Status:
COMPLETED
Comparative Efficacy of Cemiplimab to Historical Standard of Care in France
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Cancer/Squamous Cell Carcinoma of Skin
Eligibility:
All Genders
18+ years
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 advan...
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 ev...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 17 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 30 2022
Estimated Enrollment :
305 Patients enrolled
Trial Details
Trial ID
NCT05302297
Start Date
January 17 2022
End Date
September 30 2022
Last Update
December 13 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
France, France