[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-clear-cell-renal-cell-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-clear-cell-renal-cell-carcinoma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,43,66,95,120,141,168,191,212,234],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100622424","phase-3-adding-biotherapy-or-placebo-to-standard-treatment-for-advanced-kidney-cancer-100622424",false,"NCT07383441","Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer","Phase III Double Blinded Trial of Immune-Based Therapy With a Live Biotherapeutic MO-03 or Placebo for Frontline Therapy of Advanced Clear Cell Renal Cell Carcinoma [BioFront Trial]","Inclusion Criteria:\n\n* Participants must have histologically confirmed renal cell carcinoma (RCC) with clear cell component that is advanced (not amenable to curative surgery or radiation therapy) or metastatic RCC at the time of registration on study\n* Participants must have measurable\u002Fevaluable disease by RECIST 1.1 criteria. Participants with only bone metastases or only pleural effusions are considered evaluable disease and are eligible\n* Participants with new or progressive brain metastases (active brain metastases) or leptomeningeal disease must not require immediate central nervous system (CNS) specific treatment at the time of study registration or anticipated treatment during the first cycle of therapy\n* Participants must not be currently enrolled or plan to participate in treatment studies while enrolled on this study\n* Participants must not plan to take any over the counter probiotic supplements at time of study registration and while on protocol treatment\n\n  * NOTE: Vitamin and electrolyte or mineral supplements are permitted\n* Participants must not have had prior systemic therapy for advanced or metastatic RCC or any treatment with immune based combination therapy\n\n  * NOTE: Participants can have prior neo\u002Fadjuvant treatment with an anti-PD-1, anti-PD-L1, and\u002For anti-CTLA-4 antibody or other therapies for any current or prior malignancy if \\> 12 months prior to registration\n* Participants must not be receiving steroid replacement therapy for adrenal insufficiency greater than 50 mg daily of hydrocortisone or prednisone equivalent dose at the time of registration\n* Participants must not require the use of systemic corticosteroids \\> 10 mg\u002Fday of prednisone or its equivalent for any reason other than replacement therapy for adrenal insufficiency\n* Participants must not have received any systemic antibiotics within 7 days prior to registration\n\n  * NOTE: Uncontrolled infections must be completely resolved\n* Participants must be ≥ 18 years old at the time of registration\n* Participants must have a Zubrod performance status 0-2 within 28 days of registration\n* Participants must be able to safely receive at least one of the standard of care regimens, per the current Food and Drug Administration (FDA)-approved package inserts, treating investigator's discretion, and institutional guidelines\n\n  * NOTE: Participants with favorable risk as defined by the International Metastatic RCC Database Consortium (IMDC) must plan to receive one of the TKI+ immunotherapy treatment combinations. They are not able to receive regimen 1 (ipilimumab + nivolumab) for this study\n* Participants must be able to swallow and retain oral medications and have no known gastrointestinal disorders likely to interfere with absorption of oral medications\n* Participants must have serum creatinine ≤ 2 x ULN (upper limit of normal). This specimen must have been drawn and processed within 28 days prior to registration\n* Hemoglobin ≥ 8 g\u002FdL (within 28 days prior to registration)\n* Leukocytes ≥ 3 x 10\\^3\u002FuL (within 28 days prior to registration)\n* Absolute neutrophil count ≥ 1.5 x 10\\^3\u002FuL (within 28 days prior to registration)\n* Platelets ≥ 100 x 10\\^3\u002FuL (within 28 days prior to registration)\n* Total bilirubin ≤ institutional upper limit of normal (ULN) unless history of Gilbert's disease (within 28 days prior to registration) Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN\n* Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) ≤ 3 x institutional ULN (\\\u003C 5 x institutional ULN if liver metastases are present) (within 28 days prior to registration)\n* Participants must have alkaline phosphate measured as a part of the liver function assessment within 28 days prior to registration\n* Participants must have albumin corrected calcium measured within 28 days prior to registration\n* Participants with a history human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load on the most recent test results obtained within 6 months prior to registration\n* Participants with a history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to registration\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to registration\n* Participants must not have uncontrolled blood pressure and hypertension within 28 days prior to registration\n* Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* Participants must not have any known history of an autoimmune disease that prohibits the use of immune checkpoint therapy\n* Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation\u002Focclusion, and vasectomy with testing showing no sperm in the semen\n* Participants must be offered the opportunity to participate in specimen banking\n* Participants who have the ability to complete questionnaires in English or Spanish must be offered the opportunity to participate in the patient-reported outcome study\n* NOTE: As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.\n\n  * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines\n  * For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations","ALL","18 Years",{"count":19,"type":20},718,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This phase III trial compares the effect of adding live biotherapy, MO-03, to standard of care (SOC) immunotherapy, including ipilimumab, nivolumab, axitinib, pembrolizumab, cabozantinib, and lenvatinib, to SOC immunotherapy alone in treating patients with clear cell renal cell cancer that may have spread from where it first started (primary site) to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started to other places in the body (metastatic). Studies have shown that gut health (the gut microbiome) may impact the effectiveness of immunotherapy. The microbiome includes all of the bacteria and organisms naturally found in the digestive tract. MO-03, a type of biotherapy, contains material from living organisms that may help keep the digestive tract healthy and may help to increase the effect of immunotherapy. Immunotherapy with monoclonal antibodies, such as ipilimumab, nivolumab, pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Axitinib, cabozantinib, and lenvatinib are a type of angiogenesis inhibitor and tyrosine kinase inhibitor (TKI) that block certain proteins which may help keep tumor cells from growing and may also help prevent the growth of new blood vessels that tumors need to grow. Adding MO-03 to SOC immunotherapy may be more effective than SOC immunotherapy alone in treating patients with advanced or metastatic clear cell renal cell cancer.",[26,27,28,29],"Advanced Clear Cell Renal Cell Carcinoma","Metastatic Clear Cell Renal Cell Carcinoma","Stage III Renal Cell Cancer AJCC v8","Stage IV Renal Cell Cancer AJCC v8","RECRUITING","2026-06-09",{"date":33,"type":34},"2026-06-11","ACTUAL",{"date":36,"type":34},"2026-06-05",{"date":38,"type":20},"2034-01-31",{"name":40,"class":41},"SWOG Cancer Research Network","NETWORK",41,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":65},"100632180","phase-2-vsv-ifn-nis-with-ipilimumab-and-nivolumab-for-the-treatment-of-advanced-or-metastatic-clear-cell-renal-cell-carcinoma-100632180","NCT07510334","VSV-IFNβ-NIS With Ipilimumab and Nivolumab for the Treatment of Advanced or Metastatic Clear Cell Renal Cell Carcinoma","Phase 2 Clinical Evaluation of Combination Immunotherapy for Renal Cell Carcinoma","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Disease Characteristics:\n\n  * Histological confirmation of advanced (not amenable to curative surgery or radiation therapy) or metastatic \\[American Joint Committee on Cancer (AJCC) version 8 Stage IV\\] renal cell carcinoma (RCC) with a clear cell component, including all International Metastatic RCC Database Consortium (IMDC) risk categories (favorable, intermediate, and poor risk) allowed\n* Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.