Study of Pembrolizumab, Paclitaxel, and Bevacizumab for Patients with Platinum-Resistant Recurrent Ovarian Cancer

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What is this study about?

This clinical trial is focused on studying treatments for ovarian cancer, specifically in cases where the cancer has returned and is resistant to platinum-based chemotherapy. The study involves several medications: pembrolizumab, also known by its code name MK-3475, paclitaxel, bevacizumab, and a placebo. The purpose of the study is to compare the effectiveness of these treatments in combination, with or without bevacizumab, in improving the time patients live without the cancer getting worse.

Participants in the study will receive treatment through an intravenous infusion, which means the medication is given directly into a vein. The study will last for up to 24 months, during which time patients will be monitored regularly. The study aims to see how well the treatments work in stopping the cancer from progressing, as well as to observe any side effects and overall survival rates. The study will also assess the impact of the treatments on patients’ quality of life, including their general health and any symptoms related to the abdomen and gastrointestinal tract.

This trial is designed to provide valuable information on the potential benefits and risks of using these medications in combination for treating platinum-resistant recurrent ovarian cancer. By comparing different treatment combinations, the study hopes to find more effective ways to manage this challenging condition. Participants will be closely monitored by healthcare professionals throughout the study to ensure their safety and well-being.

1 joining the study

Upon joining the study, you will be randomly assigned to one of the treatment groups. This means you will either receive the study medication or a placebo, which is a substance with no active drug, in combination with other treatments.

2 treatment administration

You will receive the medications through an intravenous infusion, which means the medication will be given directly into your vein. The medications involved in the study include pembrolizumab, paclitaxel, and possibly bevacizumab.

Pembrolizumab is given as a 25 mg/mL concentrate for solution for infusion. The exact dosage and frequency will be determined by the study protocol.

Paclitaxel is also administered through intravenous infusion. The dosage and frequency will be specified by the study team.

If you are in the group receiving bevacizumab, it will also be administered through intravenous infusion. The dosage and frequency will be determined by the study protocol.

3 monitoring and assessments

Throughout the study, you will undergo regular monitoring and assessments to evaluate your health and the effects of the treatment. This includes physical exams, blood tests, and imaging studies to check the progression of your condition.

Your overall health status and quality of life will be assessed using specific questionnaires designed to measure these aspects.

4 end of treatment

The treatment phase will continue until the study’s end date or until you and your doctor decide it is best to stop. This decision will be based on your health and the study’s findings.

After completing the treatment phase, you may have follow-up visits to monitor your health and gather additional information for the study.

Who Can Join the Study?

  • The patient must have a confirmed diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
  • The patient must have adequate organ function, meaning their organs are working well enough to participate in the study.
  • The patient must have received 1 or 2 previous treatments for ovarian cancer, including at least one treatment with a platinum-based drug. Previous treatments with certain other drugs do not count as separate treatments.
  • The patient must have signed a document agreeing to participate in the study, known as informed consent.
  • The patient must show evidence of the disease getting worse within 6 months after the last dose of platinum-based chemotherapy, which is known as platinum-resistant disease.
  • The patient must be eligible to receive paclitaxel chemotherapy, and bevacizumab if it is being used.
  • The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, which means they are fully active or have some symptoms but do not need to stay in bed.
  • If the patient is a woman, she must not be pregnant or breastfeeding. If she can have children, she must use a highly effective birth control method.
  • The patient must have disease that can be evaluated by imaging tests, either measurable or non-measurable, as determined by the study doctor.
  • The patient must provide a sample of tumor tissue, either from a previous surgery or a new biopsy, that has not been treated with radiation.

Who Cannot Join the Study?

