RecruitingPHASE3INTERVENTIONAL

Study of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma

This important study is investigating a new treatment approach for adults with advanced clear cell kidney cancer that has spread or cannot be removed by surgery. It focuses on patients whose cancer has continued to grow despite previous treatment with a type of immunotherapy. The trial aims to see if adding an experimental drug called casdatifan to an established drug, cabozantinib, can slow down cancer progression more effectively than cabozantinib combined with a placebo (a dummy drug). Researchers will be carefully monitoring how long patients live without their cancer getting worse. This is a Phase 3 study, meaning it's a large-scale trial designed to confirm the effectiveness and safety of the new combination compared to standard care, with the hope of offering a new option for patients.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Arcus Biosciences, Inc.

Enrolment target

720

Start

08 Sep 2025

Estimated completion

01 Dec 2030

Metastatic Clear Cell Renal Cell Carcinoma Advanced Clear Cell Renal Cell Carcinoma

What is this study about?

This research study is about finding better ways to treat a type of advanced kidney cancer called clear cell renal cell carcinoma. When cancer is advanced, it means it has grown or spread beyond where it started. For patients whose cancer has already not responded well enough to or has grown worse after a type of treatment called immunotherapy, doctors are looking for new options.

The study is comparing two different treatment approaches. One group of patients will receive an existing cancer drug called cabozantinib, plus a new, experimental drug called casdatifan. Another group will receive cabozantinib along with a placebo, which is an inactive substance that looks just like the real drug. The main goal is to find out if the combination with casdatifan can keep the cancer from growing or spreading for a longer time compared to the combination with the placebo. This is a common way to test new drugs to see if they are better than what's currently available.

By carefully comparing these two groups, researchers hope to learn if adding casdatifan could offer a new and more effective treatment choice for patients facing this challenging form of kidney cancer. It's a big step in understanding if this new drug could become part of routine care in the future.

Key takeaways

This study is for advanced clear cell kidney cancer that has progressed after immunotherapy.
It compares a new experimental drug (casdatifan) with an established one (cabozantinib) against cabozantinib with a dummy pill.
The main goal is to see if casdatifan can keep cancer from growing for longer.
Participation involves regular hospital visits, medications, and scans.
You might get access to a new treatment, but there are potential side effects.
You can leave the study at any time without affecting your future care.

Who may be eligible?

To join this study, adults must have advanced clear cell kidney cancer that cannot be removed by surgery or has spread. Their cancer must have progressed after previously having immunotherapy. They need to be generally well enough to take part in the study activities, which is measured by a scoring system, and have at least one measurable tumour that doctors can track.

There are also some important reasons why someone might not be able to join. For example, if you've already had treatment with cabozantinib or a similar type of drug called a HIF-2α inhibitor, you likely wouldn't be eligible. Also, patients with other active cancers from the last year (unless they were minor and cured) or serious uncontrolled medical conditions like high blood pressure or significant side effects from previous treatments would not be able to participate. Pregnant women also cannot take part.

The research team will carry out several checks and tests to make sure that taking part in the study is safe and appropriate for each individual patient. They will explain all the specific requirements in detail.

Quick self-check

I have advanced clear cell kidney cancer that cannot be removed by surgery or has spread.
My cancer has progressed after having immunotherapy.
I haven't previously taken cabozantinib or a similar drug (HIF-2α inhibitor).
I am generally well and active enough for daily tasks.
I have at least one tumour that can be measured and tracked by scans.
I do not have uncontrolled high blood pressure or other serious untreated medical conditions.

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 would be randomly assigned to one of two groups: either receiving casdatifan plus cabozantinib, or cabozantinib plus a placebo (a dummy pill). You wouldn't know which group you are in, and neither would your study doctor. You'll have regular hospital visits, where you'll receive your study medication, undergo physical examinations, have blood and urine tests, and get scans (like CT or MRI) to see how the cancer is responding. These assessments are important for monitoring your health and the effectiveness of the treatment. The total duration of your participation would depend on how your cancer responds to treatment and your general health, but you'd continue treatment for as long as it's helping and you're tolerating it well. Even if you stop treatment, there will likely be follow-up appointments to monitor your health.

Potential risks and benefits

Taking part in a clinical trial offers the potential benefit of accessing an experimental treatment, casdatifan, before it's widely available, which might improve your cancer control. However, there's no guarantee the new drug will be effective for you, and like all medications, both casdatifan and cabozantinib can cause side effects. These could range from mild to severe, and the study team will monitor you closely for any issues. You are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (118)

Research Site
Gilbert, United States· Recruiting
Research Site
Goodyear, United States· Recruiting
Research Site
Phoenix, United States· Recruiting
Research Site
Duarte, United States· Recruiting
Research Site
La Jolla, United States· Recruiting
Research Site
Los Angeles, United States· Recruiting
Research Site
Sacramento, United States· Recruiting
Research Site
San Diego, United States· Recruiting
Research Site
New Haven, United States· Recruiting
Research Site
Jacksonville, United States· Recruiting
Research Site
Miami, United States· Recruiting
Research Site
Orlando, United States· Recruiting

+106 more sites — see the official record for the full list.

Common questions

What is advanced clear cell kidney cancer?

It's a type of kidney cancer that has grown or spread beyond the original site, meaning it's no longer confined to the kidney.

What is immunotherapy and why is it mentioned?

Immunotherapy is a type of cancer treatment that helps your body's immune system fight cancer. This study is for patients whose cancer has progressed after having had immunotherapy.

What is a placebo?

A placebo is a 'dummy' drug that looks exactly like the actual treatment but contains no active medicine. It helps researchers fairly compare the new drug's effects.

Will I know if I'm getting the new drug or the placebo?

No, in this type of study (called 'double-blind'), neither you nor your doctors will know which treatment you are receiving. This helps make the study results fair.

What is 'progression-free survival'?

This is a measure of how long a patient lives during and after treatment without their cancer getting worse or spreading.

How to find out more

Medical Director

clinicaltrials@arcusbio.com +1-510-462-3330 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.