[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stage-ii-renal-cell-cancer-ajcc-v8\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stage-ii-renal-cell-cancer-ajcc-v8":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,43,66],{"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":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100610358","phase-2-ivonescimab-prior-to-surgery-for-the-treatment-of-high-risk-localized-clear-cell-renal-cell-cancer-100610358",false,"NCT07226544","Ivonescimab Prior to Surgery for the Treatment of High-Risk Localized Clear Cell Renal Cell Cancer","A Phase II Study of Neoadjuvant Ivonescimab in Patients With High-Risk, Localized RCC","Inclusion Criteria:\n\n* Histologic confirmation of clear cell RCC\n* High-risk disease defined as cT2G3-4N0M0, cT3GanyN0M0, cT4GanyN0M0, cTanyGanyN+M0 (Grade determined by biopsy)\n* Candidate for partial or complete nephrectomy that extirpates all tumor tissue as part of treatment plan\n* Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1\n* Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL (no blood transfusions or growth factor therapy used within 7 days of the screening complete blood count \\[CBC\\])\n* Platelet count ≥ 100 × 10\\^9\u002FL (no blood transfusions or growth factor therapy used within 7 days of the screening CBC)\n* Hemoglobin ≥ 9.0 g\u002FdL (no blood transfusions or growth factor therapy used within 7 days of the screening CBC)\n* Creatinine clearance (CrCL) ≥ 50 mL\u002Fmin using the Cockcroft-Gault formula or estimated glomerular filtration rate (eGFR) value ≥ 60 mL\u002Fmin using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (adjustment by body surface area \\[BSA\\] is not required for eGFR)\n* Urine protein \\\u003C 2+ or 24-hour urine protein quantification \\\u003C 1.0 g\n* Serum total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); For patients with liver metastases or confirmed\u002Fsuspected Gilbert syndrome, TBIL ≤ 3 × ULN\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN; For patients with liver metastases, AST and ALT ≤ 5 × ULN\n* Coagulation: Prothrombin time (PT) or international normalized ratio (INR) ≤ 1.5 × ULN, and partial prothrombin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (unless abnormalities are unrelated to coagulopathy). This applies only to patients who are not on therapeutic anti-coagulation. Patients receiving therapeutic anti-coagulation should be on a stable dose\n* Female patients of childbearing age must have negative serum pregnancy test results before enrollment or per region-specific guidance documented in the informed consent and a negative urine pregnancy test on the day of first dose prior to dosing\n* Female patient of childbearing potential having sex with an unsterilized male partner must agree to use a highly effective method of contraception from the beginning of screening until 90 days after the last dose of the ivonescimab\n* Unsterilized male patients having sex with a female partner of childbearing potential, or a pregnant or breastfeeding partner must agree to use barrier contraception (male condom) for the duration of the treatment period until 90 days after the last dose of ivonescimab. Male patients with female partners of childbearing potential must have the female partner agree to use at least 1 form of highly effective contraception for the duration of the treatment period until 90 days after the last dose of ivonescimab\n* Adults aged 18 years or older\n\nExclusion Criteria:\n\n* Prior systemic anti-tumor treatment for RCC\n* Major surgical procedures or serious trauma within 4 weeks prior to enrollment, or plans for major surgical procedures within 4 weeks after the first dose (as determined by the investigator). Minor local procedures (excluding central venous catheterization and port implantation) within 3 days prior to enrollment\n* History of bleeding tendencies or coagulopathy and\u002For clinically significant bleeding symptoms or risk within 4 weeks prior to enrollment, including but not limited to:\n\n  * Current use of prophylactic or full-dose anticoagulants or anti-platelet agents for therapeutic purposes that is not stable prior to enrollment is not allowed. The use of full-dose anticoagulants is permitted as long as the international normalized ratio (INR) or activated partial thromboplastin time (aPTT) is within therapeutic limits according to the medical standard of the enrolling institution\n* Poorly controlled hypertension with repeated systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg after oral antihypertensive therapy\n* Active autoimmune or lung disease requiring systemic therapy (eg, with disease modifying drugs, prednisone \\> 10 mg daily or equivalent, immunosuppressant therapy) within 2 years prior to enrollment, however the following will be allowed:\n\n  * Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is permitted\n  * Intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroid injections is permitted\n* History of major diseases before enrollment, specifically:\n\n  * Unstable angina, myocardial