Active not recruitingPHASE3INTERVENTIONAL

Study of XL092 + Nivolumab vs Sunitinib in Subjects With Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma

This research study is looking for people with a type of advanced kidney cancer called non-clear cell renal cell carcinoma (nccRCC). If the cancer can't be removed by surgery, or has spread to nearby areas or other parts of the body, and you haven't received previous cancer treatment for this advanced stage, you might be able to join. The study aims to find out if a new combination of two drugs, XL092 and nivolumab, is more effective than sunitinib. Sunitinib is a commonly used treatment for this type of cancer. Participants will be randomly assigned to receive either the new drug combination or sunitinib. This is a Phase 3 study, meaning it's a larger trial designed to confirm if the new treatment is safe and works better than current options.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Exelixis

Enrolment target

317

Start

01 Jan 2023

Estimated completion

01 Jun 2028

Non-Clear Cell Renal Cell Carcinoma

What is this study about?

This study is exploring a new treatment option for a specific type of kidney cancer called non-clear cell renal cell carcinoma (nccRCC). Kidney cancer is broadly divided into 'clear cell' and 'non-clear cell' types, with non-clear cell being less common. If your doctor has told you that your kidney cancer is advanced, meaning it's grown into surrounding tissues or spread to other parts of your body, and cannot be removed by surgery, this study might be relevant to you. The main goal is to see if a new combination of medicines, XL092 and nivolumab, can offer a better way to treat this cancer compared to a standard drug called sunitinib.

Researchers want to understand if the new drug combination can help shrink tumors, slow down the cancer's growth, and improve how people feel and live compared to the current treatment. You would be considered for this study if you haven't had any previous cancer treatments for your advanced kidney cancer. This helps the researchers get a clear picture of how effective the new treatments are by themselves without interference from other drugs.

This is a 'Phase 3' study, which means it's a large-scale trial involving many people. This phase is usually the last step before a new treatment can be considered for wider use. By comparing the new combination with a standard treatment, doctors can get strong evidence about which approach leads to better outcomes for patients with nccRCC.

Key takeaways

This study is for advanced, non-clear cell kidney cancer.
It compares a new combination therapy with a standard treatment.
Participants must not have had previous treatment for their advanced cancer.
You will be randomly assigned to one of two treatment groups.
Your health will be closely monitored throughout the study.
You can stop participating at any time.

Who may be eligible?

This study is for adults aged 18 or older who have been diagnosed with advanced or metastatic non-clear cell kidney cancer. Your cancer must be of certain types, such as papillary or unclassified nccRCC, and needs to be measurable by scans. You should generally be feeling well enough to participate, with a good level of physical activity.

You should not have received any previous medication for your advanced kidney cancer. However, if you had early-stage kidney cancer completely removed by surgery and received certain treatments for it, you might still be able to join if your cancer has returned at least six months after your last treatment. Certain types of nccRCC, like chromophobe, are not included in this study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years or older?
Do you have advanced or metastatic non-clear cell kidney cancer?
Has your advanced kidney cancer NOT been treated with other medicines before?
Are you generally well and active enough for daily tasks?
Do you have suitable past biopsy samples of your cancer available?
Are you able to agree to use effective birth control if sexually active?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly assigned to one of two groups: one receiving the new combination of XL092 and nivolumab, and the other receiving sunitinib. This is like flipping a coin, but with a 2-in-3 chance of being in the new combination group (2:1 randomisation). You and your doctors will know which treatment you are receiving – this is called 'open-label'.

You will have regular hospital visits for treatments, check-ups, blood tests, and scans to monitor your progress and check for any side effects. You'll also be asked to provide an existing tissue sample (biopsy) of your cancer. The total duration of your participation will depend on how you respond to the treatment, but careful follow-up will continue for some time after you stop taking the study drugs.

Potential risks and benefits

Participating in a clinical trial may offer benefits such as access to new treatments before they are widely available, and your health will be closely monitored. However, there are potential risks, as new treatments can have side effects that are not fully known. You might also receive the standard treatment which may not work for everyone. While the researchers aim to protect your safety, side effects can range from mild to severe, and some could be serious. You can withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (163)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Exelixis Clinical Site #1
Verified postcode
Duarte, United States
Exelixis Clinical Site #164
Verified postcode
Newport Beach, United States
Exelixis Clinical Site #162
Verified postcode
San Francisco, United States
Exelixis Clinical Site #163
Verified postcode
Aurora, United States
Exelixis Clinical Site #55
Verified postcode
Jacksonville, United States
Exelixis Clinical Site #161
Verified postcode
Buffalo, United States
Exelixis Clinical Site #58
Verified postcode
New York, United States
Exelixis Clinical Site #15
Verified postcode
New York, United States
Exelixis Clinical Site #42
Verified postcode
Cleveland, United States
Exelixis Clinical Site #31
Verified postcode
Dallas, United States
Exelixis Clinical Site #88
Verified postcode
Pilar, Argentina
Exelixis Clinical Site #89
Verified postcode
Viedma, Argentina

Common questions

What is 'non-clear cell renal cell carcinoma'?

It's a less common type of kidney cancer, different from the more frequent 'clear cell' type. This study focuses specifically on this particular type.

What does 'unresectable, locally advanced or metastatic' mean?

It means the cancer can't be removed by surgery, or it has spread to nearby areas or other parts of the body.

What are XL092, Nivolumab, and Sunitinib?

These are different medicines used to treat cancer. XL092 and Nivolumab are being tested as a combination, while Sunitinib is a standard treatment.

Will I know which treatment I'm getting?

Yes, in this study, both you and your doctors will know whether you are receiving the new combination treatment or sunitinib.

Can I still join if I had treatment for my kidney cancer before?

You can't have had prior treatment for your advanced kidney cancer. However, if you had earlier treatment for completely removed kidney cancer and it returned, you might still qualify if certain conditions are met.