Clinical Trials for Non-renal Cell Carcinoma of Kidney
Currently, there are 3 ongoing clinical trials investigating treatments for non-renal cell carcinoma of kidney, including rare subtypes such as collecting duct carcinoma and medullary renal cell carcinoma. These trials are being conducted in Italy, Denmark, France, and Poland, and are testing various treatment approaches including immunotherapy, targeted therapy, and personalized treatment strategies based on genetic analysis.
Clinical trial locations
- Denmark
- France
- Italy
- Poland
Study of Pembrolizumab and Enfortumab Vedotin for Patients with Collecting Duct and Renal Medullary Carcinoma
This trial is investigating a combination treatment approach for two rare and aggressive forms of kidney cancer: collecting duct carcinoma and medullary renal cell carcinoma. The study combines two medications delivered through intravenous infusion.
Main focus: The trial aims to evaluate how effective the combination of pembrolizumab and enfortumab vedotin is in treating these specific types of kidney cancer. Researchers will measure the objective response rate, which shows how much the cancer shrinks or disappears, as well as progression-free survival and overall survival. The study will continue until December 2029.
Investigational drugs: Pembrolizumab is an immunotherapy that helps the immune system recognize and attack cancer cells by blocking a specific protein. Enfortumab vedotin is a targeted therapy that combines an antibody with chemotherapy, allowing the medication to find cancer cells and deliver treatment directly to them.
Who can participate: The trial is open to adults aged 18 and older with confirmed metastatic or advanced collecting duct carcinoma or medullary renal cell carcinoma. Participants must have measurable disease based on imaging tests and be able to carry out daily activities with minimal restrictions. A tumor tissue sample from a biopsy is required. The trial also accepts patients with hepatitis B, hepatitis C, or HIV if these conditions are well-controlled with appropriate medications.
Who cannot participate: The trial excludes patients with other types of kidney cancer, pregnant or breastfeeding women, those unable to provide informed consent, and individuals with severe medical conditions that could interfere with treatment safety. People with known allergies to the study medications are also excluded.
Study of Dabrafenib and Drug Combination for Patients with Metastatic Non-Clear Cell Kidney Cancer
This trial takes a personalized approach to treating metastatic non-clear cell kidney cancer that has spread to other parts of the body. The study involves multiple medications that may be used individually or in combination based on each patient’s specific cancer characteristics.
Main focus: The trial evaluates an individualized treatment strategy using genetic analysis of tumor tissue to determine the best medication approach for each patient. Researchers will monitor how well patients respond to treatment and how long the treatment remains effective. The study is expected to conclude by September 2025.
Investigational drugs: The trial includes multiple medications such as sunitinib, everolimus, cabozantinib, and nivolumab, among others. These drugs work through different mechanisms—some block proteins that promote cancer growth, while others help the immune system attack cancer cells more effectively. Medications are administered either orally or through intravenous infusion.
Who can participate: Eligible participants must be at least 18 years old with confirmed metastatic non-clear cell renal cell carcinoma that cannot be removed by surgery. A tumor biopsy is required to provide tissue for DNA and RNA analysis, which helps determine the treatment approach. Participants must have measurable disease, a life expectancy of more than 3 months, and adequate organ function including specific blood count levels and kidney function above certain thresholds. Women of childbearing potential must have a negative pregnancy test, and both men and women must use effective birth control methods.
Who cannot participate: The trial excludes patients with other types of cancer, those who are pregnant or breastfeeding, and individuals unable to follow study procedures or attend regular visits. People who have recently participated in other clinical trials or received recent cancer treatment may also be excluded.
Study of Long-term Safety of Tazemetostat in Patients Who Previously Participated in Tazemetostat Clinical Trials
This study focuses on monitoring the long-term safety of tazemetostat in patients who have already been receiving this medication in previous clinical trials and have shown benefit from the treatment.
Main focus: The trial evaluates the long-term safety profile of tazemetostat by tracking any side effects and how well patients tolerate the medication over extended periods. Researchers will monitor various health measures including blood cell counts, kidney function, and liver function, as well as overall survival. The study will continue until September 2025.
Investigational drug: Tazemetostat is an oral medication taken as film-coated tablets. It belongs to a class of drugs called EZH2 inhibitors, which work by blocking specific enzymes that control cancer cell growth. This targeted approach helps control the growth of certain types of cancer cells.
Who can participate: Participants must currently be receiving or have previously received tazemetostat with proven clinical benefit. They must have a life expectancy of more than 3 months and adequate blood counts, bone marrow function, kidney function, and liver function. Women who can become pregnant must have a negative pregnancy test and agree to use both a highly effective birth control method and a barrier method during treatment and for 6 months afterward. Men must either have had a vasectomy and use condoms, or their partner must use effective birth control during treatment and for 3 months after.
Who cannot participate: The trial excludes patients not currently receiving tazemetostat in a previous study, those who experienced severe side effects during previous treatment, and individuals unable to comply with long-term safety monitoring. Patients who have developed medical conditions making continued treatment unsafe, withdrawn consent from previous studies, or developed progressive disease while on treatment are also excluded. Those participating in other clinical trials simultaneously or who have developed contraindications to the medication cannot join.
Summary
The three ongoing trials for non-renal cell carcinoma of kidney reflect the complexity and rarity of these cancer subtypes. The trials are distributed across four European countries, with one trial specifically targeting the extremely rare collecting duct and medullary carcinomas in Italy, another exploring personalized treatment strategies in Denmark, and a long-term safety study available in both France and Poland.
A notable feature is the diversity of treatment approaches being investigated. These include combination immunotherapy, personalized treatment based on genetic analysis, and long-term safety monitoring of targeted therapies. The trials employ various mechanisms of action, from immune system activation to specific protein inhibition, reflecting the evolving understanding of these rare kidney cancers.
The geographic distribution is relatively limited, suggesting these rare cancer types present challenges for trial recruitment. The personalized medicine approach in the Danish trial, which tailors treatment based on individual tumor genetics, represents an innovative strategy for addressing the heterogeneity of non-clear cell kidney cancers.