A Phase 2 Study Evaluating Bladder Preservation With Enfortumab Vedotin Plus Pembrolizumab in Patients With Muscle-Invasive Urothelial Cancer

Conditions

• Muscle-invasive Bladder Urothelial Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Enfortumab vedotin — DRUG
  Enfortumab vedotin 1.25 mg/kg, IV on days 1 and 8 on a 21day cycle for 9 cycles
• Pembrolizumab — DRUG
  Subjects will receive one year of treatment with pembrolizumab IV or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex) SC. Treatment will be administered per institutional standards every 3 weeks or 6 weeks, at the physician's discretion.

Study Details

The purpose of this study is to evaluate whether Enfortumab Vedotin in combination with Pembrolizumab can achieve a clinical response that preserves the bladder and avoids the need for cystectomy or radiation therapy in patients with urothelial cancer.

Key Dates

First listed

Sep 16, 2026

Start date

Nov 30, 2026

Status verified

Sep 2026

Primary completion

Nov 30, 2034

Completion

Nov 30, 2035

Study Design

Enrollment

25 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment: All Patients
  All patients will be treated with enfortumab vedotin in combination with pembrolizumab.

Primary Outcome Measure

cT0 or cTa low-grade disease as assessed by cystoscopy and bladder biopsy, including all visually abnormal sites in addition to reTURBT or biopsy of the known site of MIBC before neo- adjuvant therapy [ Time Frame: 6 years ]

Central Contacts

• Kristen Jewkes
  801-585-1753
  [email protected]
• Umang Swami, MD
  801-585-0255
  [email protected]

Locations (1)

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