Ongoing Clinical Trials for Metastatic Renal Cell Carcinoma
There are currently 13 clinical trials ongoing worldwide investigating new treatments and imaging methods for metastatic renal cell carcinoma. These studies are exploring combinations of immunotherapy drugs, targeted therapies, and supportive care approaches to improve outcomes for patients with this type of kidney cancer that has spread to other parts of the body.
Clinical trial locations
- Austria
- Belgium
- Czechia
- Study on Cabozantinib and Drug Combination for Untreated Metastatic Renal Cell Carcinoma in Intermediate and Poor Risk Patients
- Study Comparing Nivolumab and Cabozantinib with Sunitinib for Patients with Untreated Advanced Kidney Cancer
- Study Comparing Nivolumab and Ipilimumab with Sunitinib for Patients with Advanced or Metastatic Kidney Cancer
- Study of Pembrolizumab and Axitinib Combination Versus Sunitinib for Patients with Advanced or Metastatic Kidney Cancer
- Denmark
- Finland
- France
- Study of Axitinib and Pembrolizumab for Patients with Advanced or Metastatic Papillary Renal Cell Carcinoma
- Study on Cabozantinib and Drug Combination for Untreated Metastatic Renal Cell Carcinoma in Intermediate and Poor Risk Patients
- Study Comparing Nivolumab and Ipilimumab with Sunitinib for Patients with Advanced or Metastatic Kidney Cancer
- Study of Axitinib and Immune Checkpoint Inhibitors for Patients with Untreated Advanced or Metastatic Kidney Cancer
- Study of Pembrolizumab and Axitinib Combination Versus Sunitinib for Patients with Advanced or Metastatic Kidney Cancer
- Study on Pausing Treatment with Pembrolizumab and Axitinib in Patients with Metastatic Kidney Cancer at Good or Intermediate Risk
- Germany
- Study Comparing Nivolumab and Cabozantinib with Sunitinib for Patients with Untreated Advanced Kidney Cancer
- Study Comparing Nivolumab and Ipilimumab with Sunitinib for Patients with Advanced or Metastatic Kidney Cancer
- Study of Axitinib and Immune Checkpoint Inhibitors for Patients with Untreated Advanced or Metastatic Kidney Cancer
- Study of Pembrolizumab and Axitinib Combination Versus Sunitinib for Patients with Advanced or Metastatic Kidney Cancer
- Greece
- Hungary
- Ireland
- Italy
- Study on Cabozantinib and Drug Combination for Untreated Metastatic Renal Cell Carcinoma in Intermediate and Poor Risk Patients
- Study on the Effects of Tumor Removal in Patients with Metastatic Kidney Cancer Treated with Nivolumab and Ipilimumab Combination
- Study Comparing Nivolumab and Cabozantinib with Sunitinib for Patients with Untreated Advanced Kidney Cancer
- Study of Axitinib and Nivolumab for Patients with Metastatic Renal Cell Carcinoma Not Responding Completely to Initial Treatment
- Study on Pembrolizumab for Patients with Resectable Metastases from Kidney Cancer
- Study Comparing Nivolumab and Ipilimumab with Sunitinib for Patients with Advanced or Metastatic Kidney Cancer
- Netherlands
- Study Comparing Gallium (68Ga) Gozetotide and Zirconium (89Zr) Girentuximab PET Scans for Detecting Tumors in Patients with Metastatic Renal Cell Carcinoma
- Study on Cabozantinib and Drug Combination for Untreated Metastatic Renal Cell Carcinoma in Intermediate and Poor Risk Patients
- Study Comparing Nivolumab and Ipilimumab with Sunitinib for Patients with Advanced or Metastatic Kidney Cancer
- Poland
- Study Comparing Nivolumab and Cabozantinib with Sunitinib for Patients with Untreated Advanced Kidney Cancer
- Study of Axitinib and Immune Checkpoint Inhibitors for Patients with Untreated Advanced or Metastatic Kidney Cancer
- Study of Pembrolizumab and Axitinib Combination Versus Sunitinib for Patients with Advanced or Metastatic Kidney Cancer
- Romania
- Spain
- Study Comparing Nivolumab and Cabozantinib with Sunitinib for Patients with Untreated Advanced Kidney Cancer
- Study of Axitinib and Nivolumab for Patients with Metastatic Renal Cell Carcinoma Not Responding Completely to Initial Treatment
- Study Comparing Nivolumab and Ipilimumab with Sunitinib for Patients with Advanced or Metastatic Kidney Cancer
- Study of Axitinib and Immune Checkpoint Inhibitors for Patients with Untreated Advanced or Metastatic Kidney Cancer
- Study of Pembrolizumab and Axitinib Combination Versus Sunitinib for Patients with Advanced or Metastatic Kidney Cancer
- Study of Pembrolizumab and Epacadostat vs Standard Treatment for Patients with Advanced or Metastatic Kidney Cancer
- Sweden
Study Comparing Gallium (68Ga) Gozetotide and Zirconium (89Zr) Girentuximab PET Scans for Detecting Tumors in Patients with Metastatic Renal Cell Carcinoma
This study, taking place in the Netherlands, focuses on comparing two advanced imaging techniques for detecting tumors in patients with suspected clear cell renal cell carcinoma. The trial evaluates how well 68Ga-gozetotide (PSMA) PET scans and 89Zr-girentuximab PET scans can identify tumors compared to standard CT imaging.
Main inclusion criteria: Participants must be 18 years or older with suspected metastatic clear cell renal cell carcinoma based on a recent contrast-enhanced CT scan performed within four weeks before the PET scan. The diagnosis may or may not be confirmed by biopsy. Both male and female participants are eligible.
Main exclusion criteria: Patients without metastatic renal cell carcinoma, those outside the specified age range, or those belonging to vulnerable populations cannot participate.
Focus and goal: The study aims to determine which imaging method provides more accurate detection of tumors. Participants will undergo both types of PET scans, and results will be compared with standard CT imaging to evaluate which approach offers superior tumor visualization.
Investigational drugs: The trial uses two radiopharmaceutical imaging agents: 68Ga-gozetotide, which targets the PSMA protein often elevated on cancer cells, and 89Zr-girentuximab, which binds to a protein commonly present in kidney cancer cells. Both agents are administered intravenously to help visualize cancer during PET scans.
Study of Axitinib and Pembrolizumab for Patients with Advanced or Metastatic Papillary Renal Cell Carcinoma
Conducted in France, this trial specifically targets papillary renal cell carcinoma, a less common subtype of kidney cancer. The study compares the combination of axitinib and pembrolizumab with axitinib alone.
Main inclusion criteria: Patients must be at least 18 years old with confirmed locally advanced or metastatic type 2 papillary renal cell carcinoma verified by central tissue review. Participants must not have received prior systemic treatment for their cancer. At least one measurable tumor site is required, and patients must have an ECOG performance status of 0 or 1. Adequate bone marrow, liver, and kidney function is necessary, confirmed through specific blood tests.
Main exclusion criteria: Patients with other cancer types, those who have received previous cancer treatment, individuals with serious health conditions that might interfere with the study, pregnant or breastfeeding women, and those unable to follow study procedures are excluded.
Focus and goal: The study evaluates how well the combination of axitinib (which blocks proteins helping cancer growth) and pembrolizumab (an immunotherapy drug) works compared to axitinib alone. The primary goal is to measure the objective response rate and assess treatment duration, progression-free survival, overall survival, and safety.
Investigational drugs: Axitinib is taken orally and works by blocking tyrosine kinases involved in cancer cell growth. Pembrolizumab is given intravenously and helps the immune system recognize and attack cancer cells by blocking the PD-1 protein.
Study on Cabozantinib and Drug Combination for Untreated Metastatic Renal Cell Carcinoma in Intermediate and Poor Risk Patients
This multi-country study (France, Czechia, Netherlands, Italy, Austria, Finland) explores different treatment combinations for patients classified as intermediate or poor risk who have not yet received treatment for their metastatic cancer.
Main inclusion criteria: Participants must have confirmed metastatic renal cell carcinoma and be classified as intermediate or poor risk according to IMDC criteria. They must be at least 18 years old with a Karnofsky Performance Status of 70% or higher. Adequate organ and marrow function is required, including specific levels of neutrophils, platelets, hemoglobin, liver enzymes, and kidney function. Men capable of fathering children must use condoms with spermicide, and women of childbearing potential must not be pregnant and agree to use highly effective birth control.
Main exclusion criteria: Patients who have already received treatment for metastatic renal cell carcinoma, those outside the specified age range, or those not meeting the IMDC risk criteria cannot participate.
Focus and goal: The trial compares combinations of immune checkpoint inhibitors and VEGFR tyrosine kinase inhibitors, including nivolumab with ipilimumab versus other combinations with cabozantinib, axitinib, lenvatinib, and pembrolizumab. The study aims to determine which combination is most effective in improving survival rates and delaying disease progression.
