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

Primary Purpose

Advanced Ovarian Cancer

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Bevacizumab

Durvalumab

Olaparib

Placebo olaparib

Durvalumab placebo

Carboplatin+Paclitaxel

About this trial

This is an interventional treatment trial for Advanced Ovarian Cancer focused on measuring Advanced Ovarian Cancer, Ovarian neoplasms

Eligibility Criteria

18 Years - 130 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Arm Label

Arm 1

Arm 2

Arm 3

tBRCAm cohort

Arm Description

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).

Platinum-based chemotherapy in combination with bevacizumab and durvalumab followed by maintenance bevacizumab, durvalumab and olaparib placebo.

Platinum-based chemotherapy in combination with bevacizumab and durvalumab followed by maintenance bevacizumab, durvalumab and olaparib.

Platinum-based chemotherapy in combination with bevacizumab and durvalumab followed by maintenance bevacizumab, durvalumab and olaparib. Bevacizumab is optional according to local practice.

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS) - in non-tBRCA HRD positive patients

Defined as time from randomisation to first progression by investigator assessment using modified RECIST 1.1 or death (by any cause in the absence of progression)

Progression Free Survival (PFS) - in all non-tBRCA patients

Defined as time from randomisation to first progression by investigator assessment using modified RECIST 1.1 or death (by any cause in the absence of progression)

Secondary Outcome Measures

Progression Free Survival (PFS) - in non-tBRCAm patients

Defined as time from randomisation to first progression by investigator assessment using modified RECIST 1.1 or death (by any cause in the absence of progression)

Overall Survival (OS) - in non-tBRCA HRD positive patients and in all non-tBRCA patients

Defined as the time from randomisation to death due to any cause

Second Progression (PFS2) - in non-tBRCAm patients

Defined as time from randomisation to second progression by investigator assessment of radiological progression, symptomatic progression or death (by any cause in the absence of progression)

Health-related quality of life - in non-tBRCAm patients

Change from baseline in the physical functioning subscale of the EORTC-QLQ-C30

Pathological Complete Response (pCR) - in non-tBRCAm patients

Defined as the proportion of patients with pCR in patients undergoing IDS

The pharmacokinetics (PK) and immunogenicity of durvalumab and olaparib as determined by peak concentration - in non-tBRCAm patients

Determination of durvalumab concentration in serum and olaparib concentration in plasma in a subset of patients

Objective Response Rate (ORR) - in non-tBRCAm patients

Defined as the number (%) of patients with at least one investigator-assessed visit response of CR or PR as per RECIST 1.1

Duration of response (DoR) - in non-tBRCAm patients

Defined as the time form the date of first documented response (CR/PR) until the first progression or death in the absence of disease progression

Time to first subsequent therapy (TFST) - in non-tBRCAm patients

Time elapsed from randomisation to first subsequent therapy or death

Time to second subsequent therapy (TSST) - in non-tBRCAm patients

Time elapsed from randomisation to second subsequent therapy or death

Time to discontinuation or death (TDT) - in non-tBRCAm patients

Time elapsed from randomisation to study treatment discontinuation or death

PFS - in tBRCAm patients

To assess the potential additional clinical benefit of durvalumab added to SoC and olaparib in the first line treatment of tBRCAm patients

PFS2 - in tBRCAm patients

To assess the potential additional clinical benefit of durvalumab added to SoC and olaparib in the first line treatment of tBRCAm patients

ORR - in tBRCAm patients

To assess the potential additional clinical benefit of durvalumab added to SoC and olaparib in the first line treatment of tBRCAm patients

ORR pre-surgery in IDS group - in tBRCAm patients

To assess the potential additional clinical benefit of durvalumab added to SoC and olaparib in the first line treatment of tBRCAm patients

Duration of response (DoR) - in tBRCAm patients

To assess the potential additional clinical benefit of durvalumab added to SoC and olaparib in the first line treatment of tBRCAm patients

Time to first subsequent therapy (TFST) - in tBRCAm patients

To assess the potential additional clinical benefit of durvalumab added to SoC and olaparib in the first line treatment of tBRCAm patients

