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Active, not recruitingNCT03459846BAYOUUpdated Aug 5, 2026Results posted

A Study of Durvalumab Alone and Durvalumab+Olaparib in Advanced, Platinum-Ineligible Bladder Cancer (BAYOU)

A Phase 2 interventional study of Durvalumab and Olaparib in Urinary Bladder Neoplasms, sponsored by AstraZeneca. Active, not recruiting at 44 sites in 7 countries. Open to participants aged 18 Years to 130 Years. Per ClinicalTrials.gov, last updated 2026-08-05.

Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
154
Allocation
Randomized
Ages
18 Years to 130 Years
Sex
All
01

Study summary

A Phase II, Randomized, Multi-Center, Double-Blind, Comparative Global Study to Determine the Efficacy and Safety of Durvalumab in Combination With Olaparib for First-Line Treatment in Platinum-Ineligible Patients With Unresectable Stage IV Urothelial Cancer

Read the detailed description

This is a Phase II, randomized, double-blind, placebo controlled, multi-center, comparative global study to determine the efficacy and safety of durvalumab + olaparib combination therapy versus durvalumab + placebo (durvalumab monotherapy) as first-line treatment in patients ineligible for platinum-based chemotherapy with unresectable Stage IV urothelial cancer (UC).

02

Conditions studied

  • Urinary Bladder Neoplasms

Keywords

  • Urinary Bladder Neoplasms
03

Who can participate

Ages eligible
18 Years to 130 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
154 participants (actual)

Study arms

  • Experimental
    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.

    Drug: Durvalumab · Drug: Placebo

  • Experimental
    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.

    Drug: Durvalumab · Drug: Olaparib

Interventions

  • DrugDurvalumab

    Durvalumab 1500 mg IV q4w

  • DrugOlaparib

    Olaparib PO 300 mg BID adjusted based on patient's creatinine clearance.

  • DrugPlacebo

    Matching placebo for oral tablet BID

05

What researchers measure

Primary outcomes

  1. Progression-free Survival (PFS)

    Progression-free survival based on investigator assessments according to RECIST 1.1

    Time frame: Assessments performed at baseline and every 8 weeks from date of randomization until date of objective disease progression or death (by any cause in the absence of progression), assessed up to the data cut-off date (15 Oct 2020), up to a max. of 31 months

Secondary outcomes

  1. Overall Survival (OS)

    Number of Participants with Overall Survival (OS), where OS was defined as the time from the date of randomization until death due to any cause.

    Time frame: From the date of randomization until the death due to any cause, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months

  2. Objective Response Rate (ORR)

    ORR (per RECIST 1.1 using Investigator assessments) is defined as the number (%) of patients with at least 1 visit response of complete response (CR) or partial response (PR). CR was defined as the disappearance of all target and non-target lesions; PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters

    Time frame: From the date of randomization to the date of progression or the last evaluable assessment in the absence of progression, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months

  3. Duration of Response (DoR)

    Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): \>= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. DoR is the time from the date of first documented response until the date of documented progression or death in the absence of disease progression

    Time frame: Tumor assessments every 8 weeks after randomization for the first 48 weeks and then every 12 weeks thereafter until the date of objective disease progression. Assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months

06

Results

Posted Oct 26, 2022

Participant flow

Participant flow — Overall Study
MilestoneDurva + OlaparibDurva + Placebo
Started7876
Completed00
Not completed7876
Withdrew: Death5246
Withdrew: Study terminated by sponsor2428
Withdrew: Withdrawal by subject22

Outcome measures

PrimaryProgression-free Survival (PFS)

Progression-free survival based on investigator assessments according to RECIST 1.1

Time frame:
Assessments performed at baseline and every 8 weeks from date of randomization until date of objective disease progression or death (by any cause in the absence of progression), assessed up to the data cut-off date (15 Oct 2020), up to a max. of 31 months
Reported as:
Median · Months
Progression-free Survival (PFS)
MonthsDurva + OlaparibDurva + Placebo
Progression-free Survival (PFS)4.2 (3.6 to 5.6)3.5 (1.9 to 5.1)
Statistical analysis
  • Durva + Olaparib vs Durva + Placebo · Regression, Cox · p = 0.789 · Hazard ratio (hr): 0.94 · 95% CI 0.641 to 1.387
SecondaryOverall Survival (OS)

Number of Participants with Overall Survival (OS), where OS was defined as the time from the date of randomization until death due to any cause.

