[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"clear-cell-metastatic-renal-cell-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:clear-cell-metastatic-renal-cell-carcinoma":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,57,82],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":40,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":56},"100610425","phase-1-symbiotic-gu-08-a-study-to-learn-about-the-medicine-called-pf-08634404-dosed-alone-and-in-combination-with-other-anticancer-therapies-in-adults-with-locally-advanced-or-metastatic-renal-cell-cancer-100610425",false,"NCT07227415","Symbiotic-GU-08: A Study to Learn About the Medicine Called PF-08634404 Dosed Alone and in Combination With Other Anticancer Therapies in Adults With Locally Advanced or Metastatic Renal Cell Cancer","AN INTERVENTIONAL PHASE 1B\u002F2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PF-08634404 MONOTHERAPY AND IN COMBINATION WITH OTHER ANTICANCER AGENTS IN ADULT PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC RENAL CELL CARCINOMA","Inclusion Criteria:\n\n* 18 years of age or older at screening\n* Locally advanced (not amenable to curative surgery or radiation therapy) or metastatic RCC with diagnosis confirmed by histology\u002Fcytology\n* At least one measurable (as defined by the investigator) and untreated lesion\n* Adequate hematologic, hepatic, cardiac and renal function\n* No prior systemic therapy for RCC (immunotherapy after surgery is allowed if received \\>12 months prior)\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n* All International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) based risk categories\n\nExclusion Criteria:\n\nParticipants may be excluded if they meet any of the following:\n\n* Known active brain lesions including leptomeningeal metastasis, brainstem, meningeal or spinal cord metastases or compression.\n* Clinically significant risk of haemorrhage or fistula\n* History of another malignancy within 3 years\n* History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n* active autoimmune diseases requiring systemic treatment within the past 2 years\n* uncontrolled cardiac and other comorbidities within 6 months prior to the first dose\n* Major surgery or severe trauma within 4 weeks before the first dose, or planned major surgery during the study\n* History of severe bleeding tendency or coagulation dysfunction\n* History of oesophageal varices, severe ulcers, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess or acute gastrointestinal bleeding within 6 months prior to the first dose\n* Acute, chronic or symptomatic infections\n* Participants with history of immunodeficiency","ALL","18 Years",{"count":19,"type":20},224,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This study is testing a new medicine called PF-08634404 and how it works in adults with advanced Renal Cell Carcinoma (RCC)- a type of kidney cancer that is either locally advanced (spread to nearby tissues) or metastatic (spread to other parts of the body). The study will look at the safety of the study medicine, when given alone or with other anticancer medicines, and how this type of cancer responds to them.\n\nTo join the study, participants must be adults; with locally advanced or metastatic RCC; who have not received treatment for their advanced kidney cancer.\n\nParticipants will receive study medicine either alone or with other anticancer medicines. The medicine will be given through intravenous (IV) infusions, which means it will be injected directly into a vein. All treatments will take place at clinical study sites, where trained medical staff will take care of participants during and after each visit.",[27,28,29,30,31,32,33,34,35,36,37,38,39],"Carcinoma, Renal Cell","Advanced Renal Cell Carcinoma","Renal Cancer","Renal Neoplasm","Clear Cell Renal Cell Carcinoma","Metastatic Renal Cell Carcinoma","Clear-cell Metastatic Renal Cell Carcinoma","Carcinoma, Renal Cell Metastasis","Advanced or Metastatic Renal Cell Carcinoma","Carcinoma, Renal Cell, Advanced","Metastatic Renal Cell Cancer","Metastatic Renal Cell Carcinoma ( mRCC)","Metastatic\u002FAdvanced Renal Cell Carcinoma",[41,42,43],"Renal cell carcinoma","renal cancer","renal neoplasm","RECRUITING","2026-06-03",{"date":47,"type":48},"2026-06-04","ACTUAL",{"date":50,"type":48},"2026-02-10",{"date":52,"type":20},"2028-11-01",{"name":54,"class":55},"Pfizer","INDUSTRY",109,{"id":58,"slug":59,"hasResults":11,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":4,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":64,"targetDuration":4,"studyType":21,"phases":66,"briefSummary":67,"conditions":68,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":81},"100459471","phase-2-trial-of-an-alternative-cabozantinib-dosing-schedule-in-metastatic-renal-cell-carcinoma-and-neuroendocrine-tumors-100459471","NCT05263050","Trial of an Alternative Cabozantinib Dosing Schedule in Metastatic Renal Cell Carcinoma and Neuroendocrine Tumors","GU-187: Phase II Trial of Alternative Cabozantinib Dosing Schedule in Metastatic Renal Cell Carcinoma and Neuroendocrine Tumors","Inclusion Criteria\n\n* Cohorts A and B: Histologically or cytologically confirmed advanced RCC with any clear cell or non-clear cell component. 100% sarcomatoid is permissible.\n* Cohorts A and B: Patient may have had any number of prior therapies for Cohort A, but for Cohort B patients must not have received any systemic therapy in the metastatic setting\n* Patients who have received prior (neo)adjuvant immunotherapy with pembrolizumab or similar are eligible for Cohort B IF they completed the adjuvant therapy \\> 12 months from start of trial therapy\n* Treatment naïve patients may be treated in Cohort A if deemed not candidates for nivolumab or if felt single agent cabozantinib most appropriate by the treating clinician\n* Cohort C: Well differentiated NET, grades 1-3 (any primary site) who have progressed on or are not eligible for somatostatin analogs per treating physician discretion\n* Cohort C: Disease progression within prior 12 months\n* Cohort C: Prior or concurrent treatment with somatostatin analogue allowed but no limit on lines of therapy (stable dose of somatostatin for 2 months)\n\nAll Cohorts:\n\n* At least one measurable lesion as defined by RECIST version 1.1\n* No evidence of pre-existing uncontrolled hypertension as assessed by investigator. Patients may undergo adjustments or additions to their antihypertensive regimen before or during screening to achieve optimal BP control.\n* Age \\> 18 years.\n* ECOG performance status 0 - 2\n* Patients must have normal organ and marrow function as defined below\n\n  * Leukocytes, \\> 2,000\u002FmcL\n  * Absolute neutrophil count, \\> 1,500\u002FmcL\n  * Platelets, \\> 100,000\u002FmcL\n  * Hgb, \\> 9 g\u002FdL (\\>90 g\u002FL)\n  * Total bilirubin, ≤ 1.5 x ULN (with the exception of of individuals with Gilberts syndrome who may have a bilirubin \\<3.0 mg\u002FdL)\n  * AST\u002FALT (SGOT\u002FSGPT)\u002FALP, \\< 3 x ULN ALP ≤ 5x ULN with documented bone metastases.\n  * Albumin, \\> 2.8 g\u002FdL\n  * Creatinine clearance, \\> 30 Ml\u002Fmin\u002F1.73 m2 for patients with creatinine levels above institutional normal\n  * PT\u002FINR or PTT, \\< 1.3 x the laboratory ULN\n* Ability to understand and willingness to sign a written informed consent and HIPAA consent document\n* Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception (e.g., barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 4 months after the last dose of study treatment\n\nExclusion Criteria\n\n* Patients who have had systemic anti-cancer therapy or radiotherapy within 14 days or five half-lives, whichever is shorter, prior to entering the study.\n* Radiation therapy for bone metastases within 2 weeks, any other radiation therapy within 4 weeks, or systemic treatment with radionuclides within 6 weeks before first dose of study treatment. Ongoing clinically relevant complications from prior radiation therapy would preclude eligibility.\n* Patients with prior therapy with cabozantinib.\n* Prior systemic therapy directed at advanced RCC is not allowed for patients enrolled to Cohort B (treatment-naïve group).\n* Cohort B only: Active, known or suspected autoimmune disease. Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger\n* Cohort B only: Patients have a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses \\> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.\n* Patients may not be receiving any other investigational agents\n* History of allergic reactions or hypersensitivity attributed to compound of similar chemical or biologic composition to the agent(s) used in this study\n* Current use or anticipated need for treatment with drugs or foods that are known strong CYP3A4 inhibitors and inducers. Refer to Section 5.3.2 for detailed information. The topical use of these medications (if applicable), such as 2% ketoconazole cream, is allowed.\n* Concomitant anticoagulation with coumarin agents (e.g., warfarin), direct thrombin inhibitors (e.g., dabigatran), direct factor Xa inhibitor betrixaban, or platelet inhibitors (e.g., clopidogrel). Allowed anticoagulants are the following:\n* Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH).\n* Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban in subjects without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Cardiovascular disorders:\n* Congestive heart failure New York Heart Association Class 3 or 4, unstable angina pectoris, serious cardiac arrhythmias.\n* QTcF \\> 500 msec within 28 days before first dose of study treatment.\n* Uncontrolled hypertension defined as sustained blood pressure (BP) \\> 160 mm Hg systolic or \\> 100 mm Hg diastolic despite optimal antihypertensive treatment.\n* Stroke (including transient ischemic attack \\[TIA\\]), myocardial infarction (MI), or other ischemic event, or thromboembolic event (e.g., deep venous thrombosis, pulmonary embolism) within 6 months before first dose of study treatment.\n* Subjects with a diagnosis of incidental, sub-segmental PE or DVT within 6 months are allowed if stable, asymptomatic, and treated with a stable dose of permitted anticoagulation (see exclusion criterion #6) for at least 1 week before first dose of study treatment.\n* Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation:\n* The subject has evidence of tumor invading the GI tract, active peptic ulcer disease, inflammatory bowel disease (e.g., Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis, acute obstruction of the pancreatic duct or common bile duct, or gastric outlet obstruction.\n* Abdominal fistula, GI perforation, bowel obstruction, or intra-abdominal abscess within 6 months before first dose of study treatment.\n\nNote: Complete healing of an intra-abdominal abscess must be confirmed before first dose of study treatment.\n\n* Cavitating pulmonary lesion(s) or known endotracheal or endobronchial disease manifestation.\n* Lesions invading or encasing any major blood vessels. Subjects with lesions invading the intrahepatic vasculature, including portal vein, hepatic vein, and hepatic artery, are eligible.",{"count":65,"type":20},111,[24],"This is a multi-site, three-cohort phase II trial of cabozantinib for IMDC all-risk frontline metastatic renal cell carcinoma (mRCC) patients OR any line mRCC patients who have not previously been treated with cabozantinib, and patients with pancreatic or extra-pancreatic neuroendocrine tumors.",[32,33,69,70],"Neuroendocrine Tumors","Carcinoid Tumor","2026-05-20",{"date":73,"type":48},"2026-05-22",{"date":75,"type":48},"2022-01-21",{"date":77,"type":20},"2027-02",{"name":79,"class":80},"Fox Chase Cancer Center","OTHER",1,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":89,"sex":16,"minAge":17,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":21,"phases":93,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":4},"100537559","phase-2-upfront-immune-checkpoint-inhibitors-with-deferred-cytoreductive-nephrectomy-for-metastatic-renal-cell-carcinoma-100537559","NCT06279403","Upfront Immune Checkpoint Inhibitors With Deferred Cytoreductive Nephrectomy for Metastatic Renal Cell Carcinoma","Upfront Toripalimab Plus Axitinib Combined With Deferred Cytoreductive Nephrectomy for Metastatic Renal Cell Carcinoma","Inclusion Criteria:\n\nVoluntary consent to participate in this study and signing of an informed consent form.\n\nMale or female participants aged ≥18 years and \\\u003C80 years. Histologically diagnosed with clear cell carcinoma or predominantly clear cell renal cell carcinoma.\n\nClinical stage determined by CT or MRI: anyTN1M0 or anyTN0M1; IMDC score ≤3, or ≤5 metastatic lesions involving ≤3 organs; and the primary tumor (unilateral or bilateral) is resectable.\n\nECOG performance status: 0 or 1. No clinically significant cardiac, bone marrow, hepatic, or renal function abnormalities.\n\nA willingness and ability to comply with testing and follow-up procedures.\n\nExclusion Criteria:\n\nNon-clear cell carcinoma. Severe liver or kidney dysfunction, or other severe diseases. Immune deficiency, organ transplantation, or autoimmune diseases. Severe central nervous system diseases. Other malignant tumors within the past 5 years, except for cured basal cell carcinoma of the skin and cervical carcinoma in situ.\n\nUnable to comply with regular follow-up visits due to psychological, social, family, or geographical reasons.",true,"80 Years",{"count":92,"type":20},20,[24],"Study Objective: To determine the efficacy of upfront immune checkpoint inhibitors combined with deferred cytoreductive nephrectomy in treating metastatic renal cell carcinoma.\n\nPrimary Endpoint: Pathological Major Response (MPR), defined as the percentage of residual tumor cells \\\u003C10% in the primary tumor after nephrectomy.\n\nStudy Design:\n\nPopulation: Participants meeting the diagnostic criteria with biopsy-proven clear cell renal cell carcinoma, IMDC score ≤3, or ≤5 metastatic lesions involving ≤3 organs.\n\nSample Size: 20 participants.\n\nPatient Grouping: Non-randomized.\n\nInterventions: Eligible participants will receive upfront treatment with a combination of Axitinib and Toripalimab for 4 cycles. After 2 cycles of treatment, radiological assessment will be conducted using RECIST 1.1 criteria. If disease progression is observed, the clinical trial will be terminated, and second-line treatment will be initiated according to guidelines. If disease progression is not observed, treatment will continue for 2 additional cycles followed by repeat radiological assessment before undergoing surgery.",[33,96,97],"Immune Checkpoint Inhibitors","Cytoreductive Nephrectomy","NOT_YET_RECRUITING","2024-02-25",{"date":101,"type":48},"2024-02-28",{"date":103,"type":20},"2024-03-01",{"date":105,"type":20},"2029-03-01",{"name":107,"class":80},"RenJi Hospital"]