Time to second subsequent therapy (TSST) - in tBRCAm patients

To assess the potential additional clinical benefit of durvalumab added to SoC and olaparib in the first line treatment of tBRCAm patients

Time to discontinuation or death (TDT) - in tBRCAm patients

To assess the potential additional clinical benefit of durvalumab added to SoC and olaparib in the first line treatment of tBRCAm patients

Health-related quality of life - in tBRCAm patients

Change from baseline in the physical functioning subscale of the EORTC-QLQ-C30

Proportion of patients with pCR in patients undergoing IDS - in tBRCAm patients

To assess the potential additional clinical benefit of durvalumab added to SoC and olaparib in the first line treatment of tBRCAm patients

Full Information

NCT ID

NCT03737643

First Posted

October 15, 2018

Last Updated

September 26, 2023

Sponsor

AstraZeneca

Collaborators

European Network of Gynaecological Oncological Trial Groups (ENGOT), GOG Foundation, Inc. (GOG Foundation), Myriad Genetic Laboratories, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03737643

Brief Title

Durvalumab Treatment in Combination With Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib Treatment in Advanced Ovarian Cancer Patients

Acronym

DUO-O

Official Title

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 Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

January 4, 2019 (Actual)

Primary Completion Date

September 18, 2023 (Actual)

Study Completion Date

May 25, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

Collaborators

European Network of Gynaecological Oncological Trial Groups (ENGOT), GOG Foundation, Inc. (GOG Foundation), Myriad Genetic Laboratories, Inc.

4. Oversight

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

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Advanced Ovarian Cancer

Keywords

Advanced Ovarian Cancer, Ovarian neoplasms

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

The study consists of 2 independent cohorts: 3 double-blind treatment arms cohort for patients with no tBRCA mutation, and a single open label arm cohort for patients with tBRCA mutation

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1407 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Active Comparator

Arm Description

Arm Title

Arm 2

Arm Type

Experimental

Arm Description

Platinum-based chemotherapy in combination with bevacizumab and durvalumab followed by maintenance bevacizumab, durvalumab and olaparib placebo.

Arm Title

Arm 3

Arm Type

Experimental

Arm Description

Platinum-based chemotherapy in combination with bevacizumab and durvalumab followed by maintenance bevacizumab, durvalumab and olaparib.

Arm Title

tBRCAm cohort

Arm Type

Experimental

Arm Description

Platinum-based chemotherapy in combination with bevacizumab and durvalumab followed by maintenance bevacizumab, durvalumab and olaparib. Bevacizumab is optional according to local practice.

Intervention Type

Drug

Intervention Name(s)

Bevacizumab

Intervention Description

Bevacizumab by intravenous infusion. In tBRCAm cohort bevacizumab is optional according to local practice.

Intervention Type

Drug

Intervention Name(s)

Durvalumab

Intervention Description

Durvalumab by intravenous infusion

Intervention Type

Drug

Intervention Name(s)

Olaparib

Intervention Description

Olaparib tablets

Intervention Type

Drug

Intervention Name(s)

Placebo olaparib

Intervention Description

Placebo tablets to match olaparib

Intervention Type

Drug

Intervention Name(s)

Durvalumab placebo

Intervention Description

Matching placebo for intravenous infusion

Intervention Type

Drug

Intervention Name(s)

Carboplatin+Paclitaxel

Intervention Description

Standard of care chemotherapy

Primary Outcome Measure Information:

Title

Progression Free Survival (PFS) - in non-tBRCA HRD positive patients

Description

Defined as time from randomisation to first progression by investigator assessment using modified RECIST 1.1 or death (by any cause in the absence of progression)

Time Frame

Approximately 4 years

Title

Progression Free Survival (PFS) - in all non-tBRCA patients

Description

Defined as time from randomisation to first progression by investigator assessment using modified RECIST 1.1 or death (by any cause in the absence of progression)

Time Frame

Approximately 4 years

Secondary Outcome Measure Information:

Title

Progression Free Survival (PFS) - in non-tBRCAm patients

Description

Defined as time from randomisation to first progression by investigator assessment using modified RECIST 1.1 or death (by any cause in the absence of progression)

