NCT07048457 · Yale University
Consolidative Local Therapy (CLT) in Oligo-metastatic Urothelial Carcinoma
(CONSOLIdATE-1)
What this study is about
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.
View original scientific description
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.
Interventions
PROCEDURE
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.
Primary outcome measures
12-Month Progression-Free Survival in Patients with Locally Advanced/Oligo-Metastatic Urothelial Carcinoma
Time frame: 12 month post-surgery
The primary outcome measure for this study is to evaluate the 12-month progression-free survival of consolidative therapy in participants with locally advanced or oligo-metastatic urothelial carcinoma (UC). PFS will be assessed by measuring the time from the initiation of consolidative therapy to the occurrence of disease progression or death from any cause, whichever comes first. The primary endpoint for this outcome measure is the one-year progression-free survival rate, which represents the proportion of patients remaining free from disease progression or death at 12 months following the treatment. Data collected will provide insight into the efficacy of consolidative therapies in prolonging disease stability and improving survival outcomes for this patient population.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- Participants who meet any of the following criteria will be excluded from study entry.
- Received systemic anti-cancer therapy within three weeks prior to the surgery.
- Received radiotherapy within two weeks prior to the surgery.
- Have a positive serum pregnancy test or women who are breastfeeding.
- 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.
- Have any medical condition that, in the treating investigator's opinion, poses an undue risk to the participant's participation in the study.
- Have history of central nervous system (CNS) metastasis and/or leptomeningeal metastasis.
Where
- New Haven, Connecticut
Collaborators
Medical College of Virginia Foundation
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 10, 2026 · Source of record for eligibility and locations