A Phase 2 interventional study of Durvalumab and Olaparib in Urinary Bladder Neoplasms, sponsored by AstraZeneca. Active, not recruiting at 44 sites in 7 countries. Open to participants aged 18 Years to 130 Years. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment
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Among 20 studies in Urinary Bladder Neoplasms by AstraZeneca — 5 open to participants now, 11 under way, 4 of them phase 3. Urinary Bladder Neoplasms · AstraZeneca.
Among the 20 studies in Urinary Bladder Neoplasms by AstraZeneca, this one is the 6th largest by enrollment of the 14 interventional ones that give a count, is one of 3 that started in 2018, is one of 4 in phase 2, reaches primary completion later than 1 of the 10 other live ones, and was the 7th registered.
1,800 studies on the registry are indexed under Urinary Bladder Neoplasms; 446 are open to participants now.
Browse Urinary Bladder Neoplasms studies →5 of the 20 studies in Urinary Bladder Neoplasms by AstraZeneca are open now, in 12 countries. Recruiting first, the newest first:
AstraZeneca · Sites in United States, Australia, Brazil and 13 more countries
Ages 18+
AstraZeneca · Sites in United States
Ages 18–130
AstraZeneca · Sites in Russia
Ages 18+
AstraZeneca · Sites in Australia, Brazil, Canada and 4 more countries
Ages 18+
AstraZeneca
Ages 18+
By country, each count listing its studies:
Of the 336 Urinary Bladder Neoplasms studies recruiting now, 256 (76%) set no upper age limit and 22 (7%) stop at 75 or younger; 22 take children under 18; 21 take healthy volunteers.
This study: 18 Years to 130 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
20 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 7 · Phase 3 4 · Phase 4 1
First in 2003; this study’s year is marked. 3 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 154 is above the median of 60 across 1,296 interventional studies indexed under Urinary Bladder Neoplasms.
Median enrollment 138 across the 14 interventional studies, 324 across the 6 observational. Of the 9 that completed or were terminated, 2 (22%) have results posted.
This tab as a report to print or save as PDF → With an account.
AstraZeneca is the lead sponsor of 3,502 studies on the registry; 273 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
2 of the studies in Urinary Bladder Neoplasms by AstraZeneca that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07038928AstraZenecaTReatment Approaches and bIomarkers preValence in bladdEr Cancer in RuSsian Federation | 2026-12-31 |
| NCT04644068AstraZenecaStudy of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies | 2027-05-28 |
Add all 2 to your calendar (.ics) → With an account.
Among the 20 studies in Urinary Bladder Neoplasms by AstraZeneca, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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
This is a Phase II, randomized, double-blind, placebo controlled, multi-center, comparative global study to determine the efficacy and safety of durvalumab + olaparib combination therapy versus durvalumab + placebo (durvalumab monotherapy) as first-line treatment in patients ineligible for platinum-based chemotherapy with unresectable Stage IV urothelial cancer (UC).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Durvalumab 1500 mg intravenous (IV) every 4 weeks (q4w) starting on week 1 day 1/Placebo orally (PO) twice a day (BID) starting on week 1 day 1.
Drug: Durvalumab · Drug: Placebo
Durvalumab 1500 mg IV q4w starting on week 1 day 1/Olaparib PO 300 mg BID adjusted based on patient's creatinine clearance.
Drug: Durvalumab · Drug: Olaparib
Durvalumab 1500 mg IV q4w
Olaparib PO 300 mg BID adjusted based on patient's creatinine clearance.
Matching placebo for oral tablet BID
Progression-free Survival (PFS)
Progression-free survival based on investigator assessments according to RECIST 1.1
Time frame: 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
Overall Survival (OS)
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.
