Consolidative therapy after initial response in advanced bladder cancer
Official title: Consolidative Radiation Therapy or Cystectomy After Initial Favorable Response Succeeding Enfortumab Vedotin Plus Pembrolizumab (REINFORCE)--- A Pilot Feasibility Trial
Run by University of Washington · NCT07579195 · Data updated 2026-11-12
This pilot trial tests adding radiation or surgery after a good response to EV + pembrolizumab in unresectable or oligometastatic muscle-invasive bladder cancer to see if residual disease can be eliminated or delayed from growing.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 12 (estimated) |
| Sponsor | University of Washington Academic / other |
| Drugs / interventions | radiation, enfortumab, pembrolizumab, chemotherapy |
| Locations | 1 site (Seattle, Washington) |
| Status | Recruiting |
| Started | August 20, 2026 |
| Main results expected | February 1, 2030 |
| Study ends | February 1, 2030 |
| Registry record updated | August 25, 2026 |
| Trial ID | NCT07579195 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with muscle-invasive bladder cancer (including stage III/IV per AJCC v8) who achieved complete or partial response after induction EV + pembrolizumab and have limited metastatic disease (oligometastases) or residual disease.
✕Probably not a fit
Patients with widespread metastases beyond oligometastatic criteria or those who do not achieve a radiographic response after induction therapy may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-arm phase I/II study evaluating consolidative local therapies after an initial favorable response to enfortumab vedotin and pembrolizumab in patients with advanced bladder cancer. Participants may receive bladder/pelvic radiation, potentially with radiosensitizing chemotherapy, or radical cystectomy, depending on response and physician discussion. Metastasis-directed therapy is applied for disease outside the bladder regardless of bladder status. The trial aims to determine safety and feasibility of this approach and its impact on progression-free survival. Eligible patients have completed 3-9 cycles of induction EV + pembro and meet specific metastatic criteria.
Why it matters
Potential benefit: If successful, the strategy could reduce residual cancer burden and potentially delay progression, improving long-term outcomes and quality of life.
How similar studies have gone: Prior regimens combining systemic therapy with consolidative local therapy have shown some promise in select patients with oligometastatic disease, supporting exploration of this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \>= 18 at the time of screening * Ability to understand and willingness to sign a written informed consent document * Histopathologically confirmed cTxN1-3M0, cTxNxM1 or cT4bNxM0 muscle invasive bladder cancer at initial diagnosis * Achieved a radiographic complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 criteria and at the determination of treating physicians) after 3-9 cycles of induction EV + pembro * If M1 after completion of EV + pembro, patients need to have =\< 5 sites of metastasis and all sites of metastasis should be extracranial * Note: when counting the number of oligometastatic lesions, each lymph node lesion, whether pelvic or extrapelvic, is counted (for example, 2 distinct lymph nodes in the right external iliac basin count as 2 oligometastatic lesions; one extrapelvic and one pelvic node count as 2 oligometastatic lesions, etc). Five or fewer sites of metastasis applies after the completion of EV + pembro, not at initial diagnosis * Be a candidate for consolidative radiation therapy (RT) to the pelvis (if indicated) or cystectomy (if indicated), and all sites of metastasis are amenable to RT * Life expectancy \> 6 months * Eastern Cooperative Oncology Group (ECOG) performance 0-2 * Absolute neutrophil count (ANC) \>= 1500 /mcL (within 180 days of trial registration) * Platelets \>= 100,000/mcL (within 180 days of trial registration) * Hemoglobin \> 9 g/dL (within 180 days of trial registration) * Creatinine =\< 1.5 x upper limit of normal (ULN) OR \>= 60 mL/min (within 180 days of trial registration) * Total bilirubin =\< 1.5 ULN OR direct bilirubin =\< ULN if total bilirubin \> 1.5 x ULN (within 180 days of trial registration) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x ULN OR \< 5 x ULN if patient has live metastasis (within 180 days of trial registration) * Albumin \>= 2.5 g/dL (within 180 days of trial registration) * International normalized ratio (INR) or prothrombin time (PT) =\< 1.5 x ULN unless on anticoagulation therapy, in which case PT or partial thromboplastin time (PTT) should be in the therapeutic range (within 180 days of trial registration) * PTT =\< 1.5 x ULN unless on anticoagulation therapy, in which case PT or PTT should be in the therapeutic range (within 180 days of trial registration) * Participants of child-bearing potential must be willing to employ two highly effective and acceptable forms of contraception during, and for at least 90 days after the end of radiation therapy. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 72 hours of treatment initiation * HIV-infected patients who are healthy and have a low risk of AIDS-related outcomes are included in this trial Exclusion Criteria: * Prior radiation therapy with field overlapping with current proposed radiation field, precluding delivery of meaningful dose of radiation * Intracranial metastasis * Any small cell component, or predominant (\> 50%) sarcomatoid or plasmacytoid histology * Other active malignancy or clinically relevant malignancy within past 2 years, per discussion with the principal investigator * Genetic conditions that increase sensitivity to radiation, such as Fanconi syndrome, ataxia telangiectasia, and Nijmegen breakage syndrome * Active human immunodeficiency virus (HIV) not adequately controlled, active hepatitis B (e.g., hepatitis B virus surface antigen \[HBsAg\] reactive) or hepatitis C (e.g., hepatitis C virus \[HCV\] ribonucleic acid \[RNA\] \[qualitative\] is detected), as determined by standard of care testing * Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial * Any other medical condition that may interfere with trial therapy delivery * Adults with impaired decision-making capacity, as determined by the treating physician
Where it's running
-
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States Recruiting
Study contacts
- Principal investigator: T. Martin Ma, MD, PhD — Fred Hutch/University of Washington Cancer Consortium
- Study coordinator: T. Martin Ma, MD, PhD
- Email: mma1@uw.edu
- Phone: 206-606-7318
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Combination of Enfortumab Vedotin and Pembrolizumab with Surgery for Advanced Bladder Cancer
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This trial tests a three-drug combination to see if it can safely treat unresectable or metastatic urothelial cancer in adults.
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Combining enfortumab vedotin and pembrolizumab with radiation for muscle invasive bladder cancer
This study is testing a new combination of a drug and radiation therapy to see if it helps people with muscle invasive bladder cancer who want to avoid surgery.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.