Durvalumab Treatment in Combination With Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib Treatment in Advanced Ovarian Cancer Patients (DUO-O)

June 8, 2026 updated by: AstraZeneca

A Phase III Randomised, Double-Blind, Placebo-Controlled, Multicentre Study of Durvalumab in Combination With Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib in Newly Diagnosed Advanced Ovarian Cancer Patients (DUO-O).

This is a Phase III randomised, double-blind, multi-centre study to evaluate the efficacy and safety of durvalumab in combination with standard of care platinum based chemotherapy and bevacizumab followed by maintenance durvalumab and bevacizumab or durvalumab, bevacizumab and olaparib in patients with newly diagnosed advanced ovarian cancer.

Study Overview

Status

Active, not recruiting

Conditions

Advanced Ovarian Cancer

Intervention / Treatment

Detailed Description

Eligible patients will be those patients with newly diagnosed, histologically confirmed advanced (Fédération Internationale de Gynécologie et d'Obstétrique [FIGO] Stage III-IV) ovarian, primary peritoneal cancer and/or fallopian-tube cancer. All patients should be candidates for cytoreductive surgery which could be conducted as immediate upfront primary surgery following diagnosis or can be conducted after initiation of platinum based neoadjuvant chemotherapy. All patients should be eligible to start first line platinum based chemotherapy in combination with bevacizumab.

The study aims to evaluate the efficacy and safety of standard of care (SoC) platinum-based chemotherapy and bevacizumab followed by maintenance bevacizumab either as monotherapy, or in combination with durvalumab, or in combination with durvalumab and olaparib. Therefore, this study aims to see which combination allows patients to live longer without the cancer coming back or getting worse. The study is also looking to see which combination makes patients live longer and how the treatment and the cancer affects their quality of life.

Study Type

Interventional

Enrollment (Actual)

