Real World Study on the Use of Cemiplimab in Adult Patients in UK
- Conditions
- Cutaneous Squamous Cell Carcinoma
- Interventions
- Other: No intervention
- Registration Number
- NCT05493826
- Lead Sponsor
- Sanofi
- Brief Summary
The primary objective is to describe the real-world clinical effectiveness of cemiplimab in patients with locally advanced cutaneous squamous cell carcinoma (laCSCC) or metastatic cutaneous squamous cell carcinoma (mCSCC) treated in routine clinical practice.
- Detailed Description
Patients initiating treatment with cemiplimab in the UK between 2nd July 2019 and 30th November 2020, will be followed for a minimum of 12 and a maximum of 36 months from initiation of cemiplimab.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 110
- Patients aged >=18 years at initiation of cemiplimab.
- Patients treated with >=1 dose of cemiplimab for laCSCC or mCSCC who were not suitable for curative surgery or curative radiation according to routine practice.
- Patients initiating treatment with cemiplimab in the UK between 2nd July 2019 and 30th November 2020.
- Patients who are known to have opted out of participation in any research (as required for compliance with GDPR).
- Patients participating in any form of investigative study (e.g., clinical trials) during the post-index observation period.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1 No intervention Patients treated with cemiplimab for laCSCC or mCSCC who were not suitable for curative surgery or curative radiation
- Primary Outcome Measures
Name Time Method Overall response rate (ORR) within 12 months post initiation of cemiplimab 12 months ORR, defined as the proportion of patients who have a partial or complete response to cemiplimab based on an assessment according to routine practice, as documented in medical records
- Secondary Outcome Measures
Name Time Method Demographics Baseline Age, Sex, Ethnicity
Real-world best response within 6- and 12-months post initiation of cemiplimab 6 months, 12 months Real-world best response, defined as the best response to cemiplimab observed during the observation period.
Time to partial response From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months Time to partial response, defined as time from cemiplimab initiation until the first documentation of a partial response based on assessment according to routine practice, as documented in medical records.
ORR within 6 months post initiation of cemiplimab 6 months Time to complete response From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months Time to complete response, defined as time from cemiplimab initiation until the first documentation of a complete response based on assessment according to routine practice, as documented in medical records.
Disease control rate (DCR) within 6 and 12 months post initiation of cemiplimab 6 months, 12 months DCR, defined as the proportion of patients who have a complete response, partial response or stable disease based on an assessment according to routine practice, as documented in medical records
Proportion of patients where cemiplimab treatment was interrupted, overall and by reason for interruption From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months Real-world progression-free survival (rwPFS) From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months rwPFS, defined as the time from cemiplimab initiation to date of disease progression or death as recorded in the medical records
Overall survival (OS) From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months OS, defined as the time from cemiplimab initiation to date of death from any cause.
Proportion of patients experiencing immune-related adverse reactions (irARs) of any grade (where reported in notes) From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months irAR, defined as treatment-related, immune-related adverse events (as defined by local investigator)
Duration of treatment interruption for patients experiencing irARs From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months Duration of treatment (DoT) From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months DoT, defined as the time from cemiplimab initiation to the documented date of treatment discontinuation.
Time to best response From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months The best response to cemiplimab observed during the observation period
Duration of response (DoR) From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months DoR, defined as the time from the first documentation of a complete or partial response to cemiplimab in medical records until first documentation of disease progression or death
Previous treatments Baseline Previous treatments for cemiplimab index CSCC lesion(s) during the pre-index observation period, Previous treatments for cemiplimab non-index CSCC lesion(s) during the pre-index observation period, Previous treatments for any prior skin malignancies during the pre-index observation period
Clinical characteristics outcome Baseline Proportion of patients treated with antibiotics in the 6 wks prior to or 6 wks post-initiation of cemiplimab, Proportion of patients with immunocompromised status and treatment history incl. any concomitant therapy, Proportion of patients with a history of organ transplantation, Frequency and distribution of prior organ transplantations by type, Frequency and distribution of prior malignancies overall and by type, Type of Multidisciplinary team review and referral prior to laCSCC/mCSCC diagnosis
Number of cemiplimab infusions From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months Distribution of cemiplimab dose administered at initiation From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months Initial dose of anti-inflammatory drug (e.g., steroids) used to treat irARs at onset of irARs and for the duration of irARs by steroid type From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months Medical history Baseline Co-morbidities, Eastern Cooperative Oncology Group performance status, Stage of disease, Primary CSCC lesion disease site and date diagnosed (where available), Time from diagnosis of primary disease to diagnosis of laCSCC or mCSCC not suitable for curative surgery or curative radiotherapy (where available)
Proportion of patients permanently discontinuing treatment, overall and by reason for discontinuation From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months Proportion of patients with cemiplimab treatment interruptions due to experiencing irARs From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months Proportion of patients treated with anti-inflammatory drugs (e.g., steroids) for irARs, overall and by type of irAR From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months
Trial Locations
- Locations (1)
Sanofi-Aventis UK
🇬🇧Reading, Berkshire, United Kingdom