Time Frame

Approximately 4 years

Title

Overall Survival (OS) - in non-tBRCA HRD positive patients and in all non-tBRCA patients

Description

Defined as the time from randomisation to death due to any cause

Time Frame

Approximately 7 years

Title

Second Progression (PFS2) - in non-tBRCAm patients

Description

Defined as time from randomisation to second progression by investigator assessment of radiological progression, symptomatic progression or death (by any cause in the absence of progression)

Time Frame

Approximately 7 years

Title

Health-related quality of life - in non-tBRCAm patients

Description

Change from baseline in the physical functioning subscale of the EORTC-QLQ-C30

Time Frame

Approximately 4 years

Title

Pathological Complete Response (pCR) - in non-tBRCAm patients

Description

Defined as the proportion of patients with pCR in patients undergoing IDS

Time Frame

Approximately 4 years

Title

The pharmacokinetics (PK) and immunogenicity of durvalumab and olaparib as determined by peak concentration - in non-tBRCAm patients

Description

Determination of durvalumab concentration in serum and olaparib concentration in plasma in a subset of patients

Time Frame

Approximately 4 years

Title

Objective Response Rate (ORR) - in non-tBRCAm patients

Description

Defined as the number (%) of patients with at least one investigator-assessed visit response of CR or PR as per RECIST 1.1

Time Frame

Approximately 4 years

Title

Duration of response (DoR) - in non-tBRCAm patients

Description

Defined as the time form the date of first documented response (CR/PR) until the first progression or death in the absence of disease progression

Time Frame

Approximately 4 years

Title

Time to first subsequent therapy (TFST) - in non-tBRCAm patients

Description

Time elapsed from randomisation to first subsequent therapy or death

Time Frame

Approximately 7 years

Title

Time to second subsequent therapy (TSST) - in non-tBRCAm patients

Description

Time elapsed from randomisation to second subsequent therapy or death

Time Frame

Approximately 7 years

Title

Time to discontinuation or death (TDT) - in non-tBRCAm patients

Description

Time elapsed from randomisation to study treatment discontinuation or death

Time Frame

Approximately 4 years

Title

PFS - in tBRCAm patients

Description

To assess the potential additional clinical benefit of durvalumab added to SoC and olaparib in the first line treatment of tBRCAm patients

Time Frame

Approximately 4 years

Title

PFS2 - in tBRCAm patients

Description

To assess the potential additional clinical benefit of durvalumab added to SoC and olaparib in the first line treatment of tBRCAm patients

Time Frame

Approximately 7 years

Title

ORR - in tBRCAm patients

Description

To assess the potential additional clinical benefit of durvalumab added to SoC and olaparib in the first line treatment of tBRCAm patients

Time Frame

Approximately 4 years

Title

ORR pre-surgery in IDS group - in tBRCAm patients

Description

To assess the potential additional clinical benefit of durvalumab added to SoC and olaparib in the first line treatment of tBRCAm patients

Time Frame

Approximately 4 years

Title

Duration of response (DoR) - in tBRCAm patients

Description

To assess the potential additional clinical benefit of durvalumab added to SoC and olaparib in the first line treatment of tBRCAm patients

Time Frame

Approximately 4 years

Title

Time to first subsequent therapy (TFST) - in tBRCAm patients

Description

To assess the potential additional clinical benefit of durvalumab added to SoC and olaparib in the first line treatment of tBRCAm patients

Time Frame

Approximately 7 years

Title

Time to second subsequent therapy (TSST) - in tBRCAm patients

Description

To assess the potential additional clinical benefit of durvalumab added to SoC and olaparib in the first line treatment of tBRCAm patients

Time Frame

Approximately 7 years

Title

Time to discontinuation or death (TDT) - in tBRCAm patients

Description

To assess the potential additional clinical benefit of durvalumab added to SoC and olaparib in the first line treatment of tBRCAm patients

Time Frame

Approximately 4 years

Title

Health-related quality of life - in tBRCAm patients

Description

Change from baseline in the physical functioning subscale of the EORTC-QLQ-C30

Time Frame

Approximately 4 years

Title

Proportion of patients with pCR in patients undergoing IDS - in tBRCAm patients

Description

To assess the potential additional clinical benefit of durvalumab added to SoC and olaparib in the first line treatment of tBRCAm patients

Time Frame

Approximately 4 years

Other Pre-specified Outcome Measures:

Title

Safety and tolerability of drugs by assessment of AEs/SAEs

Description

Graded according to the National Cancer Institute (NCI CTCAE)

Time Frame

Approximately 4 years

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

All female patients newly diagnosed with advanced ovarian cancer

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

130 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Philipp Harter

Organizational Affiliation

European Network of Gynaecological Oncological Trial Groups (ENGOT)

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Carol Aghajanian

Organizational Affiliation

GOG

Official's Role

Principal Investigator

Facility Information:

Facility Name

Research Site

City

Foothill Ranch

State/Province

California

ZIP/Postal Code

92610

Country

United States

Facility Name

Research Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

Research Site

City

Orange

State/Province

California

ZIP/Postal Code

92868-3298

Country

United States

Facility Name

Research Site

City

San Francisco

State/Province

California

ZIP/Postal Code

94158

Country

United States

Facility Name

Research Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

Research Site

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30912

Country

United States

Facility Name

Research Site

City

Hinsdale

State/Province

Illinois

ZIP/Postal Code

60521

Country

United States

Facility Name

Research Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

Research Site

City

Towson

State/Province

Maryland

ZIP/Postal Code

21204

Country

United States

Facility Name

Research Site

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

Research Site

City

Springfield

State/Province

Missouri

ZIP/Postal Code

65807

Country

United States

Facility Name

Research Site

City

Middletown

State/Province

New Jersey

ZIP/Postal Code

07748

Country

United States

Facility Name

Research Site

City

Montvale

State/Province

New Jersey

ZIP/Postal Code

07645

Country

United States

Facility Name

Research Site

City

Albany

State/Province

New York

ZIP/Postal Code

12208

Country

United States

Facility Name

Research Site

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

Research Site

City

Uniondale

State/Province

New York

ZIP/Postal Code

11553

Country

United States

Facility Name

Research Site

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

Research Site

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Facility Name

Research Site

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45429

Country

United States

Facility Name

Research Site

City

Hilliard

State/Province

Ohio

ZIP/Postal Code

43026

Country

United States

Facility Name

Research Site

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74134

Country

United States

Facility Name

Research Site

City

Lancaster

State/Province

Pennsylvania

ZIP/Postal Code

17601

Country

United States

Facility Name

Research Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Research Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107-5097

Country

United States

Facility Name

Research Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15224

Country

United States

Facility Name

Research Site

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84112

Country

United States

Facility Name

Research Site

City

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

Research Site

City

Innsbruck

ZIP/Postal Code

6020

Country

Austria

Facility Name

Research Site

City

Linz

ZIP/Postal Code

4020

Country

Austria

Facility Name

Research Site

City

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

Research Site

City

Aalst

ZIP/Postal Code

9300

Country

Belgium

Facility Name

Research Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Research Site

City

Namur

ZIP/Postal Code

5000

Country

Belgium

Facility Name

Research Site

City

Oostende

ZIP/Postal Code

8400

Country

Belgium

Facility Name

Research Site

City

Sint-Niklaas

ZIP/Postal Code

9100

Country

Belgium

Facility Name

Research Site

City

Barretos

ZIP/Postal Code

14784-400

Country

Brazil

Facility Name

Research Site

City

Florianópolis

ZIP/Postal Code

88034-000

Country

Brazil

Facility Name

Research Site

City

Fortaleza

ZIP/Postal Code

60810-180

Country

Brazil

Facility Name

Research Site

City

Londrina

ZIP/Postal Code

86015-520

Country

Brazil

Facility Name

Research Site

City

Porto Alegre

ZIP/Postal Code

90020-090

Country

Brazil

Facility Name

Research Site

City

Porto Alegre

ZIP/Postal Code

90110-270

Country

Brazil

Facility Name

Research Site

City

Rio de Janeiro

ZIP/Postal Code

20220-410

Country

Brazil

Facility Name

Research Site

City

Sao Paulo

ZIP/Postal Code

01317-000

Country

Brazil

Facility Name

Research Site

City

São Paulo

ZIP/Postal Code

04014-002

Country

Brazil

Facility Name

Research Site

City

Burgas

ZIP/Postal Code

8000

Country

Bulgaria

Facility Name

Research Site

City

Plovdiv

ZIP/Postal Code

4004

Country

Bulgaria

Facility Name

Research Site

City

Sofia

ZIP/Postal Code

1330

Country

Bulgaria

Facility Name

Research Site

City

Varna

ZIP/Postal Code

9000

Country

Bulgaria

Facility Name

Research Site

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4N2

Country

Canada

Facility Name

Research Site

City

Barrie

State/Province

Ontario

ZIP/Postal Code

L4M 6M2

Country

Canada

Facility Name

Research Site

City

Sudbury

State/Province

Ontario

ZIP/Postal Code

P3E 5J1

Country

Canada

Facility Name

Research Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

Facility Name

Research Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2X 3E4

Country

Canada

Facility Name

Research Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3T 1E2

Country

Canada

Facility Name

Research Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H4A 3J1

Country

Canada

Facility Name

Research Site

City

Rimouski

State/Province

Quebec

ZIP/Postal Code

G5L 5T1

Country

Canada

Facility Name

Research Site

City

Quebec

ZIP/Postal Code

G1J 1Z4

Country

Canada

Facility Name

Research Site

City

Beijing

ZIP/Postal Code

CN-100730

Country

China

Facility Name

Research Site

City

Beijing

Country

China

Facility Name

Research Site

City

Bengbu

ZIP/Postal Code

233060

Country

China

Facility Name

Research Site

City

Changchun

ZIP/Postal Code

130021

Country

China

Facility Name

Research Site

City

Changsha

ZIP/Postal Code

410008

Country

China

Facility Name

Research Site

City

Changsha

ZIP/Postal Code

430033

Country

China

Facility Name

Research Site

City

Chengdu

ZIP/Postal Code

610041

Country

China

Facility Name

Research Site

City

Chongqing

ZIP/Postal Code

400030

Country

China

Facility Name

Research Site

City

Dalian

ZIP/Postal Code

116001

Country

China

Facility Name

Research Site

City

Guangzhou

ZIP/Postal Code

510060

Country

China

Facility Name

Research Site

City

Guangzhou

ZIP/Postal Code

510080

Country

China

Facility Name

Research Site

City

Hangzhou

ZIP/Postal Code

310009

Country

China

Facility Name

Research Site

City

Hangzhou

ZIP/Postal Code

310022

Country

China

Facility Name

Research Site

City

