ROSETTA RCC-208: A Phase 1/2 Open-label, Multi-center, Randomized Study of Pumitamig Alone or in Combination with Ipilimumab or Cabozantinib in Participants with Advanced Renal Cell Carcinoma (RCC)
This clinical trial is looking at a new medicine called pumitamig (also called BNT327) for people with advanced renal cell carcinoma, which is the most common type of kidney cancer. 'Advanced' means the cancer has spread to nearby tissue or other parts of the body and cannot be cured with surgery alone. The trial has two main stages. In Phase 1, doctors want to find out how safe pumitamig is when given by itself or together with other established cancer medicines, called ipilimumab or cabozantinib. They will carefully monitor for any side effects. In Phase 2, researchers will check how well the treatment works at shrinking tumours or clearing them completely. The study aims to discover whether this new drug approach could provide a helpful, safe new option for people living with advanced kidney cancer.
At a glance
What is this study about?
Renal cell carcinoma is the most common form of kidney cancer. When this cancer reaches an advanced stage, it means it has spread beyond the kidney to other areas of the body. In these situations, surgery is usually not enough on its own, so doctors rely on drug treatments to control the cancer and help people live longer, healthier lives.
This study, called ROSETTA RCC-208, is testing an experimental medicine named pumitamig (BNT327). Pumitamig is being tested either on its own or combined with other medicines called ipilimumab and cabozantinib. These medicines work in different ways to attack cancer cells and help the body's immune system fight the disease.
The trial is divided into two parts. The first part focuses mainly on safety. Doctors will see what side effects occur, how severe they are, and what doses people can safely handle. The second part looks closely at how effective the treatment is, checking if tumours shrink or disappear, and how long the cancer stays under control.
By taking part, patients help doctors learn whether this new combination of treatments could be a safe and effective option for people facing advanced kidney cancer in the future.
Key takeaways
- Tests a new drug called pumitamig alone or combined with other cancer treatments.
- Open to adults aged 18 and older with advanced kidney cancer.
- The trial looks at both safety (side effects) and effectiveness (shrinking tumours).
- No placebo is used; all participants receive active medication.
- Joining is entirely voluntary, and you can withdraw at any time.
Who may be eligible?
This study is open to adults aged 18 and over who have been diagnosed with advanced renal cell carcinoma (kidney cancer). Both men and women can take part.
To be suitable, the cancer must be advanced, meaning it has spread or cannot be removed completely by an operation. Doctors will also need to review your overall health, including how well your heart, liver, and kidneys are working, to ensure it is safe for you to take part.
You may not be able to join if you have certain other serious medical conditions or if you have had specific cancer treatments very recently. The study team will review your full medical history and test results with you to see if the trial 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 aged 18 or older.
- I have been diagnosed with advanced or spread kidney cancer (renal cell carcinoma).
- My cancer cannot be completely removed by surgery.
- I am well enough to attend regular hospital appointments and tests.
- I am open to receiving an experimental cancer medicine.
What does participation involve?
If you decide to take part, you will have an initial screening visit where doctors perform checks such as blood tests, heart traces, and imaging scans (like CT or MRI scans) to confirm the trial is safe for you. Pumitamig and ipilimumab are given through a drip into a vein (an intravenous infusion) at the hospital clinic, while cabozantinib is taken as a daily tablet at home. You will need to visit the hospital regularly for treatments, blood tests, and health checks so the team can monitor how you are feeling. Imaging scans will be repeated every few weeks or months to see how the cancer is responding. Your participation can continue as long as the treatment is helping you and the side effects remain manageable, and the team will keep in touch to check on your health even after treatment finishes.
Potential risks and benefits
Locations (8)
- —UnverifiedIreland
- —UnverifiedRomania
- —UnverifiedItaly
- —UnverifiedSpain
- —UnverifiedCzechia
- —UnverifiedFinland
- —UnverifiedFrance
- —UnverifiedGermany
Common questions
What is pumitamig?
Pumitamig (also known as BNT327) is an experimental cancer medicine designed to help the immune system recognise and attack cancer cells.
Will I receive a placebo (dummy drug)?
No, this is an open-label study, which means every person who takes part receives active cancer medicine, not a dummy treatment.
How often will I need to visit the hospital?
You will need to visit the hospital regularly, especially at the start of treatment, for infusions, blood tests, and scans. Your study doctor will give you an exact schedule.
Do I have to pay to take part?
No, the trial treatment and all trial-related tests are provided free of charge, and some travel expenses may be covered.
Can I leave the study if I change my mind?
Yes, you can leave the study at any time without giving a reason. Your usual NHS cancer care will continue as normal.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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