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

Official Title

A Phase II, Randomized, Multi-Centre, 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

Summary:

A Phase II, Randomized, Multi-Centre, 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

Trial Description

Primary Outcome:

• The efficacy of Durvalumab+Olaparib combination therapy compared to Durvalumab + Placebo in terms of Progression-Free Survival (PFS) in patients with Platinum ineligible bladder cancer

Secondary Outcome:

• The efficacy of Durvalumab+Olaparib combination therapy compared to Durvalumab + Placebo in terms of Overall survival (OS) in patients with Platinum ineligible bladder cancer
• The efficacy of Durvalumab+Olaparib combination therapy compared to Durvalumab + Placebo in terms of Duration of response (DoR) in patients with Platinum ineligible bladder cancer
• The efficacy of Durvalumab+Olaparib combination therapy compared to Durvalumab + Placebo in terms of Objective Response Rate (ORR) in patients with Platinum ineligible bladder cancer
• The efficacy of Durvalumab+Olaparib combination therapy compared to Durvalumab + Placebo in terms of Progression-Free Survival (PFS) in patients with Platinum ineligible bladder cancer with homologous recombination repair mutated (HRRm) subgroup
• The efficacy of Durvalumab+Olaparib combination therapy compared to Durvalumab + Placebo in terms of Progression free at 6 months (PFS6) in patients with Platinum ineligible bladder cancer
• The pharmacokinetics (PK) of durvalumab and olaparib as determined by trough concentration
• Presence of anti-drug antibodies (ADA) for durvalumab
• Patient reported outcome (PRO) including Global health status/Quality of Life (QoL), assessed through questionnaire - European Organisation for Research and Treatment of Cancer 30-item core quality of life questionnaire (EORTC QLQ-C30)

This is a Phase II, randomized, double-blind, placebo controlled, multi-centre, 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).

View this trial on ClinicalTrials.gov