  • Patients who have a different type of cancer than ovarian, fallopian tube, or primary peritoneal carcinoma cannot participate.
  • Only female patients are eligible for this study.
  • Patients who are part of a vulnerable population may not be eligible. This means groups of people who might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Academisch Ziekenhuis Leiden Leiden The Netherlands
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach Kielce Poland
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Stichting Radboud University Medical Center Nijmegen The Netherlands
Universitetssykehuset Nord-Norge HF Tromsø Norway
Institut Jules Bordet Anderlecht Belgium
Uniwersytecki Szpital Kliniczny W Bialymstoku Bialystok Poland
Szpital Kliniczny Im. Ks. Anny Mazowieckiej samodzielny publiczny zakład opieki zdrowotnej Warsaw Poland
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy Warsaw Poland
Turku University Hospital Turku Finland
Aalborg University Hospital Aalborg Denmark
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Universitair Ziekenhuis Gent Gent Belgium
Deutsches Herzzentrum Berlin Berlin Germany
Universita Degli Studi Di Brescia Brescia Italy
Algemeen Ziekenhuis Groeninge Kortrijk Belgium
Centre De Cancerologue Du Grand Montpellier Montpellier France
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku Bialystok Poland
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Institut Curie – Site Saint-Cloud Saint-Cloud France
Centre Francois Baclesse Caen France
L’Hopital Prive Du Confluent Nantes France
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France
Egaeoxx Uetshkirajaz Myggogm Cnieqeh Rdwyvmyks (utrovpe Mqu Rotterdam The Netherlands
Ndcfsafd Iqufhsnh Oubnivmmk Ijq Mrcuc Sdoqglwgglicfcqipunexaowdonp Iubqmeer Biuqisfv Cracow Poland
Umhvpevjlegpov Cfhtmsg Kqcgqtleu Gdansk Poland
Ccdd Usrnekrhlf Hyfwxphg Cork Ireland

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
01.12.2021
Denmark Denmark
Not recruiting
01.12.2021
Finland Finland
Not recruiting
01.12.2021
France France
Not recruiting
01.12.2021
Germany Germany
Not recruiting
01.12.2021
Ireland Ireland
Not recruiting
01.12.2021
Italy Italy
Not recruiting
01.12.2021
Norway Norway
Not recruiting
01.12.2021
Poland Poland
Not recruiting
01.12.2021
The Netherlands The Netherlands
Not recruiting
01.12.2021

Trial locations

Pembrolizumab is a type of medication known as an immunotherapy. It works by helping your immune system fight cancer cells. In this trial, pembrolizumab is being tested to see if it can help improve the treatment of ovarian cancer when used with other medications.

Paclitaxel is a chemotherapy drug that is used to stop the growth of cancer cells. It works by interfering with the way cells divide, which can slow down or stop the spread of cancer. In this study, paclitaxel is used in combination with other treatments to see if it can be more effective against ovarian cancer.

Bevacizumab is a medication that works by blocking the growth of new blood vessels that tumors need to grow. By cutting off the blood supply, bevacizumab can help slow down the growth of cancer. In this trial, it is used alongside other treatments to see if it can improve outcomes for patients with ovarian cancer.

Ovarian carcinoma – Ovarian carcinoma is a type of cancer that begins in the ovaries, which are the reproductive glands found in women. It often starts on the surface of the ovary and can spread to other parts of the pelvis and abdomen. The disease progresses through stages, beginning with localized growth and potentially advancing to widespread metastasis. Symptoms may include abdominal bloating, pelvic pain, and changes in bowel habits. As the disease advances, it can lead to fluid accumulation in the abdomen and other systemic symptoms. The progression is typically monitored through imaging and clinical evaluation.

Fallopian tube carcinoma – Fallopian tube carcinoma is a rare cancer that originates in the fallopian tubes, which connect the ovaries to the uterus. It often presents with symptoms such as pelvic pain, abnormal vaginal bleeding, and a pelvic mass. The disease can spread to nearby organs and tissues, including the ovaries and peritoneum. As it progresses, it may cause more generalized symptoms like abdominal swelling and discomfort. The cancer is staged based on its spread, with early stages confined to the tubes and later stages involving distant metastasis. Monitoring involves regular imaging and physical examinations.

Primary peritoneal carcinoma – Primary peritoneal carcinoma is a cancer that arises from the peritoneum, the lining of the abdominal cavity. It shares many similarities with ovarian cancer, including its symptoms and progression. The disease often presents with abdominal pain, bloating, and changes in bowel habits. As it advances, it can lead to fluid buildup in the abdomen and spread to other organs. The progression is categorized into stages, with early stages being localized and later stages involving widespread dissemination. Regular monitoring through imaging and clinical assessments is essential to track its progression.

Trial ID:
2023-506177-35-00
Protocol code:
MK-3475-B96
Trial Phase:
Human Pharmacology (Phase I) – Other

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