infarction, congestive heart failure (New York Heart Association \\[NYHA\\] classification ≥ grade 2) or unstable vascular disease (eg, aortic aneurysm at risk of rupture, Moyamoya disease) that required hospitalization within 12 months prior to enrollment, or other cardiac impairment that may affect the safety evaluation of the study drug (eg, poorly controlled arrhythmias, myocardial ischemia)\n  * History of esophageal gastric varices, severe ulcers, wounds that do not heal, abdominal fistula, intra-abdominal abscesses, or acute gastrointestinal bleeding within 6 months before enrollment\n  * History of any grade arterial thromboembolic event, Grade 3 and above venous thromboembolic event, as specified in National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 12 months prior to enrollment\n  * Acute exacerbation of chronic obstructive pulmonary disease within 4 weeks before enrollment\n  * History of perforation of the gastrointestinal tract and\u002For fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection) within 6 months prior to enrollment\n* Imaging during the screening period shows that the patient has metastatic disease\n* Symptomatic central nervous system (CNS) metastases, CNS metastases with hemorrhagic features, CNS metastasis ≥ 1.5 cm, CNS radiation within 7 days prior to enrolment, potential need for CNS radiation within the first cycle, or leptomeningeal disease\n* Live vaccine or live attenuated vaccine within 4 weeks prior to planned enrolment, or if scheduled to receive a live vaccine or live attenuated vaccine during the study period. Inactivated vaccines are permitted\n* Severe infection within 4 weeks prior to enrolment, including but not limited to comorbidities requiring hospitalization, sepsis, or severe pneumonia; active infection (as determined by the investigator) requiring systemic anti-infective therapy within 2 weeks prior to enrolment (excluding antiviral therapy for hepatitis B or C)\n* Has pre-existing peripheral neuropathy that is ≥ Grade 2 by CTCAE version 5\n* Uncontrolled pleural effusions, pericardial effusions, or ascites that is clinically symptomatic\n* History of non-infectious pneumonia requiring systemic corticosteroids, or current interstitial lung disease\n* Active or prior history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)\n* Known history of human immunodeficiency virus (HIV) whose viral load is not controlled\n* Current use of systemic corticosteroids (\\> 10 mg daily prednisone or equivalent)\n* Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation\n* Patients with active hepatitis B are required to have stable or declining levels of hepatitis B DNA by polymerase chain reaction (PCR) on appropriate anti-viral therapy with acceptable tolerability for one month prior to enrolment. All patients with active hepatitis C (hepatitis C virus \\[HCV\\] antibody positive with HCV ribonucleic acid \\[RNA\\] levels above the lower limit of detection) are excluded\n* Known allergy to any component of any study drug; known history of severe hypersensitivity to other monoclonal antibodies\n* History or current evidence of any condition (medical \\[including adverse events from prior anticancer therapy, disorders secondary to tumor\\], surgical or psychiatric \\[including substance abuse\\]), or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, might lead to higher medical risk and\u002For is not in the best interest of the patient to participate, in the opinion of the treating investigator\n* Patient is breastfeeding or plans to breastfeed during the study\n* History of severe immune-mediated adverse events from immunotherapy agents (i.e. PD1\u002FPDL1\u002FCTLA4 inhibitors), or immune-related ocular toxicity, pneumonitis, or cardiomyopathy of any grade","ALL","18 Years",{"count":19,"type":20},31,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase II trial studies how well ivonescimab works prior to surgery in treating patients with high-risk clear cell kidney (renal cell) cancer that has not spread to other parts of the body (localized). Immunotherapy with monoclonal antibodies, such as ivonescimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Ivonescimab may also stop or slow the cancer by blocking the growth of new blood vessels necessary for tumor growth. Giving ivonescimab before standard surgery may make the tumor smaller.",[26,27,28,29,30],"Localized Clear Cell Renal Cell Carcinoma","Resectable Clear Cell Renal Cell Carcinoma","Stage II Renal Cell Cancer AJCC v8","Stage III Renal Cell Cancer AJCC v8","Stage IV Renal Cell Cancer AJCC v8","RECRUITING","2026-06-08",{"date":34,"type":35},"2026-06-10","ACTUAL",{"date":32,"type":20},{"date":38,"type":20},"2027-09-08",{"name":40,"class":41},"City of Hope Medical Center","OTHER",1,{"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":53,"conditions":54,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":65},"100595788","phase-2-adding-a-live-biotherapeutic-product-cbm588-to-pembrolizumab-for-the-treatment-of-renal-cell-cancer-after-surgery-100595788","NCT07037004","Adding a Live Biotherapeutic Product (CBM588) to