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Study of Chemotherapy With Pembrolizumab and Olaparib for Patients With Advanced Epithelial Ovarian Cancer Without BRCA Mutation

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What is this study about?

This clinical trial is focused on studying treatments for advanced epithelial ovarian cancer, a type of cancer that affects the ovaries. The study involves several medications, including pembrolizumab (also known as Keytruda), olaparib, paclitaxel, bevacizumab, docetaxel, and carboplatin. Some participants will receive a placebo instead of the active medications. The purpose of the study is to compare the effectiveness of these treatments in preventing the cancer from getting worse.

Participants in the study will receive chemotherapy with or without pembrolizumab, followed by maintenance treatment with olaparib or a placebo. The study will be conducted over a period of time, with regular monitoring to assess the progression of the disease. The treatments will be administered through intravenous infusions or oral tablets, depending on the specific medication.

The study aims to provide valuable information on how these treatments can help manage advanced epithelial ovarian cancer, particularly in patients without BRCA mutations. The results will help determine the best treatment options for improving the quality of life and survival rates for individuals with this type of cancer.

1 initial treatment phase

Upon joining the study, the initial treatment phase begins. This involves receiving a combination of chemotherapy drugs, including paclitaxel and carboplatin. These medications are administered through an intravenous infusion, which means they are given directly into a vein.

The treatment is typically given in cycles, with each cycle lasting about three weeks. The exact number of cycles will depend on the specific treatment plan designed for the study.

2 additional medication

In addition to chemotherapy, the study includes the administration of pembrolizumab, which is also given through an intravenous infusion. This medication is designed to help the immune system fight cancer cells.

The frequency and duration of pembrolizumab administration will be determined by the study protocol and may vary based on individual response and tolerance.

3 maintenance phase

Following the initial treatment phase, the study enters a maintenance phase. During this phase, participants may receive olaparib in the form of film-coated tablets taken orally.

The maintenance phase aims to help prevent the cancer from returning and is expected to continue for a specified period, as outlined in the study protocol.

4 monitoring and follow-up

Throughout the study, regular monitoring and follow-up appointments are scheduled. These appointments are essential for assessing the response to treatment and managing any side effects.

Participants will undergo various tests and evaluations, including imaging studies and laboratory tests, to track the progress of the treatment and ensure safety.

5 end of study participation

At the conclusion of the study, participants will have a final evaluation to assess the overall outcomes of the treatment.

Further recommendations for ongoing care and follow-up will be provided based on the results of the study and individual health needs.

Who Can Join the Study?

  • The patient must have a confirmed diagnosis of advanced epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. This includes specific types like high-grade serous, endometrioid, carcinosarcoma, mixed mullerian with high-grade serous component, clear cell, or low-grade serous ovarian cancer.
  • The patient must have just completed or be eligible for primary debulking surgery, or be a potential candidate for interval debulking surgery. Debulking surgery is a procedure to remove as much of the tumor as possible.
  • The patient must be a candidate for chemotherapy with carboplatin and paclitaxel, which can be given before or after surgery.
  • If the patient is a candidate for chemotherapy before surgery, they must have a specific ratio of cancer markers in their blood, with a CA-125:CEA ratio of 25 or higher. CA-125 and CEA are substances in the blood that can be higher in some cancer patients.
  • The patient must be able to provide a new sample of their tumor for testing specific genetic markers, such as BRCA1/2 and PD-L1, before starting the study. These markers can help understand the cancer better.
  • The patient must have a good general health status, with an ECOG performance status of 0 or 1. This is a scale used to assess how the disease affects daily living abilities, where 0 means fully active and 1 means some symptoms but nearly fully active.
  • The patient must be female and not pregnant or breastfeeding. If the patient is of childbearing potential, they must use a highly effective method of birth control or abstain from heterosexual intercourse during the study and for a specified period after the last dose of study medication. A negative pregnancy test is required before starting the study.
  • The patient must have adequate organ function, meaning their vital organs like the liver and kidneys are working well enough to participate in the study.

Who Cannot Join the Study?

  • Patients who do not have advanced epithelial ovarian cancer cannot participate. This is a type of cancer that affects the surface layer of the ovaries.
  • Only female patients are eligible, so male patients cannot participate.
  • Patients who are considered part of a vulnerable population are excluded. This means groups of people who might be at higher risk or need special protection in a study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
University Of Pecs Pecs Hungary
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Institut Gustave Roussy Villejuif France
Katholieke Universiteit te Leuven Leuven Belgium
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Hospital Universitario De Navarra Pamplona Spain

