A Study of Durvalumab Alone and Durvalumab+Olaparib in Advanced, Platinum-Ineligible Bladder Cancer (BAYOU)
NCT ID: NCT03459846
Last Updated: 2026-01-30
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE2
154 participants
INTERVENTIONAL
2018-03-16
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm 2: Durvalumab/Olaparib
Durvalumab 1500 mg IV q4w starting on week 1 day 1/Olaparib PO 300 mg BID adjusted based on patient's creatinine clearance.
Durvalumab
Durvalumab 1500 mg IV q4w
Olaparib
Olaparib PO 300 mg BID adjusted based on patient's creatinine clearance.
Arm 1: Durvalumab/Placebo
Durvalumab 1500 mg intravenous (IV) every 4 weeks (q4w) starting on week 1 day 1/Placebo orally (PO) twice a day (BID) starting on week 1 day 1.
Durvalumab
Durvalumab 1500 mg IV q4w
Placebo
Matching placebo for oral tablet BID
Interventions
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Durvalumab
Durvalumab 1500 mg IV q4w
Olaparib
Olaparib PO 300 mg BID adjusted based on patient's creatinine clearance.
Placebo
Matching placebo for oral tablet BID
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
130 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Jonathan Rosenberg, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Mark Lanasa, MD
Role: STUDY_DIRECTOR
One MedImmune Way,Gaithersburg,Maryland,United States
Locations
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Research Site
Birmingham, Alabama, United States
Research Site
Goodyear, Arizona, United States
Research Site
Fort Myers, Florida, United States
Research Site
St. Petersburg, Florida, United States
Research Site
Tampa, Florida, United States
Research Site
Louisville, Kentucky, United States
Research Site
New Hyde Park, New York, United States
Research Site
New York, New York, United States
Research Site
The Bronx, New York, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Nashville, Tennessee, United States
Research Site
Tacoma, Washington, United States
Research Site
Greater Sudbury, Ontario, Canada
Research Site
Hamilton, Ontario, Canada
Research Site
Newmarket, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Moscow, , Russia
Research Site
Moscow, , Russia
Research Site
Novosibirsk, , Russia
Research Site
Omsk, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Incheon, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Barcelona, , Spain
Research Site
Madrid, , Spain
Research Site
Madrid, , Spain
Research Site
Málaga, , Spain
Research Site
Santiago de Compostela, , Spain
Research Site
Kaohsiung City, , Taiwan
Research Site
Kaohsiung City, , Taiwan
Research Site
Taichung, , Taiwan
Research Site
Tainan, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Taoyuan, , Taiwan
Research Site
Hanoi, , Vietnam
Research Site
Ho Chi Minh City, , Vietnam
Countries
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References
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Rosenberg JE, Park SH, Kozlov V, Dao TV, Castellano D, Li JR, Mukherjee SD, Howells K, Dry H, Lanasa MC, Stewart R, Bajorin DF. Durvalumab Plus Olaparib in Previously Untreated, Platinum-Ineligible Patients With Metastatic Urothelial Carcinoma: A Multicenter, Randomized, Phase II Trial (BAYOU). J Clin Oncol. 2023 Jan 1;41(1):43-53. doi: 10.1200/JCO.22.00205. Epub 2022 Jun 23.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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2017-004556-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D933IC00003
Identifier Type: -
Identifier Source: org_study_id
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