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NCT07663747
Enfortumab Vedotin + Pembrolizumab Induction to Spare the Bladder in MIBC
Conditions: Urothelial Bladder Cancer
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 56
Sponsor: The Netherlands Cancer Institute
Location: Antoni van Leeuwenhoek ziekenhuis Amsterdam
Summary
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
Inclusion Criteria:
1. Participants who are at least 18 years of age on the day of signing informed consent.
2. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
3. 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.
Variant histology allowed, exceptions:
* no pure (\>90%) squamous
* no \>50% adenocarcinoma
* no \>50% sarcomatoid component
* no \>10% plasmacytoid component
* no small cell component
4. Archival tumor tissue sample or newly obtained TURB of the bladder tumor is available. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides.
5. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention.
6. Have adequate organ function as defined in Table 3 below. Specimens must be collected within 14 days prior to the start of study intervention.
7. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
* Not of childbearing potential (see section 9.2.1) OR
* Of childbearing potential and:
* Uses a contraceptive method that is highly effective (with a failure rate of \
Source: ClinicalTrials.gov (NCT07663747). StuddyBuddy aggregates publicly available trial information.