Cutaneous Squamous Cell CarcinomaREACT-CEMINCT05493826
Real World Study on the Use of Cemiplimab in Adult Patients in UK
An observational study of Cutaneous Squamous Cell Carcinoma, run by Sanofi at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Squamous Cell Carcinoma
- How many people
- 110 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Jul 2022to 1 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated with cemiplimab for laCSCC or mCSCC who were not suitable for curative surgery or curative radiation
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Conditions
- Cutaneous Squamous Cell Carcinoma
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Non-interventional study based on secondary use of hospital medical record
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients treated with cemiplimab for laCSCC or mCSCC who were not suitable for curative surgery or curative radiation Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (23)
ORR within 6 months post initiation of cemiplimab
Measured: 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.
Measured: 6 months, 12 months
Time to best response
The best response to cemiplimab observed during the observation period
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months
Demographics
Age, Sex, Ethnicity
Measured: 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)
Measured: 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
Measured: 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
Measured: Baseline
Number of cemiplimab infusions
Measured: 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
Measured: 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
Measured: From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months
Distribution of cemiplimab dose administered at initiation
Measured: 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)
Measured: 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
Measured: From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months
Duration of treatment interruption for patients experiencing irARs
Measured: 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
Measured: 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
Measured: From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start18 Jul 2022
- Primary completion1 Nov 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences and Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05493826
- Sponsor's protocol ID
- DUT0052
- Acronym
- REACT-CEMI
- Status last verified
- Jul 2023
- First submitted
- 7 Aug 2022
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05493826
- Acronym / sponsor ID
- REACT-CEMI / DUT0052
- Conditions
- Cutaneous Squamous Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 18 Jul 2022 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 9 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: No interventionPatients treated with cemiplimab for laCSCC or mCSCC who were not suitable for curative surgery or curative radiation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with cemiplimab for laCSCC or mCSCC who were not suitable for curative surgery or curative radiation
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNon-interventional study based on secondary use of hospital medical record | Other | Group 1 |
Primary outcome
Overall response rate (ORR) within 12 months post initiation of cemiplimab
Time frame: 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
23 secondary outcomes
ORR within 6 months post initiation of cemiplimab
Time frame: 6 months
Real-world best response within 6- and 12-months post initiation of cemiplimab
Time frame: 6 months, 12 months
Time to best response
Time frame: From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months
Time to partial response
Time frame: From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months
Time to complete response
Time frame: 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
Time frame: 6 months, 12 months
Duration of response (DoR)
Time frame: From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months
Duration of treatment (DoT)
Time frame: From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months
Real-world progression-free survival (rwPFS)
Time frame: From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months
Overall survival (OS)
Time frame: From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months
Demographics
Time frame: Baseline
Medical history
Time frame: Baseline
Previous treatments
Time frame: Baseline
Clinical characteristics outcome
Time frame: Baseline
Number of cemiplimab infusions
Time frame: 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
Time frame: 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
Time frame: From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months
Distribution of cemiplimab dose administered at initiation
Time frame: 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)
Time frame: 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
Time frame: From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months
Duration of treatment interruption for patients experiencing irARs
Time frame: 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
Time frame: 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
Time frame: From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
- Individual participant dataSharing planned: Yes. 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
Related trials for Cutaneous Squamous Cell Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 3
Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment
Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Hypopharyngeal Squamous Cell Carcinoma
RecruitingPhase 2
Treatment With Amivantamab and Hyaluronidase or Cetuximab for Advanced Skin Cancer in People With a Weakened Immune System
Locally Recurrent Skin Squamous Cell Carcinoma, Metastatic Skin Squamous Cell Carcinoma
RecruitingPhase 3
High-dose Prophylactic Gabapentin (HOPE) vs. Placebo to Prevent Opioid Use for Oral Mucositis Pain During Concurrent Chemoradiation for Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma, Stage I Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
Active, not recruitingPhase 2/3
Testing the Use of Investigational Drugs Atezolizumab and/or Bevacizumab With or Without Standard Chemotherapy in the Second-Line Treatment of Advanced-Stage Head and Neck Cancers
Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Metastatic Head and Neck Squamous Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences and Operations study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cutaneous Squamous Cell Carcinoma, run by Sanofi at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) within 12 months post initiation of cemiplimab (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2023.