Ongoing Clinical Trials for Metastatic Renal Cancer
There are currently 2 ongoing clinical trials for patients with metastatic renal cancer. These studies are testing immunotherapy treatments and targeted therapies for patients with advanced or metastatic clear cell kidney cancer. Trials are taking place across multiple European countries and are evaluating different combinations of medications to help improve treatment outcomes.
Clinical trial locations
- Belgium
- Czechia
- Finland
- France
- Germany
- Ireland
- Italy
- Netherlands
- Poland
- Portugal
- Romania
- Spain
Study of Subcutaneous Nivolumab for Patients with Previously Treated Advanced or Metastatic Clear Cell Kidney Cancer
This trial is focused on patients with advanced or metastatic clear cell renal cell carcinoma who have already received treatment. Clear cell renal cell carcinoma is a type of kidney cancer that forms in the lining of small tubes within the kidney and has spread to other parts of the body.
Main inclusion criteria:
- You must have a confirmed diagnosis of renal cell carcinoma with a clear cell component, which may include sarcomatoid features
- Your cancer must be advanced and cannot be cured with surgery or radiation, or it must be metastatic, meaning it has spread to other parts of the body
- You must have measurable disease as defined by specific tumor assessment criteria within 28 days before being assigned to a treatment group
- You should have received no more than 2 previous systemic treatment regimens
- You must have experienced intolerance or disease progression during or after your last treatment within 6 months before joining the study
- Your Karnofsky Performance Status must be 70 or higher, which measures your ability to perform everyday activities
Main exclusion criteria:
- Patients with a different type of cancer than the one being studied
- Patients who are pregnant or breastfeeding
- Patients who have participated in another clinical trial recently
- Patients with allergies to the study medication or its ingredients
- Patients taking medications that might interfere with the study treatment
- Patients with other serious health conditions that might interfere with the study
- Patients with a history of substance abuse or alcohol dependency
- Patients with an infection requiring antibiotic treatment
Focus and goal: This study is comparing two different ways of giving nivolumab, an immunotherapy drug that helps the immune system fight cancer. One method involves injecting the medication under the skin (subcutaneous), while the other involves infusing it through a vein (intravenous). The trial aims to determine whether the subcutaneous form is as effective as the traditional intravenous form, potentially offering a more convenient treatment option for patients. Participants will be randomly assigned to receive either form of the medication, and their health and cancer progression will be monitored regularly over several years to gather comprehensive data on the treatment’s effectiveness and safety.
Investigational drug: Nivolumab is an immunotherapy medication that helps the body’s immune system recognize and attack cancer cells. It works by blocking a protein called PD-1 on immune cells, which enhances the immune system’s ability to fight cancer. In this study, nivolumab is being tested in both subcutaneous (under the skin) and intravenous (into a vein) forms to compare their effectiveness in treating advanced or metastatic clear cell renal cell carcinoma.
Study on Cabozantinib, Nivolumab, and Ipilimumab for Patients with Advanced or Metastatic Kidney Cancer Who Have Not Received Prior Treatment
This trial focuses on patients with advanced or metastatic renal cell carcinoma who have not yet received any treatment for their condition. The study is investigating whether adding a targeted therapy medication to an immunotherapy combination can improve treatment outcomes.
Main inclusion criteria:
- You must have a diagnosis of advanced or metastatic renal cell carcinoma with a clear-cell component that cannot be treated with surgery or radiation
- You must be classified as having intermediate- or poor-risk cancer according to specific medical criteria
- You must have measurable disease as determined by specific guidelines
- Your Karnofsky Performance Status must be 70% or higher, indicating good ability to perform daily activities
- You must have adequate organ and bone marrow function
- Both male and female participants within the specified age range are eligible
Main exclusion criteria:
- Patients who have received any prior treatment for their metastatic renal cell carcinoma
- Patients with other types of cancer that are not stable or are being actively treated
- Patients with serious heart problems, including heart failure or recent heart attacks
- Patients with uncontrolled high blood pressure
- Patients with active infections requiring treatment
- Patients with unstable autoimmune diseases
- Patients who are pregnant or breastfeeding
- Patients who have had major surgery within the last 4 weeks
- Patients with known allergies to the study drugs
Focus and goal: This study is comparing two treatment approaches. One group receives a combination of three medications: cabozantinib (taken as a tablet), nivolumab, and ipilimumab (both given as infusions). The other group receives only the two immunotherapy drugs, nivolumab and ipilimumab. The trial is designed as a double-blind study, meaning neither participants nor researchers know which treatment each participant is receiving, to ensure unbiased results. The main goal is to measure how long participants live without the cancer getting worse (progression-free survival) and overall survival. The study will run until December 2025, with regular monitoring visits to assess the treatment’s effectiveness and any side effects.
Investigational drugs: Cabozantinib is a targeted therapy medication that works by blocking certain proteins that promote cancer cell growth and blood vessel formation. It is taken orally as a tablet. Nivolumab is an immunotherapy drug given through intravenous infusion that helps the immune system recognize and attack cancer cells by blocking a protein that normally prevents immune cells from doing their job. Ipilimumab is another immunotherapy medication administered intravenously that activates the immune system to fight cancer cells by targeting a different protein that keeps immune responses in check. Together, these medications aim to slow down or stop cancer progression through different mechanisms of action.
Summary
Currently, there are 2 active clinical trials available for patients with metastatic renal cancer across Europe. Both studies focus on advanced or metastatic clear cell renal cell carcinoma, which is the most common form of kidney cancer.
A notable feature of these trials is their widespread availability across multiple European countries. The first trial is available in 9 countries (Romania, Czechia, Italy, France, Poland, Finland, Portugal, Spain, and Ireland), while the second trial is available in 9 countries as well (Italy, France, Spain, Finland, Netherlands, Germany, Czechia, Poland, and Belgium). This broad geographic distribution provides patients across Europe with access to these investigational treatments.
The two trials address different patient populations. The first study is designed for patients who have already received treatment and are looking for alternative options, while the second trial is specifically for patients who have not yet received any treatment for their metastatic disease. This means that regardless of where you are in your treatment journey, there may be a trial option available.
Both studies feature nivolumab, an immunotherapy medication, which appears to be a central component in current research for this type of cancer. The first trial is examining different methods of administering nivolumab (under the skin versus through a vein), while the second trial combines nivolumab and ipilimumab with cabozantinib, a targeted therapy. This focus on immunotherapy reflects the current direction of cancer treatment research, which aims to harness the body’s own immune system to fight cancer cells.
If you have been diagnosed with metastatic renal cancer, it is worth discussing these trial options with your doctor to determine whether you might be eligible to participate in either study.