Other Sites

Site Name City Country Status
Hopital Prive Jean Mermoz Lyon France
Hospital General Universitario De Valencia Valencia Spain
Hospital Universitario Lucus Augusti Lugo Spain
University Hospital Olomouc Olomouc Czechia
Grand Hopital De Charleroi Charleroi Belgium
Vinzenz Von Paul Kliniken gGmbH Stuttgart Germany
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach Kielce Poland
Istituto Oncologico Veneto Padua Italy
Caritas Traegergesellschaft Saarbruecken mbH (CTS) Saarbrücken Germany
Orszagos Onkologiai Intezet Budapest Hungary
Virgen del Rocío University Hospital Sevilla Spain
Fakultni Nemocnice Brno Brno Czechia
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy Warsaw Poland
Klinikum Chemnitz gGmbH Chemnitz Germany
Jessa Ziekenhuis Hasselt Belgium
Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz Miskolc Hungary
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Centre hospitalier universitaire de Liege Liege Belgium
Klinikum Dortmund gGmbH Dortmund Germany
HELIOS Klinikum Krefeld GmbH Krefeld Germany
Universitair Ziekenhuis Gent Gent Belgium
Universitaetsklinikum Aachen AöR Aachen Germany
Staedtisches Krankenhaus Kiel GmbH Kiel Germany
Deutsches Herzzentrum Berlin Berlin Germany
Az Maria Middelares Gent Gent Belgium
Fundacion Instituto Valenciano De Oncologia Valencia Spain
Hospital San Pedro De Alcantara Caceres Spain
Fakultni Nemocnice Bulovka Prague Czechia
Hopital De Libramont Libramont-Chevigny Belgium
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku Bialystok Poland
Consorci Sanitari De Terrassa Terrassa Spain
Fundacion Onkologikoa Fundazioa Donostia / San Sebastian Spain
Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada Manresa Spain
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
University Of Debrecen Debrecen Hungary
University Hospital Ostrava Ostrava Czechia
Oncoradio Centre Oncogard Nimes France
Agxtqca Omkoglhjapv Pex Leebiizcevbwpiszb Cgjpdzznvh Catania Italy
Crazbaqxp Uiwllbvxzxnezl Sahqtjbjm Woluwe-Saint-Lambert Belgium
Athjqmewvf Psfjxqct Hnbuzyfn Dw Mnvorslld Marseille France
Ukrxabddubcqdxqtyngbp Dbnysaqzpkx Anb Duesseldorf Germany
Aljmcwd Otfzonlerlr Ukijsuehwjkxz Cdxpwjukxdux Dcewk Swejaa E Dwmbe Sddxvni Dt Tpejkq Turin Italy
Uiszsyppks Dzshm Srvrd Dm Rikd Lh Sjexxxqr Rome Italy
Irhtwjpa Cdorxb Dmpthvqodaohkylhn L'hospitalet De Llobregat Spain
Iqbifn Bonheiden Belgium
Syrmeghu Pyupkpwjl Spf z ovyg Gdynia Poland
Ikzufirz di Chpwwbphviqp Hwxjbkqkekp Urwqaglzvtvan dv Suqvu Esfneqk (atzywkp Saint Priest En Jarez France
Hapjtgtp Uipldoesprexx dw A Cmzuyq A Coruna Galicia Spain
Hrjwmmkp Uwjthvmkfrhlqj Snsgcsvfyu &siqirk Hnlurad dw Helxaahtpem STRASBOURG, Alsace France

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
18.12.2018
Czechia Czechia
Not recruiting
18.12.2018
France France
Not recruiting
18.12.2018
Germany Germany
Not recruiting
18.12.2018
Hungary Hungary
Not recruiting
18.12.2018
Italy Italy
Not recruiting
18.12.2018
Poland Poland
Not recruiting
18.12.2018
Spain Spain
Not recruiting
18.12.2018

Trial locations

Investigated drugs:

Pembrolizumab is a type of medication known as an immunotherapy. It works by helping your immune system recognize and attack cancer cells. In this trial, it is being used to see if it can help treat advanced epithelial ovarian cancer when combined with chemotherapy.

Olaparib is a medication that belongs to a group of drugs called PARP inhibitors. It works by blocking a protein that cancer cells need to repair themselves, which can help stop the cancer from growing. In this study, it is being used as a maintenance treatment to see if it can help keep the cancer from coming back after initial treatment with chemotherapy and pembrolizumab.

Investigated diseases:

Advanced epithelial ovarian cancer – This disease is a type of cancer that originates in the epithelial cells lining the ovaries. It is characterized by the abnormal growth of cells that can invade nearby tissues and spread to other parts of the body. The progression of this cancer often involves the spread to the abdominal cavity and other organs, such as the liver and lungs. As the disease advances, it can cause symptoms like abdominal bloating, pelvic pain, and changes in bowel habits. The cancer cells can form tumors that may lead to fluid accumulation in the abdomen, known as ascites. Over time, the disease can become more aggressive and challenging to manage.

Trial ID:
2022-502124-52-00
Protocol code:
MK-7339-001
NCT ID:
NCT03740165
Trial Phase:
Therapeutic confirmatory (Phase III)

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