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A sarcoma clinical trial - SRC8

Is immunotherapy plus chemotherapy better than chemotherapy alone for sarcoma patients?
Disease Site
Sarcoma Clinical Trials
Trial Code
SRC.8 ǀ NCT06422806
Trial Status
Open to patient enrollment

What is the purpose of this study?

The purpose of this study is to compare the effects on you and your sarcoma of a new immunotherapy drug with chemotherapy to chemotherapy alone, the current standard treatment.

Why is this study important?

The new drug being studied is a type of immunotherapy which helps the body's immune system attack the cancer and may interfere with the ability of tumour cells to grow and spread. The new drug has been studied in a few people and seems promising, but it is not clear if it can offer better results that standard treatment.

Who can participate in this study?

This trial is for:

  • People 18 years of age or older
  • People with undifferentiated pleomorphic sarcoma (UPS) or a poorly differentiated sarcoma
  • People with metastatic or unresectable sarcoma

This trial is not for:

  • People with a history of active interstitial lung disease
  • People with autoimmune disorders requiring use of systemic steroids 
  • People with a known history of active TB (Bacillus Tuberculosis)
  • People who are pregnant or breast-feeding
     
What are the risks?
  • If you choose to take part in this study, there is a risk that the new drug plus chemotherapy may not be as good as chemotherapy alone. There is also a risk that you could have side effects from the new drug.
  • Some of the most common side effects that the study doctors know about are: tiredness and feeling weak, diarrhea, nausea, vomiting, swelling of the skin, redness or rash, which may include hives or blistering, and may rarely be severe and or life-threatening, and itchy skin.
  • You will find details of all side effects in the consent document.
What can I expect?
  • If you choose to take part in this study, you will be randomly placed in one of two groups and you will receive either the new drug plus chemotherapy or chemotherapy alone which is commonly used to treat this disease. If you initially receive chemotherapy alone, you will be monitored and may still also receive the new drug if your cancer worsens on scans within 2 years of starting chemotherapy.

How can I find out more or join the study?

Talk to your cancer doctor if you are considering joining this study. You can share summaries like this with them and ask if they think joining the trial may be a good option for you.

Before you join this study, you will be asked to review an Informed Consent document which will tell you more about why the research is being done and your role as a participant. You will have an opportunity to discuss anything that is not clear and ask any questions you have.

Joining this study is entirely up to you and you can decide to leave at any time without giving a reason. Your decision to join or leave the trial will not affect your standard medical care.

The SRC.8 study is currently enrolling patients at cancer centres in Canada. For a full list of participating cancer centres please visit www.clinicaltrials.gov and search using NCT06422806. A direct link to the study website is here: https://www.cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-06412&loc=0&q=ea7222&rl=2

Use this trial information for your conversation with your health care team

Participating centres

Information coming soon.