Advanced Ovarian Cancer Clinical Trial
— DUO-OOfficial 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).
Verified date | January 2024 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 1407 |
Est. completion date | May 25, 2028 |
Est. primary completion date | September 18, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 130 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Austria | Research Site | Graz | |
Austria | Research Site | Innsbruck | |
Austria | Research Site | Linz | |
Austria | Research Site | Wien | |
Belgium | Research Site | Aalst | |
Belgium | Research Site | Leuven | |
Belgium | Research Site | Namur | |
Belgium | Research Site | Oostende | |
Belgium | Research Site | Sint-Niklaas | |
Brazil | Research Site | Barretos | |
Brazil | Research Site | Florianópolis | |
Brazil | Research Site | Fortaleza | |
Brazil | Research Site | Londrina | |
Brazil | Research Site | Porto Alegre | |
Brazil | Research Site | Porto Alegre | |
Brazil | Research Site | Rio de Janeiro | |
Brazil | Research Site | Sao Paulo | |
Brazil | Research Site | São Paulo | |
Bulgaria | Research Site | Burgas | |
Bulgaria | Research Site | Plovdiv | |
Bulgaria | Research Site | Sofia | |
Bulgaria | Research Site | Varna | |
Canada | Research Site | Barrie | Ontario |
Canada | Research Site | Calgary | Alberta |
Canada | Research Site | Montreal | Quebec |
Canada | Research Site | Montreal | Quebec |
Canada | Research Site | Montreal | Quebec |
Canada | Research Site | Quebec | |
Canada | Research Site | Rimouski | Quebec |
Canada | Research Site | Sudbury | Ontario |
Canada | Research Site | Toronto | Ontario |
China | Research Site | Beijing | |
China | Research Site | Beijing | |
China | Research Site | Bengbu | |
China | Research Site | Changchun | |
China | Research Site | Changsha | |
China | Research Site | Changsha | |
China | Research Site | Chengdu | |
China | Research Site | Chongqing | |
China | Research Site | Dalian | |
China | Research Site | Guangzhou | |
China | Research Site | Guangzhou | |
China | Research Site | Hangzhou | |
China | Research Site | Hangzhou | |
China | Research Site | Harbin | |
China | Research Site | Hefei | |
China | Research Site | Jinhua | |
China | Research Site | Kunming | |
China | Research Site | Lanzhou | |
China | Research Site | Luzhou | |
China | Research Site | Nan Chong | |
China | Research Site | Nanjing | |
China | Research Site | Nanning | |
China | Research Site | Nantong | |
China | Research Site | Shanghai | |
China | Research Site | Shanghai | |
China | Research Site | Wuhan | |
China | Research Site | Wuhan | |
China | Research Site | Xi'an | |
China | Research Site | Zhengzhou | |
China | Research Site | Zhengzhou | |
China | Research Site | Zhuhai | |
Denmark | Research Site | Aalborg | |
Denmark | Research Site | Aarhus N | |
Denmark | Research Site | Odense C | |
Denmark | Research Site | Roskilde | |
Denmark | Research Site | Vejle | |
Finland | Research Site | Kuopio | |
Finland | Research Site | Oulu | |
Finland | Research Site | Turku | |
France | Research Site | Besançon | |
France | Research Site | Bordeaux | |
France | Research Site | Limoges Cedex | |
France | Research Site | Lyon Cedex 08 | |
France | Research Site | Marseille | |
France | Research Site | Nantes | |
France | Research Site | Paris | |
France | Research Site | Paris | |
France | Research Site | Paris Cedex 14 | |
France | Research Site | Saint Herblain Cedex | |
France | Research Site | Vandoeuvre les Nancy | |
Germany | Research Site | Bad Homburg | |
Germany | Research Site | Berlin | |
Germany | Research Site | Bielefeld | |
Germany | Research Site | Bonn | |
Germany | Research Site | Brandenburg | |
Germany | Research Site | Dresden | |
Germany | Research Site | Düsseldorf | |
Germany | Research Site | Essen | |
Germany | Research Site | Essen | |
Germany | Research Site | Esslingen am Neckar | |
Germany | Research Site | Frankfurt | |
Germany | Research Site | Freiburg | |
Germany | Research Site | Fürth | |
Germany | Research Site | Greifswald | |
Germany | Research Site | Gütersloh | |
Germany | Research Site | Hamburg | |
Germany | Research Site | Hamburg | |
Germany | Research Site | Hamburg | |
Germany | Research Site | Hannover | |
Germany | Research Site | Hannover | |
Germany | Research Site | Jena | |
Germany | Research Site | Karlsruhe | |
Germany | Research Site | Karlsruhe | |
Germany | Research Site | Kassel | |
Germany | Research Site | Kiel | |
Germany | Research Site | Köln | |
Germany | Research Site | Leipzig | |
Germany | Research Site | Lübeck | |
Germany | Research Site | Ludwigsburg | |
Germany | Research Site | Mainz | |
Germany | Research Site | Mannheim | |
Germany | Research Site | München | |
Germany | Research Site | Offenbach am Main | |
Germany | Research Site | Oldenburg | |
Germany | Research Site | Rosenheim | |
Germany | Research Site | Rostock | |
Germany | Research Site | Saalfeld | |
Germany | Research Site | Schweinfurt | |
Germany | Research Site | Tübingen | |
Germany | Research Site | Ulm | |
Germany | Research Site | Worms | |
Hungary | Research Site | Budapest | |
Hungary | Research Site | Budapest | |
Hungary | Research Site | Debrecen | |
Hungary | Research Site | Gyor | |
Hungary | Research Site | Kaposvár | |
Hungary | Research Site | Szeged | |
Hungary | Research Site | Zalaegerszeg | |
