[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sarcomatoid-renal-cell-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sarcomatoid-renal-cell-carcinoma":63},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,84,113],{"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":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":83},"100352247","phase-2-testing-the-effectiveness-of-two-immunotherapy-drugs-nivolumab-and-ipilimumab-with-one-anti-cancer-targeted-drug-cabozantinib-for-rare-genitourinary-tumors-100352247",false,"NCT03866382","Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors","A Phase II Study of Ipilimumab, Cabozantinib, and Nivolumab in Rare Genitourinary Cancers (ICONIC)","Inclusion Criteria:\n\n* Metastatic disease defined as new or progressive lesions on cross-sectional imaging or bone scan. Patients must have at least:\n\n  * One measurable site of disease as per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1\n  * One bone lesion on bone scan (tec99 or sodium fluoride \\[NaF\\] PET\u002FCT, CT or MRI) for the bone-only cohort.\n  * Histologically confirmed diagnosis of one of the following metastatic cohorts:\n\n    * Small cell\u002F neuroendocrine carcinoma of the bladder (Cohort A)- All urothelial carcinomas with any amount of neuroendocrine differentiation (including small cell differentiation) will be included. If the tumor is purely neuroendocrine, metastasis from another site of origin should be clinically excluded\n    * Adenocarcinoma of the bladder, or urachal adenocarcinoma, or bladder\u002Furethra clear cell adenocarcinoma (Cohort B) - must be pure (per World Health Organization \\[WHO\\] definition), (i.e. urothelial carcinoma with glandular differentiation is not considered a pure adenocarcinoma\n    * Squamous cell carcinoma of the bladder (Cohort C) - must be pure (i.e. urothelial carcinoma with squamous differentiation is not considered a pure squamous cell carcinoma)\n    * Plasmacytoid urothelial carcinoma (Cohort D) - Tumor should show predominantly \\> or equal \\~ 50% plasmacytoid histology (including all types of discohesive growth, such as tumors with signet-ring and\u002For rhabdoid features as well)\n    * Any penile cancer (Cohort E)\n    * Sarcomatoid renal cell carcinoma (Cohort F) - Tumor should be predominantly sarcomatoid \\~ 50% (including rhabdoid differentiation) is also unclassified renal cell carcinomas (RCCs): all (assuming they are high grade with metastasis) malignant angiomyolipomas are allowed\n    * Other miscellaneous histologic variants of the urothelial carcinoma, such as, but not limited to (Cohort G) : Micropapillary (Tumor should show predominantly \\> or equal 50% micropapillary architecture), giant cell, lipid-rich, clear cell and nested variants (Tumor should predominantly \\> or equal 50% show these features), large cell neuroendocrine carcinoma, lymphoepithelioma-like carcinoma and mixed patterns will be considered, as well as small cell neuroendocrine prostate cancer (Only treatment-naïve primary small cell of prostate with any amount of small cell component allowed. Post-treatment small cell prostatic carcinomas are not allowed), Malignant testicular Sertoli or Leydig cell tumors, and papillary and chromophobe RCC\n\n      * Note: Translocation positive renal cell carcinoma patients are eligible. However, AREN1721 should be considered before this trial\n    * Sarcomatoid urothelial carcinoma (Cohort H) - Tumor should show predominantly \\~ 50% sarcomatoid differentiation\n    * Renal medullary carcinoma (Cohort I) - Per World Health Organization (WHO) definition, ideally confirmed with immunostains\n    * Bone-only metastatic GU tumors (non-prostate) (Cohort J) - All genitourinary histologies, except prostate are eligible\n    * Renal Collecting Duct Carcinoma (Cohort K) - Per WHO definition (medullary involvement, predominant tubular morphology, desmoplastic stromal reaction, high grade cytology, infiltrative growth pattern, and absence of other renal cell carcinoma subtype or urothelial carcinoma)\n    * Urethra carcinoma (Cohort L) - May be of any histology but if urothelial carcinoma then must be isolated to the urethra and not have metachronous or synchronous urothelial carcinoma of the bladder\n  * H\\&E slides from