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 @ 3:30 PM
Ignite Modification Date:
2025-12-24 @ 3:30 PM
NCT ID:
NCT05496192
Eligibility Criteria:
Inclusion Criteria:
* Participant must have Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
* Participants must be eligible for adjuvant therapy for melanoma or muscle-invasive Urothelial Carcinoma (UC) originating from the bladder.
* All participants must have disease-free status (DFS) documented by a complete physical examination and imaging studies within 4 weeks prior to treatment assignment.
Exclusion Criteria:
* History of ocular or uveal or mucosal melanoma.
* Upper tract UC (ureter, renal pelvis), non-muscle-invasive UC.
* Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment assignment.
* Untreated/unresected Central Nervous System (CNS) or leptomeningeal metastases.
Other protocol-defined inclusion/exclusion criteria apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05496192
Study Brief:
Protocol Section:
NCT05496192