Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03459846 · ClinicalTrials.gov registry record · Phase 2
A Study of Durvalumab Alone and Durvalumab+Olaparib in Advanced, Platinum-Ineligible Bladder Cancer (BAYOU)
A Phase 2 study of Urinary Bladder Neoplasms, sponsored by AstraZeneca.
- Active
- Registry status
- Phase 2
- Development phase
- 154
- Enrollment target
- 20
- Study locations
NCT03459846: Active Phase 2 study of Urinary Bladder Neoplasms, sponsored by AstraZeneca.
NCT03459846 is a Phase 2 study of Urinary Bladder Neoplasms that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 154 participants, below the 305-participant average among 19 other Urinary Bladder Neoplasms trials with a reported enrollment target (50% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03459846, a Phase 2 study of Urinary Bladder Neoplasms, is active but no longer recruiting, sponsored by AstraZeneca.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 154 participants
- Enrollment target
- 20
- Study locations
Study Summary
A Phase II, Randomized, Multi-Center, Double-Blind, Comparative Global Study to Determine the Efficacy and Safety of Durvalumab in Combination With Olaparib for First-Line Treatment in Platinum-Ineligible Patients With Unresectable Stage IV Urothelial Cancer
Primary Outcome
Progression-free survival based on investigator assessments according to RECIST 1.1
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Olaparib
- DRUG Durvalumab
Study Locations (20)
Ontario
- Research Site - Greater Sudbury
- Research Site - Hamilton
- Research Site - Newmarket
- Research Site - Toronto
Florida
- Research Site - Fort Myers
- Research Site - St. Petersburg
- Research Site - Tampa
New York
- Research Site - New Hyde Park
- Research Site - New York
- Research Site - The Bronx
Other
- Research Site - Moscow
- Research Site - Moscow
- Research Site - Novosibirsk
Alabama
- Research Site - Birmingham
Arizona
- Research Site - Goodyear
Kentucky
- Research Site - Louisville
Pennsylvania
- Research Site - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 154 participants |
| Start Date | 2018-03-16 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
What the registry record for NCT03459846 still lists
NCT03459846 is an interventional study that assigns participants to a tested intervention. The registered 154 participants enrollment target is mid-sized for trials with a published cap, below the 305-participant average among 19 other Urinary Bladder Neoplasms trials with a reported enrollment target (50% lower).
The record links to 1 condition, with Urinary Bladder Neoplasms appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT03459846 names 20 study sites across 11 states, led by Ontario, Florida, New York.
Frequently Asked Questions
What is clinical trial NCT03459846 about?
NCT03459846 is a clinical study titled "A Study of Durvalumab Alone and Durvalumab+Olaparib in Advanced, Platinum-Ineligible Bladder Cancer (BAYOU)". A Phase II, Randomized, Multi-Center, Double-Blind, Comparative Global Study to Determine the Efficacy and Safety of Durvalumab in Combination With Olaparib for First-Line Treatment in Platinum-Ineligible Patients With Unresectable Stage IV Urothelial Cancer
What is the current status of trial NCT03459846?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 154 participants. The study started on 2018-03-16. Estimated completion is 2026-12-31.
What conditions does trial NCT03459846 study?
This clinical trial studies the following conditions: Urinary Bladder Neoplasms.
What interventions are being tested in trial NCT03459846?
The interventions under investigation include: Placebo (DRUG), Olaparib (DRUG), Durvalumab (DRUG).
Who is sponsoring clinical trial NCT03459846?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03459846 being conducted?
This trial has 20 study locations across Alabama, Arizona, Florida, Kentucky, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Urinary Bladder Neoplasms
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03459846's enrollment target sits among peer trials
154 13th of 19 higher than 7 of 19 other Urinary Bladder Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Urinary Bladder Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Clinical Study of Intismeran Autogene (V940) and BCG in People With Bladder Cancer (V940-011/INTerpath-011)
RECRUITING · Phase 2
-
A Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder
ACTIVE NOT RECRUITING · Phase 2
-
A Study of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy
ACTIVE NOT RECRUITING · Phase 2
-
Genomic Based Assignment of Therapy in Advanced Urothelial Carcinoma
COMPLETED · Phase 2
-
Cabozantinib for Advanced Urothelial Cancer
COMPLETED · Phase 2
-
Tamoxifen for Progressive Transitional Cell Carcinoma Following Previous Chemotherapy Treatment
COMPLETED · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04300998 · 154 participants
Study of CAR-T Therapy in Older Patients
- NCT04597372 · 154 participants · Phase 2
Impact of Tamsulosin on Post-Operative Urinary Retention Following Pelvic Reconstructive Surgery
- NCT05294042 · 154 participants · NA
Patient Navigators for Children's Community Mental Health Services in High Poverty Urban Communities
- NCT05512390 · 154 participants · Phase 1
A Study to Assess the Adverse Events, Change in Disease Activity, and How Intravenously Infused ABBV-319 Moves Through the Bodies of Adult Participants With Relapsed or Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL), Follicular Lymphoma (FL), or Chronic Lymphocytic Leukemia (CLL)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI