A Phase II Study of Consolidative Local Therapy in Patients With Locally Advanced or Oligo-metastatic Urothelial Carcinoma (la/mUC) Following Treatment Response to Systemic Therapy With or Without Metastasis-directed Radiotherapy

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This study investigates the therapeutic benefit of consolidative local therapy with extirpative surgery for participants with locally advanced or oligo-metastatic urothelial carcinoma that have disease control with enfortumab vedotin-based systemic therapy and surgically resectable or previously radiated metastatic sites.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Be at least 18 years of age.

• Have provided informed consent.

• Have ECOG Performance status of 0 or 1.

• 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.

• If applicable, must be a surgical candidate for resection of non-irradiated metastatic lesion(s) at the discretion of the treating surgeon.

• Have adequate organ function as defined by:

∙ Hgb \>9.0 ng/dL.

‣ WBC \>3.0 K/mcL.

‣ PLT \>100 K /mcL.

‣ AST \<3.0 x ULN U/L.

‣ ALT \<3.0 x ULN U/L.

‣ Total Bilirubin \<2.0 x UNL mg/dL.

• Disease characteristics:

• 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.

• If variant histology present, it must be \<50% and UC must be predominant.

• 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.

⁃ 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.

Locations
United States
Connecticut
Yale University
RECRUITING
New Haven
Contact Information
Primary
Laura Kane
laura.kane@yale.edu
7733696904
Time Frame
Start Date: 2025-11-26
Estimated Completion Date: 2028-11
Participants
Target number of participants: 32
Treatments
Experimental: Radical cystectomy
The intervention in this clinical trial consists of definitive surgical management through radical cystectomy with bilateral pelvic lymph node dissection (PLND), urinary diversion, and metastasectomy of surgically resectable or previously radiated metastatic disease. Surgical approach may be either open or robotic, based on surgeon discretion and patient-specific factors. The PLND will be performed in a standard oncologic fashion, including dissection of the common iliac, external iliac, internal iliac, and obturator nodal basins bilaterally. In cases where metastatic lymph nodes are identified beyond these regions, the lymph node dissection may be extended to achieve gross resection of involved nodal disease within the abdomen or retroperitoneum.
Related Therapeutic Areas
Sponsors
Collaborators: Medical College of Virginia Foundation
Leads: Yale University

This content was sourced from clinicaltrials.gov