Completed

NCT Number: NCT06682845

Association Between Drug-related Cutaneous Adverse Events and Progression Free Survival in Patients Treated with Enfortumab Vedotin

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cutaneous Adverse

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Lyon Sud, Hospices Civils de Lyon

Oullins, 69495, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Collection of data in patients' medical files

Other

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

Primary outcomes

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.

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.

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.
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.

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.
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.

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.
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.

Identification of potential predictive risk factors associated with the occurrence of cutaneous adverse events (defined as any grade skin rash, excluding isolated pruritus).

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: SURVSKINTOX-EV

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Nov 12, 2024
Registry last updated: Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.