Active not recruitingPHASE1INTERVENTIONAL

Durvalumab With or Without Tremelimumab in Advanced Incurable Solid Malignancies Given With or Without Standard Chemotherapy Regimens

This study is for people with advanced solid cancers for which there's no cure. Researchers want to find the safest and most effective dose of two new medicines, durvalumab and tremelimumab, when given alone or with chemotherapy. They will carefully increase the dose and watch for side effects to find the best balance. They'll also look for clues in the body that might show who will benefit most from these medicines naturally. The main goal is to understand how these new treatments work and identify a dose that can help fight cancer without causing very serious problems.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

Canadian Cancer Trials Group

Enrolment target

153

Start

16 Oct 2015

Estimated completion

31 Dec 2026

Solid Malignancies

What is this study about?

This study is focusing on advanced solid cancers, which are cancers that have spread or can't be removed with surgery, and for which there isn't a known cure at present. The main aim is to test new medicines called durvalumab and tremelimumab. These medicines are designed to work with your body's immune system to fight cancer.

The researchers want to carefully find the best dose of these medicines, either alone or when given alongside standard chemotherapy. Think of it like trying to find the sweet spot: enough medicine to be effective against the cancer, but not so much that it causes very serious side effects. They will start with a low dose and slowly increase it for different groups of patients, watching very closely to make sure the side effects are manageable. They also want to understand if combining these medicines or giving them in a specific order makes a difference.

Another important part of this study is to look for 'markers' in your body. These markers are like clues that could help doctors predict which patients are most likely to respond well to durvalumab and tremelimumab. This information is really important because it could help doctors choose the right treatments for future patients more effectively. Ultimately, this study aims to gather crucial information to develop better treatments for advanced solid cancers.

Key takeaways

This study is testing new cancer medicines for advanced solid cancers.
It aims to find the safest and most effective dose.
The medicines work with your immune system, sometimes with chemotherapy.
Participation involves regular hospital visits for assessments and monitoring.
You can withdraw from the study at any time without affecting your care.

Who may be eligible?

To join this study, you must have a type of cancer that started as a solid lump, like lung cancer or breast cancer, which has spread or can't be cured with current treatments. You also need to be well enough to receive treatment, which will be assessed by your doctors. Sometimes, if you have a specific type of lung cancer (small cell lung cancer) that hasn't been treated before, you might also be able to join.

Your doctors will need to check your medical history and recent scans to make sure your cancer is suitable for this research. You might hear terms like 'ECOG performance status' – this is just a way doctors rate how well you can do daily activities. Generally, you need to be able to do most things for yourself, or be comfortable with some help, to be part of the study.

For some parts of the study, it might be okay if you've had some chemotherapy before for your advanced cancer, but this will depend on the specific treatment plan being tested. The study will also require samples of your tumour tissue, if available, and your agreement to participate in additional research 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.

Do you have an advanced solid cancer that can't be cured with current treatments?
Are you able to manage daily activities reasonably well?
Have you had recent scans and tests for your cancer?
Are you willing to provide tumour samples (if available) for research?
Are you 18 years old or older?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll receive either durvalumab alone, or durvalumab with tremelimumab, which are the study medicines. These might be given with or without standard chemotherapy, depending on the treatment group you are in. The medicines are usually given as an infusion, meaning they are delivered directly into your bloodstream through a drip.

Throughout the study, you'll have regular visits to the hospital for checks. These visits will involve blood tests, physical examinations, and scans to monitor your cancer and check for any side effects. The purpose of these initial stages of the study is to find the right dose, so your doctors will be watching you very carefully, especially when you first start treatment. You might have more frequent visits at the beginning. The total duration of your participation will depend on how you respond to the treatment and the specific study plan, but you will be kept fully informed.

Potential risks and benefits

Participating in this study might offer a chance to try a new medicine that isn't yet widely available, which could potentially help control your cancer. However, as with all treatments, there are potential risks. The study medicines, durvalumab and tremelimumab, can cause side effects. Researchers will be carefully monitoring you to make sure these are not too severe. You will be given detailed information about all known and potential side effects before you decide to join. It's really important to remember that you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (7)

Tom Baker Cancer Centre
Verified postcode
Calgary, Canada
BCCA - Vancouver Cancer Centre
Verified postcode
Vancouver, Canada
Juravinski Cancer Centre at Hamilton Health Sciences
Verified postcode
Hamilton, Canada
Cancer Centre of Southeastern Ontario at Kingston
Verified postcode
Kingston, Canada
Ottawa Hospital Research Institute
Verified postcode
Ottawa, Canada
University Health Network
Verified postcode
Toronto, Canada
CHUM - Hopital Notre-Dame
Verified postcode
Montreal, Canada

Common questions

What are durvalumab and tremelimumab?

They are new medicines designed to use your body's immune system to fight cancer.

What kind of cancer is this study for?

It's for advanced solid cancers, which are cancers that have spread or can't be cured with current treatments.

Will I receive chemotherapy?

You might receive the study medicines alone, or in combination with standard chemotherapy, depending on which treatment group you are in.

What does 'finding the highest tolerated dose' mean?

It means the researchers are carefully looking for the dose of the medicine that works best against cancer while keeping serious side effects to a minimum.

Can I stop being part of the study once I've started?

Yes, you can choose to leave the study at any time, for any reason, and it won't affect your future medical care.