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).

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: Drug: Olaparib; Drug: Bevacizumab; Drug: Placebo olaparib; Drug: Durvalumab placebo; Drug: Carboplatin+Paclitaxel; Drug: Durvalumab

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

Study Locations

• Austria
  • Graz, Austria, 8036
    • Research Site
  • Innsbruck, Austria, 6020
    • Research Site
  • Linz, Austria, 4020
    • Research Site
  • Wien, Austria, 1090
    • Research Site
• Belgium
  • Aalst, Belgium, 9300
    • Research Site
  • Leuven, Belgium, 3000
    • Research Site
  • Namur, Belgium, 5000
    • Research Site
  • Oostende, 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
  • Sao 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
  • Quebec, Canada, G1J 1Z4
    • Research Site
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
      • Research Site
  • Ontario
    • Barrie, Ontario, Canada, L4M 6M2
      • Research Site
    • 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
    • Rimouski, Quebec, Canada, G5L 5T1
      • Research Site
• China
  • Beijing, China
    • Research Site
  • Beijing, China, CN-100730
    • Research Site
  • Bengbu, China, 233060
    • Research Site
  • Changchun, China, 130021
    • Research Site
  • Changsha, China, 410008
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  • Changsha, China, 430033
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  • Chengdu, China, 610041
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  • Chongqing, China, 400030
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  • 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
  • Nan Chong, 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 C, 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 Cedex, France, 87042
    • Research Site
  • Lyon Cedex 08, 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 Cedex 14, France, 75674
    • Research Site
  • Saint Herblain Cedex, France, 44805
    • Research Site
  • Vandoeuvre les 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
  • 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, 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
  • Hannover, Germany, 30625
    • Research Site
  • Hannover, 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
  • Köln, Germany, 50935
    • 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 am Main, 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
  • Milano, Italy, 20141
    • Research Site
  • Milano, Italy, 20132
    • Research Site
  • Mirano, Italy, 30035
    • Research Site
  • Napoli, 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-shi, Japan, 811-1395
    • Research Site
  • Kashiwa-shi, Japan, 277-8567
    • Research Site
  • Kobe-shi, Japan, 650-0047
    • Research Site
  • Koto-ku, Japan, 135-8550
    • Research Site
  • Kurume-shi, Japan, 830-0011
    • Research Site
  • Kyoto-shi, Japan, 606-8507
    • Research Site
  • Minato-ku, Japan, 105-8471
    • Research Site
  • Nagoya-shi, Japan, 464-8681
    • Research Site
  • Niigata-shi, Japan, 951-8520
    • Research Site
  • Okayama-shi, Japan, 700-8558
    • Research Site
  • Sapporo-shi, Japan, 003-0804
    • Research Site
  • Sendai-shi, 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
• Korea, Republic of
  • Goyang-si, Korea, Republic of, 10408
    • Research Site
  • Seongnam-si, Korea, Republic of, 13620
    • Research Site
  • Seoul, Korea, Republic of, 03722
    • Research Site
  • Seoul, Korea, Republic of, 03080
    • Research Site
  • Seoul, Korea, Republic of, 06351
    • Research Site
  • Suwon-si, Korea, Republic of, 16499
    • 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
  • Szczecin, Poland, 70-111
    • Research Site
  • Warszawa, Poland, 02-781
    • Research Site
  • Warszawa, Poland, 04-141
    • Research Site
  • Łódź, Poland, 93-513
    • Research Site
• Romania
  • Floresti, Romania, 407280
    • 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
  • Adana, Turkey, 1260
    • Research Site
  • Ankara, Turkey, 06230
    • Research Site
  • Ankara, Turkey, 06490
    • Research Site
  • Istanbul, Turkey, 34093
    • Research Site
  • Istanbul, Turkey, 34384
    • Research Site
  • Izmir, Turkey, 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

Eligibility Criteria

• Ages Eligible for Study: 18 years to 130 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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

How is the study designed?

Design Details

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

Number of Arms

4

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) - 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)	Approximately 4 years
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)	Approximately 4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Approximately 4 years
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	Approximately 7 years
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)	Approximately 7 years
Health-related quality of life - in non-tBRCAm patients	Change from baseline in the physical functioning subscale of the EORTC-QLQ-C30	Approximately 4 years
Pathological Complete Response (pCR) - in non-tBRCAm patients	Defined as the proportion of patients with pCR in patients undergoing IDS	Approximately 4 years
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	Approximately 4 years
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	Approximately 4 years
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	Approximately 4 years
Time to first subsequent therapy (TFST) - in non-tBRCAm patients	Time elapsed from randomisation to first subsequent therapy or death	Approximately 7 years
Time to second subsequent therapy (TSST) - in non-tBRCAm patients	Time elapsed from randomisation to second subsequent therapy or death	Approximately 7 years
Time to discontinuation or death (TDT) - in non-tBRCAm patients	Time elapsed from randomisation to study treatment discontinuation or death	Approximately 4 years
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	Approximately 4 years
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	Approximately 7 years
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	Approximately 4 years
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	Approximately 4 years
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	Approximately 4 years
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	Approximately 7 years
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	Approximately 7 years
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	Approximately 4 years
Health-related quality of life - in tBRCAm patients	Change from baseline in the physical functioning subscale of the EORTC-QLQ-C30	Approximately 4 years
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	Approximately 4 years

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: European Network of Gynaecological Oncological Trial Groups (ENGOT); Myriad Genetic Laboratories, Inc.; GOG Foundation, Inc. (GOG Foundation)
• Investigators: Principal Investigator: Philipp Harter, European Network of Gynaecological Oncological Trial Groups (ENGOT); Principal Investigator: Carol Aghajanian, GOG

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2019
• Primary Completion (Actual): September 18, 2023
• Study Completion (Estimated): May 25, 2028

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 (Estimated): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Advanced Ovarian Cancer; Ovarian neoplasms
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Poly(ADP-ribose) Polymerase Inhibitors; Carboplatin; Paclitaxel; Olaparib; Durvalumab; Bevacizumab; Antibodies, Monoclonal
• 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: No
• product manufactured in and exported from the U.S.: Yes