Study of XL092 and belzutifan combination therapy in people with clear cell kidney cancer who had disease return during or after immunotherapy treatment

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What is this study about?

This clinical trial focuses on treating clear cell renal cell carcinoma, a type of kidney cancer. The study will test a combination of medications including XL092 (also known as Zanzalintinib) and Belzutifan in patients whose cancer has returned during or after previous treatment. The purpose is to evaluate how well these medications work together and to determine their safety when used in combination.

The study is divided into two phases. The first phase will focus on finding the right dose of the medications and checking their safety. The second phase will look at how effective the treatment is in fighting the cancer. The medications are taken by mouth in the form of tablets. Patients will be monitored for any side effects and how their cancer responds to the treatment.

Throughout the study, doctors will track how the tumors respond to treatment, how long the response lasts, and how long patients survive without their cancer getting worse. They will also monitor the overall survival of patients and look for any benefits from the treatment. Regular medical check-ups and tests will be performed to ensure patient safety and evaluate the treatment’s effectiveness.

1 Initial medication phase

You will receive two medications: Belzutifan (film-coated tablet) and XL092 (tablet). Both medications are taken orally.

Your blood pressure must be controlled and not exceed 140/90 mm Hg before starting the treatment.

2 Regular monitoring

Your doctor will monitor for any side effects or unwanted reactions to the medications.

Regular assessments will be performed to measure how your tumor responds to treatment using RECIST 1.1 criteria (a standardized way to measure changes in tumor size).

Blood tests will be conducted to check your organ function throughout the study.

3 Follow-up assessments

Regular imaging scans will be performed to track any changes in your kidney cancer.

Your doctor will monitor how long the treatment remains effective.

The study will track how long you remain free from disease progression.

4 Safety requirements

Male participants must continue contraception for at least 7 days after the last dose of Belzutifan and 96 days after the last dose of XL092.

Female participants must continue contraception for at least 30 days after the last dose of Belzutifan and 186 days after the last dose of XL092.

Female participants must not breastfeed for 96 days after the last dose of study medications.

5 Study completion

The study is expected to continue until June 2030.

Your participation may end earlier if your disease progresses or if you experience significant side effects.

After completing the treatment, you will continue to be monitored for any lasting effects and overall survival.

Who Can Join the Study?

Must have confirmed diagnosis of clear cell renal cell carcinoma (a type of kidney cancer) that cannot be surgically removed or has spread to other parts of the body
Must be between 18 and 120 years of age
For male participants:
– Must use contraception for at least 7 days after the last dose of Belzutifan and 96 days after the last dose of Zanzalintinib
– Must not donate sperm during this period
– Must use appropriate contraception methods or remain abstinent
For female participants:
– Must not be breastfeeding
– Must have a negative pregnancy test before starting treatment
– Must use effective contraception for at least 30 days after the last dose of Belzutifan and 186 days after the last dose of Zanzalintinib
Must not have received any previous systemic treatment (medication that travels through the bloodstream) for advanced kidney cancer, except for certain immunotherapy treatments
Must have measurable disease that can be evaluated using specific medical criteria
Must be able to swallow oral medication
Must provide a tumor tissue sample, either from previous procedures or a new biopsy
If receiving bone treatments, must have started them at least 2 weeks before beginning the study
Must have controlled blood pressure (140/90 mm Hg or lower)
Must have adequate organ function

Who Cannot Join the Study?

History of autoimmune diseases (conditions where the body’s immune system attacks its own tissues)
Active or untreated brain metastases (cancer that has spread to the brain)
Significant heart conditions including heart failure, uncontrolled high blood pressure, or irregular heart rhythm
Active infections requiring systemic treatment (medications that affect the whole body)
Previous organ transplant requiring ongoing immunosuppression (medications that weaken the immune system)
Other active cancers requiring treatment, except for certain skin cancers
Severe kidney or liver problems
Pregnancy or breastfeeding
Known allergies to study medications
Participation in other clinical trials within the past 30 days
Mental conditions that could interfere with study compliance
Use of medications that could interact with study drugs
HIV, active hepatitis B, or hepatitis C infection
History of severe reactions to similar treatments
Major surgery within 28 days before starting the study

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut De Cancerologie De Lorraine	Vandoeuvre Les Nancy	France
Institut Gustave Roussy	Villejuif	France
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy	Bydgoszcz	Poland
Centre De Lutte Contre Le Cancer Eugene Marquis	Rennes	France
Uqsifjbjaxgybe Cqjzdns Knikehzqk	Gdansk	Poland
Hcahcqbz Vbcj dqnrpcfy	Barcelona	Spain
Hzzklzfe Uvtiligtwlmlxs Slwjkxvbgh &cspnco Hbiloby dc Hnnzyndxkgb	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.09.2025
Poland	Recruiting	01.09.2025
Spain	Recruiting	01.09.2025

Trial locations

Investigated drugs:

Based on the provided trial data, I cannot extract specific medications as the source data doesn’t contain detailed information about the treatments. However, from the trial title, we can identify that this study involves:

Anti-PD-(L)1 therapy, which is a type of immunotherapy that helps the immune system recognize and fight cancer cells. It’s commonly used as an adjuvant (additional) treatment for renal cell carcinoma (RCC).

This appears to be a study investigating combinations of immune and targeted therapies, but specific medication names are not provided in the source data.

Since no other specific medications or therapies are mentioned in the provided data, I cannot provide additional medication descriptions.

Investigated diseases:

Renal cell carcinoma

Clear Cell Renal Cell Carcinoma – A type of kidney cancer that begins in the cells lining the small tubes in the kidney that filter waste from the blood. It gets its name from the clear appearance of the cancer cells when viewed under a microscope due to their high lipid and glycogen content. The disease typically starts in one kidney but can potentially spread to other parts of the body. This cancer develops when healthy cells in the kidney undergo genetic changes that cause them to grow uncontrollably and form a mass. Clear cell renal cell carcinoma is the most common form of kidney cancer in adults.

Trial ID:

2024-516437-12-00

Protocol code:

MK-3475-03C

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of XL092 and belzutifan combination therapy in people with clear cell kidney cancer who had disease return during or after immunotherapy treatment

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?