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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
Date last updated
8/02/2023

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
Not applicable
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
The primary objective of the study is to evaluate the efficacy of neoadjuvant cemiplimab as measured by Pathologic complete response (pCR) rate per independent central pathology review.

The secondary objectives of the study are:

* To evaluate the efficacy of neoadjuvant cemiplimab on measures of disease response, including:
* Major pathologic response (mPR) rate per independent central pathology review
* pCR rate and mPR rate per local pathology review
* ORR prior to surgery, according to local assessment using RECIST 1.1
* To evaluate the efficacy of neoadjuvant cemiplimab on event free survival (EFS), disease free survival (DFS), and overall survival (OS)
* To evaluate the safety profile of neoadjuvant cemiplimab
* To assess change in surgical plan (ablative and reconstructive procedures) from the screening period to definitive surgery, both according to investigator review and independent surgical expert review
* To assess change in post-surgical management plan (radiation, chemoradiation, or observation) from the screening period to post-surgery pathology review, both according to investigator review and independent surgical expert review
Trial website
https://clinicaltrials.gov/study/NCT04154943
Trial related presentations / publications
Gross ND, Miller DM, Khushalani NI, Divi V, Ruiz ES, Lipson EJ, Meier F, Su YB, Swiecicki PL, Atlas J, Geiger JL, Hauschild A, Choe JH, Hughes BGM, Schadendorf D, Patel VA, Homsi J, Taube JM, Lim AM, Ferrarotto R, Kaufman HL, Seebach F, Lowy I, Yoo SY, Mathias M, Fenech K, Han H, Fury MG, Rischin D. Neoadjuvant Cemiplimab for Stage II to IV Cutaneous Squamous-Cell Carcinoma. N Engl J Med. 2022 Oct 27;387(17):1557-1568. doi: 10.1056/NEJMoa2209813. Epub 2022 Sep 12.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04154943