[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"eye-cancer-intraocular-melanoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:eye-cancer-intraocular-melanoma":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,54],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100603412","phase-1-evaluation-of-the-safety-efficacy-and-pharmacokinetics-of-nbm-bmx-in-patients-with-metastatic-uveal-melanoma-100603412",false,"NCT07136181","Evaluation of the Safety, Efficacy, and Pharmacokinetics of NBM-BMX in Patients With Metastatic Uveal Melanoma","A Multicenter Phase Ib\u002FII Study to Evaluate the Safety, Efficacy and Pharmacokinetics of NBM-BMX in Patients With Metastatic Uveal Melanoma","NBM-BMX-UM","Inclusion Criteria:\n\n\\- Patients must meet the following criteria to be eligible for study entry:\n\n1. Signed, written IRB-approved informed consent.\n2. Men and women age ≥ 18 years\n3. ECOG Performance status ≤ 2\n4. Have measurable disease based on RECIST 1.1\n5. Histologic or cytologic confirmation of metastatic uveal melanoma\n6. Previous Therapy\n\n   * Surgery: Previous surgery is permitted provided that a minimum of 28 days (4 weeks) has elapsed between any major surgery and date of registration, and that wound healing has occurred.\n   * Cytotoxic Chemotherapy: There is no limit to the number of prior regimens received.\n   * Other Systemic Therapy: There is no limit to the number of prior therapies received for metastatic uveal melanoma. Prior treatment with tebentafusp is required for HLA-A\\*02:01-positive patients unless unavailable or clinically inappropriate, as determined by the investigator. Prior HDAC inhibitor treatment is not permitted.\n\n   Patients must have recovered (to baseline or ≤ grade 1) from all reversible toxicity related to prior chemotherapy or systemic therapy and have adequate washout as follows:\n\n   Longest of one of the following:\n   * Two weeks,\n   * 5 half-lives for investigational agents,\n\n     o For anti-cancer therapies with half-lives \\> 8 days, a washout period of at least 28 days will be acceptable,\n   * Standard cycle length of standard therapies.\n7. QTcF \\\u003C= 480 msec\n8. Adequate hematopoietic capacity, as defined by the following:\n\n   * Hemoglobin ≥ 9.0 g\u002FdL and not transfusion dependent\n   * Platelets ≥ 100,000\u002Fmm3\n   * Absolute neutrophil count ≥ 1,500 cells\u002Fmm3\n9. Adequate hepatic function, as defined by the following:\n\n   * AST and ALT ≤ 2.5 times upper limit of normal (ULN) or ≤ 5 times ULN if liver metastases are present\n   * Total bilirubin ≤ 1.5 x ULN or within 3x the ULN for patients with Gilbert disease\n   * Albumin ≥ 3.0 g\u002FdL\n10. Adequate renal function, as defined by the following:\n\n    \\- Renal: calculated creatinine clearance \\>45 mL\u002Fmin for patients between 18 and 70 years old with abnormal, increased, creatinine levels (Cockcroft-Gault formula; Appendix F). For patients who are greater than 70 years old, investigator judgment may be used to assess the renal risk of study participation.\n11. Women\u002Fmen of childbearing potential must have agreed to use two effective contraceptive methods while on study and for 6 months after the last dose of NBM-BMX.\n12. Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.\n\nExclusion Criteria:\n\nPatients who meet the following criteria will be excluded from study entry:\n\n1. Pregnant or nursing women. NOTE: Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation and for at least 6 months after the last dose of NBM-BMX. Should a man father a child, or a woman become pregnant or suspect she is pregnant while participating in this study, he or she should inform the treating physician immediately.\n2. Concurrent non-protocol-specified anti-tumor therapy (e.g., chemotherapy, other targeted therapy, radiation therapy, or photodynamic therapy)\n3. History of other malignancies within 3 years of Day 1, except for tumors with a negligible risk for metastasis or death, such as adequately treated squamous-cell carcinoma of the skin, ductal carcinoma in situ of the breast, or carcinoma in situ of the cervix.\n4. Active or uncontrolled infections or with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol.\n5. History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or renders the patient at high risk from treatment complications.\n6. Difficulty with swallowing oral medications.\n7. Currently taking moderate and strong inhibitors (e.g., gemfibrozil) or inducers of CYP2C8.\n8. A positive test for hepatitis B (HBsAg) and\u002For hepatitis C (anti-HCV antibody), unless the HBV DNA level and\u002For HCV RNA level is below the limit of detection.\n9. Any of the following within 3 months of the first dose of NBM-BMX: myocardial infarction, severe\u002Funstable angina, coronary\u002Fperipheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack.\n10. Current use or anticipated need for P-gp or BCRP inhibitors during the study period.\n11. Use of proton pump inhibitors (PPIs), H2-receptor antagonists, or other systemic acid-reducing agents within 7 days prior to Cycle 1 Day 1 or planned use during the study treatment period, unless the patient can be switched to local antacids (e.g., calcium carbonate or aluminum hydroxide) taken at least 2 hours before or after NBM-BMX dosing.\n\nPatients unable or unwilling to comply with this restriction should be excluded. Exceptions must be discussed with and approved by the Medical Monitor.","ALL","18 Years",{"count":20,"type":21},36,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This study is being done to find the best dose of an investigational drug called NBM-BMX for people with metastatic uveal melanoma, a type of eye cancer that has spread to other parts of the body.\n\nThe study will help doctors learn about the side effects of NBM-BMX, how the drug is processed in the body, and whether it may slow down or shrink tumors.