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Renal cell carcinoma – Trials in Disease

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Ongoing Clinical Trials for Renal Cell Carcinoma

Renal cell carcinoma is a type of kidney cancer that begins in the cells lining the small tubes within the kidney. Currently, 27 clinical trials are exploring new treatment approaches for this disease, testing various combinations of immunotherapies, targeted therapies, and investigational medications across multiple countries in Europe. These trials aim to improve treatment outcomes for patients with different stages of kidney cancer, from early-stage disease after surgery to advanced metastatic cancer. (Also known as: kidney cancer, clear cell renal cell carcinoma, RCC)

Clinical trial locations

Study of XL092 and belzutifan combination therapy in people with clear cell kidney cancer who had disease return during or after immunotherapy treatment

This trial is testing a combination of two medications for patients with clear cell renal cell carcinoma whose cancer has returned during or after previous immunotherapy treatment. The medications being studied are XL092 (also called Zanzalintinib) and Belzutifan, both taken orally as tablets.

Main inclusion criteria: Patients must have clear cell renal cell carcinoma that has returned or progressed after previous treatment. The cancer must be measurable using specific criteria. Participants need to have adequate organ function and controlled blood pressure. Both men and women can participate, with specific contraception requirements for those of childbearing potential.

Main exclusion criteria: Patients with autoimmune diseases, active or untreated brain metastases, significant heart conditions, active infections requiring treatment, previous organ transplants requiring immunosuppression, or severe kidney or liver problems cannot participate. Pregnant or breastfeeding women, as well as those with known allergies to the study medications, are also excluded.

Main focus and goal: The study evaluates the safety and effectiveness of combining XL092 and Belzutifan. The first phase focuses on finding the right dose and checking safety, while the second phase examines how effective the treatment is in fighting cancer. Researchers will monitor tumor response, how long the response lasts, and patient survival without disease progression.

Investigational drugs: XL092 (Zanzalintinib) and Belzutifan are the medications being tested. Both help fight cancer by targeting specific proteins involved in cancer growth and survival.

Study on Reduced Dose Intensity of Pembrolizumab and Drug Combination for Patients with Advanced or Metastatic Cancer Responding to Standard Immunotherapy

This study includes patients with kidney cancer among other cancer types. It examines whether patients who have responded well to six months of standard immunotherapy can continue with a reduced dose while maintaining the same effectiveness.

Main inclusion criteria: Patients must have advanced or metastatic cancer that has responded positively after six months of standard immunotherapy treatment. For kidney cancer specifically, patients must have renal cell carcinoma. Participants need adequate organ function and an ECOG performance status of 0 or 1.

Main exclusion criteria: Patients who have not shown a partial or complete response after six months of immunotherapy are excluded. Those with melanoma who have not shown at least a partial response cannot participate.

Main focus and goal: The primary goal is to compare standard immunotherapy dosing with a reduced dose administered every three months. Researchers will assess whether reduced dosing maintains effectiveness while potentially reducing side effects. The study tracks progression-free survival, overall survival, quality of life, and adverse events.

Investigational drugs: The study involves checkpoint inhibitors such as Pembrolizumab, Durvalumab, Avelumab, Nivolumab, Dostarlimab, Atezolizumab, and Cemiplimab, administered either at standard doses or reduced doses every three months.

Evaluating kidney cancer aggressiveness using Rubidium Chloride PET scan imaging in patients with renal cell carcinoma

This study uses a special imaging technique to evaluate how aggressive kidney tumors are without requiring additional invasive procedures.

Main inclusion criteria: Participants must be at least 18 years old with a suspected or confirmed kidney tumor between 2 and 7 centimeters in size that requires surgery. The tumor should show specific features on imaging tests. Patients must have French Social Security coverage and be willing to attend all scheduled visits and follow treatment plans.

Main exclusion criteria: Patients below 18 or above 64 years old, those who are pregnant or breastfeeding, patients with a previous history of other cancers, severe kidney dysfunction, or who cannot undergo PET scanning are excluded. Patients with metal implants, known allergies to contrast agents, or who cannot lie still during scanning also cannot participate.

Main focus and goal: The study evaluates whether the amount of Rubidium-82 absorbed by kidney tumors can accurately indicate cancer aggressiveness. Participants receive a single injection of Rubidium Chloride before undergoing a PET scan prior to surgery. The scan images are compared with the actual tumor tissue examined after surgery to verify accuracy.

Investigational drugs: Rubidium-82 is a radioactive tracer used in PET scanning that helps doctors see kidney function and evaluate tumor characteristics.

Study of Axitinib and Avelumab for Patients with Localized Renal Cell Carcinoma at Moderate to High Risk of Recurrence

This trial investigates using axitinib and avelumab before surgery to shrink tumors in patients with localized kidney cancer at moderate to high risk of recurrence.

