Register a trial

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04154943




Registration number
NCT04154943
Ethics application status
Date submitted
5/11/2019
Date registered
7/11/2019

Titles & IDs
Public title
Study of Cemiplimab in Patients With Type of Skin Cancer Stage II to IV Cutaneous Squamous Cell Carcinoma
Scientific title
A Phase 2 Study of Neoadjuvant Cemiplimab for Stage II to IV (M0) Cutaneous Squamous Cell Carcinoma (CSCC)
Secondary ID [1] 0 0
2019-003007-35
Secondary ID [2] 0 0
R2810-ONC-1901
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

Experimental: Cemiplimab - Will receive IV infusion Q3W


Treatment: Drugs: Cemiplimab
Intravenous (IV) infusion every 3 weeks (Q3W)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Pathologic Complete Response (pCR) as Assessed by Independent Central Pathology Review
Timepoint [1] 0 0
Up to 12 weeks
Secondary outcome [1] 0 0
Number of Participants With Major Pathologic Response (mPR) as Assessed by Independent Central Pathology Review
Timepoint [1] 0 0
Up to 12 Weeks
Secondary outcome [2] 0 0
Number of Participants With Pathologic Complete Response (pCR) as Assessed by Local Pathology Review
Timepoint [2] 0 0
Up to 12 weeks
Secondary outcome [3] 0 0
Number of Participants With Major Pathologic Response (mPR) as Assessed by Local Pathology Review
Timepoint [3] 0 0
Up to 12 Weeks
Secondary outcome [4] 0 0
Percentage of Participants With Objective Response Rate (ORR) Prior to Surgery, According to Investigator Assessment Using RECIST 1.1
Timepoint [4] 0 0
Up to 12 Weeks
Secondary outcome [5] 0 0
Number of Participants With Planned and Actual Surgery After Neoadjuvant Cemiplimab
Timepoint [5] 0 0
Up to 12 Weeks
Secondary outcome [6] 0 0
Number of Participants With Planned and Actual Post-Surgical Management
Timepoint [6] 0 0
Up to 14 Weeks
Secondary outcome [7] 0 0
Event Free Survival (EFS)
Timepoint [7] 0 0
Up to 50 Months
Secondary outcome [8] 0 0
Disease Free Survival (DFS)
Timepoint [8] 0 0
Up to 47 Months
Secondary outcome [9] 0 0
Overall Survival (OS)
Timepoint [9] 0 0
Up to 50 Months
Secondary outcome [10] 0 0
Incidence of Adverse Events (AEs)
Timepoint [10] 0 0
Up to 52 Months
Secondary outcome [11] 0 0
Incidence of Serious Adverse Events (SAEs)
Timepoint [11] 0 0
Up to 52 Months
Secondary outcome [12] 0 0
Incidence of Deaths
Timepoint [12] 0 0
Up to 52 Months
Secondary outcome [13] 0 0
Incidence of Laboratory Abnormalities
Timepoint [13] 0 0
Up to 52 Months

Eligibility
Key inclusion criteria
Key Inclusion Criteria

* Stage II to IV (M0) CSCC, for which surgery would be recommended in routine clinical practice. For stage II patients, lesion must be =3 cm at the longest diameter.
* At least 1 lesion that is measurable by RECIST 1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate organ, bone marrow function, and hepatic 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
Exclusion Criteria

* Solid malignancy within 5 years of the projected enrollment date, or hematologic malignancy (including chronic lymphocytic leukemia [CLL]) at any time
* Distant metastatic disease (M1), visceral and/or distant nodal
* Prior radiation therapy for CSCC
* Patients with a condition requiring corticosteroid therapy (>10 mg prednisone/day or equivalent) within 14 days of the first dose of study drug.
* Patients with active, known, or suspected autoimmune disease that has required systemic therapy within 5 years of the projected enrollment date.
* History of interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management.
* Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus (HBV or HCV) infection; or diagnosis of immunodeficiency
* Active tuberculosis

NOTE: Other protocol-defined Inclusion/Exclusion Criteria apply

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
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
Single group
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
10/03/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
5/09/2025
Actual
Sample size
Target
Accrual to date
Final
79
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Regeneron Study Site - St Leonards
Recruitment hospital [2] 0 0
Regeneron Study Site - Herston
Recruitment hospital [3] 0 0
Regeneron Study Site - Melbourne
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
3000 - Melbourne
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
District of Columbia
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
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Nebraska
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
Germany
State/province [12] 0 0
Dresden
Country [13] 0 0
Germany
State/province [13] 0 0
Essen
Country [14] 0 0
Germany
State/province [14] 0 0
Kiel
Country [15] 0 0
Germany
State/province [15] 0 0
Tübingen

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
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
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)?
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?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04154943