Harbin

ZIP/Postal Code

150081

Country

China

Facility Name

Research Site

City

Hefei

ZIP/Postal Code

230031

Country

China

Facility Name

Research Site

City

Jinhua

ZIP/Postal Code

321099

Country

China

Facility Name

Research Site

City

Kunming

ZIP/Postal Code

650118

Country

China

Facility Name

Research Site

City

Lanzhou

ZIP/Postal Code

730030

Country

China

Facility Name

Research Site

City

Luzhou

ZIP/Postal Code

646099

Country

China

Facility Name

Research Site

City

Nan Chong

ZIP/Postal Code

637000

Country

China

Facility Name

Research Site

City

Nanjing

ZIP/Postal Code

2100008

Country

China

Facility Name

Research Site

City

Nanning

ZIP/Postal Code

530021

Country

China

Facility Name

Research Site

City

Nantong

ZIP/Postal Code

226361

Country

China

Facility Name

Research Site

City

Shanghai

ZIP/Postal Code

200011

Country

China

Facility Name

Research Site

City

Shanghai

ZIP/Postal Code

200032

Country

China

Facility Name

Research Site

City

Wuhan

ZIP/Postal Code

430030

Country

China

Facility Name

Research Site

City

Wuhan

ZIP/Postal Code

430060

Country

China

Facility Name

Research Site

City

Xi'an

ZIP/Postal Code

710061

Country

China

Facility Name

Research Site

City

Zhengzhou

ZIP/Postal Code

450002

Country

China

Facility Name

Research Site

City

Zhengzhou

ZIP/Postal Code

450008

Country

China

Facility Name

Research Site

City

Zhuhai

ZIP/Postal Code

519099

Country

China

Facility Name

Research Site

City

Aalborg

ZIP/Postal Code

9000

Country

Denmark

Facility Name

Research Site

City

Aarhus N

ZIP/Postal Code

8200

Country

Denmark

Facility Name

Research Site

City

Odense C

ZIP/Postal Code

5000

Country

Denmark

Facility Name

Research Site

City

Roskilde

ZIP/Postal Code

4000

Country

Denmark

Facility Name

Research Site

City

Vejle

ZIP/Postal Code

7100

Country

Denmark

Facility Name

Research Site

City

Kuopio

ZIP/Postal Code

70210

Country

Finland

Facility Name

Research Site

City

Oulu

ZIP/Postal Code

90029

Country

Finland

Facility Name

Research Site

City

Turku

ZIP/Postal Code

20521

Country

Finland

Facility Name

Research Site

City

Besançon

ZIP/Postal Code

25000

Country

France

Facility Name

Research Site

City

Bordeaux

ZIP/Postal Code

33076

Country

France

Facility Name

Research Site

City

Limoges Cedex

ZIP/Postal Code

87042

Country

France

Facility Name

Research Site

City

Lyon Cedex 08

ZIP/Postal Code

69373

Country

France

Facility Name

Research Site

City

Marseille

ZIP/Postal Code

13273

Country

France

Facility Name

Research Site

City

Nantes

ZIP/Postal Code

44202

Country

France

Facility Name

Research Site

City

Paris Cedex 14

ZIP/Postal Code

75674

Country

France

Facility Name

Research Site

City

Paris

ZIP/Postal Code

75012

Country

France

Facility Name

Research Site

City

Paris

ZIP/Postal Code

75015

Country

France

Facility Name

Research Site

City

Saint Herblain Cedex

ZIP/Postal Code

44805

Country

France

Facility Name

Research Site

City

Vandoeuvre les Nancy

ZIP/Postal Code

54519

Country

France

Facility Name

Research Site

City

Bad Homburg

ZIP/Postal Code

61352

Country

Germany

Facility Name

Research Site

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Research Site

City

Bielefeld

ZIP/Postal Code

33604

Country

Germany

Facility Name

Research Site

City

Bonn

ZIP/Postal Code

53105

Country

Germany

Facility Name

Research Site

City

Brandenburg

ZIP/Postal Code

14770

Country

Germany

Facility Name

Research Site

City

Dresden

ZIP/Postal Code

1307

Country

Germany

Facility Name

Research Site

City

Düsseldorf

ZIP/Postal Code

40489

Country

Germany

Facility Name

Research Site

City

Essen

ZIP/Postal Code

45136

Country

Germany

Facility Name

Research Site

City

Essen

ZIP/Postal Code

45147

Country

Germany

Facility Name

Research Site

City

Esslingen am Neckar

ZIP/Postal Code

73730

Country

Germany

Facility Name

Research Site

City

Frankfurt

ZIP/Postal Code

60590

Country

Germany

Facility Name

Research Site

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