\n\nParticipants will take NBM-BMX as a capsule by mouth twice daily on an empty stomach with at least six ounces (180 mL) of water. No food or drink (other than water) should be consumed for at least two hours after each dose.\n\nParticipants will visit the clinic about once every week or two for exams and blood tests while taking NBM-BMX. After stopping treatment, a follow-up visit will occur about 30 days later.\n\nTreatment may continue as long as the cancer does not get worse and side effects remain manageable.",[28,29,30,31,32],"Metastatic Uveal Melanoma","Uveal Melanoma, Metastatic","Uveal Melanoma, Recurrent","Eye Cancer, Intraocular Melanoma","Eye Cancer",[28,34,32,35,36,37,38,39,40],"Uveal Melanoma","Intraocular Melanoma","Choroidal Melanoma","NBM-BMX","Histone Deacetylase Inhibitor (HDAC inhibitor)","Phase 1b\u002F2 Study","Pharmacokinetics","RECRUITING","2025-11-21",{"date":44,"type":45},"2025-11-28","ACTUAL",{"date":47,"type":45},"2025-11-20",{"date":49,"type":21},"2029-08-30",{"name":51,"class":52},"Novelwise Pharmaceutical Corporation","INDUSTRY",3,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":62,"targetDuration":4,"studyType":22,"phases":64,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":86},"100477894","phase-3-adjuvant-melatonin-for-uveal-melanoma-100477894","NCT05502900","Adjuvant Melatonin for Uveal Melanoma","Adjuvant Melatonin for Uveal Melanoma: A Randomized Open Phase III Study","AMUM","Inclusion Criteria:\n\n1. The patient is ≥18 years\n2. The patient has given his\u002Fher written informed consent to participate in the trial.\n3. The patient has a melanoma originating in the choroid or in the ciliary body, as diagnosed by clinical methods and\u002For histological examination.\n\n   AND at least one of the following 7 items:\n4. The patient's tumor is of size category T3d or higher, or stage IIIB or IIIC according to the American Joint Committee on Cancer (AJCC, version 8) criteria.\n5. The patient's tumor is large according to modified criteria from the Collaborative Ocular Melanoma Study (COMS), i.e. largest basal diameter \\>16 mm or apical thickness \\>8 mm.\n6. The patient's tumor was of size category T2a before plaque brachytherapy and has then recurred.\n7. The patient's tumor has an epithelioid cell type (\\>5 epithelioid cells per high power field and \\>90 % of tumor cells epithelioid).\n8. The patient's tumor has a low immunohistochemical expression of BAP1.\n9. The patient's tumor has more than 9 mitoses per high power field.\n10. The patient has \\>60 % risk of metastases within 5 years, as determined with another published and validated prognostic test (e.g. gene expression class 2).\n11. If the patient is already being treated with Melatonin, a two-week wash out period will be applied before randomization.\n\nExclusion Criteria:\n\n1. Oversensitivity or allergy to Melatonin or any of the excipients in the tablet.\n2. The patient has metastatic disease, detectable with radiological examinations or any other method (development of metastases after recruitment to the trial does not disqualify the patient from participation).\n3. The patient is unable to provide informed consent.\n4. The patient has decreased liver function (e.g., liver cirrhosis or hepatitis)\n5. The patient is pregnant or a fertile woman (Women of child-bearing potential, WOCBP). Fertility is defined as the time between menarche and menopause for women that are not permanently sterile by hysterectomy, bilateral salpingectomy, or bilateral oophorectomy. Menopause is defined as absence of menstruation for 12 months or longer without other cause.\n6. The patient is breast feeding or is planning to breastfeed before the end of the trial. Women that are included in the trial and begin to breastfeed before the end of the trial must resign from the trial.\n7. The patient has epilepsy.\n8. The patient is being treated (for more than 4 weeks) with CYP1A2 inhibitors Fluvoxamine, Ciprofloxacin, Norfloxacin, or Verapamil, with combined hormonal contraception (containing etinylestradiole and progestin), with hormonal substitution therapy, with 5- or 8-metoxypsoralene or cimetidine. If a patient starts using any of these substances for more than 4 weeks after recruitment to the trial, he or she does not need to resign from the trial but may pause the use of Melatonin, and then restart after the use of the other substance has ceased. Concurrent treatment with CYP1A2 inducers including carbamazepine, fenytoine, rifampicin, omeprazole, calcium antagonists, benzodiazepine-related hypnotics, non-steroid anti-inflammatory drugs (NSAIDs) and beta blockers is not an exclusion criterium. Concurrent treatment with warfarin or other vitamin K antagonists is not an exclusion criterium, but requires information to the patient and discussion about dose adjustments with the prescribing physician.\n9. The primary UM was diagnosed more than 12 months ago.",{"count":63,"type":21},100,[65],"PHASE3","Uveal melanoma (UM) is the most common type of cancer inside the eyes of adults. Almost half of all patients diagnosed with UM will eventually develop metastases. Once metastases occur, the median patient survival is short.\n\nIn this trial, we will test if treatment with Melatonin after primary tumor diagnosis can prevent or delay the development of metastases. 100 patients diagnosed with primary UM will be randomized to either treatment with Melatonin tablets (20 mg at night), or to a control group. Both groups will be followed for 5 years. At 5 years, the number of patients that have developed metastases in the Melatonin and control groups will be compared (primary outcome measure).",[34,68,31],"Uveal Melanoma, Posterior, Medium\u002FLarge Size",[70,71,72,73,74,75],"Melatonin","Adjuvant","Preventive","Uveal melanoma","Survival","Phase 3 trial","2025-05-12",{"date":78,"type":45},"2025-05-15",{"date":80,"type":45},"2022-10-02",{"date":82,"type":21},"2031-01-01",{"name":84,"class":85},"Gustav Stalhammar","OTHER",1]