diagnostic tumor tissue for retrospective central pathology review\n* Patients may have received up to 2 systemic anti-cancer treatments or be treatment naive. Patients with small cell carcinoma should have received a platinum-based combination regimen either as neoadjuvant, adjuvant or first-line treatment). Patients in the bone-only cohort may be urothelial carcinoma histology but must receive standard cisplatin-based chemotherapy (if cisplatin-eligible)\n* Age \\>= 18 years\n* Patients must be able to swallow oral formulation of the tablets\n* Karnofsky performance status \\>= 80%\n* Absolute neutrophil count (ANC) \\>= 1,000\u002FmcL\n* Platelet count \\>= 75,000\u002FmcL\n* Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN). For subjects with known Gilbert's disease or similar syndrome with slow conjugation of bilirubin, total bilirubin =\\\u003C 3.0 mg\u002FdL\n* Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) =\\\u003C 3.0 x institutional upper limit of normal (ULN) (or =\\\u003C 5 x ULN for patients with liver metastases or Gilbert's disease)\n* Creatinine =\\\u003C 1.5 x upper limit of normal (ULN) OR creatinine clearance \\>= 40 mL\u002Fmin\u002F1.73 m\\^2 (calculated using the Chronic Kidney Disease Epidemiology \\[CKD-EPI\\] equation or Cockcroft-Gault formula) for patients with creatinine levels above institutional normal\n* Hemoglobin \\>= 9 g\u002FdL (transfusion of packed red blood cells \\[PRBCs\\] allowed)\n* Serum albumin \\>= 3.2 g\u002FdL\n* Lipase and amylase =\\\u003C 2.0 x ULN and no radiologic (on baseline anatomical imaging) or clinical evidence of pancreatitis\n* Prior treatment with MET or VEGFR inhibitors is allowed. However, prior cabozantinib will not be allowed. Also, patients that have received both prior MET or VEGF and prior PD-1\u002FPD-L1\u002FCTLA-4 (sequentially or in combination) are also not allowed\n* No prior treatment with any therapy on the PD-1\u002FPD-L1 axis or anti- CTLA-4\u002FCTLA-4 inhibitors with the exception of patients with \"urothelial carcinoma\" histology (cohorts D, H, J, L)\n* Human immunodeficiency virus (HIV)-positive patients are eligible if on stable dose of highly active antiretroviral therapy (HAART), no clinically significant drug-drug interactions are anticipated with the current HAART regimen, CD4 counts are greater than 350 and viral load is undetectable\n* Patients with rheumatoid arthritis and other rheumatologic arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication only and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies etc. are eligible but should be considered for rheumatologic evaluation for the presence of target organ involvement and potential need for systemic treatment\n* Patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones or medications (e.g. thyroiditis managed with propylthiouracil \\[PTU\\] or methimazole) including physiologic oral corticosteroids are eligible\n* Patients who have evidence of active or acute diverticulitis, intra-abdominal abscess, and gastrointestinal (GI) obstruction, within 12 months are not eligible\n* Women of childbearing potential must have a negative pregnancy test =\\\u003C 7 days prior to registration\n\n  * Women of childbearing potential include women who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are not postmenopausal. Post menopause is defined as amenorrhea \\>= 12 consecutive months. Note: women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antiestrogens, ovarian suppression or any other reversible reason\n* Pregnant women may not participate in this study because with cabozantinib, nivolumab, and ipilimumab have 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 cabozantinib, nivolumab, and ipilimumab, breastfeeding should be discontinued if the mother is treated with these agents\n* The patient has received no cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or biologic agents (e.g., cytokines or antibodies) within 2 weeks before the first dose of study treatment\n* The patient has received no radiation therapy:\n\n  * To the lungs and mediastinum or abdomen within 4 weeks before the first dose of study treatment, or has ongoing complications, or is healing from prior radiation therapy\n  * To brain metastasis within 3 weeks for whole-brain