Main inclusion criteria: Patients must be 18 years or older with confirmed non-metastatic clear-cell renal cell carcinoma that is intermediate to high risk and can be completely removed by surgery. Participants need a WHO performance status of 0-1 and adequate blood clotting, blood health, liver function, and kidney function. Women who can become pregnant must have a negative pregnancy test before starting the study.

Main exclusion criteria: Patients with a different type of cancer, those not within the specified age range, vulnerable populations, patients with medical conditions or medications that might interfere with treatment, those with previous treatments affecting study results, pregnant or breastfeeding women, patients with allergies to study drugs, and those with serious health conditions are excluded.

Main focus and goal: The study explores the effectiveness and safety of axitinib (taken orally) and avelumab (given intravenously) when used together before surgery. The goal is to determine if this neoadjuvant therapy can shrink tumors and reduce cancer recurrence risk. The study monitors response rates, safety, and long-term outcomes.

Investigational drugs: Axitinib blocks proteins that help cancer cells grow, while Avelumab is an immunotherapy drug that helps the immune system recognize and attack cancer cells.

Study of Nivolumab and Ipilimumab for Patients with Advanced Kidney Cancer and Intermediate or Poor Risk Factors

This trial compares the effectiveness of using Nivolumab alone versus combining it with Ipilimumab in patients with advanced kidney cancer who have not received previous treatment and have certain risk factors.

Main inclusion criteria: Patients must have confirmed diagnosis of renal cell carcinoma with a clear cell component that is advanced and cannot be cured with surgery or radiation, or is metastatic. The cancer must be measurable using CT or MRI scans. Patients should not have received previous systemic therapy and must be classified as intermediate or poor risk according to specific criteria. Both male and female patients can participate.

Main exclusion criteria: Patients with other types of cancer, those who have had previous treatments interfering with study drugs, certain health conditions making the study unsafe, pregnant or breastfeeding women, patients unable to follow procedures, those with severe allergic reactions to similar drugs, active infections, certain heart conditions, or participating in another trial simultaneously are excluded.

Main focus and goal: The study evaluates how well Nivolumab works alone compared to when combined with Ipilimumab. Both medications help the immune system fight cancer by targeting different pathways. Researchers monitor progression-free survival, overall response rate, and safety throughout the trial.

Investigational drugs: Nivolumab and Ipilimumab are both immune checkpoint inhibitors that enhance the body’s immune response against cancer cells.

Study of Pembrolizumab and Enfortumab Vedotin for Patients with Collecting Duct and Renal Medullary Carcinoma

This study focuses on two rare types of kidney cancer: Collecting Duct Carcinoma and Medullary Renal Cell Carcinoma, testing a combination of Pembrolizumab and Enfortumab Vedotin.

Main inclusion criteria: Participants must be at least 18 years old with confirmed metastatic or advanced Collecting Duct Carcinoma or Medullary Renal Cell Carcinoma. Patients with HIV must have well-controlled conditions with antiretroviral therapy. Those with Hepatitis B or C must meet specific treatment requirements. Participants need measurable disease, a tumor tissue sample, an ECOG performance status of 0-1, and adequate organ function.

Main exclusion criteria: Patients with other cancer types, those who cannot provide informed consent, pregnant or breastfeeding women, patients with certain medical conditions interfering with treatment, recent clinical trial participation, allergies to study drugs, or severe uncontrolled medical conditions are excluded.

Main focus and goal: The study evaluates the safety and effectiveness of combining Pembrolizumab and Enfortumab Vedotin. The primary goal is to assess the objective response rate (how well cancer responds to treatment). Secondary goals include progression-free survival, overall survival, and treatment tolerability.

Investigational drugs: Pembrolizumab is an immunotherapy that helps the immune system recognize and fight cancer cells. Enfortumab Vedotin is an antibody-drug conjugate that combines an antibody with chemotherapy to target and kill cancer cells more effectively.

Study on Durvalumab and Tremelimumab for Patients with Kidney Cancer at Risk of Recurrence After Surgery

This trial investigates whether treatment with Durvalumab, either alone or combined with Tremelimumab, can help delay cancer recurrence or increase life expectancy in patients who have had surgery for kidney cancer.

Main inclusion criteria: Patients must have confirmed renal cell carcinoma with no visible cancer remaining after surgery (confirmed by CT scan). All RCC types are allowed except certain rare types. Patients need normal organ and bone marrow function, including specific hemoglobin, neutrophil, platelet, bilirubin, liver enzyme, and kidney function levels. Participants must be at least 18 years old, provide written informed consent, and agree to use contraception during and after the study. The Leibovich score must be between 3 and 11.

