Ongoing Clinical Trials for Recurrent Renal Cancer
There is currently 1 ongoing clinical trial for patients with recurrent renal cancer. This trial is testing a new treatment called DFF332, used alone or in combination with other medications, for advanced kidney cancer and related tumors with specific genetic changes. The study is being conducted in multiple European countries.
Clinical trial locations
- Czechia
- France
- Spain
Study of DFF332 Alone and with Everolimus or Immuno-oncology Drugs for Patients with Advanced Renal Cell Carcinoma and Tumors with HIF2α Mutations
This clinical trial is testing a new treatment approach for patients with clear cell renal cell carcinoma, a specific type of kidney cancer, as well as other cancers that have particular genetic changes known as HIF2α mutations. These mutations affect how cancer cells grow and survive, making them an important target for new therapies.
Main inclusion criteria:
- Most participants must be at least 18 years old, though a specific part of the study accepts patients from age 12
- Confirmed diagnosis of clear cell renal cell carcinoma that can be measured and tracked using medical imaging
- Cancer that cannot be removed by surgery, has spread locally, or has spread to other parts of the body
- Disease that has progressed after trying all standard treatments, including PD-1/L1 checkpoint inhibitor therapy and VEGF targeted therapy
- Ability to perform most daily activities, measured by either ECOG performance status (score of 1 or less for adults) or Lansky performance status (score of 70 or more for children aged 12-16)
- For the genetic mutation part of the study: confirmed diagnosis of cancer related to Von Hippel-Lindau disease or other specific gene mutations
Main exclusion criteria:
- Other serious health conditions that could interfere with the study
- Pregnancy or breastfeeding
- Recent participation in another clinical trial
- Allergies to the study medications
- Poorly controlled infections
- Recent surgery or major medical procedure
- History of certain heart conditions
- Inability to follow study procedures
Focus and goals:
The primary purpose of this study is to understand how safe and tolerable DFF332 is when used alone or in combination with other cancer treatments. Researchers want to determine the best dose and treatment combination for future use. The study will carefully monitor participants for side effects and changes in their health, while also tracking how the cancer responds to treatment. Measurements include overall response rate, progression-free survival, and duration of response.
Throughout the trial, participants will undergo regular check-ups including blood tests, vital signs monitoring, and electrocardiograms to ensure their safety. The study follows a structured approach, starting with eligibility confirmation, followed by initial health assessments, the treatment phase, ongoing monitoring, evaluation of how the cancer responds, and final assessments at study completion.
Investigational drugs being tested:
DFF332 is the main investigational medication in this trial. It is taken as a capsule by mouth and works by targeting proteins that help cancer cells survive and grow, specifically those involved in stabilizing HIF2α. This is a new type of targeted cancer therapy that focuses on molecular pathways altered in certain cancers.
Everolimus is an established medication that is being used in combination with DFF332 in some parts of the study. It works by blocking a protein called mTOR, which is involved in cancer cell growth, thereby helping to slow down or stop the cancer from growing. This medication is already approved for treating advanced kidney cancer.
Spartalizumab is an immune therapy being tested alongside DFF332 and other medications. It helps the body’s immune system recognize and attack cancer cells by blocking a protein called PD-1 on immune cells. This type of treatment is called an immune checkpoint inhibitor.
Taminadenant is another investigational drug used in combination with Spartalizumab and DFF332. It works by blocking adenosine receptors, which can suppress the immune response against tumors, potentially enhancing the body’s ability to fight cancer.
The study is expected to conclude in early 2025, and the data collected will help researchers understand whether these treatments can offer better options for patients with clear cell renal cell carcinoma and other cancers with specific genetic mutations.
Summary
Currently, there is one active clinical trial available for patients with recurrent renal cancer. This study is being conducted across three European countries: Czechia, France, and Spain, providing access to this experimental treatment in multiple locations.
The trial focuses on testing DFF332, a new targeted therapy, both as a single treatment and in various combinations with other cancer medications including Everolimus, Spartalizumab, and Taminadenant. This approach reflects current research interest in combination therapies that may be more effective than single treatments alone.
A notable aspect of this trial is its focus on patients whose cancer has specific genetic changes, particularly HIF2α mutations. This represents a growing trend in cancer research toward personalized medicine, where treatments are designed to target specific molecular characteristics of tumors rather than using a one-size-fits-all approach.
The study accepts patients who have already tried standard treatments without success, offering a potential option for those who have limited alternatives. It is important to note that all medications being tested are still investigational, meaning their safety and effectiveness are still being evaluated.