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Comparative Efficacy of Cemiplimab to Historical Standard of Care in France

NCT05302297 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 305

Last updated 2022-12-13

No results posted yet for this study

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

Conditions

  • Cancer/Squamous Cell Carcinoma of Skin

Interventions

DRUG

Cemiplimab

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-17
Primary Completion
2022-09-30
Completion
2022-09-30

Countries

  • France

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05302297 on ClinicalTrials.gov