Urinary Bladder NeoplasmsPhase 2BAYOUNCT03459846
A Study of Durvalumab Alone and Durvalumab+Olaparib in Advanced, Platinum-Ineligible Bladder Cancer (BAYOU)
A Phase 2 study testing Durvalumab and Olaparib in people with Urinary Bladder Neoplasms, run by AstraZeneca at 44 sites in 7 countries.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Urinary Bladder Neoplasms
- What is being tested?
- Durvalumab and Olaparib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 154 participants
- Where
- 44 sitesin 7 countries
- Study dates
- 16 Mar 2018to 31 Dec 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated, written ICF
- 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.
- 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.
- Known tumor HRR mutation status prior to randomization.
- World Health Organization (WHO)/ECOG performance status of 0, 1, or 2.
- Patients with at least 1 RECIST 1.1 target lesion at baseline.
- Ability to swallow oral medications.
- Evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients.
Who cannot join
- Active or prior documented autoimmune or inflammatory disorders.
- Other invasive malignancy within 5 years before the first dose of the IP.
- Major surgical procedure within 28 days prior to the first dose
- Brain metastases or spinal cord compression unless the patient's condition is stable and off steroid for at least 14 days
- History of active primary immunodeficiency.
- Active infection including tuberculosis (TB)
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- History of allogenic organ transplantation.
- Uncontrolled intercurrent illness
- Prior exposure to a PARP inhibitor or immune-mediated therapy.
- Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment.
- Current or prior use of immunosuppressive medication within 14 days before the first dose of the IP.
- 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).
- Receipt of live attenuated vaccine within 30 days prior to the first dose of the IP.
- Patients with a known hypersensitivity to durvalumab, olaparib, or any of the excipients of the products.
- 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.
Trial locations and contacts
44 sites in 7 countries.
44 sites in 7 countries
United States12 sites
Research Site
Birmingham, Alabama, 35294
Research Site
Fort Myers, Florida, 33901
Research Site
Goodyear, Arizona, 85338
Research Site
Louisville, Kentucky, 40202
Research Site
Nashville, Tennessee, 37232
Research Site
New Hyde Park, New York, 11042
Research Site
New York, New York, 10065
Research Site
Philadelphia, Pennsylvania, 19124
Research Site
St. Petersburg, Florida, 33705
Research Site
Tacoma, Washington, 98405
Research Site
Tampa, Florida, 33612
Research Site
The Bronx, New York, 10461
Taiwan8 sites
Research Site
Kaohsiung City, 807
Research Site
Kaohsiung City
Research Site
Taichung, 40705
Research Site
Tainan, 704
Research Site
Taipei, 10002
Research Site
Taipei, 104
Research Site
Taipei, 112
Research Site
Taoyuan City, 333
Russia7 sites
Research Site
Moscow, 105077
Research Site
Moscow, 125367
Research Site
Novosibirsk, 630108
Research Site
Omsk, 644013
Research Site
Saint Petersburg, 194354
Research Site
Saint Petersburg, 195271
Research Site
Saint Petersburg, 199178
Canada5 sites
Research Site
Greater Sudbury, Ontario, P3E 5J1
Research Site
Hamilton, Ontario, L8V 5C2
Research Site
Montreal, Quebec, H3T 1E2
Research Site
Newmarket, Ontario, L3Y 2P9
Research Site
Toronto, Ontario, M5G 2M9
South Korea5 sites
Research Site
Incheon, 21565
Research Site
Seoul, 02841
Research Site
Seoul, 03722
Research Site
Seoul, 05505
Research Site
Seoul, 06351
Spain5 sites
Research Site
Barcelona, 08036
Research Site
Madrid, 08035
Research Site
Madrid, 28041
Research Site
Málaga, 29010
Research Site
Santiago de Compostela, 15706
Vietnam2 sites
Research Site
Hanoi, 100000
Research Site
Ho Chi Minh City, 700000
About this study
Official title: 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
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).
- Conditions
- Urinary Bladder Neoplasms
- Being tested
- Durvalumab, Olaparib, Placebo
- Keywords
- Urinary Bladder Neoplasms
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DurvalumabDrug
Durvalumab 1500 mg IV q4w
OlaparibDrug
Olaparib PO 300 mg BID adjusted based on patient's creatinine clearance.
PlaceboDrug
Matching placebo for oral tablet BID
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Durvalumab/Placebo | Experimental | 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. Receives: Drug: Durvalumab; Drug: Placebo |
| Arm 2: Durvalumab/Olaparib | Experimental | Durvalumab 1500 mg IV q4w starting on week 1 day 1/Olaparib PO 300 mg BID adjusted based on patient's creatinine clearance. Receives: Drug: Durvalumab; Drug: Olaparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS)
Progression-free survival based on investigator assessments according to RECIST 1.1
Measured: 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 (3)
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.
Measured: 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
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
Measured: 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
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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start16 Mar 2018
- Primary completion15 Oct 2020
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary Bladder NeoplasmsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonathan Rosenberg, MD, Principal investigator, Memorial Sloan Kettering Cancer CenterMark Lanasa, MD, Study director, One MedImmune Way,Gaithersburg,Maryland,United States
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03459846
- Sponsor's protocol ID
- D933IC00003
- Other IDs
- 2017-004556-27, 2017
- Acronym
- BAYOU
- Status last verified
- Aug 2026
- First submitted
- 22 Feb 2018
- Last updated
- 5 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
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