NCT04579133

Neoadjuvant Durvalumab Alone Versus Durvalumab With Olaparib in Patients Ineligible for Cisplatin With Muscle-Invasive Urothelial Carcinoma of the Bladder Followed by Radical Cystectomy

Phase II Randomized Study of Neoadjuvant Durvalumab (MEDI4736) Alone Versus Durvalumab (MEDI4736) With Olaparib (AZD2281) in Patients Ineligible for Cisplatin With Muscle-Invasive Urothelial Carcinoma of the Bladder Followed by Radical Cystectomy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Latin American Cooperative Oncology Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a phase II, randomized, open-label, clinical trial including patients with muscle-invasive transitional cell carcinoma of the bladder candidates for radical cystectomy. The study will include patients ineligible for cisplatin. Patients will be centrally randomized in a 1:1 ratio to receive durvalumab plus olaparib (Arm A) or durvalumab alone (Arm B). The clinical study´s hypothesis is that for patients with muscle-invasive transitional cell carcinoma of the bladder who are not fit for cisplatin-based neoadjuvant chemotherapy, Durvalumab monotherapy will have a similar efficacy to historical chemotherapy controls and Durvalumab in combination with olaparib will be associated with an even improved efficacy results in terms of pathologic complete response (pCR).

Conditions

• Bladder Cancer
• Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	Olaparib	300 mg BID OR 200 mg BID (if glomerular filtration rate \[GFR\] 31 to 50 mL/min)
DRUG	Durvalumab	Durvalumab 1500 mg IV

Timeline

• Start date: 2021-03-01
• Primary completion: 2021-03-01
• Completion: 2021-03-01
• First posted: 2020-10-08
• Last updated: 2021-06-16

Locations

1 site across 1 country: Brazil