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New hope for bladder cancer patients who Can't take chemo?

NCT ID NCT03459846

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 06, 2026 · Updated 2 times

Summary

This Phase 2 trial is testing whether combining two drugs, durvalumab (an immunotherapy) and olaparib (a targeted therapy), can help people with advanced bladder cancer who are not healthy enough for standard platinum chemotherapy. About 154 participants will receive either the drug combo or a placebo. The study aims to see if the combination slows cancer growth and improves survival.

What this could mean

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

Active substance
durvalumab and olaparib
What this could lead to
If successful, this combination could offer a new first-line treatment option for advanced bladder cancer patients who cannot tolerate standard chemotherapy.
What could go wrong
This is a Phase 2 trial with only 154 participants, so results are preliminary. The combination may not improve survival and could cause side effects like fatigue, nausea, or immune-related reactions.

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

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

154 people

The number who actually took part.

Started

Mar 2018

Expected to finish

Dec 2026

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: 1. Provision of signed and dated, written ICF 2. Histologically or cytologically documented TCC/UC of the urothelium (including renal pelvis, ureters, urinary bladder, and urethra) also meeting the following: Unresectable, Stage IV disease; No prior systemic therapy for unresectable, Stage IV disease. 3. Ineligible for platinum-based chemotherapy defined as (i) in the opinion of the Investigator, unfit for carboplatin-based chemotherapy and (ii) meeting one of the following criteria: CrCl \<60 mL/min calculated by Cockcroft-Gault equation; Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥2 audiometric hearing loss (25 dB in 2 consecutive wave ranges); CTCAE Grade ≥2 peripheral neuropathy; New York Heart Association Class III heart failure; ECOG 2. 4. Known tumor HRR mutation status prior to randomization. 5. World Health Organization (WHO)/ECOG performance status of 0, 1, or 2. 6. Patients with at least 1 RECIST 1.1 target lesion at baseline. 7. Ability to swallow oral medications. 8. Evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients. Exclusion criteria 1. Active or prior documented autoimmune or inflammatory disorders. 2. Other invasive malignancy within 5 years before the first dose of the IP. 3. Major surgical procedure within 28 days prior to the first dose 4. Brain metastases or spinal cord compression unless the patient's condition is stable and off steroid for at least 14 days 5. History of active primary immunodeficiency. 6. Active infection including tuberculosis (TB) 7. History of allogenic organ transplantation. 8. Uncontrolled intercurrent illness 9. Prior exposure to a PARP inhibitor or immune-mediated therapy. 10. Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. 11. Current or prior use of immunosuppressive medication within 14 days before the first dose of the IP. 12. No radiation therapy is allowed, unless it is (1) definitive radiation that had been administered at least 12 months prior; (2) palliative radiation to the brain, with associated criteria for stability or lack of symptoms; or (3) palliative radiation to painful bony lesions (this must comprise less than 30% of the bone marrow) or symptomatic pelvic soft tissue mass(es). 13. Receipt of live attenuated vaccine within 30 days prior to the first dose of the IP. 14. Patients with a known hypersensitivity to durvalumab, olaparib, or any of the excipients of the products. 15. Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab and 6 months for participants taking also Olaparib in case of female participants, 90 days after receipt of the last dose of the IP in case of male participants.

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Conditions

The condition(s) this trial relates to.

bladder transitional cell carcinoma urinary bladder neoplasm Urinary Bladder Neoplasms urothelial carcinoma

As listed by the trial registrant

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

Urinary bladder neoplasms

Contacts and locations

Locations

  • Research Site

    Birmingham, Alabama, 35294, United States

  • Research Site

    Goodyear, Arizona, 85338, United States

  • Research Site

    Fort Myers, Florida, 33901, United States

  • Research Site

    St. Petersburg, Florida, 33705, United States

  • Research Site

    Tampa, Florida, 33612, United States

  • Research Site

    Louisville, Kentucky, 40202, United States

  • Research Site

    New Hyde Park, New York, 11042, United States

  • Research Site

    New York, New York, 10065, United States

  • Research Site

    The Bronx, New York, 10461, United States

  • Research Site

    Philadelphia, Pennsylvania, 19124, United States

  • Research Site

    Nashville, Tennessee, 37232, United States

  • Research Site

    Tacoma, Washington, 98405, United States

  • Research Site

    Greater Sudbury, Ontario, P3E 5J1, Canada

  • Research Site

    Hamilton, Ontario, L8V 5C2, Canada

  • Research Site

    Newmarket, Ontario, L3Y 2P9, Canada

  • Research Site

    Toronto, Ontario, M5G 2M9, Canada

  • Research Site

    Montreal, Quebec, H3T 1E2, Canada

  • Research Site

    Moscow, 105077, Russia

  • Research Site

    Moscow, 125367, Russia

  • Research Site

    Novosibirsk, 630108, Russia

  • Research Site

    Omsk, 644013, Russia

  • Research Site

    Saint Petersburg, 194354, Russia

  • Research Site

    Saint Petersburg, 195271, Russia

  • Research Site

    Saint Petersburg, 199178, Russia

  • Research Site

    Incheon, 21565, South Korea

  • Research Site

    Seoul, 02841, South Korea

  • Research Site

    Seoul, 03722, South Korea

  • Research Site

    Seoul, 05505, South Korea

  • Research Site

    Seoul, 06351, South Korea

  • Research Site

    Barcelona, 08036, Spain

  • Research Site

    Madrid, 08035, Spain

  • Research Site

    Madrid, 28041, Spain

  • Research Site

    Málaga, 29010, Spain

  • Research Site

    Santiago de Compostela, 15706, Spain

  • Research Site

    Kaohsiung City, 807, Taiwan

  • Research Site

    Kaohsiung City, Taiwan

  • Research Site

    Taichung, 40705, Taiwan

  • Research Site

    Tainan, 704, Taiwan

  • Research Site

    Taipei, 10002, Taiwan

  • Research Site

    Taipei, 104, Taiwan

  • Research Site

    Taipei, 112, Taiwan

  • Research Site

    Taoyuan City, 333, Taiwan

  • Research Site

    Hanoi, 100000, Vietnam

  • Research Site

    Ho Chi Minh City, 700000, Vietnam

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