Description:
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
Title
- Brief Title: Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC
- Official Title: 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.
Clinical Trial IDs
- ORG STUDY ID:
D933RC00001
- SECONDARY ID:
2018-001811-59
- NCT ID:
NCT03732677
Conditions
- Muscle Invasive Bladder Cancer
Interventions
Drug | Synonyms | Arms |
---|
Durvalumab | | Arm 1 |
Cisplatin | | Arm 1 |
Gemcitabine | | Arm 1 |
Purpose
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
Trial Arms
Name | Type | Description | Interventions |
---|
Arm 1 | Experimental | Chemotherapy + Durvalumab | - Durvalumab
- Cisplatin
- Gemcitabine
|
Arm 2 | Active Comparator | Chemotherapy alone | |
Eligibility Criteria
Inclusion:
- 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
- Patients who have not received prior systemic chemotherapy or immunotherapy for
treatment of MIBC
- ECOG performance status of 0 or 1
- Must have a life expectancy of at least 12 weeks at randomization
Exclusion:
- Evidence of lymph node (N2-N3) or metastatic (M1) disease at time of screening.
- Prior pelvic radiotherapy treatment within 2 years of randomization to study
- Prior exposure to immune-mediated therapy (with exclusion of Bacillus-Calmette Guerin
[BCG]), including but not limited to other anti-CTLA-4, anti-PD-1, anti PD-L1, or
anti-PD-L2 antibodies.
- Current or prior use of immunosuppressive medication within 14 days before the first
dose of investigational product (IP). The following are exceptions to this criterion:
Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra
articular injection); Systemic corticosteroids at physiologic doses not to exceed 10
mg/day of prednisone or its equivalent; Steroids as premedication for hypersensitivity
reactions (eg, CT scan premedication)
- Receipt of live attenuated vaccine within 30 days prior to the first dose of IP.
- Uncontrolled intercurrent illness
- Active infection including Tuberculosis, Hepatitis B, Hepatitis C, and Human
Immunodeficiency
Maximum Eligible Age: | 130 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Pathologic complete response (pCR) rates at time of cystectomy |
Time Frame: | Up to 6 months |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Proportion of patients who achieve <P2 at time of cystectomy |
Time Frame: | Up to 6 months |
Safety Issue: | |
Description: | |
Measure: | EFS at 24 months (EFS24) defined as time from randomization to event |
Time Frame: | Up to 24 months |
Safety Issue: | |
Description: | |
Measure: | Proportion of patients who undergo cystectomy |
Time Frame: | Up to 6 months |
Safety Issue: | |
Description: | |
Measure: | Overall survival rate at 5 years |
Time Frame: | Up to 60 months |
Safety Issue: | |
Description: | |
Measure: | PFS2 defined as time from randomization to event following subsequent therapy |
Time Frame: | Up to 84 months |
Safety Issue: | |
Description: | |
Measure: | Safety and Tolerability as evaluated by adverse events occurring throughout the study |
Time Frame: | Up to 84 months |
Safety Issue: | |
Description: | |
Measure: | Immunogenicity of durvalumab when used in combination with gemcitabine/cisplatin as measured by presence of antidrug antibodies (ADA) |
Time Frame: | Up to 12 months |
Safety Issue: | |
Description: | |
Measure: | Overall Survival |
Time Frame: | Up to 84 months |
Safety Issue: | |
Description: | |
Measure: | Metastasis-free survival per investigator assessment or local biopsy review. |
Time Frame: | Up to 48 months |
Safety Issue: | |
Description: | |
Measure: | Disease-specific survival per investigator assessment or local biopsy review. |
Time Frame: | up to 48 months |
Safety Issue: | |
Description: | |
Measure: | Disease-free survival |
Time Frame: | Up to 48 months |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | AstraZeneca |
Trial Keywords
- Bladder Cancer
- Immunotherapy
- PD-L1
- Durvalumab (MEDI4736)
Last Updated
August 9, 2021