A New Approach to Reducing Kidney Cancer Recurrence: The STRIKE Trial

By: David Grew MD MPH

“The STRIKE Trial is studying whether adding tivozanib may help reduce kidney cancer recurrence.”

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For patients with advanced kidney cancer, one of the biggest concerns after treatment is whether the cancer might come back.

The STRIKE Trial is studying whether adding a targeted therapy called tivozanib to standard treatment with pembrolizumab can help lower that risk.

This study is for certain patients with advanced kidney cancer who have already been treated with surgery or ablation, a treatment that destroys cancer cells using extreme temperatures.

The goal is to learn whether this combination approach can improve outcomes while still allowing patients to maintain a good quality of life.

What is advanced kidney cancer?

Kidney cancer happens when abnormal cells in the kidney grow out of control.

When kidney cancer spreads beyond the kidney to other parts of the body, it is called advanced or metastatic kidney cancer.

In these situations, treatment often begins with surgery to remove as much of the cancer as possible. Some patients may instead be treated with ablation, depending on their situation. After that, doctors may recommend additional treatment to lower the chance that cancer cells still hiding in the body will grow later.

Even when treatment goes well, there can still be a risk that the cancer may return.

What is the current standard treatment after surgery?

For many patients in this setting, the current standard treatment after kidney removal surgery is pembrolizumab for 1 year.

Pembrolizumab is an immunotherapy. It works by helping the immune system recognize and attack cancer cells that may still be present in the body, even if they cannot be seen on scans.

This treatment can play an important role in lowering the risk of recurrence, but like all medicines, it can cause side effects.

Many side effects are mild, such as fatigue or skin changes. In rare cases, more serious immune-related side effects can happen, which is why patients are monitored closely during treatment.

What is tivozanib?

Tivozanib is a targeted therapy that is already approved for kidney cancer that cannot be removed with surgery.

It works differently from immunotherapy. Instead of stimulating the immune system, tivozanib blocks signals that tumors use to grow new blood vessels. Without that blood supply, cancer cells may have a harder time surviving and growing.

Researchers want to know whether combining tivozanib with pembrolizumab after surgery or ablation could further lower the chance of kidney cancer coming back.

What is the STRIKE Trial studying?

The STRIKE Trial is studying whether adding tivozanib to standard pembrolizumab treatment can improve outcomes for patients with advanced kidney cancer after surgery or ablation.

The main question is:

Can pembrolizumab plus tivozanib reduce the chance of kidney cancer returning more than pembrolizumab alone?

To answer that, patients in the trial are randomly assigned to one of two groups.

What treatments do patients receive in the trial?

Group 1: Pembrolizumab alone

Patients in this group receive standard treatment with pembrolizumab through an IV for a total of 48 weeks.

Group 2: Pembrolizumab plus tivozanib

Patients in this group receive the same pembrolizumab treatment through an IV for 48 weeks.

They also take tivozanib capsules by mouth once daily for 21 days, followed by a 7-day break, for a total of 24 weeks.

Because this is a randomized study, patients do not choose which group they are placed in.

What side effects are possible?

Like any cancer treatment, the medicines used in the STRIKE Trial can cause side effects.

Pembrolizumab can cause side effects related to the immune system becoming more active. Some are mild, but rare serious immune-related side effects can occur.

Adding tivozanib may increase the risk of side effects. Common side effects may include:

• high blood pressure
• tiredness
• diarrhea
• mouth sores
• loss of appetite
• hoarseness
• skin changes, especially on the hands and feet

Many side effects are manageable, and the care team will monitor patients closely throughout treatment.

What happens after treatment?

After treatment ends, patients in the STRIKE Trial continue to be followed closely.

This follow-up includes:

• regular check-ups
• imaging scans
• lab tests

Visits happen every few months during the first year and then less often over time.

This close follow-up helps doctors watch for signs that the cancer may have returned and manage any symptoms or treatment effects that may come up.

Why is this trial important?

The STRIKE Trial is asking an important question for patients with advanced kidney cancer:

Can a combination of immunotherapy and targeted therapy lower the risk of recurrence more than standard treatment alone?

Researchers also want to understand whether patients can maintain good health and quality of life while receiving this approach.

If the combination works better, it could help shape future treatment options for patients in this setting.

Who may be eligible?

This trial may be an option for some patients with advanced kidney cancer who have already been treated with surgery or ablation.

Every clinical trial has specific eligibility criteria, so the best way to find out whether this study may be a fit is to talk with your doctor or the study team.

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For patients with advanced kidney cancer, finishing surgery or ablation is often a major step. But questions about recurrence can still remain.

The STRIKE Trial is studying whether adding tivozanib to pembrolizumab may offer another way to reduce that risk.

By comparing standard treatment with pembrolizumab alone against pembrolizumab plus tivozanib, this study may help doctors learn how to better protect patients while preserving quality of life.

To learn more about the STRIKE clinical trial, watch the video we made here.

To learn more, browse our library of kidney cancer-related topics.

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FAQs:

Do I need to avoid food when taking tivozanib?

No, not based on the FDA prescribing information. Tivozanib is labeled to be taken with or without food. That said, patients should still ask their care team how to take it, especially if they have nausea, mouth sores, or trouble eating during treatment.

Will joining the STRIKE Trial mean extra visits or tests?

Yes, it may. The National Cancer Institute notes that people in treatment trials may need more doctor visits and more tests than they would with standard treatment alone. The exact schedule depends on the study, so patients should ask the study team what extra scans, labs, or appointments are required in STRIKE.

If side effects become too difficult, can treatment ever be paused or changed?

Yes, sometimes. The FDA labeling for tivozanib includes dose interruptions and dose reductions for adverse reactions, and the FDA labeling for pembrolizumab says it may be withheld or discontinued depending on severity. In a clinical trial, exactly how this is handled depends on the study protocol, so patients should contact their care team right away if side effects are worsening.

Can I leave the STRIKE Trial later if I change my mind?

Yes. NCI states that taking part in a clinical trial is voluntary and that a person may leave the study at any time. Patients who are thinking about withdrawing should still speak with their study team first so they understand what follow-up care, monitoring, or treatment changes may be needed.

Are new treatments in clinical trials always better than standard treatment?

No. NCI explains that treatments being studied are not always better than, or even as good as, standard care, which is exactly why clinical trials are done. Patients considering STRIKE should talk with their doctor about the possible benefits, risks, and uncertainties before deciding whether the trial is right for them.