[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-kidney-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-kidney-carcinoma":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100648145","phase-1-mercaptopurine-for-the-treatment-of-hereditary-leiomyomatosis-and-renal-cell-carcinoma-hlrcc-uterinecutaneous-leiomyomas-and-kidney-cancer-100648145",false,"NCT07716735","Mercaptopurine for the Treatment of Hereditary Leiomyomatosis and Renal Cell Carcinoma (HLRCC), Uterine\u002FCutaneous Leiomyomas, and Kidney Cancer","Mercaptopurine (6-MP) for the Treatment of Manifestations of Hereditary Leiomyomatosis and Renal Cell Carcinoma (HLRCC)","Inclusion Criteria:\n\n* Age ≥ 18\n* Disease-causing, germline FH mutation including variants considered either:\n\n  * a) Pathogenic\u002Flikely pathogenic OR\n  * b) variants of unknown significance (VUS) with immunohistochemical staining showing loss of FH or high 2-SC expression in tumor tissue\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1\n* Thiopurine S-methyltransferase (TPMT) and NUDT15 homozygous, wild-type genotype\n\n  * TPMT\\*1\u002FTPMT\\*1 and NUDT15\\*1\u002F NUDT15\\*1\n* Calculated creatinine clearance ≥ 30 milliliters per minute (mL\u002Fmin) per the Cockcroft and Gault formula OR serum creatinine \\\u003C 1.5 x upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\\u003C 3 x ULN (\\\u003C 5 x ULN if liver metastases are present)\n* Total bilirubin \\\u003C 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin up to 3.0 mg\u002FdL)\n* Albumin ≥ 2.2 mg\u002FdL\n* White blood cells (WBC) \\> 2,000\u002Fmm\\^3\n* Hemoglobin (Hb) ≥ 9\n* Neutrophils \\> 1,500\u002Fmm\\^3\n* Platelets \\> 100,000\u002Fmm\\^3\n* Inclusion into ≥ 1 of the following symptomatic, disease states listed below:\n\n  * Inclusion allows entry into that cohort for efficacy assessments. Patients can be in ≥ 1 cohort if they have more than one disease manifestation fitting the below criteria. If a patient fits inclusion\u002Fexclusion into one cohort and has disease manifestations that are excluded from another cohort, they can still participate in the trial but will not be assessed for efficacy for that specific disease manifestation\n* KIDNEY CANCER COHORT: Advanced, metastatic kidney cancer disease\n* KIDNEY CANCER COHORT: Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria\n* KIDNEY CANCER COHORT: ≥ 1 lines of systemic therapy (not considering adjuvant)\n* UTERINE FIBROIDS COHORT: Age ≥ 18\n* UTERINE FIBROIDS COHORT: Female biologic sex\n* UTERINE FIBROIDS COHORT: Any pre-menopausal patient\n* UTERINE FIBROIDS COHORT: Fibroid-associated symptoms including symptomatic menorrhagia and\u002For pelvic pain\u002Fpressure\n* UTERINE FIBROIDS COHORT: Estimated ≤ 15-week uterus by bimanual exam OR by radiographic parameters (≤ 10 cm max dimension of largest fibroid or estimated weight ≤ 400 g)\n* UTERINE FIBROIDS COHORT: Be willing to use non hormonal contraception if needed\n* CUTANEOUS LEIOMYOMAS COHORT: ≥ 5 cutaneous leiomyomas\n* CUTANEOUS LEIOMYOMAS COHORT: Leiomyoma-associated pain or paresthesia causing weekly pain ≥ 4\u002F10 on a pain scale\n\nExclusion Criteria:\n\n* Absolute contraindication to the use of contrast-enhanced imaging for efficacy assessment. If moderate allergy, patients could be allowed if pre-medication can be given to limit adverse reactions. (\\*Not relevant for skin-only cohort)\n* Presence of untreated brain metastases. Treated brain metastases must be stable for 4 weeks after treatment, have no clinical symptoms, and not be on corticosteroids \\> 10 mg\u002Fday of prednisone-equivalent \\> 2 weeks prior to treatment. Patients with known leptomeningeal metastases are excluded\n* Any active or recent history of a known or suspected autoimmune disease or recent history of a syndrome that required systemic corticosteroids (\\> 10 mg daily prednisone equivalent) or immunosuppressive medications within 14 days prior to first dose of study drug. An exception is allowed for syndromes which would not be expected to recur in the absence of an external trigger. Subjects with vitiligo or type I diabetes mellitus or residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement are permitted to enroll. Inhaled steroids and adrenal replacement steroid doses \\> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease\n* History of myocarditis or congestive heart failure (as defined by New York Heart Association Functional Classification III or IV), as well as unstable angina, serious uncontrolled cardiac arrhythmia, uncontrolled infection, or myocardial infarction 6 months prior to study entry\n* Known medical condition that, in the investigator's opinion, would increase the risk associated with study participation or interfere with the interpretation of safety results\n* Individuals who are pregnant; negative serum pregnancy tests in patients of childbearing potential and consent to an effective contraceptive method (if needed Centers for Disease Control and Prevention \\[CDC\\] guidelines provided) until a minimum of 30 days after cessation of therapy\n* Individuals who wish to continue actively breast-feeding must agree to not breastfeed during the study or for 180 days after the last dose of study treatment\n* An untreated non-renal malignancy with the following exceptions:\n\n  * low risk prostate cancer on active surveillance (National Comprehensive Cancer Network \\[NCCN\\] very low\u002Flow risk)\n  * non-melanoma skin cancer\n* Any prior treated, non-renal malignancy except for those meeting the following characteristics:\n\n  * Treated stage I or II cancer from which the patient is currently in complete remission\n  * Stage III cancer in remission for \\> 2 years and is not receiving any current treatment\n  * A hematologic malignancy from which the patient is considered to be in complete remission\n* UTERINE FIBROIDS COHORT: Hormonal management ≤ 2 months of starting treatment. Including gonadotrophin releasing hormone (GnRH) analog, progestins or estrogen (pills or intrauterine devices), or ulipristal acetate\n* UTERINE FIBROIDS COHORT: GnRH analog usage ≤ 12 months of starting treatment\n* UTERINE FIBROIDS COHORT: History of uterine artery embolization\n* UTERINE FIBROIDS COHORT: Prior radiofrequency ablation to a target lesion\n* UTERINE FIBROIDS COHORT: History of MR guided focused ultrasound\n* UTERINE FIBROIDS COHORT: Myomectomy ≤ 1 year of starting therapy\n* UTERINE FIBROIDS COHORT: Concern for gynecologic malignancy\n* UTERINE FIBROIDS COHORT: Any Federation of Gynecology and Obstetrics (FIGO) 1 or FIGO 2 myomas requiring immediate treatment\n* UTERINE FIBROIDS COHORT: Planning pregnancy in the next 6 months\n* UTERINE FIBROIDS COHORT: History of endometrial ablation\n* UTERINE FIBROIDS COHORT: Hormonal intrauterine device (IUD) in place\n* CUTANEOUS LEIOMYOMAS COHORT: Willingness\u002Fability to have all cutaneous lesions completely removed","ALL","18 Years",{"count":19,"type":20},18,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This phase I\u002FII trial studies the side effects and best dose of mercaptopurine, and to see how well it works in treating patients with hereditary leiomyomatosis and renal cell carcinoma (HLRCC). HLRCC is a rare inherited disorder that increases the risk of developing benign (not cancer) tumors of the skin and the uterus (leiomyomas) and malignant (cancer) tumors of the uterus (leiomyosarcoma) and the kidney. Mercaptopurine is in a class of medications called purine antagonists. It works by stopping the growth of cancer cells.",[26,27,28,29,30,31,32,33,34],"Advanced Kidney Carcinoma","Advanced Renal Cell Carcinoma","Hereditary Leiomyomatosis and Renal Cell Carcinoma","Metastatic Kidney Carcinoma","Metastatic Renal Cell Carcinoma","Skin Leiomyoma","Stage III Renal Cell Cancer AJCC v8","Stage IV Renal Cell Cancer AJCC v8","Uterine Corpus Leiomyoma","NOT_YET_RECRUITING","2026-08-04",{"date":38,"type":39},"2026-08-06","ACTUAL",{"date":41,"type":20},"2026-12-01",{"date":43,"type":20},"2035-12-01",{"name":45,"class":46},"Jonsson Comprehensive Cancer Center","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":78},"100544111","phase-3-care1-pragmatic-clinical-trial-100544111","NCT06364631","CARE1 Pragmatic Clinical Trial","First Line Randomised Study Platform to Optimize Treatment in Patients With Metastatic Renal Cell Carcinoma","CARE1","Inclusion Criteria:\n\n1. Histologically confirmed metastatic (AJCC Stage IV) renal cell carcinoma with a clear-cell component.\n2. Intermediate- or poor-risk mRCC as defined by IMDC classification.\n3. Adult male or female patients (≥ 18 years of age at inclusion).\n4. Karnofsky Performance Status (KPS) ≥70%.\n5. Adequate organ and marrow function, according to investigator assessment and\n\n   1. Absolute neutrophil count (ANC) ≥ 1000\u002FμL (≥ 1.5 GI\u002FL)\n   2. Platelets ≥ 100,000\u002FμL (≥ 100 GI\u002FL)\n   3. Hemoglobin ≥ 8 g\u002FdL (≥ 80 g\u002FL)\n   4. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 x ULN.\n   5. Calculated creatinine clearance ≥ 30 mL\u002Fmin (≥ 0.67 mL\u002Fsec) using the CKD- EPI equation\n6. Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed.\n7. Patient should be able and willing to comply with study visits and procedures as per protocol\n8. Patients must be affiliated to a social security system or beneficiary of the same\n9. Female patients must either be of non-reproductive potential or must have a negative serum pregnancy test within 14 days prior to the administration of study drug. Childbearing potential women must have agreed to use one barrier method of contraception, such as condom, plus an additional highly effective method of contraception during treatment on this trial and for up to 5 months after the last dose of study treatment.\n10. Fertile men with a female partner of childbearing potential must agree to use one barrier method of contraception, such as condom, during treatment on this trial and for up to 4 months after the last dose of treatment. Their women of childbearing potential partner must agree to use a highly effective method of contraception during the same period.\n11. Female subjects of childbearing potential must not be pregnant at screening.\n\nExclusion Criteria:\n\n1. Prior systemic anticancer therapy for mRCC including investigational agents. Note: One prior systemic adjuvant therapy is allowed for completely resected RCC and if recurrence occurred at least 6 months after the last dose of adjuvant therapy.\n2. Uncontrolled brain metastases (adequately treated with radiotherapy and\u002For radiosurgery prior to randomization are eligible). Subjects who are neurologically symptomatic as a result of their CNS metastasis or are receiving systemic corticosteroid treatment (prednisone equivalent \\> 10 mg\u002Fday) at the planned time of randomization are not eligible.\n3. Concomitant oral anti-vitamin K anticoagulation. An exception is the use of LMWH or direct oral anticoagulants (DOAC), if considered safe by investigator assessment.\n4. The subject has uncontrolled, significant intercurrent or recent illness such as the following conditions:\n\n   a. Cardiovascular disorders:\n\n   i. Congestive heart failure (CHF) class III or IV as defined by the New York Heart Association, unstable angina pectoris, myocardial infarction, serious cardiac arrhythmias (e.g., ventricular flutter, ventricular fibrillation, Torsades de pointes).\n\n   ii. Uncontrolled hypertension despite optimal antihypertensive treatment.\n\n   iii. Stroke, or other symptomatic ischemic event or severe thromboembolic event (e.g., symptomatic pulmonary embolism \\[PE\\], incidental PE is acceptable if deemed safe by the investigator) within 3 months before randomization.\n\n   b. Active GI bleeding or symptomatic Gastrointestinal (GI) tract obstruction\n\n   c. Clinically significant bleeding including uncontrolled hematuria, hematemesis, or hemoptysis\n\n   d. Autoimmune disease that has been symptomatic or required immunosuppressive systemic treatment within the past two years from the date of randomization.\n\n   Note: Patients with a history of Crohn's disease or ulcerative colitis are always excluded\n\n   e. Any condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization.\n\n   Note: Inhaled, intranasal, intra-articular, or topical steroids are permitted. Adrenal replacement steroid doses \\> 10 mg daily prednisone equivalent are permitted. Transient short-term use of systemic corticosteroids for allergic conditions (e.g., contrast allergy) is also allowed.\n\n   f. Active infection requiring systemic treatment.\n\n   g. Major surgery (e.g., nephrectomy, GI surgery, removal of brain metastasis) within 4 weeks prior to randomization or serious non-healing wound\u002Fulcer\u002Fbone fracture.\n5. Pregnant or breastfeeding females.\n6. Any other active malignancy at time of randomization or diagnosis of another malignancy within 3 years prior to randomization that requires active treatment, except for locally curable cancers that have been apparently cured.\n7. Hypersensitivity to any of the active substances or to any of the excipients administered during the study\n8. Use of live vaccines within 28 days before randomization\n9. Persons deprived of their freedom or under guardianship, or for whom it would be impossible to undergo the medical follow-up required by the trial, for geographic, social or psychological reasons.",{"count":57,"type":20},1250,[59],"PHASE3","Systemic therapy for renal cell carcinoma (RCC) relies on 2 classes of agents: anti-angiogenic targeted therapy (Vascular endothelial growth factor Tyrosine Kinase Inhibitor- VEGFR TKI) and immune checkpoint inhibitor (ICI), targeting either PD1\u002FPDL1 axis or CTLA4. Combination therapy is SOC for clear cell RCC in all guidelines with either ICI-ICI or ICI-VEGFR TKI. However, no head-to-head comparison have been performed between the 2 approaches and patients are treated based on physician decision without clinical \u002Fbiomarker factors to guide treatment selection. PDL1 staining is, to date, the biomarker that has demonstrated its ability to enrich for overall survival benefit favoring ICI-ICI strategy in PDL1(+) and ICI-VEGFR TKI in PDL1(-) patients.\n\nStudy design has been developed to demonstrate that ICI-ICI is superior to ICI-VEGFR TKI in prolonging Overall Survival (OS) for PDL1(+) patients and to demonstrate that ICI-VEGFR TKI is superior to ICI-ICI in prolonging Progression Free Survival (PFS) and OS for PDL1(-) patients.",[62,29],"Metastatic Kidney Cancer",[64,65,66,67],"METASTATIC KIDNEY CANCER","METASTATIC KIDNEY CARCINOMA","PRAGMATIC CLINICAL TRIAL","PDL1","RECRUITING","2025-01-14",{"date":71,"type":39},"2025-01-16",{"date":73,"type":39},"2024-04-12",{"date":75,"type":20},"2032-05-05",{"name":77,"class":46},"Gustave Roussy, Cancer Campus, Grand Paris",46]