Brief Title: Consolidative Local Therapy (CLT) in Oligo-metastatic Urothelial Carcinoma

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: 12-Month Progression-Free Survival in Patients with Locally Advanced/Oligo-Metastatic Urothelial Carcinoma

Primary Outcome 1 - Timeframe: 12 month post-surgery

CONDITION

• Locally Advanced Urothelial Carcinoma
• Oligo-metastaic Urothelial Carcinoma

ELIGIBILITY

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. 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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Fed Ghali, MD

Role: Principal Investigator

Affiliation: Yale University

Overall Contact

Name: Ashley Yu

Phone: 6262528737

Email: [email protected]

LOCATION