Investigational drugs: The study uses several medications including cabozantinib (oral tablets), nivolumab (IV infusion), axitinib (oral tablets), pembrolizumab (IV infusion), ipilimumab (IV infusion), and lenvatinib (oral capsules). These drugs work through different mechanisms to block cancer growth or enhance immune response.
Study on Folic Acid for Reducing Mucositis in Patients with Metastatic Kidney Cancer Receiving Targeted Therapy
This Danish study investigates whether a folic acid supplement can help reduce mucositis, a painful inflammation and ulceration of mucous membranes caused by cancer treatment.
Main inclusion criteria: Patients must be at least 18 years old with biopsy-proven locally advanced or metastatic renal cell carcinoma. They must have grade 2 or higher mucositis during treatment with certain cancer drugs. A Karnofsky Performance status of 60% or higher is required. Patients must sign written informed consent and be willing to follow study procedures. Women of childbearing potential must have a negative pregnancy test and not be breastfeeding, and both men and women must use effective birth control.
Main exclusion criteria: Patients without metastatic renal cell carcinoma, those outside the specified age range, or those belonging to vulnerable populations that require special protection are excluded.
Focus and goal: The study aims to determine whether folic acid supplementation can reduce the severity and frequency of mucositis in patients receiving targeted therapy. Participants receive either folic acid or placebo, and mucositis is monitored using standard adverse event criteria. The study also evaluates quality of life and the need for dose reductions.
Investigational drugs: Folic acid, a B vitamin essential for cell growth and DNA repair, is administered as a 5 mg oral tablet to see if it can help regenerate damaged mucosal tissues and reduce mucositis symptoms.
Study on the Effects of Tumor Removal in Patients with Metastatic Kidney Cancer Treated with Nivolumab and Ipilimumab Combination
This Italian study examines the impact of delaying the removal of the primary kidney tumor in patients already receiving immunotherapy.
Main inclusion criteria: Patients must be at least 18 years old with confirmed clear cell renal cell carcinoma and evidence of primary kidney cancer. They must have measurable metastatic disease and an ECOG performance status of 0 or 1, indicating they can perform daily activities. Participants must be under treatment with anti-PD1-based therapy (such as axitinib with pembrolizumab, cabozantinib with nivolumab, lenvatinib with pembrolizumab, or nivolumab alone) for at least 24 but not more than 52 weeks without cancer progression. Adequate bone marrow, liver, and kidney function is required. Women and men must use adequate contraception from consent until at least 3 months after treatment ends.
Main exclusion criteria: Patients with other cancer types, those not receiving standard care with anti-PD1-based therapies, or those outside the specified age range are excluded.
Focus and goal: The study evaluates whether delaying surgical removal of the primary tumor (cytoreductive nephrectomy) affects overall survival and progression-free survival in patients responding to immunotherapy. The trial also assesses surgical safety and quality of life impacts.
Investigational drugs: The study involves anti-PD1-based therapies, which are immunotherapy treatments that help the immune system recognize and attack cancer cells by blocking the PD-1 protein on immune cells.
Study Comparing Nivolumab and Cabozantinib with Sunitinib for Patients with Untreated Advanced Kidney Cancer
This trial, conducted across Greece, Spain, Italy, Czechia, Germany, Poland, and Romania, compares a combination therapy of nivolumab and cabozantinib with the single agent sunitinib.
Main inclusion criteria: Patients must have confirmed advanced or metastatic renal cell carcinoma with a clear-cell component, which may include sarcomatoid features. The disease must be unresectable or metastatic. Participants must not have received any prior systemic therapy for their cancer, except for certain adjuvant or neoadjuvant therapy cases. Measurable disease according to medical guidelines is required. Patients must have a Karnofsky Performance Status of 70% or higher. Tumor tissue samples must be provided. Both men and women capable of reproduction must use reliable birth control methods.
Main exclusion criteria: Patients who have received previous treatment, those with other serious health conditions, pregnant or breastfeeding women, those with allergies to study medications, patients with other cancers (unless successfully treated), active infections, certain heart or lung conditions, and those participating in other trials are excluded.
Focus and goal: The study aims to determine whether the combination of nivolumab (an immunotherapy) and cabozantinib (a targeted therapy) provides better outcomes than sunitinib alone in terms of progression-free survival, overall survival, and response rates.
Investigational drugs: Nivolumab is given as an intravenous infusion and helps the immune system attack cancer. Cabozantinib is taken as oral tablets and blocks proteins cancer cells need to grow. Sunitinib, also oral, blocks proteins helping cancer grow and spread.
