RecruitingPHASE2, PHASE3INTERVENTIONAL

A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Bevacizumab in Combination With Chemotherapy in Participants With Previously Untreated, Unresectable, or Metastatic Colorectal Cancer

This research study is investigating a new treatment named pumitamig, given alongside standard chemotherapy, for individuals in the UK who have advanced bowel cancer that has spread or cannot be removed by surgery and hasn't received previous treatment. The main goal is to see how safe and effective this new combination is compared to another common treatment, bevacizumab, also given with chemotherapy. Researchers will be carefully monitoring participants to understand how well the new treatment works and if there are any side effects. This study aims to find better ways to treat advanced bowel cancer and improve outcomes for patients.

At a glance

Status

Recruiting

Phase

PHASE2, PHASE3

Sponsor

Bristol-Myers Squibb

Enrolment target

990

Start

31 Dec 2025

Estimated completion

11 Mar 2034

Untreated, Unresectable, or Metastatic Colorectal Cancer

What is this study about?

This study is about finding better ways to treat advanced bowel cancer, also known as colorectal cancer. When cancer has spread to other parts of the body (metastatic) or can't be removed by surgery (unresectable), or if it's come back after previous treatment (recurrent), doctors look for effective ways to manage it. This particular trial is for people who haven't had any treatment for their advanced bowel cancer yet.

The researchers are testing a new medicine called pumitamig. They want to see how well it works when given together with standard chemotherapy drugs, like FOLFOX or FOLFIRI. This combination is being compared to another common treatment which involves giving bevacizumab, another type of medicine, with chemotherapy. By comparing these two approaches, doctors hope to understand if pumitamig offers a new, effective, and safe treatment option.

The study involves two main stages (Phase 2 and Phase 3 of clinical trials). This means researchers are first checking the safety and initial effectiveness of the new treatment, and then, if promising, they will move on to a larger study to confirm the benefits. Ultimately, the aim is to improve the lives of people living with advanced bowel cancer by providing more treatment choices.

Key takeaways

This study is for people with advanced, previously untreated bowel cancer.
It compares a new drug (pumitamig) with chemotherapy, against a standard treatment (bevacizumab) with chemotherapy.
The aim is to find out if pumitamig offers a safer and more effective treatment option.
Participation involves regular clinic visits, assessments, and close monitoring.
There are specific health and cancer-related criteria to be eligible for the study.

Who may be eligible?

To be considered for this study, you would need to have bowel cancer that has spread or can't be removed by surgery, and you shouldn't have received any previous treatment for it. The cancer must also be confirmed by looking at a small tissue sample (biopsy).

Doctors would also need to check specific genetic features of your cancer. For instance, your cancer shouldn't show certain characteristics (called dMMR, MSI-H, or a BRAF V600E mutation). You'd also need to have parts of the cancer that can be measured to see if the treatment is working.

There are also reasons why you might not be able to join. For example, if you have untreated brain or spinal tumours, or if you've had certain serious heart problems recently. You also can't have had specific types of cancer treatment in the past, including certain immunotherapy drugs.

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 I have advanced bowel cancer that has spread or can't be removed by surgery?
Have I received any drug treatment for my advanced bowel cancer before?
Do I have any serious untreated brain or spinal tumours?
Have I had certain heart problems recently (in the last 6 months)?
Have I recently had certain types of immunotherapy treatment?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be given either the new drug (pumitamig) with chemotherapy, or the standard drug (bevacizumab) with chemotherapy. The specific chemotherapy you receive would be either FOLFOX or FOLFIRI, or CAPOX, which are common chemotherapy regimens for bowel cancer. You would have regular visits to the clinic for treatment and check-ups. These visits will involve blood tests, scans, and physical examinations to see how you're responding to the treatment and to monitor for any side effects. The total duration of your participation would depend on how your cancer responds to treatment and your health, but it would involve ongoing regular monitoring.

Potential risks and benefits

Participating in this study might offer you access to a new treatment option (pumitamig) before it's widely available. There's a chance the new treatment could be more effective than existing options, or lead to fewer side effects for some people. However, as with any medical treatment, there are potential risks and side effects associated with both pumitamig and the chemotherapy drugs, which will be carefully explained to you by the study team. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (286)

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

Local Institution - 0428
Verified postcode
Tucson, United States· Not yet recruiting
Local Institution - 0432
Verified postcode
Springdale, United States· Not yet recruiting
Local Institution - 0447
Verified postcode
La Jolla, United States· Not yet recruiting
USC/Norris Comprehensive Cancer Center
Verified postcode
Los Angeles, United States· Recruiting
University of California, Irvine (UCI) Health - UC Irvine Medical Center
Verified postcode
Orange, United States· Recruiting
Local Institution - 0317
Verified postcode
San Francisco, United States· Not yet recruiting
Local Institution - 0330
Verified postcode
Santa Monica, United States· Not yet recruiting
Local Institution - 0293
Verified postcode
Stanford, United States· Not yet recruiting
Florida Cancer Specialists - East
Verified postcode
Cape Coral, United States· Recruiting
Florida Cancer Specialists - North
Verified postcode
St. Petersburg, United States· Recruiting
Moffitt Cancer Center
Verified postcode
Tampa, United States· Recruiting
Local Institution - 0276
Verified postcode
Atlanta, United States· Not yet recruiting

Common questions

What is advanced bowel cancer?

Advanced bowel cancer means the cancer has spread from where it started (metastatic) or cannot be fully removed by surgery (unresectable).

What is pumitamig?

Pumitamig is the name of a new medication being tested in this study to see if it can help treat advanced bowel cancer when given with chemotherapy.

What is chemotherapy?

Chemotherapy uses powerful drugs to kill cancer cells or stop them from growing. In this study, common chemotherapy combinations like FOLFOX, FOLFIRI, or CAPOX are used.

What does 'untreated' mean in this study?

It means you haven't had any previous drug treatments specifically for your advanced bowel cancer before joining this study.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, and this will not affect your usual medical care.

How to find out more

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

clinical.trials@bms.com 855-907-3286 Official trial record

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