment hospital [8] 0 0
Regeneron Research Site - Woolloongabba
Recruitment hospital [9] 0 0
Regeneron Research Facility - Hobart
Recruitment hospital [10] 0 0
Regeneron Research Site - Heidelberg
Recruitment hospital [11] 0 0
Regeneron Research Site - Nedlands
Recruitment hospital [12] 0 0
Regeneron Research Site - Melbourne
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2650 - Wagga Wagga
Recruitment postcode(s) [4] 0 0
2298 - Waratah
Recruitment postcode(s) [5] 0 0
2145 - Westmead
Recruitment postcode(s) [6] 0 0
2500 - Wollongong
Recruitment postcode(s) [7] 0 0
4029 - Herston
Recruitment postcode(s) [8] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [9] 0 0
7000 - Hobart
Recruitment postcode(s) [10] 0 0
3084 - Heidelberg
Recruitment postcode(s) [11] 0 0
6009 - Nedlands
Recruitment postcode(s) [12] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Nebraska
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Virginia
Country [14] 0 0
Belgium
State/province [14] 0 0
Vlaams-Brabant
Country [15] 0 0
Belgium
State/province [15] 0 0
Bruxelles
Country [16] 0 0
Brazil
State/province [16] 0 0
Rio Grande Do Sul
Country [17] 0 0
Brazil
State/province [17] 0 0
Santa Catarina
Country [18] 0 0
Brazil
State/province [18] 0 0
Florianopolis
Country [19] 0 0
Canada
State/province [19] 0 0
Ontario
Country [20] 0 0
France
State/province [20] 0 0
Dijon Cedex
Country [21] 0 0
France
State/province [21] 0 0
Bordeaux
Country [22] 0 0
France
State/province [22] 0 0
Boulogne Billancourt
Country [23] 0 0
France
State/province [23] 0 0
La Tronche
Country [24] 0 0
France
State/province [24] 0 0
Lille
Country [25] 0 0
France
State/province [25] 0 0
Nantes
Country [26] 0 0
France
State/province [26] 0 0
Paris Cedex 10
Country [27] 0 0
France
State/province [27] 0 0
Pierre Benite Cedex
Country [28] 0 0
France
State/province [28] 0 0
Rouen cedex
Country [29] 0 0
France
State/province [29] 0 0
Villejuif Cedex
Country [30] 0 0
Germany
State/province [30] 0 0
Baden-Württemberg
Country [31] 0 0
Germany
State/province [31] 0 0
Buxtehude
Country [32] 0 0
Germany
State/province [32] 0 0
Dresden
Country [33] 0 0
Germany
State/province [33] 0 0
Essen
Country [34] 0 0
Germany
State/province [34] 0 0
Kiel
Country [35] 0 0
Ireland
State/province [35] 0 0
Leinster
Country [36] 0 0
Ireland
State/province [36] 0 0
Cork
Country [37] 0 0
Italy
State/province [37] 0 0
Brescia
Country [38] 0 0
Italy
State/province [38] 0 0
Firenze
Country [39] 0 0
Italy
State/province [39] 0 0
Napoli
Country [40] 0 0
Japan
State/province [40] 0 0
Shizuoka
Country [41] 0 0
New Zealand
State/province [41] 0 0
Auckland
Country [42] 0 0
New Zealand
State/province [42] 0 0
Palmerston North
Country [43] 0 0
Poland
State/province [43] 0 0
Silesia
Country [44] 0 0
Poland
State/province [44] 0 0
Kraków
Country [45] 0 0
Poland
State/province [45] 0 0
Poznan
Country [46] 0 0
Russian Federation
State/province [46] 0 0
Krasnodar Krai
Country [47] 0 0
Russian Federation
State/province [47] 0 0
Stavropol Region
Country [48] 0 0
Russian Federation
State/province [48] 0 0
Magnitogorsk
Country [49] 0 0
Russian Federation
State/province [49] 0 0
Omsk
Country [50] 0 0
Russian Federation
State/province [50] 0 0
Rostov-Na-Donu
Country [51] 0 0
Russian Federation
State/province [51] 0 0
Saint-Petersburg
Country [52] 0 0
Spain
State/province [52] 0 0
Cataluna
Country [53] 0 0
Spain
State/province [53] 0 0
Madrid
Country [54] 0 0
Spain
State/province [54] 0 0
Badalona
Country [55] 0 0
Spain
State/province [55] 0 0
Barcelona
Country [56] 0 0
Spain
State/province [56] 0 0
Valencia
Country [57] 0 0
United Kingdom
State/province [57] 0 0
Scotland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Regeneron Pharmaceuticals
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Sanofi
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective of the study is to compare disease-free survival (DFS) of patients with
high-risk cutaneous squamous cell carcinoma (CSCC) treated with adjuvant cemiplimab, versus
those treated with placebo, after surgery and radiation therapy (RT).

The secondary objectives of the study are:

- To compare the overall survival (OS) of high-risk CSCC patients treated with adjuvant
cemiplimab, versus those treated with placebo, after surgery and RT

- To compare the effect of adjuvant cemiplimab with that of placebo on patients' freedom
from locoregional recurrence (FFLRR) after surgery and RT

- To compare the effect of adjuvant cemiplimab with that of placebo on patients' freedom
from distant recurrence (FFDR) after surgery and RT

- To compare the effect of adjuvant cemiplimab with that of placebo on the cumulative
incidence of second primary CSCC tumors (SPTs) after surgery and RT

- To evaluate the safety of adjuvant cemiplimab and that of placebo in high-risk CSCC
patients after surgery and RT
Trial website
https://clinicaltrials.gov/show/NCT03969004
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
clinicaltrials@regeneron.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03969004