Active not recruitingPHASE3INTERVENTIONAL

A Study to Investigate Efficacy & Safety of Intratumoral INT230-6 Compared to US Standard of Care in Adults With Soft Tissue Sarcomas (INVINCIBLE-3)

The INVINCIBLE-3 study is looking into a new treatment called INT230-6 for adults with certain types of advanced soft tissue sarcoma (a cancer that affects soft tissues like muscle or fat) that can't be removed by surgery or has spread. Participants will receive either INT230-6, which is injected directly into the tumour, or one of the usual standard treatments (like Eribulin, Trabectedin, or Pazopanib) given in the US. This study is for people whose cancer has continued to grow after one or two previous treatments, usually including a common chemotherapy called anthracycline. The main aim is to find out if INT230-6 helps people live longer compared to standard care.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Intensity Therapeutics, Inc.

Enrolment target

333

Start

28 Jun 2024

Estimated completion

01 Dec 2028

Sarcoma,Soft Tissue

What is this study about?

This study is called INVINCIBLE-3, and it's trying to find a better way to treat certain advanced soft tissue sarcomas. Sarcomas are rare cancers that can develop in different parts of your body, usually in soft tissues like muscles, fat, nerves, or blood vessels. In this study, doctors are focusing on specific types of sarcoma: liposarcoma, leiomyosarcoma, and undifferentiated pleomorphic sarcoma. The cancer in this study is considered 'advanced,' meaning it cannot be removed by surgery or has spread to other parts of the body. You would be considered for this study if your cancer has already grown or come back after one or two previous treatments, including a common type of chemotherapy called anthracycline.

The study involves comparing a new treatment called INT230-6 with what is currently considered standard care. INT230-6 is a treatment that is injected directly into the tumour. The standard care options in this study might include medicines like Eribulin, Trabectedin, or Pazopanib. The main reason for doing this study is to see if INT230-6 can help people with these specific advanced sarcomas live longer than those receiving standard treatments.

By taking part, you would be helping doctors learn more about INT230-6 and potentially offer a new treatment option for others in the future. It's important to remember that this is a research study, and while the new treatment shows promise, its benefits are still being investigated.

Key takeaways

This study is for adults with advanced soft tissue sarcoma.
It tests a new treatment (INT230-6) against standard care.
The new treatment involves injections directly into the tumour.
You must have had 1-2 previous treatments for your cancer.
The main goal is to see if the new treatment helps people live longer.
Participation involves regular hospital visits for treatment and monitoring.

Who may be eligible?

This study is for adults aged 18 or over. You need to have a confirmed diagnosis of certain types of soft tissue sarcoma, specifically liposarcoma, leiomyosarcoma, or undifferentiated pleomorphic sarcoma.

Your cancer must be advanced, meaning it cannot be removed by surgery or has spread to other parts of your body. You should have already received at least one, but no more than two, previous treatments for your sarcoma, and the cancer must have grown or shown signs of progression since those treatments. Your previous treatments should have included an anthracycline-based chemotherapy, unless there was a medical reason you couldn't have it.

To join, doctors must be able to measure your cancer on scans like CT or MRI, and there needs to be at least one tumour that can be safely injected. You also need to be well enough to take part, as assessed by your doctor, and have good organ function, which will be checked with blood tests.

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.

Are you 18 years old or older?
Do you have advanced liposarcoma, leiomyosarcoma, or undifferentiated pleomorphic sarcoma?
Has your cancer grown or come back after 1 or 2 past treatments (including an anthracycline-based treatment if possible)?
Do doctors think at least one of your tumours can be directly injected?
Are you generally well enough to take part and do your blood tests show good organ function?

Answer every question to see your result.

What does participation involve?

If you join this study, you will either receive the new treatment, INT230-6, or one of the standard treatments for your type of cancer. The INT230-6 treatment is an injection given directly into your tumour. The standard treatments are usually given through an IV drip or as tablets.

You will have regular hospital visits for check-ups, scans (CT or MRI), and blood tests to see how the treatment is working and to monitor any side effects. The exact number and frequency of visits will depend on which treatment you receive. You will continue treatment for as long as it is helping you and you are not experiencing severe side effects. The total duration of your participation will depend on how you respond to treatment and for how long you are followed up by the study team.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. You might benefit from the study treatment if it works better than what's currently available, or you might help doctors learn more about sarcoma, which could help future patients. However, there's no guarantee the treatment will work for you, and you might experience side effects, some of which could be serious. The study team will explain all known risks. Remember, you can decide to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (17)

USC/Norris Comprehensive Cancer Center
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Los Angeles, United States
Sarcoma Oncology Center
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Santa Monica, United States
University of California Los Angeles (UCLA) - Santa Monica Cancer Care
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Santa Monica, United States
Yale School of Medicine - Smilow Cancer Hospital - Yale - New Haven Hospital Location
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New Haven, United States
Profound Research LLC
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Farmington Hills, United States
Nebraska Methodist Hospital
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Omaha, United States
Duke Cancer Center
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Durham, United States
The James Cancer Hospital and Solove Research Institute
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Columbus, United States
University of Pennsylvania - Abramson Cancer Center
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Philadelphia, United States
Temple University - Fox Chase Cancer Center
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Philadelphia, United States
Princess Margaret Cancer Centre
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Toronto, Canada
Centre Leon Berard
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Lyon, France

Common questions

What is soft tissue sarcoma?

Soft tissue sarcoma is a rare type of cancer that grows in the body's soft tissues, like muscles, fat, nerves, blood vessels, and fibrous tissues.

What does 'unresectable or metastatic' mean?

It means the cancer cannot be removed by surgery or has spread from where it started to other parts of the body.

What is INT230-6?

INT230-6 is a new experimental treatment being tested in this study. It is designed to be injected directly into your tumour.

What are 'standard therapies'?

These are the usual, widely accepted treatments for a specific condition, which have been proven to work to some extent.

Will I know if I'm getting the new treatment or standard care?

This is a randomised study, meaning you will be assigned to a treatment group by chance. In this type of study, participants usually know which treatment they are receiving.