1407

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Austria
- - Graz, Austria, 8036
    - Research Site
  - Innsbruck, Austria, 6020
    - Research Site
  - Linz, Austria, 4020
    - Research Site
  - Vienna, Austria, 1090
    - Research Site
Belgium
- - Aalst, Belgium, 9300
    - Research Site
  - Leuven, Belgium, 3000
    - Research Site
  - Namur, Belgium, 5000
    - Research Site
  - Ostend, Belgium, 8400
    - Research Site
  - Sint-Niklaas, Belgium, 9100
    - Research Site
Brazil
- - Barretos, Brazil, 14784-400
    - Research Site
  - Florianópolis, Brazil, 88034-000
    - Research Site
  - Fortaleza, Brazil, 60810-180
    - Research Site
  - Londrina, Brazil, 86015-520
    - Research Site
  - Porto Alegre, Brazil, 90020-090
    - Research Site
  - Porto Alegre, Brazil, 90110-270
    - Research Site
  - Rio de Janeiro, Brazil, 20220-410
    - Research Site
  - São Paulo, Brazil, 01317-000
    - Research Site
  - São Paulo, Brazil, 04014-002
    - Research Site
Bulgaria
- - Burgas, Bulgaria, 8000
    - Research Site
  - Plovdiv, Bulgaria, 4004
    - Research Site
  - Sofia, Bulgaria, 1330
    - Research Site
  - Varna, Bulgaria, 9000
    - Research Site
Canada
- Alberta
  - Calgary, Alberta, Canada, T2N 5G2
    - Research Site
- Ontario
  - Barrie, Ontario, Canada, L4M 6M2
    - Research Site
  - Greater Sudbury, Ontario, Canada, P3E 5J1
    - Research Site
  - Toronto, Ontario, Canada, M5G 2M9
    - Research Site
- Quebec
  - Montreal, Quebec, Canada, H4A 3J1
    - Research Site
  - Montreal, Quebec, Canada, H3T 1E2
    - Research Site
  - Montreal, Quebec, Canada, H2X 3E4
    - Research Site
  - Québec, Quebec, Canada, G1J 1Z4
    - Research Site
  - Rimouski, Quebec, Canada, G5L 5T1
    - Research Site
China
- - Beijing, China, CN-100730
    - Research Site
  - Beijing, China, 100026
    - Research Site
  - Bengbu, China, 233004
    - Research Site
  - Changchun, China, 130021
    - Research Site
  - Changsha, China, 410008
    - Research Site
  - Changsha, China, 430033
    - Research Site
  - Chengdu, China, 610041
    - Research Site
  - Chongqing, China, 400030
    - Research Site
  - Dalian, China, 116001
    - Research Site
  - Guangzhou, China, 510080
    - Research Site
  - Guangzhou, China, 510060
    - Research Site
  - Hangzhou, China, 310022
    - Research Site
  - Hangzhou, China, 310009
    - Research Site
  - Harbin, China, 150081
    - Research Site
  - Hefei, China, 230031
    - Research Site
  - Jinhua, China, 321099
    - Research Site
  - Kunming, China, 650118
    - Research Site
  - Lanzhou, China, 730030
    - Research Site
  - Luzhou, China, 646099
    - Research Site
  - Nanchong, China, 637000
    - Research Site
  - Nanjing, China, 2100008
    - Research Site
  - Nanning, China, 530021
    - Research Site
  - Nantong, China, 226361
    - Research Site
  - Shanghai, China, 200011
    - Research Site
  - Shanghai, China, 200032
    - Research Site
  - Wuhan, China, 430030
    - Research Site
  - Wuhan, China, 430060
    - Research Site
  - Xi'an, China, 710061
    - Research Site
  - Zhengzhou, China, 450008
    - Research Site
  - Zhengzhou, China, 450002
    - Research Site
  - Zhuhai, China, 519099
    - Research Site
Denmark
- - Aalborg, Denmark, 9000
    - Research Site
  - Aarhus N, Denmark, 8200
    - Research Site
  - Odense, Denmark, 5000
    - Research Site
  - Roskilde, Denmark, 4000
    - Research Site
  - Vejle, Denmark, 7100
    - Research Site
Finland
- - Kuopio, Finland, 70210
    - Research Site
  - Oulu, Finland, 90029
    - Research Site
  - Turku, Finland, 20521
    - Research Site
France
- - Besançon, France, 25000
    - Research Site
  - Bordeaux, France, 33076
    - Research Site
  - Limoges, France, 87042
    - Research Site
  - Lyon, France, 69373
    - Research Site
  - Marseille, France, 13273
