Study on the Effectiveness of Durvalumab, Olaparib, and Bevacizumab in Patients with Newly Diagnosed Advanced Ovarian Cancer

3 1 1

What is this study about?

This clinical trial is focused on studying the treatment of advanced ovarian cancer, specifically in patients who have been newly diagnosed with high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer. The study involves the use of several medications, including durvalumab, olaparib, and bevacizumab. Durvalumab, also known by its code name MEDI4736, is a type of medication that helps the immune system fight cancer. Olaparib, also referred to as AZD2281, is a medication that targets cancer cells with specific genetic mutations. Bevacizumab is a medication that inhibits the growth of blood vessels that supply nutrients to tumors.

The purpose of this study is to evaluate the effectiveness and safety of these medications when used in combination with standard chemotherapy. The study is designed to compare different treatment approaches: one group will receive standard chemotherapy and bevacizumab, followed by maintenance therapy with bevacizumab alone, while other groups will receive additional treatments with durvalumab or a combination of durvalumab and olaparib. The study is conducted in a randomized and double-blind manner, meaning that participants are randomly assigned to different treatment groups, and neither the participants nor the researchers know which treatment each participant is receiving.

Participants in the study will undergo a series of treatments over a period of time, with regular monitoring to assess the progression of the disease and the response to the treatment. The study aims to determine how well these treatments work in preventing the cancer from getting worse and to evaluate the overall survival of the participants. The trial will also look at other factors such as the duration of response to the treatment and the quality of life of the participants. The study is expected to continue until 2026, with the goal of providing valuable information on the treatment of advanced ovarian cancer.

1 joining the study

Upon joining the study, the patient is randomly assigned to one of the treatment groups. This process is double-blind, meaning neither the patient nor the researchers know which group the patient is in.

2 initial treatment phase

The patient receives standard chemotherapy combined with bevacizumab. Bevacizumab is administered through an intravenous infusion. The frequency and dosage are determined by the study protocol and the patient’s specific needs.

3 maintenance therapy

After completing the initial treatment phase, the patient enters the maintenance therapy phase. This involves continued treatment with bevacizumab and may include additional medications such as durvalumab and olaparib.

Durvalumab is given as an intravenous infusion, while olaparib is taken orally in the form of film-coated tablets. The dosage and frequency are specified by the study protocol.

4 monitoring and follow-up

Throughout the study, the patient’s health and response to treatment are closely monitored. This includes regular medical assessments and tests to evaluate the effectiveness and safety of the treatment.

The study aims to measure progression-free survival, which is the time from the start of the study until the disease progresses or the patient passes away.

5 end of study participation

The patient’s participation in the study concludes either at the end of the study period or if the patient decides to withdraw from the study. The estimated end date for the study is March 17, 2026.

Who Can Join the Study?

  • Female patients with newly diagnosed advanced ovarian cancer, which includes specific types like high grade serous, high grade endometrioid, clear cell ovarian cancer, carcinosarcoma, primary peritoneal cancer, or fallopian-tube cancer.
  • Patients must be at least 18 years old.
  • Patients should be candidates for surgery to remove as much of the tumor as possible, either before starting treatment or after some initial chemotherapy.
  • Patients must provide a sample of their tumor for specific genetic testing called tBRCA testing.
  • There must be evidence showing whether or not there is a BRCA1/2 mutation in the tumor tissue. BRCA1/2 are genes that, when mutated, can affect cancer risk.
  • Patients should have an ECOG performance status of 0-1, which means they are fully active or have some symptoms but can still carry out light work.
  • Patients must have normal functioning of their organs and bone marrow, which is important for overall health and ability to handle treatment.
  • Women who can have children must show they are not pregnant, either by being postmenopausal or having a negative pregnancy test.

Who Cannot Join the Study?

  • Patients who have not been newly diagnosed with advanced ovarian, fallopian, or primary peritoneal cancer.
  • Patients who do not have high-grade epithelial cancer, which is a type of cancer that starts in the cells on the surface of the ovary, fallopian tube, or peritoneum.
  • Patients who are not in FIGO stage III-IV, which means the cancer is not advanced or has not spread beyond the pelvis.
  • Patients who are not female, as the study is only for women.
  • Patients who are not in the specified age range for the study.
  • Patients who are considered part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

Site Name City Country Status
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy Warsaw Poland

Verified Sites

Other Sites

Site Name City Country Status
Ospedale San Raffaele S.r.l. Milan Italy
Turku University Hospital Turku Finland
Sygehus Lillebaelt Vejle Sygehus Vejle Denmark
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Hopital Beaujon Clichy France
Klinikum Esslingen GmbH Esslingen Am Neckar Germany
Central Hospital Of Northern Pest Military Hospital Budapest Hungary
Hochtaunus-Kliniken gGmbH Bad Homburg Germany
L’Hopital Prive Du Confluent Nantes France
Klinikum Worms gGmbH Worms Germany
Azienda Ulss 3 Serenissima Venice Italy
Romed Klinikum Rosenheim Rosenheim Germany
Azorg Aalst Belgium
Uvrumsatfk Oj Dkmeewao Debrecen Hungary
Imwrnhnb Pvfniqnutwceteu Cwvybf Cmvckp Marseille France
Rijpyd Shbfbvcfm Holbæk Denmark
Ozyshx Uvvrirgobc Hfylfexe Odense Denmark
Uouighcgxbfiupqnyudvy Tpedajauh Ard Tuebingen Germany
Cizonkk Uyizmpxgxecwvrplatzr Blhveb Kha Berlin Germany
Uvvufkcntqrjtjfzcahkg Mcjzfxni Gdeo Mannheim Germany
Hfthdrhh Ceqzrfl Ssj Cavcds Madrid Spain
Aamltbc Uasyemebvs Hylaquut Aalborg Denmark
Kftrjo Uupgqedntipyxeyyafrtx Guqa Linz Austria
Klaymjlf Kdyufk Gzzb Kassel Germany
Muanrac Clfeea &qvucwz Uuiedxppll Os Fuuughpj Freiburg Im Breisgau Germany
Kkjucnot dkt Uklszssmyfhi Mprelbvh Ahm Munich Germany
Uejpkzgqnh Of Setjio Szeged Hungary
Ukaxopwnhesv Lotozmr Leipzig Germany
Cgrcmmu Offdmccx Csqrrl Beabws Epdg Burgas Bulgaria
Cxkser Lntj Bzpndb Lyon France
Uinvhdztdd Muykbjm Cumkas Hddhqyftpifwbnftp Hamburg Germany
Ulvkxwplvykaztsveqoje Eophe Acw Essen Germany
Icopgznf fmoa Kegxduorp Tjigfhlzsjiabsiszrv uxk Iqpzqntjptjf Uqo gqvhq Ulm Germany
Uhmszlyiwoxfmvbxujibo Shtetamaeaxnffbkox Aoj Kiel Germany
Hhlhgqsy Ufnrukeblttxn 1z Dw Ocrufnr Madrid Spain
Uwtiwttswj Dgjss Salvn Dv Bdzdkuv Brescia Italy
Cjeymo Hcdqznydstx Usywxtmkawnig Duxdzx Gxjvzac Sknyrdysxoyeaiejkqtwkrsaad Namur Belgium
Wfdshpqsyfu Wabmmsrqsfxjosdhbzfa Cvivekm Ogjwjkdgk I Tblorhrluddew Ib Mcxgbhgiese W Laucs Lodz Poland
Sunkpiam Pyzgxjvua Sut z ouso Gdynia Poland
Vlrfv Sint-Niklaas Belgium
Cdhluvc Owtckkiavts Cfmmtg Pmnwqic Enli Plovdiv Bulgaria
Kidphkdk Oyerqbamm Asb Oldenburg In Holstein Germany
Gkkrys Owdwydqp Mcqrseyzwppru Bepxxcf Mshrrvlmi Mownzry Reggio Calabria Italy
Ojmcnwzs Ognoeemftu Ibblnee Budapest Hungary
Skbcxo Vvefucdtd Kdneok Mfu Oeoebi Klhzjg Kaposvar Hungary
Kyynlfrv Gtjikemydn gjheu Guetersloh Germany
Shzanzhcxfd Etj Dcjlgwez Hmbqplbp Fpf Aqyjae Txrkkirtfhnucnm Ekwb Varna Bulgaria
Pmvbusviqqwsdjenik hzaovamkczwwowq Oulu Finland
Vbyoy Cbdehhajsfb Kavvqpcd Konlhsndk Karlsruhe Germany
Mapzgjd Ctougy Ntonlxbz Cvvqrvzw Euoa Sofia Bulgaria
Uxrepqiatamey Sdghnrf Kphfnkdov Nz 2 Pbn W Sawtghhsoa Szczecin Poland
Taubcclkjfirdrapltb Gvhxawnh Aipkrzqr Gjeh Saalfeld Germany
Cwhcch Hkfmxjmhuqr Eq Upawmxymnmwqh Dt Luznhgt Limoges France
Bwplwonx Uhjkmtrrfx Hixougwj Ctdouu Besançon France
Kmclnxir Sqixzgien Rjsaxlj Rostock Germany
Sgd Ezrhtqywx Kyatrbrstly Gzrp Cologne Germany
Ajkvfs Uysdtfywhm Heeknwwi Aarhus Denmark
Adhdateery Movqbiz Hqavdrys Lecco Italy
Kmhnpnmuhmrzcw Dpvsbixi Duesseldorf Germany
Gerypfjnvoqrvrcqm Vvyfccfxf Phni Allbwe Ewkffixz Okesho Kuyuew Gyor Hungary
Zbhu Mdjdst Sgeyi Rhkgsi Kmhvgy Zalaegerszeg Hungary
Nkenplvr Ibmcrtrn Ojibuibmv Iqh Mjvcm Szoiynfltkpdboyyjjfhopzoqjdw Ibsvvjqj Bcvnxkcv Cracow Poland
Gfvqqw Uxkquaxynl Fuerldynb Frankfurt Germany
Frwzqsvw Aamrkmfqykoo Dj Mflzp Dy Tgdxfwud Fvh Terrassa Spain
Gwkqwp Hbvyylmqizx Daivqaqynlg Cioun Szfei Sppst Paris France
Pchfybhcgehjf hukhfwpqiaodqgx Kuopio Finland
Hsvsgery Aftmfz Cqeeathwz Vigo Spain
Systbvwpqfwp Kkppbegf Kzajzomsc gmvvs Karlsruhe Germany
Lwvqyqtspconpdjfmrdgqc dsy Sfyxx Siceonwyvab Genb Schweinfurt Germany
Sbzx Kduieynp Ofsjamosp Gjif Offenbach Am Main Germany
Rvhxkoinupep Cgzesb Chum Swaqdt Floresti Romania
Invepahf Mwyzohkhbf Mshpsphogh Paris France
Rru Kikiepx Llsqtyoyuskuxnblmsitch grpxc Ludwigsburg Germany
Aszlkbr Odxvlxcnfwb Oiwwvh Mlrmiwupqh Dn Tzgazq Turin Italy
Me Azronrsr Cjxmsw Crdzei Madrid Spain
Kcceycgs Bpdbqoldn gxghm Bielefeld Germany
Kcrximxc Emgcgrqyukthmiyjecqqqnde Hqpnknvxflawbdogf Essen Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
30.01.2019
Belgium Belgium
Not recruiting
30.01.2019
Bulgaria Bulgaria
Not recruiting
30.01.2019
Denmark Denmark
Not recruiting
30.01.2019
Finland Finland
Not recruiting
30.01.2019
France France
Not recruiting
30.01.2019
Germany Germany
Not recruiting
30.01.2019
Hungary Hungary
Not recruiting
30.01.2019
Italy Italy
Not recruiting
30.01.2019
Poland Poland
Not recruiting
30.01.2019
Romania Romania
Not recruiting
30.01.2019
Spain Spain
Not recruiting
30.01.2019