Time frame:
From the date of randomization until the death due to any cause, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months
Reported as:
Count of participants · Participants
Overall Survival (OS)
ParticipantsDurva + OlaparibDurva + Placebo
Died5246
Censored (includes subjects with unknown survival status or subjects who were lost to follow up)2630
Statistical analysis
  • Durva + Olaparib vs Durva + Placebo · Regression, Cox · p = 0.728 · Hazard ratio (hr): 1.07 · 95% CI 0.719 to 1.606
SecondaryObjective Response Rate (ORR)

ORR (per RECIST 1.1 using Investigator assessments) is defined as the number (%) of patients with at least 1 visit response of complete response (CR) or partial response (PR). CR was defined as the disappearance of all target and non-target lesions; PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters

Time frame:
From the date of randomization to the date of progression or the last evaluable assessment in the absence of progression, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months
Reported as:
Count of participants · Participants
Objective Response Rate (ORR)
ParticipantsDurva + OlaparibDurva + Placebo
Response2214
No Response5662
Statistical analysis
  • Durva + Olaparib vs Durva + Placebo · Regression, Logistic · p = 0.142 · Odds ratio (or): 1.76 · 95% CI 0.821 to 3.778
SecondaryDuration of Response (DoR)

Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): \>= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. DoR is the time from the date of first documented response until the date of documented progression or death in the absence of disease progression

Time frame:
Tumor assessments every 8 weeks after randomization for the first 48 weeks and then every 12 weeks thereafter until the date of objective disease progression. Assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months
Reported as:
Median · Months
Duration of Response (DoR)
MonthsDurva + OlaparibDurva + Placebo
Duration of Response (DoR)8.9 (4.7 to 12.1)14.8 (7.5 to 17.2)

Adverse events

Collected over From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Durva + Olaparib52/78 (66.7%)37/76 (48.7%)65/76 (85.5%)
Durva + Placebo46/76 (60.5%)26/76 (34.2%)63/76 (82.9%)
Most frequent serious events
Showing 10 of 56
Most frequent serious events
EventDurva + OlaparibDurva + Placebo
Urinary tract infectionInfections and infestations6/766/76
AnaemiaBlood and lymphatic system disorders5/761/76
Renal failureRenal and urinary disorders4/760/76
HaematuriaRenal and urinary disorders3/761/76
HydronephrosisRenal and urinary disorders3/761/76
PneumoniaInfections and infestations3/762/76
Acute kidney injuryRenal and urinary disorders2/763/76
FatigueGeneral disorders2/761/76
PyrexiaGeneral disorders2/761/76
Chronic kidney diseaseRenal and urinary disorders1/760/76
Most frequent other events
Showing 10 of 33
Most frequent other events
EventDurva + OlaparibDurva + Placebo
AnaemiaBlood and lymphatic system disorders34/7621/76
FatigueGeneral disorders22/7613/76
NauseaGastrointestinal disorders20/766/76
Decreased appetiteMetabolism and nutrition disorders19/7610/76
ConstipationGastrointestinal disorders13/7612/76
DiarrhoeaGastrointestinal disorders10/765/76
AstheniaGeneral disorders10/762/76
Urinary tract infectionInfections and infestations9/764/76
Blood creatinine increasedInvestigations8/764/76
Back painMusculoskeletal and connective tissue disorders8/767/76

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Durva + OlaparibDurva + PlaceboTotal
Mean73.4 ± 10.870.2 ± 10.2671.9 ± 10.62
Sex: Female, Male
Sex: Female, Male(Participants)Durva + OlaparibDurva + PlaceboTotal
Female222143
Male5655111
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Durva + OlaparibDurva + PlaceboTotal
Hispanic or Latino336
Not Hispanic or Latino7573148
07

Study locations

44 sites
  • 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
08

References and documents

Publications

  • 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. PubMed 35737919 ↗

Study documents

  • Study protocol · Jul 9, 2021
  • Statistical analysis plan · Oct 4, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Supporting information: Study protocol, Sap

09

Registry details

Key details

Study ID
NCT03459846
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Mar 9, 2018
Start date
Mar 16, 2018
Primary completion
Oct 15, 2020
Completion
Dec 31, 2026 (estimated)
Results posted
Oct 26, 2022
Last update
Aug 5, 2026

Study contacts

Jonathan Rosenberg, MD
principal investigator · Memorial Sloan Kettering Cancer Center
Mark Lanasa, MD
study director · One MedImmune Way,Gaithersburg,Maryland,United States

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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