    - Research Site
  - Nantes, France, 44202
    - Research Site
  - Paris, France, 75012
    - Research Site
  - Paris, France, 75015
    - Research Site
  - Paris, France, 75674
    - Research Site
  - Saint-Herblain, France, 44805
    - Research Site
  - Vandœuvre-lès-Nancy, France, 54519
    - Research Site
Germany
- - Bad Homburg, Germany, 61352
    - Research Site
  - Berlin, Germany, 10117
    - Research Site
  - Bielefeld, Germany, 33604
    - Research Site
  - Bonn, Germany, 53105
    - Research Site
  - Brandenburg, Germany, 14770
    - Research Site
  - Cologne, Germany, 50935
    - Research Site
  - Dresden, Germany, 1307
    - Research Site
  - Düsseldorf, Germany, 40489
    - Research Site
  - Essen, Germany, 45136
    - Research Site
  - Essen, Germany, 45147
    - Research Site
  - Esslingen am Neckar, Germany, 73730
    - Research Site
  - Frankfurt, Germany, 60590
    - Research Site
  - Freiburg im Breisgau, Germany, 79106
    - Research Site
  - Fürth, Germany, 90766
    - Research Site
  - Greifswald, Germany, 17475
    - Research Site
  - Gütersloh, Germany, 33332
    - Research Site
  - Hamburg, Germany, 20246
    - Research Site
  - Hamburg, Germany, 20357
    - Research Site
  - Hamburg, Germany, 22457
    - Research Site
  - Hanover, Germany, 30625
    - Research Site
  - Hanover, Germany, 30177
    - Research Site
  - Jena, Germany, 07747
    - Research Site
  - Karlsruhe, Germany, 76135
    - Research Site
  - Karlsruhe, Germany, 76133
    - Research Site
  - Kassel, Germany, 34125
    - Research Site
  - Kiel, Germany, 24105
    - Research Site
  - Leipzig, Germany, 04103
    - Research Site
  - Ludwigsburg, Germany, 71640
    - Research Site
  - Lübeck, Germany, 23538
    - Research Site
  - Mainz, Germany, 55131
    - Research Site
  - Mannheim, Germany, 68167
    - Research Site
  - München, Germany, 81377
    - Research Site
  - Offenbach, Germany, 63069
    - Research Site
  - Oldenburg, Germany, 26133
    - Research Site
  - Rosenheim, Germany, 83022
    - Research Site
  - Rostock, Germany, 18057
    - Research Site
  - Saalfeld, Germany, 07318
    - Research Site
  - Schweinfurt, Germany, 97422
    - Research Site
  - Tübingen, Germany, 72016
    - Research Site
  - Ulm, Germany, 89075
    - Research Site
  - Worms, Germany, 67550
    - Research Site
Hungary
- - Budapest, Hungary, 1122
    - Research Site
  - Budapest, Hungary, 1062
    - Research Site
  - Debrecen, Hungary, 4032
    - Research Site
  - Győr, Hungary, 9024
    - Research Site
  - Kaposvár, Hungary, 7400
    - Research Site
  - Szeged, Hungary, 6725
    - Research Site
  - Zalaegerszeg, Hungary, 8900
    - Research Site
Italy
- - Brescia, Italy, 25123
    - Research Site
  - Lecce, Italy, 73100
    - Research Site
  - Lecco, Italy, 23900
    - Research Site
  - Milan, Italy, 20141
    - Research Site
  - Milan, Italy, 20132
    - Research Site
  - Mirano, Italy, 30035
    - Research Site
  - Naples, Italy, 80131
    - Research Site
  - Reggio Calabria, Italy, 89100
    - Research Site
  - Reggio Emilia, Italy, 42100
    - Research Site
  - Roma, Italy, 00168
    - Research Site
  - Torino, Italy, 10126
    - Research Site
  - Torino, Italy, 10128
    - Research Site
Japan
- - Fukuoka, Japan, 811-1395
    - Research Site
  - Kashiwa-shi, Japan, 277-8567
    - Research Site
  - Kobe, Japan, 650-0047
    - Research Site
  - Kurume-shi, Japan, 830-0011
    - Research Site
  - Kyoto, Japan, 606-8507
    - Research Site
  - Kōtoku, Japan, 135-8550
    - Research Site
  - Minatoku, Japan, 105-8471
    - Research Site
  - Nagoya, Japan, 464-8681
    - Research Site
  - Niigata, Japan, 951-8520
    - Research Site
  - Okayama, Japan, 700-8558
    - Research Site
  - Sapporo, Japan, 003-0804
    - Research Site
  - Sendai, Japan, 980-8574
    - Research Site