Pembrolizumab for the Treatment of Renal Cell Cancer After Surgery","Impact of Microbiome Modulation With CBM588 in Combination With Pembrolizumab for Adjuvant Therapy of High-Risk, Resected Renal Cell Carcinoma (RCC)","Inclusion Criteria:\n\n* Be willing and able to provide informed consent for the trial\n* Histological confirmation of renal cell carcinoma (RCC) with a clear-cell or sarcomatoid component\n* Pathologic stage of pT2, G4 or sarcomatoid, N0M0; pT3, any grade, N0M0; pT4, any grade, N0M0; pTany, any grade, N+M0; or M1 no evidence of disease (NED) after resection\n* No prior systemic immunotherapy for RCC\n* Eastern Cooperative Oncology Group (ECOG) performance status \\\u003C 2\n* Males and females, ages ≥ 18\n* Any ethnicity or race\n* Calculated creatinine clearance ≥ 30 milliliters per minute (mL\u002Fmin) per the Cockcroft and Gault formula or serum creatinine \\\u003C 1.5 x upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\\u003C 3 x ULN (\\\u003C 5 x ULN if liver metastases are present)\n* Total bilirubin \\\u003C 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin up to 3.0 mg\u002FdL)\n* Adequate bone marrow function defined by any of the following laboratory test findings: white blood cells (WBC) \\> 2,000\u002Fmm\\^3, neutrophils \\> 1,500\u002Fmm\\^3, platelets \\> 100,000\u002Fmm\\^3\n* Female subjects of child-bearing potential and female partners of male subjects must agree to use a highly effective method of contraception during treatment and for at least 5 months after the last dose\n\n  * Highly effective methods of contraception include: tubal ligation, an approved hormonal contraceptive such as oral contraceptives, patches, implants, injections, rings or hormonally impregnated intrauterine device (IUD), or IUD\n\nExclusion Criteria:\n\n* Prior radiation or anti-PD1, anti-PDL1, or anti-CTLA-4 therapy for RCC\n* Any active or recent history of a known or suspected autoimmune disease or recent history of a syndrome that required systemic corticosteroids (\\> 10 mg daily prednisone equivalent) or immunosuppressive medications except for syndromes which would not be expected to recur in the absence of an external trigger. Subjects with vitiligo or type I diabetes mellitus or residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement are permitted to enroll\n* Active interstitial lung disease (ILD)\u002Fpneumonitis or history of ILD\u002Fpneumonitis requiring treatment with systemic steroids\n* Baseline pulse oximetry less than 92% \"on room air\"\n* Current use, or intent to use probiotics, prebiotics, yogurt, bacterial fortified foods and other natural supplements ≤ 2 weeks prior to treatment initiation and during the period of treatment\n* Any condition requiring systemic treatment with corticosteroids (\\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to first dose of study drug. Inhaled steroids and adrenal replacement steroid doses \\> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease\n* Uncontrolled adrenal insufficiency\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* Not recovered to ≤ grade 1 toxicities related to any prior therapy before administration of study drug\n* Women who are pregnant or breastfeeding\n* 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",{"count":51,"type":20},62,[23],"This phase II trial compares the effect of adding a Live Biotherapeutic Product called CBM588 to pembrolizumab versus pembrolizumab alone in preventing return of disease (recurrence) after surgery for patients with renal cell cancer. Pembrolizumab is an immune checkpoint inhibitor. Immunotherapy with monoclonal antibodies such as pembrolizumab may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Pembrolizumab is approved for the treatment of renal cell cancer after surgery. Research has shown that changes to the composition of the healthy bacteria in the body (the microbiome), may improve a patient's response to treatment with immunotherapy. CBM588, a Live Biotherapeutic Product (LBP) containing a bacteria called Clostridium butyricum, has been shown to improve outcomes in patients treated with immunotherapy for other types of cancer. Adding CBM588 to treatment with pembrolizumab after surgery may cause changes in the microbiome that improve patient response to treatment and reduce disease recurrence, compared to pembrolizumab alone.",[55,56,28,29,30],"Clear Cell Renal Cell Carcinoma","Sarcomatoid Renal Cell Carcinoma","2026-06-05",{"date":59,"type":35},"2026-06-09",{"date":61,"type":20},"2027-01-01",{"date":63,"type":20},"2028-10-24",{"name":40,"class":41},2,{"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":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":4},"100632644","phase-2-testing-the-safety-and-feasibility-of-immunotherapy-drugs-botensilimab-and-balstilimab-before-surgery-for-clear-cell-renal-cell-carcinoma-neo-robot-trial-100632644","NCT07516366","Testing the Safety and Feasibility of Immunotherapy Drugs, Botensilimab and Balstilimab, Before Surgery for Clear Cell Renal Cell Carcinoma, NEO RoBOT Trial","Pilot Phase II Trial Evaluating Safety