Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC
Phase 3
Active, not recruiting
- Conditions
- Muscle Invasive Bladder Cancer
- Interventions
- Registration Number
- NCT03732677
- Lead Sponsor
- AstraZeneca
- Brief Summary
A Global Study to Determine the Efficacy and Safety of Durvalumab in Combination with Gemcitabine+Cisplatin for Neoadjuvant Treatment and Durvalumab Alone for Adjuvant Treatment in Patients with Muscle-Invasive Bladder Cancer
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1063
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 2 Gemcitabine Chemotherapy alone Arm 1 Cisplatin Chemotherapy + Durvalumab Arm 1 Gemcitabine Chemotherapy + Durvalumab Arm 1 Durvalumab Chemotherapy + Durvalumab Arm 2 Cisplatin Chemotherapy alone
- Primary Outcome Measures
Name Time Method Pathologic complete response (pCR) rates at time of cystectomy Up to 6 months Event-free survival (EFS) per central review defined as time from randomization to event Up to 48 months
- Secondary Outcome Measures
Name Time Method Proportion of patients who undergo cystectomy Up to 6 months Immunogenicity of durvalumab when used in combination with gemcitabine/cisplatin as measured by presence of antidrug antibodies (ADA) Up to 12 months EFS at 24 months (EFS24) defined as time from randomization to event Up to 24 months Overall survival rate at 5 years Up to 60 months Disease-free survival Up to 48 months Proportion of patients who achieve <P2 at time of cystectomy Up to 6 months PFS2 defined as time from randomization to event following subsequent therapy Up to 84 months Safety and Tolerability as evaluated by adverse events occurring throughout the study Up to 84 months Disease-specific survival per investigator assessment or local biopsy review. up to 48 months Metastasis-free survival per investigator assessment or local biopsy review. Up to 48 months Overall Survival Up to 84 months
Trial Locations
- Locations (1)
Research Site
🇻🇳Hochiminh, Vietnam