[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Peter MacCallum Cancer Centre, Australia\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":584},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,20,0,[8,50,86,120,149,181,211,238,270,296,321,352,380,402,436,466,490,519,540,560],{"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":25,"conditions":26,"keywords":28,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100634569","phase-1-autologous-chimeric-antigen-receptor-car-t-cells-targeting-the-kappa-myeloma-antigen-kma-in-kappa-restricted-multiple-myeloma-patients-with-relapsedrefractory-disease-100634569",false,"NCT07541391","Autologous Chimeric Antigen Receptor (CAR) T-cells Targeting the Kappa Myeloma Antigen (KMA) in Kappa Restricted Multiple Myeloma Patients With Relapsed\u002FRefractory Disease","A Phase I Study of Autologous Chimeric Antigen Receptor (CAR) T-cells Targeting the Kappa Myeloma Antigen (KMA) in Kappa Restricted Multiple Myeloma Patients With Relapsed\u002FRefractory Disease","KOALA","Inclusion Criteria:\n\n1. Patient has provided written informed consent using the KOALA Patient Information and Consent Form (PICF)\n2. Age ≥ 18 years on the day of signing informed consent form\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 2 (Appendix 2)\n4. Life expectancy of ≥ 3 months, as assessed by the Investigator\n5. A diagnosis of kappa-restricted RR MM with evidence of KMA on the surface of bone marrow plasma cells using flow cytometry analysis as determined by investigator\n6. Have received at least 2 prior lines of therapy including a proteosome inhibitor and an immunomodulatory imide drug with evidence of disease progression as per IMWG criteria (Appendix 1) after the most recent line of therapy Note 1: induction with or without haematopoietic stem cell transplant (SCT), consolidation and maintenance therapy is considered a single line of therapy Note 2: Patients who have had prior treatment with a CAR T-cell therapy are eligible after a minimum of a 12 week washout between infusions.\n7. Have measurable disease as defined by: • Serum IgG, IgA, IgM M protein ≥ 0.5 g\u002FdL; or • Serum IgD M protein ≥ 0.05 g\u002FdL; or • An abnormal free light chain (FLC) assay (Freelite™) demonstrating an excess of kFLC with a kFLC component of at least 100 mg\u002FL and an abnormal k:λ FLC ratio Note: Patients who do not have measurable disease but who have demonstrable disease (i.e., oligo-secretory myeloma) based on evidence of bone lesions by at least 2 prior PET scan studies showing persistent disease may be included\n8. Last dose of nitrosourea, nitrogen mustards, or monoclonal antibody must have been at least 4 weeks prior to registration; autologous SCT must have been at least 12 weeks prior to registration; and allogeneic SCT must have been at least 24 weeks prior to registration. Limited field radiotherapy to painful lesions is allowed during Screening and bridging but must be completed 48 hours prior to planned apheresis and lymphodepleting chemotherapy\n9. Adequate haematological function documented within 7 days prior to registration, defined as: • Haemoglobin ≥ 80 g\u002FL (peripheral red blood cell transfusion support is allowed if marrow infiltrate is ≥ 50%) • Absolute neutrophil count (ANC) ≥ 1.0 x 109\u002FL (GCSF support is allowed) , and ANC \\> 0.5 x 109\u002FL is allowed if neutropenia is due to disease infiltration of bone marrow) • Absolute lymphocyte count (ALC) ≥ 0.1 x 109\u002FL • Platelets ≥ 50 x 109\u002FL (platelet transfusion support is allowed for platelets ≥ 30 if due to disease infiltration by bone marrow, or splenomegaly due to disease involvement)\n10. Adequate cardiac function, defined as: • Left ventricular ejection fraction (LVEF) ≥ 40% on echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 90 days prior to registration• No suspicion for intercurrent deterioration in left ventricular function as assessed by the Investigator\n11. Adequate pulmonary function, defined as: • Oxygen saturation measured by pulse oximetry ≥ 90% on room air\n12. Adequate renal function documented within 7 days prior to registration, defined as any one of: • A serum creatinine ≤ 1.5 x upper limit of normal (ULN) • Creatinine clearance (CrCl) of ≥ 40 mL\u002Fmin calculated by Cockcroft-Gault formula (Appendix 3) • CrCl ≥ 40 mL\u002Fmin calculated by 24-hour urine collection post-ovulation methods) and withdrawal are not acceptable • Glomerular filtration rate (GFR) ≥ 40 mL\u002Fmin by renal scintigraphy\n13. Adequate hepatic function documented within 7 days prior to registration, defined as all of: • Total bilirubin ≤ 1.5 x ULN (or ≤ 3.0 x ULN in patients with Gilbert's syndrome or documented liver involvement) • Alanine aminotransferase (ALT) ≤ 3.0 x ULN (or ≤ 5.0 x ULN in patients with documented liver involvement) • Aspartate aminotransferase (AST) ≤ 3.0 x ULN (or ≤ 5.0 x ULN in patients with documented liver involvement)\n14. Taking a maximum corticosteroid dose of 20 mg of oral prednisone or equivalent\n15. Females of childbearing potential (FCBP) and nonsterile male patients (with partners of childbearing potential) must agree to use highly effective methods of contraception from registration on the study to 2 months after the PMCC-COE-KMA infusion or until PMCC-COE-KMA CAR T-cells are no longer present by quantitative PCR on 2 consecutive tests whichever is later. Effective methods of contraception are: • Total abstinence from sexual intercourse when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptablemethods of contraception • Female sterilisation (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or bilateral tubal ligation at least 6 weeks prior to registration. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by followup hormone level assessment • Male sterilisation (at least 6 months prior to Screening), noting that for female patients on the study, the vasectomised male partner should be the sole partner for that patient • Use of oral, (oestrogen and progesterone), injected or implanted hormonal methods of contraception or placement of an intrauterine device or intrauterine system, or other forms of hormonal contraception that have comparable efficacy (failure rate \\\u003C 1%), for example hormone vaginal ring or transdermal hormone contraception. In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months prior to registration • Women are considered post-menopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., ageappropriate history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at least 6 weeks prior to registration. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment is she considered not of childbearing potential\n16. Females of childbearing potential must have a negative serum beta-human chorionic gonadotropin (β-hCG) pregnancy test within 3 days prior to registration\n17. Sexually active male patients must use a condom during intercourse and must agree to refrain from sperm donation, from registration on the study until 52 weeks after the PMCC-COE-KMA infusion\n\nExclusion Criteria:\n\n1. A diagnosis of lambda-restricted MM\n2. Plasma cell leukaemia at the time of Screening (\\> 5% circulating plasma cells by standard differential), Waldenström's macroglobulinaemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary amyloid light-chain amyloidosis\n3. Known active, or prior history of, central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM\n4. Major surgery within 4 weeks prior to registration\n5. Receipt of a live, attenuated vaccine (except for COVID-19) within 4 weeks prior to the planned commencement of lymphodepleting conditioning\n6. Receipt of any investigational medical product within the last 30 days, or after 5 halflives (whichever is the shortest) prior to planned leukapheresis\n7. Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure or myocardial infarction within 6 months prior to Screening or class III to IV cardiac disease as defined by the New York Heart Association Functional Classification\n8. Clinically significant neurological disorders (e.g., uncontrolled seizure disorder, severe brain injury, dementia, Parkinson's disease, or autoimmune\u002Finflammatory disorders \\[e.g., Guillain-Barre syndrome, motor neuron disease, chronic inflammatory demyelinating polyneuropathy\\]) Note: Patients with a seizure disorder who have been seizure free and without modification to anti-epileptic therapy in the past 12 months are eligible\n9. History of other active malignancy, with the exception of: • Adequately treated in situ carcinoma of the cervix or breast • Adequately treated basal cell carcinoma of skin or localised squamous cell carcinoma of the skin • Low grade malignancies that are being observed and do not require treatment (e.g., low risk prostate cancer) • Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent and without evidence of recurrence for at least 2 years prior to registration\n10. Active human immunodeficiency virus (HIV) or hepatitis A, B, or C infection • Patients who are positive for HIV by enzyme-linked immunosorbent assay or Western Blot, are ineligible • Patients who are seropositive for hepatitis C virus (HCV) are eligible if their most recent HCV DNA assay is undetectable (including those that have received curative therapy) • Patients who are seropositive for hepatitis B virus (HBV) because of vaccination are eligible\n11. Other clinically significant active infection confirmed by clinical evidence, imaging, or positive laboratory tests (e.g., blood cultures, viral DNA\u002FRNA by PCR)\n12. A known history or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy (with the exception of