  - Shinjuku-ku, Japan, 160-8582
    - Research Site
  - Sunto-gun, Japan, 411-8777
    - Research Site
  - Toyoake-shi, Japan, 470-1192
    - Research Site
Peru
- - Bellavista, Peru, CALLAO 2
    - Research Site
  - La Libertad, Peru, 13013
    - Research Site
  - Lima, Peru, Lima 34
    - Research Site
  - Lima, Peru, LIMA 41
    - Research Site
  - Lima, Peru, LIMA 31
    - Research Site
  - Lima, Peru, Lima 32
    - Research Site
  - San Isidro, Peru, 27
    - Research Site
Poland
- - Gdynia, Poland, 81-519
    - Research Site
  - Lodz, Poland, 93-513
    - Research Site
  - Szczecin, Poland, 70-111
    - Research Site
  - Warsaw, Poland, 02-781
    - Research Site
  - Warsaw, Poland, 04-141
    - Research Site
Romania
- - Floreşti, Romania, 407280
    - Research Site
South Korea
- - Goyang-si, South Korea, 10408
    - Research Site
  - Seongnam-si, South Korea, 13620
    - Research Site
  - Seoul, South Korea, 03080
    - Research Site
  - Seoul, South Korea, 03722
    - Research Site
  - Seoul, South Korea, 06351
    - Research Site
  - Suwon, South Korea, 16499
    - Research Site
Spain
- - Córdoba, Spain, 14004
    - Research Site
  - Madrid, Spain, 28034
    - Research Site
  - Madrid, Spain, 28041
    - Research Site
  - Madrid, Spain, 28040
    - Research Site
  - Madrid, Spain, 28033
    - Research Site
  - Terrassa(Barcelona), Spain, 08221
    - Research Site
  - Vigo, Spain, 36312
    - Research Site
Turkey (Türkiye)
- - Adana, Turkey (Türkiye), 1260
    - Research Site
  - Ankara, Turkey (Türkiye), 06230
    - Research Site
  - Ankara, Turkey (Türkiye), 06490
    - Research Site
  - Istanbul, Turkey (Türkiye), 34093
    - Research Site
  - Istanbul, Turkey (Türkiye), 34384
    - Research Site
  - Izmir, Turkey (Türkiye), 35100
    - Research Site
United States
- California
  - Foothill Ranch, California, United States, 92610
    - Research Site
  - Los Angeles, California, United States, 90095
    - Research Site
  - Orange, California, United States, 92868-3298
    - Research Site
  - San Francisco, California, United States, 94158
    - Research Site
- Florida
  - Tampa, Florida, United States, 33612
    - Research Site
- Georgia
  - Augusta, Georgia, United States, 30912
    - Research Site
- Illinois
  - Hinsdale, Illinois, United States, 60521
    - Research Site
- Indiana
  - Indianapolis, Indiana, United States, 46202
    - Research Site
- Maryland
  - Towson, Maryland, United States, 21204
    - Research Site
- Michigan
  - Detroit, Michigan, United States, 48202
    - Research Site
- Missouri
  - Springfield, Missouri, United States, 65807
    - Research Site
- New Jersey
  - Middletown, New Jersey, United States, 07748
    - Research Site
  - Montvale, New Jersey, United States, 07645
    - Research Site
- New York
  - Albany, New York, United States, 12208
    - Research Site
  - New York, New York, United States, 10065
    - Research Site
  - Uniondale, New York, United States, 11553
    - Research Site
- North Carolina
  - Durham, North Carolina, United States, 27710
    - Research Site
- Ohio
  - Cleveland, Ohio, United States, 44195
    - Research Site
  - Dayton, Ohio, United States, 45429
    - Research Site
  - Hilliard, Ohio, United States, 43026
    - Research Site
- Oklahoma
  - Tulsa, Oklahoma, United States, 74134
    - Research Site
- Pennsylvania
  - Lancaster, Pennsylvania, United States, 17601
    - Research Site
  - Philadelphia, Pennsylvania, United States, 19104
    - Research Site
  - Philadelphia, Pennsylvania, United States, 19107-5097
    - Research Site
  - Pittsburgh, Pennsylvania, United States, 15224
    - Research Site
- Utah
  - Salt Lake City, Utah, United States, 84112
    - Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 130 years (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Key Inclusion Criteria:

Female patients with newly diagnosed, histologically confirmed, advanced (Stage III-IV) high grade epithelial ovarian cancer including high grade serious, high grade endometriod, clear cell ovarian cancer or carcinosarcoma, primary peritoneal cancer and / or fallopian-tube cancer

Patients must be aged ≥18 years of age. For patients enrolled in Japan that are aged <20 year
All patients should be candidates for cytoreductive surgery either: upfront primary surgery OR plan to undergo chemotherapy with interval debulking surgery
Evidence of presence or absence of BRCA1/2 mutation in tumour tissue
Mandatory provision of tumour sample for centralised tBRCA testing
ECOG performance status 0-1
Patients must have preserved organ and bone marrow function
Postmenopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test

Key Exclusion Criteria:

Non-epithelial ovarian cancer, borderline tumors, low grade epithelial tumors or mucinous histology

Prior systemic anti-cancer therapy for ovarian cancer
Inability to determine the presence or absence of a deleterious or suspected deleterious BRCA mutation
Prior treatment with PARP inhibitor or immune mediated therapy
Planned intraperitoneal cytotoxic chemotherapy
Active or prior documented autoimmune or inflammatory disorders
Patients considered a poor medical risk due to a serious, uncontrolled intercurrent illness
Clinically significant cardiovascular disease
Patients with known brain metastases
History of another primary malignancy except for:
- Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of study treatment and of low potential risk for recurrence (patients who have received prior adjuvant chemotherapy for early stage breast cancer may be eligible, provided that it was completed ≥3 years prior to registration, and that the patient remains free of recurrent or metastatic disease)
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- Adequately treated carcinoma in situ without evidence of disease
- Endometrial cancer FIGO Stage IA, Grade 1 or Grade 2
Persistent toxicities CTCAE Grade >2 caused by previous cancer therapy
Patients with a known hypersensitivity to olaparib, durvalumab or any of the excipients of these products and to the combination/comparator agents
Breast feeding women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 1 Platinum-based chemotherapy in combination with bevacizumab and durvalumab placebo (saline IV infusion) followed by maintenance bevacizumab, durvalumab placebo (saline IV infusion) and olaparib placebo (tablets).	Drug: Bevacizumab Bevacizumab by intravenous infusion. In tBRCAm cohort bevacizumab is optional according to local practice. Drug: Placebo olaparib Placebo tablets to match olaparib Drug: Durvalumab placebo Matching placebo for intravenous infusion Drug: Carboplatin+Paclitaxel Standard of care chemotherapy
Experimental: Arm 2 Platinum-based chemotherapy in combination with bevacizumab and durvalumab followed by maintenance bevacizumab, durvalumab and olaparib placebo.	Drug: Bevacizumab Bevacizumab by intravenous infusion. In tBRCAm cohort bevacizumab is optional according to local practice. Drug: Placebo olaparib Placebo tablets to match olaparib Drug: Carboplatin+Paclitaxel Standard of care chemotherapy Drug: Durvalumab Durvalumab by intravenous infusion
Experimental: Arm 3 Platinum-based chemotherapy in combination with bevacizumab and durvalumab followed by maintenance bevacizumab, durvalumab and olaparib.	Drug: Olaparib Olaparib tablets Drug: Bevacizumab Bevacizumab by intravenous infusion. In tBRCAm cohort bevacizumab is optional according to local practice. Drug: Carboplatin+Paclitaxel Standard of care chemotherapy Drug: Durvalumab Durvalumab by intravenous infusion
Experimental: tBRCAm cohort Platinum-based chemotherapy in combination with bevacizumab and durvalumab followed by maintenance bevacizumab, durvalumab and olaparib. Bevacizumab is optional according to local practice.	Drug: Olaparib Olaparib tablets Drug: Bevacizumab Bevacizumab by intravenous infusion. In tBRCAm cohort bevacizumab is optional according to local practice. Drug: Carboplatin+Paclitaxel Standard of care chemotherapy Drug: Durvalumab Durvalumab by intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival (PFS) by Investigator Assessment Using Modified RECIST 1.1 - Full Analysis Set Time Frame: At baseline, within 3 weeks of last dose of chemotherapy, then every 12 weeks for 3 years and thereafter every 24 weeks. Assessed until primary analysis - (05DEC2022 for Global cohort, 17MAR2025 for China cohort) - upto 46 months	To determine the efficacy of durvalumab in combination with platinum based chemotherapy and bevacizumab and continued as maintenance in combination with bevacizumab and olaparib versus SoC platinum based chemotherapy in combination with bevacizumab by assessment of PFS (using investigator assessment according to Response Evaluation Criteria in Solid Tumours version 1.1 [RECIST 1.1]) in the first line treatment of patients with newly diagnosed advanced ovarian cancer. Per MTP, the comparison of SoC+D+O v SoC in the Non-tbRCAm patients is a primary endpoint. SoC+D v SoC is reported separately as a secondary endpoint. Results for tBRCAm SoC+D+O are not presented as this was prespecified to be assessed only in the Non-tBRCAm patients.	At baseline, within 3 weeks of last dose of chemotherapy, then every 12 weeks for 3 years and thereafter every 24 weeks. Assessed until primary analysis - (05DEC2022 for Global cohort, 17MAR2025 for China cohort) - upto 46 months
Progression-free Survival (PFS) by Investigator Assessment Using Modified RECIST 1.1 - (Full Analysis Set, HRD Positive) Time Frame: At baseline, within 3 weeks of last dose of chemotherapy, then every 12 weeks for 3 years and thereafter every 24 weeks. Assessed until DCO1 - (05DEC2022 for Global cohort, 17MAR2025 for China cohort) - upto 46 months	To determine the efficacy of durvalumab and olaparib assessed by PFS in the first line treatment of patients with newly diagnosed advanced ovarian cancer. Per MTP, the comparison of SoC+D+O v SoC in the Non-tBRCAm HRD positve population is a primary endpoint. SoC+D v SoC is reported separately as a secondary endpoint. Results for tBRCAm SoC+D+O are not presented as as this was prespecified to be assessed only in the Non-tBRCAm patients.	At baseline, within 3 weeks of last dose of chemotherapy, then every 12 weeks for 3 years and thereafter every 24 weeks. Assessed until DCO1 - (05DEC2022 for Global cohort, 17MAR2025 for China cohort) - upto 46 months

Secondary Outcome Measures

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and tolerability of drugs by assessment of AEs/SAEs Time Frame: Approximately 4 years	Graded according to the National Cancer Institute (NCI CTCAE)	Approximately 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

GOG Foundation

European Network of Gynaecological Oncological Trial Groups (ENGOT)

Myriad Genetic Laboratories, Inc.

Investigators

Principal Investigator: Philipp Harter, European Network of Gynaecological Oncological Trial Groups (ENGOT)
Principal Investigator: Carol Aghajanian, GOG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2019

Primary Completion (Actual)

March 17, 2025

Study Completion (Estimated)

December 23, 2026

Study Registration Dates

First Submitted

October 15, 2018

First Submitted That Met QC Criteria

November 8, 2018

First Posted (Actual)

November 9, 2018

Study Record Updates

Last Update Posted (Actual)

June 9, 2026

Last Update Submitted That Met QC Criteria

June 8, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

D081RC00001
2017-004632-11 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the de-identified 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.

