Trial · NCT03459846

A Study of Durvalumab Alone and Durvalumab+Olaparib in Advanced, Platinum-Ineligible Bladder Cancer (BAYOU)

NCT03459846, Phase 2, Active not recruiting, AstraZeneca; results first posted 2022-10-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of Durvalumab Alone and Durvalumab+Olaparib in Advanced, Platinum-Ineligible Bladder Cancer (BAYOU). Trials, record NCT03459846. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03459846

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of Durvalumab Alone and Durvalumab+Olaparib in Advanced, Platinum-Ineligible Bladder Cancer (BAYOU)
NCT number: NCT03459846
Status: Active not recruiting
Phases: Phase 2
Enrollment: 154 participants, actual
Lead sponsor: AstraZeneca
Conditions: Urinary Bladder Neoplasms
Interventions: Durvalumab, Olaparib, Placebo
First posted: 2018-03-09
Last updated: 2026-08-05
Other registries' IDs: eudract:2017-004556-27
Results first posted: 2022-10-26

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Progression-free Survival (PFS)	Assessments performed at baseline and every 8 weeks from date of randomization until date of objective disease progression or death (by any cause in the absence of progression), assessed up to the data cut-off date (15 Oct 2020), up to a max. of 31 months	Progression-free survival based on investigator assessments according to RECIST 1.1
Secondary	Overall Survival (OS)	From the date of randomization until the death due to any cause, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months	Number of Participants with Overall Survival (OS), where OS was defined as the time from the date of randomization until death due to any cause.
Secondary	Objective Response Rate (ORR)	From the date of randomization to the date of progression or the last evaluable assessment in the absence of progression, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months	ORR (per RECIST 1.1 using Investigator assessments) is defined as the number (%) of patients with at least 1 visit response of complete response (CR) or partial response (PR). CR was defined as the disappearance of all target and non-target lesions; PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters
Secondary	Duration of Response (DoR)	Tumor assessments every 8 weeks after randomization for the first 48 weeks and then every 12 weeks thereafter until the date of objective disease progression. Assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months	Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): \>= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. DoR is the time from the date of first documented response until the date of documented progression or death in the absence of disease progression

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Progression-free Survival (PFS)	Assessments performed at baseline and every 8 weeks from date of randomization until date of objective disease progression or death (by any cause in the absence of progression), assessed up to the data cut-off date (15 Oct 2020), up to a max. of 31 months	Full analysis set	Months	MEDIAN
SECONDARY	Overall Survival (OS)	From the date of randomization until the death due to any cause, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months	Full analysis set	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Objective Response Rate (ORR)	From the date of randomization to the date of progression or the last evaluable assessment in the absence of progression, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months	Full analysis set	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Duration of Response (DoR)	Tumor assessments every 8 weeks after randomization for the first 48 weeks and then every 12 weeks thereafter until the date of objective disease progression. Assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months	Duration of Response (DoR) was calculated for all responders (N=36)	Months	MEDIAN

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Progression-free Survival (PFS)	Durva + Olaparib		4.2	95% Confidence Interval 3.6 to 5.6	Months
Progression-free Survival (PFS)	Durva + Placebo		3.5	95% Confidence Interval 1.9 to 5.1	Months
Overall Survival (OS)	Durva + Olaparib	Died	52		Participants
Overall Survival (OS)	Durva + Placebo	Died	46		Participants
Overall Survival (OS)	Durva + Olaparib	Censored (includes subjects with unknown survival status or subjects who were lost to follow up)	26		Participants
Overall Survival (OS)	Durva + Placebo	Censored (includes subjects with unknown survival status or subjects who were lost to follow up)	30		Participants
Objective Response Rate (ORR)	Durva + Olaparib	Response	22		Participants
Objective Response Rate (ORR)	Durva + Placebo	Response	14		Participants
Objective Response Rate (ORR)	Durva + Olaparib	No Response	56		Participants
Objective Response Rate (ORR)	Durva + Placebo	No Response	62		Participants

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Durva + Olaparib	78
Overall Study	STARTED	Durva + Placebo	76
Overall Study	COMPLETED	Durva + Olaparib	0
Overall Study	COMPLETED	Durva + Placebo	0
Overall Study	NOT COMPLETED	Durva + Olaparib	78
Overall Study	NOT COMPLETED	Durva + Placebo	76

Source ClinicalTrials.gov

Adverse events178

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anaemia	Blood and lymphatic system disorders	Durva + Olaparib	34	76	50
other	Anaemia	Blood and lymphatic system disorders	Durva + Placebo	21	76	22
other	Hypothyroidism	Endocrine disorders	Durva + Olaparib	7	76	7
other	Hypothyroidism	Endocrine disorders	Durva + Placebo	4	76	5
other	Nausea	Gastrointestinal disorders	Durva + Olaparib	20	76	23
other	Nausea	Gastrointestinal disorders	Durva + Placebo	6	76	6
other	Constipation	Gastrointestinal disorders	Durva + Olaparib	13	76	14
other	Constipation	Gastrointestinal disorders	Durva + Placebo	12	76	15
other	Diarrhoea	Gastrointestinal disorders	Durva + Olaparib	10	76	12
other	Diarrhoea	Gastrointestinal disorders	Durva + Placebo	5	76	7

1 to 10 of 178Source ClinicalTrials.gov

See all 178 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Durva + Olaparib	52	78
Total, all-cause mortality	Durva + Placebo	46	76
Total, other adverse events	Durva + Olaparib	65	76
Total, other adverse events	Durva + Placebo	63	76
Total, serious adverse events	Durva + Olaparib	37	76
Total, serious adverse events	Durva + Placebo	26	76

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
35737919	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Durva + Olaparib vs Durva + Placebo: deaths from any cause	Trial comparisons
Durva + Olaparib vs Durva + Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03459846

GET https://conductscience.org/api/trials/v1/NCT03459846/events?page=2

API reference For AI assistants