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Immunotherapy combo shows promise in bladder cancer trial

NCT ID NCT06960577

Disease control Sponsor: AstraZeneca 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Aug 05, 2026 · Updated 2 times

Summary

This study tests whether adding the immunotherapy drug durvalumab to standard chemotherapy before and after bladder cancer surgery is safe and effective. About 150 people with muscle-invasive bladder cancer will receive durvalumab plus either ddMVAC or gemcitabine/cisplatin chemo before surgery, then durvalumab alone after. The goal is to see if this combination reduces side effects and improves outcomes in a real-world setting.

What this could mean

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

Active substance
Durvalumab (an immunotherapy drug) plus chemotherapy (ddMVAC or gemcitabine/cisplatin)
What this could lead to
If successful, this could show that adding durvalumab to standard chemo before and after bladder cancer surgery improves safety and effectiveness, potentially leading to a new standard treatment.
What could go wrong
This is an early-phase, single-arm study with no placebo group, so results may not be definitive. Side effects from combining immunotherapy and chemotherapy can be serious.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 150 people

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

Started

May 2025

Expected to finish

Oct 2028

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: * Participants with clinical tumour stage T2-T4aN0/1M0 or T1N1M0 with transitional or mixed transitional cell histology * Patients must be planning to undergo radical cystectomy * Patients who have not received prior systemic chemotherapy or immunotherapy for treatment of muscle-invasive bladder cancer * ECOG performance status of 0 or 1 * Minimum life expectancy of 12 weeks at first dose of study medication Exclusion criteria: * Evidence of lymph node (N2-N3) or metastatic (M1) disease * Inoperable tumour(s) with fixation to the pelvic wall on clinical examination * Prior exposure to immune-mediated therapy including, but not limited to, other anti CTLA-4, anti-PD 1, anti-PD L1 and anti-PD-L2 antibodies, excluding Bacillus Calmette-Guérin * Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab * Any concomitant medication known to be contraindicated to the chemotherapy (ddMVAC or gem/cis). * Uncontrolled intercurrent illness.

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Conditions

The condition(s) this trial relates to.

infiltrating bladder urothelial carcinoma urinary bladder neoplasm Urinary Bladder Neoplasms

As listed by the trial registrant

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

Cisplatin Doxorubicin Gemcitabine Immune checkpoint inhibitors Methotrexate Urinary bladder neoplasms Vinblastine

How to take part

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

  1. The places running it

    48 sites in 7 countries. 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

    RECRUITING

    Chermside, 4032, Australia

  • Research Site

    RECRUITING

    Elizabeth Vale, 5112, Australia

  • Research Site

    RECRUITING

    Heidelberg, 3084, Australia

  • Research Site

    RECRUITING

    Hong Kong, Australia

  • Research Site

    RECRUITING

    Kogarah, 2217, Australia

  • Research Site

    RECRUITING

    Macquarie University, 2109, Australia

  • Research Site

    RECRUITING

    Murdoch, 6150, Australia

  • Research Site

    WITHDRAWN

    Port Macquarie, 2444, Australia

  • Research Site

    RECRUITING

    St Leonards, 2065, Australia

  • Research Site

    RECRUITING

    Barretos, 14784-400, Brazil

  • Research Site

    WITHDRAWN

    Jaú, 17210-080, Brazil

  • Research Site

    WITHDRAWN

    Natal, 59075-740, Brazil

  • Research Site

    RECRUITING

    Porto Alegre, 91350-200, Brazil

  • Research Site

    WITHDRAWN

    Rio de Janeiro, 20230-130, Brazil

  • Research Site

    RECRUITING

    Santo André, 09060-650, Brazil

  • Research Site

    WITHDRAWN

    São José do Rio Preto, 15090-000, Brazil

  • Research Site

    RECRUITING

    São Paulo, 01246-000, Brazil

  • Research Site

    RECRUITING

    Hamilton, Ontario, L8V 5C2, Canada

  • Research Site

    NOT_YET_RECRUITING

    London, Ontario, N6A 5W9, Canada

  • Research Site

    WITHDRAWN

    Ottawa, Ontario, K1H 8L6, Canada

  • Research Site

    NOT_YET_RECRUITING

    Montreal, Quebec, H3T 1E2, Canada

  • Research Site

    RECRUITING

    Québec, Quebec, G1J 1Z4, Canada

  • Research Site

    RECRUITING

    Sherbrooke, Quebec, J1H 5N4, Canada

  • Research Site

    NOT_YET_RECRUITING

    Angers, 49055, France

  • Research Site

    WITHDRAWN

    Angers, 49933, France

  • Research Site

    NOT_YET_RECRUITING

    Bordeaux, 33075, France

  • Research Site

    RECRUITING

    Chambray-lès-Tours, 37170, France

  • Research Site

    WITHDRAWN

    Dijon, 21079, France

  • Research Site

    RECRUITING

    Lille, 59037, France

  • Research Site

    RECRUITING

    Lyon, 69008, France

  • Research Site

    RECRUITING

    Marseille, 13009, France

  • Research Site

    RECRUITING

    Montpellier, 34070, France

  • Research Site

    RECRUITING

    Nice, 06189, France

  • Research Site

    RECRUITING

    Nîmes, 30029, France

  • Research Site

    RECRUITING

    Paris, 75010, France

  • Research Site

    RECRUITING

    Paris, 75900, France

  • Research Site

    NOT_YET_RECRUITING

    Pierre-Bénite, 69310, France

  • Research Site

    RECRUITING

    Poitiers, 86021, France

  • Research Site

    RECRUITING

    Quint-Fonsegrives, 31130, France

  • Research Site

    RECRUITING

    Rennes, 35000, France

  • Research Site

    WITHDRAWN

    Rouen, 76230, France

  • Research Site

    RECRUITING

    Strasbourg, 67033, France

  • Research Site

    RECRUITING

    Suresnes, 92150, France

  • Research Site

    RECRUITING

    Florence, 50139, Italy

  • Research Site

    RECRUITING

    Orbassano, 10043, Italy

  • Research Site

    RECRUITING

    Roma, 00144, Italy

  • Research Site

    NOT_YET_RECRUITING

    Amsterdam, 1066CX, Netherlands

  • Research Site

    WITHDRAWN

    Nijmegen, 6500 HB, Netherlands

  • Research Site

    NOT_YET_RECRUITING

    Rotterdam, 3015 GD, Netherlands

  • Research Site

    RECRUITING

    Barcelona, 08025, Spain

  • Research Site

    RECRUITING

    Barcelona, 08035, Spain

  • Research Site

    RECRUITING

    Barcelona, 08036, Spain

  • Research Site

    RECRUITING

    Barcelona, 8003, Spain

  • Research Site

    RECRUITING

    Girona, 17007, Spain

  • Research Site

    WITHDRAWN

    Las Palmas de Gran Canaria, 35016, Spain

  • Research Site

    RECRUITING

    Lugo, 27003, Spain

  • Research Site

    RECRUITING

    Madrid, 28033, Spain

  • Research Site

    RECRUITING

    Madrid, 28040, Spain

  • Research Site

    RECRUITING

    Santiago de Compostela, 15706, Spain

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