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.
ClinicalTrials.gov processed this data on June 28, 2024. Link to the current ClinicalTrials.gov record.Recruitment Status
ACTIVE, NOT RECRUITING (See Contacts and Locations)Verified June 2024 by AstraZeneca
Sponsor
AstraZenecaInformation Provided by (Responsible Party)
AstraZenecaClinicaltrials.gov Identifier
NCT03732677Other Study ID Numbers: D933RC00001
First Submitted: October 5, 2018
First Posted: November 6, 2018
Last Update Posted: July 1, 2024
Last Verified: June 2024
History of Changes
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Study Description
Not Provided| Condition or Disease | Intervention/Treatment |
|---|---|
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Study Design
| Study Type | Interventional |
|---|---|
| Actual Enrollment | 1063 participants |
| Design Allocation | Randomized |
| Interventional Model | Parallel Assignment |
| Masking | None (Open Label) |
| Primary Purpose | Treatment |
| 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. |
| Study Start Date | November 16, 2018 |
| Anticipated Primary Completion Date | June 30, 2025 |
| Anticipated Study Completion Date | June 30, 2026 |
Groups and Cohorts
| Group/ Cohort | Intervention/ Treatment |
|---|---|
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Outcome Measures
Primary Outcome Measures
- 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
- Proportion of patients who achieve
[Up to 6 months] - EFS at 24 months (EFS24) defined as time from randomization to event [Up to 24 months]
- Proportion of patients who undergo cystectomy [Up to 6 months]
- Overall survival rate at 5 years [Up to 60 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]
- Immunogenicity of durvalumab when used in combination with gemcitabine/cisplatin as measured by presence of antidrug antibodies (ADA) [Up to 12 months]
- Overall Survival [Up to 84 months]
- Metastasis-free survival per investigator assessment or local biopsy review. [Up to 48 months]
- Disease-specific survival per investigator assessment or local biopsy review. [up to 48 months]
- Disease-free survival [Up to 48 months]
Eligibility Criteria
| Ages Eligible for Study | 18 Years to 130 Years (Adult, Older Adult) |
|---|---|
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | No |
| Inclusion Criteria |
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| Exclusion Criteria |
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Contacts and Locations
| Sponsors and Collaborators | AstraZeneca |
|---|---|
| Locations |
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More Information
Additional Relevant MeSH Terms
- Urinary Bladder Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Urinary Bladder Diseases
- Urologic Diseases
- Male Urogenital Diseases