Time frame: 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
Objective Response Rate (ORR)
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
Time frame: 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
Duration of Response (DoR)
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
Time frame: 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
| Milestone | Durva + Olaparib | Durva + Placebo |
|---|---|---|
| Started | 78 | 76 |
| Completed | 0 | 0 |
| Not completed | 78 | 76 |
| Withdrew: Death | 52 | 46 |
| Withdrew: Study terminated by sponsor | 24 | 28 |
| Withdrew: Withdrawal by subject | 2 | 2 |
Progression-free survival based on investigator assessments according to RECIST 1.1
| Months | Durva + Olaparib | Durva + Placebo |
|---|---|---|
| Progression-free Survival (PFS) | 4.2 (3.6 to 5.6) | 3.5 (1.9 to 5.1) |
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.
| Participants | Durva + Olaparib | Durva + Placebo |
|---|---|---|
| Died | 52 | 46 |
| Censored (includes subjects with unknown survival status or subjects who were lost to follow up) | 26 | 30 |
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
| Participants | Durva + Olaparib | Durva + Placebo |
|---|---|---|
| Response | 22 | 14 |
| No Response | 56 | 62 |
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
| Months | Durva + Olaparib | Durva + Placebo |
|---|---|---|
| Duration of Response (DoR) | 8.9 (4.7 to 12.1) | 14.8 (7.5 to 17.2) |
Collected over From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Durva + Olaparib | 52/78 (66.7%) | 37/76 (48.7%) | 65/76 (85.5%) |
| Durva + Placebo | 46/76 (60.5%) | 26/76 (34.2%) | 63/76 (82.9%) |
| Event | Durva + Olaparib | Durva + Placebo |
|---|---|---|
| Urinary tract infectionInfections and infestations | 6/76 | 6/76 |
| AnaemiaBlood and lymphatic system disorders | 5/76 | 1/76 |
| Renal failureRenal and urinary disorders | 4/76 | 0/76 |
| HaematuriaRenal and urinary disorders | 3/76 | 1/76 |
| HydronephrosisRenal and urinary disorders | 3/76 | 1/76 |
| PneumoniaInfections and infestations | 3/76 | 2/76 |
| Acute kidney injuryRenal and urinary disorders | 2/76 | 3/76 |
| FatigueGeneral disorders | 2/76 | 1/76 |
| PyrexiaGeneral disorders | 2/76 | 1/76 |
| Chronic kidney diseaseRenal and urinary disorders | 1/76 | 0/76 |
| Event | Durva + Olaparib | Durva + Placebo |
|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 34/76 | 21/76 |
| FatigueGeneral disorders | 22/76 | 13/76 |
| NauseaGastrointestinal disorders | 20/76 | 6/76 |
| Decreased appetiteMetabolism and nutrition disorders | 19/76 | 10/76 |
| ConstipationGastrointestinal disorders | 13/76 | 12/76 |
| DiarrhoeaGastrointestinal disorders | 10/76 | 5/76 |
| AstheniaGeneral disorders | 10/76 | 2/76 |
| Urinary tract infectionInfections and infestations | 9/76 | 4/76 |
| Blood creatinine increasedInvestigations | 8/76 | 4/76 |
| Back painMusculoskeletal and connective tissue disorders | 8/76 | 7/76 |
| Age, Continuous(Years) | Durva + Olaparib | Durva + Placebo | Total |
|---|---|---|---|
| Mean | 73.4 ± 10.8 | 70.2 ± 10.26 | 71.9 ± 10.62 |
| Sex: Female, Male(Participants) | Durva + Olaparib | Durva + Placebo | Total |
|---|---|---|---|
| Female | 22 | 21 | 43 |
| Male | 56 | 55 | 111 |
| Race/Ethnicity, Customized(Participants) | Durva + Olaparib | Durva + Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 3 | 6 |
| Not Hispanic or Latino | 75 | 73 | 148 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Supporting information: Study protocol, Statistical analysis plan
Time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Data sharing details ↗ · astrazenecagroup-dt.pharmacm.com
Ran from Mar 2018 to primary completion in Oct 2020, 30 months.
Results were first posted in Oct 2022, 2 years after primary completion. A results delay was requested in May 2021.
Of 39 industry-sponsored phase 2 interventional studies under Urinary Bladder Neoplasms, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 52. This study's 30 months is below that.
Counting every sponsor, half of 194 studies reached it within 52 months; a quarter within 36 and three quarters within 91.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Olaparib