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 @ 10:41 PM
Ignite Modification Date:
2025-12-24 @ 10:41 PM
NCT ID:
NCT05699135
Eligibility Criteria:
Inclusion Criteria:
* Enrolled in the Canadian avelumab1LM Patient support program (PSP)
* Histologically confirmed diagnosis of stage IV LA/mUC
* No evidence of disease progression following first-line platinum-based chemotherapy
* Receipt of avelumab1LM following 1L platinum-based chemotherapy
* Received the last dose of chemotherapy no more than 10 weeks before entering the PSP
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* ≥6 months of follow-up from initiation of AVE 1LM therapy until study end date, unless the patient has died, with known date of death.
Exclusion Criteria:
* Diagnosed with LA/mUC and enrolled in the PSP, but did not receive avelumab
* Pregnancy at index date
* Participation in an interventional clinical trial at any point during the study period
The index date will be considered as the initiation of index therapy. The index therapy will be considered as the avelumab 1LM treatment after 1L platinum-based chemotherapy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05699135
Study Brief:
Protocol Section:
NCT05699135