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Clinical Trials for Clear Cell Renal Cell Carcinoma

Clear cell renal cell carcinoma is the most common type of kidney cancer in adults. Currently, 12 clinical trials are testing new treatment combinations and approaches for patients whose cancer has spread or returned after previous treatments. These trials are taking place across multiple countries in Europe and include various medication combinations aimed at improving patient outcomes. (Also known as: ccRCC, Clear Cell Kidney Cancer, Clear Cell 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, XL092 and Belzutifan, for patients whose cancer has returned during or after previous immunotherapy treatment. The study is divided into two phases: the first focuses on finding the right dose and checking safety, while the second evaluates how effective the treatment is in fighting the cancer.

Main inclusion criteria: Participants must have confirmed diagnosis of clear cell renal cell carcinoma that cannot be surgically removed or has spread. They must be between 18 and 120 years of age and have not received any previous systemic treatment for advanced disease, except for certain immunotherapy treatments. Participants must have measurable disease, be able to swallow oral medication, provide a tumor tissue sample, and have controlled blood pressure (140/90 mm Hg or lower). Both male and female participants must use appropriate contraception methods during and after the study.

Main exclusion criteria: Patients with a history of autoimmune diseases, active or untreated brain metastases, significant heart conditions, active infections requiring systemic treatment, previous organ transplants requiring ongoing immunosuppression, other active cancers, severe kidney or liver problems, pregnancy or breastfeeding, known allergies to study medications, participation in other clinical trials within the past 30 days, mental conditions that could interfere with compliance, or major surgery within 28 days before starting the study cannot participate.

Trial focus: The study aims to evaluate how well XL092 and Belzutifan work together and to determine their safety when used in combination. Participants receive both medications orally in tablet form. Doctors will monitor any side effects and track how the tumors respond to treatment, how long the response lasts, and how long patients survive without their cancer getting worse. Regular medical check-ups and tests will be performed throughout the study to ensure patient safety and evaluate treatment effectiveness.

Investigational drugs: The study involves XL092 (also known as Zanzalintinib) and Belzutifan, both taken orally in tablet form. These medications work by targeting specific pathways that help cancer cells grow and survive.

Study on Cabozantinib and Nivolumab for Older Patients with Kidney Cancer

This trial focuses on studying how two medications, Cabozantinib and Nivolumab, are used in real-life settings among older patients with advanced or metastatic renal cell carcinoma. The study aims to gather information on how patients respond to treatment, including any changes in their cancer and their overall health.

Main inclusion criteria: Patients must be 70 years old or older with a confirmed diagnosis of advanced or metastatic renal-cell carcinoma. They should not have received any treatment for their cancer in the metastatic setting and must have a Performance Status between 0 to 2. Sexually active male patients must agree to use contraception during the study and for at least 5 months after the last treatment. Patients must understand, sign, and date the informed consent form and be part of a social security system.

Main exclusion criteria: Patients who do not have renal carcinoma, are not diagnosed with metastatic clear-cell renal cell cancer, are not in the specified age range for the study, or are part of a vulnerable population cannot participate.

Trial focus: The study follows patients to see how they respond to treatment with Cabozantinib (taken as a tablet) and Nivolumab (given through an infusion). Researchers will track how well patients tolerate the medications, any side effects they experience, and how the treatment affects their quality of life. The study will monitor various outcomes including how long patients live without the cancer getting worse, their overall survival, and their response to treatment based on medical imaging.

Investigational drugs: Cabozantinib is a tyrosine kinase inhibitor taken orally in tablet form that works by blocking proteins that promote cancer cell growth and blood vessel formation. Nivolumab is an immune checkpoint inhibitor given as an intravenous infusion that helps the immune system recognize and attack cancer cells more effectively.

Study on Raludotatug Deruxtecan for Patients with Advanced or Metastatic Solid Tumors, Including Gynecological and Genitourinary Cancers

This trial evaluates the effectiveness and safety of Raludotatug Deruxtecan in people with advanced or metastatic solid tumors, including certain types of gynecological and genitourinary cancers such as endometrial cancer, cervical cancer, non-high-grade serous ovarian cancer, urothelial cancer, and clear cell renal cell carcinoma.

Main inclusion criteria: Adults 18 years or older must have a confirmed diagnosis of ccRCC that cannot be removed by surgery or has spread to other parts of the body. They must have been treated with no more than 3 previous treatments, including a PD-(L)1 checkpoint inhibitor and a VEGF-TKI. Participants must have at least one tumor that can be biopsied and measured, must agree to provide a biopsy sample before treatment, and must have shown tumor growth on a scan after the most recent treatment. They must have an ECOG performance status of 0 or 1.

