Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma
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ClinicalTrials.gov Identifier: NCT03969004 |
Recruitment Status :
Active, not recruiting
First Posted : May 31, 2019
Last Update Posted : February 8, 2021
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Sponsor:
Regeneron Pharmaceuticals
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
Tracking Information | |||||||||||||||||||||
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First Submitted Date ICMJE | May 6, 2019 | ||||||||||||||||||||
First Posted Date ICMJE | May 31, 2019 | ||||||||||||||||||||
Last Update Posted Date | February 8, 2021 | ||||||||||||||||||||
Actual Study Start Date ICMJE | June 4, 2019 | ||||||||||||||||||||
Estimated Primary Completion Date | October 16, 2023 (Final data collection date for primary outcome measure) | ||||||||||||||||||||
Current Primary Outcome Measures ICMJE |
DFS defined as time from randomization to the first documented disease recurrence (local, regional and/or distant); or death due to any cause. [ Time Frame: Up to 54 months ] For patients who do not have a tumor recurrence or death, DFS will be censored on the date of last disease assessment.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||
Change History | |||||||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||||||
Descriptive Information | |||||||||||||||||||||
Brief Title ICMJE | Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma | ||||||||||||||||||||
Official Title ICMJE | 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 | ||||||||||||||||||||
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:
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Detailed Description | Not Provided | ||||||||||||||||||||
Study Type ICMJE | Interventional | ||||||||||||||||||||
Study Phase ICMJE | Phase 3 | ||||||||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Cutaneous Squamous Cell Carcinoma | ||||||||||||||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||||||||||||||||
Actual Enrollment ICMJE |
75 | ||||||||||||||||||||
Original Estimated Enrollment ICMJE |
412 | ||||||||||||||||||||
Estimated Study Completion Date ICMJE | February 11, 2026 | ||||||||||||||||||||
Estimated Primary Completion Date | October 16, 2023 (Final data collection date for primary outcome measure) | ||||||||||||||||||||
Eligibility Criteria ICMJE | Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria apply |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||||
Listed Location Countries ICMJE | Australia, Belgium, Brazil, Canada, France, Germany, Greece, Ireland, Italy, Japan, New Zealand, Poland, Russian Federation, Spain, United Kingdom, United States | ||||||||||||||||||||
Removed Location Countries | |||||||||||||||||||||
Administrative Information | |||||||||||||||||||||
NCT Number ICMJE | NCT03969004 | ||||||||||||||||||||
Other Study ID Numbers ICMJE | R2810-ONC-1788 2019-000566-38 ( EudraCT Number ) |
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Has Data Monitoring Committee | Yes | ||||||||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Regeneron Pharmaceuticals | ||||||||||||||||||||
Study Sponsor ICMJE | Regeneron Pharmaceuticals | ||||||||||||||||||||
Collaborators ICMJE | Sanofi | ||||||||||||||||||||
Investigators ICMJE |
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PRS Account | Regeneron Pharmaceuticals | ||||||||||||||||||||
Verification Date | April 2020 | ||||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |