Enfortumab Vedotin + Pembrolizumab Induction to Spare the Bladder in MIBC

Sponsor
The Netherlands Cancer Institute
Study ID
NCT07663747
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Urothelial Bladder Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Enfortumab Vedotin — DRUG
    Induction: 4 cycles (d1,8; 1.25 mg/kg)
  • Pembrolizumab — DRUG
    Induction: 4 cycles 200mg and after cCR 400 mg q6 weeks. Total 1 year from start of therapy
  • Radiation — RADIATION
    The preference will be a four-week schedule, in which 55 Gy radiotherapy will be administered using intensity modulated radiation therapy (IMRT)
  • Chemoradiation — OTHER
    by local protocol; by local protocol; Mitomycin C/fluoropyrimidines in the Netherlands) * No disease outside the bladder (e.g. involvement of ureter, prostatic urethra or (suspected) lymph node metastases) * No bilateral hydronephrosis * No multifocal CIS * Adequate bladder function: Post-micturition residual volume of \< 200 cc, International Prostate Symptom Score (IPSS) \< 15 points; revised urinary incontinence scale \< 8 points; no daily or continuous catheter use.
  • Cystectomy — PROCEDURE
    Surgical removal of the bladder

Study Details

This is a Phase 2 clinical intervention trial to assess efficacy of induction EVP to spare the bladder in stage T2-4aN0-1 urothelial bladder cancer (UBC), using a response-adapted approach

Key Dates

First listed
Jun 23, 2026
Start date
Sep 1, 2026
Status verified
Jun 2026
Primary completion
Apr 1, 2031
Completion
Apr 1, 2032

Study Design

Enrollment
56 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: After induction therapy and cCR: maintenance pembrolizumab only
    Patients receive four 3-weekly cycles of induction Enfortumab Vedotin on days 1, 8 and Pembrolizumab day 1. If, after tumor assessment, the response is deemed a cCR, patients can be randomized to this group. This arm will receive Pembrolizumab maintenance: 400 mg q6weeks.
  • Experimental: After induction therapy and cCR: consolidative radiotherapy, followed by maintenance pembrolizumab.
    Patients receive four 3-weekly cycles of induction Enfortumab Vedotin on days 1, 8 and Pembrolizumab day 1. If, after tumor assessment, the response is deemed a cCR, patients can be randomized to this group. This arm will receive consolidative radiotherapy followed by Pembrolizumab maintenance: 400 mg q6weeks.
  • Other: By residual disease may still receive bladder-sparing treatment
    Patients receive four 3-weekly cycles of induction Enfortumab Vedotin on days 1, 8 and Pembrolizumab day 1. If, after tumor assessment, the response is deemed a non-cCR, patients can be placed in this group. In this arm, patients may still receive bladder-sparing treatment using chemoradiotherapy (by local protocol; Mitomycin C/fluoropyrimidines in the Netherlands), followed by Pembrolizumab maintenance: 400 mg q6weeks.
  • Other: By residual disease cannot receive bladder-sparing treatment
    Patients receive four 3-weekly cycles of induction Enfortumab Vedotin on days 1, 8 and Pembrolizumab day 1. If, after tumor assessment, the response is deemed a non-cCR, patients can be placed in this group. In this arm, patients will undergo a radical cystectomy, followed by Pembrolizumab maintenance: 400 mg q6weeks.

Primary Outcome Measure

Estimated 2-year bladder-intact event-free survival (BI-EFS) for the intention-to-treat population, measured from day 1 of treatment until the moment of analysis [ Time Frame: From the first dose of study treatment up to 2 years of follow-up ]

Central Contacts

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