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

Sponsor
Latin American Cooperative Oncology Group
Study ID
NCT04579133
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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).

Key Dates

Start date
Mar 1, 2021
Status verified
Jun 2021
Primary completion
Mar 1, 2021
Completion
Mar 1, 2021

Study Design

Enrollment
140 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: durvalumab plus olaparib
    Durvalumab 1500 mg IV week 0, 3, 6 plus Olaparib tablets will be given orally on a continuous dosing schedule 300 mg BID OR 200 mg BID (if glomerular filtration rate \[GFR\] 31 to 50 mL/min) to complete 9 weeks of treatment.
  • Experimental: durvalumab alone
    Durvalumab 1500 mg IV week 0, 3, 6 to complete 9 weeks of treatment

Primary Outcome Measure

Pathological complete response rate (pCR) [ Time Frame: 24 weeks ]

Related Studies