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 @ 7:02 PM
Ignite Modification Date:
2025-12-24 @ 7:02 PM
NCT ID:
NCT07048457
Eligibility Criteria:
Inclusion Criteria:
1. Be at least 18 years of age.
2. Have provided informed consent.
3. Have ECOG Performance status of 0 or 1.
4. Be surgical candidate for extirpative surgery of primary site with standard bilateral pelvic lymph node dissection and urinary diversion at the discretion of urological oncologist.
5. If applicable, must be a surgical candidate for resection of non-irradiated metastatic lesion(s) at the discretion of the treating surgeon.
6. Have adequate organ function as defined by:
1. Hgb \>9.0 ng/dL.
2. WBC \>3.0 K/mcL.
3. PLT \>100 K /mcL.
4. AST \<3.0 x ULN U/L.
5. ALT \<3.0 x ULN U/L.
6. Total Bilirubin \<2.0 x UNL mg/dL.
Disease characteristics:
7. Have histologically confirmed diagnosis of locally advanced or oligo-metastatic urothelial carcinoma defined by presence of five or few distinct metastatic lesions at the time of diagnosis of metastatic disease.
8. If variant histology present, it must be \<50% and UC must be predominant.
9. Must have begun the first cycle of enfortumab-vedotin-based first-line therapy at least three months prior to the surgery and have continued therapy and the treatment duration must have not exceeded six months from the start of the first cycle. Treatment interruption, modification and discontinuation due to adverse events are allowed. Metastasis-directed radiotherapy (MDRT) is allowed.
10. The most recent restaging scan prior to signing ICD must show stable disease, partial response or complete response per treating investigator-assessed RECIST v1.1. In case of stable disease or partial response, MDRT is highly recommended. Enrollment of such participants should be discussed with the PI.
Exclusion Criteria:
Participants who meet any of the following criteria will be excluded from study entry.
1. Received systemic anti-cancer therapy within three weeks prior to the surgery.
2. Received radiotherapy within two weeks prior to the surgery.
3. Have a positive serum pregnancy test or women who are breastfeeding.
4. Have other concurrent medical, surgical or psychiatric conditions that, in the treating investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.
5. Have any medical condition that, in the treating investigator's opinion, poses an undue risk to the participant's participation in the study.
6. Have history of central nervous system (CNS) metastasis and/or leptomeningeal metastasis.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07048457
Study Brief:
Protocol Section:
NCT07048457