\n\n  * NOTE: Liver lesions that have been previously embolized (bland embolization, chemo- or radio-embolization) or have undergone percutaneous thermoablation are not eligible as target lesions. Tumor lesions in a previously irradiated area are not considered measurable disease; disease that is measurable by physical examination only is not eligible\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2\n* Hemoglobin ≥ 9.0 g\u002FdL (obtained ≤ 15 days prior to registration)\n* Absolute neutrophil count (ANC) ≥ 1500\u002Fmm\\^3 (obtained ≤ 15 days prior to registration)\n* Platelet count ≥ 100,000\u002Fmm\\^3 (obtained ≤ 15 days prior to registration)\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (obtained ≤ 15 days prior to registration)\n* Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement) (obtained ≤ 15 days prior to registration)\n* Prothrombin time (PT)\u002Finternational normalization ratio (INR)\u002Factivated partial thromboplastin time (aPTT) ≤ 1.5 x ULN OR if patient is receiving anticoagulant therapy and INR or aPTT is within target range of therapy (≤ 5 x ULN for patients with liver involvement) (obtained ≤ 15 days prior to registration)\n* Serum creatinine ≤ 1.5 x upper limit of normal (ULN) OR creatinine clearance ≥ 50 ml\u002Fmin using the chronic kidney disease epidemiology (CKD-EPI) creatinine equation (per National Kidney Foundation) (obtained ≤ 15 days prior to registration)\n\n  * NOTE: See calculator at National Kidney Foundation website here: https:\u002F\u002Fwww.kidney.org\u002Fprofessionals\u002Fkdoqi\u002Fgfr\\_calculator\n* Negative pregnancy test done ≤ 8 days prior to registration, for persons of childbearing potential only\n* Provide written informed consent\n* Willingness to provide mandatory blood specimens for correlative research\n* Willingness to provide mandatory tissue specimens for correlative research\n* Willing to return to Mayo Clinic for follow-up (during the active monitoring phase of the study)\n\nExclusion Criteria:\n\n* Any of the following because this study involves an investigational agent, the genotoxic, mutagenic and teratogenic effects of which on the developing fetus and newborn are unknown:\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential and persons able to father a child who are unwilling to employ adequate contraception\n* Prior treatment for advanced or metastatic RCC \\[American Joint Committee on Cancer (AJCC) Stage IV\\]\n* History of portal vein thrombosis involving more than intrahepatic portal vein branches: thrombosis of the right or left portal vein branch or the bifurcation, partial or complete obstruction of the portal vein trunk\n\n  * NOTE: Level 0 or 1 tumor thrombus remain eligible; Level 2, 3, of 4 tumor thrombus related to the primary kidney tumor are ineligible\n* Has received a live vaccine ≤ 30 days prior to registration\n\n  * NOTE: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines and are NOT allowed\n* Any of the following prior therapies:\n\n  * Surgery ≤ 3 weeks prior to registration\n  * Chemotherapy ≤ 2 weeks prior to registration\n  * Radiation therapy ≤ 2 weeks prior to registration\n  * Therapy in the first-line setting for advanced or metastatic RCC\n  * Adjuvant immunotherapy during which or in the ≤ 6 months immediately following, relapse or disease progression has occurred\n* New York Heart Association classification III or IV, known symptomatic coronary artery disease, or symptoms of coronary artery disease on systems review, or known cardiac arrhythmias \\[atrial fibrillation or supraventricular tachycardia (SVT)\\]\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Uncontrolled intercurrent illness including, but not limited to:\n\n  * ongoing or active infection\n  * symptomatic congestive heart failure\n  * unstable angina pectoris\n  * cardiac arrhythmia\n  * dyspnea at rest due to complications of advanced malignancy or other disease that requires continuous oxygen therapy\n  * or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Current immunodeficiency or immunosuppression and receiving systemic corticosteroids at \\> 10mg\u002Fday prednisone or equivalent ≤ 1 week prior to registration.\n\n  * NOTE: Inhaled steroids for pulmonary disease are permitted\n* Known history of the following:\n\n  * Suspected active organ-threatening autoimmune disease including, but not limited to, inflammatory bowel disease, autoimmune hepatitis, lupus, or pneumonitis which can flare while receiving immune checkpoint inhibitor (ICI) treatment.\n\n    * NOTE: Patients with well-controlled or clinically inactive autoimmune diseases are eligible\n  * Non-infectious pneumonitis that required steroids, current pneumonitis, carcinomatous meningitis, or interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity\n* Known or ongoing illness or infection including:\n\n  * Any active Grade 3 or higher \\[per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version (v) 5.0\\] viral, bacterial, or fungal infection ≤ 2 weeks of registration.\n  * Acute hepatitis B (HBV) or acute hepatitis C virus (HCV)\n\n    * NOTE: Patients with chronic HBV or HCV with adequate liver function per inclusion criteria are still eligible\n  * Patients known to be HIV positive and currently receiving antiretroviral therapy\n  * Known history of active tuberculosis (TB) (bacillus tuberculosis)\n  * Uncontrolled hypertension and\u002For diabetes\n  * Clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease requiring hospitalization ≤ 3 months prior to treatment)\n* Receiving concurrent anti-cancer therapy (chemotherapy, immunotherapy, radiotherapy, or any other investigational agent or therapy considered investigational (used for a non-Food and Drug Administration (FDA) approved indication and in the context of a research investigation)\n* Known concurrent malignancy that is progressing or requires active treatment\n\n  * EXCEPTIONS: basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in-situ cervical cancer that has been treated with curative intent, prostate cancer confined to the prostate gland with Gleason score ≤ 6, as well as any cancer treated with curative intent or any prior cancer with a disease-free interval of ≥ 3 years\n* History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias",{"count":51,"type":20},18,[53],"PHASE2","This phase II trial tests adding VSV-IFNβ-NIS to standard of care ipilimumab and nivolumab for the treatment of clear cell renal cell carcinoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). A virus modified in the laboratory, such as VSV-IFNβ-NIS, may be able to kill tumor cells without damaging normal cells. Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving VSV-IFNβ-NIS with ipilimumab and nivolumab may be effective for the treatment of advanced or metastatic clear cell renal cell carcinoma.",[26,27,28,29],"2026-06-03",{"date":36,"type":34},{"date":59,"type":34},"2026-04-21",{"date":61,"type":20},"2033-08-01",{"name":63,"class":64},"Mayo Clinic","OTHER",1,{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":21,"phases":75,"briefSummary":76,"conditions":77,"keywords":78,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":94},"100593844","phase-3-study-of-casdatifan-and-cabozantinib-versus-placebo-and-cabozantinib-in-patients-with-advanced-clear-cell-renal-cell-carcinoma-100593844","NCT07011719","Study of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma","A Randomized, Double-Blind, Active-Control, Multicenter Phase 3 Trial of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma","Inclusion Criteria:\n\n* Unresectable and measurable locally advanced or metastatic renal cell carcinoma with a primary clear cell component.\n* A Karnofsky Performance Status (KPS) score ≥ 80%\n* At least 1 target lesion measurable by computed tomography\u002Fmagnetic resonance imaging per RECIST 1.1, not within a field of prior radiation therapy.\n* Adequate organ and marrow function, ≤ 1 week prior to randomization.\n* Women of childbearing potential (WOCBP) must have a negative serum pregnancy test.\n\nExclusion Criteria:\n\n* Received prior treatment with a HIF-2α inhibitor or cabozantinib.\n* Other prior malignancy active within the previous year except for locally curable cancers that have been apparently cured.\n* Ongoing clinically significant toxicities related to any prior anticancer treatment, or toxicities Grade ≥ 3 per National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0) regardless of relatedness to prior anticancer therapies.\n* Uncontrolled or poorly controlled hypertension, defined as a sustained blood pressure \\> 150 mmHg systolic or \\> 90 mmHg diastolic despite optimal antihypertensive treatment.\n* History of leptomeningeal disease or spinal cord compression.\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":74,"type":20},720,[23],"The purpose of the study is to evaluate the progression-free survival (PFS) of casdatifan versus placebo when each is given in combination with cabozantinib in adult patients with confirmed advanced or metastatic clear cell Renal Cell Carcinoma who have experienced progression on or after prior anti-PD-1 or anti-PD-L1 immunotherapy.",[27,26],[79,27,26,80,81,82,83],"Casdatifan","Kidney Cancer","PEAK-1","AB521","ccRCC","2026-05-29",{"date":86,"type":34},"2026-06-02",{"date":88,"type":34},"2025-09-08",{"date":90,"type":20},"2030-12",{"name":92,"class":93},"Arcus Biosciences, Inc.","INDUSTRY",118,{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":21,"phases":104,"briefSummary":106,"conditions":107,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":119},"100602835","phase-1-immunotherapy-nivolumab-and-ipilimumab-with-and-without-a-live-biotherapeutic-product-exl01-for-the-treatment-of-metastatic-renal-cell-cancer-100602835","NCT07128680","Immunotherapy (Nivolumab and Ipilimumab) With and Without a Live Biotherapeutic Product (EXL01) for the Treatment of Metastatic Renal Cell Cancer","A Randomized Study of Nivolumab and Ipilimumab With and Without EXL01 in First-Line Treatment of Metastatic Renal Cell Carcinoma (mRCC)","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies\n\n  * If unavailable, exceptions may be granted with study principal investigator (PI) approval\n* Age: ≥ 18 years at time of signing informed consent\n* Eastern Cooperative Oncology Group (ECOG) ≤ 2\n* Life expectancy \\> 3 months\n* Histologically confirmed renal cell carcinoma with clear cell renal cell carcinoma component with or without sarcomatoid component\n* Advanced (not amenable to curative surgery or radiation therapy) or metastatic (American Joint Committee on Cancer \\[AJCC\\] stage IV) renal cell carcinoma with any disease risk disease by International Metastatic RCC Database Consortium (IMDC) criteria (good-, intermediate- or poor-risk)\n* No prior systemic therapy for RCC with the following exception:\n\n  * One prior adjuvant or neoadjuvant therapy for completely resectable RCC if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy, provided that the patient has fully recovered from acute toxic effects to prior anti-cancer therapy\n* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1\n* Absolute neutrophil count (ANC) ≥ 1,000\u002Fmm\\^3\n\n  * NOTE: Growth factor is not permitted within 14 days of ANC assessment unless cytopenia is secondary to disease involvement\n* Platelets ≥ 100,000\u002Fmm\\^3\n\n  * NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment unless cytopenia is secondary to disease involvement\n* Hemoglobin ≥ 9g\u002FdL\n\n  * NOTE: Red blood cell transfusions are not permitted within 14 days of hemoglobin assessment unless cytopenia is secondary to disease involvement\n* Total bilirubin ≤ 1.5 X upper limit of normal (ULN) (except for subjects with Gilbert Syndrome, who may have total bilirubin up to 3.0 mg\u002FdL)\n* Aspartate aminotransferase (AST) ≤ 3.0 x ULN\n* Alanine aminotransferase (ALT) ≤ x ULN\n* Creatinine clearance of ≥ 30 mL\u002Fmin per 24-hour urine test or the Cockcroft-Gault formula or serum creatinine \\\u003C 1.5 x upper limit of normal (ULN)\n* If not receiving anticoagulants: International normalized ratio (INR) OR prothrombin (PT) ≤ 1.5 x ULN\n* If on anticoagulant therapy: PT must be within therapeutic range of intended use of anticoagulants\n* If not receiving anticoagulants: Activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN\n* If on anticoagulant therapy: aPTT must be within therapeutic range of intended use of anticoagulants\n* If seropositive for HIV, hepatitis C virus (HCV) or hepatitis B virus (HBV), nucleic acid quantitation must be performed. Viral load must be undetectable. HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* Meets other institutional and federal requirements for infectious disease titer requirements\n\n  * Note infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy\n* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test within 72 hours of study start\n\n  * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception (e.g., barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 5 months after the last dose of nivolumab or ipilimumab for women with childbearing potential, and 5 months after the last dose of nivolumab or ipilimumab for men. For EXL01, female participants should continue contraception for 30 days after the last dose\n* Female subjects of childbearing potential must not be pregnant at screening. Female subjects are considered to be of childbearing potential unless one of the following criteria is met: documented permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman \\> 45 years-of-age in the absence of other biological or physiological causes. In addition, females \\\u003C 55 years-of-age must have a serum follicle stimulating \\[FSH\\] level \\> 40 mIU\u002FmL to confirm menopause).\n\n  * Note: Documentation may include review of medical records, medical examinations, or medical history interview by study site\n\nExclusion Criteria:\n\n* Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways\n* Current use, or intent to use probiotics, prebiotics, bacterial fortified foods and other natural supplements ≤ 2 week prior to treatment initiation and during the period of treatment\n* Any botanical preparation (e.g. herbal supplements or traditional Chinese medicines) intended to treat the disease under study or provide supportive care\n* Fecal microbiota transplant within 3 months prior to screening\n\n  * Note: Patients must have recovered adequately from the toxicity and\u002For complications from the treatment prior to starting study intervention\n* Patients requiring chronic antibiotic therapy at the time of study enrollment\n* Unstable cardiac disease as defined by one of the following:\n\n  * Cardiac events such as myocardial infarction (MI) within the past 6 months\n  * NYHA (New York Heart Association) heart failure class III-IV\n  * Uncontrolled atrial fibrillation or hypertension\n* Active interstitial lung disease (ILD)\u002Fpneumonitis or history of ILD\u002Fpneumonitis requiring treatment with systemic steroids\n* Known medical condition (e.g., a condition associated with diarrhea or acute diverticulitis) that, in the investigator's opinion, would increase the risk associated with study participation or study drug administration or interfere with the interpretation of safety results\n* Receipt of any type of cytotoxic, biologic, or other systemic anticancer therapy (including investigational) within 4 weeks before first dose of study treatment\n* Radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before first dose of study treatment. Patients must have recovered adequately from the toxicity and\u002For complications from the treatment prior to starting study intervention\n* Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and\u002For surgery (including radiosurgery) and stable for at least 4 weeks prior to first dose of study treatment after radiotherapy or at least 4 weeks prior to first dose of study treatment after major surgery (e.g., removal or biopsy of brain metastasis). Subjects must have complete wound healing from major surgery or minor surgery before first dose of study treatment. Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of first dose of study treatment\n* Administration of a live, attenuated vaccine within 30 days before first dose of study treatment\n* The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:\n\n  * Any condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days before first dose of study treatment\n\n    * Note: Inhaled, intranasal, intra-articular, or topical steroids are permitted. Adrenal replacement steroid doses ≤ 10 mg daily prednisone equivalent are permitted. Transient short-term use of systemic corticosteroids for allergic conditions (e.g., contrast allergy) is also allowed\n  * History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan\n* Active inflammatory intestinal disease (Crohn disease, Hemorrhagic recto-colitis, coeliac disease) or any serious chronic intestinal disease with uncontrolled diarrhea\n* Known positive test for tuberculosis infection where there is clinical or radiographic evidence of active mycobacterial infection\n* Major surgery within 28 days (4 weeks) prior to first dose of study treatment\n\n  * Note: Participants who had surgery \\> 4 weeks prior to screening must have recovered adequately from any toxicity and\u002For complications from the surgery or trauma prior to starting study intervention\n* Malabsorption syndrome\n* Uncompensated\u002Fsymptomatic hypothyroidism\n* Moderate to severe hepatic impairment (Child-Pugh B or C)\n* Requirement for hemodialysis or peritoneal dialysis\n* History of solid organ or allogenic stem cell transplant\n* Other clinically significant disorders that would preclude safe study participation.\n\n  * Any active, known, or suspected autoimmune disease will be excluded, with the following exceptions:\n\n    * Type 1 diabetes mellitus.\n    * Hypothyroidism only requiring hormone replacement.\n    * Skin disorders (e.g., vitiligo, psoriasis, or alopecia) not requiring systemic treatment.\n    * Conditions not expected to recur in the absence of an external trigger\n* Gastrointestinal (GI) obstruction, poor oral intake, or difficulty in taking oral medication or difficulties in swallowing; nasogastric tubes are not permitted or unwillingness or inability to receive IV administration\n* Known history or newly diagnosed GI parasitic infection within 3 months prior to screening. Patients must have recovered adequately from the toxicity and\u002For complications from the treatment prior to starting study intervention\n* Previously identified allergy or hypersensitivity to components of the study treatment formulations or history of severe infusion-related reactions to monoclonal antibodies. Subjects with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption are also excluded\n* A patient with a known serious hypersensitivity to any component of the drug formulation for EXL01, or any other live biotherapeutic product (LBP), should not receive EXL01\n* Hypersensitivity to soy products\n* Any other active malignancy at time of first dose of study treatment or diagnosis of another malignancy within 3 years prior to first dose of study treatment that requires active treatment, except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast\n* Females only: Pregnant or breastfeeding\n* Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":103,"type":20},33,[105],"PHASE1","This phase I trial tests the safety and effectiveness of nivolumab and ipilimumab with and without EXL01 for the treatment