Cancer/Squamous Cell Carcinoma of SkinTOSCANCT05302297
Comparative Efficacy of Cemiplimab to Historical Standard of Care in France
An observational study of Cancer/Squamous Cell Carcinoma of Skin, run by Sanofi at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer/Squamous Cell Carcinoma of Skin
- What is being tested?
- Cemiplimab
- Type of treatment
- Injection or infusion
- How many people
- 305 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jan 2022to 30 Sep 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: The source population for this study will be adult patients with metastatic or locally advanced CSCC who are not candidates for curative surgery or curative radiation and who received cemiplimab in monotherapy through the cATU or patient included in the nATU that evolved into the cATU (treatment group) and patients who initiated a systemic therapy as 1st, 2nd or 3rd line of treatment before the start of the cemiplimab nATU, i.e. initiated from August 1st 2013 to August 1st 2018 (control group) recruited from particpating sites in France. The study will aim to enroll approximately 250 patients in the cemiplimab group and 625 patients in the control group from up to 34 sites which included at least 4 patients in the cohort temporary authorization of use.
Who may be able to join
- 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:
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A reTrOspective Study on Patient's Data From the French Cemiplimab Cohort ATU Programs Compared to Standard of Care in France
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
Read the detailed description
Study duration is approximately 9 months. For the Standard of Care Arm, data of the subjects evaluated between 01 Aug 2013 and 01 Aug 2018 was observed. For the Cemiplimab arm, data of the subjects evaluated between Aug 2018 and October 2019 was observed.
- Conditions
- Cancer/Squamous Cell Carcinoma of Skin
- Being tested
- Cemiplimab
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CemiplimabDrug
Also called SAR439684- Libtayo
Pharmaceutical Form: Concentrate solution for injection for intravenous (IV) infusion Route of Administration: Intravenous (IV) infusion
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group (Cemiplimab) | 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. Receives: Drug: Cemiplimab | |
| Control Group | 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 Receives: Drug: Cemiplimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
The difference OS between treatment and control groups expressed as a Hazard Ratio (HR). OS is the time between treatment initiation and the date of death from any cause. For participants who are alive at data cutoff collection, their survival time will be censored at the last date that they were known to be alive.
Measured: 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
Secondary outcomes (3)
Progression-Free Surivival (PFS)
Difference in PFS between interventional and control groups expressed as a HR. Defined as the time elapsed from date of first treatment intake to the date of documented recurrent or progressive disease reported by the Investigator or death due to any cause, whichever occurs first. Disease progression will be assessed by tumour response evaluation according to Investigator assessment. Tumour response will be evaluated per routine clinical practice as progressive/not progressive by the physian.
Measured: 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
Duration of Response (DOR)
Defined as the time elapsed between the first reported objective response (complete or partial response) and the first date of recurrent or progressive disease or death due to any cause, whichever occurs first. Tumour response will be evaluated per routine clinical practice by the physician.
Measured: 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
Objective Response Rate (ORR)
Defined as the proportion of participants who achieve partial or complete response from the start of the study treatment. The ORR will be assessed by tumour response evaluation according to Investigator assessment. Tumour response will be evaluated per routine clinical practice by the physician)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start17 Jan 2022
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer/Squamous Cell Carcinoma of SkinStudies 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
- 305 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05302297
- Sponsor's protocol ID
- OBS17334
- Other IDs
- U1111-1275-9937
- Acronym
- TOSCA
- Status last verified
- Dec 2022
- First submitted
- 21 Mar 2022
- Last updated
- 13 Dec 2022
- 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 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A reTrOspective Study on Patient's Data From the French Cemiplimab Cohort ATU Programs Compared to Standard of Care in France
- ClinicalTrials.gov ID
- NCT05302297
- Acronym / sponsor ID
- TOSCA / OBS17334
- Conditions
- Cancer/Squamous Cell Carcinoma of Skin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 17 Jan 2022 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 31 Mar 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.
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
Detailed description
Study duration is approximately 9 months. For the Standard of Care Arm, data of the subjects evaluated between 01 Aug 2013 and 01 Aug 2018 was observed. For the Cemiplimab arm, data of the subjects evaluated between Aug 2018 and October 2019 was observed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group (Cemiplimab) | – | Drug: CemiplimabPatients 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. |
| Control Group | – | Drug: CemiplimabPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The source population for this study will be adult patients with metastatic or locally advanced CSCC who are not candidates for curative surgery or curative radiation and who received cemiplimab in monotherapy through the cATU or patient included in the nATU that evolved into the cATU (treatment group) and patients who initiated a systemic therapy as 1st, 2nd or 3rd line of treatment before the start of the cemiplimab nATU, i.e. initiated from August 1st 2013 to August 1st 2018 (control group) recruited from particpating sites in France. The study will aim to enroll approximately 250 patients in the cemiplimab group and 625 patients in the control group from up to 34 sites which included at least 4 patients in the cohort temporary authorization of use.
Key inclusion criteria (11 listed)
- 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
- 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
Key exclusion criteria (5 listed)
- Patient treated by another anti- Programmed Cell Death Receptor-1 (PD1)
- -Patient subsequently treated with cemiplimab
- The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
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 |
|---|---|---|
| CemiplimabAlso: SAR439684- LibtayoPharmaceutical Form: Concentrate solution for injection for intravenous (IV) infusion Route of Administration: Intravenous (IV) infusion | Drug | Control Group, Treatment Group (Cemiplimab) |
Primary outcome
Overall Survival (OS)
Time frame: 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
The difference OS between treatment and control groups expressed as a Hazard Ratio (HR). OS is the time between treatment initiation and the date of death from any cause. For participants who are alive at data cutoff collection, their survival time will be censored at the last date that they were known to be alive.
3 secondary outcomes
Progression-Free Surivival (PFS)
Time frame: 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
Duration of Response (DOR)
Time frame: 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
Objective Response Rate (ORR)
Time frame: 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
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 13 Dec 2022.
- 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 Cancer/Squamous Cell Carcinoma of Skin
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
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
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
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
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 & 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 Cancer/Squamous Cell Carcinoma of Skin, run by Sanofi at 1 site in France.
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 11 inclusion and 5 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 13 Dec 2022. 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 France. 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 Survival (OS) (time frame: 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). 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 13 Dec 2022.