Study of Pembrolizumab and Chemotherapy for Patients with Recurrent Platinum-Sensitive Low-Grade Serous Ovarian Cancer

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What is this study about?

This clinical trial is focused on studying a type of cancer known as low-grade serous ovarian cancer, which can also affect the fallopian tubes and the lining of the abdomen, known as the peritoneum. The study is investigating the effectiveness of a treatment that combines a medication called pembrolizumab with chemotherapy. Pembrolizumab, also known by its code name MK-3475, is a type of drug that helps the immune system fight cancer cells.

The purpose of this study is to determine if pembrolizumab, when used in combination with chemotherapy, can help patients with this type of cancer live longer without the disease getting worse. Participants in the study will receive the treatment and be monitored over a period of time to see how well the cancer responds. The study will also look at the safety of the treatment and how it affects the quality of life for those involved.

Throughout the study, participants will receive pembrolizumab through an intravenous infusion, which means the medication is given directly into a vein. The study will last for several months, and participants will have regular check-ups to monitor their health and the progress of the treatment. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the treatment. The study aims to provide valuable information on the potential benefits of pembrolizumab for patients with low-grade serous ovarian cancer.

1 joining the study

Upon joining the study, the participant provides written informed consent.

A pregnancy test is performed for women of childbearing potential to ensure they are not pregnant at the beginning of treatment.

The participant must have a tumor tissue sample available, either from previous archives or a newly obtained biopsy.

2 initial assessment

An initial assessment is conducted to confirm eligibility, including a review of medical history and current health status.

Adequate organ and bone marrow function is verified as per the study protocol.

3 treatment initiation

The treatment involves the administration of pembrolizumab in combination with chemotherapy.

Pembrolizumab is given as a solution for infusion through intravenous administration.

The specific dosage and frequency of administration are determined by the study protocol.

4 ongoing treatment and monitoring

The participant receives regular infusions of pembrolizumab and chemotherapy as per the study schedule.

Progression-free survival is monitored at 6, 12, 18, and 24 months.

Regular assessments are conducted to evaluate the response to treatment and monitor for any side effects.

5 end of treatment evaluation

At the end of the treatment period, a comprehensive evaluation is conducted to assess the overall response to the therapy.

The primary endpoint is the 12-month progression-free survival rate.

Secondary endpoints include overall response rate, overall survival, and quality of life assessments.

6 follow-up

Participants are followed up for a period of time after the treatment to monitor long-term outcomes and any delayed side effects.

Quality of life is assessed until 6 months after progression.

Who Can Join the Study?

Must be a female who is at least 18 years old.
Must have a confirmed diagnosis of low-grade serous ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. These are specific types of cancer affecting the ovaries, fallopian tubes, or the lining of the abdomen.
Must have completed at least one previous treatment with platinum-containing therapy. This includes treatments like carboplatin or cisplatin. It’s okay if the patient has also had maintenance therapy with drugs like bevacizumab or letrozole. If the patient had chemotherapy before surgery as their first treatment, it counts as one treatment. The patient may have had surgery to remove cancer in the first or second treatment.
Must have platinum-sensitive disease, meaning the cancer came back or got worse after platinum therapy, but not sooner than 6 months after the last platinum treatment.
Must have an ECOG performance status of 0 or 1. This is a scale that measures how well a patient can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to do light work.
If the patient can become pregnant, they should not be pregnant at the start of the study and should not become pregnant during the study. A pregnancy test is required before starting the study. The patient must agree to use birth control during the study and for 6 months after the last treatment.
Must provide written consent to participate in the trial.
Must have a sample of the tumor available, either from a previous biopsy or a new one. The sample should not be from an area that has been treated with radiation. Tissue blocks are preferred over slides, and new samples are preferred over old ones.
Must have proper functioning of organs and bone marrow, as specified in the study protocol.

Who Cannot Join the Study?

Patients who do not have recurrent platin sensitive low-grade serous ovarian cancer. This type of cancer affects the ovaries, fallopian tubes, or the lining of the abdomen.
Patients who are not female, as the study is only for female participants.
Patients who are not within the specified age range for the study.
Patients who belong to a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Ktviahpo Eadzwwxlwilytjkdlnqgbfif Hdcyslasjgxykplgl	Essen	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	22.02.2022

Trial locations

Investigated drugs:

Pembrolizumab

Pembrolizumab is a medication used in this trial to help the immune system fight cancer cells. It works by blocking a specific protein on the surface of immune cells, allowing them to better detect and attack cancer cells. In this study, pembrolizumab is being tested to see if it is effective in treating patients with low-grade serous ovarian cancer.

Chemotherapy is a type of cancer treatment that uses drugs to destroy cancer cells. In this trial, chemotherapy is combined with pembrolizumab to see if the combination is more effective than chemotherapy alone. The goal is to stop the cancer from growing and spreading, and to improve the patient’s progression-free survival rate.

Investigated diseases:

Recurrent Platinum-Sensitive Low-Grade Serous Ovarian Cancer – This is a type of ovarian cancer that tends to grow slowly and is characterized by its sensitivity to platinum-based chemotherapy. It originates in the cells lining the ovaries and can also affect the fallopian tubes and the peritoneum, which is the lining of the abdominal cavity. The disease is termed “recurrent” because it returns after initial treatment, and “platinum-sensitive” because it responds well to platinum-based drugs. As the cancer progresses, it may spread to nearby tissues and organs. Symptoms can include abdominal pain, bloating, and changes in bowel habits. The progression of the disease can vary, with some patients experiencing long periods without symptoms.

Trial ID:

2023-508155-40-00

Protocol code:

NOGGO-ov44

NCT ID:

NCT04575961

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Pembrolizumab and Chemotherapy for Patients with Recurrent Platinum-Sensitive Low-Grade Serous Ovarian Cancer

What is this study about?

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