of renal cell cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. EXL01 is a live biotherapeutic product containing a strain of bacteria called Faecalibacterium prausnitzii. It may enhance a patient's response to treatment with immune checkpoint inhibitors like nivolumab and ipilimumab by altering the composition of the bacteria in the gut. Adding EXL01 to treatment with nivolumab and ipilimumab may be safe and more effective than giving nivolumab and ipilimumab alone.",[26,108,27,109,28,29],"Advanced Sarcomatoid Renal Cell Carcinoma","Metastatic Sarcomatoid Renal Cell Carcinoma","2026-05-07",{"date":112,"type":34},"2026-05-11",{"date":114,"type":34},"2026-03-23",{"date":116,"type":20},"2028-08-25",{"name":118,"class":64},"City of Hope Medical Center",2,{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":127,"targetDuration":4,"studyType":21,"phases":129,"briefSummary":130,"conditions":131,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":140},"100467051","phase-2-genetic-testing-to-select-therapy-for-the-treatment-of-advanced-or-metastatic-kidney-cancer-optic-rcc-study-100467051","NCT05361720","Genetic Testing to Select Therapy for the Treatment of Advanced or Metastatic Kidney Cancer, OPTIC RCC Study","Optimal Treatment by Invoking Biologic Clusters in Renal Cell Carcinoma (OPTIC RCC)","Inclusion Criteria:\n\n* Histological confirmation of RCC with a clear cell component\n* Advanced (not amenable to curative surgery or radiation therapy) or metastatic (American Joint Committee on Cancer \\[AJCC\\] stage IV) RCC\n* Patient can comprehend and sign the study informed consent form\n* Male or female \\>= 18 years of age at the time of informed consent\n* Karnofsky performance status (KPS) of \\>= 70%\n* No prior systemic therapy for RCC in the neoadjuvant, adjuvant or metastatic setting\n* At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1\n* Tumor tissue for ribonucleic acid (RNA)-sequencing (tumor tissue from bony metastasis is not suitable but a soft tissue component around bone is acceptable)\n\n  * Screening tissue consent- Patient must be assigned to either Cluster 1\u002F2 or 4\u002F5. Patients assigned to cluster 3\u002F6\u002F7 will not be eligible for the treatment study\n* Adequate renal function defined as calculated creatinine clearance \\>= 30 mL\u002Fmin per the Cockcroft and Gault formula\n* Adequate liver function defined by:\n\n  * Total bilirubin =\\\u003C 1.5 times the upper limit of normal (ULN) except for unconjugated hyperbilirubinemia of Gilbert's syndrome\n  * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\\\u003C 3 x ULN\n* Women of childbearing potential (WOCBP) must have a negative serum pregnancy test during screening and prior to receiving first dose of protocol-indicated treatment\n\n  * Women of childbearing potential (WOCBP) is defined as any female who has experienced menarche who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or is not postmenopausal\n  * Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 years of age in the absence of other biological or physiological causes\n\nExclusion Criteria:\n\n* =\\\u003C 14 days before first dose of protocol-indicated treatment:\n\n  * Major surgery requiring general anesthesia\n* Inadequately controlled hypertension (systolic blood pressure \\[SBP\\] \\> 160\u002F90 mmHg)\n\n  * Anti-hypertensive medications are permitted.\n* Active infection requiring infusional treatment\n* Has preexisting gastrointestinal or non-gastrointestinal fistula\n* Proteinuria \\> 2 g\u002F 24 hours (hrs)\n\n  * If patient has 1+ protein on urine dipstick then a 24 hr urine collection is required\n* Non-healing wounds on any part of the body (for patients assigned to Cabo\u002FNivo only)\n* Known clinically significant active bleeding including hemoptysis\n* Inability to swallow oral medication; or the presence of a poorly controlled gastrointestinal disorder that could significantly affect the absorption of oral study drug (for patients assigned to Cabo\u002FNivo only) - e.g., Crohn's disease, ulcerative colitis, chronic diarrhea (defined as \\> 4 loose stools per day), malabsorption, or bowel obstruction\n* Significant cardiovascular disease or condition including:\n\n  * Class III or IV cardiovascular disease according to the New York Heart Association (NYHA) functional criteria\n  * Unstable angina pectoris (i.e., last episode =\\\u003C 3 months prior to first dose of protocol-indicated treatment)\n  * Myocardial infarction within 3 months prior to starting treatment\n* Subjects with central nervous system (CNS) metastases are eligible after they have completed local therapy (e.g., whole brain radiation therapy \\[WBRT\\], surgery or radiosurgery)\n* Any condition requiring systemic treatment with either systemic corticosteroids (\\> 10 mg\u002Fday prednisone or equivalent daily) or other immunosuppressive medications within 14 days prior to initiating protocol-indicated treatment\n* In the absence of active autoimmune disease: Subjects are permitted the use of corticosteroids with minimal systemic absorption (e.g., topical, ocular, intra-articular, intranasal, and inhalational), =\\\u003C 10 mg\u002Fday prednisone or equivalent daily; and physiologic replacement doses of systemic corticosteroids =\\\u003C 10 mg\u002Fday prednisone or equivalent daily (e.g., hormone replacement therapy needed in patients with hypophysitis)",{"count":128,"type":20},54,[53],"This phase II trial tests whether using genetic testing of tumor tissue to select the optimal treatment regimen works in treating patients with clear cell renal cell (kidney) cancer that has spread to other places in the body (advanced or metastatic). The current Food and Drug Administration (FDA)-approved regimens for advanced kidney cancer fall into two categories. One treatment combination includes two immunotherapy drugs (nivolumab plus ipilimumab), which are delivered by separate intravenous infusions into a vein. The other combination is one immunotherapy drug (nivolumab infusion) plus an oral pill taken by mouth (cabozantinib). Nivolumab and ipilimumab are \"immunotherapies\" which release the brakes of the immune system, thus allowing the patient's own immune system to better kill cancer cells. Cabozantinib is a \"targeted therapy\" specifically designed to block certain biological mechanisms needed for growth of cancer cells. In kidney cancer, cabozantinib blocks a tumor's blood supply. The genetic (DNA) makeup of the tumor may affect how well it responds to therapy. Testing the makeup (genes) of the tumor, may help match a treatment (from one of the above two treatment options) to the specific cancer and increase the chance that the disease will respond to treatment. The purpose of this study is to learn if genetic testing of tumor tissue may help doctors select the optimal treatment regimen to which advanced kidney cancer is more likely to respond.",[26,27,28,29],{"date":133,"type":34},"2026-04-27",{"date":135,"type":34},"2022-12-06",{"date":137,"type":20},"2027-07-01",{"name":139,"class":64},"Vanderbilt-Ingram Cancer Center",6,{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":147,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":149,"targetDuration":4,"studyType":21,"phases":151,"briefSummary":152,"conditions":153,"keywords":158,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":119},"100602406","phase-2-a-study-of-sasanlimab-palbociclib-and-axitinib-in-metastatic-renal-cell-carcinoma-100602406","NCT07123090","A Study of Sasanlimab, Palbociclib and Axitinib in Metastatic Renal Cell Carcinoma","A Phase 2 Study of Sasanlimab, Palbociclib and Axitinib in Metastatic Renal Cell Carcinoma - SPARCC","SPARCC","Inclusion Criteria:\n\n* Histologically or cytologically confirmed unresectable advanced or metastatic renal cell carcinoma with a clear cell component or translocation renal cell carcinoma. Patients with clear cell carcinoma and sarcomatoid histology are eligible.\n\n  * a. For tRCC please refer to the following for eligibility definitions:\n\n    * i. TFE3 (Xp11.2) translocation RCC: confirmed by IHC; however, FISH should be utilized if IHC is not optimal (ie, conclusive) or unavailable.\n    * ii. TFEB rearranged RCC: confirmed by FISH; TFEB amplified tumors are excluded.\n  * b. A formalin-fixed, paraffin-embedded (FFPE) tumor tissue block from a de novo tumor biopsy obtained during screening will be required (biopsied tumor lesion should not be a RECIST target lesion). Alternatively, a recently obtained archival FFPE tumor tissue block (not cut slides from a primary or metastatic tumor resection or biopsy) can be provided if the following criteria are met:\n\n    * i. The biopsy or resection was performed within 1 year of registration AND\n    * ii. The patient has not received any intervening systemic anti-cancer treatment from the time the tissue was obtained and registration onto the current study. If an FFPE tissue block cannot be provided as per documented regulations then 15 unstained slides (10 minimum) will be acceptable\n  * c. Availability of an archival FFPE tumor tissue block from primary diagnosis specimen (if available and not provided per above). If an FFPE tissue block cannot be provided as per documented regulations, then 15 unstained slides (10 minimum) will be acceptable.\n* Measurable disease as per RECIST 1.1. See Section 11 for the evaluation of measurable disease.