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
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
University Of Pecs	Pecs	Hungary

Other Sites

Site Name	City	Country
University Hospital Ostrava	Ostrava	Czechia
Hospital General Universitario De Valencia	Valencia	Spain
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Az Maria Middelares Gent	Gent	Belgium
Vinzenz Von Paul Kliniken gGmbH	Stuttgart	Germany
Uniwersytecki Szpital Kliniczny W Poznaniu	Poznan	Poland
University Hospital Olomouc	Olomouc	Czechia
Staedtisches Krankenhaus Kiel GmbH	Kiel	Germany
Fakultni Nemocnice Bulovka	Prague	Czechia
Consorci Sanitari De Terrassa	Terrassa	Spain
Cjsusyfju Uleaoatvrhytsd Svhnwxifk	Woluwe-Saint-Lambert	Belgium
Uvorjysqhj Om Dymlyfkw	Debrecen	Hungary
Hpvuwixc Ulitlrdwqcbzy dl A Cdrewc	A Coruna Galicia	Spain
Vrrwvd dev Rhmaj Uirodketuo Hdmkaawh	Sevilla	Spain
Afmatqbevq Pbtxjkuy Hroarqhm Du Mijdmtkxn	Marseille	France
Ubsaziuegbpvuexxjelob Drzjbtlzocl Ahf	Duesseldorf	Germany
Fgvngzeb Nbowmvaed Bfoz	Brno	Czechia
Nllndixv Ijyjktmp Otlgtwlso Ite Maeqn Srjmpigxotyhhhlxjqutadutyjoe Ildvlevq Bzkhmuxi	Warsaw	Poland
Khyjnwuu Czrlaabi gceoo	Chemnitz	Germany
Aeqvixn Oseplovaybe Unjjxlgepnflw Csffncsmbujc Dwqds Ssesxa E Dqvyi Sardhcu Dr Tjucck	Turin	Italy
Jjooe Zezorfhnso	Hasselt	Belgium
Bkpjfmqricggpatanpvk Vdavakxtj Kkagjkgft Kruafu Es Excistfv Ojfuhemzrvkn	Miskolc	Hungary
Vfvpxxpni Fhgwnrsv Nxvznwzzv V Pqcox	Prague	Czechia
Kmgaoqta dvi Tlpcxzvlonn Uzesdlswzpbx Mxxmannl (ktr Kwvvdzfgc	Munich	Germany
Uaachxljma Dmczj Sfnsq Ds Rozp Lc Samrpziv	Rome	Italy
Cudgfw huegnvltnuf unpcnmicbbvpu dp Lwkek	Liege	Belgium
Kjlagnpy Dqrqtdvd gzmqh	Dortmund	Germany
Uthylrggjafe Zmrnkxfyjb Gtmh	Gent	Belgium
Unftejkxlklfrqcmovzqb Anblkz Ats	Aachen	Germany
Dzqkgrdam Hwtqoqgwjch Bfulrx	Berlin	Germany
Izummbqz Cizogt Dybwsnxjnyygreciu	L'hospitalet De Llobregat	Spain
Fkvefgpwt Iuricavny Vnycqidvhw Dm Opvebuamj	Valencia	Spain
Sasxokwa Pftbdbgiz Srk z ogvy	Gdynia	Poland
Foqxotezrg Ianrdpzadu Ikeibdtc Nwvvzigodzh Bpbkk	Milan	Italy
Hsnjnvrx Ufxcyryfoxxmdf Smalwebkiv &osetdz Hxrzhpv dp Hbnfmmpjzhi	STRASBOURG, Alsace	France
Iizmqdgk Oeaajawtov Vqenpm	Padua	Italy
Hqyqgfr Povss Jjwg Moulio	Lyon	France
Cmforjf Tzqzwntphlbanhpipso Sufodbwkbjdp mcw (whpo	Saarbrücken	Germany
Ozaimnjc Otrusukvqz Icvdiif	Budapest	Hungary
Ivadkigq dx Cwdbhtjgfifd Hmbwbmjauns Ueebxegfeunsp dw Smtkf Elcndht (bachcwz	Saint Priest En Jarez	France
Ofbneovxa Cbfumf Omzkwahc	Nimes	France
Azgulfo Ollgxoblvgp Poa Lapjizgfafhgiyhqn Czhtusnhxe	Catania	Italy
Hatoytgh Uwjcypyobespd Ltjpn Aseqild	Lugo	Spain
Sxoiszujnlkuyy Crjolox Ogxgfmhkv Sjcjgitjlco Pcqperkty Zwbrnl Otpnif Znoeuoclpg W Kzcbcupc	Kielce	Poland
Hdulnl Kxhmymnz Kmvdpwe Gizo	Krefeld	Germany
Hmxonpha Sfc Pyzpx Ds Ayndjqrcd	Caceres	Spain
Gwtgb Hmqdhrt Di Cxwwzpzqa	Charleroi	Belgium
Isvmsy	Bonheiden	Belgium
Hkxepgm Dh Lyxisaizy	Libramont-Chevigny	Belgium
Bqmwptgbgoaa Cwdfsjz Ocayjsuca Ixq Mcaul Slzqarljrcdlbotbaa W Bmpauxqrlkc	Bialystok	Poland
Fgeobqpnc Oasegnxrguu Fvplixdkt	Donostia / San Sebastian	Spain
Abnzctd Xdtnu Atdmzsykmqdq Ugimmbgcuuobe Dz Mmsezmm Fjuahklh Pwybtss	Manresa	Spain

Trial status

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

Ovarian epithelial cancer

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?