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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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Scientific title
A Phase 2 Study of Neoadjuvant Cemiplimab for Stage II to IV (M0) Cutaneous Squamous Cell Carcinoma (CSCC)
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Secondary ID [1]
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2019-003007-35
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Secondary ID [2]
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R2810-ONC-1901
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cutaneous Squamous Cell Carcinoma
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Condition category
Condition code
Cancer
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Non melanoma skin cancer
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Cancer
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Kidney
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Intervention/exposure
Study type
Interventional
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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)
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Pathologic Complete Response (pCR) as Assessed by Independent Central Pathology Review
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Assessment method [1]
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Timepoint [1]
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Up to 12 weeks
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Secondary outcome [1]
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Number of Participants With Major Pathologic Response (mPR) as Assessed by Independent Central Pathology Review
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Assessment method [1]
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Timepoint [1]
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Up to 12 Weeks
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Secondary outcome [2]
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Number of Participants With Pathologic Complete Response (pCR) as Assessed by Local Pathology Review
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Assessment method [2]
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Timepoint [2]
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Up to 12 weeks
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Secondary outcome [3]
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Number of Participants With Major Pathologic Response (mPR) as Assessed by Local Pathology Review
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Assessment method [3]
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Timepoint [3]
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Up to 12 Weeks
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Secondary outcome [4]
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Percentage of Participants With Objective Response Rate (ORR) Prior to Surgery, According to Investigator Assessment Using RECIST 1.1
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Assessment method [4]
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Timepoint [4]
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Up to 12 Weeks
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Secondary outcome [5]
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Number of Participants With Planned and Actual Surgery After Neoadjuvant Cemiplimab
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Assessment method [5]
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Timepoint [5]
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Up to 12 Weeks
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Secondary outcome [6]
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Number of Participants With Planned and Actual Post-Surgical Management
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Assessment method [6]
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Timepoint [6]
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Up to 14 Weeks
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Secondary outcome [7]
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Event Free Survival (EFS)
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Assessment method [7]
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Timepoint [7]
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Up to 50 Months
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Secondary outcome [8]
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Disease Free Survival (DFS)
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Assessment method [8]
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Timepoint [8]
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Up to 47 Months
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Secondary outcome [9]
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Overall Survival (OS)
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Assessment method [9]
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Timepoint [9]
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Up to 50 Months
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Secondary outcome [10]
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Incidence of Adverse Events (AEs)
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Assessment method [10]
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Timepoint [10]
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Up to 52 Months
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Secondary outcome [11]
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Incidence of Serious Adverse Events (SAEs)
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Assessment method [11]
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Timepoint [11]
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Up to 52 Months
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Secondary outcome [12]
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Incidence of Deaths
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Assessment method [12]
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Timepoint [12]
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Up to 52 Months
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Secondary outcome [13]
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Incidence of Laboratory Abnormalities
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Assessment method [13]
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Timepoint [13]
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Up to 52 Months
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
10/03/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
5/09/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
79
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Regeneron Study Site - St Leonards
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Recruitment hospital [2]
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Regeneron Study Site - Herston
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Recruitment hospital [3]
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Regeneron Study Site - Melbourne
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Recruitment postcode(s) [1]
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2065 - St Leonards
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Recruitment postcode(s) [2]
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4029 - Herston
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Recruitment postcode(s) [3]
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3000 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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District of Columbia
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Country [3]
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United States of America
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State/province [3]
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Florida
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Country [4]
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United States of America
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State/province [4]
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Maryland
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Country [5]
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United States of America
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State/province [5]
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Massachusetts
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Country [6]
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United States of America
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State/province [6]
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Michigan
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Country [7]
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United States of America
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State/province [7]
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Nebraska
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Country [8]
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United States of America
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State/province [8]
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New York
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Country [9]
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United States of America
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State/province [9]
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North Carolina
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Country [10]
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United States of America
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State/province [10]
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Ohio
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Country [11]
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United States of America
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State/province [11]
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Texas
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Country [12]
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Germany
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State/province [12]
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Dresden
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Country [13]
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Germany
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State/province [13]
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Essen
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Country [14]
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Germany
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State/province [14]
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Kiel
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Country [15]
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Germany
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State/province [15]
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Tübingen
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Regeneron Pharmaceuticals
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Sanofi
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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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
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04154943
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Clinical Trial Management
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Address
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Regeneron Pharmaceuticals
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04154943
Download to PDF