Italy | Research Site | Brescia | |
Italy | Research Site | Lecce | |
Italy | Research Site | Lecco | |
Italy | Research Site | Milano | |
Italy | Research Site | Milano | |
Italy | Research Site | Mirano | |
Italy | Research Site | Napoli | |
Italy | Research Site | Reggio Calabria | |
Italy | Research Site | Reggio Emilia | |
Italy | Research Site | Roma | |
Italy | Research Site | Torino | |
Italy | Research Site | Torino | |
Japan | Research Site | Fukuoka-shi | |
Japan | Research Site | Kashiwa-shi | |
Japan | Research Site | Kobe-shi | |
Japan | Research Site | Koto-ku | |
Japan | Research Site | Kurume-shi | |
Japan | Research Site | Kyoto-shi | |
Japan | Research Site | Minato-ku | |
Japan | Research Site | Nagoya-shi | |
Japan | Research Site | Niigata-shi | |
Japan | Research Site | Okayama-shi | |
Japan | Research Site | Sapporo-shi | |
Japan | Research Site | Sendai-shi | |
Japan | Research Site | Shinjuku-ku | |
Japan | Research Site | Sunto-gun | |
Japan | Research Site | Toyoake-shi | |
Korea, Republic of | Research Site | Goyang-si | |
Korea, Republic of | Research Site | Seongnam-si | |
Korea, Republic of | Research Site | Seoul | |
Korea, Republic of | Research Site | Seoul | |
Korea, Republic of | Research Site | Seoul | |
Korea, Republic of | Research Site | Suwon-si | |
Peru | Research Site | Bellavista | |
Peru | Research Site | La Libertad | |
Peru | Research Site | Lima | |
Peru | Research Site | Lima | |
Peru | Research Site | Lima | |
Peru | Research Site | Lima | |
Peru | Research Site | San Isidro | |
Poland | Research Site | Gdynia | |
Poland | Research Site | Lódz | |
Poland | Research Site | Szczecin | |
Poland | Research Site | Warszawa | |
Poland | Research Site | Warszawa | |
Romania | Research Site | Floresti | |
Spain | Research Site | Córdoba | |
Spain | Research Site | Madrid | |
Spain | Research Site | Madrid | |
Spain | Research Site | Madrid | |
Spain | Research Site | Madrid | |
Spain | Research Site | Terrassa(Barcelona) | |
Spain | Research Site | Vigo | |
Turkey | Research Site | Adana | |
Turkey | Research Site | Ankara | |
Turkey | Research Site | Ankara | |
Turkey | Research Site | Istanbul | |
Turkey | Research Site | Istanbul | |
Turkey | Research Site | Izmir | |
United States | Research Site | Albany | New York |
United States | Research Site | Augusta | Georgia |
United States | Research Site | Cleveland | Ohio |
United States | Research Site | Dayton | Ohio |
United States | Research Site | Detroit | Michigan |
United States | Research Site | Durham | North Carolina |
United States | Research Site | Foothill Ranch | California |
United States | Research Site | Hilliard | Ohio |
United States | Research Site | Hinsdale | Illinois |
United States | Research Site | Indianapolis | Indiana |
United States | Research Site | Lancaster | Pennsylvania |
United States | Research Site | Los Angeles | California |
United States | Research Site | Middletown | New Jersey |
United States | Research Site | Montvale | New Jersey |
United States | Research Site | New York | New York |
United States | Research Site | Orange | California |
United States | Research Site | Philadelphia | Pennsylvania |
United States | Research Site | Philadelphia | Pennsylvania |
United States | Research Site | Pittsburgh | Pennsylvania |
United States | Research Site | Salt Lake City | Utah |
United States | Research Site | San Francisco | California |
United States | Research Site | Springfield | Missouri |
United States | Research Site | Tampa | Florida |
United States | Research Site | Towson | Maryland |
United States | Research Site | Tulsa | Oklahoma |
United States | Research Site | Uniondale | New York |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca | European Network of Gynaecological Oncological Trial Groups (ENGOT), GOG Foundation, Inc. (GOG Foundation), Myriad Genetic Laboratories, Inc. |
United States, Austria, Belgium, Brazil, Bulgaria, Canada, China, Denmark, Finland, France, Germany, Hungary, Italy, Japan, Korea, Republic of, Peru, Poland, Romania, Spain, Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Safety and tolerability of drugs by assessment of AEs/SAEs | Graded according to the National Cancer Institute (NCI CTCAE) | Approximately 4 years | |
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Pathological Complete Response (pCR) - in non-tBRCAm patients | Defined as the proportion of patients with pCR in patients undergoing IDS | Approximately 4 years | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Time to first subsequent therapy (TFST) - in non-tBRCAm patients | Time elapsed from randomisation to first subsequent therapy or death | Approximately 7 years | |
Secondary | Time to second subsequent therapy (TSST) - in non-tBRCAm patients | Time elapsed from randomisation to second subsequent therapy or death | Approximately 7 years | |
Secondary | Time to discontinuation or death (TDT) - in non-tBRCAm patients | Time elapsed from randomisation to study treatment discontinuation or death | Approximately 4 years | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Health-related quality of life - in tBRCAm patients | Change from baseline in the physical functioning subscale of the EORTC-QLQ-C30 | Approximately 4 years | |
Secondary | 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 |
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