radiotherapy (WBXRT), and 2 weeks for stereotactic body radiation therapy (SBRT) before the first dose of study treatment\n  * To the abdomen within 4 weeks before the first dose of study treatment, or has ongoing complications, or is healing from prior radiation therapy\n  * To any other site(s) within 2 weeks before the first dose of study treatment\n* The patient has received no radionuclide treatment within 6 weeks of the first dose of study treatment\n* The patient has received no prior treatment with a small molecule kinase inhibitor within 14 days or five half-lives of the compound or active metabolites, whichever is longer, before the first dose of study treatment\n* The patient has received no prior treatment with hormonal therapy within 14 days or five half-lives of the compound or active metabolites, whichever is longer, before the first dose of study treatment. Subjects receiving gonadotropin-releasing hormone (GnRH) agonists and antagonists are allowed to participate\n* The patient has not received any other type of investigational agent within 14 days before the first dose of study treatment\n* The patient must have recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) =\\\u003C grade 1 from toxicity due to all prior therapies except alopecia, neuropathy and other non-clinically significant adverse events (AEs) defined as lab elevation with no associated symptoms or sequelae\n* The patient may not have active brain metastases or epidural disease. Patients with brain metastases previously treated with whole brain radiation or radiosurgery who are asymptomatic and do not require steroid treatment for at least 2 weeks before starting study treatment are eligible. Neurosurgical resection of brain metastases or brain biopsy is permitted if completed at least 3 months before starting study treatment. Baseline brain imaging with contrast-enhanced CT or MRI scans for subjects with known brain metastases is required to confirm eligibility\n* No concomitant treatment with warfarin. Aspirin (up to 325 mg\u002Fday), thrombin or factor Xa inhibitors, low-dose warfarin (=\\\u003C 1 mg\u002Fday), prophylactic and therapeutic low molecular weight heparin (LMWH) are permitted\n* No chronic concomitant treatment with strong CYP3A4 inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, and St. John's wort) or strong CYP3A4 inhibitors\n\n  * Because the lists of these agents are constantly changing, it is important to regularly consult medical reference texts such as the Physicians' Desk Reference may also provide this information. As part of the enrollment\u002Finformed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product\n* The patient has not experienced any of the following:\n\n  * Clinically-significant gastrointestinal bleeding within 6 months before the first dose of study treatment\n  * Hemoptysis of \\>= 0.5 teaspoon (2.5 mL) of red blood per day within 1 months before the first dose of study treatment\n  * Any other signs indicative of pulmonary hemorrhage within 3 months before the first dose of study treatment\n* The patient has no tumor invading any major blood vessels\n* The patient has no evidence of tumor invading the GI tract (esophagus, stomach, small or large bowel, rectum or anus), or any evidence of endotracheal or endobronchial tumor within 28 days before the first dose of cabozantinib. Patients with rectal tumor masses are not eligible\n* The patient has no uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:\n\n  * Cardiovascular disorders including:\n\n    * Congestive heart failure (CHF): New York Heart Association (NYHA) class III (moderate) or class IV (severe) at the time of screening.