and Feasibility of Neoadjuvant Botensilimab and Balstilimab in Clear Cell Renal Cell Carcinoma (NEO RoBOT)","Inclusion Criteria:\n\n* Patients must have biopsy-confirmed, non-metastatic, high-risk renal cell carcinoma (RCC) with a clear cell component, defined as clinical stage T2N0, T3N0, T4N0, or any T stage with N1 disease (i.e., T2a-T4NanyM0 or TanyN1M0), and no evidence of metastatic disease\n* Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of botensilimab in combination with balstilimab in patients \\\u003C 18 years of age, children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (or Karnofsky ≥ 60%)\n* Patients must be considered suitable for curative-intent surgical resection of RCC, including radical or partial nephrectomy, as determined by the urology team and the treating physician according to standard clinical guidelines\n* Absolute neutrophil count ≥ 1,000\u002FmcL\n* Platelets ≥ 100,000\u002FmcL\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3 x institutional ULN\n* Glomerular filtration rate (GFR) 50 mL\u002Fmin\u002F1.73 m\\^2\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* 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. Also including a prior history of renal cell carcinoma\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better\n* Patients must be scheduled to undergo either partial or radical nephrectomy as part of treatment plan\n* The effects of botensilimab and balstilimab on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and 4 months after completion of treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of botensilimab and balstilimab administration. All patients of childbearing potential must undergo a blood or urine pregnancy test within 14 days prior to receiving the first dose of botensilimab and balstilimab to confirm they are not pregnant. If dosing is delayed beyond this window, the pregnancy test must be repeated to ensure results remain current\n* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants\n* Availability of pre-treatment archival slides or tissue blocks is required for inclusion in the study\n\nExclusion Criteria:\n\n* Patients who have suspected or proven metastatic renal cell carcinoma\n* Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1) with the exception of alopecia\n* Patients who are receiving any other investigational agents\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to botensilimab or balstilimab\n* Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous\n* Pregnant women are excluded from this study because botensilimab and balstilimab are agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with botensilimab or balstilimab, breastfeeding should be discontinued if the mother is treated with botensilimab or balstilimab\n* Patients without a clear cell component in their baseline kidney biopsy or non-clear cell renal cell carcinoma (RCC) are excluded from this study\n* Patients who have received prior treatment for RCC, including surgery, radiation, thermos-ablation or systemic therapy including immune checkpoint inhibitors, or VEGF tyrosine kinase inhibitors (TKIs)\n* Patients who have received prior treatment with an anti-PD-1, anti-programmed cell death protein ligand 1 (PD-L1), anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways\n* Patients who have undergone major surgery within 28 days prior to the start of the study\n* Patients with any active or recent history of a known or suspected autoimmune disease or recent history of a syndrome that required systemic corticosteroids (\\> 10 mg daily prednisone equivalent) or immunosuppressive medications within 14 days prior to first dose of study drug; the exception would be for syndromes which would not be expected to recur in the absence of an external trigger. Inhaled steroids and adrenal replacement steroid doses \\> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease\n* Patients with vitiligo or type I diabetes mellitus or residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement are permitted to enroll",{"count":74,"type":20},16,[23],"This phase II trial tests the effect of botensilimab and balstilimab before surgery (neoadjuvant) in treating patients with high-risk clear cell renal cell cancer that has not spread from where it first started to other areas of the body (non-metastatic). The current standard treatment for patients with non-metastatic clear cell renal cell cancer may include surgery to completely remove the tumor. This typically involves removing the kidney or part of the kidney (nephrectomy). Immunotherapy with monoclonal antibodies, such as botensilimab and balstilimab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving neoadjuvant botensilimab and balstilimab may be safe, tolerable, and\u002For effective in treating patients with high-risk non-metastatic clear cell renal cell cancer before undergoing a nephrectomy.",[55,28,29,30],"NOT_YET_RECRUITING","2026-05-14",{"date":81,"type":35},"2026-05-15",{"date":83,"type":20},"2026-08-21",{"date":85,"type":20},"2027-08-30",{"name":87,"class":88},"National Cancer Institute (NCI)","NIH"]