This site is intended for U.S. residents only.

A NEW STUDY FORPeople With Advanced or Metastatic Kidney Cancer

with papillary, unclassified, and translocation‑associated subtypes

Not actual participants.

About STELLAR-304


STELLAR-304 is a Phase 3 – During this phase of a clinical trial, researchers test how well a new investigational treatment works compared to a standard treatment for a disease or condition. This phase also seeks to understand the safety of the study drugs, including what kind of side effects the study drugs may cause. Clinical trial – A type of medical research study that tests how well new medical approaches work in people. to check whether a new Investigational – A type of drug or medicine that is being studied in a clinical trial and has not been approved for general use by regulatory agencies like the U.S. Food and Drug Administration (FDA). combination of two medicines (zanzalintinib and nivolumab) works to treat kidney cancer with These are different types of kidney cancer. A pathologist looks at cancer cells under a microscope to figure out which type of kidney cancer you have.. These subtypes of kidney cancer are also called non–clear cell renal cell carcinoma. This trial is for patients whose kidney cancer continued to grow or spread to other parts of the body (metastasized) after other treatments.

Clinical trials help researchers and doctors learn more about medical conditions. Studies like this one help researchers understand whether a study drug is safe and if it works to treat a certain disease or condition. Researchers also use clinical trials to find out how well potential new treatments work in many different types of patients.

THE COMBINATION OF ZANZALINTINIB AND NIVOLUMAB HAS NOT BEEN APPROVED BY THE U.S. FOOD AND DRUG ADMINISTRATION (FDA). THE SAFETY AND EFFECTIVENESS OF THIS STUDY TREATMENT HAVE NOT BEEN PROVEN AND ARE BEING STUDIED AS PART OF THIS CLINICAL TRIAL.

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Contact Us

Call Exelixis Medical Information at 1-888-393-5494 (toll-free) or 1-303-389-1847, or email medinfo@exelixis.com to learn more about this study.

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Not actual participants.

Who Can Join the STELLAR-304 Clinical Trial?


Each clinical trial clearly states who can or cannot join. This is called the eligibility criteria. People with kidney cancer may be able to take part in STELLAR-304 if they

  • Are 18 years of age or older
  • Have kidney cancer with papillary, unclassified, or translocation-associated subtypes
  • Have cancer that doctors cannot remove surgically (unresectable) that is locally advanced or has spread to other parts of the body (metastatic)
  • Have not been treated with drugs for this type of kidney cancer, except in certain cases

Talk with your doctor to learn more about other eligibility requirements you must meet to join the clinical trial. Download the STELLAR-304 Discussion Guide to help start the conversation.

Participation = Representation


People from different backgrounds can experience the same disease differently. For example, Black people have a higher risk of getting certain types of kidney cancer. Having diverse representation in clinical trials helps show if new medicines are safe and work well for people likely to use the medicines.

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Talk with your doctor to learn if this study may be an option for you

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Discussion Guide (Questions for your doctor)

To find out more about joining the STELLAR-304 trial, download the Discussion Guide with questions that will help you talk with your doctor.

DOWNLOAD

Learn More About the Study


People enrolled in STELLAR-304 will be randomly assigned to one of two treatment groups by chance. Twice as many people will be selected for Group 1 as for Group 2. Each group will be treated with different study drugs for their advanced or metastatic kidney cancer. People will know what group they are assigned to and what treatment they will receive.

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Group 1

People in this group will receive the new treatment combination being studied: zanzalintinib and nivolumab.

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Group 2

People in this group will receive a medicine approved for metastatic kidney cancer: sunitinib.

Volunteering for a study is a personal choice. We encourage people from all backgrounds to consider joining the STELLAR-304 clinical trial. Talk to a healthcare provider you trust about clinical trials as a treatment option.

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People in the study will be assigned to a treatment group. Each group will be treated with different drugs.

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A computer will randomly assign each person to a treatment group by chance:

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Group 1 will get zanzalintinib
and nivolumab.

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Group 2 will get sunitinib.

A doctor will carefully monitor the health of each person in the study and watch for side effects.

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ClinicalTrials.gov

Additional details about STELLAR‑304 can be found at ClinicalTrials.gov by searching for NCT05678673.

VISIT CLINICALTRIALS.GOV

Is There a Clinical Study Site Near Me?


STELLAR-304 will take place in the United States and abroad. For specific location and site information, and to confirm whether sites near you are still enrolling new patients, call Exelixis Medical Information at 1-888-393-5494 (toll-free) or 1-303-389-1847, or email medinfo@exelixis.com.

Currently open or planned clinical site cities:

Trial sites may stop enrolling participants at any time. Please check back if you do not see a trial site located near you.

Resources


The following third-party sites can provide information and resources for people living with kidney cancer. They provide educational materials, including webinars and patient guides, and information about support groups.

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Cancer.net

Information from the American Society of Clinical Oncology (ASCO) for people living with cancer, as well as for their families and caregivers.

VISIT ASCO

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Kidney Cancer Association

The Kidney Cancer Association (KCA) is dedicated to supporting and empowering patients and caregivers, and leading change through advocacy and research. Patient education, support services, and resources are available.

VISIT KCA

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CancerCare

Founded in 1944, CancerCare is the leading national organization providing free, professional support services and information to help people manage the emotional, practical, and financial challenges of cancer.

VISIT CancerCare

These are third-party organizations and websites that are not owned or controlled by Exelixis, Inc. Exelixis, Inc. makes no representation regarding the content, accuracy, or completeness of the information provided by these organizations and on these third-party websites. Use and access to the information on these third-party websites is subject to the terms, limitations, and conditions set by that website.

THE COMBINATION OF ZANZALINTINIB AND NIVOLUMAB HAS NOT BEEN APPROVED BY THE FDA. THE SAFETY AND EFFECTIVENESS OF THIS STUDY TREATMENT HAVE NOT BEEN PROVEN AND ARE BEING STUDIED AS PART OF THIS CLINICAL TRIAL.