RecruitingPHASE1, PHASE2INTERVENTIONAL

A Study to Evaluate the Safety and Tolerability of Pumitamig Alone or In Combination With Ipilimumab in Participants With First-Line Advanced or Unresectable Hepatocellular Carcinoma (HCC) (ROSETTA HCC-206)

This research study, called ROSETTA HCC-206, is being conducted for people in the UK who have advanced liver cancer, known as hepatocellular carcinoma (HCC), that hasn't been treated before and cannot be removed with surgery. The study is testing a new medicine called Pumitamig, sometimes on its own and sometimes combined with another existing medicine called Ipilimumab. The main purpose is to understand if these treatments are safe and what their side effects might be. This is a Phase 1 and Phase 2 study, which means it's an early stage of research focusing on safety, finding the right doses, and seeing if the treatment shows any promise. Participants will be closely monitored by a medical team.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Bristol-Myers Squibb

Enrolment target

198

Start

16 Mar 2026

Estimated completion

14 Oct 2031

Hepatocellular Carcinoma (HCC)

What is this study about?

This study, known as ROSETTA HCC-206, is designed to investigate a new treatment approach for a type of liver cancer called hepatocellular carcinoma (HCC). HCC is the most common type of liver cancer, and this study focuses on advanced cases that haven't been treated with other medicines yet and can't be removed through an operation. Researchers want to learn more about a new medicine called Pumitamig. They will give it to some patients on its own and to others combined with another medicine called Ipilimumab, which is already used to treat some cancers.

The main goal of this research is to see how safe these medicines are and if people can tolerate them well. This means tracking any side effects and how participants feel while taking the treatment. This is a 'Phase 1' and 'Phase 2' study, which are early steps in developing new medicines. In Phase 1, the focus is heavily on safety and finding the best dose. In Phase 2, researchers continue to check safety and also look for early signs that the treatment might be working.

Understanding the safety and side effects of new treatments is a crucial part of developing better medicines for liver cancer. By taking part, volunteers help doctors learn if Pumitamig could be a helpful option in the future for people with advanced liver cancer. The information gathered from this study will help guide further research and potentially lead to new treatments.

Key takeaways

This study is for advanced, untreatable liver cancer.
It tests a new medicine, Pumitamig, with or without Ipilimumab.
The main focus is on the safety and side effects of the treatments.
Participation involves regular hospital visits for monitoring and treatment.
You can stop participating at any time.
It's an early-stage study, exploring new options for HCC patients.

Who may be eligible?

To be able to take part in this study, you would need to meet certain conditions. Firstly, doctors must have confirmed that you have liver cancer (Hepatocellular Carcinoma, or HCC) that is advanced or can't be removed by surgery. You also shouldn't have had any other regular treatments for this advanced liver cancer yet. Your general health and ability to do daily activities would be checked by a doctor using a scale, and you would need to be in good enough health, described as a score of 0 or 1 on this scale.

There are also reasons why you might not be able to join. For example, if you have severe bleeding problems or conditions that affect your blood clotting, this study might not be suitable. Similarly, if you've had an organ transplant or have certain autoimmune diseases (where your body's immune system attacks itself), you wouldn't be able to participate. The medical team will review your full health history to ensure it's safe for you to take part.

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 you have a confirmed diagnosis of liver cancer (HCC) that is advanced or cannot be removed by surgery?
Have you *not* received any prior treatment for your advanced liver cancer?
Are you generally feeling well and able to carry out most daily activities?
Do you have good overall health, without serious bleeding issues, organ transplants, or certain autoimmune diseases?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have regular visits to the hospital or clinic. These visits will involve various tests and checks to monitor your health and how you are responding to the treatment. This could include physical examinations, blood tests, and scans. You will receive the study medication (Pumitamig, either alone or with Ipilimumab) according to a specific schedule, which the study team will explain in detail.

The overall length of your participation in the study will depend on how you respond to the treatment and other factors. You will have regular follow-up appointments to check on your health even after you stop taking the study medication. The study team will make sure you understand the commitment involved and answer all your questions. You can always ask for more details about the schedule of visits and tests.

Potential risks and benefits

Participating in this study might offer some potential benefits, such as gaining access to a new treatment for advanced liver cancer that isn't yet widely available. You will also receive careful medical attention and monitoring throughout the study. However, like all medicines, Pumitamig and Ipilimumab can cause side effects. These could range from mild to more serious, and the research team will explain all known or expected risks before you decide to join. It's very important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (59)

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

Local Institution - 0070
Verified postcode
Los Angeles, United States· Not yet recruiting
Local Institution - 0107
Verified postcode
Chicago, United States· Not yet recruiting
John Theurer Cancer Center at Hackensack University Medical Center
Verified postcode
Hackensack, United States· Recruiting
Local Institution - 0100
Verified postcode
Mineola, United States· Not yet recruiting
Providence Portland Medical Center
Verified postcode
Portland, United States· Recruiting
Providence St. Vincent Medical Center
Verified postcode
Portland, United States· Recruiting
Tennessee Oncology
Verified postcode
Nashville, United States· Recruiting
Vanderbilt University Medical Center
Verified postcode
Nashville, United States· Recruiting
Local Institution - 0083
Verified postcode
Seattle, United States· Not yet recruiting
Royal Prince Alfred Hospital
Verified postcode
Camperdown, Australia· Recruiting
Local Institution - 0033
Verified postcode
Westmead, Australia· Not yet recruiting
Sunshine Coast University Hospital
Verified postcode
Birtinya, Australia· Recruiting

Common questions

What is advanced liver cancer (HCC)?

Hepatocellular carcinoma (HCC) is the most common type of liver cancer. 'Advanced' means the cancer has grown or spread, and 'unresectable' means it cannot be removed by surgery.

What are Pumitamig and Ipilimumab?

Pumitamig is a new medicine being tested. Ipilimumab is a medicine already used for some cancers, aimed at helping your body's immune system fight the cancer.

Why are they studying these medicines?

The main goal is to find out if these medicines, alone or together, are safe and well-tolerated for people with advanced liver cancer. They also want to see if they might help treat the cancer.

What does 'Phase 1' and 'Phase 2' mean?

These are early stages of testing new treatments. Phase 1 mainly checks for safety and the right dose, while Phase 2 continues to check safety and looks for early signs that the treatment is working.

Will I definitely get the new medicine?

Participants in this study will receive either Pumitamig alone or Pumitamig with Ipilimumab. Your study doctor will explain which treatment group you would be in.

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.