IPD Sharing Supporting Information Type

STUDY_PROTOCOL
SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Effects of a Probiotic Intervention on the Gut and Vaginal Microbiome in Patients With Advanced or Recurrent Ovarian Cancer Undergoing Treatment With Platinum Chemotherapy

Recurrent Ovarian Carcinoma | Stage III Ovarian Cancer AJCC v8 | Stage IV Ovarian Cancer AJCC v8 | Advanced Ovarian Carcinoma | Stage II Ovarian Cancer AJCC v8

United States
AstraZeneca

Recruiting

A First-in-human Dose Escalation and Expansion Study to Evaluate the Safety, and Tolerability of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors (CYCAD-1)

ER+ HER2- Advanced Breast Cancer | High-grade Serous Ovarian Cancer (HGSOC)

United States, United Kingdom, Spain, Australia, South Korea
AstraZeneca

Completed

Study to Assess the Safety and Tolerability of a PARP Inhibitor in Combination With Carboplatin and/or Paclitaxel

Advanced Ovarian Cancer | Paclitaxel | Carboplatin | Triple Negative Metastatic Breast Cancer

Belgium, Netherlands, United Kingdom

Clinical Trials on Olaparib

The Netherlands Cancer Institute

Recruiting

The PROOV Study: Exploiting the Synergistic Effect of PARP Inhibition With Cisplatin and Hyperthermia During Interval Cytoreductive Surgery and HIPEC in Ovarian Cancer (PROOV)

Ovarian Cancer | Fallopian Tube Cancer | Epithelial Cancer

Netherlands
M.D. Anderson Cancer Center

Recruiting

Phase 1b Trial of BMS-986504 in Combination With Olaparib in Patients With MTAP Loss

Solid Tumor | Advanced Cancer

United States
Daewoong Pharmaceutical Co. LTD.

Recruiting

Bioequivalence Study of DWZ2501 in Patients With Advanced BRCA-mutated High-grade Ovarian Cancer

Cancer | Ovarian Cancer

South Korea
AstraZeneca

Not yet recruiting

PROLONG (PRostateOLaparibONcombinationGcc) Study (PROLONG)

Metastatic Castration-resistant Prostate Cancer (mCRPC)
Azienda Ospedaliero-Universitaria di Modena

Recruiting

Real wOrld studY in the Adjuvant Setting for High Risk earLy Breast Cancer Patients (ROYAL)

Breast Cancer

Italy
Memorial Sloan Kettering Cancer Center

Completed

A Study of Olaparib and Low Dose Radiotherapy for Small Cell Lung Cancer

Small Cell Lung Carcinoma | Small-cell Lung Cancer

United States
AstraZeneca
Merck Sharp & Dohme LLC; IQVIA Pty Ltd

Completed

A Study Using Olaparib Tablets for Subjects With Advanced Solid Tumours. (IVIVC)

Malignant Solid Tumor

Belgium
CSPC Ouyi Pharmaceutical Co., Ltd.

Completed

Bioequivalence Study of Olaparib Tablets Under Fasting and Fed Conditions in Healthy Subjects

Healthy Participants

China
Sichuan Baili Pharmaceutical Co., Ltd.
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.

Not yet recruiting

A Study of BL-B01D1 Combination Therapy in Patients With Metastatic Castration-resistant Prostate Cancer

Castration-resistant Prostate Cancer

China
Bai-Rong Xia
Qilu Pharmaceutical Co., Ltd.

Recruiting

An Exploratory Study on the Use of Ipalotinib (Tislelizumab) Combined With Sunitinib and Olaparib for Neoadjuvant Therapy in HRD-positive Advanced Ovarian Cancer

Ovary Cancer

China

Durvalumab Treatment in Combination With Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib Treatment in Advanced Ovarian Cancer Patients (DUO-O)

A Phase III Randomised, Double-Blind, Placebo-Controlled, Multicentre Study of Durvalumab in Combination With Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib in Newly Diagnosed Advanced Ovarian Cancer Patients (DUO-O).

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

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Phase

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Ages Eligible for Study

Accepts Healthy Volunteers

Description

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How is the study designed?

Design Details

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Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

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Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Other Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

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Collaborators

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Primary Completion (Actual)

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First Submitted

First Submitted That Met QC Criteria

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Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

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Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

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