Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2025-12-24 @ 6:35 PM
NCT ID:
NCT06657157
Eligibility Criteria:
Inclusion Criteria:
* Adult patients, ≥18 years of age at the time of signing the informed consent form (ICF)
* Patients with histologically confirmed metastatic or locally advanced, unresectable urothelial carcinoma
* Patients who did not receive any systemic treatment for their laUC or mUC (treatment-naïve)
* Patients who are able to receive enfortumab vedotin and pembrolizumab according to the respective medicinal product information
Exclusion Criteria:
* Patients with contraindications for enfortumab vedotin and/or pembrolizumab
* Patients who have received a systemic therapy for their laUC or mUC (e.g. platinum-based chemotherapy, checkpoint-inhibitors)
* Patients who have previously been treated with enfortumab vedotin, other MMAE-based antibody-drug-conjugates or PD-(L)1-checkpoint inhibitors
* Patients who received neoadjuvant or adjuvant platinum-based chemotherapy \<12 months ago
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06657157
Study Brief:
Protocol Section:
NCT06657157