Study on Retifanlimab, Doxorubicin, and Ifosfamide for Adults with Certain Types of Sarcoma in the Abdomen, Limbs, and Trunk

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What is this study about?

This clinical trial is focused on studying a type of cancer called retroperitoneal sarcoma, which can occur in the area behind the abdominal organs, as well as in the limbs and trunk wall. The study is investigating a treatment that combines a new medication called Retifanlimab (INCMGA00012) with standard chemotherapy drugs, Doxorubicin and Ifosfamide. These medications are given as a solution through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

The purpose of the study is to explore how effective this combination treatment is in reducing the size of the tumor before surgery. Participants in the study will receive the treatment over a period of time, and the response of the tumor will be assessed by examining the tissue removed during surgery. The study will also monitor the safety of the treatment and how long patients remain free from cancer progression or survive after starting the treatment.

Throughout the study, participants will receive regular check-ups and monitoring to ensure their well-being and to track the effects of the treatment. The study aims to provide valuable information on whether adding Retifanlimab to the chemotherapy regimen can improve outcomes for patients with this type of sarcoma. The results will help determine if this combination could become a standard treatment option in the future.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including age, health status, and type of sarcoma.

A negative pregnancy test is required for women of childbearing potential before starting the treatment.

2 initial assessment

An initial assessment is conducted to evaluate overall health, including blood tests and imaging scans to measure the size of the tumor.

3 treatment phase

The treatment involves a combination of retifanlimab, ifosfamide, and doxorubicin hydrochloride, all administered through intravenous infusion.

Retifanlimab is given as a solution for infusion. The dosage and frequency are determined by the study protocol.

Ifosfamide and doxorubicin hydrochloride are also administered as solutions for infusion, with specific dosages and schedules outlined in the study.

4 monitoring and follow-up

Regular monitoring is conducted to assess the response to treatment and manage any side effects.

Progression-free survival and overall survival are tracked, with assessments at specified intervals.

5 surgical evaluation

After the treatment phase, a surgical evaluation is performed to assess the tumor’s response, focusing on the percentage of viable tumor cells remaining.

6 end of study participation

Participation in the study concludes with a final assessment, and long-term follow-up may be conducted to monitor health outcomes.

Who Can Join the Study?

Patients must have a specific type of cancer called undifferentiated pleomorphic sarcoma in the limbs, trunk wall, or retroperitoneum, confirmed by a specialized network.
The disease must be measurable, meaning there is at least one tumor that can be measured using a CT scan.
Patients need to have normal blood, kidney, liver, and thyroid function. This includes specific levels for hemoglobin, white blood cells, liver enzymes, bilirubin, albumin, and creatinine.
The heart’s pumping ability, known as left ventricular ejection fraction, must be at least 50% as checked by an ultrasound or a special scan.
Women who can have children must have a negative pregnancy test before starting the study and agree to use effective birth control during and after the study.
Both men and women must agree to use effective birth control during the study and for a period after the study ends.
No other cancers diagnosed or treated in the last 2 years, except for certain types that are considered adequately treated.
Any side effects from previous treatments must have improved to a mild level, except for hair loss and mild nerve pain.
Patients must sign a consent form to participate in the study.
Patients must have social security as required by French law.
The need for chemotherapy before surgery must be confirmed by a specialized team.
The cancer must not have spread to other parts of the body and must be removable by surgery.
There must be at least one tumor that can be biopsied for research purposes.
No previous treatment for the current cancer.
Patients must be 18 years or older.
Patients must be able to perform daily activities with minimal assistance, as measured by the Eastern Cooperative Oncology Group (ECOG) performance status.
Patients must have a life expectancy of more than 3 months.

Who Cannot Join the Study?

Patients who have already received treatment for their sarcoma.
Patients with sarcomas that have spread to other parts of the body (metastatic).
Patients with sarcomas that cannot be surgically removed (unresectable).
Patients who are not adults.
Patients who are part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Cdclft Lfkl Bwcphk	Lyon	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	14.12.2022

Trial locations

Investigated drugs:

Retifanlimab (INCMGA00012) is an investigational medication being studied for its potential to help the body’s immune system fight cancer. In this trial, it is being tested to see if it can improve the effectiveness of chemotherapy in treating certain types of sarcomas, which are cancers that develop in the body’s connective tissues.

Doxorubicin is a chemotherapy drug used to treat various types of cancer. It works by slowing or stopping the growth of cancer cells. In this trial, doxorubicin is used as part of a combination therapy to treat sarcomas.

Ifosfamide is another chemotherapy medication that is used to treat different cancers, including sarcomas. It works by interfering with the DNA of cancer cells, preventing them from growing and dividing. In this study, ifosfamide is combined with other treatments to evaluate its effectiveness in treating sarcomas.

Investigated diseases:

Undifferentiated Pleomorphic Sarcoma – This is a type of soft tissue sarcoma that typically occurs in the retroperitoneal area, limbs, or trunk wall. It is characterized by a mix of different cell types and lacks a specific pattern, making it difficult to classify under a single category. The disease often presents as a painless mass that can grow rapidly. As it progresses, it may invade surrounding tissues and organs, leading to various symptoms depending on its location. The sarcoma is considered resectable, meaning it can potentially be removed surgically if detected early. However, it does not typically spread to distant parts of the body, which is referred to as non-metastatic.

Trial ID:

2023-509498-21-00

Protocol code:

IB 2021-01

NCT ID:

NCT04968106

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Retifanlimab, Doxorubicin, and Ifosfamide for Adults with Certain Types of Sarcoma in the Abdomen, Limbs, and Trunk

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?