Substudy 03B: A Study of Immune and Targeted Combination Therapies in Participants With Second Line Plus (2L+) Renal Cell Carcinoma (MK-3475-03B/KEYMAKER-U03)
This research study, called Substudy 03B, is investigating new ways to treat advanced kidney cancer, specifically clear cell renal cell carcinoma (ccRCC), when previous treatments haven't worked well. Researchers are testing different combinations of experimental drugs to see if they are safe and effective. The study has two main parts: a first phase to check the safety of the drug combinations, and then a second phase to see how well they work. The main goal is to find better treatment options for people living with this type of kidney cancer.
At a glance
What is this study about?
This study, called Substudy 03B, is part of a bigger research effort (U03) looking into new treatments for kidney cancer, specifically a type called clear cell renal cell carcinoma (ccRCC). When we talk about "advanced" kidney cancer, it means the cancer has grown or spread, and "second line plus" means you've already had at least one other treatment that hasn't fully worked.
The main idea behind this study is to combine different experimental drugs in new ways. Researchers believe that by using these drugs together, they might be more effective at fighting the cancer than using them alone. The full list of specific drugs being tested in various combinations includes Pembrolizumab, MK-4830, Belzutifan, Lenvatinib, Pembrolizumab/Quavonlimab, and Favezelimab/Pembrolizumab. These drugs work in different ways to target cancer cells or boost the body's own immune system to fight the cancer.
This study is happening in two main stages. The first stage, called the "safety lead-in phase," is all about carefully checking for any side effects or problems with the new drug combinations. Doctors will start with small groups of patients to make sure the combinations are tolerable. Once they understand the safety profile, the study will move to the "efficacy phase" to see how well the treatments actually work against the cancer. This is an important step in finding potentially better treatments for people with advanced kidney cancer.
Key takeaways
- This study tests new combinations of drugs for advanced kidney cancer.
- It's for people whose kidney cancer has progressed after previous treatments.
- The study aims to check the safety and effectiveness of the new drug combinations.
- Participation involves regular clinic visits for monitoring.
- You can withdraw from the study at any time.
Who may be eligible?
To join this study, you need to have a specific type of advanced kidney cancer called clear cell renal cell carcinoma. You must have already tried other treatments for your kidney cancer, and the cancer must have started growing again either during or after those treatments. This includes treatments that target specific growth factors (VEGF-TKI) and/or treatments that help your immune system (PD-(L)1 checkpoint inhibitors).
You also need to be able to swallow pills and be in reasonably good general health, meaning your organs like your heart, liver, and kidneys are working well enough. Your blood pressure needs to be properly controlled with medication, and any side effects from your previous treatments should have mostly cleared up.
There are also some requirements for men regarding contraception during the study and for a period afterwards if certain drugs are used. Doctors will explain all these details to make sure the study is a good fit for you.
- Do I have clear cell renal cell carcinoma (a type of kidney cancer)?
- Has my cancer grown or spread after trying other treatments?
- Can I swallow oral medications (pills)?
- Is my general health, including blood pressure, well-managed? From previous treatments, are side effects mostly gone (Grade 1 or less)?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to join this study, you will be given a combination of experimental medications. You will have regular visits to the clinic for medical check-ups, blood tests, and scans to monitor your health and how the treatment is working. This will help doctors understand the safety of the drugs and their effect on your cancer. These visits will be more frequent at the beginning and then might spread out over time. The total duration of your participation will depend on how you respond to the treatment and the study's protocol, but it could last for many months to a year or more, followed by a period of follow-up.
Potential risks and benefits
Locations (51)
- University of California at San Francisco ( Site 3008)San Francisco, United States
- Yale-New Haven Hospital-Yale Cancer Center ( Site 3011)New Haven, United States
- University of Chicago ( Site 3013)Chicago, United States
- University of Iowa ( Site 3012)Iowa City, United States
- Henry Ford Health System ( Site 3014)Detroit, United States
- Laura and Isaac Perlmutter Cancer Center ( Site 3016)New York, United States
- Memorial Sloan Kettering Cancer Center ( Site 3002)New York, United States
- Duke Cancer Institute ( Site 3015)Durham, United States
- UPMC Cancer Center/Hillman Cancer Center ( Site 3017)Pittsburgh, United States
- Vanderbilt University Medical Center ( Site 3004)Nashville, United States
- UTSW Medical Center ( Site 3003)Dallas, United States
- Blacktown Hospital ( Site 3601)Blacktown, Australia
+39 more sites — see the official record for the full list.
Common questions
What does 'advanced' kidney cancer mean?
It means the cancer has grown outside the kidney or has spread to other parts of your body.
What does 'experimental' treatment mean?
It means the treatments are still being tested and aren't yet approved for general use. Their full effects and side effects are still being understood.
Will I definitely get one of the new drug combinations?
Yes, everyone in this study will receive one of the experimental drug combinations being tested.
What if I experience side effects during the study?
Your medical team will closely monitor you for any side effects and will provide care and support to help manage them.
Can I leave the study if I change my mind?
Yes, you are free to leave the study at any time, for any reason, without affecting your medical care.
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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