New strategy aims to eliminate residual bladder cancer after drug combo
NCT ID NCT07579195
First seen Jun 25, 2026 · Last updated Aug 26, 2026 · Updated 7 times
Summary
This early-phase trial tests whether adding radiation therapy or bladder removal surgery can safely eliminate remaining cancer in patients with advanced bladder cancer who have already responded to a drug combination. The study enrolls 12 adults with muscle-invasive bladder cancer that has spread to lymph nodes or a few distant sites. The goal is to see if this approach can delay cancer progression and allow patients to stop systemic therapy sooner, reducing long-term side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- enfortumab vedotin plus pembrolizumab followed by radiation therapy or surgery
- What this could lead to
- If successful, this approach could allow patients to stop systemic therapy earlier, reducing side effects while maintaining cancer control.
- What could go wrong
- This is a small, early-phase feasibility trial with only 12 participants, so results may not apply broadly. Radiation and surgery carry risks of side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- Expected to finish
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Feb 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fred Hutch/University of Washington Cancer Consortium
RECRUITINGSeattle, Washington, 98109, United States
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Other studies related to the condition(s) this trial covers.
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- New hope for bladder cancer patients who Can't take chemo
- Keytruda may let some bladder cancer patients avoid bladder removal