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Bladder cancer duo: BCG plus immunotherapy drug shows promise in early trial

NCT ID NCT05943106

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 14, 2026 · Updated 2 times

Summary

This phase 3 trial is testing whether adding the immunotherapy drug durvalumab to standard BCG treatment can safely control high-risk non-muscle-invasive bladder cancer. About 100 adults who have never received BCG before will get both treatments for up to a year. The main goal is to check for serious side effects, while also seeing how well the combination works.

What this could mean

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

Active substance
BCG (a weakened germ given into the bladder) plus durvalumab (an immunotherapy drug given by IV)
What this could lead to
If it works, this combination could offer a more effective way to control high-risk bladder cancer and reduce the chance of it coming back.
What could go wrong
This is an early-phase, single-arm study with no placebo group, so results may not prove the combination is better than standard care. Side effects from both drugs could 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

100 people

The number who actually took part.

Started

Aug 2023

Expected to finish

Mar 2027

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 to 130 years

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: * BCG-naïve (defined as participants not having received prior intravesical BCG or who previously received but stopped BCG more than 3 years before study entry). * Local histological confirmation (based on cytology and/or pathology report) of high-risk transitional cell carcinoma of the urothelium of the urinary bladder confined to the mucosa or submucosa. * Complete resection of all Ta/T1 papillary disease prior to enrollment, with the transurethral resection of bladder tumor (TURBT) removing high-risk NMIBC (non-muscle invasive bladder cancer) performed not more than 4 months before enrollment in the study. * No prior radiotherapy for bladder cancer. * A life expectancy of at least 12 weeks (90 days). * Adequate organ and marrow function * World Health Organization/Eastern Cooperative Oncology Group performance status of 0 or 1 at screening * No prior exposure to immune-mediated therapy of cancer * A candidate for BCG treatment. * Local histological confirmation (based on cytology and/or pathology report) of high-risk transitional cell carcinoma of the urothelium of the urinary bladder confined to the mucosa or submucosa. A high-risk tumor is defined as one of the following: T1 tumor; High-grade/G3 tumor; CIS. Exclusion Criteria: * Evidence of muscle-invasive, locally advanced, metastatic, and/or extra-vesical bladder cancer (ie, T2, T3, T4, and / or Stage IV). * Predominantly variant histology such as micropapillary, plasmacytoid, nested, sarcomatoid, microcystic, squamous and adeno variants of UC representing \> 50% of tumor tissue or other than urothelial tumors as assessed by pathology. * Evidence of lymphovascular invasion of bladder tumor, except if treatment with BCG is deemed to be the only clinically viable treatment. * Immediate cystectomy is indicated. * Known or documented absolute and/or relative contraindication of adjuvant intravesical BCG treatment. * Concurrent extravesical, non-muscle-invasive transitional cell carcinoma of the urothelium. * History of allogenic organ transplantation. Participants with any history of allogenic stem cell transplantation are also excluded. * Active or prior documented autoimmune or inflammatory disorders. * Participants with hypothyroidism stable on hormone replacement. * History of active primary immunodeficiency. * Active infection including hepatitis B (known positive HBV/HBsAg result), HCV, or HIV 1/2 (positive HIV) antibodies. * Current or prior use of immunosuppressive medication within 14 days before the first durvalumab dose. * Female participants who are pregnant or breastfeeding or male or female participants of reproductive potential who are not willing to employ highly effective birth control. * Any concurrent chemotherapy, study intervention, biologic or hormonal therapy for cancer treatment; uncontrolled intercurrent illness; * History of another primary malignancy except for Malignancy treated with curative intent and with no known active disease ≥ 2 years; Adequately treated nonmelanoma skin cancer or lentigo maligna without evidence of disease; Adequately treated CIS without evidence of disease; Prostate cancer of stage ≤ T2cN0M0 without biochemical recurrence or progression that in the opinion of the Investigator does not require active intervention. * Previous or concurrent treatment with potent systemic immunostimulatory agents

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Conditions

The condition(s) this trial relates to.

non-invasive bladder urothelial carcinoma Non-Muscle Invasive Bladder Neoplasms superficial urinary bladder carcinoma

As listed by the trial registrant

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

Non-muscle invasive bladder cancer

Contacts and locations

Locations

  • Research Site

    Phoenix, Arizona, 85054, United States

  • Research Site

    Little Rock, Arkansas, 72211, United States

  • Research Site

    San Diego, California, 92123, United States

  • Research Site

    Lakewood, Colorado, 80228, United States

  • Research Site

    Hialeah, Florida, 33016, United States

  • Research Site

    Jacksonville, Florida, 32209, United States

  • Research Site

    Greenwood, Indiana, 46143, United States

  • Research Site

    Wichita, Kansas, 67226, United States

  • Research Site

    Baltimore, Maryland, 21203, United States

  • Research Site

    Hanover, Maryland, 21076, United States

  • Research Site

    Royal Oak, Michigan, 48073, United States

  • Research Site

    Troy, Michigan, 48084, United States

  • Research Site

    Syracuse, New York, 13210, United States

  • Research Site

    Cincinnati, Ohio, 45212, United States

  • Research Site

    Bala-Cynwyd, Pennsylvania, 19004-1017, United States

  • Research Site

    Myrtle Beach, South Carolina, 29572, United States

  • Research Site

    Nashville, Tennessee, 37209, United States

  • Research Site

    Austin, Texas, 78759, United States

  • Research Site

    Spokane, Washington, 99202, United States

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