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Prophylactic Study on Severe Skin Toxicity Associated with Enfortumab Vedotin: A Prospective Multicenter Study (PEACE Study (Prophylactic study of Enfortumab vedotin-Associated Cutaneous Events))

A Study to Prevent Skin Problems Caused by Padcev (Enfortumab Vedotin)
(PEACE Study (Prophylactic study of Enfortumab vedotin-Associated Cutaneous Events))

Aya Nishizawa

Department of Dermatology and Dermatologic Oncology, Tokyo Metropolitan Komagome Hospital

3-18-22 Honkomagome, Bunkyo-ku, Tokyo 113-8677, Japan

ayanishiza@yahoo.co.jp

Aya Nishizawa

Department of Dermatology and Dermatologic Oncology, Tokyo Metropolitan Komagome Hospital

3-18-22 Honkomagome, Bunkyo-ku, Tokyo 113-8677, Japan

+81-3-3823-2101

ayanishiza@yahoo.co.jp

Recruiting

Mar. 05, 2026

Interventional

single arm study

open(masking not used)

historical control

single assignment

prevention purpose

1. Patients aged 20 years or older who have provided written informed consent.
2. Patients diagnosed with advanced urothelial carcinoma.
3. Patients scheduled to receive treatment with enfortumab vedotin (EV).
4. Patients with good performance status (ECOG PS 0-2).

1. Patients who have already started treatment with enfortumab vedotin (EV).
2. Patients with a history of hypersensitivity to zinc preparations.
3. Patients with severe comorbidities (e.g., uncontrolled diabetes, active infection).
4. Patients judged ineligible for the study by the investigator.

Both

Advanced urothelial carcinoma, Enfortumab vedotin-induced cutaneous adverse events

For urothelial cancer patients with low serum zinc levels (less than 80 ug/dL) at screening, zinc supplementation therapy (e.g., zinc acetate hydrate) will be administered concurrently with the initiation of Enfortumab Vedotin (Padcev).

Enfortumab vedotin, Padcev, Cutaneous adverse events, Zinc, Urothelial carcinoma

Zinc preparation

C67, L27.0

D015032

Incidence of Grade 3 or higher cutaneous adverse events (according to CTCAE v5.0) within 3 months after the initiation of enfortumab vedotin (EV) treatment.

1. Incidence of cutaneous adverse events (all Grades)
2. Incidence of dysgeusia (taste disorder)
3. Rates of dose reduction, interruption, and discontinuation of EV
4. Continuation rate of EV treatment
5. Time to onset of cutaneous adverse events
6. Time to recovery from cutaneous adverse events
7. Changes in serum zinc levels over time

+81-3-5320-5821

Feb. 05, 2026

none