Renal cell carcinoma stage IV Trials in Disease

Study Comparing Nivolumab and Ipilimumab with Sunitinib for Patients with Advanced or Metastatic Kidney Cancer

This clinical trial is investigating the effectiveness of two different treatment approaches for advanced or metastatic renal cell carcinoma, a type of kidney cancer that has spread beyond the kidney to other parts of the body. The study compares a combination of two immunotherapy medications, nivolumab and ipilimumab, with a single targeted therapy medication called sunitinib.

Main inclusion criteria:

• You must have a confirmed diagnosis of renal cell carcinoma with a clear-cell component
• Your cancer must be advanced or metastatic, meaning it cannot be cured with surgery alone or has spread to other parts of the body
• You must not have had any previous treatments for this type of cancer, with one limited exception: if you received treatment after surgery that did not include drugs targeting a protein called VEGF, and your cancer returned at least 6 months after that treatment ended
• Your ability to perform everyday activities must be at a level of at least 70% on the Karnofsky Performance Status scale, which measures how well you can care for yourself
• Your cancer must be measurable according to specific medical criteria
• A sample of your tumor tissue must be available for the study
• You must be an adult

Main exclusion criteria:

• You cannot have other types of cancer
• You cannot have received previous treatment specifically for renal cell carcinoma
• You cannot have severe heart problems or uncontrolled high blood pressure
• You cannot have active infections
• You cannot have autoimmune diseases, which are conditions where the body's immune system attacks its own tissues
• You cannot be pregnant or breastfeeding
• You cannot have a history of severe allergic reactions
• You cannot be taking certain medications that might interfere with the study treatments
• You cannot have a history of drug or alcohol abuse

Main focus and goal:

The trial aims to determine which treatment approach provides better outcomes for patients in terms of overall survival and how long patients live without their cancer getting worse. Participants will be randomly assigned to receive either the combination of nivolumab and ipilimumab given through intravenous infusion, or sunitinib taken orally as capsules. Throughout the study, which is expected to continue until August 2028, participants will have regular check-ups, blood tests, and imaging tests to monitor their health and assess how the treatment is affecting their cancer.

Investigational drugs being tested:

Nivolumab is an immunotherapy medication that works by helping your immune system recognize and attack cancer cells more effectively. It is classified as an immune checkpoint inhibitor, which means it blocks a protein that normally prevents immune cells from killing cancer cells. In this trial, nivolumab is given as an intravenous infusion directly into the bloodstream.

Ipilimumab is another immunotherapy drug that works alongside nivolumab. It boosts the immune system's ability to fight cancer by blocking a protein that normally keeps immune cells in check, allowing them to attack cancer cells more effectively. Like nivolumab, it is also given as an intravenous infusion and is classified as an immune checkpoint inhibitor.

Sunitinib is a targeted therapy medication that works differently from the immunotherapy drugs. It blocks certain proteins that promote the growth of cancer cells and blood vessels that supply tumors, effectively limiting the cancer's ability to grow and spread. Sunitinib is taken orally in capsule form and is classified as a tyrosine kinase inhibitor. It is currently used as a standard treatment option and is being compared to the immunotherapy combination to determine which approach may be more effective.

Summary

Currently, there is one active clinical trial for patients with advanced or metastatic renal cell carcinoma Stage IV. This trial is notably being conducted across 13 European countries, including Finland, Belgium, Netherlands, Spain, France, Italy, Czechia, Austria, Hungary, Germany, Denmark, Sweden, and Ireland, providing widespread access to this research opportunity.

The trial focuses on comparing two distinct treatment approaches: a combination immunotherapy approach using nivolumab and ipilimumab versus a single targeted therapy approach using sunitinib. This comparison is particularly important as it may help determine whether the newer immunotherapy combination offers advantages over the currently used standard treatment with sunitinib. The study is designed to evaluate both how long patients live and how long they live without their cancer progressing, which are key measures of treatment effectiveness.

The wide geographic distribution of this trial across multiple European countries suggests a significant collaborative effort to gather comprehensive data and provide access to this research for a diverse patient population across Europe.