Durvalumab + Olaparib for Bladder Cancer (BAYOU Trial)

Palo Alto (17 mi)

Overseen byJonathan Rosenberg, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: AstraZeneca

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial tests a combination of two drugs, durvalumab and olaparib, for patients with advanced bladder cancer who can't receive standard chemotherapy. Durvalumab helps the immune system attack cancer, while olaparib makes it harder for cancer cells to repair themselves. The goal is to see if this combination is more effective than using durvalumab alone.

Eligibility Criteria

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.

Inclusion Criteria

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

I am post-menopausal or not currently pregnant.

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

I can swallow pills.

I can take care of myself and perform daily activities.

I know my tumor's HRR mutation status.

Exclusion Criteria

I am not currently on any cancer treatments like chemotherapy or hormone therapy.

I have or had an autoimmune or inflammatory disorder.

I do not have an active infection, including TB.

I have not undergone radiation therapy, or I meet specific criteria for it.

I haven't taken immunosuppressive drugs in the last 14 days.

I have received an organ transplant from another person.

I have not had major surgery in the last 28 days.

I have previously been treated with a PARP inhibitor or immunotherapy.

I do not have any unmanaged ongoing illnesses.

Treatment Details

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.

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.

Durvalumab is already approved in European Union, United States, Japan for the following indications:

🇪🇺 Approved in European Union as Imfinzi for: