Comparative Efficacy of Cemiplimab to Historical Standard of Care in France
NCT ID: NCT05302297
Last Updated: 2022-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
305 participants
OBSERVATIONAL
2022-01-17
2022-09-30
Brief Summary
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-Assess the effectiveness of cemiplimab versus other available systemic therapies in patients up to 2018 or say historical system organ class (SOC) with metastatic or locally advanced cutaneous Squamous Cell Carcinoma (CSCC) who are not candidates for curative surgery or curative radiation, on overall survival (OS).
Secondary Objectives:
* Assess Progression Free Survival (PFS)
* To assess Duration of Response (DOR)
* To assess Objective Response Rate (ORR)
* To describe adverse events leading to treatment interruptions and deaths
Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Treatment Group (Cemiplimab)
Patients treated with cemiplimab in monotherapy through the Cohort Temporary Authorization for Use (cATU) or patients included in the Nominative Temporary Authorization for Use( nATU) that evolved into the cATU and meeting the inclusion/exclusion criteria of the study.
Cemiplimab
Pharmaceutical Form: Concentrate solution for injection for intravenous (IV) infusion Route of Administration: Intravenous (IV) infusion
Control Group
Patients treated with other systemic treatments meeting the inclusion/exclusion criteria of the study who initiated at least one systemic treatment for advanced CSCC before start date of the cemiplimab nATU
Cemiplimab
Pharmaceutical Form: Concentrate solution for injection for intravenous (IV) infusion Route of Administration: Intravenous (IV) infusion
Interventions
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Cemiplimab
Pharmaceutical Form: Concentrate solution for injection for intravenous (IV) infusion Route of Administration: Intravenous (IV) infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Adult 18 years of age or older
* With an unresectable locally advanced CSCC (who are not candidates for curative surgery or curative radiation therapy) or metastatic CSCC (nodal or distant)
* Subject alive at start data collection who has received information note and has not opposed to data collection OR
* Subject who died before study initiation and who has not opposed to data collection for research purpose when he/she was alive
Treatment Group:
* Patient treated by cemiplimab in monotherapy through the cATU or patient included in the nATU that evolved into the cATU.
* With an Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 at the time of cemiplimab initiation
Control Group:
* Patient treated by any systemic treatment initiated until August 1st , 2018 included
* With an ECOG score of 0 or 1 at the time of treatment initiation for at least one line of systemic therapy initiated from August 1st 2013 to August 1st 2018. The related treatment line must be among the 3 first systemic treatment lines for patients having initiated more than 3 lines.
Exclusion Criteria
\- Patient treated by another anti- Programmed Cell Death Receptor-1 (PD1)
Control group:
-Patient subsequently treated with cemiplimab
The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
18 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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France, , France
Countries
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Other Identifiers
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U1111-1275-9937
Identifier Type: REGISTRY
Identifier Source: secondary_id
OBS17334
Identifier Type: -
Identifier Source: org_study_id