Study of Pembrolizumab, MK-4830, and Chemotherapy for Patients with High-Grade Serous Ovarian Cancer

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What is this study about?

This clinical trial is focused on studying treatments for High-Grade Serous Ovarian Cancer, as well as related conditions like Primary Peritoneal Cancer and Fallopian Tube Cancer. The study is testing a combination of medications to see how effective they are in treating these cancers. The main medications being studied are Pembrolizumab (also known as Keytruda), MK-4830, Carboplatin, Paclitaxel, Bevacizumab, and Docetaxel. These medications are given as solutions through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

The purpose of the study is to evaluate whether adding MK-4830 to the standard treatment of Pembrolizumab and chemotherapy can lead to a greater reduction in cancer-related DNA in the blood. Participants will receive these treatments over a period of time, with some receiving a placebo instead of MK-4830. The study will monitor changes in the levels of cancer-related DNA in the blood, as well as the overall response to the treatment, including any side effects experienced by participants.

Throughout the study, participants will undergo regular assessments to track their response to the treatment. This includes measuring changes in cancer-related DNA and evaluating the effectiveness of the treatment in reducing cancer cells. The study aims to provide valuable information on whether the addition of MK-4830 can improve outcomes for patients with these types of cancer.

1 joining the study

Upon joining the study, you will be informed about the trial’s purpose and procedures. You will be asked to provide consent to participate.

You will undergo initial assessments to confirm eligibility, including a review of your medical history and a physical examination.

2 initial treatment phase

You will begin treatment with a combination of medications administered through an intravenous infusion. This includes carboplatin, paclitaxel, and pembrolizumab. The specific dosages and frequency will be determined by the study team.

The treatment will be given in cycles, with each cycle lasting a few weeks. You will receive the infusions at a healthcare facility.

3 additional treatment with mk-4830

Depending on the study group you are assigned to, you may receive an additional medication called MK-4830 through intravenous infusion.

This medication will be administered alongside the standard treatment regimen.

4 monitoring and assessments

Throughout the trial, you will have regular appointments to monitor your health and response to the treatment. This includes blood tests and imaging studies.

The study team will evaluate changes in circulating tumor DNA (ctDNA) to assess the treatment’s effectiveness.

5 surgery

If you are a candidate, you may undergo interval debulking surgery. This procedure aims to remove as much of the tumor as possible.

The timing and specifics of the surgery will be discussed with you by the study team.

6 follow-up treatment

After surgery, you will continue to receive chemotherapy and possibly other medications as part of the study protocol.

The treatment will continue for a specified duration, with regular monitoring to track your progress.

7 completion and final assessments

Upon completing the treatment phase, you will undergo final assessments to evaluate the overall response to the therapy.

The study team will discuss the results with you and provide guidance on any further steps or follow-up care needed.

Who Can Join the Study?

The patient must have a confirmed diagnosis of Stage III or Stage IV high-grade serous ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. These are advanced stages of certain types of cancer affecting the ovaries, the lining of the abdomen, or the fallopian tubes.
The patient must be a candidate for carboplatin and paclitaxel chemotherapy. This means the patient should be able to receive these specific cancer-fighting drugs before and after surgery.
The patient must be a candidate for interval debulking surgery, which is a surgery to remove as much of the tumor as possible after some initial treatment.
The patient must be able to provide a sample of the tumor tissue, either from a previous biopsy or a new one. A biopsy is a procedure where a small piece of tissue is taken from the body to be examined.
The patient must have adequate organ functions, meaning their vital organs like the liver, kidneys, and heart are working well enough to handle the treatment.
The patient must be female.

Who Cannot Join the Study?

Patients with a history of other types of cancer that are not primary peritoneal cancer or fallopian tube cancer cannot participate.
Only female patients are eligible for this study.
Patients who are considered part of a vulnerable population may not be eligible. This means people who might need special protection or care, like those with certain disabilities or conditions.
Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important to check if you meet the age criteria.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Hospital Universitario 12 De Octubre	Madrid	Spain
Az Maria Middelares Gent	Gent	Belgium
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o.	Siedlce	Poland
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach	Kielce	Poland
Uniwersytecki Szpital Kliniczny W Poznaniu	Poznan	Poland
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Itecmhnj Cwyjvy Dujtajhnhzbktufnh	L'hospitalet De Llobregat	Spain
Nnuwxprl Issheyfg Oepiiewca Inv Msjge Scfpgyyaqlpcpeeldfjtjpgkqjbr Igzzxdma Busiqvmq	Cracow	Poland
Usjemnrrxkunac Cforedp Kxskippgd	Gdansk	Poland
Utbfgwrjhw Ow Amdvexy	Edegem	Belgium
Hcpwaiwd Vyla duwcpvsw	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	28.07.2022
Italy	Not recruiting	28.07.2022
Poland	Not recruiting	28.07.2022
Spain	Not recruiting	28.07.2022

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, pembrolizumab is used to help treat high-grade serous ovarian cancer by boosting the body’s natural defenses against the cancer.

MK-4830 is an experimental medication being studied to see if it can enhance the effects of pembrolizumab and chemotherapy. It is thought to work by targeting specific pathways in the immune system to help it fight cancer more effectively. In this trial, MK-4830 is being tested to see if it can improve treatment outcomes for patients with high-grade serous ovarian cancer when used alongside pembrolizumab and standard chemotherapy.

Investigated diseases:

Primary peritoneal cancer – This cancer originates in the peritoneum, a thin layer of tissue lining the abdomen. It shares similarities with ovarian cancer in terms of symptoms and progression. The disease often begins with the abnormal growth of cells in the peritoneum, which can spread to other abdominal organs. As it progresses, it may cause abdominal swelling, pain, and digestive issues. The cancer cells can spread through the peritoneal cavity, leading to further complications. It is often diagnosed at an advanced stage due to its subtle early symptoms.

Fallopian tube cancer – This rare type of cancer starts in the fallopian tubes, which connect the ovaries to the uterus. It typically begins with the uncontrolled growth of cells in the lining of the fallopian tubes. As the disease progresses, it can cause symptoms such as pelvic pain, abnormal vaginal bleeding, and a palpable mass. The cancer may spread to nearby organs and tissues, including the ovaries and peritoneum. It often remains undetected until it has advanced, due to its nonspecific symptoms. The progression can lead to complications in the reproductive and abdominal areas.

Trial ID:

2023-505005-16-00

Protocol code:

MK-4830-002

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Pembrolizumab, MK-4830, and Chemotherapy for Patients with High-Grade Serous Ovarian Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?