Main exclusion criteria: Patients with advanced or metastatic solid tumors that fall outside the specified categories, those not within the specified age range, those not part of the specified clinical trial groups, or those who are part of a vulnerable population that the study does not include cannot participate.

Trial focus: The study aims to assess how well Raludotatug Deruxtecan works in treating these cancers and to monitor any side effects. Participants will receive the treatment through an intravenous infusion, and researchers will follow them over a period to observe the treatment’s impact on their cancer and overall health. Throughout the trial, researchers will focus on understanding how the treatment affects the size and growth of the tumors, as well as any changes in participants’ health.

Investigational drugs: Raludotatug Deruxtecan (R-DXd) is an antibody-drug conjugate administered intravenously. It is designed to deliver a potent anti-cancer agent directly to cancer cells, helping to stop their growth and spread while minimizing damage to healthy cells.

Study on the Safety and Effects of [68Ga]Ga-DPI-4452 and [177Lu]Lu-DPI-4452 in Patients with Advanced or Metastatic Solid Tumors

This trial studies certain types of cancer that are difficult to remove through surgery or have spread to other parts of the body, including clear cell renal cell carcinoma, pancreatic ductal adenocarcinoma, and colorectal cancer. The study is testing two new treatments: Debio 0328 and Debio 0228, both administered through a vein.

Main inclusion criteria: For Part A, patients must have a confirmed diagnosis of cancer that cannot be removed by surgery and has spread, including ccRCC, PDAC, or CRC. They must have measurable disease using RECIST v1.1 guidelines, an ECOG performance status of 0-2, adequate bone marrow and organ function, and specific blood count levels. For Parts B and C, patients must have progressing cancer that cannot be removed by surgery and has spread, measurable disease using RECIST v1.1, an ECOG performance status of 0-1, life expectancy of more than 6 months, adequate bone marrow and organ function, and adequate blood clotting ability.

Main exclusion criteria: Patients with tumors that can be surgically removed, medical conditions other than the specified types of cancer, those not within the specified age range, those unable to give informed consent, those who are pregnant or breastfeeding, those with certain medical conditions that might interfere with the study, those who have received certain treatments recently, those with allergies to the study medication, or those participating in another clinical trial cannot participate.

Trial focus: The study is divided into three parts. In Part A, participants receive a single dose of Debio 0328 to assess its safety and imaging capabilities. In Part B, the study determines the best dose of Debio 0228 for each type of cancer. Part C explores the potential of Debio 0228 to reduce tumor size. Throughout the study, participants will be closely monitored for any side effects and changes in their health.

Investigational drugs: [68Ga]Ga-DPI-4452 is a radiopharmaceutical agent used for imaging purposes to help visualize tumors. [177Lu]Lu-DPI-4452 is a radiopharmaceutical therapeutic agent that delivers targeted radiation to tumor cells to help reduce tumor size.

Study on the Safety and Effects of Temferon for Patients with Metastatic Renal Cell Carcinoma Using a Drug Combination

This trial is testing a treatment called Temferon for patients with metastatic renal cell carcinoma, a type of kidney cancer that has spread to other parts of the body. Temferon is a gene therapy that uses a patient’s own blood stem cells, which are modified to produce interferon alpha-2, a protein that helps the immune system fight cancer.

Main inclusion criteria: Patients must be between 18 and 70 years old with confirmed diagnosis of advanced or metastatic RCC with a clear cell component. They must have no planned radiotherapy or surgery to remove cancer from the target area within four months after initial screening, cancer that has worsened after receiving standard treatments, ECOG PS 0-1, measurable cancer, expected to live more than six months, recovered from side effects of previous treatments, good heart, kidney, liver, lung, and blood function, and disease large enough to allow a biopsy. Women who can have children must have a negative pregnancy test and agree to use effective birth control, and men with partners who can have children must agree to use contraception.

Main exclusion criteria: Patients who do not have metastatic clear cell renal cell carcinoma, have not shown disease progression after receiving standard treatments, are not within the specified age range, are not part of the specified clinical trial groups, or are considered part of a vulnerable population cannot participate.

Trial focus: The study evaluates the safety and biological response of Temferon in patients with metastatic renal cell carcinoma. Participants will receive a single dose of Temferon, and the study will monitor how well the treatment is tolerated and how it affects the cancer. The study involves other medications including Cabozantinib, Busulfan, Pembrolizumab, Plerixafor, and Lenograstim, which are used to prepare the body for gene therapy and support the treatment process.

