Clinical trial NCT06682845: Association Between Drug-related Cutaneous Adverse Events and Progression Free Survival in Patients Treated with Enfortumab Vedotin
Official title: Association Between Drug-related Cutaneous Adverse Events and Progression Free Survival in Patients Treated with Enfortumab Vedotin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cutaneous Adverse
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

- 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.

Exclusion Criteria:

-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

Primary outcomes:
measure: Progression-Free Survival (PFS) according to the occurrence of cutaneous adverse events (AE)
timeFrame: From the start of EV treatment until disease progression or death, with data collected from 01/01/2015 to 02/05/2024.
Secondary outcomes:
measure: Overall Survival (OS) according to the occurrence of cutaneous adverse events (AE)
timeFrame: From the start of EV treatment until death from any cause, with data collected from 01/01/2015 to 02/05/2024.
measure: PFS/OS according to blistering toxicity
timeFrame: 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.
measure: PFS/OS according to cutaneous AE in patients co-treated with anti-PD1
timeFrame: 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.
measure: Identification of predictive risk factors for cutaneous AE
timeFrame: 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.
Other outcomes:
Locations:
city: Oullins
country: France
facility: Hôpital Lyon Sud, Hospices Civils de Lyon
Study officials:
References: