Locally Advanced Urothelial CarcinomaPhase 2CONSOLIdATE-1NCT07048457
Consolidative Local Therapy (CLT) in Oligo-metastatic Urothelial Carcinoma
A Phase 2 study testing Radical cystectomy in people with Locally Advanced Urothelial Carcinoma and Oligo-metastaic Urothelial Carcinoma, run by Yale University at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Locally Advanced Urothelial Carcinoma, Oligo-metastaic Urothelial Carcinoma
- What is being tested?
- Radical cystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Nov 2025to Nov 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
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- 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. 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
University of Wisconsin Madison
Madison, Wisconsin, 53705
Maria Flory, 608-262-8652, flory@urology.wisc.edu
Kyle A. Richards, MD, FACS
- Recruiting
Yale University
New Haven, Connecticut, 06510
Amanda Davis, 475-321-7899, amanda.davis@yale.edu
Fed Ghali, MD
About this study
Official title: 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
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.
Read the detailed description
This is a single-arm, open-label, phase 2 clinical trial designed to evaluate the impact of consolidative local therapy in participants with locally advanced/oligo-metastatic urothelial carcinoma (UC) who have demonstrated stable or responsive disease to first-line systemic therapy.
- Being tested
- Radical cystectomy
- Keywords
- demonstrated stable or responsive disease to first-line systemic therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical cystectomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Radical cystectomy | Experimental | 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. Receives: Procedure: Radical cystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
12-Month Progression-Free Survival in Patients with Locally Advanced/Oligo-Metastatic Urothelial Carcinoma
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.
Measured: 12 month post-surgery
Secondary outcomes (5)
Frequency of Treatment-Related Adverse Events in Patients with Locally Advanced/Oligo-Metastatic Urothelial Carcinoma
This secondary outcome measure focuses on assessing the frequency and severity of treatment-related adverse events (AEs) in participants with locally advanced or oligo-metastatic urothelial carcinoma (UC) undergoing consolidative therapy. This assessment will utilize the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 to document the type, frequency, and grade of AEs reported by participants during and after the treatment period. The aim is to comprehensively evaluate the safety and tolerability of the consolidative therapy.
Measured: Assessed 30 days and 90 days post-surgery
Frequency of 30-Day Postoperative Complications in Patients with Locally Advanced/Oligo-Metastatic Urothelial Carcinoma
This secondary outcome measure focuses on evaluating the incidence and severity of postoperative complications occurring within 30 days following surgical resection or multi-dose radiotherapy (MDRT) in participants with locally advanced or oligo-metastatic urothelial carcinoma. The assessment will be conducted using the Clavien-Dindo classification system, which categorizes surgical complications based on the intervention required for management. The goal is to understand the short-term impacts of the treatment on patient recovery and ensure that potential risks are clearly identified and managed.
Measured: 30 days post-surgery
Changes in EORTC QLQ-C30 Global Health Status / Quality of Life (GHS/QoL) Subscale Scores Pre- and Post-Intervention Patients with Locally Advanced/Oligo-Metastatic Urothelial Carcinoma
This outcome measure evaluates changes in quality of life using the EORTC QLQ-C30 Global Health Status / Quality of Life (GHS/QoL) subscale. The primary endpoint is the change in GHS/QoL subscale scores from pre-intervention to post-intervention. The scores will be analyzed to determine if there is an improvement in the perceived global health and quality of life of the participants following the intervention.
Measured: At screening, 30 days post-surgery, 180 days post-surgery then finally at 365 days post-surgery
Correlation Between Circulating Tumor DNA (ctDNA) Levels and Disease Recurrence Following Local Therapy in Patients with Locally Advanced/Oligo-Metastatic Urothelial Carcinoma
This secondary outcome measure aims to evaluate the correlation between circulating tumor DNA (ctDNA) levels and disease recurrence in participants with locally advanced or oligo-metastatic urothelial carcinoma (UC) following local therapy, including surgical resection or multi-dose radiotherapy (MDRT).
The assessment will involve:
Changes in ctDNA Status and Quantification: Measuring ctDNA levels at baseline (pre-intervention) and at specified intervals post-intervention to observe changes over time. This includes quantifying the concentration of ctDNA in blood samples using advanced molecular techniques.
Correlation with Disease Recurrence: Analyzing the relationship between ctDNA levels and disease recurrence rates. This will involve comparing ctDNA concentrations with clinical outcomes to determine if changes in ctDNA levels can serve as a predictive biomarker for disease recurrence after local therapy.
Measured: At screening then at 30, 90, 180, 270 and 365 days post-surgery
Changes in EuroQoL Five Dimensions Five Level (EQ-5D-5L) Scores Pre- and Post-Intervention in Patients with Locally Advanced/Oligo-Metastatic Urothelial Carcinoma
This outcome measure evaluates changes in quality of life using the EuroQoL Five Dimension Five Level (EQ-5D-5L) questionnaire. The primary endpoint is the change in EQ-5D-5L scores from pre-intervention to post-intervention. The analysis will include both the single index value for health status and the visual analogue scale (VAS) score, aiming to measure improvements in quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Measured: At screening, 30 days post-surgery, 180 days post-surgery then finally at 365 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start26 Nov 2025
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Urothelial CarcinomaStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fed Ghali, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07048457
- Sponsor's protocol ID
- 2000039076
- Acronym
- CONSOLIdATE-1
- Status last verified
- Oct 2026
- First submitted
- 16 Jun 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No