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

NCT06682845 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 22

Last updated 2024-11-12

No results posted yet for this study

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.

Conditions

  • Cutaneous Adverse

Interventions

OTHER

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

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-02
Primary Completion
2024-05-02
Completion
2024-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06682845 on ClinicalTrials.gov