\n* Age ≥ 18 years.\n* ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A).\n* Normal organ and marrow function as defined below:\n\n  * a. Absolute neutrophil count ≥1.5×109\u002FL\n  * b. Platelets ≥100×109\u002FL\n  * c. Hemoglobin ≥9g\u002FdL (RBC transfusions allowed)\n  * d. Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN) with the following exception: patients with known Gilbert disease should have a total serum bilirubin ≤ 3 x ULN\n  * e. AST(SGOT)\u002FALT(SGPT) ≤1.5 × ULN\n  * f. Creatinine clearance ≥30 mL\u002Fmin according to the CKD-EPI equation. (APPENDIX C)\n  * g. Urine protein \\\u003C1+ by urinalysis; If ≥1+ protein or otherwise suggestive of any proteinuria above a trace amount (per local institutional standards), a random urine protein and creatinine ratio (UPCR) should be collected. A 24-hour urine collection can also be utilized for direct measurement. When multiple modalities are used, the 24-hour urine measurement takes precedence over the random UPCR; refer to section 6.2 for further guidance.\n* Women of child-bearing potential and men must agree to use adequate contraception (intrauterine device or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. If condoms are used as a barrier method, a spermicidal agent should be added as a double barrier protection. A negative pregnancy serum test should be obtained within 7 days of therapy initiation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she must discontinue treatment immediately. Data on fetal outcome and breast-feeding are to be collected for regulatory reporting and drug safety evaluation. Participants treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 90 days after completion of sasanlimab, axitinib and palbociclib administration.\n* Ability to swallow oral medications.\n* Ability to understand and willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Treatment with the following prior therapies:\n\n  * a. Prior systemic therapy for advanced or metastatic RCC.\n  * b. Prior adjuvant or neoadjuvant therapy for RCC if disease progression or relapse has occurred within 12 months of last dose of such therapy. Treatment with an immune checkpoint inhibitor in the adjuvant setting is allowed providing more than 12 months have elapsed since last dose or completion of therapy.\n  * c. Prior treatment with any immunotherapeutic agent (IL-2, IFN-α, anti-PD(L)-1, anti-CTLA-4, or any other antibody or drug targeting T-cell co-stimulation or immune checkpoint pathways).\n  * d. Prior therapy with axitinib or other therapies targeting VEGF pathway in the metastatic setting (adjuvant therapy is allowed).\n\n    e. Prior therapy with any CDK4\u002F6 inhibitor.\n* Participants with untreated brain metastases. Participants with metastatic CNS tumors may participate in this trial, if the participant is ≥ 4 weeks from therapy completion (incl. radiation and\u002For surgery), is clinically stable at the time of study entry and is not receiving corticosteroid therapy \\>10 mg\u002Fday prednisone equivalents. A repeat MRI or CT brain to show stability is required.\n* Wide field radiation therapy ≤ 2 weeks prior to treatment start. Prior palliative radiotherapy to metastatic non-target lesion(s) is permitted if completed at least 48hrs prior to patient registration.\n* Untreated deep vein thrombosis or pulmonary embolism, or event of deep vein thrombosis or pulmonary embolism within 2 weeks of treatment start. Patient should be on at least 1 week of anticoagulation before C1D1.\n* Major surgery\u002Fsurgical procedures within the past 4 weeks prior to registration.\n* The patient has serious and\u002For uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease - also see 3.2.22, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment \\[e.g. estimated creatinine clearance \\\u003C30ml\u002Fmin\\], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea).\n* Current or prior use of immunosuppressive medication within 7 days prior to registration, except the following:\n\n  * a. Intranasal, inhaled, topical steroids, or local steroid injections (eg. intra-articular injection).\n  * b. Systemic corticosteroids at physiologic doses ≤10 mg\u002Fday of prednisone or equivalent.\n  * c. Steroids as premedication for hypersensitivity reactions (eg. CT scan premedication).\n* Known severe hypersensitivity reactions to monoclonal antibodies (Grade ≥3) or any history of anaphylaxis.\n* Active autoimmune disease that might deteriorate when receiving an immunostimulatory agents. Patients with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroidism not requiring immunosuppressive treatment are eligible.\n* Vaccination within 4 weeks of the first dose of sasanlimab and while on trial is prohibited except for administration of inactivated vaccines (for example, inactivated influenza or shingles vaccines). Note, the COVID19 vaccine is not a live vaccine and permitted.\n* Grade ≥3 hemorrhage within 4 weeks of registration.\n* Patient with active systemic bacterial infection (requiring IV antibiotics at the time of initiating study treatment), fungal infection, or detectable viral infection. Patients with known viral infection (such as HIV) are excluded given the potential for interactions between antiretroviral agents and palbociclib and axitinib, and the potential for increased risk of life-threatening infection with therapy that is myelosuppressive. If patients are not known to have HIV, a HIV test is required prior to registration.\n* Patients with known Hepatitis B or Hepatitis C infection are excluded only if there is evidence of active infection (detectable Hepatitis B surface antigen, detectable HBV DNA, or detectable Hepatitis C RNA).\n* Prior allogenic or autologous stem cell or any solid organ transplant.\n* Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of oral drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).\n* Participants who are currently taking therapeutic doses of warfarin sodium or any other coumadin-derivative anticoagulant. Therapeutic use of low molecular weight heparin and factor Xa inhibitors (eg. apixaban, rivaroxaban) is permitted.\n* Other malignancy diagnosed within 2 years of treatment start unless negligible risk of metastases or death according to the investigator (included but not limited to carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer, ductal carcinoma in situ of the breast, non-muscle invasive urothelial carcinoma, or other malignancy not deemed to impact patients 5-year life expectancy).\n* Has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), myocarditis, sudden cardiac arrest.\n* Has had any major cardiovascular event within 6 months prior to treatment start, including but not limited to: myocardial infarction, unstable angina, cerebrovascular accident, transient ischemic event or New York Heart Association Class III or IV heart failure.\n* Ongoing cardiac dysrhythmias of NCI CTCAE Grade ≥2 or history of long QTC syndrome. Any history of myocarditis.\n* History of interstitial lung disease or other restrictive lung disease, as well as history of symptomatic respiratory condition considered clinically significant by the investigator. Individuals with a history of radiotherapy to the thorax and any history of pneumonitis will be excluded.\n* Current or past tobacco users with a history of cigarette smoking greater than 30 pack-yrs (i.e., # of packs of cigarettes smoked per day × # of years patient has smoked \\> 30).\n* Participants with a known hypersensitivity to the study compounds or to its excipients.\n* Current use or anticipated need for treatment with drugs or foods that are known strong CYP3A4\u002F5 inhibitors, including their administration within 7 days prior to treatment start (eg. Grapefruit juice or grapefruit\u002Fgrapefruit-related citrus fruits \\[eg. Seville oranges, pomelos\\], ketoconazole, miconazole, itraconazole, voriconazole, , clarithromycin, telithromycin, indinavir, saquinavir, ritonavir, nelfinavir, amprenavir, fosamprenavir nefazodone, lopinavir, troleandomycin, mibefradil, and conivaptan). The topical use of these medications (if applicable), such as 2% ketoconazole cream, is allowed.\n* Current use or anticipated need for drugs that are known strong CYP3A4\u002F5 inducers, including their administration within 14 days prior to treatment start (eg. Phenobarbital, rifampin, phenytoin, carbamazepine, rifabutin, 23albociclib, clevidipine, St John's wort).\n* Participants who have taken herbal medications within 7 days prior to treatment start. Herbal medications include, but are not limited to St. John's wort, Kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng.\n* Females that are pregnant or breastfeeding.\n* Judgement by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements.",{"count":150,"type":20},25,[53],"The goal of this research study is to evaluate how well and safely the study drugs sasanlimab, palbociclib, and axitinib work for treatment of participants with advanced clear cell renal cell carcinoma (ccRCC) or translocation renal cell carcinoma (tRCC).