Active not recruitingPHASE1, PHASE2INTERVENTIONAL

COLUMBIA-1: Novel Oncology Therapies in Combination With Chemotherapy and Bevacizumab as First- Line Therapy in MSS-CRC

The COLUMBIA-1 study is looking for people with advanced bowel cancer that has spread to other parts of the body (metastatic) and has a specific genetic feature called 'microsatellite stable' (MSS). This study aims to find out if adding new medicines to the usual first treatment for this type of cancer (a chemotherapy called FOLFOX, along with a drug called bevacizumab) can make it safer and more effective. It's a two-part study. The first part checks the safety of these new drug combinations, and the second part looks at how well they work and if they are still safe. By testing these combinations, researchers hope to improve treatment options for patients with MSS bowel cancer.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

MedImmune LLC

Enrolment target

Start

13 Sep 2019

Estimated completion

24 Nov 2026

Metastatic Microsatellite-stable Colorectal Cancer

Results

Results from this study

Posted November 2023

Results have been published for this study.

Primary outcome

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) in Part 1

An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.

Full results on the registry

What is this study about?

The COLUMBIA-1 study is investigating new ways to treat advanced bowel cancer (also known as colorectal cancer) that has spread to other parts of the body. This specific type is called 'microsatellite stable' (MSS), which describes a particular genetic characteristic of the cancer cells. For many people with advanced MSS bowel cancer, the first treatment they receive is a combination of chemotherapy drugs called FOLFOX, along with another drug called bevacizumab.

This study is testing if adding new, experimental cancer medicines, called durvalumab and oleclumab, to the standard FOLFOX and bevacizumab treatment can make it more effective or safer. Researchers want to see if these new combinations can improve how well patients respond to treatment and how long they live, compared to the standard treatment alone.

The study is designed in two stages. The first stage focuses on safety, making sure the new drug combinations don't cause too many serious side effects. Once the safest doses are found, the study moves to the second stage, which looks at how well these new combinations work against the cancer, while still keeping a close eye on safety. This type of research is crucial for finding better treatments for various cancers.

Key takeaways

This study evaluates new treatments for advanced bowel cancer that has spread.
It's for people whose cancer is 'microsatellite stable' (MSS).
New drugs are combined with standard chemotherapy and bevacizumab.
The study aims to improve safety and effectiveness of first-line treatment.
It involves regular hospital visits for treatment and monitoring.

Who may be eligible?

To join this study, you generally need to be at least 18 years old and have been diagnosed with advanced bowel cancer that has spread (metastatic) and is 'microsatellite stable' (MSS). It's important that this is your first time receiving treatment for your advanced cancer, although you may have had chemotherapy in the past if your cancer hadn't spread yet and if it didn't come back too soon after that treatment.

You'll also need to be in generally good health, as assessed by your doctor, and able to carry out your daily activities without too much difficulty. The cancer must be measurable, meaning doctors can see and track at least one tumour. There are also specific checks for your organ function, like your kidneys and liver, to make sure they are working well enough for you to safely receive the study treatments.

There are certain reasons why you might not be able to join, such as having recently had a blood clot, certain heart conditions, or other serious health problems. The study also cannot include individuals who have previously had an organ transplant or certain autoimmune conditions. Your doctor will carefully review all your medical history to confirm if this study is right for you.

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.

I am 18 years old or older.
I have advanced bowel cancer that has spread (metastatic).
My cancer has been confirmed as 'microsatellite stable' (MSS).
I have not had treatment for advanced cancer before.
I am generally in good health and can do most daily activities.
I don't have certain other serious health problems like recent blood clots or specific heart issues.

Answer every question to see your result.

What does participation involve?

If you decide to take part in the COLUMBIA-1 study, you will first go through a screening process to make sure you meet all the requirements. This involves various tests, scans, and blood samples. If you qualify, you will then be randomly assigned to receive either the standard treatment alone or the standard treatment plus one of the new experimental drugs.

The treatments will involve regular visits to the clinic for infusions of the medications. The frequency and duration of these visits will depend on the specific treatment plan. You will have regular checks, including blood tests, scans, and physical examinations, to monitor how well the treatment is working and to watch for any side effects. The study will continue for a period, with follow-up appointments even after active treatment, to track your health and the long-term effects. The total duration of your participation will vary depending on your response to treatment and the study's protocol, but it will involve a significant time commitment.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving a new experimental treatment that could potentially be more effective than standard care, or it might help researchers learn more about treating your type of cancer, which could help future patients. However, there's no guarantee the experimental treatments will work better, or even as well as, the standard treatment. The main risks involve potential side effects from the study drugs, which can range from mild to serious, and some could be unexpected, as these are new combinations. Your doctors and the study team will monitor you closely for any side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (21)

Research Site
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Los Angeles, United States
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Sacramento, United States
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Ann Arbor, United States
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Las Vegas, United States
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New York, United States
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Canton, United States
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Providence, United States
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Chattanooga, United States
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Nashville, United States
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Houston, United States
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Charlottesville, United States
Research Site
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Clayton, Australia

Common questions

What does 'metastatic microsatellite-stable (MSS) colorectal cancer' mean?

It means your bowel cancer has spread to other parts of your body, and the cancer cells have a particular genetic feature called 'microsatellite stable' (MSS). This is important because it can affect how the cancer responds to different treatments.

What are 'novel oncology therapies'?

These are new types of cancer treatments that are still being studied. In this trial, they are drugs called durvalumab and oleclumab, which are being tested in combination with standard treatments.

What is the purpose of a Phase 1b/2 study?

Phase 1b usually checks the safety and finds the right dose of a new treatment. Phase 2 then looks at how well the treatment works against the cancer, while still checking for safety.

Will I definitely get one of the new drugs?

No. You will be randomly assigned to get either the standard treatment alone or the standard treatment plus one of the new drugs. It’s like flipping a coin for which group you are in.

How long will I be in the study?

The time you spend in the study will vary, depending on how your cancer responds to treatment and the specific study plan. It involves regular clinic visits for treatment and follow-up monitoring.