Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer/Squamous Cell Carcinoma of Skin | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cemiplimab | Drug | Cemiplimab | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- 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.
- interventionNames
- Drug: Cemiplimab
- label
- 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
- interventionNames
- Drug: Cemiplimab
Primary outcomes (1)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
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