Cutaneous AdverseSURVSKINTOX-EVNCT06682845
Association Between Drug-related Cutaneous Adverse Events and Progression Free Survival in Patients Treated with Enfortumab Vedotin
An observational study of Cutaneous Adverse, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Enfortumab vedotin (EV) is an antibody-drug conjugate (ADC) targeting nectin-4. In patients with metastatic urothelial carcinoma, EV in combination with pembrolizumab (anti-PD1) provides significantly better progression-free and global survival than platinum-based chemotherapies, with the benefit observed from the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Adverse
- What is being tested?
- Collection of data in patients' medical files
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- 2 May 2024to 30 Jun 2024
- 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: Adult patients who have received enfortumab vedotin treatment at the Centre Léon Bérard or Hôpital Lyon Sud, and who do not object to the collection of their data.
Who may be able to join
- All adult patients who have been treated with enfortumab vedotin at Hôpital Lyon Sud or Centre Léon Bérard and for whom follow-up data of at least 6 months are available are eligible for inclusion. To be included, patients must be willing and able to provide non-opposition consent for participation in this study and for the use of their medical data in this context.
Who cannot join
- -Any medical, social, or psychiatric condition that might impair the patient's capacity to provide informed consent to participate in the study and to the use of their medical data is considered an exclusion criterion
Trial locations and contacts
1 site in 1 country.
About this study
Enfortumab vedotin (EV) is an antibody-drug conjugate (ADC) targeting nectin-4. In patients with metastatic urothelial carcinoma, EV in combination with pembrolizumab (anti-PD1) provides significantly better progression-free and global survival than platinum-based chemotherapies, with the benefit observed from the first line of treatment. However, EV is associated with a high frequency of cutaneous adverse events (AE), which may be due to physiological Nectin-4 expression in keratinocytes. These cutaneous toxicities include bullous/blistering toxicities and toxic epidermal necrolysis-like AE. While the association between cutaneous AE and survival has been demonstrated with anti-PD1, its association with survival in patient treated with ADC remains unknown. The objective of this retrospective dual-centric study is to determine whether there is an association between drug-related cutaneous AE and progression free survival in patients treated with EV.
- Conditions
- Cutaneous Adverse
- Being tested
- Collection of data in patients' medical files
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of data in patients' medical filesOther
- Demographic data
- Health data: body mass index, weight, tobacco consumption, history of hyperglycemia/ diabetes mellitus, Eastern Cooperative Oncology Group (ECOG) status, glomerular filtration rate, hemoglobin rate
- Cancer-related data: date of diagnosis, tumoral site, tumor histology type, histology grade, date of first metastases involvement, presence of visceral metastases, presence of liver metastases, presence of lymph node-only metastases
- Treatment-related data: previous line of treatment, co-treatment with anti-PD1, enfortumab vedotin (EV) treatment start date, EV treatment end date, EV posology, presence of EV reduction of dose or increased interval between perfusions, number of EV cycles
- Adverse events (AE)-related data: occurrence of cutaneous AE, grade of cutaneous AE, date of cutaneous AE, type of cutaneous AE, management of cutaneous AE, discontinuation of EV treatment, rechallenge of EV treatment
- Outcomes data: best overall response rate
| Study group | Role | What they receive |
|---|---|---|
| EV patients | Adult patients who have received enfortumab vedotin treatment at the Centre Léon Bérard or Hôpital Lyon Sud, and who do not object to the collection of their data. Receives: Other: Collection of data in patients' medical files |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS) according to the occurrence of cutaneous adverse events (AE)
Progression-Free Survival (PFS) is defined as the time from the start of EV treatment to the occurrence of disease progression or death from any cause, whichever occurs first. This measure will assess the impact of any grade cutaneous adverse events (AEs) on PFS.
Measured: From the start of EV treatment until disease progression or death, with data collected from 01/01/2015 to 02/05/2024.
Secondary outcomes (4)
Overall Survival (OS) according to the occurrence of cutaneous adverse events (AE)
Overall Survival (OS) is defined as the time from the start of EV treatment to death from any cause. This measure will assess the impact of any grade cutaneous adverse events (AEs) on OS.
Measured: From the start of EV treatment until death from any cause, with data collected from 01/01/2015 to 02/05/2024.
PFS/OS according to blistering toxicity
This measure will assess PFS and OS in relation to the occurrence of blistering toxicity. Blistering toxicity is defined as a dermatosis with vesicular, bullous, and/or exfoliative lesions.
Measured: From the start of EV treatment until disease progression, death, or first occurrence of blistering toxicity, with data collected from 01/01/2015 to 02/05/2024.
PFS/OS according to cutaneous AE in patients co-treated with anti-PD1
This measure will assess PFS and OS in relation to the occurrence of cutaneous adverse events in patients who are also receiving anti-PD1 treatment.
Measured: From the start of combined EV and anti-PD1 treatment until disease progression or death, with data collected from 01/01/2015 to 02/05/2024.
Identification of predictive risk factors for cutaneous AE
Identification of potential predictive risk factors associated with the occurrence of cutaneous adverse events (defined as any grade skin rash, excluding isolated pruritus).
