RecruitingPHASE1INTERVENTIONAL

A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)

This study, called INTRINSIC, is investigating new ways to treat bowel cancer that has spread to other parts of the body (this is called metastatic colorectal cancer). We're testing different ‘targeted therapies’ and ‘immunotherapies’. These are types of medicines that work in specific ways against cancer. We are particularly interested in how safe and effective these treatments are for people whose cancer has certain genetic 'biomarkers'. These biomarkers help us understand which treatments might work best for an individual. If you join, your cancer's biomarkers will be checked, and you would receive a treatment chosen specifically for those features. This is an early-stage study, meaning we are still gathering important information about these new approaches.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Hoffmann-La Roche

Enrolment target

542

Start

22 Oct 2021

Estimated completion

31 Aug 2030

Metastatic Colorectal Cancer

What is this study about?

This study, known as INTRINSIC, is an important research project looking into advanced bowel cancer. At Patient.info, we understand that a diagnosis of metastatic colorectal cancer can be worrying, and finding effective treatments is crucial.

Researchers are investigating whether newer types of medicines, called 'targeted therapies' and 'immunotherapies', can help people with this condition. Unlike traditional chemotherapy, targeted therapies are designed to attack specific weaknesses in cancer cells, often linked to certain genetic changes or 'biomarkers'. Immunotherapies, on the other hand, help your body's own immune system fight the cancer. This study aims to find out if these specific treatments are safe and if they can effectively shrink tumors or slow their growth for people whose cancer has particular biomarkers.

To figure this out, participants in the study will have their cancer cells tested for these biomarkers. Based on these test results, they will be given a specific treatment or combination of treatments that is thought to be most suitable for their cancer's unique characteristics. This 'personalised' approach is a promising area in cancer care, hoping to offer more effective treatments with potentially fewer side effects.

Key takeaways

This study is for advanced bowel cancer that has spread.
It tests new treatments based on your cancer's genetic features.
You will receive a treatment chosen specifically for your cancer's 'biomarkers'.
It's an early-stage study looking at safety and effectiveness.
Participation involves regular hospital visits and monitoring.

Who may be eligible?

To join this study, you would need to be at least 18 years old and have bowel cancer that has spread to other parts of your body. An important part of joining is that your cancer cells will need to be tested for specific genetic markers (called biomarkers). These tests help the doctors decide if one of the study treatments might be right for you.

You also need to be well enough to take part, meaning you can generally carry out your daily activities without too much difficulty. The study doctors will carefully check your overall health, including your organ function, to make sure it's safe for you to participate. You must also have some measurable cancer spots, which doctors can track to see if the treatment is working.

There are also some reasons why you might not be able to join. For example, if you are currently taking part in another study that involves an experimental treatment, you may not be eligible. The study team will discuss all the requirements with you and answer any questions you have to help you understand if this study is a good fit.

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 bowel cancer that has spread?
Are you generally able to carry out your daily activities well?
Are you willing to have tests to check your cancer's genetic features?
Are you not currently in another experimental drug study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the process will involve several steps. First, you'll provide your consent, which means you agree to be in the study after having all your questions answered. Then, your medical team will perform various tests, including blood tests and scans, and they will review your cancer's biomarker results to see if you qualify for a specific treatment. You will also need to provide a tumor tissue sample for further research.

Once enrolled, you will receive one of the study treatments, which could be a targeted therapy or immunotherapy, either alone or in combination with other standard treatments like FOLFOX or FOLFIRI chemotherapy. The treatments will be given at specific times, and you'll have regular hospital visits for check-ups, blood tests, and scans to monitor your health and how the treatment is working.

The duration of your participation will depend on how you respond to the treatment and your overall health. You will continue to be monitored for safety and effectiveness throughout the study. The study team will explain the exact schedule of visits and treatments, along with how often you'll need to attend the clinic, should you decide to participate.

Potential risks and benefits

Taking part in any clinical trial involves potential benefits and risks. A potential benefit of joining this study is that you might receive a new treatment that isn't yet widely available, which could be more effective for your specific type of cancer. However, there's no guarantee that the treatment will work for you, and it might not be better than standard treatments. As with all medicines, there are potential side effects, and some of the treatments in this study are still being investigated, so not all side effects may be known. The study team will explain all the potential risks and 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 (82)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

UAB Comprehensive Cancer Center
Verified postcode
Birmingham, United States· Withdrawn
Mayo Clinic Arizona
Verified postcode
Phoenix, United States· Completed
City of Hope Comprehensive Cancer Center
Verified postcode
Duarte, United States· Active not recruiting
cCare
Verified postcode
Encinitas, United States· Withdrawn
USC Norris Cancer Center
Verified postcode
Los Angeles, United States· Completed
Cedars-Sinai Medical Center
Verified postcode
Los Angeles, United States· Active not recruiting
UCLA
Verified postcode
Los Angeles, United States· Recruiting
Hoag Memorial Hospital Presbyterian
Verified postcode
Newport Beach, United States· Withdrawn
Stanford Cancer Center
Verified postcode
Stanford, United States· Completed
University of Colorado Cancer Center
Verified postcode
Aurora, United States· Active not recruiting
Rocky Mountain Cancer Centers, LLP
Verified postcode
Lone Tree, United States· Recruiting
Yale Cancer Center
Verified postcode
New Haven, United States· Recruiting

Common questions

What is 'metastatic colorectal cancer'?

This means bowel (colon or rectal) cancer that has spread from where it started to other parts of your body.

What are 'biomarkers'?

Biomarkers are specific features, often genetic changes, found in your cancer cells that can help doctors choose the most suitable treatment for you.

What is a 'targeted therapy'?

Targeted therapies are medicines designed to attack specific weaknesses in cancer cells, often linked to certain biomarkers, usually leaving healthy cells alone.

Will I definitely get one of the new drugs?

If you join the study, you will receive a treatment specifically chosen based on the biomarkers found in your cancer. This could be a new drug or a combination therapy.

Can I stop participating in the study if I want to?

Yes, you can leave the study at any time, for any reason, and it will not affect the medical care you receive in the future.

How to find out more

Reference Study ID Number: WO42758 https://forpatients.roche.com/

global-roche-genentech-trials@gene.com 888-662-6728 (U.S. and Canada) Official trial record

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