Main exclusion criteria: Patients who have not had surgery, those not at intermediate or high risk of recurrence, patients unable to receive the study medications, and vulnerable populations are excluded.

Main focus and goal: The study compares Durvalumab alone or combined with Tremelimumab versus active monitoring after surgery. Researchers assess whether these treatments can prevent cancer recurrence and improve overall survival. Regular monitoring tracks cancer progression and patient health throughout the study.

Investigational drugs: Durvalumab and Tremelimumab are both immunotherapy medications that help the immune system fight cancer by targeting specific proteins.

Study on PET Imaging with Fianlimab and Cemiplimab for Patients with Advanced Solid Tumors, with or without Platinum-Based Chemotherapy

This study includes kidney cancer patients among those with various advanced solid tumors, testing Fianlimab and Cemiplimab with or without platinum-based chemotherapy, using PET imaging to monitor treatment response.

Main inclusion criteria: Patients must be at least 18 years old with advanced solid tumors including renal cell carcinoma. Participants need at least one biopsy-accessible lesion, measurable disease, an ECOG performance status of 0-1, a life expectancy of at least 12 weeks, and adequate organ and bone marrow function. This includes specific requirements for hemoglobin, neutrophil count, lymphocyte count, platelet count, kidney function, and liver function.

Main exclusion criteria: Patients with metastatic solid tumors who cannot benefit from the specific treatment, those not within the specified age range, vulnerable populations, and patients unable to follow study procedures are excluded.

Main focus and goal: The study aims to find the best dose of Fianlimab and optimal timing for PET scans to assess treatment effectiveness. It also evaluates the safety of Fianlimab. Participants undergo PET scans before and during treatment to monitor how cancer responds. The investigational imaging agent 89Zr-DFO-REGN3767 helps visualize specific proteins on cancer cells.

Investigational drugs: Cemiplimab is an immunotherapy that helps the immune system recognize and attack cancer cells. Platinum-based chemotherapy uses drugs containing platinum to damage cancer cell DNA. 89Zr-DFO-REGN3767 is an imaging agent that helps visualize treatment response through PET scans.

Study Comparing Tivozanib and Nivolumab Combination to Tivozanib Alone in Patients with Renal Cell Carcinoma After Previous Immune Therapy

This trial compares the effectiveness of combining Tivozanib with Nivolumab versus using Tivozanib alone in patients whose cancer has progressed after previous treatment with immune checkpoint inhibitors.

Main inclusion criteria: Patients must be 18 years or older with a life expectancy of at least 3 months. They must have kidney cancer with a clear cell component that has progressed during or after at least 6 weeks of checkpoint inhibitor treatment, either as first or second treatment option. Patients need to have recovered from previous treatment side effects, have measurable disease, an ECOG performance status of 0-1, and all participants must follow specific contraceptive measures.

Main exclusion criteria: Patients without renal cell carcinoma, those who have not received appropriate previous treatments with checkpoint inhibitors, and vulnerable populations are excluded.

Main focus and goal: The study evaluates whether combining Tivozanib (taken orally) with Nivolumab (given intravenously) improves progression-free survival compared to Tivozanib alone. Researchers monitor how long patients live without their cancer getting worse, as well as overall survival, response rates, and duration of response.

Investigational drugs: Tivozanib blocks proteins that help cancer cells grow and spread. Nivolumab is an immune checkpoint inhibitor that helps the body’s immune system recognize and attack cancer cells more effectively.

Study of Axitinib and Immune Checkpoint Inhibitors for Patients with Untreated Advanced or Metastatic Kidney Cancer

This study tests several medication combinations for patients with advanced kidney cancer who have not yet received treatment, comparing different immune checkpoint inhibitors used with Axitinib.

Main inclusion criteria: Patients must have untreated locally advanced or metastatic renal cell carcinoma with an IMDC risk score of intermediate (1-2) or poor (3-6). The cancer must be measurable using specific criteria. Participants need adequate hematologic and end-organ function (checked within 14 days before starting treatment), clear-cell renal cell carcinoma (with possible sarcomatoid features), negative hepatitis B and C tests (or specific conditions if positive), and be 18-64 years old. Both male and female patients can participate.

Main exclusion criteria: Patients who have received treatment for advanced kidney cancer, those not within the specified age range, patients belonging to specific clinical trial groups not included, and vulnerable populations are excluded.

Main focus and goal: The study evaluates the safety and effectiveness of different combinations: Tobemstomig with Axitinib, Tiragolumab with Tobemstomig and Axitinib, or Pembrolizumab with Axitinib. The goal is to determine which combination works best in treating advanced kidney cancer. Researchers monitor tumor response, disease progression, and safety throughout the trial.