\n\nThe name of the study drugs involved in this research study is:\n\n* Sasanlimab (a type of monoclonal antibody)\n* Palbociclib (a type of kinase inhibitor)\n* Axitinib (a type of Vascular endothelial growth factor inhibitor)",[154,155,156,26,80,157],"Metastatic Renal Cell Carcinoma","Metastatic Renal Cancer","Renal Cell Carcinoma","Translocation Renal Cell Carcinoma",[154,155,156,26,80,157,83,159],"tRCC",{"date":161,"type":34},"2026-03-25",{"date":163,"type":34},"2025-11-24",{"date":165,"type":20},"2028-02-01",{"name":167,"class":64},"Stephanie Berg",{"id":169,"slug":170,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":4,"eligibilityCriteria":174,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":175,"targetDuration":4,"studyType":21,"phases":177,"briefSummary":178,"conditions":179,"keywords":4,"overallStatus":182,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":119},"100609754","phase-2-rp2-and-tivozanib-for-the-treatment-of-metastatic-renal-cell-cancer-after-progression-on-immunotherapy-100609754","NCT07218692","RP2 and Tivozanib for the Treatment of Metastatic Renal Cell Cancer After Progression on Immunotherapy","A Phase 2 Study of RP2 With Tivozanib in Patients With Metastatic Renal Carcinoma After Progression to Immunotherapy","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* Must be willing to consent to provide fresh tumor biopsy sample or archival tumor biopsy sample obtained within 90 days before the first dose of study treatment\n\n  * If unavailable, exceptions may be granted with study principal investigator (PI) approval\n* Male or female who is 18 years of age or older at the time of signed informed consent\n* Eastern Cooperative Oncology Group (ECOG) 0 or 1\n* Histologically confirmed renal cell carcinoma with a clear-cell or sarcomatoid component\n* Patients must have received exactly one prior line or two prior lines of systemic therapy in the advanced or metastatic setting, including mandatory exposure to both an immune checkpoint inhibitor (ICI) and one antiangiogenic tyrosine kinase inhibitor (TKI). Prior treatment with hypoxia inducible factor (HIF)-α inhibitors is not permitted. Patients who received adjuvant immunotherapy and experienced disease recurrence within 6 months of completing treatment may also be eligible, and such therapy will count toward prior lines\n* Has injectable tumor(s), which alone or in aggregate, total at least 1 cm in diameter of RP2\n* Has at least 1 measurable tumor of ≥ 1 cm in longest diameter (or ≥ 1.5 cm shortest diameter for lymph nodes) as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1\n* Fully recovered from the acute toxic effects (except alopecia) to ≤ grade 1 to prior anti-cancer therapy\n* White blood cell (WBC) count ≥ 2.0 x 10\\^9\u002FL\n* Absolute neutrophil count (ANC) ≥ 1,500\u002Fmm\\^3\n\n  * NOTE: Growth factor is not permitted within 14 days of ANC assessment unless cytopenia is secondary to disease involvement\n* Platelets ≥ 100,000\u002Fmm\\^3\n\n  * NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment unless cytopenia is secondary to disease involvement\n* Hemoglobin ≥ 9g\u002FdL\n\n  * NOTE: Red blood cell transfusions are not permitted within 14 days of hemoglobin assessment unless cytopenia is secondary to disease involvement\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (unless has Gilbert's disease)\n* Aspartate aminotransferase (AST) ≤ 3.0 x ULN\n* Alanine aminotransferase (ALT) ≤ 3.0 x ULN\n* Creatinine clearance of ≥ 30 mL\u002Fmin per the Cockcroft-Gault formula or serum creatinine \\\u003C 1.5 x upper limit of normal (ULN)\n* If not receiving anticoagulants: International normalized ratio (INR) OR prothrombin (PT) ≤ 1.5 x ULN\n* If on anticoagulant therapy: PT must be within therapeutic range of intended use of anticoagulants\n* Left ventricular ejection fraction (LVEF) ≥ 50%\n\n  * Note: To be performed within 28 days prior to day 1 of protocol therapy\n* QT interval corrected for heart rate using Bazetts's formula (QTcB) ≤ 480 ms\n\n  * Note: To be performed within 28 days prior to day 1 of protocol therapy\n* Women of childbearing potential (WOCBP) must have a negative serum beta-human chorionic gonadotropin (β-hCG) test with a minimum sensitivity of 25 IU\u002FL or equivalent units of β-hCG within 72 hours before the first dose and a negative urine pregnancy test on dose 1 day 1\n* Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at and for at least (a) 90 days after the last dose of RP2 or for one month after the last dose of tivozanib. Men must also agree to refrain from donating sperm during the treatment period and for at least 90 days after the last dose of RP2\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n\nExclusion Criteria:\n\n* Received a live vaccine within 28 days before the first dose of study treatment\n\n  * Note: Seasonal influenza vaccines for injection or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines are generally inactivated vaccines and are allowed. Live\u002Fattenuated vaccines (such as the intranasal influenza vaccines) are not allowed\n* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study treatment\n\n  * Note: Patients who have entered the follow-up phase of an investigational study may participate if it has been 4 weeks after the last dose of the previous investigational agent\n* Systemic anticancer therapies within 4 weeks of the first dose of study drug. The prior anti-PD-1 or anti-PD-L1 containing regimen is excluded from this requirement\n* Received prior treatment with an oncolytic virus therapy\n* Received radiotherapy within 2 weeks of start of study treatment. Patients must have recovered from all radiation-related toxicities (except for radiation-induced xerostomia), not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤ 2 weeks of radiotherapy) to non-central nervous system (CNS) disease\n\n  * Note: Patients must have recovered (to grade ≤ 1 or baseline) from all adverse events (AEs) due to previous therapies. Patients with grade ≤ 2 neuropathy may be eligible if approved by the medical monitor\n* Unstable cardiac disease as defined by one of the following:\n\n  * Cardiac events such as myocardial infarction (MI) within the past 6 months\n  * NYHA (New York Heart Association) heart failure class III-IV\n  * Uncontrolled atrial fibrillation or hypertension\n* History of allergy or sensitivity to study drug components or prior monoclonal antibody treatment; known hypersensitivity to Chinese hamster ovary cell products\n* Known human immunodeficiency virus (HIV) infection\n* Known acute or chronic hepatitis B (defined as hepatitis B surface antigen \\[HBsAg\\] reactive) or known acute or chronic hepatitis C virus (defined as HCV ribonucleic acid \\[RNA\\] \\[qualitative\\] is detected)\n\n  * Note 1: If HCV RNA testing not available, may use quantitative HCV RNA testing (preferred) or qualitative HCV antibody detection\n  * Note 2: For patients with known acute or chronic hepatitis B virus (HBV) and\u002For HCV infection, HBV and\u002For HCV viral load by real-time polymerase chain reaction (qPCR) must be below the limit of quantitation for the laboratory test used, and they must not have had recent treatment within 12 weeks for HBV or HCV with antiviral medications. Patients with acute or chronic HBV or HCV must be expected to not require antiviral therapy during the RP2 treatment period\n* Clinically significant uncontrolled illness\n* Active significant herpetic infections or prior complications of herpes simplex virus 1 (HSV-1) infection (eg, herpetic keratitis or encephalitis) or requires intermittent or chronic use of systemic (oral or intravenous \\[IV\\]) antivirals with known antiherpetic activity (eg, acyclovir)\n\n  * Note: Patients with sporadic cold sores may be enrolled if no active cold sores are present at the time of dose 1 day 1\n* Systemic infection requiring IV antibiotics or other serious infection within 14 days before dosing\n* Significant bleeding event within the last 12 months that places the patient at unjustifiable risk for bleeding from intratumoral injection procedures, based on Investigator or interventional radiologist assessment\n* Other active malignancy. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Known central nervous system (CNS) metastases and\u002For carcinomatous meningitis\n* History of interstitial lung disease, idiopathic pulmonary fibrosis, organizing pneumonia (eg, bronchiolitis obliterans), non-infectious pneumonitis that required steroids, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan\n\n  * Note: History of radiation pneumonitis in the radiation field (fibrosis) is permitted\n* Active tuberculosis\n* History or evidence of psychiatric, substance abuse, or any other clinically significant disorder, condition, or disease (except for those outlined above) that, in the opinion of the investigator or the medical monitor, would pose a risk to patient safety or interfere with the study evaluation, procedures, or completion\n* Active, known, or suspected autoimmune disease requiring systemic treatment\n\n  * Note: Patients with type 1 diabetes mellitus and\u002For hypothyroidism requiring only hormone replacement, and\u002For with autoimmune skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, and\u002For prior non-serious autoimmune conditions not expected to recur are permitted to enroll\n* Conditions requiring treatment with immunosuppressive doses (\\> 10 mg per day of prednisone or equivalent) of systemic corticosteroids within 14 days before dose 1 day 1\n\n  * Note: Patients who require a brief course (≤ 7 days) of corticosteroids (eg, as prophylaxis for imaging studies due to hypersensitivity to contrast agents) are