\n    * Concurrent uncontrolled hypertension defined as sustained blood pressure (BP) \\> 150 mm Hg systolic, or \\> 90 mm Hg diastolic despite optimal antihypertensive treatment within 7 days of the first dose of study treatment\n    * The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) \\> 500 ms within 28 days before randomization. Note: if initial QTcF is found to be \\> 500 ms, two additional electrocardiograms (EKGs) separated by at least 3 minutes should be performed. If the average of these three consecutive results for QTcF is =\\\u003C 500 ms, the subject meets eligibility in this regard\n    * Any history of congenital long QT syndrome\n    * Any of the following within 6 months before registration of study treatment:\n\n      * Unstable angina pectoris\n      * Clinically-significant cardiac arrhythmias (patients with atrial fibrillation are eligible)\n      * Stroke (including transient ischemic attack \\[TIA\\], or other ischemic event)\n      * Myocardial infarction\n      * Cardiomyopathy\n  * No significant gastrointestinal disorders particularly those associated with a high risk of perforation or fistula formation including:\n\n    * Any of the following that have not resolved within 28 days before the first dose of study treatment:\n\n      * Active peptic ulcer disease\n      * Acute diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, or malabsorption syndrome\n    * None of the following within 2 years before the first dose of study treatment:\n\n      * Abdominal fistula or genitourinary fistula\n      * Gastrointestinal perforation\n      * Bowel obstruction or gastric outlet obstruction\n      * Intra-abdominal abscess. Note: Complete resolution of an intra-abdominal abscess must be confirmed prior to initiating treatment with cabozantinib even if the abscess occurred more than 2 years before the first dose of study treatment\n  * Disorders associated with a high risk of fistula formation including percutaneous endoscopic gastrostomy (PEG) tube placement are not eligible\n  * No other clinically significant disorders such as:\n\n    * Severe active infection requiring IV systemic treatment within 14 days before the first dose of study treatment\n    * Serious non-healing wound\u002Fulcer\u002Fbone fracture within 28 days before the first dose of study treatment\n    * History of organ or allogeneic stem cell transplant\n    * Concurrent uncompensated hypothyroidism or thyroid dysfunction within 7 days before the first dose of study treatment (for asymptomatic patients with an elevated thyroid-stimulating hormone \\[TSH\\], thyroid replacement may be initiated if clinically indicated without delaying the start of study treatment)\n  * No history of major surgery as follows:\n\n    * Major surgery within 3 months of the first dose of cabozantinib; however, if there were no wound healing complications, patients with rapidly growing aggressive cancers, may start as soon as 6 weeks if wound has completely healed post-surgery\n    * Minor surgery within 1 month of the first dose of cabozantinib if there were no wound healing complications or within 3 months of the first dose of cabozantinib if there were wound complications excluding core biopsies and mediport placement\n    * Complete wound healing from prior surgery must be confirmed before the first dose of cabozantinib irrespective of the time from surgery\n* No history of severe hypersensitivity reaction to any monoclonal antibody\n* No evidence of active malignancy, requiring systemic treatment within 2 years of registration\n* No history of allergic reactions attributed to compounds of similar chemical or biologic composition to cabozantinib, nivolumab, ipilimumab or other agents used in study\n* No positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection. If HBV sAG is positive, subsequent ribonucleic acid (RNA) polymerase chain reaction (PCR) must be negative\n* No patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids. These include, but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded because of the risk of recurrence or exacerbation of disease","ALL","18 Years",{"count":19,"type":20},314,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase II trial studies how well cabozantinib works in combination with nivolumab and ipilimumab in treating patients with rare genitourinary (GU) tumors that has spread from where it first started (primary site) to other places in the body. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib, nivolumab, and ipilimumab may work better in treating patients with genitourinary tumors that have no treatment options compared to giving cabozantinib, nivolumab, or ipilimumab alone.",[26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70],"Bladder Adenocarcinoma","Bladder Clear Cell Adenocarcinoma","Bladder Mixed Adenocarcinoma","Bladder Neuroendocrine Carcinoma","Bladder Small Cell Neuroendocrine Carcinoma","Bladder Squamous Cell Carcinoma","Chromophobe Renal Cell Carcinoma","Collecting Duct Carcinoma","Invasive Bladder Giant Cell Urothelial Carcinoma","Invasive Bladder Lymphoepithelioma-Like Carcinoma","Invasive Bladder Nested Urothelial Carcinoma","Invasive Bladder Plasmacytoid Urothelial Carcinoma","Invasive Bladder Sarcomatoid Urothelial Carcinoma","Invasive Bladder Urothelial Carcinoma","Kidney Medullary Carcinoma","Large Cell Neuroendocrine Carcinoma","Malignant Testicular Leydig Cell Tumor","Malignant Testicular Sertoli Cell Tumor","Metastatic Bladder Carcinoma","Metastatic Bladder Clear Cell (Glycogen-Rich) Urothelial Carcinoma","Metastatic Bladder Giant Cell Urothelial Carcinoma","Metastatic Bladder Large Cell Neuroendocrine Carcinoma","Metastatic Bladder Lipid-Rich Urothelial Carcinoma","Metastatic Bladder Micropapillary Urothelial Carcinoma","Metastatic Bladder Plasmacytoid Urothelial Carcinoma","Metastatic Bladder Sarcomatoid Urothelial Carcinoma","Metastatic Bladder Small Cell Neuroendocrine Carcinoma","Metastatic Bladder Squamous Cell Carcinoma","Metastatic Chromophobe Renal Cell Carcinoma","Metastatic Kidney Medullary Carcinoma","Metastatic Malignant Genitourinary System Neoplasm","Metastatic Papillary Renal Cell Carcinoma","Metastatic Penile Carcinoma","Metastatic Prostate Small Cell Neuroendocrine Carcinoma","Metastatic Sarcomatoid Renal Cell Carcinoma","Metastatic Urethral Carcinoma","Papillary Renal Cell Carcinoma","Sarcomatoid Renal Cell Carcinoma","Stage IV Bladder Cancer AJCC v8","Stage IV Penile Cancer AJCC v8","Stage IV Renal Cell Cancer AJCC v8","Stage IV Urethral Cancer AJCC v8","Stage IVB Prostate Cancer AJCC v8","Urachal Adenocarcinoma","Urethral Clear Cell Adenocarcinoma","RECRUITING","2026-07-01",{"date":74,"type":75},"2026-07-02","ACTUAL",{"date":77,"type":75},"2019-05-13",{"date":79,"type":20},"2027-02-28",{"name":81,"class":82},"National Cancer Institute (NCI)","NIH",581,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":21,"phases":93,"briefSummary":94,"conditions":95,"keywords":100,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":112},"100550440","phase-2-an-investigational-scan-89zr-dfo-gmab-petct-compared-to-contrast-enhanced-ct-for-the-detection-of-recurrent-clear-cell-renal-cell-cancer-after-surgery-comparing-carbonic-anhydrase-ix-caix-pet-ct-to-conventional-pet-ct-for-post-op-staging-in-kidney-cancer-100550440","NCT06447103","An Investigational Scan (89Zr-DFO-GmAb PET\u002FCT) Compared to Contrast-Enhanced CT for the Detection of Recurrent Clear Cell Renal Cell Cancer After Surgery Comparing Carbonic Anhydrase IX (CAIX) PET CT to Conventional PET CT for Post-Op Staging in Kidney Cancer","89Zr-DFO-GmAb PET\u002FCT vs Contrast-Enhanced CT for Detection of Recurrent Clear Cell Renal Cell Carcinoma After Surgery","Inclusion Criteria:\n\n* Age ≥ 18\n* Histologically confirmed clear cell renal cell carcinoma (RCC) (ccRCC) (based on partial\u002Fradical nephrectomy\u002Fmetastasectomy)\n\n  * For tumors with extensive sarcomatoid features, if there is evidence of areas of clear cell and high CAIX expression throughout the tumor on immunohistochemistry, they will be allowed on study\n* Subjects must have undergone definitive treatment of their primary tumor (partial\u002Fradical nephrectomy) +\u002F- resection of metastatic disease to no evidence of disease (NED) with a prior nephrectomy \\\u003C 2 years)\n* Surgery must have been performed between 4-16 weeks at the time of planned imaging\n* Subjects are considered to have a high risk of recurrence based on the following criteria:\n\n  * Intermediate-high risk ccRCC:\n\n    * pathologic tumor stage 2 (pT2), grade 4, or sarcomatoid, N0, M0\n    * pathologic tumor stage 3 (pT3), any grade, N0, M0\n  * High risk ccRCC:\n\n    * pathologic tumor stage 4 (pT4), any grade, N0, M0\n    * pT any stage, any grade, number of positive nodes (pN+), M0\n  * M1 now NED: pathologically-confirmed ccRCC, undergoing a resection of a solitary, isolated soft tissue metastasis within two years from initial nephrectomy\n* Negative serum pregnancy tests in female patients of childbearing potential. (Women of child bearing potential \\[WOCBP\\] require a negative pregnancy test within 24 hours (urine) prior