Measured: Retrospective analysis of data from the treatment initiation until the last recorded follow-up, with data collected from 01/01/2015 to 02/05/2024.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start2 May 2024
- Primary completion2 May 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous AdverseStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06682845
- Sponsor's protocol ID
- 69HCL24_0588
- Acronym
- SURVSKINTOX-EV
- Status last verified
- Nov 2024
- First submitted
- 10 Jun 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Drug-related Cutaneous Adverse Events and Progression Free Survival in Patients Treated with Enfortumab Vedotin
- ClinicalTrials.gov ID
- NCT06682845
- Acronym / sponsor ID
- SURVSKINTOX-EV / 69HCL24_0588
- Conditions
- Cutaneous Adverse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 2 May 2024 (actual)
- Primary completion
- 2 May 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 12 Nov 2024 (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.
Enfortumab vedotin (EV) is an antibody-drug conjugate (ADC) targeting nectin-4. In patients with metastatic urothelial carcinoma, EV in combination with pembrolizumab (anti-PD1) provides significantly better progression-free and global survival than platinum-based chemotherapies, with the benefit observed from the first line of treatment. However, EV is associated with a high frequency of cutaneous adverse events (AE), which may be due to physiological Nectin-4 expression in keratinocytes. These cutaneous toxicities include bullous/blistering toxicities and toxic epidermal necrolysis-like AE. While the association between cutaneous AE and survival has been demonstrated with anti-PD1, its association with survival in patient treated with ADC remains unknown. The objective of this retrospective dual-centric study is to determine whether there is an association between drug-related cutaneous AE and progression free survival in patients treated with EV.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EV patients | – | Other: Collection of data in patients' medical filesAdult patients who have received enfortumab vedotin treatment at the Centre Léon Bérard or Hôpital Lyon Sud, and who do not object to the collection of their data. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who have received enfortumab vedotin treatment at the Centre Léon Bérard or Hôpital Lyon Sud, and who do not object to the collection of their data.
Key inclusion criteria (1 listed)
- All adult patients who have been treated with enfortumab vedotin at Hôpital Lyon Sud or Centre Léon Bérard and for whom follow-up data of at least 6 months are available are eligible for inclusion. To be included, patients must be willing and able to provide non-opposition consent for participation in this study and for the use of their medical data in this context.
Key exclusion criteria (1 listed)
- -Any medical, social, or psychiatric condition that might impair the patient's capacity to provide informed consent to participate in the study and to the use of their medical data is considered an exclusion criterion
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 |
|---|---|---|
| Collection of data in patients' medical files* Demographic data * Health data: body mass index, weight, tobacco consumption, history of hyperglycemia/ diabetes mellitus, Eastern Cooperative Oncology Group (ECOG) status, glomerular filtration rate, hemoglobin rate * Cancer-related data: date of diagnosis, tumoral site, tumor histology type, histology grade, date of first metastases involvement, presence of visceral metastases, presence of liver metastases, presence of lymph node-only metastases * Treatment-related data: previous line of treatment, co-treatment with anti-PD1, enfortumab vedotin (EV) treatment start date, EV treatment end date, EV posology, presence of EV reduction of dose or increased interval between perfusions, number of EV cycles * Adverse events (AE)-related data: occurrence of cutaneous AE, grade of cutaneous AE, date of cutaneous AE, type of cutaneous AE, management of cutaneous AE, discontinuation of EV treatment, rechallenge of EV treatment * Outcomes data: best overall response rate | Other | EV patients |
Primary outcome
Progression-Free Survival (PFS) according to the occurrence of cutaneous adverse events (AE)
Time frame: From the start of EV treatment until disease progression or death, with data collected from 01/01/2015 to 02/05/2024.
Progression-Free Survival (PFS) is defined as the time from the start of EV treatment to the occurrence of disease progression or death from any cause, whichever occurs first. This measure will assess the impact of any grade cutaneous adverse events (AEs) on PFS.
4 secondary outcomes
Overall Survival (OS) according to the occurrence of cutaneous adverse events (AE)
Time frame: From the start of EV treatment until death from any cause, with data collected from 01/01/2015 to 02/05/2024.
PFS/OS according to blistering toxicity
Time frame: From the start of EV treatment until disease progression, death, or first occurrence of blistering toxicity, with data collected from 01/01/2015 to 02/05/2024.
PFS/OS according to cutaneous AE in patients co-treated with anti-PD1
Time frame: From the start of combined EV and anti-PD1 treatment until disease progression or death, with data collected from 01/01/2015 to 02/05/2024.
Identification of predictive risk factors for cutaneous AE
Time frame: Retrospective analysis of data from the treatment initiation until the last recorded follow-up, with data collected from 01/01/2015 to 02/05/2024.
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 12 Nov 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Adverse, run by Hospices Civils de Lyon 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 1 inclusion and 1 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 12 Nov 2024. 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?
Progression-Free Survival (PFS) according to the occurrence of cutaneous adverse events (AE) (time frame: From the start of EV treatment until disease progression or death, with data collected from 01/01/2015 to 02/05/2024.). 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 12 Nov 2024.