Comparative Efficacy of Cemiplimab to Historical Standard of Care in France (TOSCA)

Sanofi

Status: Completed

Conditions: Cancer/Squamous Cell Carcinoma of Skin

Treatments: Drug: Cemiplimab

Study type: Observational

Funder types: Industry

Identifiers

NCT05302297

OBS17334

U1111-1275-9937 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 305 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

305 participants in 2 patient groups

Treatment Group (Cemiplimab)

Description:

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.

Treatment:

Drug: Cemiplimab

Control Group

Description:

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

Treatment:

Drug: Cemiplimab