Clinical trial NCT05302297: Comparative Efficacy of Cemiplimab to Historical Standard of Care in France
Official title: A reTrOspective Study on Patient's Data From the French Cemiplimab Cohort ATU Programs Compared to Standard of Care in France
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer/Squamous Cell Carcinoma of Skin
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2022-03-31
Enrollment: 305
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The source population for this study will be adult patients with metastatic or locally advanced CSCC who are not candidates for curative surgery or curative radiation and who received cemiplimab in monotherapy through the cATU or patient included in the nATU that evolved into the cATU (treatment group) and patients who initiated a systemic therapy as 1st, 2nd or 3rd line of treatment before the start of the cemiplimab nATU, i.e. initiated from August 1st 2013 to August 1st 2018 (control group) recruited from particpating sites in France. The study will aim to enroll approximately 250 patients in the cemiplimab group and 625 patients in the control group from up to 34 sites which included at least 4 patients in the cohort temporary authorization of use.

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: 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
Secondary outcomes:
measure: Progression-Free Surivival (PFS)
timeFrame: 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
measure: Duration of Response (DOR)
timeFrame: 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
measure: Objective Response Rate (ORR)
timeFrame: 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
Other outcomes:
Locations:
city: France
country: France
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: