Efficacy of Prophylactic Topical Steroid Administration for Enfortumab Vedotin-Related Cutaneous Toxicity

JRCT ID: jRCTs051240214

Registered date:13/12/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Urothelial carcinoma
• Date of first enrollment: 13/12/2024
• Target sample size: 48
• Study type: Interventional
• Intervention(s): The study drug (Delmovate ointment or Vaseline ointment, double-blind) is applied to the right and left axilla/groin/medial upper arm/medial thigh/flexor wrist/waist twice daily in the morning and evening from the evening before the start of the standard EV dose until Day 28.

Outcome(s)

• Primary Outcome: Frequency of grade 2 or higher skin disorders based on CTCAE v5.0 or SDRIFE up to 4 weeks of EV administration
• Secondary Outcome: Safety, frequency of skin disorders of all grades or SDRIFE up to 12 weeks of EV, frequency of EV withdrawal, dose reduction, or discontinuation due to skin disorders, site-specific IGA score at visit date and at discontinuation up to 12 weeks of EV, pain and pruritus scale up to 12 weeks of EV, objective response rate at 12 weeks, progression-free survival, overall survival, blood cortisol and adrenocorticotropic hormone (ACTH) levels, and EQ-5D-5L score up to 12 weeks of EV

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Male and female patients receiving EV at the standard initial dose (1.25 mg/kg) for the treatment of unresectable urothelial carcinoma that has progressed after previous chemotherapy.

Exclude criteria

1. Patients with a history of EV administration.
2. Patients receiving concurrent immune checkpoint inhibitors.
3. Patients treated with systemic steroid therapy (prednisolone equivalent >10 mg/day) within 2 weeks prior to the first dose of EV.
4. Patients with an ECOG Performance Status of 3 or higher, with an assessment of ECOG Performance Status within 7 days prior to the first dose of EV
5. Patients with poorly controlled eczema, atopic dermatitis, psoriasis vulgaris, or autoimmune bullous disease.

Related Information

• Primary Sponsor: Kita Yuki
• Source(s) of Monetary Support: Astellas Pharma Inc.