Facility Name

Research Site

City

Fürth

ZIP/Postal Code

90766

Country

Germany

Facility Name

Research Site

City

Greifswald

ZIP/Postal Code

17475

Country

Germany

Facility Name

Research Site

City

Gütersloh

ZIP/Postal Code

33332

Country

Germany

Facility Name

Research Site

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

Research Site

City

Hamburg

ZIP/Postal Code

20357

Country

Germany

Facility Name

Research Site

City

Hamburg

ZIP/Postal Code

22457

Country

Germany

Facility Name

Research Site

City

Hannover

ZIP/Postal Code

30177

Country

Germany

Facility Name

Research Site

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

Research Site

City

Jena

ZIP/Postal Code

07747

Country

Germany

Facility Name

Research Site

City

Karlsruhe

ZIP/Postal Code

76133

Country

Germany

Facility Name

Research Site

City

Karlsruhe

ZIP/Postal Code

76135

Country

Germany

Facility Name

Research Site

City

Kassel

ZIP/Postal Code

34125

Country

Germany

Facility Name

Research Site

City

Kiel

ZIP/Postal Code

24105

Country

Germany

Facility Name

Research Site

City

Köln

ZIP/Postal Code

50935

Country

Germany

Facility Name

Research Site

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Research Site

City

Ludwigsburg

ZIP/Postal Code

71640

Country

Germany

Facility Name

Research Site

City

Lübeck

ZIP/Postal Code

23538

Country

Germany

Facility Name

Research Site

City

Mainz

ZIP/Postal Code

55131

Country

Germany

Facility Name

Research Site

City

Mannheim

ZIP/Postal Code

68167

Country

Germany

Facility Name

Research Site

City

München

ZIP/Postal Code

81377

Country

Germany

Facility Name

Research Site

City

Offenbach am Main

ZIP/Postal Code

63069

Country

Germany

Facility Name

Research Site

City

Oldenburg

ZIP/Postal Code

26133

Country

Germany

Facility Name

Research Site

City

Rosenheim

ZIP/Postal Code

83022

Country

Germany

Facility Name

Research Site

City

Rostock

ZIP/Postal Code

18057

Country

Germany

Facility Name

Research Site

City

Saalfeld

ZIP/Postal Code

07318

Country

Germany

Facility Name

Research Site

City

Schweinfurt

ZIP/Postal Code

97422

Country

Germany

Facility Name

Research Site

City

Tübingen

ZIP/Postal Code

72016

Country

Germany

Facility Name

Research Site

City

Ulm

ZIP/Postal Code

89075

Country

Germany

Facility Name

Research Site

City

Worms

ZIP/Postal Code

67550

Country

Germany

Facility Name

Research Site

City

Budapest

ZIP/Postal Code

1062

Country

Hungary

Facility Name

Research Site

City

Budapest

ZIP/Postal Code

1122

Country

Hungary

Facility Name

Research Site

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Research Site

City

Győr

ZIP/Postal Code

9024

Country

Hungary

Facility Name

Research Site

City

Kaposvár

ZIP/Postal Code

7400

Country

Hungary

Facility Name

Research Site

City

Szeged

ZIP/Postal Code

6725

Country

Hungary

Facility Name

Research Site

City

Zalaegerszeg

ZIP/Postal Code

8900

Country

Hungary

Facility Name

Research Site

City

Brescia

ZIP/Postal Code

25123

Country

Italy

Facility Name

Research Site

City

Lecce

ZIP/Postal Code

73100

Country

Italy

Facility Name

Research Site

City

Lecco

ZIP/Postal Code

23900

Country

Italy

Facility Name

Research Site

City

Milano

ZIP/Postal Code

20132

Country

Italy

Facility Name

Research Site

City

Milano

ZIP/Postal Code

20141

Country

Italy

Facility Name

Research Site

City

Mirano

ZIP/Postal Code

30035

Country

Italy

Facility Name

Research Site

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Research Site

City

Reggio Calabria

ZIP/Postal Code

89100

Country

Italy

Facility Name

Research Site

City

Reggio Emilia

ZIP/Postal Code

42100

Country

Italy

Facility Name

Research Site

City

Roma

ZIP/Postal Code

00168

Country

Italy

Facility Name

Research Site

City

Torino

ZIP/Postal Code

10126

Country

Italy

Facility Name

Research Site

City

Torino

ZIP/Postal Code

10128

Country

Italy

Facility Name

Research Site

City

Fukuoka-shi

ZIP/Postal Code

811-1395

Country

Japan

Facility Name

Research Site

City

