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Study on Pembrolizumab and Olaparib for Patients with Resectable Soft Tissue Sarcoma

Verified siteRegistered drugNo placebo

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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 type of cancer known as Soft Tissue Sarcoma, specifically two subtypes: Undifferentiated Pleomorphic Sarcoma and Dedifferentiated Liposarcoma. The study will explore the effects of a treatment using a medication called Pembrolizumab, which is administered through an infusion, and may also include another medication called Olaparib, taken as a tablet. The purpose of the study is to evaluate how these treatments work in patients with these specific types of cancer.

Participants in the study will receive Pembrolizumab with or without Olaparib before undergoing standard surgery to remove the cancer. This period before surgery is referred to as the "Window of Opportunity." After the surgery, patients will continue to receive Pembrolizumab as an additional treatment. The study aims to understand the potential of these medications to enhance the body's immune response against the cancer.

The trial will involve regular monitoring and assessments to track the effects of the treatment. This includes checking the cancer's response to the medication and any changes in the tumor. The study will also look at the overall health and recovery of the participants over time. The goal is to gather information that could help improve treatment options for patients with Soft Tissue Sarcoma in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase
The initial treatment phase involves the administration of pembrolizumab and possibly olaparib. Pembrolizumab is given as a solution for infusion, which means it is administered directly into the bloodstream through a vein.
Olaparib, if included in the treatment, is taken orally in the form of film-coated tablets. The specific dosage and frequency of these medications will be determined by the study protocol.
Step 2
Window of opportunity (WoO) treatment
During the WoO treatment phase, the focus is on evaluating the potential effects of the medications on the tumor. This phase occurs before the standard surgical procedure.
The primary goal is to assess changes in the tumor, particularly the increase in certain immune cells, as well as the overall response of the tumor to the treatment.
Step 3
Surgical procedure
Following the WoO treatment, a surgical procedure is performed to remove the tumor. This surgery is planned based on the initial assessment of the tumor's resectability.
The surgery aims to achieve complete removal of the tumor, and the quality of the resection is evaluated post-surgery.
Step 4
Adjuvant treatment phase
After the surgical procedure, an adjuvant treatment phase with pembrolizumab is conducted. This phase is intended to support the body's immune response and help prevent the recurrence of the tumor.
The duration and specific details of this phase are determined by the study protocol and the patient's response to the initial treatments.
Step 5
Follow-up and monitoring
Regular follow-up visits are scheduled to monitor the patient's health and the status of the disease. These visits include various assessments to check for any signs of recurrence or complications.
The follow-up period extends for a significant duration, potentially up to two years post-surgery, to ensure comprehensive monitoring of the patient's recovery and overall health.

Who can join the trial?

19 criteria

Must be a male or female patient aged 18 years or older at the time of signing the consent form.
Hepatitis B, C, and HIV tests are not needed unless there is a known history of these infections or if required by local health authorities.
For those with Hepatitis B, they can participate if they have been on antiviral treatment for at least 4 weeks and have no detectable virus in their blood before starting the study.
For those with a history of Hepatitis C, they can participate if the virus is not detectable in their blood at the start of the study and they have completed treatment at least 4 weeks before starting the study.
For those with a history of HIV, they can participate if they have been on antiviral treatment for at least 4 weeks and have no detectable virus in their blood before starting the study.
Female participants must not be pregnant or breastfeeding and must agree to use birth control during the study and for a certain period after the last dose of treatment.
Male participants must agree to use birth control during the study and for a certain period after the last dose of treatment and must not donate sperm during this time.
Participants must agree not to donate blood during the study and for 90 days after the last dose of treatment.
Participants must understand, sign, and date the consent form before any study-specific procedures are done.
Participants must be willing to undergo a biopsy and attend study visits and procedures as required by the study.
Participants must be part of a social security system or have equivalent coverage.
Must have a confirmed diagnosis of certain types of soft tissue sarcoma, as stated in a pathology report and confirmed by a doctor.
The tumor must be removable by surgery at the time of joining the study, and there should be no need for chemotherapy before surgery.
No signs of cancer spread to other parts of the body on a CT scan or similar imaging test.
Patients with a local return of cancer after surgery can join if they haven't had chemotherapy or radiation before.
Must have specific structures called Tertiary Lymphoid Structures identified in a tumor sample by a qualified pathologist.
The main tumor must be measurable by imaging tests and suitable for repeated assessments.
Must have a performance status of 0 or 1, meaning they are fully active or have some restrictions but can carry out light work.
Must have adequate blood and organ function as shown by lab tests done within 3 days before the first study treatment.

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Institut Gustave Roussy
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Villejuif, France

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Investigated drugs

Pembrolizumab
is a medication used in this trial to help the body's immune system fight cancer. It works by blocking a specific protein on cancer cells, which allows the immune system to better recognize and attack these cells. In this study, pembrolizumab is being tested to see how well it can enhance the immune response in patients with certain types of soft tissue sarcoma.
Olaparib
is another medication being tested in this trial. It is used to interfere with the repair of damaged DNA in cancer cells, which can lead to the death of these cells. In this study, olaparib is being evaluated to see if it can improve the effectiveness of pembrolizumab in treating soft tissue sarcoma.

What is already known about the treatment

Pembrolizumab
This medication is administered intravenously and is currently being studied in clinical trials for its potential use in treating certain types of soft tissue sarcoma, specifically undifferentiated pleomorphic sarcoma and dedifferentiated liposarcoma. Pembrolizumab is an immunotherapy drug that works by blocking a protein called PD-1, which helps the immune system recognize and attack cancer cells. It is classified as a monoclonal antibody and is already approved for use in various other cancers.
Olaparib
This medication is taken orally and is being evaluated in combination with pembrolizumab for its effectiveness in treating specific soft tissue sarcomas. Olaparib is a PARP inhibitor, which means it works by interfering with the DNA repair process in cancer cells, leading to their death. It is classified as a targeted therapy and is already approved for use in certain types of breast and ovarian cancers.

Investigated diseases

Undifferentiated Pleomorphic Sarcoma
This is a type of soft tissue sarcoma that typically occurs in the limbs, particularly the legs. It is characterized by a mix of different cell types and lacks a specific pattern, making it difficult to classify. The disease often presents as a rapidly growing mass, which can invade surrounding tissues. It may cause symptoms such as swelling or pain in the affected area. The progression can vary, with some tumors growing slowly while others may expand more quickly.
Dedifferentiated Liposarcoma
This is a subtype of liposarcoma, a cancer that arises in fat cells, and is known for having areas of well-differentiated liposarcoma alongside more aggressive, dedifferentiated areas. It often occurs in the retroperitoneum, which is the space in the abdomen behind the peritoneum. The disease typically presents as a painless mass, but as it grows, it can cause discomfort or interfere with organ function. The dedifferentiated component tends to grow more rapidly and can spread to other parts of the body. The progression of the disease can vary, with some cases remaining localized while others may metastasize.