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D933IC00003 (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

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 vs. durvalumab-placebo (durvalumab monotherapy) as a first-line treatment in patients ineligible for platinum-based chemotherapy with unresectable stage IV urothelial cancer.

Status

Coming soon

Primary Study Objective(s)

The objective of this study is to assess the efficacy of durvalumab-olaparib combination therapy compared with durvalumab-placebo in terms of progression-free survival.

Core eligibility

Note: This is only a partial list of eligibility criteria.

Including patients who:

  • Have histologically or cytologically documented TCC/UC of the urothelium (including renal pelvis, ureters, urinary bladder, and urethra) also meeting the following: 
    • Is unresectable, Stage IV disease
    • Have no prior systemic therapy for unresectable, stage IV disease.
  • Are ineligible for platinum-based chemotherapy defined as: 
    • The opinion of the investigator, unfit for carboplatin-based chemotherapy 
    • 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 two consecutive wave ranges)
      • CTCAE Grade ≥2 peripheral neuropathy
      • New York Heart Association Class III heart failure
      • ECOG 2
  • Have known tumor HRR mutation status prior to randomization
  • Have World Health Organization/ECOG performance status of 0, 1, or 2
  • Have at least one RECIST 1.1 target lesion at baseline
  • Have the ability to swallow oral medications
  • Have evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients

Excluding patients who:

  • Have active or prior documented autoimmune or inflammatory disorders
  • Have had other invasive malignancy within five years before the first dose of the IP
  • Have had a major surgical procedure within 28 days prior to the first dose
  • Have brain metastases or spinal cord compression unless the patient's condition is stable and off steroid for at least 14 days
  • Have a history of active primary immunodeficiency
  • Have an active infection including tuberculosis
  • Have a history of allogenic organ transplantation
  • Have uncontrolled intercurrent illness
  • Have had prior exposure to a PARP inhibitor or immune-mediated therapy
  • Have any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment
  • Have current or prior use of immunosuppressive medication within 14 days before the first dose of the IP
  • Have had radiation therapy, unless:
    • It is definitive radiation that had been administered at least 12 months prior
    • It is palliative radiation to the brain, with associated criteria for stability or lack of symptoms
    • It is palliative radiation to painful bony lesions (this must comprise less than 30 percent of the bone marrow) or symptomatic pelvic soft tissue mass(es)
  • Have had receipt of live attenuated vaccine within 30 days prior to the first dose of the IP
  • Have a known hypersensitivity to durvalumab, olaparib, or any of the excipients of the products
  • Are females, 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

Learn more about your cancer

     

Coming soon

 

Learn more at

clinicaltrials.gov

 

Principal Investigator(s)

Mahdi Taha

David L. Topolsky

Alan Tan