to receiving investigational product)\n* Consent to practice double-barrier contraception until a minimum of 42 days after 89Zr-DFO-GmAb administration\n* Individual must be able to remain still and lie flat for duration of the diagnostic imaging procedure (less than 1 hour)\n\nExclusion Criteria:\n\n* Inability to provide written informed consent\n* Any evidence of residual disease or known metastasis at the time of planned 89Zr-DFO-GmAb administration\n* Prior post-operative imaging for confirmation of disease status\n* An untreated non-renal malignancy with the following exceptions:\n\n  * Low risk prostate cancer on active surveillance (National Comprehensive Cancer Network \\[NCCN\\] very low\u002Flow risk)\n  * Non-melanoma skin cancer\n* Any prior treated malignancy meeting the following characteristics:\n\n  * Treated stage I or II cancer from which the patient is currently in complete remission\n  * A stage III cancer from which the patient is progressing or has been disease-free for and has required active treatment (e.g. adjuvant or maintenance therapy) within the past 3 years prior to enrollment\n  * A hematologic malignancy from which the patient is currently in complete remission\n* Contraindication to the use of iodinated contrast-enhanced CT agents, based on:\n\n  * Severe allergy (for which pre-medication cannot limit adverse reactions) or\n  * Estimated glomerular filtration rate (GFR) ≤ 30 ml\u002Fmin\u002F1.73m\\^2\n* Prior use of systemic therapy treatment for kidney cancer (PD-1, PD-L1, tyrosine kinase or TOR inhibitor) or radiotherapy within 4 weeks of enrollment\n* Exposure to experimental diagnostic or therapeutic drug within 14 days from date of planned administration\n* Women who are pregnant or breastfeeding\n* Known hypersensitivity to girentuximab\n* Known inability to remain still and lie flat imaging procedure (about 30 minutes)",{"count":92,"type":20},91,[23],"This phase II trial compares the safety and effectiveness of 89Zr-DFO-GmAb positron emission tomography (PET)\u002Fcomputed tomography (CT) compared to contrast-enhanced CT after surgery in detecting clear cell renal cell cancer that has come back (recurrent). For some patients, the risk of recurrence after surgery remains high. Conventional CT methods, such as contrast-enhanced CT, may not detect small volume or micrometastatic disease. PET\u002FCT with radiotracers, such as 89Zr-DFO-GmAb, may improve detection of tumor cells. Girentuximab (GmAb), a monoclonal antibody, is tagged with zirconium-89, a radioactive atom (which is also known as an isotope). The zirconium-89 (89Zr) isotope is attached to girentuximab with desferrioxamine (DFO) and this combined product is called 89Zr-DFO-girentuximab. 89Zr-DFO-girentuximab attaches itself to a protein on the surface of clear cell renal cell tumor cells called CAIX. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, 89Zr-DFO-GmAb. Because some cancers, including clear cell renal cell cancer, take up 89Zr-DFO-GmAb it can be seen with PET. CT utilizes x-rays that traverse body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient's body. Using contrast agents with CT scan to enhance the images (contrast-enhanced CT) is standard of care imaging. 89Zr-DFO-GmAb PET\u002FCT may be safe and effective compared to contrast-enhanced CT in detecting recurrent clear cell renal cell cancer after surgery.",[96,63,97,98,99],"Clear Cell Renal Cell Carcinoma","Stage II Renal Cell Cancer","Stage III Renal Cell Cancer","Stage IV Renal Cell Cancer",[101],"Renal","2026-06-11",{"date":104,"type":75},"2026-06-15",{"date":106,"type":75},"2024-08-06",{"date":108,"type":20},"2030-12-01",{"name":110,"class":111},"Jonsson Comprehensive Cancer Center","OTHER",1,{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":21,"phases":122,"briefSummary":123,"conditions":124,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":136},"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":121,"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.",[96,63,125,126,66],"Stage II Renal Cell Cancer AJCC v8","Stage III Renal Cell Cancer AJCC v8","2026-06-05",{"date":129,"type":75},"2026-06-09",{"date":131,"type":20},"2027-01-01",{"date":133,"type":20},"2028-10-24",{"name":135,"class":111},"City of Hope Medical Center",2]