corticosteroids up to 20 mg\u002Fday of oral prednisolone or equivalent)\n13. Current active graft-versus-host disease requiring immunosuppression (with the exception of corticosteroids up to 20 mg\u002Fday of oral prednisolone or equivalent)\n14. Other significant life-threatening illness, medical condition, or laboratory abnormality that, in the opinion of the Investigator, could compromise the patient's safety, impair their ability to receive PMCC-COE-KMA, or put the study outcomes at undue risk\n15. Known hypersensitivity to the excipients of PMCC-COE-KMA or to any product to be given to the patient as per the study protocol (e.g., tocilizumab and lymphodepleting agents)\n16. Women who are lactating\n17. Presence of any psychological, social, geographical, or other condition for which, in the opinion of the site Investigator, participation would not be in the best interest of the patient (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments","ALL","18 Years",{"count":20,"type":21},12,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The study proposed here intends to evaluate the safety and efficacy of escalating doses of autologous PMCC-COE-KMA CAR T-cells administered to patients with relapsed\u002Frefractory multiple myeloma that expresses the KMA. The PMCC-COE-KMA CAR T-cells will be produced using LV and administered to patients after lymphodepleting conditioning chemotherapy. Considering the poor prognosis of myeloma patients who have relapsed after ≥ 2 lines of therapy, combined with evidence of PMCC-COE-KMA CAR T-cell specificity, as well as the efficacy and manageable toxicity of PMCC-COE-KMA, investigators believe the potential benefits outweigh the risks of this trial.",[27],"Relapsed\u002FRefractory Multiple Myeloma",[29,30,31,32,33,27,34,35,36],"CART","Chimeric Antigen Receptor (CAR) T-cells","Kappa Myeloma Antigen","KMA","Multiple Myeloma","PMCC-COE-KMA","HaemalogiX","KMCAR","RECRUITING","2026-05-22",{"date":40,"type":41},"2026-05-27","ACTUAL",{"date":43,"type":21},"2026-05",{"date":45,"type":21},"2030-01",{"name":47,"class":48},"Peter MacCallum Cancer Centre, Australia","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":57,"minAge":18,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},"100633525","evaluating-ovarian-toxicity-outcomes-following-immunotherapy-in-patients-with-triple-negative-breast-cancer-tnbc-100633525","NCT07527819","Evaluating Ovarian Toxicity Outcomes Following Immunotherapy in Patients With Triple-Negative Breast Cancer (TNBC)","FERTILE","Inclusion Criteria:\n\n1. Patient has provided written informed consent using the FERTILE Patient Information and Consent form (PICF)\n2. Early-stage TNBC (definition determined as per clinicians' discretion)\n3. Female patients between 18 and 42 years of age\n4. Planned to receive at least one dose of neoadjuvant chemotherapy-ICI with a PD-(L)1 inhibitor including but not limited to pembrolizumab, atezolizumab, durvalumab or nivolumab\n5. Planned to receive gonadotrophin releasing hormone (GnRH) agonist with neoadjuvant chemotherapy\n\nExclusion Criteria:\n\n1. Previous removal of both ovaries or ovarian ablation (such as bilateral ovarian radiotherapy)\n2. Patients who have previously received immunotherapy or chemotherapy prior to registration\n3. Receiving or planned to receive adjuvant endocrine therapy Note: patients using GnRH agonist for POI prevention are not excluded\n4. Post-menopausal as defined by the investigator\n5. Presence of any psychological, social, geographical, or other condition for which, in the opinion of the site Investigator, participation would not be in the best interest of the patient (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments","FEMALE","42 Years",{"count":60,"type":21},75,"OBSERVATIONAL","This study aims to collect information about the effects of chemotherapy combined with immunotherapy (immune checkpoint inhibitors) for early-stage triple-negative breast cancer (TNBC) on ovarian function and fertility.\n\nYou may be eligible for this study if you have been diagnosed with early-stage TNBC and are planning to receive neoadjuvant chemotherapy combined with immunotherapy before surgery. Additional eligibility criteria apply.\n\nParticipants who choose to enroll will be asked to complete questionnaires and provide blood samples before and after treatment to measure hormone levels related to ovarian function. Information about menstrual patterns, fertility preservation discussions, and reproductive health will also be collected. Some participants may undergo ultrasound assessments to evaluate ovarian reserve and endometrial thickness. Follow-up will continue for up to 24 months after treatment to assess long-term ovarian function.\n\nNo additional or experimental cancer treatments will be provided as part of this study. This is an observational study only, and participants will receive standard cancer treatment as recommended by their treating team.\n\nIt is hoped this research will provide important information about the potential effects of chemotherapy and immunotherapy on ovarian health and fertility in women receiving treatment for early-stage TNBC.",[64],"Triple Negative Breast Cancer (TNBC)",[66,67,68,69,70,71,72,73,74,75],"Premature Ovarian Insufficiency","chemotherapy","immunotherapy","fertility","immune checkpoint inhibitors","ovarian function","ovarian toxicity","cytokines","inflammation","menopause","NOT_YET_RECRUITING","2026-04-07",{"date":79,"type":41},"2026-04-14",{"date":81,"type":21},"2026-04-08",{"date":83,"type":21},"2031-12-31",{"name":47,"class":48},9,{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":22,"phases":95,"briefSummary":97,"conditions":98,"keywords":101,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":4},"100583912","stereotactic-ablative-body-radiotherapy-sabr-with-maintenance-of-systemic-therapy-versus-physicians-choice-of-systemic-therapy-for-oligoprogressive-er-positive-her-2-negative-breast-cancer-ii-100583912","NCT06882499","Stereotactic Ablative Body Radiotherapy (SABR) With Maintenance of Systemic Therapy Versus Physicians' Choice of Systemic Therapy for Oligoprogressive ER-positive, Her-2 Negative Breast Cancer II","AVATARII","INCLUSION CRITERIA\n\nPatients will be eligible for inclusion in this trial if all the following criteria apply:\n\n1. Patient has signed the AVATAR-II Patient Information and Consent Form (PICF)\n2. Male or female, ≥ 18 years of age at the time signing consent\n3. Patients with histologically proven ER-positive, HER2-negative advanced breast cancer receiving an ET in combination with a CDK 4\u002F6 inhibitor. Biopsy of metastatic disease if technically feasible but not mandatory\n4. Patients must have evidence of extracranial metastatic disease, with no evidence of uncontrolled intracranial metastases. (Controlled intracranial metastases are defined as stable disease on repeat CT imaging performed at least one month apart.)\n5. Patients must have evidence of radiological response to ET and CDK 4\u002F6 inhibitor for a minimum of six months prior to randomisation (defined as either stable disease or partial response).\n\n   Note: Patient must have ongoing stability\u002Fresponse in at least one lesion at the time of randomisation.\n6. Evidence of new or existing OPD, as determined by the Investigator and defined according to RECIST1.1 (33), via CT on a per-lesion basis (between 1-5 metastases, including the primary) as follows:\n\n   * At least a 20% increase in the diameter of a lesion, taking as reference the smallest diameter on a previous CT scan with an absolute increase of at least 5mm\n   * Appearance of a new lesion(s) Note: A new lesion can be identified using various imaging modalities, such as PET-CT or WBBS, as long as the lesion is visible on serial CT scans.\n7. For patients with liver or lung metastases, maximum of 3 oligoprogressive lesions in single organ\n8. All OPD must be amenable to SABR, as per the radiotherapy guidelines in section 11.1 and Appendix 4 and 5\n9. ECOG performance status 0-2\n10. Life expectancy ≥ 6 months\n11. Clinician and patient are willing to continue current line of therapy\n12. Patient is able to complete QoL questionnaires, and other assessments required as part of the study\n\nEXCLUSION CRITERIA\n\nPatients will not be eligible for inclusion in this trial if any of the following criteria apply:\n\n1. Is pregnant or lactating at the time of randomisation\n2. Evidence of more than one clone of metastatic disease e.g., a patient with both ER-positive and triple negative clones of disease And ER-negative and\u002For HER2-positive disease would be excluded from the study\n3. Evidence of leptomeningeal disease\n4. Evidence of malignant cord compression\n5. Evidence of lesion within femoral bone requiring surgical fixation\n6. Patients with risk of bone fracture are not candidate for SABR (Appendix 4 and 5)\n7. Previous chemotherapy for metastatic disease Note: chemotherapy for primary breast cancer is allowed\n8. Contraindications to radiotherapy\n9. Any condition deeming the patient unsuitable to comply with the study\n10. Substantial overlap with previously treated area. Reirradiation is permitted with the condition that the combined plan adheres to the specific dose constraints outlined in this protocol. It is advised to use biological effective dose (BED) calculations to correlate previous doses with the tolerance doses documented in the protocol\n11. Evidence of progression in more than 5 lesions\n12. Prior SABR delivered for oligoprogressive disease with the intent of delaying a change in systemic therapy.",{"count":94,"type":21},74,[96],"NA","The goal of this clinical trial is to assess Stereotactic Ablative Radiotherapy (SABR) as a method to delay a change in systemic therapy in patients with oligoprogressive ER-positive, HER2-negative advanced breast cancer. The main question it aims to answer is to assess whether the addition of SABR to continuation of first line endocrine therapy and CDK 4\u002F6 inhibitor (Arm A) to patients with oligoprogressive ER-positive, HER2-negative advanced breast cancer could have longer time to strategy failure (TSF) in comparison to physician choice of systemic treatment (Arm B) in patients who had progressed first line.\n\nThe treatment strategy in Arm A is to maintain patients on current endocrine therapy and CDK 4\u002F6 inhibitor, controlling localised progressing sites of disease with SABR. Treatment strategy in Arm B is to maintain disease control with physician's choice of systemic therapy alone.",[99,100],"Breast Cancer, Metastatic","Metastatic Breast Cancer",[102,103,104,105,106,107,108,109,110,111],"ER-positive, HER2-negative","selective estrogen receptor degrader","endocrine therapy","aromatase inhibitor","CDK 4\u002F6 inhibitor","SABR","oligoprogression","oligometastases","oligometastatic","sbrt","2026-03-31",{"date":114,"type":41},"2026-04-02",{"date":116,"type":21},"2026-06",{"date":118,"type":21},"2032-06",{"name":47,"class":48},{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":126,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":22,"phases":130,"briefSummary":132,"conditions":133,"keywords":136,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":49},"100609696","phase-2-novel-treatment-of-radiation-associated-dysphagia-with-statins-100609696","NCT07217938","Novel Treatment of Radiation Associated Dysphagia With Statins","TRADstat: Novel Treatment of Radiation Associated Dysphagia With Statins","TRADstat","Inclusion Criteria:\n\n1. Patient has provided written informed consent using the TRADstat PICF\n2. Patients aged 18 years or older at screening\n3. Received curative intent (chemo)radiotherapy to the nasopharynx, oropharynx, hypopharynx or larynx at least 2 years prior to screening\n4. Moderate-severe RAD using validated cut-offs (PAS score \\> 3 and\u002For DIGEST grading ≥ 2), identified on a VFSS conducted within the last 12 months\n5. Adequate kidney function defined as estimated glomerular filtration rate (eGFR) ≥ 40 ml\u002Fmin\n6. Adequate hepatic function defined as:\n\n   * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels less than 2 times the upper normal limit (ULN)\n   * Bilirubin level at least 1.5 times lower than the ULN\n7. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-2 (Appendix 1)\n\nExclusion Criteria:\n\n1. Known hypersensitivity to pravastatin and\u002For any excipients\n2. Diagnosis of myasthenia (muscle weakness)\n3. History of head or neck surgery, other than excisional biopsy or post treatment neck dissection\n4. Known active malignancy\n5. Currently taking statin medication\n6. Currently taking prohibited medicines (long-term steroids or drugs listed under Section 8.4)\n7. History of severe heart failure; a history of muscle toxicity during previous treatments with fibrates or statins; a history of hereditary muscle diseases\n8. Known medical condition(s) that may impact swallowing function (e.g., stroke, neurological conditions, tracheostomy)\n9. Pregnant or breastfeeding",{"count":129,"type":21},48,[131],"PHASE2","The aim of this trial is to examine the feasibility, acceptability, and potential efficacy of a 12-month course of pravastatin as an antifibrotic agent for managing dysphagia (swallowing problems) in patients previously treated with radiotherapy for head and neck cancer (HNC). The purpose is to assess whether pravastatin, a medication approved in Australia for cholesterol management, can improve swallowing in people with long-term radiation-associated dysphagia following HNC treatment.\n\nThe trial will recruit 48 patients, with an anticipated accrual period of approximately 6 months. Eligible patients will be identified from the Principal Investigator's current study, ERADICATE, or through referral by a radiation oncologist or speech pathologist diagnosing radiation-induced dysphagia.\n\nParticipants will receive 40 mg of pravastatin daily for up to 12 months, with swallowing assessments conducted before, during, and after treatment.",[134,135],"Radiation-associated Dysphagia","Head &Amp; Neck Cancer",[137,138,139,140],"Radiation-associated dysphagia","Dysphagia","Head & neck cancer","Pravastatin","2026-03-01",{"date":143,"type":41},"2026-03-03",{"date":145,"type":41},"2025-12-05",{"date":147,"type":21},"2028-10-01",{"name":47,"class":48},{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":153,"acronym":154,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":156,"targetDuration":4,"studyType":22,"phases":157,"briefSummary":158,"conditions":159,"keywords":161,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":178,"leadSponsor":180,"locationsCount":49},"100626326","phase-2-phase-ii-trial-of-lu-177-fap-2286-in-patients-with-carcinoma-of-unknown-primary-100626326","NCT07434180","Phase II Trial of Lu-177 FAP-2286 in Patients With Carcinoma of Unknown Primary","Lu-FAP CUP","Inclusion Criteria\n\nPatients must meet all the following criteria for trial entry:\n\n1. Patient has provided written informed consent\n2. Patients aged 18 years or over at Screening\n3. Diagnosed with CUP based on a diagnostic work-up, including, but not limited to; a detailed clinical assessment; a CT CAP; pathological review of tumour tissue; and other appropriate tests as per the Cancer Council Optimal Care Pathway guidelines.\n4. Progressed on 1st line platinum doublet chemotherapy +\u002F- immunotherapy +\u002F- antibody therapy\n5. 68Ga-FAPI-46 positive disease on 68Ga-FAPI-46-PET\u002FCT defined as 68Ga-FAPI-46 uptake at PET\u002FCT with SUVmax of ≥ 8 in at least 50% of target lesions and above surrounding background in the remaining target lesions\n6. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Appendix 1).\n7. Life expectancy greater than 3 months\n8. Adequate bone marrow, hepatic and renal function defined by the following laboratory results:\n\n   * Haemoglobin ≥ 90 g\u002FL independent of transfusion (no red blood cell transfusion within 4 weeks before the haematology Screening assessment)\n   * Absolute neutrophil count ≥ 1.5 x 109\u002FL\n   * Platelet count ≥ 100 x 109\u002FL\n   * Creatinine clearance (CrCl) ≥ 60 mL\u002Fmin calculated using the Cockcroft-Gault equation (Appendix 2)\n   * Serum bilirubin ≤ 1.5 x upper limit of normal (ULN); Patients with known Gilbert's disease may have a bilirubin ≥ 3.0 x ULN\n   * Aspartate transaminase (AST) or alanine transaminase (ALT) ≤ 2 x ULN (or ≤ 5 x ULN in the presence of liver metastases)\n9. Have measurable disease per RECIST1.1 (Appendix 3)\n10. Sexually active Patients are willing to use medically acceptable forms of barrier contraception as outlined in Section 8.1.5.1, during treatment and for 6 months following the last dose of treatment\n11. Women of childbearing potential (WCBP) must have a negative serum pregnancy test result\n12. Willing to undergo biopsies if disease is considered accessible and biopsy is feasible\n13. Willing and able to comply with all trial requirements, including all treatment and required assessments and follow-up procedures, in the Investigator's judgment\n\nExclusion Criteria:\n\n* Patients who meet any of the following criteria will be excluded from trial entry:\n\n  1. Uncontrolled medical or psychological conditions that may prevent commencement of systemic treatment\n  2. Symptomatic and\u002For untreated central nervous system metastases or leptomeningeal disease. Patients must be clinically stable for at least 4 weeks without steroid treatment\n  3. Surgical procedure (minor surgery ≤ 5 days, or major surgery ≤ 21 days) prior to registration or active infection requiring systemic treatment Note: Placement of vascular access devices, laparoscopy and prophylactic procedures to stabilise bone lesions are not considered major surgical procedures\n  4. Received anticancer treatment ≤ 14 days prior to registration (≤ 28 days prior in case of checkpoint inhibitor or other antibody therapies)\n  5. Severe impaired cardiac function (left ventricular ejection fraction \\\u003C 35%) or clinically significant uncontrolled cardiac disease\n  6. Severe urinary incontinence, voiding dysfunction, or unrelieved urinary obstruction\n  7. Ongoing AEs from anticancer treatment \\> Grade 1 as per CTCAE v5.0, with the exception of alopecia\n  8. Received prior radiopharmaceutical therapy or radioembolisation, or prior extensive external beam radiation therapy (EBRT) to bone marrow or any prior EBRT directly to kidney or received any EBRT within 2 weeks prior to registration\n  9. Concurrent illness, including severe infection that may jeopardise the ability of the patient to undergo procedures outlined in this protocol with reasonable safety\n  10. Prior cancer diagnosis with the exception of:\n\n      * Malignancy treated with curative intent and with no known active disease ≥ 3 years and of low potential risk of recurrence\n      * Adequately treated basal cell or squamous cell skin carcinoma or non-invasive melanoma\n      * Adequately treated non-muscle invasive bladder cancer (Tis, Ta and low grade T1 tumours)\n      * Adequately treated carcinoma in situ without evidence of disease\n  11. Cancer patients with incidental histologic findings of prostate cancer that, in the opinion of the Investigator, is not deemed to require active therapy (e.g., incidental prostate cancer identified following cystoprostatectomy that is tumour\u002Fnode\u002Fmetastasis stage ≤ pT2N0)\n  12. Greater than one prior line of systemic treatment\n  13. Known allergy or reaction to 18F, 68Ga or 177Lu radiopharmaceuticals\n  14. Concurrent illness, including severe infection that may jeopardise the ability of the patient to undergo the procedures outlined in the protocol with reasonable safety",{"count":5,"type":21},[131],"The aim of the study is to test if a new radionuclide therapy, called 177-Lu-FAP-2286, works to treat cancer in patients with Cancer of Unknown Primary (CUP).",[160],"Cancer of Unknown Primary",[162,163,164,165,166,167,168,169,170,171,172,173],"cancer of unknown primary","177Lu-FAP-2286","Ga-FAPI-46","theranostic","FAP-2286","Fibroblast Activation Protein (FAP)","cancer-associated fibroblasts (CAF)","radiopharmaceutical","Targeted radioligand therapy (TRT)","Targeted radionuclide therapy","Peptide-Targeted Radioligand Therapy (PTRT)","Peptide Receptor Radionuclide Therapy (PRRT)","2026-02-22",{"date":176,"type":41},"2026-02-25",{"date":116,"type":21},{"date":179,"type":21},"2030-06",{"name":47,"class":48},{"id":182,"slug":183,"hasResults":11,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":187,"eligibilityCriteria":188,"healthyVolunteers":189,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":190,"targetDuration":4,"studyType":22,"phases":192,"briefSummary":193,"conditions":194,"keywords":196,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":49},"100622773","a-study-to-describe-the-effect-of-photobiomodulation-low-level-laser-therapy-in-reducing-the-severity-and-incidence-of-oral-mucositis-oral-ulceration-in-oral-cancer-patients-undergoing-radiation-treatment-100622773","NCT07387978","A Study to Describe the Effect of Photobiomodulation (Low Level Laser Therapy) in Reducing the Severity and Incidence of Oral Mucositis (Oral Ulceration) in Oral Cancer Patients Undergoing Radiation Treatment","A Pilot Study to Describe the Effect of Photobiomodulation in Reducing the Severity and Incidence of Oral Mucositis in Oral Cancer Patients Undergoing Radiation Treatment","PBM","Inclusion Criteria:\n\n* Patient has provided written informed consent using the PBM PICF\n* Age ≥ 18 years of age at Screening\n* Histological diagnosis of HNC of the oral cavity with no evidence of macroscopic or microscopic residual disease post-surgery (R0 or R1 resection) with histopathological confirmation and no gross residual lymphadenopathy in the planned PBM treatment area\n* Planned treatment with RT or chemoradiotherapy to a dose of ≥ 50 Gy Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 (Appendix 1)\n* Intact oral mucosa (no visible ulceration, dehiscence, or active infection)\n\nExclusion Criteria:\n\n* Gross macroscopic and\u002For microscopic residual disease post-surgery (R2 resection) or gross residual lymphadenopathy in the planned PBM treatment area\n* Prior RT to the head and neck including the oral or oropharyngeal mucosa\n* Prior cytotoxic chemotherapy in the last 3 months\n* Diagnosis of photosensitive disorder (cutaneous porphyria, xeroderma pigmentosum, etc)\n* Concurrent administration of cetuximab\n* Known to be pregnant or planning to become pregnant within the trial period\n* Diagnosis of epilepsy",true,{"count":191,"type":21},30,[96],"The goal of this study is to describe the effect of photobiomodulation (PBM) on the incidence and severity of oral mucositis in post-operative oral cancer patients receiving radiotherapy +\u002F- chemotherapy.\n\nParticipants will receive PBM treatment five times a week throughout the course of their radiotherapy.\n\nThe main question it aims to answer is whether photobiomodulation reduces the incidence and severity of oral mucositis.",[195],"Oral Mucositis",[197,198,199,200,201,202],"photobiomodulation","low level laser therapy","head and neck cancer","oral cancer","radiotherapy","oral mucositis","2026-01-27",{"date":205,"type":41},"2026-02-04",{"date":207,"type":41},"2025-11-26",{"date":209,"type":21},"2028-11",{"name":47,"class":48},{"id":212,"slug":213,"hasResults":11,"nctId":214,"briefTitle":215,"officialTitle":215,"acronym":216,"eligibilityCriteria":217,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":218,"enrollmentInfo":219,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":221,"conditions":222,"keywords":224,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":237},"100603569","immune-checkpoint-inhibitor-related-gonadal-toxicity-in-premenopausal-women-and-men-with-melanoma-100603569","NCT07138222","IMmune checkPoint Inhibitor Related gonAdal toxiCiTy in Premenopausal Women and Men With Melanoma","IMPACT","Inclusion Criteria:\n\nPatients will be eligible for inclusion in this trial if all the following criteria apply:\n\n1. Patient has provided written informed consent using the IMPACT Patient Information and Consent form (PICF)\n2. Diagnosis of melanoma (Stage II, III or IV) in the de novo or recurrent setting\n3. Has a life expectancy of greater than or equal to 1 year\n4. Planned to receive ICI treatment, either in the neoadjuvant, adjuvant or metastatic setting, including as:\n\n   * Monotherapy\n   * Combination therapy\n\n   For cohort 1: premenopausal women with melanoma\n5. Age greater than or equal to 18 and less than or equal to 45 years at the time of signing consent\n6. Patient is premenopausal (defined as baseline FSH within the premenopausal range per local laboratory at registration). Women on hormonal contraception who have an abnormal FSH level, will be included if their AMH level is greater than or equal to 1.0 pmol\u002FL at registration\n7. AMH level greater than or equal to 1.0 pmol\u002FL at registration\n\n   For Cohort 2: men with melanoma\n8. Age greater than or equal to 18 and less than or equal to 60 years at the time of signing consent\n9. Fasting morning total testosterone, LH and FSH within the normal range (per local laboratory) at the time registration\n\nExclusion Criteria:\n\nPatients will not be eligible for inclusion in this trial if any of the following criteria apply:\n\n1. Previous removal of both ovaries (females) or previous removal of both testes or previous vasectomy (males)\n2. Planned for or previously had pelvic radiotherapy\n3. Any medications within the prior 6 months known to disrupt the hypothalamic pituitary gonadal axis, e.g., GnRH agonists or antagonists, selective estrogen receptor modulators (SERMs), aromatase inhibitors, testosterone, anabolic steroids, etc.\n4. Previous or concurrent alkylating or platinum-based chemotherapy within the last 2 years\n5. Previous use of ICI\n6. History of hypogonadism\n7. Presence of any psychological, social, geographical, or other condition for which, in the opinion of the site Investigator, participation would not be in the best interest of the patient (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments","60 Years",{"count":220,"type":21},80,"This study aims to capture information regarding the effect of immune checkpoint inhibitor (ICI) treatment for melanoma on reproductive organ function and sex hormone levels.\n\nYou may be eligible for this study if you are aged 18 years or older, you have been diagnosed with melanoma (Stage II, III or IV) and you are planning to receive ICI treatment. Additional criteria will apply dependent upon your biological sex characteristics.\n\nAll participants who choose to enroll in this study will be asked to complete a series of questionnaires and provide blood at 4 of their scheduled treatment visits. These visits are anticipated to add 30 minutes to the scheduled visit time. Male participants will also be asked to provide semen samples at 2 of their scheduled treatment visits. These visits are anticipated to add an additional 30 minutes to the scheduled visit time. No additional or novel treatments will be offered to participants who choose to enroll in this study, this is an observational study only.\n\nIt is hoped this research will contribute important information regarding the potential toxic effects of ICI treatment on sexual and reproductive function in patients with melanoma who are receiving ICI treatment.",[223],"Melanoma (Skin Cancer)",[225,226,70,68,227,71,228,69,73,74],"melanoma","skin cancer","gonadal toxicity","testicular function","2026-01-26",{"date":231,"type":41},"2026-01-28",{"date":233,"type":41},"2025-09-11",{"date":235,"type":21},"2027-12",{"name":47,"class":48},6,{"id":239,"slug":240,"hasResults":11,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":244,"eligibilityCriteria":245,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":246,"targetDuration":4,"studyType":22,"phases":248,"briefSummary":249,"conditions":250,"keywords":255,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":269},"100596903","early-versus-late-stopping-of-antibiotics-in-adults-with-high-risk-hematological-malignanciesreceiving-cellular-therapies-and-fever-100596903","NCT07051525","Early Versus Late Stopping of Antibiotics in Adults With High-risk Hematological Malignancies\u002FReceiving Cellular Therapies and Fever","Early Versus Late Stopping of Antibiotics in Adults With High Risk Haematological Malignancies\u002FReceiving Cellular Therapies and Fever (ELSA- Adult)","ELSA-Adult","Inclusion Criteria:\n\nAdult patients ( ≥18 years) who are receiving either:\n\n* Conditioning chemotherapy for an autologous or allogeneic haematopoietic cell transplant or CAR T cell therapy, OR\n* Induction remission chemotherapy for acute leukaemia,\n\nAND develop fever ( ≥38degC) between time of initiation of chemotherapy\u002Fconditioning administration and ANC recovery to ≥500 cells\u002Fmm3 post the ANC nadir,\n\nAND fever subsequently has settled (\\\u003C38degC) for ≥48 and \\\u003C96h hours.