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Durvalumab + Olaparib for Bladder Cancer (BAYOU Trial)

Phase 2

Waitlist Available

Led By Jonathan Rosenberg, MD

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ineligibility for platinum-based chemotherapy as defined by specific criteria

Evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

BAYOU Trial Summary

This trial is testing a combination of two drugs, durvalumab and olaparib, to see if it is effective and safe in treating patients with urothelial cancer that has spread and cannot be removed by surgery.

Who is the study for?

This trial is for adults with advanced bladder cancer that can't be surgically removed and who haven't had systemic therapy. They must not qualify for platinum-based chemotherapy, have a certain performance status, and be able to take oral meds. Pregnant or breastfeeding individuals, those with autoimmune diseases, recent major surgery, uncontrolled illnesses, or prior treatments with similar drugs are excluded.Check my eligibility

What is being tested?

The BAYOU study is testing the effectiveness of Durvalumab alone versus its combination with Olaparib against bladder cancer in patients ineligible for platinum chemo. It's a phase II trial where participants are randomly assigned to receive either both drugs or one drug plus a placebo without knowing which they're getting.See study design

What are the potential side effects?

Durvalumab may cause immune-related issues like inflammation in various organs and infusion reactions. Olaparib could lead to blood cell count changes, nausea, fatigue among other side effects. The combination might increase these risks.

BAYOU Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I cannot receive platinum-based chemotherapy due to certain conditions.

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I am post-menopausal or not currently pregnant.

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My bladder cancer is advanced and hasn't been treated with systemic therapy.

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I can swallow pills.

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I can take care of myself and perform daily activities.

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I know my tumor's HRR mutation status.

BAYOU Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-free Survival (PFS)

Secondary outcome measures

Duration of Response (DoR)

Objective Response Rate (ORR)

Overall Survival (OS)

Other outcome measures

Changes in WHO/ECOG performance status

Number of Participants with Treatment-Related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE)

BAYOU Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm 2: Durvalumab/OlaparibExperimental Treatment2 Interventions

Durvalumab 1500 mg IV q4w starting on week 1 day 1/Olaparib PO 300 mg BID adjusted based on patient's creatinine clearance.

Group II: Arm 1: Durvalumab/PlaceboExperimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Durvalumab

2017

Completed Phase 2

~3870

Olaparib

2007

Completed Phase 4

~2140

Placebo

1995

Completed Phase 3

~2670

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,257 Previous Clinical Trials

288,593,632 Total Patients Enrolled

Mark Lanasa, MDStudy DirectorOne MedImmune Way,Gaithersburg,Maryland,United States

Jonathan Rosenberg, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

2 Previous Clinical Trials

394 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Olaparib obtained regulatory clearance from the U.S. Food and Drug Administration?

"The safety profile of Olaparib was assigned a score of 2, since it has only been tested in Phase 2 trials and there is no data to support its efficacy."

Answered by AI

What is the current size of the participant cohort for this medical investigation?

"At this moment, the trial is not enrolling participants. The study was initially advertised on March 16th 2018 and had its most recent update on October 3rd 2022. If searching for other trials involving urinary bladder cancer or Olaparib, 315 and 484 studies respectively are in need of volunteers."

Answered by AI

Are there any elderly individuals involved in this investigation?

"The requirements for this medical trial dictate that prospective participants must be between 18 and 130 years of age. For minors, there are 23 trials available with 794 studies intended for seniors."

Answered by AI

What criteria must be met to qualify for participation in this research project?

"Patients applicable for this clinical trial must have urinary bladder cancer and be aged between 18 and 130. Thus far, 154 individuals have been accepted into the program."

Answered by AI

Has Olaparib been explored in other clinical investigations?

"Currently, there are 484 clinical trials evaluating Olaparib. Of these active studies, 75 have progressed to Phase 3 of testing. Houston is the epicentre for research on this drug with 19978 sites running related experiments worldwide."

Answered by AI

Are there any spots still available for the trial?

"According to the clinicaltrials.gov platform, this particular medical trial has since concluded its recruitment phase and is not looking for more patients at the moment. The study was first opened on March 16th 2018, with an update posted in October 3rd 2022 being the last one before closure. Nonetheless, 799 other trials are currently searching for participants across diverse locations."

Answered by AI

Is this a pioneering experiment?

"At present, 486 ongoing investigations are being conducted in 65 nations and 1846 cities concerning olaparib. The initial examination of the drug was sponsored by AstraZeneca back in 2005 and 98 patients were included; it concluded its Phase 1 approval stage. Since then, a further 18488 trials have been carried out."

Answered by AI

To what ailments is Olaparib typically administered?

"Olaparib is the preferred medication for managing this medical condition, however it can also be applied to treat pharmacotherapy, primary peritoneal cancer and advanced directives."

Answered by AI

In what geographic areas is this research conducted?

"This clinical experiment is taking place at 18 sites, including Goodyear, Tampa and New Hyde Park. Prospective participants should select the closest site to avoid long-distance travel commitments."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2018. "A Study of Durvalumab Alone and Durvalumab+Olaparib in Advanced, Platinum-Ineligible Bladder Cancer (BAYOU)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03459846.

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