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RecruitingPHASE1, PHASE2INTERVENTIONAL

A Study to Evaluate the Safety, Tolerability, and Efficacy of Pumitamig Alone or in Combination With Ipilimumab or Cabozantinib in Participants With Advanced Renal Cell Carcinoma (RCC) (ROSETTA RCC-208)

This study, called ROSETTA RCC-208, is exploring new ways to treat advanced kidney cancer, specifically renal cell carcinoma (RCC). It's testing a new drug, Pumitamig, either on its own or alongside existing treatments like Ipilimumab or Cabozantinib. The main goals are to find out if these treatments are safe, how well people tolerate them, and how effective they are at tackling the cancer. This research is in earlier stages (Phase 1 and Phase 2), meaning it's still gathering important information about these potential new therapies for kidney cancer patients.

At a glance

Status
Recruiting
Phase
PHASE1, PHASE2
Sponsor
Bristol-Myers Squibb
Enrolment target
254
Start
26 Mar 2026
Estimated completion
26 Nov 2031

What is this study about?

This study is a clinical trial investigating advanced renal cell carcinoma (RCC), which is a type of kidney cancer that has spread or can't be removed by surgery. The researchers are particularly interested in a new experimental treatment called Pumitamig. They want to understand if Pumitamig, when used alone or in combination with other established cancer drugs like Ipilimumab or Cabozantinib, can be a safe and effective option for patients.

The study is divided into two parts, known as Phase 1 and Phase 2. In Phase 1, the focus is largely on safety and finding the right dose of the experimental drug. Once a safe dose is established, Phase 2 then looks more closely at how well the treatment works against the cancer, while still monitoring safety very closely. By combining these two phases, researchers can gather crucial information efficiently.

The ultimate aim of this research is to discover new and better treatment options for people living with advanced kidney cancer. By carefully studying these different drug combinations, scientists hope to improve the outlook for patients who currently have limited choices. This kind of research is vital for advancing medical science and developing future therapies.

Key takeaways

  • Tests an experimental drug, Pumitamig, for advanced kidney cancer.
  • Combines Pumitamig with Ipilimumab or Cabozantinib in some parts of the study.
  • Aims to assess safety, how well it's tolerated, and effectiveness.
  • For adults (18+) with unresectable or metastatic kidney cancer.
  • Involves regular clinic visits, tests, and scans.
  • Participation is voluntary, and you can withdraw anytime.

Who may be eligible?

To be considered for this study, you would need to have advanced kidney cancer (renal cell carcinoma) that doctors can't remove with surgery or radiation, or cancer that has spread. This could be either a common type (clear cell RCC) or a less common type (non-clear cell RCC) for the initial part of the study.

Generally, you shouldn't have had previous treatment for advanced kidney cancer, though there are a few exceptions. For example, if you had treatment after surgery that wasn't designed to block specific growth factors, or if new cancer appeared more than six months after that treatment. Also, if you're in certain parts of the study, you shouldn't have previously received drugs like ipilimumab or cabozantinib.

It's important that your cancer can be measured by doctors, and you shouldn't have untreated cancer that has spread to your brain or spinal cord. Other health conditions, like serious heart problems, active lung disease, or conditions requiring high doses of certain medications that suppress the immune system, might mean you're not suitable for this 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.

  1. Do you have advanced kidney cancer (renal cell carcinoma) that cannot be removed by surgery or has spread?
  2. Has your advanced kidney cancer (RCC) not been treated before with systemic therapy (with a few exceptions)?
  3. Do you not have untreated cancer that has spread to your brain or spinal cord?
  4. Do you not have significant heart problems or active lung disease like interstitial lung disease?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll receive one of the study treatments, which could be Pumitamig on its own, or Pumitamig combined with either Ipilimumab or Cabozantinib. You would have regular visits to the clinic for medical examinations, blood tests, and scans (like CT scans or MRI scans) to see how the treatment is working and monitor your health. You might also need to answer questionnaires about how you're feeling. The exact number of visits, tests, and how long you'd be on the treatment can vary, but generally, you'd continue treatment as long as it's benefiting you and you're not experiencing significant side effects. There might also be a follow-up period after you stop treatment to monitor your health.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as receiving a new experimental treatment for your kidney cancer that might be more effective than standard options, and you'll be closely monitored by a healthcare team. However, there are also potential risks involved. Experimental drugs can have side effects, which might be mild or severe, and not everyone responds positively to new treatments. All possible side effects will be explained to you in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (72)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Local Institution - 0117
    Verified postcode
    New Haven, United States· Not yet recruiting
  • Sibley Memorial Hospital
    Verified postcode
    Washington D.C., United States· Recruiting
  • Local Institution - 0126
    Verified postcode
    Orlando, United States· Not yet recruiting
  • Local Institution - 0124
    Verified postcode
    Iowa City, United States· Not yet recruiting
  • Johns Hopkins Hospital
    Verified postcode
    Baltimore, United States· Recruiting
  • Washington University School of Medicine
    Verified postcode
    St Louis, United States· Recruiting
  • Local Institution - 0096
    Verified postcode
    Hauppauge, United States· Not yet recruiting
  • Local Institution - 0135
    Verified postcode
    Cincinnati, United States· Not yet recruiting
  • Local Institution - 0127
    Verified postcode
    Cleveland, United States· Not yet recruiting
  • MUSC Hollings Cancer Center
    Verified postcode
    Charleston, United States· Recruiting
  • Carolina Urologic Research Center, LLC
    Verified postcode
    Myrtle Beach, United States· Recruiting
  • Local Institution - 0158
    Verified postcode
    Salt Lake City, United States· Withdrawn

Common questions

What is advanced renal cell carcinoma?

It's a type of kidney cancer that has spread beyond the kidney or can't be removed by surgery.

What are Pumitamig, Ipilimumab, and Cabozantinib?

Pumitamig is an experimental drug, while Ipilimumab and Cabozantinib are established cancer treatments. They work in different ways to fight cancer.

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

Phase 1 studies focus on safety and finding the right dose of a new drug. Phase 2 studies then look at how well the drug works and continue to monitor for safety.

Will I know which treatment I'm getting?

During the study, you will be informed if you are receiving Pumitamig alone or in combination with one of the other drugs mentioned.

Can I stop participating in the study at any time?

Yes, you have the right to withdraw from the study at any point, and doing so will not affect your future medical care.

How to find out more

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

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

Interested in taking part?

Register your interest

Share your details and the research team for "A Study to Evaluate the Safety, Tolerability, and Efficacy o…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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