Study of Axitinib and Nivolumab for Patients with Metastatic Renal Cell Carcinoma Not Responding Completely to Initial Treatment
This study in Spain and Italy investigates whether adding axitinib to nivolumab improves outcomes for patients who haven’t achieved a complete response after initial treatment with nivolumab and ipilimumab.
Main inclusion criteria: Patients must be at least 18 years old with confirmed advanced renal cell carcinoma with clear-cell subtype. They must have completed treatment with nivolumab and ipilimumab without severe side effects and without achieving complete response or disease progression. At least one measurable tumor is required. A Karnofsky Performance Status of 70% or higher is needed. Adequate organ and bone marrow function must be demonstrated through blood tests. Tumor tissue samples must be available. Both sexually active men and women capable of reproduction must use effective birth control.
Main exclusion criteria: Patients with other cancer types, those outside the age range, individuals unable to follow study procedures, those with other serious health conditions, pregnant or breastfeeding women, participants in other trials, those with recent surgeries or planned surgeries, individuals with severe allergic reactions to study medications, and those with active infections are excluded.
Focus and goal: The trial compares the combination of axitinib and nivolumab to nivolumab alone in patients who did not achieve complete response to initial immunotherapy. The study evaluates overall response rate, duration of response, progression-free survival, overall survival, and safety.
Investigational drugs: Axitinib is taken orally and works by blocking proteins that promote cancer growth. Nivolumab is given intravenously and helps the immune system attack cancer cells by blocking the PD-1 pathway. Ipilimumab, used in the initial treatment phase, is another immunotherapy that activates the immune system.
Study on Pembrolizumab for Patients with Resectable Metastases from Kidney Cancer
This Italian study examines whether pembrolizumab can delay cancer progression in patients with oligometastatic renal cell carcinoma who are candidates for surgery or radiation therapy.
Main inclusion criteria: Participants must be at least 18 years old with confirmed clear cell renal cell carcinoma. They must have undergone partial or complete kidney removal (nephrectomy) with no cancer cells at the tissue edges. Patients must have a limited number of metastases (maximum of 3, each less than 3 cm) that can be treated with surgery or radiotherapy. New metastases should have appeared within 5 years after primary tumor or previous metastases were removed. Patients must have adequate organ function and an ECOG performance status of 0 to 1. No previous systemic therapy for renal cell carcinoma should have been received. Tumor tissue samples must be provided.
Main exclusion criteria: Patients with other serious health conditions, pregnant or breastfeeding women, those with another cancer history (unless successfully treated), participants in other trials, individuals with allergies to study medication, active infections, certain heart, lung, liver, kidney, or immune system problems, recent cancer treatments, recent surgeries, or recent live vaccine administration are excluded.
Focus and goal: The study evaluates whether pembrolizumab can extend the time until cancer progression or appearance of new metastases in patients with limited metastatic disease. The trial also assesses overall survival and monitors side effects.
Investigational drugs: Pembrolizumab (KEYTRUDA) is administered as an intravenous infusion. It works by blocking the PD-1 pathway, helping the immune system recognize and attack cancer cells more effectively.
Study Comparing Nivolumab and Ipilimumab with Sunitinib for Patients with Advanced or Metastatic Kidney Cancer
This extensive multi-country study (Finland, Belgium, Netherlands, Spain, France, Italy, Czechia, Austria, Hungary, Germany, Denmark, Sweden, Ireland) compares the combination of two immunotherapy drugs with a single targeted therapy drug.
Main inclusion criteria: Patients must have confirmed renal cell carcinoma with clear-cell component, which may include sarcomatoid features. The disease must be advanced (not curable with surgery or radiation) or metastatic. No previous systemic therapy for the cancer is allowed, except for one prior post-surgical treatment that did not include VEGF-targeting drugs if cancer recurred at least 6 months after treatment. A Karnofsky Performance Status of at least 70% is required. Measurable disease and tumor tissue samples are necessary.
Main exclusion criteria: Patients with other cancers (unless successfully treated over 5 years ago), active infections requiring treatment, severe allergic reactions to similar drugs, uncontrolled high blood pressure, significant heart problems, brain metastases (unless treated and stable), pregnant or breastfeeding women, recent investigational drug use, autoimmune diseases, organ transplant history, and known HIV, hepatitis B, or hepatitis C infections are excluded.
Focus and goal: The trial compares how long patients live and how long they live without cancer progression when treated with nivolumab and ipilimumab combination versus sunitinib alone.
