Study of Pemigatinib and Retifanlimab for Patients with Advanced Dedifferentiated Liposarcoma

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What is this study about?

This clinical trial is focused on studying a type of cancer called dedifferentiated liposarcoma, which is a rare form of cancer that develops in fat cells. The study is testing two treatments: Pemigatinib, which is taken as a tablet, and Retifanlimab (also known by its code name INCMGA00012), which is given as a solution through an intravenous infusion. The purpose of the study is to evaluate the potential benefits of these treatments for patients with advanced dedifferentiated liposarcoma.

Participants in the study will receive either the active treatments or a placebo. The study will monitor the progression of the disease over a period of time, looking at how long patients live without the disease getting worse and how their bodies respond to the treatments. The study will also assess the overall survival of patients, which means the length of time patients live from the start of the treatment. Additionally, the study will track any side effects or adverse events that occur during the treatment period.

The trial will also evaluate changes in patients’ quality of life and their ability to perform daily activities. This will be done using a questionnaire designed to measure these aspects. The study aims to provide valuable information on the effectiveness and safety of Pemigatinib and Retifanlimab in treating advanced dedifferentiated liposarcoma, potentially leading to improved treatment options for patients with this condition.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, diagnosis of dedifferentiated liposarcoma, and the presence of measurable lesions.

A biopsy may be required to provide tissue samples, unless archival tumor tissue is available. The biopsy is performed only if it is considered safe.

2 treatment initiation

The treatment phase begins with the administration of two medications: pemigatinib and retifanlimab.

Pemigatinib is taken orally in the form of 4.5 mg tablets. The specific dosage schedule will be provided by the healthcare team.

Retifanlimab is administered through an intravenous infusion. The frequency and duration of these infusions will be determined by the healthcare team.

3 ongoing monitoring

Throughout the study, regular monitoring is conducted to assess the response to treatment and any side effects.

Progression-free survival is evaluated at 24 weeks to determine the time from the first dose to disease progression or death.

Additional assessments include objective response rate, overall survival, and changes in quality of life.

4 response evaluation

The response to treatment is evaluated using criteria such as the objective response rate and best overall response.

Time to response and duration of response are calculated to understand the effectiveness of the treatment.

5 adverse events monitoring

Any adverse events or serious adverse events are monitored and recorded. This includes changes in laboratory values, vital signs, and physical examinations.

The severity of these events is graded according to established criteria.

6 study completion

The study is estimated to conclude by April 2027. At the end of the study, a final assessment is conducted to evaluate the overall outcomes and any long-term effects of the treatment.

Who Can Join the Study?

Be 18 years of age or older on the day of signing the consent form.
Have a confirmed diagnosis of Dedifferentiated Liposarcoma (DDLPS). This means a medical report must show the presence of DDLPS with positive results for a test called MDM2 immunohistochemistry or MDM2 amplification. These tests can be done using special methods like fluorescence in situ hybridization, polymerase chain reaction (PCR), or sequencing-based methods.
Have at least one tumor that can be measured using a CT scan and cannot be removed by surgery or other treatments. If the tumor is in an area that was treated before, it can still be measured if it has grown since the last treatment.
Be willing to provide a sample of the tumor tissue through a procedure called a biopsy at specific times during the study. If a previous sample is available, it can be used instead. The biopsy will only be done if it is safe for the patient.
Have a performance status of 0-2 on the ECOG Performance Scale, which is a way to measure how well a person can perform daily activities.

Who Cannot Join the Study?

Patients who have a different type of cancer than Dedifferentiated Liposarcoma cannot participate. Dedifferentiated Liposarcoma is a specific type of cancer that starts in fat cells.
Patients who are not within the specified age range cannot participate. The age range for this study is typically adults.
Patients who are not able to understand or follow the study procedures cannot participate.
Patients who have other serious health conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have participated in another clinical trial recently may not be eligible.
Patients who have allergies or reactions to the study medications cannot participate.
Patients who are unable to provide informed consent cannot participate. Informed consent means they understand the study and agree to take part.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Karolinska University Hospital	Solna	Sweden
Oslo University Hospital HF	Oslo	Norway
Hgunt Bsozou Hs	Bergen	Norway
Amlftx Umhtfjutjs Hapabxza	Aarhus	Denmark
Svsfovtcrlf Ugwabcpokl Hcrobaqgbdsqovi Gkxrhlvobhttqpxie	Gothenburg	Sweden

Trial status

Country	Status	Recruitment Start
Denmark	Not yet recruiting	01.10.2023
Norway	Recruiting	01.10.2023
Sweden	Recruiting	01.10.2023

Trial locations

Investigated drugs:

Pemigatinib is a medication being studied for its potential benefits in treating advanced dedifferentiated liposarcoma, a type of cancer. It works by targeting specific pathways in cancer cells that are involved in their growth and survival, potentially slowing down or stopping the progression of the disease.

Retifanlimab is another medication involved in the study, which is being evaluated for its effectiveness in treating advanced dedifferentiated liposarcoma. It is designed to help the immune system recognize and attack cancer cells, potentially improving the body’s ability to fight the cancer.

Dedifferentiated Liposarcoma – Dedifferentiated liposarcoma is a type of cancer that originates in fat cells and is characterized by the presence of both well-differentiated and dedifferentiated components. It typically occurs in the deep soft tissues of the body, such as the retroperitoneum, which is the area behind the abdominal cavity. The disease progresses as the dedifferentiated component, which is more aggressive, grows and spreads more rapidly than the well-differentiated part. Patients may experience symptoms related to the size and location of the tumor, such as pain or swelling. As the tumor enlarges, it can press on nearby organs and tissues, leading to additional complications. The progression of dedifferentiated liposarcoma can vary, with some tumors growing slowly while others may advance more quickly.

Trial ID:

2022-501993-21-00

Protocol code:

PERELI

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Pemigatinib and Retifanlimab for Patients with Advanced Dedifferentiated Liposarcoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?