Active not recruitingPHASE2INTERVENTIONAL

Study of DNA Damage, Angiogenesis, and PD-L1 Inhibitors in Advanced Solid Tumors

This study is testing new combinations of medicines for people with advanced colorectal cancer, pancreatic cancer, or a type of muscle cancer called leiomyosarcoma. All these cancers are "mismatch repair proficient," meaning a specific genetic feature is present. The study wants to see how these new drug combinations – Durvalumab with either Olaparib or Cediranib – affect the cancer and the body. Researchers will collect samples like blood and stool, and take images to understand these changes. About 90 people will take part in this study at the Princess Margaret Cancer Centre to help find better ways to treat these cancers.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

University Health Network, Toronto

Enrolment target

Start

08 Apr 2019

Estimated completion

01 Jan 2027

Mismatch Repair Proficient Colorectal Cancer Pancreatic Adenocarcinoma Leiomyosarcoma

What is this study about?

This study, called a 'Phase 2' trial, is looking at new ways to treat certain types of advanced cancer. The cancers included are colorectal cancer (bowel cancer), pancreatic cancer, and a rare muscle cancer called leiomyosarcoma. For these cancers, standard treatments might not have worked, or perhaps there are no standard treatments available, or the patient and their doctor feel a different approach is needed. The main goal is to find out if combining existing cancer drugs in new ways can be more effective.

The study combines a drug called Durvalumab, which helps your own immune system fight cancer, with one of two other drugs: Olaparib or Cediranib. Olaparib works by stopping cancer cells from repairing themselves, while Cediranib aims to stop new blood vessels from growing to feed the tumour. By putting these drugs together, researchers hope to improve treatment for these specific cancers.

To understand how these drug combinations are working, the research team will look at changes in the cancer cells' genetic makeup, how the immune system responds, and changes seen in imaging scans. They will also collect samples like blood and stool. This research is important because it could lead to new and better treatment options for people with these advanced cancers.

Key takeaways

New drug combinations are being tested for advanced colorectal, pancreatic, and leiomyosarcoma cancers.
The study combines an immune-boosting drug (Durvalumab) with either Olaparib or Cediranib.
Researchers will collect samples and scans to understand how the treatments affect the body.
The study is a 'Phase 2' trial, meaning it's exploring how well the treatment works and any side effects.
You would need to meet specific health and cancer criteria to be eligible to join.

Who may be eligible?

To be considered for this study, you must be at least 18 years old. You will need to have a specific type of advanced colorectal, pancreatic, or leiomyosarcoma cancer that has either not responded to previous standard treatments, or where there are no standard treatments, or if you and your doctor agree that standard treatments aren't the best option for you right now.

It's important that you are generally well enough to take part. Doctors use a scale to check this, and you would need to be at a '0' or '1' level. Also, the medical team would need to be able to take a sample (biopsy) from one of your tumours, and you would need to be willing to give a sample of your tumour tissue. You can have had previous immune-boosting cancer treatments.

There's no limit to how many previous cancer treatments you've had. However, you would need to have stopped any previous anti-cancer treatments for at least four weeks before starting this study. For women who could become pregnant, two negative pregnancy tests would be required.

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 colorectal cancer, pancreatic cancer, or leiomyosarcoma?
Has standard treatment not worked for your cancer, or is it not suitable for you?
Are you generally feeling well enough to participate in a study?
Can you have a small sample (biopsy) taken from one of your tumours?
If you are a woman who could get pregnant, are you willing to have two negative pregnancy tests?

Answer every question to see your result.

What does participation involve?

If you join this study, you will first need to sign a consent form, meaning you understand and agree to take part. You'll have various tests, including biopsies of your tumour, blood samples, stool samples, and imaging scans like CT or MRI. These initial tests will help the doctors understand your cancer and overall health.

You will then be assigned to one of two groups: one receiving Durvalumab with Olaparib, or the other receiving Durvalumab with Cediranib. Durvalumab is given through a drip into your vein every four weeks. If you are in the Olaparib group, you will take this pill twice a day every day. If you are in the Cediranib group, you will take this pill once a day for five days each week, with two days off.

You will have regular appointments for your treatments, further blood tests, scans, and other assessments to see how you are responding to the treatment and for any side effects. The study will continue for as long as the treatment is benefiting you and you are tolerating it well.

Potential risks and benefits

Taking part in a clinical trial may offer the potential benefit of trying a new treatment combination that might be more effective for your cancer than available options. However, it's also important to remember that these are new combinations, and there's no guarantee the treatment will work for you. There is a risk of side effects from the drugs being tested, some of which could be serious. The medical team will monitor you closely for any unwanted effects and will discuss these with you before you start. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

Princess Margaret Cancer Centre
Verified postcode
Toronto, Canada

Common questions

What type of cancers are included in this study?

This study is for people with advanced colorectal cancer, pancreatic cancer, or leiomyosarcoma where standard treatments haven't worked or aren't suitable.

What drugs are being tested?

The study is testing combinations of Durvalumab with either Olaparib or Cediranib.

How will I receive the treatments?

Durvalumab is given through a drip every four weeks. Olaparib is a pill taken twice daily. Cediranib is a pill taken five days a week, with two days off.

What kind of tests will I have?

You'll have tumour biopsies, blood and stool samples, and imaging scans like CT or MRI to monitor your progress.

Can I stop participating if I want to?

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