not excluded. Physiologic replacement doses of systemic corticosteroids are permitted, only if the dose does not exceed 10 mg\u002Fday prednisone equivalent\n* History of life-threatening toxicity related to prior immune therapy (eg, anti-cytotoxic T lymphocyte antigen 4 or anti-PD-1\u002Fanti-PD-L1 treatment or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways \\[eg, CD40,4-1BB\\]) except those that are unlikely to recur or are expected to be manageable with standard countermeasures (eg, hormone replacement after adrenal crisis). Individual cases should be discussed with medical monitor if needed\n* Conditions in which anticoagulant therapies cannot be safely stopped in the periprocedural period or patients on coumadin with a target INR \\> 2.5 or that cannot be temporarily reversed to INR ≤ 1.7\n* Treatment with botanical preparations (eg, herbal supplements or traditional Chinese medicines) intended for general health support or to treat the disease under study within 2 weeks before treatment\n* Prior organ transplantation including allogeneic stem-cell transplantation\n* Major surgery within 28 days before starting treatment or anticipated major surgery while on study\n\n  * Note: If a patient received major surgery, they must have recovered adequately from the intervention before starting study treatment and must have adequate wound healing, based on investigator's assessment or surgeon's assessment, before starting tivozanib\n* Females only: Pregnant or breastfeeding\n* History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating investigator\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":176,"type":20},35,[53],"This phase II trial tests the effect of RP2 and tivozanib in treating patients with renal cell cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and that is growing, spreading, or getting worse (progressive) after receiving immunotherapy with immune checkpoint inhibitors (ICIs). RP2 is a herpes simplex virus (a viral infection commonly known as the \"cold sore virus\") that has been changed to infect and destroy tumor cells and to activate (turn on) the human immune system to attack the tumor cells. Tivozanib hydrochloride blocks certain proteins, which may help keep tumor cells from growing. It may also prevent the growth of new blood vessels that tumors need to grow. Tivozanib hydrochloride is a type of tyrosine kinase inhibitor and a type of antiangiogenesis agent. Giving RP2 and tivozanib may be safe, tolerable, and\u002For effective in treating patients with metastatic renal cell cancer that has progressed after receiving immunotherapy with ICIs.",[26,180,108,27,154,109,181,28,29],"Advanced Renal Cell Carcinoma","Recurrent Renal Cell Carcinoma","NOT_YET_RECRUITING","2025-10-16",{"date":185,"type":34},"2025-10-20",{"date":187,"type":20},"2026-08-11",{"date":189,"type":20},"2027-08-11",{"name":118,"class":64},{"id":192,"slug":193,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":198,"targetDuration":4,"studyType":21,"phases":200,"briefSummary":201,"conditions":202,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":65},"100600472","phase-1-study-of-hs-10516-combination-therapy-in-patients-with-advanced-renal-cell-carcinoma-100600472","NCT07097935","Study of HS-10516 Combination Therapy in Patients With Advanced Renal Cell Carcinoma","A Phase Ib\u002FII Clinical Study Evaluating the Safety, Efficacy, Tolerability, and Pharmacokinetics of HS-10516 Combination Therapy in Patients With Advanced Renal Cell Carcinoma","Inclusion Criteria:\n\n1. Men or women aged more than or equal to (≥) 18 years.\n2. Histologically confirmed unresectable, locally advanced or metastatic clear cell renal cell carcinoma (ccRCC) with disease progression during or after receiving ≥1 prior line of systemic therapy in the advanced setting.\n3. Patients have at least one target lesion according to RECEST 1.1. The requirements for target lesions are: measurable lesions without local treatment such as irradiation, or with definite progress after local treatment, with the longest diameter ≥ 10 mm in the baseline period (in case of lymph nodes, the shortest axis ≥ 15 mm is required). Patients with only brain and\u002For bone lesions as target lesions will not be included.\n4. ECOG performance status was 0-1 and did not deteriorate in the previous 2 weeks.\n5. Estimated life expectancy greater than (\\>) 12 weeks.\n6. Reproductive-age women agree to use adequate contraception and cannot breastfeed while participating in this study and for a period of 12 months after the last dose. Likewise, men also consent to use adequate contraceptive method within the same time limit.\n7. Females must have the evidence of non-childbearing potential\n8. Sign informed consent form.\n\nExclusion Criteria:\n\n1. Prior or Current Treatments:\n\n   1. Previous or current use of hypoxia-inducible factor inhibitors.\n   2. Previous or current use of lenvatinib.\n   3. Use of Chinese herbal medicine with antitumor indications within 2 weeks prior to the first dose or requirement for such treatment during the study.\n   4. Administration of cytotoxic chemotherapy or other systemic antitumor therapies (e.g., endocrine therapy, molecular targeted therapy) within 2 weeks or 5 half-lives (whichever is shorter) prior to the first dose, or requirement for such treatments during the study.\n   5. Use of large-molecule antitumor drugs within 4 weeks prior to the first dose or requirement for such treatment during the study.\n   6. Use of CYP2C19 strong inhibitors\u002Finducers or narrow therapeutic index sensitive substrates within 7 days prior to the first dose, or requirement for continued use during the study.\n   7. Local radiotherapy (except brain radiotherapy; see Criterion 6) within 2 weeks prior to the first dose, or \\>30% bone marrow irradiation\u002Flarge-field radiotherapy within 4 weeks prior to the first dose.\n   8. Major surgery (e.g., craniotomy, thoracotomy, laparotomy; Grade 3\u002F4 per Chinese Medical Technical Clinical Application Regulations) within 4 weeks prior to the first dose.\n   9. Participation in other interventional clinical trials within 4 weeks prior to the first dose or within 5 half-lives of investigational drugs (whichever is longer).\n2. Resting pulse oximetry \\\u003C92% at screening.\n3. Severe pulmonary dysfunction requiring intermittent\u002Flong-term oxygen therapy.\n4. Unresolved Grade \\>1 toxicities from prior anti-tumor therapy (per CTCAE v5.0).\n5. History of second primary malignancy.\n6. Known or suspected active CNS metastases\u002Fleptomeningeal disease.\n7. Inadequate bone marrow reserve or serious organ dysfunction.\n8. Severe, uncontrolled, or active cardiovascular disease.\n9. Severe or poorly controlled diabetes.\n10. Severe or poorly controlled hypertension.",{"count":199,"type":20},104,[105,53],"This is a multicenter, open-label, Phase Ib\u002FII clinical study evaluating the safety, efficacy, tolerability, and pharmacokinetic\u002Fpharmacodynamic (PK\u002FPD) profiles of HS-10516 in combination with lenvatinib in patients with advanced clear cell renal cell carcinoma (ccRCC) who have progressed after receiving at least one prior line of systemic therapy. The study comprises two distinct phases: a dose exploration phase and a proof-of-concept phase.",[26],"2025-07-30",{"date":205,"type":34},"2025-08-01",{"date":207,"type":34},"2025-07-10",{"date":209,"type":20},"2028-07-10",{"name":211,"class":93},"Jiangsu Hansoh Pharmaceutical Co., Ltd.",{"id":213,"slug":214,"hasResults":11,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":4,"eligibilityCriteria":218,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":219,"enrollmentInfo":220,"targetDuration":4,"studyType":21,"phases":222,"briefSummary":223,"conditions":224,"keywords":4,"overallStatus":182,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":4},"100582973","phase-1-a-clinical-research-of-cd70-targeted-car-nkt-cells-cgc738-therapy-in-rcc-100582973","NCT06870279","A Clinical Research of CD70-targeted CAR-NKT Cells (CGC738) Therapy in RCC","A Clinical Research Evaluating the Safety and Efficacy of CD70-targeted CAR-NKT Cells (CGC738) Therapy in Subjects With Advanced Clear Cell Renal Cell Carcinoma","Inclusion Criteria:\n\n* 1\\. Age 18 to 75 years.\n* 2.ECOG 0-1 points.\n* 3\\. The expected survival time is more than 3 months.\n* 4\\. Patients with advanced ccRCC confirmed by histology or cytology to be recurrent or metastatic after at least first-line treatment.\n* 5\\. IHC: CD70 positive.\n* 6\\. At least one measurable lesion at baseline per RECIST version 1.1.\n* 7\\. The functions of important organs are basically normal:\n* 8\\. Pregnancy tests for women of childbearing age shall be negative, both men and women agreed to use effective contraception.\n\nExclusion Criteria:\n\n* 1\\. Use of cell therapy within the previous one month.\n* 2\\. Subjects with other malignant tumors within the past 2 years, except basal or squamous skin cancer, superficial bladder cancer, and breast cancer in situ, have been completely cured and do not need follow-up treatment.\n* 3\\. Patients with leptomeningeal metastasis or central nervous system metastasis, and definite central nervous system underlying diseases with significant symptoms.\n* 4\\. Immunotherapy, targeted drug therapy or chemotherapy within 5 drug half-lives within 2 weeks before cell infusion.