Investigational drugs: Nivolumab and ipilimumab are both given as intravenous infusions and work by helping the immune system recognize and attack cancer cells through different immune checkpoint pathways. Sunitinib is taken orally as a capsule and blocks proteins that cancer cells need to grow and spread.
Study of Axitinib and Immune Checkpoint Inhibitors for Patients with Untreated Advanced or Metastatic Kidney Cancer
Conducted in Germany, Poland, France, and Spain, this trial explores combinations of axitinib with different immune checkpoint inhibitors to find the most effective approach.
Main inclusion criteria: Patients must have untreated locally advanced or metastatic renal cell carcinoma with an IMDC risk score of intermediate (1 or 2) or poor (3 to 6). The cancer must be clear-cell type with possible sarcomatoid features. At least one measurable tumor is required. Adequate blood and organ function must be demonstrated within 14 days before starting treatment. Patients must be between 18 and 64 years old. Negative hepatitis B and C tests are required (with follow-up testing if needed).
Main exclusion criteria: Patients who have received prior treatment, those outside the specified age range, individuals belonging to clinical trial groups not included in the study, or those from vulnerable populations requiring special protection are excluded.
Focus and goal: The study compares different combinations of medications including tobemstomig (RO7247669) with axitinib, tiragolumab with tobemstomig and axitinib, versus a control group receiving pembrolizumab with axitinib. The goal is to determine which combination provides the best effectiveness and safety profile.
Investigational drugs: Tobemstomig, tiragolumab, and pembrolizumab are all immune checkpoint inhibitors given intravenously that help the immune system fight cancer. Axitinib is taken orally and blocks proteins that help cancer cells grow.
Study of Pembrolizumab and Axitinib Combination Versus Sunitinib for Patients with Advanced or Metastatic Kidney Cancer
This study in Hungary, France, Spain, Czechia, Poland, Germany, and Ireland compares a combination immunotherapy and targeted therapy approach with a single targeted therapy.
Main inclusion criteria: Patients must have confirmed renal cell carcinoma with clear-cell component (may include sarcomatoid features). The disease must be locally advanced or metastatic, or recurrent. Measurable disease according to medical guidelines is required. No prior systemic therapy for advanced cancer is allowed. Tumor tissue samples must be provided. A Karnofsky Performance Status of 70% or higher is necessary. Adequate organ function must be demonstrated. Men capable of fathering children and women of childbearing potential must use reliable birth control.
Main exclusion criteria: Patients with other metastatic cancers, those with another cancer within 5 years (except certain skin cancers), active infections requiring treatment, history of severe allergic reactions, uncontrolled high blood pressure, significant heart problems, brain metastases (unless treated and stable), pregnant or breastfeeding women, recent investigational drug use, autoimmune diseases, organ transplant history, and known HIV, hepatitis B, or hepatitis C infections are excluded.
Focus and goal: The trial compares the combination of pembrolizumab (immunotherapy) and axitinib (targeted therapy) with sunitinib (targeted therapy) alone to determine which approach provides better outcomes in terms of progression-free survival and overall survival.
Investigational drugs: Pembrolizumab is given intravenously and helps the immune system attack cancer by blocking the PD-1 protein. Axitinib is taken orally and blocks proteins cancer cells need to grow. Sunitinib, also oral, blocks proteins helping cancer grow and blood vessel formation.
Summary
The ongoing clinical trials for metastatic renal cell carcinoma show a strong focus on combination therapies, particularly pairing immune checkpoint inhibitors with targeted therapies. The most frequently studied immunotherapy drugs are nivolumab, pembrolizumab, and ipilimumab, while axitinib, cabozantinib, sunitinib, and lenvatinib are the most common targeted therapies being investigated.
Geographically, trials are heavily concentrated in European countries, with France, Spain, Italy, and Germany hosting the most studies. Several multi-country trials span across 6-13 European nations, reflecting coordinated international research efforts. Notable is that many trials compare new combination approaches against sunitinib, which appears to be considered a standard reference treatment.
The studies address various patient populations and treatment scenarios: newly diagnosed patients, those not responding to initial therapy, patients considering treatment pauses, and individuals with specific subtypes like papillary renal cell carcinoma. Some innovative approaches include investigating imaging techniques for better tumor detection, exploring supportive care with folic acid for treatment side effects, and evaluating the timing of surgical intervention in patients already receiving immunotherapy.
Most trials require patients to have adequate organ function, good performance status, and no prior treatment for their metastatic disease, though some specifically target patients who have already started treatment. The research reflects a shift toward personalized medicine, with several studies stratifying patients by risk categories using the IMDC scoring system.
