Recruiting

Study of Pembrolizumab with Etoposide and Cisplatin for First-Line Treatment in Patients with Small Cell Ovarian Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a rare type of cancer called small cell ovarian carcinoma of hypercalcemic type. The study will explore the effects of a treatment combination that includes the medication pembrolizumab, known by its brand name Keytruda, along with a chemotherapy regimen based on etoposide and cisplatin. These medications are administered as solutions for infusion, which means they are given directly into the bloodstream through a vein.

The purpose of the study is to estimate how well this combination treatment works in achieving a complete response, which means the disappearance of all signs of cancer in response to treatment. Participants will receive the treatment over several cycles, with each cycle involving the administration of the medications. The study is designed to observe the effects of the treatment over time, without using a placebo group. The trial will also monitor the safety of the treatment and document its effectiveness using a standard method called RECIST 1.1, which is a set of rules used to measure how well a cancer treatment works.

This study is non-randomized, meaning all participants will receive the same treatment without being randomly assigned to different groups. It is a phase II trial, which means it is focused on assessing the effectiveness of the treatment and gathering more information about its safety. The trial is multicentric, indicating that it will be conducted at multiple centers or locations. The study aims to provide valuable insights into the potential benefits of combining pembrolizumab with etoposide and cisplatin for treating this specific type of ovarian cancer.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the participant must have a confirmed diagnosis of small cell carcinoma of the ovary. The participant should be at least 12 years old and have not received prior treatment, except for one cycle of chemotherapy.
The participant must start the treatment within four weeks after the first cycle of chemotherapy, beginning at cycle 2.
Step 2
Treatment initiation
The treatment involves a combination of chemotherapy and immunotherapy. The medications used include pembrolizumab, cisplatin, cyclophosphamide, doxorubicin hydrochloride, and etoposide.
All medications are administered as a solution for infusion. The specific dosage and frequency will be determined by the healthcare provider based on individual patient needs.
Step 3
Treatment monitoring
Throughout the treatment, the participant's response will be monitored using a method called RECIST 1.1, which helps in assessing the size of the tumor.
Safety will be evaluated using a standard called NCI CTC-AE v5 to ensure the participant's well-being during the trial.
Step 4
Completion of treatment
The primary goal is to achieve a complete response, meaning the disappearance of all signs of cancer in response to treatment.
The estimated end date for the trial is February 5, 2030, with recruitment starting on June 17, 2024.

Who can join the trial?

16 criteria

Patients must have a confirmed diagnosis of **ovarian small cell carcinoma**. This is a specific type of cancer affecting the ovaries.
Patients must be at least 12 years old on the day they sign the informed consent form.
Patients should not have received any prior treatment for their cancer, except they can be included after one cycle of chemotherapy. They must start the study treatment within 4 weeks after the first cycle of chemotherapy.
The cancer stage must be between **FIGO I to IV**. FIGO is a system used to describe how much the cancer has spread.
Patients must have an **ECOG Performance Status** of 0 or 1. This is a scale used to assess how well a patient can perform daily activities.
Patients must have adequate organ function, which includes:
**Marrow function**: White blood cells > 2000/mm³, Neutrophils > 1500/mm³, Platelets > 100,000/mm³, and Hemoglobin > 9 g/dL.
**Liver function**: ALT and AST levels less than 3 times the normal limit, and total bilirubin less than 1.5 times the normal limit (except for Gilbert Syndrome).
**Thyroid function**: Normal or controlled with medication.
**Heart function**: Left ventricular ejection fraction (LVEF) greater than 55%.
**Kidney function**: Serum creatinine less than 2 times the normal limit or creatinine clearance greater than 60 mL/min.
The participant or their legal representative must provide written informed consent before any study-specific procedures.
Participants must have medical insurance coverage.
Participants must be willing to comply with all study procedures and be available for the duration of the study.
Women of childbearing potential must have a negative pregnancy test within 72 hours before starting treatment.
Women of reproductive potential must use highly effective contraception during the study and for a specified period after the last dose of treatment.

Who cannot join the trial?

3 criteria

Patients who do not have a confirmed diagnosis of ovarian small cell carcinoma.
Patients who are male, as the study is only for female participants.
Patients who are part of a vulnerable population, which means they might need special protection or care.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Besancon University Hospital Center
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Besançon, France
Centr Georges Francois Leclerc
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Dijon, France
Centre Hospitalier Et Universitaire De Limoges
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Limoges, France

Trial locations

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Investigated drugs

Pembrolizumab
is an immunotherapy medication used in this trial. It works by helping the immune system recognize and attack cancer cells more effectively. It is often used in combination with other treatments to enhance the body's natural defenses against cancer.
Etoposide
is a chemotherapy drug that helps stop the growth of cancer cells by interfering with their DNA. It is used in this trial to treat small cell ovarian carcinoma by slowing or stopping the spread of cancer cells.
Cisplatin
is another chemotherapy medication used in this trial. It works by damaging the DNA of cancer cells, which prevents them from dividing and growing. Cisplatin is often used in combination with other chemotherapy drugs to increase its effectiveness against cancer.

What is already known about the treatment

Pembrolizumab
Pembrolizumab is administered intravenously and is currently being studied in combination with chemotherapy for treating small cell ovarian carcinoma of the hypercalcemic type. It is an immunotherapy drug that works by blocking a protein called PD-1 on the surface of immune cells, allowing the immune system to better attack cancer cells. Pembrolizumab is classified as a monoclonal antibody and is widely recognized in medical literature for its role in treating various cancers.
Etoposide
Etoposide is given intravenously or orally and is used in combination with other chemotherapy drugs to treat small cell ovarian carcinoma. It works by inhibiting an enzyme called topoisomerase II, which is necessary for DNA replication, thereby preventing cancer cells from dividing and growing. Etoposide is classified as a topoisomerase inhibitor and is well-documented in medical literature for its effectiveness in treating different types of cancer.
Cisplatin
Cisplatin is administered intravenously and is part of the chemotherapy regimen for small cell ovarian carcinoma. It functions by forming cross-links in DNA, which ultimately leads to cell death, particularly in rapidly dividing cancer cells. Cisplatin is classified as a platinum-based chemotherapy drug and is extensively used in oncology for its efficacy in treating various malignancies.

Investigated diseases

Ovarian Small Cell Carcinoma – This is a rare and aggressive form of cancer that originates in the ovary. It is characterized by the presence of small, round cancer cells that can grow and spread rapidly. The disease often presents with symptoms such as abdominal pain, bloating, and changes in menstrual cycles. As it progresses, it may lead to the formation of tumors that can affect surrounding tissues and organs. The exact cause of ovarian small cell carcinoma is not well understood, but it is known to occur more frequently in younger women. Early detection is challenging due to the non-specific nature of its symptoms.