NCT05302297

Comparative Efficacy of Cemiplimab to Historical Standard of Care in France

A reTrOspective Study on Patient's Data From the French Cemiplimab Cohort ATU Programs Compared to Standard of Care in France

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 305 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Cancer/Squamous Cell Carcinoma of Skin

Interventions

Type	Name	Description
DRUG	Cemiplimab	Pharmaceutical Form: Concentrate solution for injection for intravenous (IV) infusion Route of Administration: Intravenous (IV) infusion

Timeline

• Start date: 2022-01-17
• Primary completion: 2022-09-30
• Completion: 2022-09-30
• First posted: 2022-03-31
• Last updated: 2022-12-13

Locations

1 site across 1 country: France