Comparative Efficacy of Cemiplimab to Historical Standard of Care in France

Conditions

• Cancer/Squamous Cell Carcinoma of Skin

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Cemiplimab — DRUG
  Pharmaceutical Form: Concentrate solution for injection for intravenous (IV) infusion Route of Administration: Intravenous (IV) infusion

Study Details

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

Key Dates

Start date

Jan 17, 2022

Status verified

Dec 2022

Primary completion

Sep 30, 2022

Completion

Sep 30, 2022

Study Design

Enrollment

305 participants (actual)

Arms

• Arm: 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.
• Arm: 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

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: From patient advanced CSCC diagnosis date up to last medical record available on site or the end of the observation period (July 2022),whichever occurred first ]