A Phase III, Randomized, Open-Label, Multi-Center, Global Study to Determine the Efficacy and Safety of Durvalumab in Combination with Gemcitabine+Cisplatin for Neoadjuvant Treatment Followed by Durvalumab Alone for Adjuvant Treatment in Patients with Muscle-Invasive Bladder Cancer

Phase 3

Completed

• Conditions: bladder cancer; Muscle-invasive bladder cancer; 10038364

• Registration Number: NL-OMON52537
• Lead Sponsor: Astra Zeneca

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 52

Inclusion Criteria

Patient resectable muscle-invasive bladder cancer with clinical stage
T2-T4aN0/1M0 with transitional and mixed transitional cell histology;
Patients must be planning to undergo a radical cystectomy at the time of
randomization;
Patients who have not received prior systemic chemotherapy or immunotherapy for
treatment of MIBC;
ECOG performance status of 0 or 1 at enrollment.
Availability of tumor sample prior to study entry;
Must have a life expectancy of at least 12 weeks at randomization.

Exclusion Criteria

Evidence of lymph node involvement or metastatic disease at the time of
screening., Contra-indication to any of the study drugs, Requires
immunosuppression medication for a concomitant condition, Active or prior
documented autoimmune or inflammatory disorders

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To assess the efficacy of durvalumab + G+C combination therapy<br /><br>(neoadjuvant)/durvalumab alone (adjuvant) (Arm 1) compared to G+C combination<br /><br>therapy (neoadjuvant)/no adjuvant treatment (Arm 2) in terms of pCR and EFS in<br /><br>MIBC patients with adequate renal function.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Proportion of patients who achieve <P2 at time of cystectomy [ Time Frame: Up<br /><br>to 6 months ]<br /><br>EFS at 24 months (EFS24) defined as time from randomization to event [ Time<br /><br>Frame: Up to 24 months ]<br /><br>Proportion of patients who undergo cystectomy [ Time Frame: Up to 6 months ]<br /><br>Overall survival rate at 5 years [ Time Frame: Up to 60 months ]<br /><br>PFS2 defined as time from randomization to event following subsequent therapy [<br /><br>Time Frame: Up to 84 months ]<br /><br>Safety and Tolerability as evaluated by adverse events occurring throughout the<br /><br>study [ Time Frame: Up to 84 months ]<br /><br>Immunogenicity of durvalumab when used in combination with<br /><br>gemcitabine/cisplatin as measured by presence of antidrug antibodies (ADA) [<br /><br>Time Frame: Up to 12 months ]</p><br>