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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
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

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

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

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

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.
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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
No
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
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).
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
No
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
27
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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