Enfortumab Vedotin + Pembrolizumab Induction to Spare the Bladder in MIBC
ConditionUrothelial Bladder Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Netherlands Cancer Institute
About this trial
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
Eligibility criteria
Qualifiers
Participants who are at least 18 years of age on the day of signing informed consent.
The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
Patients with histologically confirmed cT2-4aN0-1M0 urothelial bladder cancer, seeking an alternative to radical cystectomy and/or patients who are medically unfit for surgery.
no pure (>90%) squamous
Disqualifiers
Previous pelvic irradiation
Upper tract urothelial cancer
Extensive carcinoma in situ (CIS) of the bladder
Bilateral hydronephrosis
Trial design
Treatments tested in this trial
- Enfortumab Vedotin
- Pembrolizumab
- Radiation
- Chemoradiation
- Cystectomy
Treatment groups
56 Participants
are divided into 4 treatment groupsSponsors and collaborators
The Netherlands Cancer Institute
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
Astellas Pharma Inc
Collaborator
Source ClinicalTrials.gov