Trial locations

Durvalumab is a medication used in this trial to help the immune system attack cancer cells. It is a type of immunotherapy that works by blocking a protein that stops the immune system from working properly, allowing it to better fight the cancer.

Bevacizumab is a medication that helps to prevent the growth of new blood vessels that tumors need to grow. By blocking these blood vessels, it can help to slow down or stop the growth of the cancer.

Olaparib is a medication that targets cancer cells with specific genetic defects. It works by interfering with the cancer cells’ ability to repair their DNA, which can lead to the death of these cells. This medication is used as part of the maintenance therapy in the trial to help keep the cancer from coming back after initial treatment.

Investigated Diseases:

High Grade Epithelial Ovarian Cancer – This is a type of cancer that begins in the cells on the surface of the ovary. It is characterized by its rapid growth and tendency to spread to other parts of the body, often being diagnosed at an advanced stage. The disease progresses as cancer cells multiply and invade nearby tissues, potentially spreading to the abdominal lining and other organs. Symptoms may include abdominal bloating, pelvic pain, and changes in bowel habits. The progression of the disease can lead to the accumulation of fluid in the abdomen and other complications. Early detection is challenging due to the subtlety of initial symptoms.

Fallopian Tube Cancer – This rare cancer originates in the fallopian tubes, which connect the ovaries to the uterus. It often presents with symptoms similar to ovarian cancer, such as pelvic pain and abnormal vaginal discharge. The disease progresses as cancer cells grow and may spread to nearby organs and tissues. It is typically diagnosed at an advanced stage due to the lack of specific early symptoms. The cancer can cause blockages in the fallopian tubes, leading to further complications. As it advances, it may spread to the abdominal cavity and beyond.

Primary Peritoneal Cancer – This cancer develops in the peritoneum, the lining of the abdominal cavity, and is closely related to ovarian cancer. It progresses similarly to ovarian cancer, with cancer cells spreading across the peritoneal surface. Symptoms can include abdominal pain, bloating, and digestive disturbances. The disease often advances before being detected, as early symptoms are non-specific. It can lead to the accumulation of fluid in the abdomen, known as ascites. The cancer may spread to other abdominal organs and tissues as it progresses.

Trial ID:
2022-502747-35-00
Protocol code:
DUO-O/D081RC00001
NCT ID:
NCT03737643
Trial Phase:
Therapeutic confirmatory (Phase III)

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