\n* 5\\. Active hepatitis B, HIV positive and HCV positive.\n* 6\\. Active infection or uncontrollable infection.\n* 7\\. Uncontrollable or significant heart disease.\n* 8\\. Unstable respiratory diseases, including interstitial pneumonia.\n* 9\\. Uncontrolled ascites and pleural effusion.\n* 10.Known to have active or uncontrolled autoimmune diseases, such as Crohns disease, rheumatoid arthritis, systemic lupus erythematosus, etc.\n* 11.Subjects who are using systemic steroids or steroid inhalers for treatment.\n* 12.Pregnant or lactating female subjects.\n* 13.Other investigators deem it unsuitable to participate in the study","75 Years",{"count":221,"type":20},28,[105],"This is a phase I, open-label, single-arm study conducted to evaluate the efficacy, safety and PK of CGC738 in the treatment of advanced clear cell renal cell carcinoma (ccRCC).",[26],"2025-04-19",{"date":227,"type":34},"2025-04-24",{"date":229,"type":20},"2025-05-25",{"date":231,"type":20},"2026-12-31",{"name":233,"class":64},"RenJi Hospital",{"id":235,"slug":236,"hasResults":11,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":4,"eligibilityCriteria":240,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":241,"targetDuration":4,"studyType":21,"phases":242,"briefSummary":243,"conditions":244,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":65},"100546781","phase-1-cbm588-capsules-in-combination-with-nivolumab-and-ipilimumab-for-the-treatment-of-advanced-stage-kidney-cancer-100546781","NCT06399419","CBM588 Capsules in Combination With Nivolumab and Ipilimumab for the Treatment of Advanced Stage Kidney Cancer","An Open-Label, Phase I, Dose-Finding Study of CBM588 in Combination With Nivolumab\u002FIpilimumab for Patients With Advanced Stage Renal Cell Carcinoma","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies\n\n  * If unavailable, exceptions may be granted with study principle investigator (PI) approval\n* Eastern Cooperative Oncology Group (ECOG) ≤ 2\n* Age ≥ 18 years\n* Histologically confirmed renal cell carcinoma with clear cell renal cell carcinoma component or sarcomatoid component\n* Advanced (not amenable to curative surgery or radiation therapy) or metastatic (American Joint Committee on Cancer \\[AJCC\\] stage IV) renal cell carcinoma with intermediate- or poor-risk disease by International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) criteria\n* No prior systemic therapy for renal cell carcinoma (RCC) with the following exception:\n\n  * One prior adjuvant or neoadjuvant therapy for completely resectable RCC if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy\n* Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1\n* Fully recovered from the acute toxic effects (except alopecia) to ≤ grade 1 to prior anti-cancer therapy\n* Absolute neutrophil count (ANC) ≥ 1500\u002FuL without granulocyte colony-stimulating factor support\n* White blood cell count ≥ 2500\u002FuL\n* Platelets ≥ 100,000\u002FuL without transfusion\n* Hemoglobin ≥ 8 g\u002FdL\n* Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) ≤ 3 x upper limit of normal (ULN). ALP ≤ 5 x ULN with documented bone metastases\n* Total bilirubin ≤ 1.5 x ULN (for subjects with Gilbert's disease ≤ 3 x ULN)\n* Serum albumin ≥ 2.8 g\u002Fdl\n* Prothrombin time (PT)\u002Finternational normalized ratio (INR) or partial thromboplastin time (PTT) test \\\u003C 1.3 x the laboratory ULN\n* Serum calculated creatinine clearance ≥ 50mL\u002Fmin using the Cockcroft-Gault equation\n* Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception (e.g., barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 5 months after the last dose of nivolumab for women with childbearing potential, and 7 months after the last dose of nivolumab for men\n* Female subjects of childbearing potential must not be pregnant at screening. Female subjects are considered to be of childbearing potential unless one of the following criteria is met: documented permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman \\> 45 years-of-age in the absence of other biological or physiological causes. In addition, females \\\u003C 55 years-of-age must have a serum follicle stimulating (FSH) level \\> 40 mIU\u002FmL to confirm menopause).\n\n  * Note: Documentation may include review of medical records, medical examinations, or medical history interview by study site\n\nExclusion Criteria:\n\n* Prior treatment with ipilimumab and\u002For nivolumab\n* Current use, or intent to use, probiotics, yogurt, or bacterial fortified foods during the period of treatment\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent\n* Active interstitial lung disease (ILD)\u002Fpneumonitis or history of ILD\u002Fpneumonitis requiring treatment with systemic steroids\n* Known medical condition (e.g., a condition associated with diarrhea or acute diverticulitis) that, in the investigator's opinion, would increase the risk associated with study participation or study drug administration or interfere with the interpretation of safety results\n* Receipt of any type of cytotoxic, biologic, or other systemic anticancer therapy (including investigational) within 4 weeks before first dose of study treatment\n* Radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible\n* Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and\u002For surgery (including radiosurgery) and stable for at least 4 weeks prior to first dose of study treatment after radiotherapy or at least 4 weeks prior to first dose of study treatment after major surgery (e.g., removal or biopsy of brain metastasis). Subjects must have complete wound healing from major surgery or minor surgery before first dose of study treatment. Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of first dose of study treatment\n* Administration of a live, attenuated vaccine within 30 days before first dose of study treatment\n* The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:\n\n  * Any condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days before first dose of study treatment. Note: Inhaled, intranasal, intra-articular, or topical steroids are permitted. Adrenal replacement steroid doses ≤ 10 mg daily prednisone equivalent are permitted. Transient short-term use of systemic corticosteroids for allergic conditions (e.g., contrast allergy) is also allowed\n  * Active infection requiring systemic treatment. Acute or chronic hepatitis B or C infection, known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness requiring systemic treatments, or known positive test for tuberculosis infection where there is clinical or radiographic evidence of active mycobacterial infection\n  * History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan\n  * Malabsorption syndrome\n  * Uncompensated\u002Fsymptomatic hypothyroidism\n  * Moderate to severe hepatic impairment (Child-Pugh B or C)\n  * Requirement for hemodialysis or peritoneal dialysis\n  * History of solid organ or allogenic stem cell transplant\n  * Other clinically significant disorders that would preclude safe study participation\n\n    * Any active, known, or suspected autoimmune disease will be excluded, with the following exceptions:\n\n      * Type 1 diabetes mellitus\n      * Hypothyroidism only requiring hormone replacement\n      * Skin disorders (e.g., vitiligo, psoriasis, or alopecia) not requiring systemic treatment\n      * Conditions not expected to recur in the absence of an external trigger\n* Pregnant or lactating females\n* Inability to swallow tablets\u002Fcapsules or unwillingness or inability to receive IV administration\n* Previously identified allergy or hypersensitivity to components of the study treatment formulations or history of severe infusion-related reactions to monoclonal antibodies. Subjects with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption are also excluded\n* Any other active malignancy at time of first dose of study treatment or diagnosis of another malignancy within 3 years prior to first dose of study treatment that requires active treatment, except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast\n* Exclusion of subjects with a history of myocarditis or congestive heart failure (as defined by New York Heart Association Functional Classification III or IV), as well as unstable angina, serious uncontrolled cardiac arrhythmia, uncontrolled infection, or myocardial infarction 6 months prior to study entry\n* Exclusion of subjects whose baseline pulse oximetry is less than 92% on room air\n* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":221,"type":20},[105],"This phase I trial tests the safety, side effects, best dose, and effectiveness of CBM588 in combination with nivolumab and ipilimumab in treating patients with kidney cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). CBM588 is a live biotherapeutic that may help improve the effects of immunotherapy. Nivolumab and ipilimumab are monoclonal antibodies that may interfere with the ability of tumor cells to grow and spread by enhancing the ability of the body's immune cells to attack tumor cells. CBM588 in combination with nivolumab and ipilimumab may be safe, tolerable, and\u002For effective in treating patients with advanced stage kidney cancer.",[26,180,108,27,154,109,28,29],"2024-05-28",{"date":247,"type":34},"2024-05-30",{"date":249,"type":20},"2024-06-19",{"date":251,"type":20},"2026-10-19",{"name":253,"class":93},"Osel, Inc."]