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New immunotherapy combo takes aim at bladder and urinary tract cancers

NCT ID NCT07815665

Disease control Sponsor: Summit Therapeutics Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Last updated Sep 11, 2026

Summary

Researchers are testing whether adding ivonescimab to enfortumab vedotin works better than adding pembrolizumab to enfortumab vedotin in people with locally advanced or metastatic urothelial cancer who have not yet received systemic treatment. The trial enrolls about 800 adults with cancer of the bladder, renal pelvis, ureter, or urethra. In the first part, researchers check safety and find the best ivonescimab dose; in the second part, they compare how long participants live without their cancer worsening and how long they live overall.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ivonescimab, an experimental immunotherapy drug, given with enfortumab vedotin
What this could lead to
If ivonescimab plus enfortumab vedotin works better than the current standard pairing, it could become a new first-line option for people with advanced urothelial cancer.
What could go wrong
This is an early-phase comparison, and combining two powerful drugs can cause serious side effects. The ivonescimab combination may not outperform the pembrolizumab combination, and results in this trial may not apply to everyone.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 800 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: * 18 years and older * ECOG 0-1 * Life expectancy ≥ 6 months * Histologically documented unresectable LA/mUC (transitional cell carcinoma) of the bladder, renal pelvis, ureter, or urethra with ≥50% urothelial carcinoma component * No prior systemic therapy for LA/mUC * At least one measurable non-cerebral lesion according to RECIST v1.1 * Adequate organ function Exclusion Criteria: * Locally advanced disease that is resectable or suitable for local therapy with curative intent. * Tumors containing any small cell or neuroendocrine differentiation * Ongoing sensory or motor neuropathy Grade 2 or higher. * Radiographic findings consistent with a high risk of bleeding * History of perforation of the gastrointestinal tract and/or fistula, history of gastrointestinal obstruction, extensive bowel resection within 6 months prior to first dose.

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Conditions

The condition(s) this trial relates to.

transitional cell carcinoma urothelial carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic urothelial carcinoma Metastatic urothelial carcinoma (UC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    7 sites. 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

  • Research Site

    NOT_YET_RECRUITING

    Phoenix, Arizona, 85054, United States

  • Research Site

    RECRUITING

    Los Angeles, California, 90067, United States

  • Research Site

    NOT_YET_RECRUITING

    Washington D.C., District of Columbia, 20010, United States

  • Research Site

    NOT_YET_RECRUITING

    Jacksonville, Florida, 32224, United States

  • Research Site

    NOT_YET_RECRUITING

    Rochester, Minnesota, 55905, United States

  • Research Site

    NOT_YET_RECRUITING

    Nashville, Tennessee, 37203, United States

  • Research Site

    RECRUITING

    Spokane, Washington, 99208, United States

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