Investigational drugs: Temferon consists of genetically modified autologous stem cells that produce human Interferon-α2. It is classified as a gene therapy product. The study also involves supportive medications such as Busulfan, Plerixafor, Lenograstim, and Cabozantinib.

Study of Lutetium-177-PSMA treatment for patients with advanced clear cell kidney cancer who had progression after first or second line therapy

This study evaluates a new treatment approach using Lutetium-PSMA-617 for patients whose cancer has spread to other parts of the body and has continued to grow despite previous treatments. The treatment involves receiving intravenous infusions of the radioactive medication that specifically targets cancer cells.

Main inclusion criteria: Participants must have confirmed clear cell renal cell carcinoma through tissue examination (sarcomatoid features are acceptable), be at least 18 years old, and have previously received and shown disease progression after treatment with at least one immunotherapy targeting PD-1/PD-L1 and at least one VEGFR-TKI. They must have at least one PSMA-positive cancer lesion with specific uptake values, tumors that can be measured using RECIST 1.1 criteria, adequate blood test results including white blood cell count, hemoglobin, platelet count, kidney function, and liver function. Participants must have good physical function with an ECOG performance status of 0 or 1 and be able to understand and sign an informed consent form.

Main exclusion criteria: Patients with prior history of other cancers within 3 years, known active brain metastases, severe heart conditions, active uncontrolled infections, known positive test for HIV, active hepatitis B or C, pregnant or breastfeeding women, serious medical conditions that could interfere with participation, inability to understand or sign informed consent, previous treatment with radioligand therapy, known allergic reactions to study medications, or participation in another clinical trial within 30 days cannot participate.

Trial focus: The purpose is to determine how well Lutetium-PSMA-617 works in treating advanced kidney cancer that has not responded well to other treatments. Patients may receive up to six treatments over a period of 36 weeks. Each treatment session delivers a carefully measured dose of the radioactive medication that attaches to specific proteins found on cancer cells. Doctors will monitor how the cancer responds to the treatment through regular imaging scans, and the treatment’s safety will be carefully monitored throughout the study period.

Investigational drugs: 177Lu-PSMA-617 (Lutetium PSMA-617) is a targeted radiopharmaceutical therapy that combines a radioactive substance (Lutetium-177) with a molecule that specifically targets PSMA proteins on cancer cells. It is administered intravenously and delivers localized radiation to cancer cells.

Study on the Effectiveness of Early PSMA-PET Scans with Gozetotide in Patients with Metastatic Renal Cancer Undergoing Standard Immunotherapy

This trial uses a special imaging technique called PSMA-PET scan with 68Ga-Gozetotide tracer to evaluate how early changes in the scan can predict the effectiveness of standard cancer treatments in patients with metastatic clear cell renal carcinoma.

Main inclusion criteria: Adult patients over 18 years old, both male and female, must have a confirmed diagnosis of clear cell Renal Carcinoma Cell (ccRCC), with a sarcomatoid component allowed. They must be eligible for treatment with either a combination of ICI + ICI or ICI + TKI, have an expected survival of at least 6 months, have PSMA positive lesions on a PSMA-PET/CT scan, be able to give their consent, and have metastatic ccRCC.

Main exclusion criteria: Patients who do not have metastatic clear cell Renal Carcinoma, are not within the specified age range, or are part of a vulnerable population cannot participate.

Trial focus: Participants will undergo a PSMA-PET scan early in their treatment process, which will be repeated six weeks after starting their cancer treatment (which may include combinations of immune checkpoint inhibitors and tyrosine kinase inhibitors). The study aims to see if changes in the scan results can help predict how well the cancer treatment is working, as measured by the Disease Control Rate at six months. The study will also look at Objective Response Rate and Progression-Free Survival.

Investigational drugs: 68Ga-PSMA is a radiopharmaceutical used in diagnostic imaging that binds to PSMA on cancer cells, allowing for detailed imaging through PET/CT scans.

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

This trial investigates the effectiveness and safety of a treatment combination involving Belzutifan and Pembrolizumab for patients with renal cell carcinoma, specifically the clear cell subtype, who have undergone surgery to remove the kidney tumor. The study includes a comparison group that receives a placebo along with Pembrolizumab.

Main inclusion criteria: Patients must have a confirmed diagnosis of renal cell carcinoma with a clear cell component and specific risk levels (intermediate-high risk, high risk, or M1 no evidence of disease). They must have had a complete removal of the primary tumor through surgery within 12 weeks before being randomly assigned to a treatment group, have an ECOG performance status of 0 to 1 within 10 days before randomization, and have adequate organ function. Male and female patients must agree to use contraception during the study and for specified periods after the last dose. Female patients who can become pregnant must agree to use reliable contraception methods.

