Active not recruitingPHASE2INTERVENTIONAL

A Study of Immune Checkpoint Inhibitor Combinations With Axitinib in Participants With Untreated Locally Advanced Unresectable or Metastatic Renal Cell Carcinoma

This study is investigating new combinations of medicines for people with advanced kidney cancer (renal cell carcinoma) that hasn't been treated yet. The main aim is to see how safe these new combinations are. Researchers are testing tobemstomig, both on its own and with another drug called tiragolumab, alongside axitinib. They are comparing these new combinations to a standard treatment, which is pembrolizumab with axitinib. All these medicines are types of 'immune checkpoint inhibitors' or similar drugs that help your own immune system fight cancer. The study specifically focuses on a common type of kidney cancer called clear-cell renal cell carcinoma (ccRCC) that is locally advanced or has spread to other parts of the body.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Hoffmann-La Roche

Enrolment target

199

Start

21 Apr 2023

Estimated completion

31 Oct 2026

Renal Cell Carcinoma

What is this study about?

This clinical trial is for people in the UK living with advanced kidney cancer, specifically a type called clear-cell renal cell carcinoma, which hasn't been treated before. In this condition, the cancer has either spread too far to be removed by surgery or has already spread to other parts of the body. The study is exploring different combinations of drugs that work by helping your body's own immune system find and fight the cancer cells. These types of treatments are often called 'immunotherapies' or 'immune checkpoint inhibitors'.

The main goal of this particular study is to see how safe these new drug combinations are. Researchers are comparing two new combinations with a treatment that is already used. The new combinations involve a drug called tobemstomig, either by itself with axitinib, or with an additional drug called tiragolumab and axitinib. These are being compared to the existing combination of pembrolizumab and axitinib. By studying these different combinations, doctors hope to find safer and potentially more effective ways to treat this type of kidney cancer.

Finding new and better treatments for advanced kidney cancer is really important. This study is in 'Phase 2', which means it's one of the earlier stages of research. In this phase, doctors are focusing on safety and getting a better understanding of how the drugs work in a larger group of people. The information gathered from this study will help determine if these new combinations are promising enough to be studied further in even larger trials (Phase 3) later on, with the ultimate aim of improving patient care.

Key takeaways

This study is for advanced kidney cancer (renal cell carcinoma) that hasn't been treated before.
It's testing combinations of new immune-boosting drugs alongside axitinib.
The main goal is to check how safe these new drug combinations are.
Participation involves regular clinic visits for treatment, tests, and monitoring.
You can stop participating at any time.
Your involvement helps advance knowledge about kidney cancer treatments.

Who may be eligible?

To join this study, you would generally need to be an adult (18 or older) with clear-cell kidney cancer that is advanced or has spread, and hasn't been treated with other similar drugs before. Your general health and how well you can go about your daily activities would need to be good (your doctor will check this). You would also need to have areas of cancer that can be measured.

However, there are several reasons why you might not be able to join. For example, if you are pregnant or breastfeeding, or planning to become pregnant soon, you cannot take part. If you have had certain serious heart problems, uncontrolled high blood pressure, or a history of specific brain metastases, you would also likely not be able to participate. You also can't be receiving other drugs that interact with the study medications or have certain severe medical conditions such as liver problems or infections like HIV, Hepatitis B, or C.

The research team will carefully check all these requirements to make sure the study is safe for you and that the results will be accurate. It's important to discuss any health conditions or medications you take with the study doctor.

Quick self-check

Do you have advanced or metastatic clear-cell kidney cancer that hasn't been treated with similar drugs yet?
Are you generally healthy and able to perform daily activities with ease?
Are you not pregnant or breastfeeding, and not planning to become pregnant soon?
Do you have measurable areas of cancer?
Do you have no severe uncontrolled heart, liver, or active infection conditions?
Have you not had a major surgery in the last few weeks and don't anticipate one soon?

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'll be given one of the drug combinations – either tobemstomig with axitinib, tobemstomig with tiragolumab and axitinib, or pembrolizumab with axitinib. The specific schedule and how the drugs are given (some might be injections, others tablets) will be explained by the study team. You'll have regular visits to the clinic for medical checks, blood tests, and scans to see how you're responding to the treatment and to monitor for any side effects.

These visits will happen frequently at first, and then become less often as the study progresses. The treatment portion of the study will continue as long as the treatment is working and you are tolerating it well. After you finish the treatment part, you will have a follow-up period where the study team will continue to check in on your health for a certain amount of time, which can vary depending on the drug. The total duration of your involvement, including both treatment and follow-up, will be clearly explained by the research team.

Potential risks and benefits

Participating in a clinical trial may offer potential benefits, such as access to new treatments before they are widely available, and close monitoring by a dedicated medical team. Your involvement also contributes to medical research, helping others in the future. However, there are potential risks, including side effects from the study medications, which can vary and range from mild to severe, and the treatment might not work for everyone. You will be fully informed of all known and potential risks before you decide to join. It's important to remember that participating is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (44)

University of Alabama at Birmingham
Birmingham, United States
UC Irvine Medical Center
Orange, United States
Sibley Memorial Hospital
Washington D.C., United States
Emory University
Atlanta, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, United States
SCRI Oncology Partners
Nashville, United States
Vanderbilt University Medical Center
Nashville, United States
UT Southwestern Medical Center
Dallas, United States
Sunshine Coast University Hospital
Birtinya, Australia
Peking University First Hospital
Beijing, China
Beijing Cancer Hospital
Beijing, China
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
Nanjing, China

+32 more sites — see the official record for the full list.

Common questions

What is 'Renal Cell Carcinoma'?

It's the most common type of kidney cancer. 'Clear-cell' is a specific kind of renal cell carcinoma.

What do 'immune checkpoint inhibitors' do?

These are drugs that help your body's immune system recognise and attack cancer cells more effectively.

Why is 'Phase 2' important?

Phase 2 trials focus on understanding how safe new treatments are and if they show promise, often in a larger group of people than earlier studies.

Do I get to choose which drugs I receive?

No, participants are usually assigned to a treatment group by chance (like a lottery) to ensure a fair comparison between the different drug combinations.

Will I have to pay to be in the study?

No, all study-related treatments and assessments are usually provided free of charge if you're eligible and choose to participate.