\n\n\\[participants will be stratified into pre-neutropenic (ANC ≥500 cells\u002Fmm3) and neutropenic (ANC\\\u003C500 cells\u002Fmm3) strata based on ANC level at 48 hours post fever onset, as per international consensus definition of neutropenic fever\\]\n\nExclusion Criteria:\n\n* \\- Prolonged fever prior to defervescence (documented daily temperature ≥38.0°C for ≥ 5 days)\n* Documented positive blood culture for bacteria since onset of fever episode and prior to randomisation\n* Documented other infection (clinically or microbiologically defined) requiring antibacterial treatment\n* Grade 2 or higher mucositis (WHO) or neutropenic enterocolitis\n* Clinically unstable and\u002For admission to ICU at time of potential randomization\n* Within 28 days of last randomization\n* Prior randomization during current chemotherapy\u002Fconditioning cycle\n* Pregnant or breastfeeding\n* Currently being treated for CRS Grade 3 or 4, and\u002For ICANS Grade 3 or 4 (defined as per ASTCT Consensus Guidelines, Lee et al)",{"count":247,"type":21},214,[96],"Pre-neutropenic fever (PNF) (fever following chemotherapy but before developing low white cells) and neutropenic fever (NF) (fever in the setting of low white cells) are very common after chemotherapy for acute leukemia, bone marrow transplantation or Chimeric Antigen Receptor T-cell (CAR T) therapy. Often, there is no bacterial cause for fever found, and in the setting of a well patient with resolved fever, some studies have shown it to be safe to cease antibiotic therapy which was commenced at the onset of fever. This reduces the overall exposure to antibiotics, which can be beneficial to the patient (reduced risk of resistant bugs emerging, reduced serious side effects). However, some subgroups of high-risk patients have been underrepresented in these studies (in particular, those who have received a bone marrow transplant from a donor, those with longer duration of low white cells) and none have been performed in Australia, hence applying this data to our setting and patient groups is indirect and further data are needed. This study plans to recruit participants who have received chemotherapy for acute leukemia or a stem cell transplant (either their own cells or a donor's cells) or CAR T-cell therapy and perform a trial to compare early stopping of antibiotics (STOP arm) to the standard of care, which traditionally involves continuing antibiotics until the white cell count reaches above a specific threshold. The primary study outcome is duration of days free of antibiotics within 28 days of study allocation. The investigators will also observe for important clinical outcomes including rates of fever recurrence, bloodstream and other infections, intensive care admission and mortality. Patients will stay in hospital during this period, even in the setting of stopping antibiotics, and these antibiotics can be recommenced urgently according to the sepsis protocol if there is concern for infection.",[251,252,253,254],"Leukemia","CART Therapy","Transplantation, Stem Cell","Infections, Bacterial",[256,257,258,259,260],"EPIC","ELSA","Febrile neutropaenia","Febrile neutropenia","antibitoics","2025-12-07",{"date":263,"type":41},"2025-12-15",{"date":265,"type":41},"2025-12-03",{"date":267,"type":21},"2028-02-05",{"name":47,"class":48},2,{"id":271,"slug":272,"hasResults":11,"nctId":273,"briefTitle":274,"officialTitle":274,"acronym":275,"eligibilityCriteria":276,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":277,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":279,"conditions":280,"keywords":282,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":49},"100524183","siderophore-labelled-positron-emission-tomography-for-correlating-invasive-fungal-infections-100524183","NCT06105411","Siderophore-labelled Positron Emission Tomography for Correlating Invasive Fungal InfeCtions","SPECIFIC","Inclusion Criteria:\n\n1. Patient has provided written informed consent\n2. Aged 18 years or older at written informed consent\n3. Within 2 weeks of proven or probable or possible invasive fungal infection (IFI) diagnosis as per EORTC criteria\n4. Imaging consistent with invasive pulmonary aspergillosis on CT or FDG-PET\u002FCT with lesions at least 8mm in diameter\n5. Patient is willing and able to comply with the protocol for the duration of the study including scheduled visits such as follow up\n\nExclusion Criteria:\n\n1. Women who are pregnant or lactating.\n2. Iron infusion within one week prior to scan",{"count":278,"type":21},10,"This trial will demonstrate localised uptake of a radiolabelled fungal component (siderophore) in areas of known specific invasive fungal (Aspergillus) infection.",[281],"Invasive Fungal Infections",[281,283,284,285,286,287],"Siderophore","PET","Siderophore-labelled Position Emission tomography","68Ga-labelled TAFC PET\u002FCT scan","Aspergillus spp.","2025-08-28",{"date":290,"type":41},"2025-09-05",{"date":292,"type":41},"2023-12-01",{"date":294,"type":21},"2027-04",{"name":47,"class":48},{"id":297,"slug":298,"hasResults":11,"nctId":299,"briefTitle":300,"officialTitle":300,"acronym":301,"eligibilityCriteria":302,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":303,"targetDuration":4,"studyType":22,"phases":304,"briefSummary":305,"conditions":306,"keywords":308,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":313,"lastUpdatePostDateStruct":314,"startDateStruct":316,"completionDateStruct":318,"leadSponsor":320,"locationsCount":49},"100603689","home-based-photo-biomodulation-for-management-of-lymphoedema-and-radiation-fibrosis-in-patients-after-head-and-neck-cancer-a-single-arm-feasibility-trial-100603689","NCT07139782","Home-Based Photo-Biomodulation for Management of Lymphoedema and Radiation Fibrosis in Patients After Head and Neck Cancer: A Single-Arm Feasibility Trial","HOME-PBM","Inclusion Criteria:\n\n1. Patient has provided written informed consent using the HOME-PBM patient information and consent form\n2. Patient is referred to the Lymphoedema Clinic for the management of head and neck lymphoedema and\u002For radiation fibrosis\n3. Previously received curative-intent treatment (surgery and\u002For \\[chemo\\]radiotherapy) for mucosal head and neck cancer\n4. Patient is able to attend appointments in person\n5. Adults aged 18 years or older at Screening\n6. Patient able to speak and read English\n\nExclusion Criteria:\n\n1. Patient has cognitive impairment that in the opinion of the Investigator would interfere with their ability to participate in the trial (e.g., complete outcome measures, perform the intervention)\n2. Residual or recurrent disease within the head and neck\n3. Has a diagnosis of photosensitive disorder (cutaneous porphyria, xeroderma pigmentosum, etc.)\n4. Patient has tuberculosis or another form of virulent bacteria\n5. Patient has a contraindication to receiving PBM treatment\n6. Patient has no internet enabled device for telehealth video follow-up appointment",{"count":191,"type":21},[96],"This feasibility trial will test the use of photo-biomodulation (PBM) therapy, predominantly self-delivered in the patient's home for 12-weeks, following completion of radiotherapy treatment for head and neck cancer.\n\nThe primary objective is to establish feasibility of recruitment (uptake). Secondary objectives are to assess safety, additional elements of feasibility (adherence to the intervention, return of the device and attrition at the 3-month follow-up appointment) and acceptability of the trial to patients.\n\nSecondary measures will be performed to assess trends in effects of the intervention (pre-post intervention, within-group measures) for managing lymphoedema and radiation fibrosis.",[307],"Head and Neck Cancer",[199,309,310,311,312],"photo-biomodulation","radiation fibrosis","lymphoedema","physiotherapy","2025-08-22",{"date":315,"type":41},"2025-08-24",{"date":317,"type":21},"2025-09-04",{"date":319,"type":21},"2026-10-31",{"name":47,"class":48},{"id":322,"slug":323,"hasResults":11,"nctId":324,"briefTitle":325,"officialTitle":325,"acronym":326,"eligibilityCriteria":327,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":328,"targetDuration":4,"studyType":22,"phases":330,"briefSummary":331,"conditions":332,"keywords":334,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":351},"100578547","phase-2-clonal-dynamics-of-chronic-lymphocytic-leukaemia-treated-with-pirtobrutinib-after-previous-treatment-with-zanubrutinib-100578547","NCT06812715","Clonal Dynamics of Chronic Lymphocytic Leukaemia Treated With Pirtobrutinib After Previous Treatment With Zanubrutinib","PIPOZA","Inclusion Criteria:\n\n1. Patient has provided written informed consent using the PIPOZA Patient Information and Consent Form (PICF)\n2. Confirmed diagnosis of CLL according to iwCLL 2018 criteria, also including CLL with atypical immunophenotype\n3. Prior systemic therapy, which must include zanubrutinib as the most recent prior line of therapy. Patients must have received at least one cycle (28 days) of zanubrutinib\n4. Patients must have an indication for second- or subsequent-line treatment in the opinion of the investigator as defined by iwCLL 2018 criteria, including:\n\n   * Where the original indication for treatment has not resolved with initial therapy and it is considered reasonable to initiate second-line treatment without waiting for formal disease progression to be manifest\n   * Where the rate of disease progression is considered rapid, and initiation of subsequent therapy is considered acceptable before formal progression where there is substantial persisting disease burden\n5. Age 18 years of age or