Kashiwa-shi

ZIP/Postal Code

277-8567

Country

Japan

Facility Name

Research Site

City

Kobe-shi

ZIP/Postal Code

650-0047

Country

Japan

Facility Name

Research Site

City

Koto-ku

ZIP/Postal Code

135-8550

Country

Japan

Facility Name

Research Site

City

Kurume-shi

ZIP/Postal Code

830-0011

Country

Japan

Facility Name

Research Site

City

Kyoto-shi

ZIP/Postal Code

606-8507

Country

Japan

Facility Name

Research Site

City

Minato-ku

ZIP/Postal Code

105-8471

Country

Japan

Facility Name

Research Site

City

Nagoya-shi

ZIP/Postal Code

464-8681

Country

Japan

Facility Name

Research Site

City

Niigata-shi

ZIP/Postal Code

951-8520

Country

Japan

Facility Name

Research Site

City

Okayama-shi

ZIP/Postal Code

700-8558

Country

Japan

Facility Name

Research Site

City

Sapporo-shi

ZIP/Postal Code

003-0804

Country

Japan

Facility Name

Research Site

City

Sendai-shi

ZIP/Postal Code

980-8574

Country

Japan

Facility Name

Research Site

City

Shinjuku-ku

ZIP/Postal Code

160-8582

Country

Japan

Facility Name

Research Site

City

Sunto-gun

ZIP/Postal Code

411-8777

Country

Japan

Facility Name

Research Site

City

Toyoake-shi

ZIP/Postal Code

470-1192

Country

Japan

Facility Name

Research Site

City

Goyang-si

ZIP/Postal Code

10408

Country

Korea, Republic of

Facility Name

Research Site

City

Seongnam-si

ZIP/Postal Code

13620

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

06351

Country

Korea, Republic of

Facility Name

Research Site

City

Suwon-si

ZIP/Postal Code

16499

Country

Korea, Republic of

Facility Name

Research Site

City

Bellavista

ZIP/Postal Code

CALLAO 2

Country

Peru

Facility Name

Research Site

City

La Libertad

ZIP/Postal Code

13013

Country

Peru

Facility Name

Research Site

City

Lima

ZIP/Postal Code

LIMA 31

Country

Peru

Facility Name

Research Site

City

Lima

ZIP/Postal Code

Lima 32

Country

Peru

Facility Name

Research Site

City

Lima

ZIP/Postal Code

LIMA 34

Country

Peru

Facility Name

Research Site

City

Lima

ZIP/Postal Code

LIMA 41

Country

Peru

Facility Name

Research Site

City

San Isidro

ZIP/Postal Code

Country

Peru

Facility Name

Research Site

City

Gdynia

ZIP/Postal Code

81-519

Country

Poland

Facility Name

Research Site

City

Szczecin

ZIP/Postal Code

70-111

Country

Poland

Facility Name

Research Site

City

Warszawa

ZIP/Postal Code

02-781

Country

Poland

Facility Name

Research Site

City

Warszawa

ZIP/Postal Code

04-141

Country

Poland

Facility Name

Research Site

City

Łódź

ZIP/Postal Code

93-513

Country

Poland

Facility Name

Research Site

City

Floresti

ZIP/Postal Code

407280

Country

Romania

Facility Name

Research Site

City

Córdoba

ZIP/Postal Code

14004

Country

Spain

Facility Name

Research Site

City

Madrid

ZIP/Postal Code

28033

Country

Spain

Facility Name

Research Site

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

Research Site

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Research Site

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Research Site

City

Terrassa(Barcelona)

ZIP/Postal Code

08221

Country

Spain

Facility Name

Research Site

City

Vigo

ZIP/Postal Code

36312

Country

Spain

Facility Name

Research Site

City

Adana

ZIP/Postal Code

1260

Country

Turkey

Facility Name

Research Site

City

Ankara

ZIP/Postal Code

06230

Country

Turkey

Facility Name

Research Site

City

Ankara

ZIP/Postal Code

06490

Country

Turkey

Facility Name

Research Site

City

Istanbul

ZIP/Postal Code

34093

Country

Turkey

Facility Name

Research Site

City

Istanbul

ZIP/Postal Code

34384

Country

Turkey

Facility Name

Research Site

City

Izmir

ZIP/Postal Code

35100

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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 URL

https://astrazenecagroup-dt.pharmacm.com/DT/Home

Learn more about this trial

Durvalumab Treatment in Combination With Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib Treatment in Advanced Ovarian Cancer Patients

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

Advanced Ovarian Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial