[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"kidney-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:kidney-cancer":37},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,67,0,25,[9,59,90,131,198,228,254,275,300,322,346,370,398,423,448,470,499,529,568,590,621,643,662,686,713],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":58},"100597545","distance-based-exercise-to-preserve-function-and-prevent-disability-100597545",false,"NCT07059884","Distance-Based Exercise to Preserve Function and Prevent Disability","DEFEND","Inclusion Criteria:\n\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Participants must have histologically confirmed diagnosis of one of the following cancers: anus, bladder, breast, cervix, colon\u002Frectum, endometrium, esophagus, gallbladder, head\u002Fneck, kidney, liver, lung, ovary, pancreas, prostate, sarcoma, stomach\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Participants must be initiating outpatient cytotoxic chemotherapy for curative intent of at least 10 weeks duration (with or without concurrent radiation, immunotherapy, or other targeted therapy). Patients must be enrolled and baseline measures collected on or before administration of their second cycle of cytotoxic therapy. Patients receiving outpatient cytotoxic chemotherapy for curative intent in the neoadjuvant or adjuvant setting are eligible. Patients receiving definitive chemoradiation for the tumors listed above, are also eligible. Regimens of immunotherapy or monoclonal antibodies ONLY are not eligible\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Age 18-64 years\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot have metastatic cancer\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot have documentation in the medical record of severe cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity. Examples would include unstable angina, recent myocardial infarction, oxygen-dependent pulmonary disease, and osteoarthritis requiring imminent joint replacement. Moderate arthritis that does not preclude physical activity is not a reason for ineligibility\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot be pregnant, because this study involves remotely delivered exercise, and cannot be breast-feeding as patients must be receiving cytotoxic chemotherapy, during which breast-feeding is contraindicated\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot have documentation in the medical record of current alcohol, substance abuse, or dementia\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Engaged in full time gainful employment of at least 30 hours per week at the time of cancer diagnosis\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Currently no self-report of engagement in competitive sports (e.g. not training for running races, triathlons, etc.) AND no self-report of twice weekly progressive resistance exercise training for at least 3 consecutive months within the past year\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Self-reported ability to walk for 6 minutes (use of assistive devices will be allowed)\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Not participating in another weight loss, physical activity, or dietary intervention clinical trial\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Predicted 6MWT distance of 550 meters or less\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Concurrent enrollment in treatment or supportive care trials (other than those focused on weight loss or exercise) is allowed with the permission of the Alliance Executive Officer and both studies' study chairs\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Eligibility is restricted to individuals who can comprehend and read English given that participation in the study will require the ability to read intervention materials and work with a coach through telehealth sessions\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): The trial is unable to accommodate the needs of deaf or blind participants as the study relies on language and visualization of exercise through telehealth sessions\n* CLINICAL STAKEHOLDER ELIGIBILITY CRITERIA: Clinicians and research staff from enrolling sites who meet following criterion will be deemed eligible to participate as a clinical stakeholder:\n\n  \\* Providing clinical care for participating patients on this study\n* CLINICAL STAKEHOLDER ELIGIBILITY CRITERIA: Ability to speak and understand English\n\nExclusion Criteria:\n\n\\-","ALL","18 Years",{"count":20,"type":21},104,"ESTIMATED","INTERVENTIONAL",[24],"NA","This clinical trial studies whether an exercise program can be successfully delivered to patients receiving treatment for cancer through virtual sessions and allow patients to exercise in their own home. Treatments for cancer can cause side effects such as fatigue and loss of strength. These side effects can make it difficult to work, take care of family, and do other things the patient wants to do. Preliminary research shows that exercise can help prevent some of these side effects, but it can be more difficult to start an exercise program when a patient is receiving cancer treatment. The exercise program in this study is delivered through telehealth (TH) video calls. The TH sessions are delivered by trained staff that supervise resistance exercises. The trained staff also provide guidance to the patient on completing unsupervised aerobic sessions on their own. This may be a successful way to deliver an exercise program and make it easier for cancer patients to exercise in their own home during treatment.",[27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45],"Localized Malignant Solid Neoplasm","Anal Cancer","Bladder (Urothelial, Transitional Cell) Cancer","Breast Cancer","Cervical Cancer","Colon Cancer","Endometrial Cancer","Esophageal Cancer","Gall Bladder Cancer","Gastric Cancer","Kidney Cancer","Liver Cancer","Lung Cancer","Head and Neck Cancer","Ovarian Cancer","Pancreatic Cancer","Prostate Cancer","Rectal Cancer","Sarcoma","RECRUITING","2026-07-01",{"date":49,"type":50},"2026-07-02","ACTUAL",{"date":52,"type":50},"2026-02-11",{"date":54,"type":21},"2027-08-31",{"name":56,"class":57},"Alliance for Clinical Trials in Oncology","OTHER",18,{"id":60,"slug":61,"hasResults":12,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":67,"enrollmentInfo":68,"targetDuration":4,"studyType":22,"phases":70,"briefSummary":72,"conditions":73,"keywords":74,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":89},"100644733","phase-2-perioperative-ursodeoxycholic-acid-for-renal-protection-in-adults-undergoing-partial-nephrectomy-for-renal-tumors-100644733","NCT07672860","Perioperative Ursodeoxycholic Acid for Renal Protection in Adults Undergoing Partial Nephrectomy for Renal Tumors","Protective Effect of Perioperative Ursodeoxycholic Acid Intervention Against Ischemia-Reperfusion Injury During Partial Nephrectomy: A Single-Center, Prospective, Double-Blind, Randomized Controlled Trial (PURIFY Trial)","PURIFY","1\\. Inclusion Criteria\n\nPatients must meet all of the following criteria to be eligible for inclusion in the study:\n\n1. The patient has fully understood the study and has voluntarily signed the informed consent form (ICF);\n2. Male or female patients aged 18 to 75 years, inclusive, at the time of signing the ICF;\n3. Imaging diagnosis consistent with stage T1 renal tumor, as assessed by MRI or CT;\n4. No definite collecting system invasion on preoperative MRI or CT assessment;\n5. The patient is scheduled to undergo partial nephrectomy (PN) or renal tumor enucleation after clinical evaluation by the physician and full discussion with the patient;\n6. Preoperative assessment indicates that main renal artery clamping with warm ischemia is planned;\n7. The surgery will be performed by a surgeon with experience in at least 50 cases of PN or renal tumor enucleation, and renal artery clamping will be performed using standardized vascular clamp application;\n8. Screening eGFR ≥30 mL\u002Fmin\u002F1.73 m², calculated using the CKD-EPI equation;\n9. No history of allergy or intolerance to UDCA or other bile acid preparations, and no UDCA contraindications or biliary tract-related diseases that, in the investigator's judgment, would make the patient unsuitable for UDCA treatment;\n10. The subject is willing and able to comply with the scheduled visits, treatment, laboratory tests, and other study-related procedures required by the protocol.\n\n2\\. Exclusion Criteria\n\nPatients meeting any of the following criteria will be excluded from the study:\n\n1. Emergency surgery, defined as surgery required for medical reasons within 24 hours;\n2. Patients who are considered preoperatively to have a significant risk of bleeding, or whose surgery is expected to require complex renal reconstruction, and who are judged by the investigator to be unsuitable for participation in this study;\n3. Patients for whom non-standard ischemia techniques, such as selective\u002Fsegmental arterial clamping or zero-ischemia techniques, are planned preoperatively;\n4. Patients with a history of renal surgery on either kidney or previous kidney transplantation;\n5. Solitary kidney;\n6. History of major abdominal organ surgery within 1 year before surgery, which, in the investigator's judgment, may affect the conduct of the current surgery, safety assessment, or evaluation of study endpoints;\n7. Active lesions or clinically significant imaging abnormalities in either kidney that may substantially affect renal function assessment or perioperative AKI risk evaluation, including but not limited to renal artery stenosis, polycystic kidney disease, chronic pyelonephritis, severe hydronephrosis, or renal atrophy;\n8. Use of UDCA, chenodeoxycholic acid, bile acid sequestrants, or other drugs that may significantly affect bile acid metabolism within 1 month before screening;\n9. Continuous or systemic use of nephrotoxic drugs for more than 1 week within 3 months before screening, including but not limited to nonsteroidal anti-inflammatory drugs and aminoglycoside antibiotics;\n10. Continuous or systemic use of drugs that may significantly affect the gut microbiota or bile acid metabolism within 1 month before screening, including antibiotics, probiotics, high-dose glucocorticoids, immunosuppressants, potent laxatives, or antidiarrheal agents;\n11. Participation in another interventional clinical study within 3 months before screening, or ongoing treatment with another investigational drug or device;\n12. Uncontrolled active infection during the screening period, including but not limited to urinary tract infection, pulmonary infection, intra-abdominal infection, or systemic infection;\n13. Uncontrolled blood pressure abnormalities during the screening period, including mean seated SBP ≥180 mmHg or DBP ≥110 mmHg; symptomatic hypotension, SBP \\\u003C90 mmHg, or hypovolemia as judged by the investigator;\n14. History of New York Heart Association (NYHA) class III-IV heart failure, or hospitalization due to heart failure\u002Ffluid retention within 6 months before screening;\n15. Hepatic impairment, defined as meeting any of the following criteria: history of hepatic encephalopathy, history of esophagogastric varices, history of portocaval shunt surgery, Child-Pugh class C hepatic impairment, ALT or AST \\>3 × ULN, or total bilirubin \\>2 × ULN during the screening period;\n16. Diseases or surgical history that may significantly affect the absorption, distribution, metabolism, or excretion of the study drug, including but not limited to:\n\n1\\. history of active inflammatory bowel disease within the previous 6 months; 2. history of major gastrointestinal surgery, such as gastrectomy, gastrointestinal anastomosis, or bowel resection; 3. history of gastrointestinal ulcer and\u002For gastrointestinal or rectal bleeding within the previous 6 months; 4. history of pancreatic injury or pancreatitis within the previous 6 months; (17) Pregnant or breastfeeding women; (18) Women of childbearing potential who have a positive pregnancy test during the screening period, or who are unwilling to use effective contraception during the study; (19) Patients with a history of other malignancies are excluded, except for malignancies confirmed to have been cured or in remission for ≥5 years, radically resected basal cell carcinoma or squamous cell carcinoma of the skin, or carcinoma in situ at any site； (20) Any other severe or uncontrolled medical disease, psychiatric disorder, or laboratory abnormality that may increase the risk associated with study participation, affect subject compliance, or interfere with the interpretation of study results, including but not limited to organ failure, active or uncontrolled immunodeficiency disease, active or uncontrolled HBV\u002FHCV\u002FHIV infection, cognitive impairment, or severe psychiatric disorder.","75 Years",{"count":69,"type":21},146,[71],"PHASE2","The goal of this clinical trial is to learn if ursodeoxycholic acid, also called UDCA, can help protect kidney function in adults undergoing partial nephrectomy for kidney tumors. It will also learn about the safety of UDCA when used around the time of surgery.\n\nBefore the randomized part of the study begins, the first 6 participants will receive UDCA in a safety run-in phase. These participants will be closely monitored for side effects, laboratory abnormalities, and other medical problems to assess the preliminary safety and tolerability of perioperative UDCA administration. If no unacceptable safety concerns are identified, the study will proceed to the randomized, placebo-controlled phase.\n\nThe main questions this study aims to answer are:\n\n1. Is perioperative UDCA administration safe in patients undergoing surgery for renal tumors?\n2. Does UDCA lower the risk of acute kidney injury within 48 hours after partial nephrectomy?\n3. Does UDCA reduce the decline in kidney function after surgery?\n4. Does UDCA increase blood levels of UDCA and related bile acids during the perioperative period?\n5. What medical problems do participants have when taking UDCA around the time of surgery?\n6. Researchers will also evaluate whether UDCA affects urinary biomarkers of kidney injury.\n\nResearchers will compare UDCA with a placebo, a look-alike substance that contains no active drug, to see if UDCA can help protect the kidney from ischemia-reperfusion injury during partial nephrectomy.\n\nParticipants will:\n\n1. Take UDCA or a placebo three times a day from 2 days before surgery until 5 days after surgery.\n2. Undergo partial nephrectomy as planned by their treating surgeon.\n3. Have blood tests before and after surgery to check kidney function, liver function, and bile acid levels.\n4. Participants will provide urine samples before and after surgery for the assessment of kidney injury biomarkers.\n5. Be monitored for side effects, surgical complications, and other medical problems during hospitalization and follow-up.",[37],[75,76,77,78,79],"ursodeoxycholic acid","Ischemia-reperfusion injury","Acute kidney injury","perioperative","partial nephrectomy","2026-06-25",{"date":82,"type":50},"2026-06-29",{"date":84,"type":50},"2026-06-01",{"date":86,"type":21},"2027-12",{"name":88,"class":57},"Jinling Hospital, China",1,{"id":91,"slug":92,"hasResults":12,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":100,"phases":4,"briefSummary":101,"conditions":102,"keywords":114,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":123,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":130},"100618120","predicting-response-to-immunotherapy-from-analysis-of-live-tumor-biopsies-elephas-05-100618120","NCT07327489","Predicting Response to Immunotherapy From Analysis of Live Tumor Biopsies (ELEPHAS-05)","Predicting Response to Immunotherapy From Analysis of Live Tumor Biopsies","ELEPHAS-05","Inclusion Criteria:\n\n1. Able and willing to provide informed consent for participation\n2. Age ≥18 years at time of consent.\n3. Have a suspected or confirmed cancer diagnosis that is to be evaluated by means of a biopsy.\n4. Subjects who are newly diagnosed or have suspected cancer must be treatment-naïve at the time of biopsy. All other subjects should have the biopsy performed before starting their next line of treatment.\n\nExclusion Criteria:\n\n1. Have a known auto-immune disease or prior condition (prior organ transplant, chronic kidney or liver disease) that renders them ineligible for immunotherapy (IO) treatment.\n2. Severely immunocompromised person(s). Examples include patients on immunosuppressants, HIV positive patients on antiretrovirals, post transplantation patients.\n3. Pregnant person(s).",{"count":99,"type":21},2000,"OBSERVATIONAL","This study will collect tumor specimens with correlated clinical and demographic data from patients who are undergoing a biopsy or similar procedure to obtain tumor tissue as a normal course of their medical management or diagnostic work-up for suspected or confirmed cancer.",[103,104,105,106,107,108,109,110,33,40,37,38,111,112,113],"Cancer","Immunotherapy","Advanced Solid Tumors Cancer","Bladder Cancer","TNBC, Triple Negative Breast Cancer","Colorectal Cancer","DMMR Colorectal Cancer","MSI-H Colorectal Cancer","NSCLC (Non-small-cell Lung Cancer)","Skin Cancer","Melanoma (Skin Cancer)",[104,115,116,103,117,118,119,120,121,122],"Live Tumor Biopsy","Elephas","Imaging","Tumor Cutting","Treatment Response","Core Needle Biopsy","Forceps Biopsy","Punch Biopsy",{"date":82,"type":50},{"date":125,"type":50},"2025-04-14",{"date":127,"type":21},"2038-04",{"name":116,"class":129},"INDUSTRY",8,{"id":132,"slug":133,"hasResults":12,"nctId":134,"briefTitle":135,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":138,"sex":17,"minAge":139,"maxAge":140,"enrollmentInfo":141,"targetDuration":143,"studyType":100,"phases":4,"briefSummary":144,"conditions":145,"keywords":180,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":190,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":197},"100210159","integrated-cancer-repository-for-cancer-research-100210159","NCT02012699","Integrated Cancer Repository for Cancer Research","iCaRe2","Inclusion Criteria\n\n* Diagnosis\u002Fhistory of cancer\n* Risk for developing cancer or suspicious clinical findings\n* No history of cancer (normal control registry)\n* Able to provide informed consent\n* 19 years of age or older\n* English or Spanish speaking individuals\n\nExclusion Criteria\n\n* Unable to provide informed consent because of cognitive impairment\n* Non-English or non-Spanish speaking individuals",true,"19 Years","110 Years",{"count":142,"type":21},999999,"80 Years","The iCaRe2 is a multi-institutional resource created and maintained by the Fred \\& Pamela Buffett Cancer Center to collect and manage standardized, multi-dimensional, longitudinal data and biospecimens on consented adult cancer patients, high-risk individuals, and normal controls. The distinct characteristic of the iCaRe2 is its geographical coverage, with a significant percentage of small and rural hospitals and cancer centers. The iCaRe2 advances comprehensive studies of risk factors of cancer development and progression and enables the design of novel strategies for prevention, screening, early detection and personalized treatment of cancer. Centers with expertise in cancer epidemiology, genetics, biology, early detection, and patient care can collaborate by using the iCaRe2 as a platform for cohort and population studies.",[42,146,39,34,147,32,44,148,28,149,150,151,36,38,152,153,154,155,106,37,156,43,157,158,159,160,161,162,163,164,165,166,167,168,112,169,170,171,30,172,173,45,174,175,41,33,176,177,178,179],"Thyroid Cancer","Thymus Cancer","Gastrointestinal Stromal Tumors","Bile Duct Cancer","Duodenal Cancer","Gallbladder Cancer","Small Intestine Cancer","Peritoneal Surface Malignancies","Familial Adenomatous Polyposis","Lynch Syndrome","Penile Cancer","Testicular Cancer","Ureter Cancer","Urethral Cancer","Hypopharyngeal Cancer","Laryngeal Cancer","Lip Cancer","Oral Cavity Cancer","Nasopharyngeal Cancer","Oropharyngeal Cancer","Paranasal Sinus Cancer","Nasal Cavity Cancer","Salivary Gland Cancer","Central Nervous System Tumor","Central Nervous System Cancer","Mesothelioma","Leukemia","Melanoma","Unknown Primary Tumor","Multiple Myeloma","Vaginal Cancer","Neuroendocrine Tumors","Plasma Cell Dyscrasia","Healthy Control",[42,146,181,182,183,184,185,186,187,188,30,189,178,179],"Esophageal cancer","Thymus cancer","Pancreatic tumor","Esophageal tumor","Thymus tumor","Thyroid Tumor","Thyroid Nodule","Lung Tumor","Neuroendocrine tumor",{"date":82,"type":50},{"date":192,"type":50},"2013-11-01",{"date":194,"type":21},"2099-12",{"name":196,"class":57},"University of Nebraska",42,{"id":199,"slug":200,"hasResults":12,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":4,"eligibilityCriteria":204,"healthyVolunteers":138,"sex":17,"minAge":205,"maxAge":4,"enrollmentInfo":206,"targetDuration":4,"studyType":100,"phases":4,"briefSummary":208,"conditions":209,"keywords":213,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":223,"completionDateStruct":4,"leadSponsor":225,"locationsCount":89},"100060106","collection-of-serum-and-tissue-samples-from-patients-with-biopsy-proved-or-suspected-malignant-disease-100060106","NCT00026884","Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease","Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Diseases","* INCLUSION CRITERIA:\n* Individuals with biopsy-proven malignant disease\n* Individuals suspected of having a malignant disease\n* Individuals who have or are suspected of having an inherited genitourinary malignant disorder\n* Participants must be \\>= 2 years of age\n* A relative (related by blood) of an individual with a confirmed or suspected diagnosis of a malignant disease or an inherited genitourinary malignant disorder.\n* All participants and parents\u002Fguardians, for children younger than 18 years of age, must sign an informed consent document indicating their understanding of the investigational nature and the risks of this study before any protocol related studies are performed.\n\nEXCLUSION CRITERIA:\n\n-Individuals whose co-morbidities preclude surgical intervention.","2 Years",{"count":207,"type":21},5950,"Selected individuals suspected of having or with prior biopsy proof of malignant disease will be seen in the Urologic Oncology Branch, NCI. Blood samples may be collected at the time of the initial visit and at periodic intervals during the course of the disease. These samples will be stored in the tissue bank of the Urologic Oncology Branch. Aliquots of malignant and normal tissue will be collected at the time of surgery and stored in the tissue bank, Urologic Oncology Branch, NCI. These materials will be used in the research efforts of the Urologic Oncology Branch, NCI....",[210,211,37,212,106],"Malignant Neoplasms","Hereditary Neoplastic Syndromes","Renal Cancer",[214,215,216,217,218,219],"Serum","Collection of Tissue","Malignant Disease","Molecular Basis","Genome Sequencing","Natural History","2026-06-23",{"date":222,"type":50},"2026-06-24",{"date":224,"type":50},"1998-03-12",{"name":226,"class":227},"National Cancer Institute (NCI)","NIH",{"id":229,"slug":230,"hasResults":12,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":234,"eligibilityCriteria":235,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":236,"targetDuration":4,"studyType":100,"phases":4,"briefSummary":238,"conditions":239,"keywords":240,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":253},"100308304","uroccr-database-french-research-network-for-kidney-cancer--uroccr-100308304","NCT03293563","UroCCR Database: French Research Network for Kidney Cancer -UroCCR","UroCCR Database: French Research Network for Kidney Cancer (National Multidisciplinary Clinical and Biological Database on Kidney Cancer)","UroCCR","Inclusion Criteria:\n\n* Adult patient with kidney cancer\n* Patient with no opposition to collection of its data for the study\n\nExclusion Criteria: none",{"count":237,"type":21},30000,"Kidney cancer management has become increasingly complex with the diversification of treatment options and the integration of multidisciplinary care. To meet these challenges, the UroCCR network was established in France as a national registry and research platform dedicated to renal cancer. Funded by the French National Cancer Institute (INCa), UroCCR prospectively collects comprehensive real-world data on patient care and disease evolution, while systematically linking these records with annotated biological samples (plasma, urine, and both healthy and tumour tissues). For each case, more than one thousand variables may be recorded, covering clinical, imaging, and patient-reported information.\n\nMore than a registry, UroCCR is a collaborative network of clinical and research professionals using a shared, evolving tool that supports rapid implementation of studies and fosters active knowledge generation. Unlike retrospective registries or sample-centred biobanks, UroCCR offers prospective, patient-focused inclusion and a wide scope of investigation-from translational and technological research to clinical evaluation and social sciences. It also supports multiple ancillary studies, including retrospective analyses and prospective clinical or observational trials, and operates under a structured governance system with recognised national and international labels.\n\nBy combining a rigorously structured, multicentre dataset with linkage to the French national health data system (SNDS), the platform uniquely unites detailed clinical annotation with population-wide coverage, creating a high-value environment for advancing kidney cancer research and care.",[37],[241,242,243,244],"Kidney cancer","Surgical approaches","Medical treatment","Multicentric and multidisciplinary network","2026-06-22",{"date":80,"type":50},{"date":248,"type":4},"2011-12",{"date":250,"type":21},"2040-12",{"name":252,"class":57},"University Hospital, Bordeaux",68,{"id":255,"slug":256,"hasResults":12,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":4,"eligibilityCriteria":260,"healthyVolunteers":138,"sex":17,"minAge":205,"maxAge":4,"enrollmentInfo":261,"targetDuration":4,"studyType":100,"phases":4,"briefSummary":263,"conditions":264,"keywords":267,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":272,"completionDateStruct":4,"leadSponsor":274,"locationsCount":89},"100061785","hereditary-leiomyomatosis-renal-cell-cancer---study-of-the-genetic-cause-and-the-predisposition-to-renal-cancer-100061785","NCT00050752","Hereditary Leiomyomatosis Renal Cell Cancer - Study of the Genetic Cause and the Predisposition to Renal Cancer","Hereditary Leiomyomatosis Renal Cell Cancer (HLRCC): Identification of the Disease Gene, and Characterization of the Predisposition to Renal Cancer","* INCLUSION CRITERIA:\n* Individuals suspected or known to have phenotype or genotype suggestive of Hereditary Leiomyomatosis and Renal Cell Cancer Syndrome (HLRCC), such as:\n\n  * Cutaneous leiomyoma and kidney cancer; or\n  * Cutaneous leiomyoma and uterine leiomyoma; or\n  * Multiple cutaneous leiomyoma; or\n  * Kidney cancer and uterine leiomyomata; or\n  * Renal tumor histology consistent with HLRCC including, but not limited to: Collecting Duct and\u002For Papillary, Type II\n* All participants and parents\u002Fguardians, for children younger than 18 years of age, must sign an informed consent document indicating their understanding of the investigational nature and the risks of this study before any protocol related studies are performed.\n* Participants must be \\>= 2 years of age.\n* A relative (related by blood) of an individual with a confirmed or suspected diagnosis of HLRCC.\n\nEXCLUSION CRITERIA:\n\nNone",{"count":262,"type":21},1130,"This study will investigate what causes hereditary leiomyomatosis renal (kidney) cell cancer, or HLRCC, and how the disease is related to the development of kidney tumors. Leiomyomas are benign (non-cancerous) tumors arising from smooth muscle. HLRCC can cause various health problems. Some people develop red bumps on their skin that can be painful at times. Some women with HLRCC can develop leiomyomas of the uterus. In some families, people with HLRCC develop kidney tumors. This study will try to determine:\n\n* What gene changes (mutations) cause HLRCC\n* What kind of kidney tumors develop in HLRCC and how they grow\n* What the chance is that a person with HLRCC will develop a kidney tumor\n\nPeople with known or suspected HLRCC (and their family members of any age) may be eligible for this study. This includes people in families in which one or more members has skin leiomyoma and kidney cancer; skin leiomyoma and uterine leiomyoma; multiple skin leiomyomas; kidney cancer and uterine leiomyomas, or kidney cancer consistent with HLRCC, including, but not limited to, collecting duct or papillary, type II. Candidates will be screened with a physical examination, family history, and, for affected family members, a review of medical records, including pathology slides and computed tomography (CT) or magnetic resonance imaging (MRI) scans.\n\nParticipants will undergo tests and procedures that may include the following:\n\n* Review of medical records, x-rays, and tissue slides\n* Physical examination and family history\n* Skin examination\n* Gynecological examination for women\n* Interviews with a cancer doctor, cancer nurses, kidney surgeon, and genetic counselor\n* Blood tests for:\n\n  1. Genetic research to identify the gene responsible for HLRCC\n  2. Evaluation of liver, kidney, heart, pancreas, and thyroid function\n  3. Complete blood count and clotting profile\n  4. Pregnancy test for pre-menopausal women\n  5. PSA test for prostate cancer in men over age 40\n* CT or MRI scans (for participants 15 years of age and older only)\n* Skin biopsy (surgical removal of a small sample of skin tissue)\n* Cheek swab or mouth rinse to collect cells for genetic analysis\n* Medical photographs of lesions\n* Questionnaire\n\nWhen the tests are completed, participants will discuss the results with a doctor and possibly a genetic nurse or genetic counselor. The genetic findings will not be revealed to participants because their meaning and implications may not yet be understood. Participants may be asked to return to NIH from every 3 months to every 3 years, depending on their condition, for follow-up examinations and tests.",[265,266,37],"Renal Tumor Histology","Cutaneous Leiomyoma",[212,268,269,266,219],"Hereditary Leiomyomatosis","Uterine Fibroid","2026-06-19",{"date":220,"type":50},{"date":273,"type":50},"2003-02-24",{"name":226,"class":227},{"id":276,"slug":277,"hasResults":12,"nctId":278,"briefTitle":279,"officialTitle":280,"acronym":4,"eligibilityCriteria":281,"healthyVolunteers":138,"sex":17,"minAge":205,"maxAge":4,"enrollmentInfo":282,"targetDuration":4,"studyType":100,"phases":4,"briefSummary":284,"conditions":285,"keywords":289,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":297,"completionDateStruct":4,"leadSponsor":299,"locationsCount":89},"100060545","genetic-analysis-of-birt-hogg-dube-syndrome-and-characterization-of-predisposition-to-kidney-cancer-100060545","NCT00033137","Genetic Analysis of Birt Hogg-Dube Syndrome and Characterization of Predisposition to Kidney Cancer","Birt-Hogg-Dub(SqrRoot)(Copyright) Syndrome: Characterization of the FLCN Disease Gene and Predisposition to Renal Cancer, Cutaneous Fibrofolliculoma and Pulmonary Cysts","* INCLUSION CRITERIA:\n\nIndividuals that meet one or more of the following criteria:\n\n-Suspected or known to have phenotype or genotype suggestive of Birt-Hogg-Dube (BHD), such as:\n\n--Individuals with at least one histologically confirmed fibrofolliculomas;\n\nor\n\n--Individuals with clinical evidence of multiple skin papules (without fibrofolliculoma biopsy confirmation) and a personal or family history of spontaneous pneumothorax\u002For kidney cancer;\n\nor\n\n--Individuals with spontaneous pneumothorax and skin papules or kidney cancer and a positive family history of spontaneous pneumothorax, skin papules or kidney cancer;\n\nor\n\n--Individuals with a known germline FLCN gene mutation\n\nOR\n\n-Renal tumor histology consistent with BHD, including, but not limited to those suggestive of chromophobe, hybrid oncocytic neoplasm or oncocytoma.\n\nOR\n\n* Are a relative (related by blood) of an individual with a confirmed or suspected diagnosis of BHD.\n\n  -Participants must be \\>= 2 years of age.\n* For children less than 18 years of age, parental permission or legal guardian consent will be obtained.\n\nEXCLUSION CRITERIA:\n\nNone.",{"count":283,"type":21},950,"This study will investigate the genetic cause of Birt Hogg-Dube (BHD) syndrome and the relationship of this disorder to kidney cancer. BHD is a rare inherited condition characterized by papules, or bumps-benign tumors involving hair follicles-on the head and neck. People with BHD are at increased risk of developing kidney cancer. Scientists have identified the chromosome (strand of genetic material in the cell nucleus) that contains the BHD gene and the region of the gene on the chromosome. This study will try to learn more about:\n\n* The characteristics and type of kidney tumors associated with BHD\n* The risk of kidney cancer in people with BHD\n* Whether more than one gene causes BHD\n* The genetic mutations (changes) responsible for BHD\n\nIndividuals with known or suspected Birt Hogg-Dube syndrome, and their family members, may be eligible for this study. Candidates will be screened with a family history and review of medical records, including pathology reports for tumors, and films of computed tomography (CT) and magnetic resonance imaging (MRI) scans.\n\nParticipants may undergo various tests and procedures, including the following:\n\n* Physical examination\n* Review of personal and family history with a cancer doctor, cancer nurses, kidney surgeon, and genetic counselor\n* Chest and other x-rays\n* Ultrasound (imaging study using sound waves)\n* MRI (imaging study using radiowaves and a magnetic field)\n* CT scans of the chest and abdomen (imaging studies using radiation)\n* Blood tests for blood chemistries and genetic testing\n* Skin evaluation, including a skin biopsy (surgical removal of a small skin tissue sample for microscopic evaluation)\n* Cheek swab or mouthwash to collect cells for genetic analysis\n* Lung function studies\n* Medical photography of skin lesions\n\nThese tests will be done on an outpatient basis in either one day or over 3 to 4 days. When the studies are complete, participants will receive counseling about the findings and recommendations. Individuals with kidney lesions may be asked to return periodically, such as every 3 to 36 months, based on their individual condition, to document the rate of progression of the lesions.",[286,37,287,288],"Kidney Neoplasms","Pneumothorax","FLCN Protein, Human",[287,290,291,292,293,219],"Kidney","Fibrofolliculoma","BHD","Neoplasms","2026-06-16",{"date":296,"type":50},"2026-06-17",{"date":298,"type":50},"2002-05-13",{"name":226,"class":227},{"id":301,"slug":302,"hasResults":12,"nctId":303,"briefTitle":304,"officialTitle":305,"acronym":4,"eligibilityCriteria":306,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":307,"targetDuration":4,"studyType":22,"phases":309,"briefSummary":310,"conditions":311,"keywords":312,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":318,"completionDateStruct":319,"leadSponsor":321,"locationsCount":130},"100642052","a-study-of-a-side-effects-and-resource-navigation-program-for-people-with-cancer-100642052","NCT07646847","A Study of a Side Effects and Resource Navigation Program for People With Cancer","I CARE (Immunotherapy Cutaneous Adverse Events REsearch) - A Trial With Diverse Cancer Patients to Determine the Impact of SDoH and Side Effects Navigation Program on Treatment Continuation","Inclusion Criteria:\n\n* Documentation of Disease\n\n  o Patient must have pathologically confirmed kidney, bladder, breast, or lung cancer (per EMR)\n* Prior Treatment\n\n  o Within two weeks (+\u002F- 2 weeks) of starting PD-1 or PD(L)-1 immune checkpoint inhibitors as monotherapy or in combination with other therapies (per EMR)\n* Age ≥ 18 (per EMR)\n* Not Pregnant and Not Nursing (per self-report)\n* At least one essential need (e.g., food, transportation, housing), as determined by the ICCAN Essential Needs Screener (per self-report)\n* Lives in New York metro area, including Long Island, New Jersey, Connecticut, and Pennsylvania (per self-report)\n* Can speak English or Spanish (per self-report)\n* Has no significant psychiatric disturbance sufficient to preclude completion of the assessment measures, interview, or informed consent (i.e., acute psychiatric symptoms which require individual treatment) (per EMR, patient's care team, or study team)\n* Has no presence of cognitive impairment disorder (i.e., delirium or dementia) sufficient to preclude meaningful informed consent and\u002For data collection (per EMR, patient's care team, or study team)",{"count":308,"type":21},200,[24],"The purpose of this study is to find out if the navigation program helps participants manage immunotherapy treatment better than usual care. Investigators will also look at how the navigation program impacts participants' quality of life. Investigators will measure quality of life by having participants complete questionnaires.",[37,106,30,39],[37,106,30,39,313,314],"Memorial Sloan Kettering Cancer Center","25-338","2026-06-09",{"date":317,"type":50},"2026-06-15",{"date":315,"type":50},{"date":320,"type":21},"2029-06-09",{"name":313,"class":57},{"id":323,"slug":324,"hasResults":12,"nctId":325,"briefTitle":326,"officialTitle":326,"acronym":327,"eligibilityCriteria":328,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":329,"targetDuration":4,"studyType":100,"phases":4,"briefSummary":331,"conditions":332,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":337,"startDateStruct":339,"completionDateStruct":341,"leadSponsor":343,"locationsCount":345},"100470233","marathon-of-hope-cancer-centres-network-study-for-ontario-mohccn-o-100470233","NCT05403177","Marathon of Hope Cancer Centres Network Study for Ontario (MOHCCN-O)","MOHCCN-O","Inclusion Criteria:\n\n1. Patients with histological and\u002For cytological confirmation of blood or solid tumor malignancies. For tumour types where pre-surgical biopsy is not routinely performed to confirm a pathologic diagnosis of cancer, patients may consent to this protocol, but eligibility must be confirmed after pathology is finalized demonstrating presence of malignancy\n2. All patients must be able to satisfy the required minimum data elements for the 15k gold standard cohort through:\n\n   1. Already existing data that satisfies the minimal requirements of a gold standard case (refer to Table 1)\n   2. Have sufficient biospecimens (tumor and\u002For blood samples) available for more comprehensive molecular and immunophenotypic characterization\n3. Patients who do not satisfy the required minimum data elements but would like to participate, maybe requested to donate blood and undergo a fresh biopsy if the archived Formalin-fixed paraffin-embedded (FFPE) samples are not available, or in cases where a fresh tumor biopsy is deemed necessary for molecular profiling.\n4. Participating patients must agree to share their anonymized clinical and genomic data\n\nExclusion Criteria:\n\nNone.",{"count":330,"type":21},500,"The Marathon of Hope Cancer Centres Network (MOHCCN) is a national network of cancer centres that pursue collaborative cancer research in precision medicine (an emerging approach for disease treatment and prevention that considers individual variability in DNA, environment and lifestyle) to accelerate the discovery of innovations and improve the health outcomes for cancer patients",[30,108,333,37,43,334,40,172,335,39,173,336],"Pancreas Cancer","Ovary Cancer","Lymphoma","Solid Tumor",{"date":338,"type":50},"2026-06-10",{"date":340,"type":50},"2022-06-23",{"date":342,"type":21},"2030-10",{"name":344,"class":57},"University Health Network, Toronto",3,{"id":347,"slug":348,"hasResults":12,"nctId":349,"briefTitle":350,"officialTitle":351,"acronym":4,"eligibilityCriteria":352,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":353,"targetDuration":4,"studyType":22,"phases":355,"briefSummary":356,"conditions":357,"keywords":358,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":360,"lastUpdatePostDateStruct":361,"startDateStruct":363,"completionDateStruct":365,"leadSponsor":367,"locationsCount":369},"100526693","patient-navigation-program-to-improve-clinical-trial-enrollment-in-cancer-patients-100526693","NCT06138067","Patient Navigation Program to Improve Clinical Trial Enrollment in Cancer Patients","A Pilot Study of Low Versus High Intensity Patient Navigation Program to Improve the Enrollment on Clinical Trials Among Cancer Patients","1. Age ≥ 18 years\n2. Patient with a current diagnosis of a primary solid tumor including: prostate cancer and kidney cancer\n3. Being seen at the Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Johns Hopkins University (JHU) or Wellspan Health Center\n4. Available therapeutic trial for the patient as determined through pre-screening\u002Fmedical record review",{"count":354,"type":21},90,[24],"The goal of this clinical trial is to test the utility of patient navigation by comparing high intensity patient navigation to low intensity navigation approaches to improving cancer trial enrollment of patients treated in academic and community cancer centers. Patient navigation is a strategy for increasing patients access to cancer care by helping the participant overcome barriers in the participants communities and within the health care system by providing a bridge between the patient and the health care system. The primary objective of this study is to determine if a high intensity patient navigation program will improve patients enrollment on clinical trial in comparison to a low intensity patient navigation. Participants who agree to participate and are eligible will be randomly assigned to either the high intensity or low intensity approach.",[43,37],[359],"clinical trials enrollment rate","2026-06-03",{"date":362,"type":50},"2026-06-05",{"date":364,"type":50},"2025-12-01",{"date":366,"type":21},"2027-01",{"name":368,"class":57},"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins",2,{"id":371,"slug":372,"hasResults":12,"nctId":373,"briefTitle":374,"officialTitle":374,"acronym":375,"eligibilityCriteria":376,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":377,"targetDuration":4,"studyType":100,"phases":4,"briefSummary":379,"conditions":380,"keywords":385,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":388,"lastUpdatePostDateStruct":389,"startDateStruct":391,"completionDateStruct":393,"leadSponsor":395,"locationsCount":397},"100453457","learn-learning-environment-for-artificial-intelligence-in-radiotherapy-new-technology-100453457","NCT05184790","LEARN: Learning Environment for Artificial Intelligence in Radiotherapy New Technology","LEARN","Inclusion Criteria:\n\n* Will receive radiation therapy for brain, breast, head and neck, kidney, liver, pancreas, prostate, spine cancer treatment or cardiac arrhythmia treatment at a participating centre.\n* Will receive CT planning, and a cone beam CT scan for at least one fraction of radiation therapy.\n* Will receive intrafraction x-ray imaging for the liver, pancreas, prostate, spine cancer treatment or cardiac arrhythmia treatment. As intrafraction imaging is not common standard of care for brain, breast, head and neck and kidney cancer treatments there is no requirement to have intrafraction x-ray imaging data for these anatomical sites.\n* Provides written informed consent.\n\nExclusion Criteria:\n\n* Less than 18 years of age",{"count":378,"type":21},300,"This study will develop a whole-of-body markerless tracking method for measuring the motion of the tumour and surrounding organs during radiation therapy to enable real-time image guidance.\n\nRoutinely acquired patient data will be used to improve the training, testing and accuracy of a whole-of-body markerless tracking method. When the markerless tracking method is sufficiently advanced, according to the PI of each of the data collection sites, the markerless tracking method will be run in parallel to, but not intervening with, patient treatments during data acquisition.",[381,30,382,383,37,40,38,42,384],"Arrhythmias, Cardiac","Prostatic Cancer","Brain Cancer","Spinal Neoplasm",[386,387],"Radiation Therapy","markerless tracking","2026-05-18",{"date":390,"type":50},"2026-05-19",{"date":392,"type":50},"2023-02-28",{"date":394,"type":21},"2028-01-31",{"name":396,"class":57},"University of Sydney",4,{"id":399,"slug":400,"hasResults":12,"nctId":401,"briefTitle":402,"officialTitle":403,"acronym":4,"eligibilityCriteria":404,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":405,"targetDuration":4,"studyType":22,"phases":407,"briefSummary":409,"conditions":410,"keywords":413,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":415,"lastUpdatePostDateStruct":416,"startDateStruct":417,"completionDateStruct":419,"leadSponsor":421,"locationsCount":89},"100493077","phase-1-drug-screening-using-novel-imd-in-renal-cell-carcinoma-100493077","NCT05700461","Drug Screening Using Novel IMD in Renal Cell Carcinoma","Pilot Study of an Implantable Microdevice for in Situ Evaluation of Drug Response in Renal Cell Carcinoma","Inclusion Criteria:\n\n* Patients must have the ability to understand and the willingness to sign a written informed consent document.\n* Participants must have confirmed or suspected localized or metastatic renal cell carcinoma, and must be planned for either nephrectomy or metastatectomy as part of their clinical care. The lesion planned for excision must be at least 1cm in size.\n* Participants must be 18 years of age or older.\n* Participants must be evaluated by a medical oncologist who will determine the clinically appropriate treatment strategy based on clinical history and extent of disease.\n* Patients must be deemed medically stable to undergo both percutaneous procedures and standard-of-care surgical procedures.\n* Participants will undergo laboratory testing within 30 days prior to the procedure (or within 72 hours if there has been a change in the clinical status since the initial blood draw). Patients must have absolute neutrophil count ≥1,000\u002FmcL, platelets ≥50,000\u002FmcL, INR \\\u003C 1.5 and PTT \\\u003C1.5x control.\n* Participants must have undergone CT or MRI that assesses the extent of disease and allows the research team to assess for study eligibility. This will have been done as part of the standard-of-care.\n* The participant's case must be reviewed by representatives of interventional radiology and the appropriate surgical subspecialty to assess the following factors:\n* Patient is clinically stable to undergo microdevice implantation and surgical procedures\n* Patient has sufficient volume of disease to allow implantation of the microdevice\n* Patient has a lesion for which the microdevice is a) amenable to percutaneous placement, and b) amenable to removal at the time of surgery\n* Patients must be willing to undergo research-related genetic sequencing (somatic and germline) and data management, including the deposition of de-identified genetic sequencing data in NIH central data repositories.\n\nExclusion Criteria\n\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit the safety of a biopsy and\u002For surgery.\n* Uncorrectable bleeding or coagulation disorder known to cause increased risk with surgical or biopsy procedures (detailed below).",{"count":406,"type":21},20,[408],"PHASE1","This research is being done to study the safety and feasibility of implanting and retrieving a microdevice that releases microdoses of 19 specific drugs or drug combinations as a possible tool to evaluate the effectiveness of several cancer drugs against metastatic renal cell carcinoma (RCC).\n\nThe name of the intervention(s) involved in this study are:\n\n* Implantable Microdevice (IMD)\n* Surgery (excision of tumor)\n* Drugs used in this study will only include drugs already used as standard of care for the treatment of metastatic renal cell carcinoma (RCC)",[411,412,37],"Renal Cell Carcinoma","Metastatic Renal Cell Carcinoma",[411,412,37,414],"Suspected Renal Cell Carcinoma","2026-05-14",{"date":388,"type":50},{"date":418,"type":50},"2024-12-01",{"date":420,"type":21},"2029-08-31",{"name":422,"class":57},"Oliver Jonas",{"id":424,"slug":425,"hasResults":12,"nctId":426,"briefTitle":427,"officialTitle":428,"acronym":4,"eligibilityCriteria":429,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":430,"targetDuration":4,"studyType":22,"phases":432,"briefSummary":433,"conditions":434,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":439,"lastUpdatePostDateStruct":440,"startDateStruct":442,"completionDateStruct":444,"leadSponsor":446,"locationsCount":89},"100567833","phase-1-brodalumab-in-the-treatment-of-immune-related-adverse-events-100567833","NCT06673329","Brodalumab in the Treatment of Immune-Related Adverse Events","Safety and Efficacy of Brodalumab in the Treatment of Immune-Related Adverse Events: A Pilot Study","Inclusion Criteria:\n\n* Ability to provide written informed consent by subject or guardian\n* Individuals \\>18 years of age\n* Diagnosis of an irAE clinically suspected to be IL-17 mediated\n* Intent-to-treat or prior treatment with systemic steroids for irAE management\n* Histology-proven primary advanced or metastatic solid organ malignancy treated with immunotherapy. Patients being treated with curative intent are not eligible to enroll.\n* Subject has a negative test for tuberculosis during screening defined as either: negative purified protein derivative (PPD) (\\\u003C 5 mm of induration at 48 to 72 hours after test is placed) OR negative QuantiFERON test. Tuberculosis testing must be performed within 30 days prior to trial initiation.\n* Subjects with a positive PPD and a history of Bacillus Calmette-Guérin vaccination are allowed with a negative QuantiFERON test.\n* Subjects with a positive PPD test (without a history of Bacillus Calmette-Guérin vaccination) or subjects with a positive or indeterminate QuantiFERON test are allowed if they have all of the following: no symptoms of tuberculosis (defined as fever, shortness of breath, cough or night sweats), documented history of a completed course of adequate prophylaxis (per local standard of care), no known exposure to a case of active tuberculosis after most recent prophylaxis, no evidence of active tuberculosis on chest radiograph within 3 months prior to the first dose of brodalumab.\n\nExclusion Criteria:\n\n* Estimated creatinine clearance \\\u003C 40 mg\u002Fmin\n* Active suicidal ideation or severe depression (as defined by the Diagnostic and Statistical Manual of Mental Disorders Version IV criteria (DSM-IV)) at the time of enrollment or a PHQ-9 score \\> 20\n* History of prior suicide attempts\n* PHQ-9 score greater \\>5 and \\\u003C 20 without an established mental health provider who verifies stability in their depression\n* Current or prior drug or alcohol abuse within the past 6 months (as defined by the DSM IV)\n* In the opinion of the investigator, the patient requires additional immunosuppressive treatment (other than corticosteroids and brodalumab)\n* Known hypersensitivity or contraindication to brodalumab, corticosteroids or any components of brodalumab\n* Prior treatment with brodalumab\n* Pregnancy, breastfeeding, or use of a nonreliable method of contraception\n\n  * For patients assigned female at birth: lack of willingness to use highly effective methods of birth control during treatment and for at least 4 weeks after the last dose of brodalumab (except if surgically sterile or at least 2 years postmenopausal, with postmenopausal status confirmed by Follicle-Stimulating Hormone (FSH) in the postmenopausal range).\n  * Highly effective methods of birth control include: use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. Oral contraceptive pills must be supplemented by a barrier method.\n  * Patients planning to become pregnant while enrolled in the study and within 4 weeks after the last dose of brodalumab will not be permitted to enroll\n* Chronic or current severe infection requiring IV therapy\n* Evidence of active hepatitis B, C, or tuberculosis.\n* History of latent tuberculosis infection which is incompletely treated based upon local standard of care or which was never treated\n* History of or active Crohn's disease.\n* Myocardial infarction, unstable angina pectoris or stroke within the past 12 months prior to the first investigational product dose\n* Any concurrent medical condition or electrocardiogram (ECG) abnormality that, in the opinion of the investigator, could cause this study to be detrimental to the subject.\n* Any medical condition or treatment for a condition that, in the opinion of the investigator, might interfere with participation in the study or affect the reliability of clinician assessment or patient self-report\n* Other known clinically significant active medical conditions, such as:\n\n  * Severe cardiovascular disease, including advanced heart failure (American Heart Association Stage D)\n  * Aspartate aminotransferase (AST) and or alanine aminotransferase (ALT) greater than 2 times the upper limit of normal or greater than 3 times the upper limit of normal in patients with liver metastases measured on at least two separate occasions\n  * Direct bilirubin greater than or equal to 1.5 mg\u002FdL in patients with or without liver metastases\n  * Bone marrow insufficiency unrelated to the irAE (according to investigator judgment) with White Blood Cell (WBC) \\\u003C2000\u002Fmm3, absolute neutrophil count \\\u003C1500\u002F mm3, thrombocytopenia (platelet count) \\\u003C50,000\u002Fmm3, hemoglobin \\\u003C 8.0 g\u002FdL\n* Plan to proceed with further curative intent treatment for cancer at the time of enrollment despite the presence of irAE\n* Participation in another therapeutic clinical trial and receipt of investigational drugs within 4 weeks before the screening visit\n* Previous diagnosis of an autoimmune disease or administration of immunosuppressants in a time frame that would impede interpretation of brodalumab administration\n* Planned use of immunosuppressive agents other than steroids (including infliximab, vedolizumab, tocilizumab etc.) or administration of such agents within 28 days of trial initiation\n* Administration of live-virus vaccines within 4 weeks before the first dose of brodalumab",{"count":431,"type":21},11,[408],"The purpose of this study is to test the safety and effectiveness of using brodalumab in patients who develop side effects from cancer immune therapy. Immune-related side effects are due to activation of the immune system in patients who previously received immunotherapy and the goal of this study is to help better control these side effects. Brodalumab is often used to treat patients with autoimmune diseases (diseases where the immune system is activated against normal organs) and safe doses and treatment schedules have been determined in these patients. Immune-related side effects appear to closely mirror these autoimmune conditions. Brodalumab has not been approved by the United States Food and Drug Administration (FDA) for use in immunotherapy side effects but it has been approved for treatment of autoimmune conditions.",[30,34,37,39,146,435,42,436,437,32,44,40,438,38,112,43,157,336],"Gynecologic Cancer","Stomach Cancer","Brain Tumor","Oral Cancer","2026-05-11",{"date":441,"type":50},"2026-05-13",{"date":443,"type":50},"2025-03-11",{"date":445,"type":21},"2027-11",{"name":447,"class":57},"Brian Henick, MD",{"id":449,"slug":450,"hasResults":12,"nctId":451,"briefTitle":452,"officialTitle":453,"acronym":4,"eligibilityCriteria":454,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":455,"targetDuration":4,"studyType":100,"phases":4,"briefSummary":456,"conditions":457,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":462,"lastUpdatePostDateStruct":463,"startDateStruct":465,"completionDateStruct":467,"leadSponsor":468,"locationsCount":89},"100413113","tdm-for-optimized-outcome-in-patients-with-mrcc-100413113","NCT04659343","TDM for Optimized Outcome in Patients With mRCC.","Therapeutic Drug Monitoring for Optimized Outcome in Patients With Metastatic Renal Cell Carcinoma","Inclusion Criteria:\n\n* Patients in Denmark with medically treated metastatic renal cell carcinoma.\n\nExclusion Criteria:\n\n* No written informed consent.",{"count":308,"type":21},"The purpose of this observational study is to assess the role of plasma concentration monitoring of treatment drugs for patients with metastatic renal cell carcinoma (mRCC) in terms of efficacy and side effects. It furthermore holds microbiome characterization of CPI-treated patients.\n\nFurthermore, the investigators examines the role of anti-drug antibodies and receptor polymorphisms in CTLA-4 and PD-1 receptors in treatment failure among patients with mRCC treated with check point immunotherapy (CPI). Moreover, polymorphisms in the UGT1A1 gene will be correlated with the pazopanib treatment dose.",[37,458,459,460,461],"Renal Cell Carcinoma Metastatic","Drug Toxicity","Drug Side Effect","Drug Mechanism","2026-04-28",{"date":464,"type":50},"2026-05-04",{"date":466,"type":50},"2020-11-01",{"date":420,"type":21},{"name":469,"class":57},"Niels Fristrup",{"id":471,"slug":472,"hasResults":12,"nctId":473,"briefTitle":474,"officialTitle":475,"acronym":476,"eligibilityCriteria":477,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":478,"targetDuration":4,"studyType":22,"phases":480,"briefSummary":481,"conditions":482,"keywords":484,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":462,"lastUpdatePostDateStruct":492,"startDateStruct":493,"completionDateStruct":495,"leadSponsor":497,"locationsCount":498},"100360779","deferred-cytoreductive-nephrectomy-in-synchronous-metastatic-renal-cell-carcinoma-the-nordic-sun-trial-100360779","NCT03977571","Deferred Cytoreductive Nephrectomy in Synchronous Metastatic Renal Cell Carcinoma: The NORDIC-SUN-Trial","Multicenter Randomized Trial of Deferred Cytoreductive Nephrectomy in Synchronous Metastatic Renal Cell Carcinoma Receiving Checkpoint Inhibitors: a Trial Evaluating the Impact of Surgery or No Surgery. The NORDIC-SUN-Trial","NORDIC-SUN","Inclusion Criteria:\n\n1. Signed written informed consent obtained prior to any study specific procedures.\n2. Patient must be willing and able to comply with the protocol.\n3. Age ≥18.\n4. Core needle biopsy proven metastatic renal cell carcinoma - all histologic subtypes acceptable.\n5. Synchronous metastatic renal cell carcinoma with the primary tumor present in the kidney.\n6. Measurable disease as per RECIST v 1.1\n7. Patients for which Nivolumab\u002FIpilimumab or a TKI\u002FIO-combination is considered indicated according to the recommendations by the European Medicines Agency and the national health authorities of participating countries. The prescription of nivolumab\u002Fipilimumab or a TKI\u002FIO-combination in the circumstances of the study is considered as a standard treatment.\n8. Females with a negative serum pregnancy test unless childbearing potential can be otherwise excluded (postmenopausal, hysterectomy or oophorectomy) and not lactating.\n9. Fertile women of childbearing potential (\\\u003C2 years after last menstruation) and men must use effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgical sterilization).\n10. Karnofsky Performance status ≥70\n11. Life expectancy of greater than 4 months.\n12. The required laboratory values are as follows:\n\n    * Adequate bone marrow function (Leucocytes \\> 3.0 x 109\u002Fl, platelets \\> 100 x 109\u002Fl, hemoglobin \\> 6.0 mmol\u002Fl or \\> 10.0 g\u002FdL.)\n    * International normalized ratio (INR) ≤ 1.2 x upper limit of normal (ULN)\n    * Adequate hepatic function (bilirubin ≤ 1.5 x ULN, ALAT ≤ 2.5 x ULN or ≤ 5 x ULN if liver lesions)\n    * Adequate kidney function (eGFR \\> 35 mL\u002Fmin)\n\nExclusion Criteria:\n\n1. Prior systemic treatment for mRCC\n2. Other cancer within 3 years (except in situ basal cell carcinoma and localised prostate cancer with undetectable PSA).\n3. Major surgical procedure, open surgical biopsy, or significant traumatic injury within 28 days prior to enrollment\n4. Clinically significant (i.e active) cardiovascular disease for example cerebrovascular accidents (\\\u003C 6 months before inclusion), myocardial infarction (\\\u003C 6 months before inclusion), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure.\n5. No symptomatic brain metastasis requiring systemic corticosteroids (\\> 10 mg daily prednisone equivalent)\n6. Recent (within the 30 days prior to inclusion) treatment with another investigational drug or participation in another investigational study.\n7. Any active or recent history of a known or suspected autoimmune disease or recent history of a condition that require systemic corticosteroids (\\> 10 mg daily prednisone equivalent) or other immunosuppressive medications, excluding inhaled steroids and topical steroids. Subjects with vitiligo or type I diabetes mellitus or residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, psoriasis not requiring systemic treatment are permitted to enroll.\n8. Known hypersensitivity to monoclonal antibodies.\n9. Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).\n10. Any positive test for hepatitis B- or C-Virus indicating acute or chronic infection.\n11. Oral or i.v. antibiotics administered 14 days prior to initiation of systemic therapy.",{"count":479,"type":21},400,[24],"BACKGROUND: For synchronous metastatic renal cell carcinoma (RCC), surgical resection of the primary tumor in the presence of distant metastases has been the standard of therapy for select patients followed by systemic therapy. In the era of TKIs two randomized trials, CARMENA and SURTIME, have questioned the role and timing of surgery in these patients, results point towards no surgery or a deferred approach.\n\nRATIONALE: The antitumor activity of immune checkpoint blockage (ICB) is more potent than other therapy in mRCC. The deferred cytoreductive nephrectomy approach ensures systemic therapy for all patients, avoid systemic treatment delay, and spare surgery in patients with progressive tumors. Current data only point towards a survival benefit for cytoreductive nephrectomy in intermediate risk patients, but not in poor risk patients\n\nHYPOTHESIS: Deferred cytoreductive nephrectomy after initial nivolumab combined with ipilimumab or a TKI\u002FIO-combination will improve OS in patients with synchronous metastatic RCC and ≤3 IMDC risk features\n\nThis is an open, randomized, multicenter comparison trial, designed to evaluate the effect of deferred cytoreductive nephrectomy compared with no surgery following initial nivolumab combined with ipilimumab or a TKI-combination, in mRCC patients with IMDC intermediate and poor risk.",[37,458,483],"Synchronous Neoplasm",[485,486,487,488,489,490,491],"Cytoreduction Surgical Procedures","Nephrectomy","Ipilimumab","Nivolumab","Laboratory biomarker analysis","Gene Expression","Liquid Biopsy",{"date":464,"type":50},{"date":494,"type":50},"2020-07-06",{"date":496,"type":21},"2031-12-01",{"name":469,"class":57},6,{"id":500,"slug":501,"hasResults":12,"nctId":502,"briefTitle":503,"officialTitle":504,"acronym":505,"eligibilityCriteria":506,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":507,"targetDuration":4,"studyType":22,"phases":509,"briefSummary":510,"conditions":511,"keywords":512,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":521,"lastUpdatePostDateStruct":522,"startDateStruct":524,"completionDateStruct":526,"leadSponsor":528,"locationsCount":89},"100556494","rein-3d-print-mechanics-100556494","NCT06525831","Rein 3D PRINT MECHANICS","Multimodal Imaging of the Biomechanical Properties of Kidney Tumors: Feasibility, Inter-modality Correspondence and Diagnostic Value","Rein3DP-M","Inclusion Criteria:\n\n* Adult patients (≥ 18 years of age)\n* Scheduled for surgical management with nephrectomy for kidney tumor in the urology department of Bordeaux University Hospital\n* CT scan available or scheduled for surgery\n* Consent expressed for integration of the UroCCR database\n* Expressed consent for participation in the Rein 3D Print Mechanics study\n* Patients affiliated or benefiting from social security system\n\nExclusion Criteria:\n\n* \\- Pregnant or breast-feeding women\n* Contraindication to MRI (Magnetic Resonance Imaging)\n* Contraindication to injection of gadoline contrast agents\n* Biopsy performed within 15 days prior to MRI, CT and ultrasound scans (risk of artifactual alteration, via iatrogenic hemorrhagic changes, of the biomechanical properties of the renal tumor and parenchyma).\n* Presence of thoracolumbar arthrodesis material\n* Obese patient (body mass index ≥ 30 kg\u002Fm²)\n* Cystic renal tumors with solid component (corresponding to either parietal thickening or tumor bud) \\\u003C 2 cm\n* Necrotic renal tumors with solid component (corresponding to either parietal thickening or tumor bud) \\\u003C 2 cm\n* Ascites\n* Person under legal protection\n* Difficulty understanding and expressing in French",{"count":508,"type":21},50,[24],"The goal of this innovative project is to evaluate the correspondence between several imaging modalities for characterizing the elasticity of healthy and pathological renal tissue which could help improve the realism of 3D prints used by urological surgeons and allow the identification of new, complementary imaging biomarkers. The main objective is to develop a predictive model of the biomechanical properties of normal and pathological kidney tissue, as assessed by the reference method (Magnetic Resonance (MR)-elastography).",[37],[513,514,515,516,517,518,519,520],"Renal-Cell Carcinoma","Renal Elasticity","Biomarkers","Ultrasound","CT-scan","Magnetic Resonance Imaging","AFRI","Diffusion weighted imaging","2026-04-08",{"date":523,"type":50},"2026-04-14",{"date":525,"type":50},"2025-03-07",{"date":527,"type":21},"2027-05-07",{"name":252,"class":57},{"id":530,"slug":531,"hasResults":12,"nctId":532,"briefTitle":533,"officialTitle":534,"acronym":4,"eligibilityCriteria":535,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":536,"targetDuration":4,"studyType":22,"phases":538,"briefSummary":539,"conditions":540,"keywords":554,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":558,"lastUpdatePostDateStruct":559,"startDateStruct":561,"completionDateStruct":563,"leadSponsor":565,"locationsCount":567},"100543937","phase-1-a-study-of-oral-7hp349-alintegimod-in-combination-with-ipilimumab-followed-by-nivolumab-monotherapy-100543937","NCT06362369","A Study of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy","A Phase 1b\u002F2a Multi-Center, Dose Escalation and Reference Regimen-Controlled, Multi-Cohort Study to Determine the Safety and Efficacy of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy in Patients With Locally Advanced or Metastatic Cancers Following One or More Prior Therapies","Inclusion and Exclusion Criteria for Phase 1b\n\nInclusion Criteria\n\n1. Adult patients (age 18 or older)\n2. Patient has a histologically confirmed diagnosis of any of the following locally advanced or metastatic solid tumors: melanoma, pleural mesothelioma, renal cell carcinoma, MSI-high or mismatch repair-deficient colorectal cancer, hepatocellular carcinoma, and non-small cell lung cancer with no EGFR or anaplastic lymphoma kinase (ALK) genomic tumor aberrations, or tumor types for which the combination of ipilimumab and nivolumab has been FDA approved. Patients may have received treatment with anti PD-1\u002FPD-L1.\n3. ANC ≥ 1000\u002FµL without use of G-CSF, Hgb ≥ 9 g\u002FdL without required blood transfusion for at least 5 days prior to pretreatment baseline, and platelet count ≥ 75,000\u002FµL without transfusions for at least 5 days prior to pretreatment baseline.\n4. ECOG performance status of 0 or 1.\n5. Has a life expectancy of \\> 12 weeks.\n6. Renal and hepatic function requirements:\n\n   * a. Renal function with either an eCrCL ≥ 60 mL\u002Fmin (modified Cockcroft-Gault) or eGFR ≥ 60 mL\u002Fmin\u002F1.73 m2 (using MDRD or CKD-EPI or similar equations).\n   * b. Hepatic function with ALT\u002FAST ≤ 3 x ULN, total bilirubin ≤ 1.5 x ULN (except for patients with Gilbert Syndrome). If patients have hepatic metastases, then AST\u002FALT≤ 5 x ULN will be allowed.\n7. Men receiving the investigational drug and are sexually active with women of child-bearing potential (WCBP) must use contraception during treatment and for 5 half-lives after the last dose of the investigational drug or Women, not otherwise meeting other exclusion criteria, who are WCBP must be on contraception for a minimum duration of 3 months prior to treatment and continue contraception during treatment and for 5 half-lives after the last dose of the investigational drug.\n8. All Grade 3 AEs related to prior therapies have returned to Grade 1 or resolved to baseline (this includes with appropriate therapy in the case of thyroid dysfunction).\n9. All patients must have measurable disease by applicable RECIST criteria.\n10. Willing to allow blood samples to be used for research.\n\nExclusion Criteria:\n\n1. Patients must not have received prior anticancer therapy or radiation therapy within the 3 weeks and must not have undergone major surgery within 4 weeks prior to initiation of treatment on protocol. Palliative radiation therapy is allowed. For small molecules (MW \\\u003C 0.9 kDA), the washout period is 3 weeks or 5 half-lives, whatever comes first.\n2. Active brain metastasis or leptomeningeal disease. Patients with treated brain metastasis must have stable disease, evidenced by MRI brain imaging for at least 4 weeks, and the patient must have been off steroids for at least 2 weeks prior to first dose of study drug.\n3. Previous episodes of ≥ Grade 3 (G3) immune-related toxicity that includes G3 colitis, G3 pneumonitis, G3 skin rash, G3 increase in liver enzymes (with the exception of symptoms that in the opinion of the investigator will not compromise the patients' safety on the trial. Patients with stable endocrinological AEs (e.g., hypothyroidism, adrenal insufficiency, hypopituitarism, or diabetes mellitus) are allowed.\n4. Persistent toxicity of NCI CTCAE version 5 Grade \\> 1 severity that is related to prior therapy.\n\n   Note: Sensory neuropathy, hypothyroidism or alopecia of Grade ≤ 2 are acceptable. Other Grade 2 toxicities of prior treatments that are controlled with medication (e.g., diabetes or hypertension) are permitted.\n5. Concurrent administration of medications or foods that are strong inhibitors or inducers of cytochrome p450 3A (CYP3A) within 2 weeks before study intervention. Alintegimod may increase exposure to CYP3A4 substrates; consider a dose reduction of such substrates and monitor for signs of toxicities of co-administered sensitive CYP3A substrates (see listing of strong inhibitors and inducer drugs in FDA tables). An alternative is to replace such agents with drugs that are not CYP3A4 metabolized if at all feasible.\n6. The patient has cardiac conditions as follows:\n\n   * a) myocarditis;\n   * b) uncontrolled hypertension (blood pressure \\> 160\u002F100) despite optimal therapy;\n   * c) uncontrolled angina; ventricular arrhythmias; congestive heart failure (New York Heart Association Class II or above);\n   * d) prior or current cardiomyopathy;\n   * e) uncontrolled atrial fibrillation with heart rate \\> 100 beats per minute (bpm); unstable ischemic heart disease (myocardial infarction within 6 months prior to starting treatment or angina requiring use of nitrates more than once weekly);\n   * f) concomitant medication with drugs known to cause Torsades de Pointes;87\n   * g) QT interval correction for heart rate using Fridericia's formula (QTcF) ≥ 470 ms (average from 3 QTcF values on the triplicate 12-lead electrocardiogram \\[ECG\\]) at screening.\n7. Known history of a positive test for HIV, or positive test for hepatitis B (positive for HBsAg) or hepatitis C (HCV RNA).\n8. Concurrent malignancies are permitted if they were previously treated, and all treatment of that malignancy was completed at least 2 years before enrollment and no evidence of disease exists, or with agreement from the Principal Investigator (PI), patients who have a concurrent malignancy that is clinically stable and does not require tumor-directed treatment are eligible to participate if the risk of the prior malignancy interfering with either safety or efficacy endpoints is very low, or with agreement from the PI, other malignancies may be permitted if the risk of the prior malignancy interfering with either safety or efficacy end points is very low. Adequately treated basal or squamous cell carcinoma or carcinoma in situ is allowed.\n9. Men receiving the investigational drug and are sexually active with women of child-bearing potential (WOCBP) must use contraception during treatment and for 5 half-lives after the last dose of the investigational drug or Women, not otherwise meeting other exclusion criteria, who are WOCBP must be on contraception for a minimum duration of 3 months prior to treatment and continue contraception during treatment and for 5 half-lives after the last dose of the investigational drug.\n10. The patient has concurrent severe and\u002For uncontrolled medical disease that could compromise participation in the study (i.e., uncontrolled diabetes, severe infection requiring active treatment, severe malnutrition, chronic severe liver or renal disease).\n11. Use of corticosteroids or other immunosuppressive medication, current or within 14 days of administration of Alintegimod with the following exceptions:\n\n    * a) Topical, intranasal, inhaled, ocular, intra-articular corticosteroids;\n    * b) Physiological doses of replacement corticosteroids (e.g., for adrenal insufficiency) are not to exceed 10 mg\u002Fday of prednisone or equivalent.\n    * c) Corticosteroid premedication for infusion and\u002For hypersensitivity reactions.\n    * d) Patients may be treated with a short (\\\u003C24h) pulse course of corticosteroids to mitigate infusion or hypersensitivity reactions to radiocontrast agents.\n12. Receipt of live attenuated vaccine within 28 days of the first dose of Alintegimod.\n13. Serious autoimmune disease at the discretion of the treating Investigator: patients with a history of active serious inflammatory bowel disease (including Crohn's disease and ulcerative colitis) and autoimmune disorders such as rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus or autoimmune vasculitis (e.g., Wegener's Granulomatosis) are excluded from participation in this study\n14. Active or history of pneumonitis (drug-induced), idiopathic pulmonary fibrosis, Interstitial Lung Disease (ILD), or lung disease that may interfere with assessment of pneumonitis. History of radiation pneumonitis in a previous radiation field is permitted.\n15. Previous participation in a study of any investigational agent within 21 days of enrollment or within 5 half-lives of the study treatment, whichever is the least.\n16. Use of mechanical ventilation or having a resting O2 saturation \\\u003C 90% (on room air) by pulse-oximetry, require renal dialysis, require vasopressors, and\u002For severe hepatic sinusoidal obstruction syndrome.\n17. Proven or suspected ongoing systemic infection requiring IV antibiotics.\n18. Women who are pregnant or lactating.\n\n    Note: Women of childbearing potential (WOCBP) must have a \"negative\" serum pregnancy test within 1 week prior to treatment. Non-childbearing potential is defined as 1 of the following:\n    * a) Postmenopausal with \\> 1 year since last menses and:\n    * 1\\. If ≥ 65 years old, follicle-stimulating hormone (FSH) \\> 40 mIU\u002FmL.\n    * 2\\. If ≥ 65 years old and not on hormone replacement therapy (HRT), FSH \\> 30 mIU\u002FmL.\n    * 3\\. If ≥ 65 years old and on HRT, the FSH requirement is not applicable. Postmenopausal females on HRT will be allowed if HRT has been stable for ≥ 6 months prior to dosing of study drug(s).\n    * b) Written medical documentation of being sterilized (e.g., hysterectomy, double oophorectomy, bilateral salpingectomy) with the procedure performed ≥ 6 months prior to dosing study drug(s).\n\n    Note: Tubal ligation is not considered a form of permanent sterilization.\n19. Psychiatric illness\u002Fsocial circumstances that would limit compliance with study requirements and substantially increase the risk of adverse events or have compromised ability to provide written informed consent.\n20. Patients who have had allogeneic tissue or solid organ transplantation. Prior T cell therapy is allowed\n21. Use of biotin (i.e., Vitamin B7) or supplements containing biotin higher than the daily adequate intake of 30 µg (NIH-ODS 2022; Section 5.9.2.1).\n\n    Note: Patients who switch from a high dose to a dose of ≤30 µg\u002Fday are eligible for study entry.\n22. Any condition that is in the opinion of the investigator may compromise patient's participation in the trial.\n23. Active peptic ulcer disease or gastritis, active diverticulitis, or other serious gastrointestinal disease associated with diarrhea within the past 2 years before the start of therapy or GI disease which affects oral drug absorption.\n24. Patients with known soy allergy.",{"count":537,"type":21},126,[408,71],"This study is an open-label Phase Ib (Part A) dose escalation followed by a blinded, randomized, multi cohort Phase 2a (Part B) comparison of combination vs. reference regimens.\n\nCurrently study will only be enrolling the Phase 1b and the Phase 2a protocol requirements will be added to the study near completion of the Phase 1b",[541,542,173,543,544,411,545,546,108,547,548,549,37,112,550,551,552,553],"Advanced Cancer","Advanced Solid Tumor","Metastasis","Pleural Mesothelioma","MSI-High","Mismatch Repair Deficiency","Hepatocellular Carcinoma","Hepatocellular Cancer","Renal Cell Cancer","Non Small Cell Lung Cancer","NSCLC","Anaplastic Lymphoma Kinase Genomic Tumor Aberrations","ALK Genomic Tumor Aberrations",[555,556,557],"Phase 1","Phase 1b","7 Hills Pharma","2026-04-07",{"date":560,"type":50},"2026-04-13",{"date":562,"type":50},"2024-08-23",{"date":564,"type":21},"2028-12-31",{"name":566,"class":129},"7 Hills Pharma, LLC",5,{"id":569,"slug":570,"hasResults":12,"nctId":571,"briefTitle":572,"officialTitle":573,"acronym":574,"eligibilityCriteria":575,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":576,"targetDuration":4,"studyType":22,"phases":578,"briefSummary":579,"conditions":580,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":582,"lastUpdatePostDateStruct":583,"startDateStruct":584,"completionDateStruct":586,"leadSponsor":588,"locationsCount":345},"100513747","phase-2-neoadjuvant-pembrolizumab-and-axitinib-in-renal-cell-carcinoma-with-inferior-vena-cava-tumor-thrombus-100513747","NCT05969496","Neoadjuvant Pembrolizumab and Axitinib in Renal Cell Carcinoma With Inferior Vena Cava Tumor Thrombus","Neoadjuvant Pembrolizumab and Axitinib in Renal Cell Carcinoma With Associated Inferior Vena Cava Tumor Thrombus (NEOPAX)","NEOPAX","Inclusion Criteria:\n\n* Provision to sign and date the consent form.\n* Stated willingness to comply with all study procedures and be available for the duration of the study.\n* Participant self-identified gender ages \\>\u002F= 18 years old is acceptable and appropriate if they meet other inclusion criteria.\n* Histologically proven clear cell component RCC.\n* An upfront candidate for definitive surgery per treating Urologist.\n* Suitable for and willing to undergo nephrectomy (either cytoreductive or with curative intent) per treating urologist.\n* T Stage of any of the following: cT3b, cT3c, cT4\n* N stage of any of the following: cN0 or cN1\n* M stage of any of the following: cM0 or cM1\n* ECOG performance status 0 - 2.\n* Urinalysis \\\u003C2+ protein. If dipstick is ≥2+ then a 24-hour urine collection should be performed, and the patient may enter the trial if urinary protein is \\\u003C2g per 24 hours.\n* All participants who have reproductive potential must have a negative serum or urine pregnancy test within a maximum of 14 days prior to starting trial treatment.\n\nReproductive potential is defined as the following:\n\n* Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:\n\n  * Women \\\u003C50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy)\n  * Women ≥50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \\>1 year ago, had chemotherapy-induced menopause with last menses \\>1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy\n  * For males with reproductive potential, use effective birth control during treatment with Axitinib and Pembrolizumab is recommended.\n\nExclusion Criteria:\n\n* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to enrollment.\n* Has had major surgery within 4 weeks or received radiation therapy within 1 week prior to enrollment to the study.\n* Has had prior treatment with any anti-programmed cell death (anti-PD-1) or programmed cell death ligand 1 (PD-L1), or an antibody targeting any other immune-regulatory receptors or mechanisms.\n* Has received prior systemic anti-cancer therapy for RCC with vascular endothelial growth factor (VEGF)\u002FVEGF receptors (VEGFR).\n* Has a history of severe hypersensitivity reaction (e.g., generalized rash\u002Ferythema, hypotension, bronchospasm, angioedema, or anaphylaxis) to Axitinib.\n* Has a diagnosis of immunodeficiency OR is receiving a systemic steroid therapy greater than Prednisone 10 mg daily or a steroid equivalent, or any other form of immunosuppressive therapy within 7 days prior to enrollment to the study except in the case of central nervous system (CNS) metastases.\n* Has an active autoimmune disease requiring systemic treatment within the past 2 years OR a documented history of clinically severe autoimmune disease. Note: Participants with vitiligo, Sjogren's syndrome, Type 1 diabetes, resolved childhood asthma\u002Fatopy, hypothyroidism or adrenal or pituitary insufficiency who are stable on hormone replacement are not excluded.\n* Has a known additional malignancy that has progressed or has required active treatment in the last 3 years. Note: Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ such as breast cancer in situ, thyroid cancer (papillary, hurthle cell or follicular), or localized prostate cancer are acceptable if they have undergone potentially curative therapy.\n* Has known active CNS metastases and\u002For carcinomatous meningitis.\n* Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.\n* ALT or AST above 3 times the upper limit of normal\n* Has received a live virus vaccine within 30 days of enrollment to the study.\n* Active GI bleeding, as evidenced by hematemesis, hematochezia, or melena in the past 3 months without evidence of resolution documented by endoscopy or colonoscopy.\n* Intraluminal metastatic lesion with suspected bleeding, inflammatory bowel disease, ulcerative colitis or other GI condition associated with increased risk of perforation.\n* Has QT interval corrected for heart rate (QTc) ≥480 msec.\n* Has a history of any of the following cardiovascular conditions within 12 months of enrollment to the study:\n\n  * Myocardial infarction\n  * Unstable angina pectoris\n  * Cardiac angioplasty or stenting\n  * Coronary\u002Fperipheral artery bypass graft\n  * Class III or IV congestive heart failure per New York Heart Association\n  * Cerebrovascular accident or transient ischemic attack\n* Has poorly controlled hypertension defined as systolic blood pressure (SBP) ≥150 mm Hg and\u002For diastolic blood pressure (DBP) ≥90 mm Hg on 3 or more dose optimized anti- hypertensive medication.\n* Has evidence of inadequate wound healing per treating physician discretion.\n* Has active bleeding disorder or other history of significant bleeding episodes within 30 days of enrollment to the study.\n* Has current use (within 7 days of enrollment) or anticipated need for treatment with drugs or foods that are known to be strong cytochrome P450 (CYP3A4\u002F5) inhibitors.\n* Has current use (within 7 days of enrollment) or anticipated need for treatment with drugs that are known strong CYP3A4\u002F5 inducers, including but not limited to carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, and St. John's wort; or drugs that are known with proarrhythmic potential.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study by subject self-report.\n* Has had a prior solid organ transplant.\n* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study drug.",{"count":577,"type":21},17,[71],"The primary objective of this study is to evaluate whether the combination of Pembrolizumab and Axitinib given in the neoadjuvant setting can change the Inferior Vena Cava Tumor Thrombus burden. A decrease in the size of the tumor thrombus can potentially lead to decrease in surgical complications, improve patient related health outcomes, and improve long term outcomes such as progression free survival and overall survival.",[212,37,411,581],"Inferior Vena Cava Thrombosis","2026-04-06",{"date":560,"type":50},{"date":585,"type":50},"2023-12-04",{"date":587,"type":21},"2029-11",{"name":589,"class":57},"University of Colorado, Denver",{"id":591,"slug":592,"hasResults":12,"nctId":593,"briefTitle":594,"officialTitle":595,"acronym":596,"eligibilityCriteria":597,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":598,"targetDuration":4,"studyType":22,"phases":600,"briefSummary":601,"conditions":602,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":612,"lastUpdatePostDateStruct":613,"startDateStruct":614,"completionDateStruct":616,"leadSponsor":618,"locationsCount":620},"100550264","phase-1-a-study-of-vet3-tgi-in-patients-with-solid-tumors-100550264","NCT06444815","A Study of VET3-TGI in Patients With Solid Tumors","A Phase 1\u002F1b Study of VET3-TGI Administered Alone and in Combination With Atezolizumab in Patients With Advanced Solid Tumors","STEALTH-001","Key Inclusion Criteria:\n\n* Have pathologically confirmed, advanced, unresectable, or metastatic solid tumors. Preferred indications include, but are not limited to, breast carcinoma, bladder carcinoma, cervical squamous carcinoma, colorectal carcinoma, esophageal carcinoma, head and neck squamous carcinoma, renal cell carcinoma, ovarian carcinoma, sarcoma, thymoma, and uterine carcinoma.\n* Failed, intolerant to, or refused potentially curative treatment options, including but not limited to, standard of care molecularly targeted agents, immunotherapy (e.g., anti -pembrolizumab\u002FPDL1 antibodies), and chemotherapy\n* Measurable disease as per RECIST 1.1 criteria\n* At least one tumor amenable to safe ITu injections and\u002For biopsies\n* ECOG performance status 0 or 1\n* Demonstrate adequate organ function\n* Must be willing to comply with all protocol procedures and adhere to post-treatment care instructions\n\nAdditional Inclusion criteria exist\n\nKey Exclusion Criteria:\n\n* Prior systemic therapy washout (dependent upon the therapy)\n* Requires use of anti-platelet or anti-coagulant therapy that cannot be safely suspended for per protocol biopsies or intra-tumoral injections.\n* CNS metastases and\u002For carcinomatous meningitis that have not been completely resected or completely irradiated.\n* Prior history of myocarditis\n* Known HIV\u002FAIDS, active HBV or HCV infection.\n* Receiving high dose immunosuppressive medication or has a significant immunodeficiency (e.g. transplant recipient, etc).\n\nAdditional Exclusion criteria exist",{"count":599,"type":21},60,[408],"VET3-TGI is an oncolytic immunotherapy designed to treat advanced cancers. VET3-TGI has not been given to human patients yet, and the current study is designed to find a safe and effective dose of VET3-TGI when administered by direct injection into tumor(s) (called an intratumoral injection) or when given intravenously (into the vein) both alone and in combination with atezolizumab in patients with solid tumors (STEALTH-001).",[603,604,605,31,37,411,606,607,171,608,609,610,611],"Solid Tumor, Adult","Microsatellite Stable Colorectal Cancer","Head and Neck Squamous Cell Carcinoma","Melanoma Stage IV","Merkel Cell Carcinoma of Skin","Non-small Cell Lung Cancer","Cutaneous Squamous Cell Carcinoma (CSCC)","Urothelial Carcinoma Bladder","Squamous Cell Carcinoma","2026-04-01",{"date":558,"type":50},{"date":615,"type":50},"2024-09-16",{"date":617,"type":21},"2027-12-31",{"name":619,"class":129},"KaliVir Immunotherapeutics",7,{"id":622,"slug":623,"hasResults":12,"nctId":624,"briefTitle":625,"officialTitle":625,"acronym":4,"eligibilityCriteria":626,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":627,"targetDuration":4,"studyType":22,"phases":629,"briefSummary":630,"conditions":631,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":634,"lastUpdatePostDateStruct":635,"startDateStruct":637,"completionDateStruct":639,"leadSponsor":641,"locationsCount":89},"100623841","phase-1-a-phase-1b-study-of-hc-7366-an-agonist-of-isr-with-immunotherapy-in-kidney-cancer-shark-100623841","NCT07401875","A Phase 1b Study of HC-7366, an Agonist of ISR With Immunotherapy in Kidney Cancer (SHARK)","Eligibility Criteria\n\n1. Ability to understand and the willingness to sign a written informed consent document\n2. Male or female ≥ 18 years of age\n3. Confirmed diagnosis of clear cell RCC\n4. Stage IV metastatic RCC per American Joint Committee on Cancer\n5. Triplet Cohort (IO\u002FIO): No prior systemic therapy for advanced RCC or prior adjuvant therapy allowed.\n6. Doublet Cohort: Participant must have progressed on at least one PD1 based doublet regimen (IO\u002FIO or IO\u002FTKI). Prior adjuvant therapy is allowed and does count as one line of systemic therapy.\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 )\n8. At least one measurable lesion as defined by RECIST 1.1\n\n   • A tumor lesion situated in a previously irradiated area is considered a measurable\u002Ftarget lesion only if subsequent disease progression has been documented in the lesion\n9. Has pathology-confirmed RCC. Extra tissue should be submitted if available for correlatives. Formalin-fixed paraffin-embedded tissue blocks are preferred to slides. Details pertaining to tumor tissue submission can be found in the Lab Procedures Manual.\n10. Willing and able to undergo bone and brain scans at baseline and continue to have scans performed if positive at screening.\n11. Adequate organ function within 28 days prior to first dose of protocol-indicated treatment, including:\n\n    * White blood cell (WBC) ≥ 2,000 \u002FμL\n    * Absolute neutrophil count (ANC) ≥ 1,000\u002FμL\n    * Platelet count ≥ 100,000\u002FμL\n    * Hemoglobin (Hgb) ≥ 9.0 g\u002FdL in prior 4 weeks. Blood transfusions are allowed to achieve this.\n    * Serum creatinine ≤ upper limit of normal (ULN), or calculated creatinine clearance ≥ 30 mL\u002Fmin (per the Cockcroft-Gault formula,)\n    * Total bilirubin ≤ ULN (except subjects with Gilbert Syndrome, who must have total bilirubin \\\u003C 3.0 mg\u002FdL)\n    * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN\n12. Women must not be breastfeeding while taking the study drug and for up to five months after the last dose of study drug\n13. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 24 hours 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    * If menopausal status is considered for the purpose of evaluating childbearing potential, women \\\u003C 62 years of age must have a documented serum follicle stimulating hormone (FSH) level within laboratory reference range for postmenopausal women, in order to be considered postmenopausal and not of childbearing potential\n14. Women of childbearing potential (WOCBP) must agree to follow instructions for acceptable contraception prior to the study and from the time of signing consent, for the duration of the study participation and for 23 weeks after their last dose of protocol-indicated treatment\n\n    * The effects of HC-7366 on the developing human fetus are unknown. For this reason and because first-in-class, first-in-human agents as well as other therapeutic agents used in this trial are known to be teratogenic, 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. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114).\n    * Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the study and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. 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.\n15. Men not azoospermic who are sexually active with WOCBP must agree to follow instructions for acceptable contraception prior to the study and from the time of signing consent, for the duration of the study participation, and for 31 weeks after their last dose of protocol-indicated treatment\n16. Participant s with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n17. Participant s with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n18. Participant s with previously treated brain metastases may be eligible provided they are radiologically (by MRI) and clinically stable (i.e., without evidence of disease progression) for at least 4 weeks (28 days) by repeat imaging (repeat imaging should be performed during study screening), with no evidence of new or enlarging brain metastases, and without requirement for steroid treatment for at least 28 days prior to the first dose of study drug or study therapy. (CT is acceptable if MRI is contraindicated)\n19. Participant s with a prior or concurrent malignancy whose natural history or treatment does not interfere with the safety or efficacy assessment of the investigational regimen are eligible for this study\n20. Participant s 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 study, participant s should be class 2B or better\n\nExclusion Criteria\n\n1\\. For the Triplet Cohort (Nivo\u002FIpi\u002FHC-7366):\n\n* Prior systemic treatment including neoadjuvant or adjuvant therapy including an immune checkpoint inhibitor or TKI 2. For the Doublet Cohort (Nivo\u002FHC-7366):\n* More than 3 prior lines of systemic therapy allowed\n* Has received any type of small molecule kinase inhibitor (including investigational kinase inhibitor) ≤ 2 weeks before start of study drug or study therapy 3. ≤ 28 days before first dose of protocol-indicated treatment:\n* Major surgery requiring general anesthesia 4. ≤ 14 days before first dose of protocol-indicated treatment:\n* Radiosurgery or radiotherapy\n* Minor surgery. (Note: Placement of a vascular access device is not considered minor or major surgery)\n* Active infection requiring systemic treatment 5. Known or suspected clinically significant active bleeding including active hemoptysis 6. Inability to swallow oral medication; or the presence of a poorly controlled gastrointestinal disorder that could significantly affect the absorption of oral study drug - e.g. Crohn's disease, ulcerative colitis, chronic diarrhea (defined as \\> 4 loose stools per day), malabsorption, or bowel obstruction 7. Central nervous system (CNS) metastasis, unless asymptomatic and radiologically (by MRI) and clinically stable (i.e., without evidence of disease progression) for at least 4 weeks (28 days) by repeat imaging (repeat imaging should be performed during study screening), with no evidence of new or enlarging brain metastases, and without requirement for steroid treatment for at least 28 days prior to the first dose of study drug or study therapy. (CT is acceptable if MRI is contraindicated 8. Any condition requiring systemic treatment with either 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, intraarticular, intranasal, and inhalational) ≤ 10 mg\u002Fday prednisone or equivalent daily; and physiologic replacement doses of systemic corticosteroids ≤ 10 mg\u002Fday prednisone or equivalent daily (e.g. hormone replacement therapy needed in participants with hypophysitis) 9. Active, known or suspected autoimmune disease\n* Subjects with type I diabetes mellitus; hypothyroidism only requiring hormone replacement; skin disorders such as vitiligo, psoriasis or alopecia not requiring systemic treatment; or conditions not expected by the investigator to recur in the absence of an external trigger are permitted to enroll 10. Known psychiatric condition, social circumstance, or other medical condition reasonably judged by the investigator to unacceptably increase the risk of study participation; or to prohibit the understanding or rendering of informed consent or anticipated compliance with and interpretation of scheduled visits, treatment schedule, laboratory tests and other study requirements 11. Pregnant women are excluded from this study because HC-7366 is novel, first-in-class small molecule agent 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 HC-7366, breastfeeding should be discontinued if the mother is treated with HC-7366. These potential risks may also apply to other agents used in this study 12. Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this study 13. Participants who are receiving any other investigational agents",{"count":628,"type":21},35,[408],"To find out if the combination of HC-7366 and nivolumab (with or without ipilimumab) can help to control ccRCC. The",[556,632,633,37],"HC-7366","SHARK","2026-03-31",{"date":636,"type":50},"2026-04-02",{"date":638,"type":50},"2026-03-24",{"date":640,"type":21},"2029-11-30",{"name":642,"class":57},"M.D. Anderson Cancer Center",{"id":644,"slug":645,"hasResults":12,"nctId":646,"briefTitle":647,"officialTitle":648,"acronym":649,"eligibilityCriteria":650,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":651,"targetDuration":4,"studyType":100,"phases":4,"briefSummary":652,"conditions":653,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":654,"lastUpdatePostDateStruct":655,"startDateStruct":656,"completionDateStruct":658,"leadSponsor":660,"locationsCount":89},"100557000","study-of-post-operative-complications-after-laparoscopic-outpatient-nephrectomy-100557000","NCT06532422","Study of Post-operative Complications After Laparoscopic Outpatient Nephrectomy","Study of Post-operative Complications After Laparoscopic Outpatient Nephrectomy in Patients With Localised Kidney Cancer","NEPHRAMBU","Inclusion Criteria:\n\n* Patients over 18 ;\n* Localised kidney cancer ;\n* Validation of curative treatment at a multidisciplinary consultation meeting;\n* Partial or total laparoscopic nephrectomy scheduled on an outpatient basis;\n* Membership of a social security scheme or receiving State Medical Aid;\n* Patient able to understand the information relating to the study, to read the information leaflet and who has given his\u002Fher oral non-objection.\n\nExclusion Criteria:\n\n* Emergency intervention ;\n* Patient not eligible for outpatient treatment;\n* Long-term curative anti-coagulant treatment ;\n* Resident more than 100km from the clinic;\n* Home alone on the first night;\n* Patient of protected age (under guardianship or curatorship, or deprived of liberty).",{"count":508,"type":21},"The purpose of this study is to compare to assess the incidence of post-operative complications related to nephrectomy, which occur up to 1 month after the operation.",[37],"2026-03-27",{"date":612,"type":50},{"date":657,"type":50},"2024-12-13",{"date":659,"type":21},"2026-09",{"name":661,"class":57},"GCS Ramsay Santé pour l'Enseignement et la Recherche",{"id":663,"slug":664,"hasResults":12,"nctId":665,"briefTitle":666,"officialTitle":667,"acronym":668,"eligibilityCriteria":669,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":670,"enrollmentInfo":671,"targetDuration":4,"studyType":22,"phases":672,"briefSummary":673,"conditions":674,"keywords":677,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":638,"lastUpdatePostDateStruct":679,"startDateStruct":681,"completionDateStruct":683,"leadSponsor":685,"locationsCount":89},"100346136","phase-2-study-of-olaparib-in-metastatic-renal-cell-carcinoma-patients-with-dna-repair-gene-mutations-100346136","NCT03786796","Study of Olaparib in Metastatic Renal Cell Carcinoma Patients With DNA Repair Gene Mutations","Phase II Study of Olaparib in Metastatic Renal Cell Carcinoma Patients Harboring a BAP-1 or Other DNA Repair Gene Mutations (ORCHID)","ORCHID","Inclusion Criteria:\n\n* Willing and able to provide written informed consent. Provision of informed consent is required prior to any study procedures.\n* Patients aged 18 years of age or older.\n* Histological proof of renal cell carcinoma (both clear cell and non-clear cell allowed).\n* Metastatic (AJCC Stage IV) renal cell carcinoma.\n* Somatic or germline mutation in BAP-1, ATM, BRCA1, BRCA2, PALB2, CHEK2, BRIP1, RAD51C, BARD1, CDK12, CHEK1, FANCL, PP2R2A, RAD51B, RAD51D, or RAD54L as documented by a clinical CLIA-grade, tissue, saliva or blood-based genetic test.\n* At least one prior treatment with an anti-angiogenic agent or immune checkpoint inhibitor.\n* Any number of prior systemic therapies is allowed (cytokine, anti-angiogenic, mTOR, immune checkpoint blockage or clinical trial).\n* Must have measurable disease as defined by RECIST 1.1 criteria.\n* Participants must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below:\n\n  * Hemoglobin ≥ 10.0 g\u002FdL with no blood transfusion in the past 28 days\n  * Absolute neutrophil count (ANC) ≥ 1.5 x 10\\^9\u002FL\n  * Platelet count ≥ 100 x 10\\^9\u002FL\n  * Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)\n  * Aspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT)) \u002F Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) ≤ 2.5 x institutional ULN unless liver metastases are present in which case they must be ≤ 5 x ULN.\n\nNote: Patients with elevations in bilirubin, AST, or ALT should be thoroughly evaluated for the etiology of this abnormality prior to entry and patients with evidence of viral infection should be excluded.\n\n* Patients must have a creatinine clearance ≥ 40 mL\u002Fmin calculated by Cockroft-Gault formula or 24 hour urine test.\n* ECOG PS ≤ 1.\n* Participants must have a life expectancy ≥ 16 weeks.\n* Postmenopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on day 1.\n\nPostmenopausal is defined as:\n\n* Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments.\n* Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) levels in the post menopausal range for women under 50 years old.\n* Radiation-induced oophorectomy with last menses \\> 1 year ago.\n* Chemotherapy-induced menopause with \\> 1 year interval since last menses.\n* Surgical sterilization (bilateral oophorectomy or hysterectomy).\n* Male patients must use a condom during treatment and for 3 months after the last dose of olaparib when having sexual intercourse with a pregnant woman or with a woman of childbearing potential. Female partners of male patients should also use a highly effective form of contraception if they are of childbearing potential.\n\nExclusion Criteria:\n\n* Other malignancy unless curatively treated with no evidence of disease for ≥ 5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS), Stage 1, grade 1 endometrial carcinoma. Patients with a history of localized triple negative breast cancer may be eligible, provided they completed their adjuvant chemotherapy \\> 3 years prior to registration, and that the patient remains free of recurrent or metastatic disease.\n* Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required. The patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 4 weeks prior to treatment. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days.\n* Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).\n* Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.\n* Breast feeding women.\n* Use of any prohibited concomitant medications within the prior 2 weeks.\n* Involvement in the planning and\u002For conduct of the study (applies to both AstraZeneca staff and\u002For staff at the study site).\n* Participation in another clinical study with an investigational product during the last 2 weeks.\n* Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment.\n* Any previous treatment with PARP inhibitor, including olaparib.\n* Resting ECG with QTc \\> 500 ms and\u002For indication of uncontrolled cardiac conditions, as judged by the investigator (e.g. unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, electrolyte disturbances, etc.), or patients with congenital and\u002For family history of long QT syndrome.\n* Concomitant use of known strong CYP3A inhibitors (e.g. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (e.g. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting olaparib is 2 weeks. During the study, if co-administration of a strong or moderate inhibitor is required because there is no suitable alternative medication, exception to this criterion may be allowed with a suitable dose reduction of olaparib.\n* Concomitant use of known strong CYP3A inducers (e.g. phenobarbital, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers (e.g. bosentan, efavirenz, modafinil). The required washout period prior to starting olaparib is 5 weeks for phenobarbital or enzalutamide and 3 weeks for other agents.\n* Persistent toxicities (\\> Common Terminology Criteria for Adverse Event (CTCAE) grade 2) caused by previous cancer therapy, excluding alopecia.\n* Patients with myelodysplastic syndrome (MDS)\u002Facute myeloid leukemia (AML) or with features suggestive of MDS\u002FAML.\n* Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.\n* Poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent.\n* Unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.\n* Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV).\n* Known hypersensitivity to olaparib or any of the excipients of the product.\n* Known active hepatitis (i.e. Hepatitis B or C) due to risk of transmitting the infection through blood or other body fluids.\n* No packed red blood cells and\u002For platelet transfusions within the last 28 days prior to study entry.","120 Years",{"count":406,"type":21},[71],"Single arm, single site, open-label Phase II study of the effects of oral olaparib in participants with metastatic renal cell carcinoma that harbor an inactivating mutation in BAP-1, ATM, BRCA1, BRCA2, PALB2, CHEK2, BRIP1, RAD51C, BARD1, CDK12, CHEK1, FANCL, PP2R2A, RAD51B, RAD51D, or RAD54L who have had prior treatment with at least one immune checkpoint inhibitor or anti-VEGF therapy. Must have measurable disease on CT imaging per RECIST 1.1 criteria.",[411,412,37,675,676],"Renal Carcinoma","Kidney Cancer Metastatic",[678],"Olaparib",{"date":680,"type":50},"2026-03-30",{"date":682,"type":50},"2019-06-03",{"date":684,"type":21},"2028-03",{"name":368,"class":57},{"id":687,"slug":688,"hasResults":12,"nctId":689,"briefTitle":690,"officialTitle":691,"acronym":692,"eligibilityCriteria":693,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":694,"targetDuration":4,"studyType":22,"phases":695,"briefSummary":696,"conditions":697,"keywords":701,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":704,"lastUpdatePostDateStruct":705,"startDateStruct":707,"completionDateStruct":709,"leadSponsor":711,"locationsCount":369},"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":7,"type":21},[71],"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)",[412,698,411,699,37,700],"Metastatic Renal Cancer","Advanced Clear Cell Renal Cell Carcinoma","Translocation Renal Cell Carcinoma",[412,698,411,699,37,700,702,703],"ccRCC","tRCC","2026-03-23",{"date":706,"type":50},"2026-03-25",{"date":708,"type":50},"2025-11-24",{"date":710,"type":21},"2028-02-01",{"name":712,"class":57},"Stephanie Berg",{"id":714,"slug":715,"hasResults":12,"nctId":716,"briefTitle":717,"officialTitle":718,"acronym":4,"eligibilityCriteria":719,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":720,"targetDuration":4,"studyType":22,"phases":722,"briefSummary":723,"conditions":724,"keywords":726,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":727,"lastUpdatePostDateStruct":728,"startDateStruct":730,"completionDateStruct":732,"leadSponsor":734,"locationsCount":345},"100623513","phase-2-pre-neoshift-rcc-neoadjuvant-hif-inhibitor-immunotherapy-in-rcc-100623513","NCT07397611","Pre-NEOSHIFT-RCC: Neoadjuvant HIF-Inhibitor Immunotherapy in RCC","PRE-surgical NEOadjuvant Sandwich Immunotherapy With HIF inhibiTion in Renal Cell Carcinoma (PRENEOSHIFT-RCC)","Inclusion Criteria:\n\n* Adult patients age ≥ 18 years.\n* Histologically confirmed diagnosis of ccRCC by a core-needle biopsy. Patients who have not had prior biopsy may undergo screening if they have suspected RCC but can only proceed to registration if ccRCC (any component) is confirmed on the pre-treatment study biopsy.\n* Stage cT2 RCC with grade 4 or sarcomatoid features, ≥cT3 Nx RCC, or cTany N+ RCC disease for which partial or radical nephrectomy is planned. For clinical staging, a kidney MRI is highly preferred over a CT Abdomen.\n* Participants must have measurable disease i.e. a primary renal tumor that can be accurately measured in at least one dimension as ≥10 mm (≥1 cm) with CT scan or MRI. See Section 11 (Measurement of Effect) for the evaluation of measurable disease.\n* Participants must be planned for surgical resection of their primary renal tumor.\n* ECOG performance status of 0-1.\n* Participants must have adequate organ and marrow function, based upon meeting all of the following laboratory criteria within 14 days before first dose of study treatment:\n\n  1. Absolute neutrophil count ≥ 1.0 × 10\\^9\u002FL without granulocyte colony-stimulating factor support within 2 weeks of screening laboratory sample collection.\n  2. Platelet count ≥ 100 × 10\\^9\u002FL without transfusion within 2 weeks of screening laboratory sample collection.\n  3. Hemoglobin ≥ 10.0 g\u002FdL (or 6.2 mmol\u002FL).\n  4. Aspartate transaminase (AST) ≤ 2.5 × upper limit of normal (ULN)\n  5. Alanine aminotransferase (ALT) ≤ 2.5 × ULN.\n  6. Bilirubin ≤ 1.5 × ULN (except participants with Gilbert syndrome who must have total bilirubin \\\u003C 3.0 mg\u002FdL).\n  7. Activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN.\n  8. Ambulatory oxygen saturation \\>92% on room air at time of screening.\n  9. Serum albumin ≥ 2.8 g\u002Fdl.\n  10. INR ≤ 1.5.\n  11. Calculated creatinine clearance ≥ 40 mL\u002Fmin (≥ 0.67 mL\u002Fsec) using the Cockcroft-Gault equation:\n\n      ---Males: (140 - age) x weight (kg)\u002F(serum creatinine \\[mg\u002FdL\\] × 72)\n\n      ---Females: \\[(140 - age) x weight (kg)\u002F(serum creatinine \\[mg\u002FdL\\] × 72)\\] × 0.85\n* No exercise-induced desaturation on a 6-minute walk test, defined as a blood oxygen saturation by pulse oximetry ≤ 88%.\n* No active clinical pneumonitis at screening.\n* No medical history of severe chronic obstructive pulmonary disease (COPD)\n* Screening echocardiogram or MUGA scan must demonstrate a left ventricular ejection fraction (LVEF) greater than the institutional lower limit of normal (LLN).\n* Negative serum pregnancy test at screening for women of childbearing potential. Female subjects are considered to be of childbearing potential unless one of the following criteria is met: 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 hormone \\[FSH\\] level \\> 40 mIU\u002FmL to confirm menopause). Note: Documentation may include review of medical records, medical examination, or medical history interview by study site staff.\n* Sexually active fertile subjects and their partners must agree to use highly effective methods of contraception during the course of the study and for the following durations after the last dose of treatment (whichever is later). An additional contraceptive method, such as a barrier method (eg, condom), is required. In addition, men must agree not to donate sperm and women must agree not to donate eggs (ova, oocyte) for the purpose of reproduction during these same periods. 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.\n* Through 7 days after the last dose of casdatifan and 120 days after the last dose of zimberelimab for women of childbearing potential and for men\n* Ability to understand and the willingness to sign a written informed consent document.\n* Ability to swallow tablets.\n\nExclusion Criteria:\n\n* Any prior systemic therapy for treatment of renal cell carcinoma.\n* Any radiation therapy within 4 weeks before the first dose of study treatment.\n* Any clear evidence of distant metastases. Enlarged lymph nodes that are planned to be removed during nephrectomy are permitted.\n* Clinical pneumonitis or concern for inflammatory lung disease at time of screening.\n* Any complementary medications (eg, herbal supplements or traditional Chinese medicines) with the intention to treat the disease under study within 2 weeks before first dose of study treatment.\n* Other prior malignancy active within the previous year except for locally curable cancers (\\>90%) that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix, breast, or Gleason 6 prostate cancer. Also, indolent malignancies, including but not limited to early-stage chronic lymphocytic leukemia and follicular lymphoma, that don't require anti-cancer treatment, could be allowed after discussion with the medical monitor.\n* QTc ≥ 480 msec using Fridericia's correction (QTcF) (based on an average of triplicate recordings).\n* Malabsorption condition that would alter the absorption of orally administered medications.\n* Patient has had any major cardiovascular event within 6 months prior to study drug administration including but not limited to myocardial infarction, unstable angina, cerebrovascular accident, transient ischemic event, pulmonary embolism, clinically significant ventricular arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes) or New York Heart Association Class III or IV heart failure.\n* The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:\n\n  a. Cardiovascular disorders: i. Congestive heart failure New York Heart Association Class 2 or greater, unstable angina pectoris, serious cardiac arrhythmias (eg, ventricular flutter, ventricular fibrillation, Torsades de pointes).\n\nii. Uncontrolled hypertension defined as sustained blood pressure (BP) \\> 150 mm Hg systolic or \\> 95 mm Hg diastolic despite optimal antihypertensive treatment.\n\niii. Any history of stroke (including transient ischemic attack \\[TIA\\]), myocardial infarction, or other clinically significant ischemic event within 12 months before first dose of study treatment.\n\niv. Clinically significant pulmonary embolism (PE) or deep vein thrombosis (DVT) or prior clinically significant venous or non-CVA\u002FTIA arterial thromboembolic events within 3 months before to first dose of study treatment. Thrombus felt due to tumor and not a bland thrombus is permitted.\n\nNote: Subjects with a diagnosis of DVT\u002FPE due to bland thrombus need to be asymptomatic and have at least 4 weeks of anticoagulation before first dose of study treatment.\n\nv. Any history of myocarditis.\n\nb. Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation: i. Tumors invading the GI-tract from external viscera. ii. Active and symptomatic peptic ulcer disease, inflammatory bowel disease, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, or acute pancreatitis.\n\niii. Acute obstruction of the bowel, gastric outlet, or pancreatic or biliary duct within 6 months unless the cause of obstruction is definitively managed and subject is asymptomatic.\n\niv. Abdominal fistula, gastrointestinal perforation, bowel obstruction, or intra-abdominal abscess within 6 months before the first dose. Note: Complete healing of an intra-abdominal abscess must be confirmed before the first dose of study treatment.\n\nv. Known gastric or esophageal varices. vi. Ascites requiring drainage within 28 days prior to initiation of protocol therapy c. Autoimmune disease that has been symptomatic or required treatment with 1mg\u002Fkg of corticosteroids within the past two years from the date of randomization. Diabetes mellitus and thyroid auto-immune diseases are excluded.\n\nd. Any condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. 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 (eg, contrast allergy) is also allowed. Corticosteroids given as short course premedication is acceptable.\n\n* Other clinically significant disorders that would preclude safe study participation.\n\n  1. Active infection requiring systemic treatment. Note: Prophylactic antibiotic treatment is allowed.\n  2. Infection with acute or chronic hepatitis B or C with detectable viral load, human immunodeficiency virus (HIV) infection with detectable viral load or acquired immunodeficiency syndrome (AIDS)-related illness.\n  3. Serious non-healing wound\u002Fulcer\u002Fbone fracture. Note: non-healing wounds or ulcers are permitted if due to tumor-associated skin lesions.\n  4. Pharmacologically uncompensated, symptomatic hypothyroidism.\n  5. Moderate to severe hepatic impairment (Child-Pugh B or C).\n  6. History of solid organ or allogeneic stem cell transplant.\n* Major surgery (as defined in Appendix B) within 4 weeks prior to first dose of study treatment. Minor surgery (eg, simple excision, tooth extraction) within 7 days before the first dose of study treatment. Complete wound healing from major or minor surgery must have occurred at least prior to the first dose of study treatment.\n* Patients who are receiving treatment with strong CYP3A4 inhibitors and inducers should have a washout period of 28 days or 5 half-lives of the concerning medicine prior to starting casdatifan.\n* History of psychiatric illness, mental condition or substance use disorders that are likely to interfere with ability to comply with protocol requirements or give informed consent.\n* Use of any live vaccines against infectious diseases within 28 days of first dose of study drug.\n* Current breastfeeding.\n* Previously identified allergy or hypersensitivity to components of the study treatment formulations.\n* Any use of supplemental or intermittent oxygen therapy.\n* Other conditions, which in the opinion of the Investigator, would compromise the safety of the patient or the patient's ability to complete the study.",{"count":721,"type":21},32,[71],"The purpose of this study is to see whether the drug casdatifan is safe and effective either by itself or in combination with the drug zimberelimab in participants with resectable clear cell renal cell carcinoma (ccRCC).\n\nThe names of the study drugs involved in this study are:\n\n* Casdatifan (a type of HIF-2α inhibitor)\n* Zimberelimab (a type of monoclonal antibody)",[411,37,725,675],"Kidney Neoplasm",[411,37,725,675,702],"2026-03-18",{"date":729,"type":50},"2026-03-20",{"date":731,"type":50},"2026-03-09",{"date":733,"type":21},"2029-09-30",{"name":735,"class":57},"Dana-Farber Cancer Institute"]