older at time of signing the PICF\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n7. Must have adequate bone marrow function, as defined below:\n\n   * Absolute neutrophil count \\> 0.75 × 109\u002FL; if marrow is known to be infiltrated by CLL, granulocyte-colony stimulating factor (G-CSF) support may be used to achieve eligibility criteria\n   * Platelets ≥ 30 × 109\u002FL independent of transfusions within 7 days prior to screening assessment\n   * Haemoglobin ≥ 70 g\u002FL independent of transfusions within 7 days prior to screening assessment\n8. Normal hepatic function defined as:\n\n   * Total bilirubin ≤ 1.5× upper limit of normal (ULN) or ≤ 3.0 x ULN with documented liver involvement and\u002For Gilbert's Disease\n   * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C 3.0 × ULN or ≤ 5.0 × ULN with documented liver involvement\n9. Adequate renal function defined as creatinine clearance of \\> 30 mL\u002Fminute calculated by Cockroft-Gault formula or using biochemical or nuclear medicine techniques\n10. Ability to swallow tablets\n11. Patients must have had a zanubrutinib washout period of at least 24 hours prior to the planned start date of pirtobrutinib on Day 1 Cycle 1\n12. Prior treatment-related adverse events must have recovered to Grade ≤ 1 or pretreatment baseline with the exception of alopecia and Grade 2 peripheral neuropathy\n13. Women of childbearing potential defined as not postmenopausal for at least 2 years or surgically sterile must have a negative serum pregnancy test documented within 14 days prior to planned started date of pirtobrutinib on Day 1 Cycle 1\n14. Men with partners of childbearing potential or women of childbearing potential must agree to use a highly effective contraceptive method of birth control during study treatment and for at least 6 months following the last dose of study drug. Sperm donation is prohibited during the duration of participation in this study and for 6 months after the last dose of study drug. Acceptable methods of birth control are:\n\n    * Combined estrogen and progestin containing hormonal contraception associated with inhibition of ovulation given orally, intravaginally, or transdermally\n    * Progestin-only hormonal contraception associated with inhibition of ovulation given orally, by injection, or by implant\n    * Intrauterine device Intrauterine hormone-releasing system\n    * Bilateral tubal occlusion\n    * Vasectomised partner\n    * Sexual abstinence: Considered a highly effective method only if defined as refraining from heterosexual intercourse during an entire period of risk associated with the study treatment. The reliability of sexual abstinence needs will be evaluated in relation to the duration of the study and to the usual lifestyle of the patient\n15. The patient understands the purpose of the trial and procedures required for the trial which includes compliance with the protocol requirements and restrictions listed in the PICF and in this protocol\n\nExclusion Criteria:\n\n1. Known or suspected Richter's Transformation to diffuse large B-cell lymphoma, prolymphocytic leukaemia, or Hodgkin lymphoma at any time prior to registration\n2. Known or suspected history of central nervous system involvement\n3. History of allogeneic or autologous stem cell transplant or chimeric antigen receptor T-cell (CAR-T) therapy within the past 60 days and\u002For with any of the following:\n\n   * Active graft versus host disease\n   * Cytopenias from incomplete blood cell count recovery post-transplant or CAR-T therapy\n   * Need for anti-cytokine therapy for toxicity from CAR-T therapy; residual symptoms of neurotoxicity Grade \\> 1 from CAR-T therapy\n   * Ongoing immunosuppressive therapy\n4. Positive serology for human immunodeficiency virus (HIV) test in Screening 5. Concurrent anticancer therapy\n\n6\\. Use of ≥ 20 mg prednisone QD or equivalent dose of steroid per day within 7 days prior to the planned pirtobrutinib start date on Day 1 Cycle 1. Patients may not be on prednisone of any dose intended for antineoplastic use 7. Vaccination with a live vaccine within 28 days prior to registration 8. Prolongation of the corrected QT interval using the Fredericia formula (QTcF) \\> 470 msec (QTcF is calculated using Fridericia's Formula: QTcF = QT \u002F \\[RR0.33\\])\n\n* Correction of suspected drug induced QTcF prolongation can be attempted at the investigator's discretion and only if clinically safe to do so with either discontinuation of the offending drug or switch to another drug not known to be associated with QTcF prolongation\n* Manual correction for underlying bundle branch block is allowed Note: Patients with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker 9. Female patient who is pregnant or plans to become pregnant within 1 month after the last dose of study treatment 10. Female patient who is lactating or plans to breastfeed during the study or within 1 week after the last dose of study drug 11. Active second malignancy 12. Clinically significant active malabsorption syndrome including surgical resection of small intestine or other condition likely to affect gastrointestinal (GI) absorption of the oral administered study drugs 13. Active hepatitis B or C infection defined as:\n* Hepatitis B virus (HBV): positive hepatitis B surface antigen (HbsAg) or hepatitis B core antibody (anti-HBc). If anti-HBc positive with surface antigen negative, patient will need to have a negative result for hepatitis B DNA before start of study therapy. Patients who are anti-HBc positive and hepatitis B polymerase chain reaction positive will be excluded\n* Hepatitis C virus (HCV): positive hepatitis C antibody. If positive hepatitis C antibody result, patient will need to have a negative result for hepatitis C ribonucleic acid (RNA) before start of study therapy. Patients who are hepatitis C RNA positive will be excluded 14. Known active cytomegalovirus infection Note: Patients with an unknown or negative status are eligible 15. Evidence of other clinically significant uncontrolled condition(s) including, but not limited to, uncontrolled systemic infection (viral, bacterial, parasitic, or fungal) or other clinically significant active disease process which, in the opinion of the investigator, may pose a risk for patient participation. Screening for chronic conditions is not required 16. Active uncontrolled auto-immune cytopenia (e.g., autoimmune haemolytic anaemia, idiopathic thrombocytopenic purpura) where new therapy is introduced, or concomitant medication escalated within the 4 weeks prior to registration is required to maintain adequate blood counts. Stable controlled auto-immune cytopenias are allowed as long as required blood count criteria are met 17. Prior treatment with pirtobrutinib 18. Patients requiring therapeutic anticoagulation with warfarin or another vitamin K antagonist 19. Known hypersensitivity to any component or excipient of pirtobrutinib 20. Significant cardiovascular disease defined as:\n* Unstable angina or acute coronary syndrome within the past 2 months prior to registration\n* History of myocardial infarction within 3 months prior to registration\n* Documented left ventricular ejection fraction by any method of ≤ 40% in the 12 months prior to registration\n* ≥ Grade 3 New York Heart Association functional classification system of heart failure\n* Uncontrolled or symptomatic arrhythmias 21. History of uncontrolled or symptomatic arrhythmias including Grade ≥ 3 arrhythmia on a prior BTKi 22. History of major bleeding on a prior BTKi NOTE: Major bleeding is defined as bleeding having 1 or more of the following features: potentially life-threatening bleeding with signs or symptoms of hemodynamic compromise; bleeding associated with a decrease in the Hb level of at least 20 g\u002FL; or bleeding in a critical area or organ (e.g., retroperitoneal, intra-articular, pericardial, epidural, or intracranial bleeding or intramuscular bleeding with compartment syndrome) 23. History of stroke or intracranial haemorrhage within 6 months prior to registration 24. Major surgery within 4 weeks prior to registration 25. History of bleeding diathesis 26. Current treatment with strong P-glycoprotein (P-gp) inhibitors",{"count":329,"type":21},40,[131],"This is a multicentre single-arm prospective phase II trial evaluating pirtobrutinib in the treatment of relapsed\u002Frefractory (R\u002FR) Chronic Lymphocytic Leukaemia (CLL) patients who have previously received zanubrutinib, and to specifically evaluate Bruton Tyrosine Kinase (BTK) mutational status (clonal dynamics) before, during and after treatment with pirtobrutinib.",[333],"Chronic Lymphocytic Leukemia",[335,336,337,338,339,340,341,342],"Pirtobrutinib","Bruton Tyrosine Kinase","BTK mutation","clonal dynamics","CLL","BTK inhibitor","Chronic Lymphocytic Leukaemia","Leukaemia","2025-08-04",{"date":345,"type":41},"2025-08-06",{"date":347,"type":41},"2025-05-05",{"date":349,"type":21},"2031-05",{"name":47,"class":48},3,{"id":353,"slug":354,"hasResults":11,"nctId":355,"briefTitle":356,"officialTitle":356,"acronym":357,"eligibilityCriteria":358,"healthyVolunteers":11,"sex":359,"minAge":18,"maxAge":4,"enrollmentInfo":360,"targetDuration":4,"studyType":22,"phases":361,"briefSummary":362,"conditions":363,"keywords":365,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":372,"lastUpdatePostDateStruct":373,"startDateStruct":375,"completionDateStruct":377,"leadSponsor":379,"locationsCount":49},"100599890","phase-1-phase-ib-trial-of-177lu-psma-it-therapy-in-combination-with-olaparib-and-pembrolizumab-in-patients-with-metastatic-castration-resistant-prostate-cancer-100599890","NCT07090369","Phase Ib