Active not recruitingPHASE1, PHASE2INTERVENTIONAL

Substudy 03A: A Study of Immune and Targeted Combination Therapies in Participants With First Line (1L) Renal Cell Carcinoma (MK-3475-03A)

This study, called 'Substudy 03A', is part of a larger research effort to find better treatments for a type of kidney cancer called renal cell carcinoma (RCC). Specifically, this substudy is focusing on kidney cancer that is advanced (has spread) and has not been treated with medicines before. We are testing new combinations of experimental drugs to see how safe they are and how well they work. Some of these drugs are called Pembrolizumab, Favezelimab, Belzutifan, Lenvatinib, and Quavonlimab. This research is in its earlier stages (Phase 1 and 2), meaning we are carefully checking the safety first before seeing how effective they are. The aim is to find combinations that patients can tolerate well.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

400

Start

16 Dec 2020

Estimated completion

17 Jul 2026

Carcinoma, Renal Cell

What is this study about?

This study, known as 'Substudy 03A', is looking into new ways to treat a specific type of kidney cancer called renal cell carcinoma (RCC). This is cancer that starts in the kidneys. For this study, we are focusing on kidney cancer that has spread to other parts of the body or has come back after previous treatment, and for which patients haven't yet received any medication-based treatments.

Researchers are investigating several new medicines, often in combinations, including ones called Pembrolizumab, Favezelimab, Belzutifan, Lenvatinib, and Quavonlimab. These medicines work in different ways to fight cancer, for example, by boosting the body's own immune system or by targeting specific features of the cancer cells. The goal is to see if combining these experimental medicines can be more effective and safe than current treatments.

This substudy is in its early phases (Phase 1 and 2). This means that the main focus is first on carefully checking the safety of these new drug combinations and finding the right doses. After ensuring they are safe enough, the study will then look more closely at how well they work to treat the cancer. This step-by-step approach is crucial for developing new medicines responsibly.

Key takeaways

This study explores new drug combinations for advanced kidney cancer.
It's for people whose kidney cancer has spread and who haven't had drug treatment for it yet.
The focus is on checking safety first, then how well the treatments work.
You'll be closely monitored with regular checks and tests.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, people must have kidney cancer that has been confirmed by a doctor and has either spread to other parts of the body or come back. This should be the first time they are receiving medication-based treatment for this advanced kidney cancer, although previous surgery or other non-medication treatments for kidney cancer are generally fine if completed a year ago or more.

Participants need to be able to swallow tablets or capsules, and their body organs (like the liver and kidneys) need to be working well. Blood pressure must be controlled, and any side effects from previous treatments must have mostly gone away. Men and women of childbearing age will need to use contraception during the study and for some time after to prevent pregnancy. Women must not be pregnant or breastfeeding.

There are also reasons why someone might not be able to join. For example, if you have significant heart problems, specific breathing issues, or a particular level of protein in your urine, you might not be eligible. The study team will review all your medical information carefully to see if this study is right for you.

Quick self-check

Do I have kidney cancer that has spread or returned?
Have I NOT had any drug treatments for this advanced kidney cancer before?
Am I generally healthy enough, with good organ function?
Am I able to swallow oral medicines?
If I am a woman of childbearing age, am I willing to use contraception during the study?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

Taking part in this study would involve regular visits to the hospital or clinic for assessments, which will include blood tests, scans, and other checks to monitor your health and how the treatment is working. You will receive the study medications, which may include tablets you take by mouth and/or medicines given by infusion (into a vein). The study starts with a 'safety lead-in' period, where the doses and combinations are carefully monitored. After this, if the treatment is tolerated, the study will continue to look at how effective it is.

Detailed information about the exact schedule of visits, tests, and medication administration will be provided by the study team. You will be closely monitored throughout the study to track any side effects and see how you are responding to the treatment. The total duration of participation will vary depending on how you respond to the treatment and the study's design, including follow-up appointments after you stop taking the study medication.

Potential risks and benefits

Taking part in this study could offer potential benefits, such as access to new, experimental treatments for your kidney cancer that aren't yet widely available. These treatments might be more effective for some people. However, as these are new medicines, there are potential risks and side effects that are not yet fully known. The study team will carefully monitor you for any side effects and will explain all known risks before you decide to join. Remember, participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (55)

University of California at San Francisco ( Site 1008)
San Francisco, United States
Yale-New Haven Hospital-Yale Cancer Center ( Site 1011)
New Haven, United States
University of Chicago ( Site 1013)
Chicago, United States
University of Iowa ( Site 1012)
Iowa City, United States
Henry Ford Health System ( Site 1014)
Detroit, United States
Laura and Isaac Perlmutter Cancer Center ( Site 1016)
New York, United States
Memorial Sloan Kettering Cancer Center ( Site 1002)
New York, United States
Duke Cancer Institute ( Site 1015)
Durham, United States
UPMC Cancer Center/Hillman Cancer Center ( Site 1017)
Pittsburgh, United States
UTSW Medical Center ( Site 1003)
Dallas, United States
Blacktown Hospital ( Site 1601)
Blacktown, Australia
St George Hospital ( Site 1602)
Kogarah, Australia

+43 more sites — see the official record for the full list.

Common questions

What type of kidney cancer is this study for?

This study is for a specific type called renal cell carcinoma (RCC) that has spread or returned, and for which you haven't had prior systematic drug treatment.

What medicines are being tested?

We're testing combinations of experimental medicines like Pembrolizumab, Favezelimab, Belzutifan, Lenvatinib, and Quavonlimab.

What are 'Phase 1' and 'Phase 2' studies?

These are early phases of research. Phase 1 mainly checks safety, and Phase 2 looks more closely at how well the treatment works after safety has been assessed.

Do I have to take tablets?

Some of the medicines are taken by mouth (tablets), and others might be given by drip (infusion).

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, and it won't affect your future medical care.