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

NCT03459846 | Active Not Recruiting Phase 2 Results DMC FDA Drug

• 2 other identifiers: D933IC000032017-004556-27
• Study Type: interventional
• Target: 154
• Locations: 7 countries
• Sites: 44

Brief 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

Conditions

Urinary Bladder Neoplasms

Keywords

Urinary Bladder Neoplasms

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS)

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

  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)

  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)

  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)

  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

Study Arms (2)

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.

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.

Drug: Durvalumab; Drug: Olaparib

Interventions

Durvalumab DRUG

Durvalumab 1500 mg IV q4w

Arm 1: Durvalumab/Placebo; Arm 2: Durvalumab/Olaparib

Olaparib DRUG

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

Arm 2: Durvalumab/Olaparib

Placebo DRUG

Matching placebo for oral tablet BID

Arm 1: Durvalumab/Placebo

Eligibility Criteria

• Age: 18 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (44)

Research Site

Birmingham, Alabama, 35294, United States

Location

Research Site

Goodyear, Arizona, 85338, United States

Location

Research Site

Fort Myers, Florida, 33901, United States

Location

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St. Petersburg, Florida, 33705, United States

Location

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Tampa, Florida, 33612, United States

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Louisville, Kentucky, 40202, United States

Location

Research Site

New Hyde Park, New York, 11042, United States

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New York, New York, 10065, United States

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The Bronx, New York, 10461, United States

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Philadelphia, Pennsylvania, 19124, United States

Location

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Nashville, Tennessee, 37232, United States

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Tacoma, Washington, 98405, United States

Location

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Greater Sudbury, Ontario, P3E 5J1, Canada

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Hamilton, Ontario, L8V 5C2, Canada

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Newmarket, Ontario, L3Y 2P9, Canada

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Toronto, Ontario, M5G 2M9, Canada

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Montreal, Quebec, H3T 1E2, Canada

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Moscow, 105077, Russia

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Moscow, 125367, Russia

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Novosibirsk, 630108, Russia

Location

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Omsk, 644013, Russia

Location

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Saint Petersburg, 194354, Russia

Location

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Saint Petersburg, 195271, Russia

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Saint Petersburg, 199178, Russia

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Incheon, 21565, South Korea

Location

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Seoul, 02841, South Korea

Location

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Seoul, 03722, South Korea

Location

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Seoul, 05505, South Korea

Location

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Seoul, 6351, South Korea

Location

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Barcelona, 08036, Spain

Location

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Madrid, 08035, Spain

Location

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Madrid, 28041, Spain

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Research Site

Málaga, 29010, Spain

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Santiago de Compostela, 15706, Spain

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Research Site

Kaohsiung City, 807, Taiwan

Location

Research Site

Kaohsiung City, Taiwan

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Research Site

Taichung, 40705, Taiwan

Location

Research Site

Tainan, 704, Taiwan

Location

Research Site

Taipei, 10002, Taiwan

Location

Research Site

Taipei, 104, Taiwan

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Research Site

Taipei, 112, Taiwan

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Research Site

Taoyuan, 333, Taiwan

Location

Research Site

Hanoi, 100000, Vietnam

Location

Research Site

Ho Chi Minh City, 700000, Vietnam

Location

Related Publications (1)

• 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.

  PMID: 35737919 DERIVED

Related Links

• Related Info
• Related Info
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MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

durvalumab; olaparib

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Global Clinical Lead
• Organization: AstraZeneca Clinical Study Information Center

information.center@astrazeneca.com

1-877-240-9479

Study Officials

• Jonathan Rosenberg, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

• Mark Lanasa, MD

  One MedImmune Way,Gaithersburg,Maryland,United States

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: March 9, 2018
• Study Start: March 16, 2018
• Primary Completion: October 15, 2020
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 30, 2026
• Results First Posted: October 26, 2022

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Locations

ES (5); US (12); CA (5); VN (2); KR (5); RU (7); TW (8)