Main exclusion criteria: Participants with any other type of cancer besides renal cell carcinoma, individuals not within the specified age range, participants who are part of a vulnerable population, people who are not able to follow the study procedures or take the study medication as required, or individuals who have any medical condition that the study doctors believe would make it unsafe for them to participate cannot join.

Trial focus: The purpose is to compare how well patients do without the cancer coming back after treatment with Belzutifan plus Pembrolizumab versus those receiving a placebo plus Pembrolizumab. Belzutifan is taken as a film-coated tablet, while Pembrolizumab is given as a solution for infusion. The main focus is on disease-free survival, and researchers will also look at overall survival, any side effects experienced by participants, and changes in quality of life.

Investigational drugs: Belzutifan is a hypoxia-inducible factor inhibitor administered orally that works by blocking HIF-2α protein involved in cancer cell growth. Pembrolizumab is an immune checkpoint inhibitor given through intravenous infusion that helps the immune system recognize and attack cancer cells by blocking the PD-1 pathway.

Study of Belzutifan for Patients with Advanced Kidney Cancer

This trial tests a medication called Belzutifan for patients with Advanced Renal Cell Carcinoma, which is kidney cancer that has spread beyond the kidney. The study compares two different doses of Belzutifan—120 mg and 200 mg—to determine which dose is more effective.

Main inclusion criteria: Patients must have a confirmed diagnosis of advanced renal cell carcinoma, be able to provide a sample of their tumor tissue (either an old sample or a new one from a biopsy), have experienced disease progression after receiving treatment with anti-PD-1/L1 therapy, not have received more than three different treatments for their advanced kidney cancer, and have recovered from any side effects of previous treatments to a mild level (except for certain nerve-related or hormone-related side effects that are still manageable). Both male and female patients are eligible.

Main exclusion criteria: The trial does not specify detailed exclusion criteria in the provided data, but general exclusions would apply for patients unable to follow study procedures or with conditions making participation unsafe.

Trial focus: Participants will receive one of the two doses of Belzutifan daily as a film-coated tablet. The study will monitor how well the cancer responds to the treatment and how long the effects last. It will also track the overall health and survival of the participants, as well as any side effects they may experience. Throughout the study, participants will be regularly assessed to see how their cancer is responding to the treatment.

Investigational drugs: Belzutifan is a hypoxia-inducible factor inhibitor administered orally in tablet form. It works by blocking the HIF-2α protein, which is involved in the growth of cancer cells, and belongs to the class of targeted cancer therapies.

Study of Cabozantinib for Patients with Advanced Renal Cell Carcinoma Previously Treated with One Immunotherapy Drug

This trial studies Cabozantinib in patients whose cancer has spread and who have already been treated with a type of medicine called an immunocheckpoint inhibitor. The treatment is designed to slow down or stop the growth of cancer cells.

Main inclusion criteria: Patients must sign a written informed consent form, have adequate blood test results meeting certain levels (including blood cell counts, liver enzymes, and kidney function), have had one previous cancer treatment with a PD1/PDL1 inhibitor, be 18 years or older, have a diagnosis of clear cell renal cell carcinoma, have measurable disease that has shown growth in scans, use effective birth control during the study and for 4 months after the last treatment, have a Karnofsky performance status of 70% or higher, and have a life expectancy of more than 3 months. Women who can have children must not be pregnant at the start of the study.

Main exclusion criteria: Patients who have not been treated with an immunocheckpoint inhibitor, have not been diagnosed with metastatic clear cell renal cell carcinoma, are not within the specified age range, are not part of the specified clinical trial group, or are not considered part of the vulnerable population selected for the study cannot participate.

Trial focus: The purpose is to see how well Cabozantinib works in patients who have already received one immunocheckpoint inhibitor. Participants will take Cabozantinib orally and will be monitored to see how their cancer responds to the treatment. The study will look at progression-free survival, overall survival, response rates, and the safety of the drug.

Investigational drugs: Cabozantinib is a tyrosine kinase inhibitor administered orally in tablet form. It works by blocking enzymes that promote cancer cell growth and blood vessel formation, targeting specific proteins involved in cancer cell proliferation.

Study on the Effectiveness of Relatlimab, Ipilimumab, and Nivolumab in Patients with High-Risk Clear Cell Renal Cell Cancer

This trial tests a combination of treatments for high-risk non-metastatic clear cell renal cell carcinoma before surgery. The treatments include three medications: Relatlimab, Ipilimumab, and Nivolumab, which are given through a drip into a vein. Some participants will receive a placebo.

