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 @ 1:00 PM
Ignite Modification Date:
2025-12-24 @ 1:00 PM
NCT ID:
NCT06138561
Eligibility Criteria:
Inclusion Criteria:
* Age ≥65-years-old (study will limit total enrollment of patients between ages 65-70 to 20% of the total study population)
* Unresectable or metastatic bladder cancer with histologically proven urothelial carcinoma. Any component of variant histology is allowed
* Cisplatin-ineligible as determined by the subject's primary oncologist
* Receiving treatment with chemotherapy (+/- immunotherapy maintenance), enfortumab vedotin-pembrolizumab combination therapy or immunotherapy alone
* Ability to understand and the willingness to sign a written informed consent document and to complete patient reported outcomes that will be in English or Spanish either alone or with assistance of study researcher or family
Exclusion Criteria:
* Subjects who elect to not undergo cancer-directed therapy
* Subjects obtaining their care outside of DFCI or DFCI affiliate sites
* Advanced cognitive impairment or inability to complete surveys
* Participants who are receiving any other investigational agents for this condition (if appropriate only).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT06138561
Study Brief:
Protocol Section:
NCT06138561