Investigational drugs: Tobemstomig and Tiragolumab are immune checkpoint inhibitors being studied for their potential to help the immune system fight cancer. Axitinib blocks proteins that help cancer cells grow. Pembrolizumab is another immune checkpoint inhibitor used as a comparison treatment.

Study of Belzutifan and Palbociclib for Patients with Advanced Renal Cell Carcinoma

This trial investigates the effects of Belzutifan alone and in combination with Palbociclib in patients with advanced clear cell renal cell carcinoma who have already received at least two previous treatments.

Main inclusion criteria: Patients must have confirmed unresectable Stage IV renal cell carcinoma that has progressed after receiving at least two treatments including an immune checkpoint inhibitor and a VEGF-targeted therapy. The cancer must be measurable using specific criteria. Participants must have recovered from all previous treatment side effects. Both male and female patients are eligible.

Main exclusion criteria: Patients with different cancer types, those not within the required age range, pregnant or breastfeeding women, patients with serious medical conditions interfering with the study, recent clinical trial participants, patients with recent major surgery, active infections requiring treatment, allergies to study medications, or mental health conditions affecting participation are excluded.

Main focus and goal: The study is divided into two parts. Part 1 focuses on finding the right dose and checking safety. Part 2 evaluates how effectively the treatments work in fighting cancer. Researchers monitor tumor response, progression-free survival, overall survival, and any side effects experienced by participants.

Investigational drugs: Belzutifan is being tested both on its own and in combination with Palbociclib. Palbociclib works by inhibiting proteins involved in cell division, which may help slow down cancer cell growth.

Summary

The 27 ongoing clinical trials for renal cell carcinoma reflect a diverse and comprehensive approach to treating this disease at various stages. A significant concentration of trials is taking place in France, with 17 trials, followed by Poland, Italy, Spain, and Germany, each hosting multiple studies. This geographic distribution demonstrates strong European commitment to advancing kidney cancer research.

The trials encompass several treatment approaches. Many studies focus on immunotherapy combinations, with pembrolizumab appearing frequently across multiple trials, often combined with other medications such as lenvatinib, belzutifan, or axitinib. Immune checkpoint inhibitors like nivolumab, ipilimumab, durvalumab, and atezolizumab are being tested both alone and in various combinations.

Notably, several trials are exploring treatment for patients at different disease stages. Some studies focus on post-surgical patients at risk of recurrence, while others target advanced or metastatic disease. A few trials specifically address rare subtypes of kidney cancer, such as collecting duct carcinoma and medullary renal cell carcinoma, which often have limited treatment options.

The trials also investigate innovative approaches, including reduced-dose immunotherapy strategies, new imaging techniques using radioactive tracers, and novel combinations of targeted therapies with immunotherapies. Several studies are comparing different administration methods, such as subcutaneous versus intravenous delivery, to improve patient convenience and comfort.

Overall, these trials demonstrate significant progress in developing personalized treatment strategies for renal cell carcinoma, with a strong emphasis on combination therapies that target multiple aspects of cancer growth and immune system function. The breadth of research suggests promising future treatment options for patients with kidney cancer at all stages of the disease.

Ongoing Clinical Trials on Renal cell carcinoma

  • Study on Nivolumab Dose Optimization for Patients with Melanoma or Renal Cell Carcinoma Showing Complete, Partial, or Stable Response

    Not yet recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study of Axitinib and Avelumab for Patients with Localized Renal Cell Carcinoma at Moderate to High Risk of Recurrence

    Not yet recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study of Cabozantinib for Patients with Advanced Renal Cell Carcinoma After Checkpoint Inhibitor Treatment

    Not recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany

  • Study of Dabrafenib and Drug Combination for Patients with Metastatic Non-Clear Cell Kidney Cancer

    Not recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

  • Study on Atezolizumab and Cabozantinib for Patients with Advanced Renal Cell Carcinoma After Tumor Progression Post-Immune Checkpoint Inhibitor Treatment

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany Poland

  • Study on Patient Preference for Subcutaneous Pembrolizumab with Hyaluronidase vs. Intravenous Pembrolizumab in Melanoma, Renal Cell Carcinoma, and Lung Cancer Patients

    Not recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Poland

  • Study of Nivolumab and Ipilimumab for Patients with Advanced Kidney Cancer and Intermediate or Poor Risk Factors

    Not recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Czechia France Greece Italy Poland +2

  • Study on the Safety and Effects of Relatlimab and Nivolumab for Patients with Advanced Solid Tumors

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Denmark Finland France Germany Italy +3

  • Study of Pembrolizumab, Lenvatinib, and Belzutifan for Patients with Renal Cell Carcinoma

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Hungary The Netherlands Poland Spain

  • Study of V940 and Pembrolizumab for Patients with Renal Cell Carcinoma After Surgery

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Italy Poland Spain

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