Real World Study on the Use of Cemiplimab in Adult Patients in UK (REACT-CEMI)

Real-world Evidence Study on the Early Use of Cemiplimab in the UK: REACT-CEMI (Real World Evidence of Advanced CSCC Treatment - With CEMIplimab)

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.

Study Overview

• Status: Completed
• Conditions: Cutaneous Squamous Cell Carcinoma
• Intervention / Treatment: Other: No intervention

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.

• Study Type: Observational
• Enrollment (Actual): 110

Contacts and Locations

Study Locations

• United Kingdom
  • Berkshire
    • Reading, Berkshire, United Kingdom, RG6 1PT
      • Sanofi-Aventis UK

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients treated with cemiplimab for laCSCC or mCSCC who were not suitable for curative surgery or curative radiation

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Patients treated with cemiplimab for laCSCC or mCSCC who were not suitable for curative surgery or curative radiation	Other: No intervention; Non-interventional study based on secondary use of hospital medical record

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall response rate (ORR) within 12 months post initiation of cemiplimab	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	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR within 6 months post initiation of cemiplimab		6 months
Real-world best response within 6- and 12-months post initiation of cemiplimab	Real-world best response, defined as the best response to cemiplimab observed during the observation period.	6 months, 12 months
Time to best response	The best response to cemiplimab observed during the observation period	From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months
Time to partial response	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.	From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months
Time to complete response	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.	From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months
Disease control rate (DCR) within 6 and 12 months post initiation of cemiplimab	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	6 months, 12 months
Duration of response (DoR)	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	From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months
Duration of treatment (DoT)	DoT, defined as the time from cemiplimab initiation to the documented date of treatment discontinuation.	From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months
Real-world progression-free survival (rwPFS)	rwPFS, defined as the time from cemiplimab initiation to date of disease progression or death as recorded in the medical records	From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months
Overall survival (OS)	OS, defined as the time from cemiplimab initiation to date of death from any cause.	From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months
Demographics	Age, Sex, Ethnicity	Baseline
Medical history	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)	Baseline
Previous treatments	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	Baseline
Clinical characteristics outcome	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	Baseline
Number of cemiplimab infusions		From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months
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
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
Distribution of cemiplimab dose administered at initiation		From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months
Proportion of patients experiencing immune-related adverse reactions (irARs) of any grade (where reported in notes)	irAR, defined as treatment-related, immune-related adverse events (as defined by local investigator)	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
Duration of treatment interruption for patients 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
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

Collaborators and Investigators

• Sponsor: Sanofi
• Investigators: Study Director: Clinical Sciences and Operations, Sanofi

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2022
• Primary Completion (Actual): November 1, 2022
• Study Completion (Actual): November 1, 2022

Study Registration Dates

• First Submitted: August 7, 2022
• First Submitted That Met QC Criteria: August 7, 2022
• First Posted (Actual): August 9, 2022

Study Record Updates

• Last Update Posted (Actual): July 14, 2023
• Last Update Submitted That Met QC Criteria: July 13, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Carcinoma, Squamous Cell
• Other Study ID Numbers: DUT0052

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No