Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New strategy aims to eliminate residual bladder cancer after drug combo

NCT ID NCT07579195

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 12 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Feb 2030

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Muscle-invasive bladder carcinoma are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Fred Hutch/University of Washington Cancer Consortium

    RECRUITING

    Seattle, Washington, 98109, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.