Comparative Efficacy of Cemiplimab to Historical Standard of Care in France (TOSCA)
Study Overview
Primary Objective:
-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
Study details
Study duration is approximately 9 months. For the Standard of Care Arm, data of the subjects evaluated between 01 Aug 2013 and 01 Aug 2018 was observed. For the Cemiplimab arm, data of the subjects evaluated between Aug 2018 and October 2019 was observed.
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
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Conditions:
Cancer/Squamous Cell Carcinoma of Skin
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Age: 18 Years
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Gender: All
Inclusion Criteria:
All patients:
- 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:
All patients:
- 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.
