Substudy 03C: A Study of Combination Therapies in Participants With Renal Cell Carcinoma With Recurrent Disease During or After Anti-PD-(L)1 Therapy (MK-3475-03C/KEYMAKER-U03)
This research study, called Substudy 03C, is testing new combinations of medicines (Belzutifan and Zanzalintinib) for a type of kidney cancer known as renal cell carcinoma. Specifically, it's for people whose cancer has returned after they’ve had a certain type of immunotherapy treatment (anti-PD-(L)1 therapy). The main goal is to check how safe these new drug combinations are and how well they work to treat the cancer. This study is part of a larger ongoing research program, and it's looking for participants aged 18 to 120. It involves two main stages: an initial safety check, followed by a phase to see how effective the treatments are.
At a glance
What is this study about?
This study, called Substudy 03C, is part of a bigger research effort (KEYMAKER-U03) looking into new ways to treat kidney cancer, specifically a type called renal cell carcinoma (RCC). The focus of this particular substudy is on patients whose kidney cancer has come back after they've already received a type of immunotherapy treatment known as anti-PD-(L)1 therapy. If you or someone you know has been through this situation, this study aims to explore new treatment options.
The researchers are testing combinations of two experimental medicines, Belzutifan and Zanzalintinib. The main purpose is to figure out if these combinations are safe to use and whether they can effectively treat the cancer. It's really important to find new treatments for those whose cancer has returned, and studies like this help us understand if new drug combinations could be a valuable option in the future.
The study will happen in two stages. First, there's a 'safety lead-in' phase. This is where a small number of participants will take the new drug combinations, and doctors will carefully monitor them to make sure the treatments are well-tolerated and don't cause too many side effects. Once they're confident about the safety, the study will move on to an 'efficacy phase,' which means they'll look more closely at how well the treatments work against the cancer. This careful, step-by-step approach ensures patient safety is prioritised throughout the research.
Key takeaways
- This study is for kidney cancer (renal cell carcinoma) that has returned after immunotherapy.
- It’s testing new combinations of experimental oral drugs, Belzutifan and Zanzalintinib.
- The main goals are to check the safety and effectiveness of these new treatments.
- Participation involves taking medication and regular clinic visits for monitoring.
- You can withdraw from the study at any time.
- It’s open to adults aged 18 and older, with specific health requirements.
Who may be eligible?
To join this study, you would generally need to have kidney cancer (renal cell carcinoma) that has spread or is difficult to remove, with a specific type called 'clear cell' component. You should also have previously received immunotherapy (anti-PD-(L)1 therapy) for your advanced kidney cancer, and the cancer must have returned either during that treatment or within 24 months of stopping it. You need to be able to swallow tablets, and doctors will need a tissue sample from your tumour. Your blood pressure should be well-controlled, and your organs need to be working properly.
There are also some reasons why you might not be able to join. For example, if you've had significant bleeding problems, certain heart conditions in the last year, a recent blood clot (DVT) that isn't fully stable, or certain lung conditions like idiopathic pulmonary fibrosis. If you’ve had major surgery recently (within eight weeks) or have serious wounds, or if you need regular draining for fluid around your lungs or heart, you also wouldn't be able to participate.
The study is open to both men and women, aged between 18 and 120 years old.
- Do you have kidney cancer (renal cell carcinoma) with a clear cell component that has spread or is advanced?
- Has your cancer returned after you received anti-PD-(L)1 immunotherapy?
- Can you swallow oral medications?
- Is your blood pressure well-controlled, and do you have good organ function?
- Have you not had any recent significant bleeding, severe heart issues, or recent major surgery?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you will be given the experimental medications, Belzutifan and Zanzalintinib, which you will take by mouth. The study involves regular visits to the clinic for assessments, including blood tests, physical examinations, and scans to monitor your health and how the treatment is affecting your cancer. Doctors will carefully track any side effects you experience. The exact number of visits and the total duration in the study will depend on how you respond to the treatment and the stage of the study, but it will involve an initial safety check followed by a longer period to assess the treatment's effectiveness. You'll also have a follow-up period after you stop taking the study medication to ensure your health continues to be monitored.
Potential risks and benefits
Locations (29)
- UCSF Medical Center at Mission Bay ( Site 5008)San Francisco, United States· Recruiting
- Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 5026)Mineola, United States· Recruiting
- Laura and Isaac Perlmutter Cancer Center ( Site 5016)New York, United States· Recruiting
- Memorial Sloan Kettering Cancer Center ( Site 5002)New York, United States· Recruiting
- Duke Cancer Institute ( Site 5015)Durham, United States· Recruiting
- UPMC Cancer Center/Hillman Cancer Center ( Site 5017)Pittsburgh, United States· Recruiting
- Vanderbilt University Medical Center ( Site 5004)Nashville, United States· Recruiting
- Centro de Estudios Clínicos SAGA ( Site 6110)Santiago, Chile· Recruiting
- Bradfordhill ( Site 6101)Santiago, Chile· Recruiting
- C.H.U. de Strasbourg Hopital de Hautepierre ( Site 5203)Strasbourg, France· Recruiting
- Institut Claudius Regaud ( Site 5200)Toulouse, France· Recruiting
- Centre Eugene Marquis ( Site 5205)Rennes, France· Recruiting
+17 more sites — see the official record for the full list.
Common questions
What type of cancer is this study for?
This study is for a type of kidney cancer called renal cell carcinoma, specifically the 'clear cell' type, which has returned after previous immunotherapy treatment.
What are the new treatments being tested?
The study is testing combinations of two experimental medicines called Belzutifan and Zanzalintinib.
What is 'immunotherapy' and why is it mentioned?
Immunotherapy is a type of treatment that helps your body's own immune system fight cancer. This study is for people whose kidney cancer has returned after previously receiving a specific type of immunotherapy.
How long does the study last?
The total duration in the study will vary for each person, depending on how they respond to the treatment and the study's design. It includes a safety phase and an effectiveness phase.
Can I stop participating if I want to?
Yes, you have the right to withdraw from the study at any time, for any reason, and it will not affect your usual medical care.
How to find out more
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Always speak to your GP or specialist before deciding to take part in a study.
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