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RecruitingPHASE3INTERVENTIONAL

Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas

This study is for people with aggressive soft tissue sarcomas called dedifferentiated liposarcoma (DDLPS) or undifferentiated pleomorphic sarcoma (UPS), especially if the cancer has spread or can't be removed by surgery. We want to see if adding an immunotherapy drug called pembrolizumab to standard chemotherapy (doxorubicin) works better than chemotherapy alone. Immunotherapy helps your body's own immune system fight the cancer. We hope this combination will help patients live longer without their cancer getting worse. The study will also carefully check for any side effects and how long responses to treatment last. It's a 'Phase 3' study, meaning it's a key step towards understanding if this new approach could become a standard treatment.

At a glance

What is this study about?

This study is looking into new ways to treat certain types of aggressive soft tissue sarcomas. These are rare cancers that start in tissues like fat, muscle, or nerves. Specifically, this trial is for people diagnosed with dedifferentiated liposarcoma (DDLPS) or undifferentiated pleomorphic sarcoma (UPS), especially if the cancer has spread to other parts of the body or can't be removed with surgery. These types of sarcomas can be challenging to treat, so researchers are always looking for more effective options.

The main goal of this study is to compare two treatment approaches. One group of patients will receive standard chemotherapy with a drug called doxorubicin. The other group will receive doxorubicin plus an immunotherapy drug called pembrolizumab. Doxorubicin is a chemotherapy drug designed to kill cancer cells, while pembrolizumab works by boosting your body's own immune system to fight the cancer. The doctors want to find out if combining these two treatments is more effective than chemotherapy on its own.

By comparing these two groups, researchers hope to see if the combination treatment can stop the cancer from growing or spreading for longer. They will also look at how long people live, how many patients respond to the treatment, and what side effects might occur. Understanding these factors is crucial for developing better treatments and improving the lives of patients with these aggressive sarcomas.

Key takeaways

  • This study compares a new combination of immunotherapy + chemotherapy to chemotherapy alone.
  • It's for specific aggressive soft tissue sarcomas that have spread or cannot be removed.
  • The goal is to see if the combination can stop cancer growth for longer.
  • Participants will receive treatment through a drip, with regular monitoring.
  • It's a Phase 3 study, aiming to find better standard treatments.
  • There are potential benefits and risks, which will be fully explained.

Who may be eligible?

To join this study, you need to be at least 18 years old and have a confirmed diagnosis of dedifferentiated liposarcoma (DDLPS), undifferentiated pleomorphic sarcoma (UPS), or a similar poorly differentiated sarcoma. It's important that your cancer has either spread to other parts of your body (metastatic) or cannot be removed through surgery (unresectable).

There are also some important rules about pregnancy and breastfeeding. You cannot take part if you are pregnant or breastfeeding, as the treatments could be harmful. If you are a woman who could become pregnant, you'll need to have a negative pregnancy test before starting the study. Both men and women taking part must agree to use effective birth control or avoid sexual activity during the study and for a period afterwards.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you at least 18 years old?
  2. Do you have a confirmed diagnosis of dedifferentiated liposarcoma (DDLPS), undifferentiated pleomorphic sarcoma (UPS), or a similar sarcoma?
  3. Has your cancer spread or can it not be completely removed by surgery?
  4. Are you not pregnant or breastfeeding, and can you use effective birth control if needed?
Answer every question to see your result.

What does participation involve?

If you join this study, you would be randomly assigned to one of two treatment groups. In one group, you would receive the chemotherapy drug doxorubicin. In the other group, you would receive doxorubicin along with the immunotherapy drug pembrolizumab. Both drugs are given through a drip into your vein.

You would receive treatment cycles every 21 days. The doxorubicin would be given for up to 6 cycles. The pembrolizumab, if you're in that group, would continue for up to 2 years, as long as your cancer isn't getting worse and you're not experiencing severe side effects. You'd also have regular check-ups, scans (like diagnostic imaging), heart tests (like echocardiograms or MUGA scans), and blood tests to monitor your health and how the treatment is working. Some tissue samples might also be collected. The study doctors will carefully explain all the tests and visits involved.

Potential risks and benefits

Participating in this study might offer potential benefits, such as access to a new experimental treatment combination that could be more effective than standard care for your type of cancer. However, there's no guarantee of benefit, and the treatments may not work for everyone. Like all medical treatments, both chemotherapy and immunotherapy carry potential risks and side effects, which can range from mild to severe. Your study doctor will discuss all known side effects in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (255)

  • Mayo Clinic Hospital in Arizona
    Verified postcode
    Phoenix, United States· Recruiting
  • Banner University Medical Center - Tucson
    Verified postcode
    Tucson, United States· Recruiting
  • University of Arizona Cancer Center-North Campus
    Verified postcode
    Tucson, United States· Recruiting
  • Kaiser Permanente Dublin
    Verified postcode
    Dublin, United States· Recruiting
  • Kaiser Permanente-Fremont
    Verified postcode
    Fremont, United States· Recruiting
  • Kaiser Permanente Fresno Orchard Plaza
    Verified postcode
    Fresno, United States· Recruiting
  • Kaiser Permanente-Fresno
    Verified postcode
    Fresno, United States· Recruiting
  • UC San Diego Moores Cancer Center
    Verified postcode
    La Jolla, United States· Recruiting
  • Keck Medicine of USC Koreatown
    Verified postcode
    Los Angeles, United States· Recruiting
  • Los Angeles General Medical Center
    Verified postcode
    Los Angeles, United States· Recruiting
  • USC / Norris Comprehensive Cancer Center
    Verified postcode
    Los Angeles, United States· Recruiting
  • Cedars-Sinai Medical Center
    Verified postcode
    Los Angeles, United States· Recruiting

Common questions

What is a 'sarcoma'?

Sarcomas are rare cancers that grow in the body's soft tissues, like muscles, fat, nerves, or blood vessels.

What is immunotherapy?

Immunotherapy helps your own body's immune system fight cancer cells, similar to how it fights infections.

Why a 'Phase 3' study?

Phase 3 means this is a large study comparing a new treatment to standard care to see if it's better before it can be widely used.

Will I know which treatment I'm getting?

No, you will be randomly assigned to a group, and neither you nor your doctor will usually know which treatment you are receiving until the study is complete, unless medically necessary.

What if my cancer gets worse during the study?

If your cancer progresses while on chemotherapy alone, you may then be able to receive the immunotherapy drug, pembrolizumab, as a separate treatment.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Measuring if Immunotherapy Plus Chemotherapy is Better Than …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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