Clinical trial NCT05493826: Real World Study on the Use of Cemiplimab in Adult Patients in UK
Official title: Real-world Evidence Study on the Early Use of Cemiplimab in the UK: REACT-CEMI (Real World Evidence of Advanced CSCC Treatment - With CEMIplimab)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cutaneous Squamous Cell Carcinoma
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2022-08-09
Enrollment: 110
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: Patients treated with cemiplimab for laCSCC or mCSCC who were not suitable for curative surgery or curative radiation

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Overall response rate (ORR) within 12 months post initiation of cemiplimab
timeFrame: 12 months
Secondary outcomes:
measure: ORR within 6 months post initiation of cemiplimab
timeFrame: 6 months
measure: Real-world best response within 6- and 12-months post initiation of cemiplimab
timeFrame: 6 months, 12 months
measure: Time to best response
timeFrame: From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months
measure: Time to partial response
timeFrame: From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months
measure: Time to complete response
timeFrame: From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months
measure: Disease control rate (DCR) within 6 and 12 months post initiation of cemiplimab
timeFrame: 6 months, 12 months
measure: Duration of response (DoR)
timeFrame: From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months
measure: Duration of treatment (DoT)
timeFrame: From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months
measure: Real-world progression-free survival (rwPFS)
timeFrame: From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months
measure: Overall survival (OS)
timeFrame: From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months
measure: Demographics
timeFrame: Baseline
measure: Medical history
timeFrame: Baseline
measure: Previous treatments
timeFrame: Baseline
measure: Clinical characteristics outcome
timeFrame: Baseline
measure: Number of cemiplimab infusions
timeFrame: From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months
measure: Proportion of patients where cemiplimab treatment was interrupted, overall and by reason for interruption
timeFrame: From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months
measure: Proportion of patients permanently discontinuing treatment, overall and by reason for discontinuation
timeFrame: From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months
measure: Distribution of cemiplimab dose administered at initiation
timeFrame: From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months
measure: Proportion of patients experiencing immune-related adverse reactions (irARs) of any grade (where reported in notes)
timeFrame: From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months
measure: Proportion of patients with cemiplimab treatment interruptions due to experiencing irARs
timeFrame: From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months
measure: Duration of treatment interruption for patients experiencing irARs
timeFrame: From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months
measure: Proportion of patients treated with anti-inflammatory drugs (e.g., steroids) for irARs, overall and by type of irAR
timeFrame: From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months
measure: 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
timeFrame: From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: Sanofi-Aventis UK
state: Berkshire
Study officials:
affiliation: Sanofi
name: Clinical Sciences and Operations
role: STUDY_DIRECTOR
References: