Last reviewed · How we verify
NCT06682845: SURVSKINTOX-EV
Association Between Drug-related Cutaneous Adverse Events and Progression Free Survival in Patients Treated with Enfortumab Vedotin
trial testing Collection of data in patients' medical files in Cutaneous Adverse in 22 participants. Completed in 30 June 2024.
2 May 2024
Quick facts
| Lead sponsor | Hospices Civils de Lyon |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 22 |
| Start date | 2 May 2024 |
| Primary completion | 2 May 2024 |
| Estimated completion | 30 June 2024 |
| Sites | 1 location across France |
Drugs / interventions tested
- Collection of data in patients' medical files
Conditions studied
- Cutaneous Adverse — all drugs for Cutaneous Adverse →
Sponsor
Hospices Civils de Lyon — full company profile →
Who can join
18 and older, any sex, with Cutaneous Adverse. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06682845
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06682845 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hospices Civils de Lyon
- Last refreshed: 12 November 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06682845.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing