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A Study of Durvalumab Alone and Durvalumab+Olaparib in Advanced, Platinum-Ineligible Bladder Cancer (BAYOU) | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

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

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

NCT03459846•AstraZeneca

View on ClinicalTrials.gov

Summary

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).

Eligibility

Age

18 - 130 years

Sex

ALL

Healthy Volunteers

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.
+5 more criteria

Locations (44)

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

Key Dates

Start Date

March 16, 2018

Primary Completion Date

October 15, 2020

Completion Date

December 31, 2026

Last Updated

January 30, 2026

Enrollment

154

ACTUAL participants

Conditions

Urinary Bladder Neoplasms

Interventions

Durvalumab

DRUG

Olaparib

DRUG

Placebo

DRUG

A Clinical Study of MK-3120 in People With Bladder Cancer (MK-3120-003)

NCT07222488

Bladder CancerUrinary Bladder Neoplasms

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RECRUITINGPHASE1

FORAGER-1: A Study of LOXO-435 (LY3866288) in Participants With Cancer With a Change in a Gene Called FGFR3

NCT05614739

Urinary Bladder NeoplasmsNeoplasm Metastasis+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 30, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Clinical Study of MK-3120 in People With Bladder Cancer (MK-3120-003)

FORAGER-1: A Study of LOXO-435 (LY3866288) in Participants With Cancer With a Change in a Gene Called FGFR3

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