Main inclusion criteria: Participants must be at least 18 years old with confirmed diagnosis of resectable clear cell RCC that can be measured and biopsied, with no history of cancer spreading to distant parts of the body. They must be at intermediate to high risk based on specific clinical and biopsy criteria, have WHO Performance Status of 0 or 1, have an expected life expectancy of more than six months, have recovered from side effects of previous treatments to a mild level, be willing to have three tumor biopsies and extra blood tests, not have had previous treatments targeting CTLA-4, PD-1, PD-L1, or LAG-3, and not have taken immune-suppressing medications within 2 weeks before starting treatment. Women who can have children must have a negative pregnancy test and agree to use effective birth control, and men with partners who can have children must agree to use contraception. The disease must be large enough to allow a biopsy, and patients must have good heart, kidney, liver, lung, and blood function.

Main exclusion criteria: Patients with a history of distant metastases, those who have previously received CTLA-4/PD-1/PD-L1/LAG-3 directed immunotherapy, or patients under 18 years old cannot participate.

Trial focus: The purpose is to find out how well these medications work together in treating high-risk non-metastatic clear cell RCC. Participants will receive different combinations of these medications before they have surgery to remove the cancer. The study will look at how the cancer responds to the treatment and how safe the medications are. Regular check-ups and tests will monitor the treatment’s effects on cancer and overall health.

Investigational drugs: Nivolumab is an immune checkpoint inhibitor administered intravenously that works by blocking the PD-1 protein on immune cells. Ipilimumab helps activate the immune system by targeting a specific protein on immune cells. Relatlimab is being tested in combination with these other immunotherapy drugs.

Summary

The 12 clinical trials for clear cell renal cell carcinoma demonstrate a strong focus on immunotherapy and targeted therapy combinations. The majority of trials are testing innovative treatment approaches for patients whose cancer has progressed after previous treatments, reflecting the need for new options in advanced disease stages.

Geographically, these trials are concentrated in Western Europe, with France, Spain, Belgium, and Italy hosting the most studies. The widespread availability across multiple countries increases access for European patients seeking experimental treatments.

Several trials focus on combination therapies involving immunotherapy drugs such as Nivolumab, Pembrolizumab, and Ipilimumab, often paired with targeted therapies like Cabozantinib or Belzutifan. This reflects the current trend in oncology toward combining different treatment mechanisms to improve outcomes. Notably, some studies are exploring novel approaches such as radioligand therapy with Lutetium-177-PSMA and gene therapy with Temferon.

The trials include patients at various disease stages, from high-risk non-metastatic disease requiring treatment before surgery to advanced metastatic cases. This comprehensive approach addresses the full spectrum of treatment needs in clear cell renal cell carcinoma. Many trials specifically target patients who have already received immunotherapy, addressing the important clinical question of what treatments work after initial therapies fail.

Ongoing Clinical Trials on Clear cell renal cell carcinoma

  • A study of PF-08634404, ipilimumab, and axitinib in adults with advanced or metastatic kidney cancer

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany Spain

  • A Study Testing Casdatifan and Cabozantinib Compared to Placebo and Cabozantinib in Patients With Advanced Clear Cell Kidney Cancer

    Recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia France Germany Italy The Netherlands Poland +2

  • Study of Lutetium-177-PSMA treatment for patients with advanced clear cell kidney cancer who had progression after first or second line therapy

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Spain

  • Study on Cabozantinib and Nivolumab for Older Patients with Kidney Cancer

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study on the Safety and Effects of [68Ga]Ga-DPI-4452 and [177Lu]Lu-DPI-4452 in Patients with Advanced or Metastatic Solid Tumors

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France

  • REGN10597 Alone or with Cemiplimab in Adults with Advanced Solid Tumours, Melanoma, or Clear-Cell Renal-Cell Carcinoma

    Not yet recruiting

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

  • Study on Raludotatug Deruxtecan for Patients with Advanced or Metastatic Solid Tumors, Including Gynecological and Genitourinary Cancers

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Denmark France Italy Spain

  • Study of Cabozantinib for Patients with Advanced Renal Cell Carcinoma Previously Treated with One Immunotherapy Drug

    Not recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

  • Study on the Effectiveness of Relatlimab, Ipilimumab, and Nivolumab in Patients with High-Risk Clear Cell Renal Cell Cancer

    Not recruiting

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

  • 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

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