Active not recruitingPHASE2INTERVENTIONAL

iSCORE: Immunotherapy Sequencing in COlon and REctal Cancer

This research trial, called iSCORE, is exploring a new treatment combination for advanced bowel cancer that has spread to other parts of the body. The study is for patients whose cancer has specific genetic features (RAS/RAF wild type) and who initially responded well to a type of treatment called EGFR inhibitors, but whose cancer has since grown again. Participants will receive two immunotherapy drugs, Nivolumab and Relatlimab, to see if this combination can help control the cancer for longer. This is a small, early-stage study (Phase 2) conducted at one medical centre, aiming to understand how safe and effective these drugs are together for this specific group of patients. It could offer a new treatment possibility where previous therapies have stopped working.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Royal Marsden NHS Foundation Trust

Enrolment target

Start

27 Mar 2019

Estimated completion

01 Sep 2024

Metastatic Colorectal Cancer

What is this study about?

The iSCORE trial is an important research study investigating a new way to treat advanced colorectal cancer (bowel cancer that has spread, also known as metastatic). The main idea behind this study is to see if combining two immunotherapy drugs, Nivolumab and Relatlimab, can be an effective treatment option for a specific group of patients.

This trial is particularly focused on patients whose bowel cancer has certain genetic characteristics (called RAS/RAF wild type) and who have previously responded well to an earlier treatment type (EGFR inhibitors like Cetuximab or Panitumumab). However, for these patients, their cancer has unfortunately started to grow again after that initial positive response. The study aims to offer a new approach when standard treatments might no longer be working as well.

Immunotherapy works by helping your body's own immune system recognise and fight cancer cells. By combining these two drugs, the researchers hope to boost this immune response even more effectively. This is a Phase 2 trial, which means it's an earlier stage study focusing on safety and whether the treatment shows promise, rather than broadly comparing it to existing standard treatments. The insights gained from this study could be crucial for developing new treatment strategies for advanced bowel cancer.

Key takeaways

Investigates new immunotherapy combination for advanced bowel cancer.
For patients whose cancer stopped responding to previous EGFR inhibitor treatments.
Potential for a new treatment option when others have failed.
Involves regular intravenous treatment, scans, and biopsies.
Up to 2 years of treatment, or until cancer progression.

Who may be eligible?

This study is looking for men and women aged 18 or over who have advanced bowel cancer that has spread.

To be considered, your cancer needs to have specific genetic features (RAS/RAF wild type) and it must have previously responded to a type of treatment called EGFR inhibitors. However, your cancer must have started to grow again after that treatment. You should generally be feeling well enough for a clinical trial, as assessed by the study doctors.

There are also some medical requirements about your organ function (like your liver and kidneys) and blood test results to make sure it's safe for you to take part. Women who could become pregnant and men must also agree to use effective contraception during and for some time after the study.

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 bowel cancer that has spread?
Has your cancer started to grow again after previous EGFR inhibitor treatment?
Are your general health and organ functions considered good enough for a trial?
Are you able to or willing to use effective contraception if needed?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll receive two drugs, Nivolumab and Relatlimab, given through a drip every four weeks. Before starting treatment, you'll have a sample of your tumour taken (a biopsy) and will need to undergo various checks to make sure you're suitable. Another biopsy will be taken about three weeks after beginning treatment.

Throughout the study, you'll have regular scans (CT or MRI) every eight weeks for the first year, and then every twelve weeks after that, to see how the treatment is working. You'll continue the treatment for up to two years, or until your cancer starts to grow again. Even if your cancer grows, the doctors might decide you can continue treatment if you're still benefiting. There will be further biopsies if your cancer progresses. The study aims to include 25 participants and is expected to enrol patients over about two and a half years.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as gaining access to new treatments before they are widely available, and closely monitored medical care. While there's a chance the treatment could help control your cancer, there's no guarantee it will work for everyone. As with any medication, there are potential risks and side effects from the drugs, which the study team will discuss in detail with you. Your safety will be closely monitored throughout the trial. It's important to remember that participating is entirely voluntary, and you have the right to withdraw from the study at any time without affecting your future medical care.

Locations (1)

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

The Royal Marsden NHS Foundation Trust
Verified postcode
London, United Kingdom

Common questions

What kind of cancer is this study for?

It's for advanced colorectal cancer (bowel cancer that has spread) with specific genetic features, where previous treatments stopped working.

What are the treatments in this study?

Participants will receive two immunotherapy drugs, Nivolumab and Relatlimab, together.

How long will I be on the treatment?

You could be on the treatment for up to two years, or until your cancer starts to grow again.

Will I have to have biopsies?

Yes, you'll need biopsies before starting treatment, about three weeks into treatment, and potentially if your cancer progresses.

Where is this study taking place?

This is a single-centre study, meaning it's being conducted at one specific medical location.