Trial of 177Lu-PSMA-I&T Therapy in Combination With Olaparib and Pembrolizumab in Patients With Metastatic Castration Resistant Prostate Cancer","LumOnate","Inclusion Criteria:\n\n1. Patient must have provided written informed consent using the LumOnate Patient Information and Consent Form (PICF)\n2. Patient must be ≥ 18 years of age at Screening\n3. Willing and able to comply with treatment schedule, laboratory testing, and other requirements of the study\n4. Histologically confirmed adenocarcinoma of the prostate without neuroendocrine or small cell differentiation\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n6. At least 2 weeks since the completion of prior therapy, including surgery or radiotherapy\n7. PSA \\> 5 ng\u002FmL\n8. Significant PSMA avidity on PSMA PET\u002FCT, defined as a minimum uptake of SUVmax 15 at a site of disease, and SUVmax \\> 10 at other sites of disease ≥ 10mm (unless subject to factors explaining a lower uptake, e.g. respiratory motion, reconstruction artefact)\n9. Radiographic evidence of metastatic disease documented with either bone scan or CT scan (Appendix 2)\n10. Patients must have adequate bone marrow, hepatic and renal function documented within 28 days prior to registration, defined as:\n\n    * Haemoglobin ≥ 100 g\u002FL independent of transfusions (no red blood cell transfusion in last 8 weeks)\n    * Absolute neutrophil count ≥ 1.5 x 109\u002FL\n    * Platelets ≥ 150 x 109\u002FL\n    * Total bilirubin ≤ 1.5 x upper limit of normal (ULN) except for patients with known Gilbert's syndrome\n    * Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN if there is no evidence of liver metastasis or ≤ 5 x ULN in the presence of liver metastases\n    * Albumin ≥ 30 g\u002FL\n    * Adequate renal function: Patients must have creatinine clearance (CrCl) estimated of ≥ 51 mL\u002Fmin using the Cockcroft-Gault equation or based on a 24 hour urine test\n11. Patients must have progressed on an ARPI (e.g. enzalutamide, abiraterone, darolutamide\u002For apalutamide). Determination of disease progression on an ARPI will be made by the local Investigator\n12. Patients must have progressive disease defined as any one of the following:\n\n    1. PSA progression: minimum of two rising PSA values from a baseline measurement with an interval of ≥ 1 week between each measurement. The PSA value at screening should be ≥ 5 ng\u002FmL\n    2. Soft tissue or visceral disease progression as per modified RECIST 1.1 criteria (Appendix 2)\n    3. Bone progression: ≥ 2 new lesions on bone scan (Appendix 2)\n13. Prior surgical orchiectomy or chemical castration maintained on ongoing luteinizing hormone-releasing hormone analogue (agonist or\n14. Patients must have a life expectancy ≥ 24 weeks\n15. Non-sterilised male patients who are sexually active with a female partner of childbearing potential must use a condom from screening to approximately 3 months after the last dose of treatment. Female partners of male patients should also use a highly effective form of contraception throughout this period\n16. Patients who are deemed to have disease that is safe and amenable to biopsy based on screening PSMA PET scans will be mandated to consent to paired tumour biopsies at Screening and on treatment\n\nExclusion Criteria:\n\n1. Prior chemotherapy for mCRPC. Prior docetaxel is permitted if given in the setting of hormone sensitive disease\n2. Site(s) of disease that are FDG positive with low PSMA expression defined by PSMA SUVmax \\\u003C 10\n3. Extensive marrow disease defined by a \"Super Scan\" on bone scintigraphy or diffuse marrow infiltration on PSMA PET\n4. Active brain metastases or leptomeningeal metastases\n5. Any prior exposure to anti-PD-1, anti-PD-L1\u002FL2, anti-CD137, or anti-CTLA-4 antibody or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathway\n6. Any prior exposure to PARP inhibitors, platinum, or radionuclide therapy\n7. Patients with a history or clinical features suggestive of myelodysplastic syndrome\u002Facute myeloid leukaemia or previously known clonal haemopoiesis\n8. Patients unable to swallow orally administered medications or with gastrointestinal disorders likely to interfere with the absorption of the study medication\n9. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on High Resolution Computed Tomography scan or psychiatric illness\u002Fsocial situations that is likely to impede participation and \u002For compliance in the study\n10. Patients with active, known, or suspected autoimmune disease Note: Patients with vitiligo, type 1 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 are permitted to enrol\n11. Patients with a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 7 days of registration Note: Inhaled or topical steroids, and adrenal replacement doses \\> 10 mg daily prednisone are permitted in the absence of active autoimmune disease\n12. Malignancy within the previous 2 years other than basal cell or squamous cell carcinomas, skin or melanoma in situ, or other cancers that are unlikely to recur within 24 months\n13. Positive test for hepatitis B virus surface antigen (HBsAg) or hepatitis C ribonucleic acid (HCV PCR) indicating acute or chronic infection\n14. Patients with symptomatic or impending cord compression unless appropriately treated beforehand and clinically stable\n15. Persistent toxicities (CTCAE ≥ Grade 2) caused by previous cancer therapy, excluding alopecia\n16. Previous history of interstitial lung disease or non-infectious pneumonitis\n17. Resting ECG indicating uncontrolled, potentially reversible cardiac conditions, as judged by the Investigator (e.g., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation \\> 500 ms, electrolyte disturbances, etc.), or patients with congenital long QT syndrome\n18. Known hypersensitivity to olaparib or pembrolizumab or any of the excipients of olaparib or pembrolizumab\n19. Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV) 1\u002F2. Only need to check this if there is a clinical history. HIV-infected (HIV1\u002F2 antibody-positive) patients may participate if they meet all the following eligibility requirements:\n\n    * They must be on an anti-retroviral regimen with evidence of at least two undetectable viral loads within the past 6 months on this same regimen; the most recent undetectable viral load must be within 12 weeks prior to registration\n    * They must have a CD4 count ≥ 250 cells\u002FµL over the past 6 months on this same anti-retroviral regimen and must not have had a CD4 count \\\u003C 200 cells\u002FµL over the past 2 years unless it was deemed related to the cancer and\u002For chemotherapyinduced bone marrow suppression\n    * For patients who have received chemotherapy in the past 6 months, a CD4 count \\\u003C 250 cells\u002FµL during chemotherapy is permitted as long as viral loads were undetectable during this same chemotherapy\n    * They must have an undetectable viral load and a CD4 count ≥ 250 cells\u002FµL within 7 days prior to registration\n    * They must not be currently receiving prophylactic therapy for an opportunistic infection and must not have had an opportunistic infection within 6 months prior to registration\n20. Concomitant use of known strong cytochrome P450, family 3 (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\n21. Concomitant use of known strong (e.g., phenobarbital, enzalutamide, 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 and enzalutamide, and 3 weeks for other agents\n22. Previous allogenic bone marrow transplant or double umbilical cord blood transplantation\n23. Participation in another clinical study with an investigational product or another systemic therapy administered within 3 weeks prior to registration","MALE",{"count":5,"type":21},[24],"This phase 1b trial is designed to evaluate the safety and tolerability of olaparib in combination with 177Lutetium-Prostate Specific Membrane Antigen (177 Lu-PSMA) and pembrolizumab in patients with metastatic castration resistant prostate cancer (mCRPC).",[364],"Metastatic Castrate Resistant Prostate Cancer (mCRPC)",[366,367,368,369,370,371],"prostate cancer","olaparib","pembrolizumab","177Lu-PSMA","metastatic castrate resistant prostate cancer","triplet therapy","2025-07-24",{"date":374,"type":41},"2025-07-29",{"date":376,"type":21},"2025-11-01",{"date":378,"type":21},"2028-12-01",{"name":47,"class":48},{"id":381,"slug":382,"hasResults":11,"nctId":383,"briefTitle":384,"officialTitle":385,"acronym":386,"eligibilityCriteria":387,"healthyVolunteers":11,"sex":359,"minAge":18,"maxAge":4,"enrollmentInfo":388,"targetDuration":4,"studyType":22,"phases":390,"briefSummary":391,"conditions":392,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":395,"startDateStruct":397,"completionDateStruct":399,"leadSponsor":401,"locationsCount":351},"100482332","phase-2-lu-psma-for-oligometastatic-prostate-cancer-treated-with-stereotactic-ablative-radiotherapy-100482332","NCT05560659","Lu-PSMA for Oligometastatic Prostate Cancer Treated With STereotactic Ablative Radiotherapy","Lu-PSMA for Oligometastatic Prostate Cancer Treated With STereotactic Ablative Radiotherapy, a Randomised Phase II Parallel Cohort Trial","POPSTAR II","Inclusion Criteria:\n\n1. Male aged 18 years or older at screening\n2. Patient has provided written informed consent\n3. Histologically confirmed prostate adenocarcinoma w\n4. Prior definitive treatment of the primary with either curative intent radiotherapy and\u002For surgery\n5. Patient has 1-5 sites of nodal or bony metastases on 68Ga-PSMA or 18F-DCFPyL PET\u002FCT\n6. Adequate haematological function as defined by:\n\n   * Absolute neutrophil count (ANC) ≥1.5 x 109\u002FL\n   * Platelet count \\>150x 109\u002FL\n   * Haemoglobin ≥100 g\u002FL\n   * Creatinine Clearance ≥ 40mL\u002Fmin (Cockcroft-Gault formula)\n7. Assessed as suitable for SABR by a radiation oncologist\n8. Patients must agree to use an adequate method of contraception\n9. Have a performance status of 0-1 on the ECOG Performance Scale\n\nExclusion Criteria:\n\n1. Prior systemic therapy for metastatic prostate cancer. Prior ADT is allowed but ADT within 6 months of screening for the study is not allowed. If patients have received prior ADT, serum testosterone levels must be above the lower limit of normal\n2. Any visceral (AJCCC M1c) metastases\n3. Symptomatic cord compression, or clinical or imaging findings concerning for impending cord compression\n4. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator\n5. Has a known additional malignancy that is progressing or required active treatment in the last 2 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 that has undergone potentially curative therapy are not excluded.",{"count":389,"type":21},92,[131],"The aim of this study is to assess the progression free survival (PFS) of SABR alone and SABR + 177Lu-prostate-specific membrane antigen (PSMA) in patients with oligometastatic prostate cancer undergoing PSMA positron emission tomography (PET) staging.",[393],"Oligometastatic Prostate Cancer","2025-07-08",{"date":396,"type":41},"2025-07-11",{"date":398,"type":41},"2023-12-14",{"date":400,"type":21},"2027-05",{"name":47,"class":48},{"id":403,"slug":404,"hasResults":11,"nctId":405,"briefTitle":406,"officialTitle":407,"acronym":408,"eligibilityCriteria":409,"healthyVolunteers":11,"sex":17,"minAge":410,"maxAge":4,"enrollmentInfo":411,"targetDuration":4,"studyType":22,"phases":412,"briefSummary":413,"conditions":414,"keywords":416,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":429,"startDateStruct":431,"completionDateStruct":433,"leadSponsor":435,"locationsCount":237},"100547913","phase-2-mrd-directed-consolidation-with-epcor-only-or-epcor-r2-post-anti-cd19-car-tcell-therapy-for-large-b-cell-lymphoma-100547913","NCT06414148","MRD-Directed Consolidation With Epcor-only or Epcor-R2 Post Anti-CD19 CAR TCell Therapy for Large B-Cell Lymphoma","A Phase II Open-Label, Multi-Centre Study of Minimal Residual Disease-Directed Consolidation With Epcoritamab or Epcoritamab-Lenalidomide-Rituximab Post Anti-CD19 CAR TCell Therapy for Large B-Cell Lymphoma (EpLCART)","EpLCART","Inclusion Criteria\n\n1. Age ≥ 16 years old at the time of signing the patient information and consent form (PICF)\n2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n3. A diagnosis of relapsed\u002Frefractory large B-cell lymphoma\n4. Received Therapeutic Good Administration (TGA) approved anti-CD19 CAR T-cell therapy as the most recent large B-cell lymphoma treatment.\n5. Partial metabolic response (PMR) or complete metabolic response (CMR) as per the Lugano criteria on the most recent PET\u002FCT performed at any point between Day +25 and Day +100 post CAR T-cell infusion, when compared with the most recent PET\u002FCT prior to CAR T-cell infusion.\n6. MRD positive by a ctDNA assay on a blood sample taken at any point between Day +25 and Day +100 post CAR T-cell infusion.\n7. Adequate haematological function documented within 7 days prior to randomisation\n8. Adequate cardiac function.\n9. Adequate renal function, documented within 7 days prior to randomisation\n10. Adequate hepatic function documented within 7 days prior to randomisation\n11. Complete resolution of cytokine release syndrome (CRS), macrophage-activation syndrome (MAS)\u002Fhaemophagocytic lymphohistiocytosis (HLH) or immune effector cell-associated neurotoxicity syndrome (ICANS) related to prior CAR T-cell therapy.\n12. Female patients of childbearing potential (FCBP) must be willing to follow the contraceptive method\u002Fprocedure as outline in the PICF\n13. Sexually active males must agree to use a condom during sexual contact with a pregnant female or a FCBP for the course of the study through to 4 months after the last dose of epcoritamab, even if he has undergone a successful vasectomy\n14. Women must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction. Men must also not donate sperm during the trial and for 4 months after receiving the last dose of epcoritamab\n15. The patient understands the purpose of the trial and procedures required for the trial which includes compliance with the protocol requirements and restrictions listed in the PICF and in this protocol\n\nExclusion Criteria\n\n1. A history of Grade 4 CRS or ICANS related to prior CAR T-cell therapy\n2. Patients whose lymphoma is known to be CD20 negative on the most recent biopsy prior to CAR T-cell therapy\n3. Ongoing active bacterial, viral, fungal, mycobacterial, parasitic, or other infection requiring systemic treatment\n4. Progression or relapse within 3 months after a regimen containing a bispecific antibody targeting CD3 and CD20\n5. A diagnosis of primary central nervous system (CNS) lymphoma\n6. Active secondary CNS involvement of lymphoma at time of screening\n7. A known history or current autoimmune disease or other diseases resulting in permanent immunosuppression\n8. Known cognitive impairment would place the patient at increased risk of complications from ICANS\n9. A known history of hepatitis B serology consistent with acute or chronic infection\n10. A known history of hepatitis C serology consistent with acute or chronic infection\n11. A known history of testing positive for human immunodeficiency virus (HIV)\n12. Any comorbidity conferring a life expectancy of \\\u003C 5 years (e.g., second malignancy) or that in the opinion of the site investigator may significantly impact the ability to complete the trial therapy and follow-up or affect the interpretation of results\n13. Exposed to live or live attenuated vaccine within 4 weeks prior to signing the PICF.\n14. Women who are pregnant or lactating\n15. Known hypersensitivity to epcoritamab, lenalidomide, rituximab, tocilizumab or their excipients\n16. Presence of any psychological, social or geographical or other condition for which participation would not be in the best interest of the patient","16 Years",{"count":329,"type":21},[131],"This is a Phase II open-label, two-arm randomised non-comparative, multi-centre study to evaluate the efficacy of Epcor-only (Epcoritamab alone) or Epcor-R2 (Epcoritamab, lenalidomide and rituximab) as consolidation post anti-CD19 CAR T-cell therapy for patients that have responded by conventional criteria but who are at high risk of progression by virtue of being Minimal Residual Disease (MRD) positive as determined by a Circulating Tumour DNA (ctDNA) assay.",[415],"Relapsed\u002FRefractory Large B-cell Lymphoma",[417,418,419,420,421,422,423,424,425,426,427],"Minimal Residual Disease","Large B-Cell Lymphoma","Anti-CD19","CAR T","ctDNA","Lymphoma","DLBCL","HGBL","Epcoritamab","Lenalidomide","Rituximab","2025-06-04",{"date":430,"type":41},"2025-06-05",{"date":432,"type":41},"2024-05-14",{"date":434,"type":21},"2028-05",{"name":47,"class":48},{"id":437,"slug":438,"hasResults":11,"nctId":439,"briefTitle":440,"officialTitle":441,"acronym":442,"eligibilityCriteria":443,"healthyVolunteers":11,"sex":359,"minAge":18,"maxAge":4,"enrollmentInfo":444,"targetDuration":4,"studyType":22,"phases":446,"briefSummary":447,"conditions":448,"keywords":451,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":458,"lastUpdatePostDateStruct":459,"startDateStruct":461,"completionDateStruct":463,"leadSponsor":465,"locationsCount":49},"100479317","phase-1-evaluation-of-radioligand-treatment-in-men-with-metastatic-castration-resistant-prostate-cancer-with-161tbtb-psma-it-100479317","NCT05521412","EValuation of radIOLigand Treatment in mEn With Metastatic Castration-resistant Prostate Cancer With [161Tb]Tb-PSMA-I&T","EValuation of radIOLigand Treatment in mEn With Metastatic Castration-resistant Prostate Cancer With [161Tb]Tb-PSMA-I&T: Phase I\u002FII Study","VIOLET","Inclusion Criteria:\n\n1. Patient has provided written informed consent.\n2. Male patients must be 18 years of age or older at the time of written informed consent.\n3. Histologically or cytologically confirmed adenocarcinoma of the prostate, OR unequivocal diagnosis of metastatic prostate cancer (i.e., involving bone or pelvic lymph nodes or para-aortic lymph nodes) with an elevated serum prostate specific antigen (PSA).\n4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.\n5. Patients must have had prior treatment with at least one line of taxane chemotherapy, unless medically unsuitable.\n6. Patients must have had prior treatment with at least one second-generation androgen receptor (AR)-targeted agent (e.g., enzalutamide, abiraterone, apalutamide or darolutamide).\n7. Patients must have progressive disease defined according to The Prostate Cancer Clinical Trials Working Group 3 (PCWG3) as any one of the following:\n\n   1. PSA progression - minimum of 2 rising PSA values from a baseline measurement with an interval of ≥ 1 week between each measurement\n   2. Soft tissue progression as per Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1) criteria\n   3. Bone progression: ≥ 2 new lesions on bone scan\n8. Prior surgical orchiectomy or chemical castration maintained on luteinizing hormone-releasing hormone (LHRH) analogue (agonist or antagonist).\n9. Serum testosterone levels ≤ 1.75nmol\u002FL (≤ 50ng\u002FdL).\n10. Significant prostate specific membrane antigen (PSMA) avidity on PSMA positron emission tomography (PET)\u002Fcomputed tomography (CT), defined as a minimum uptake of maximum standardised uptake value (SUVmax) 20 at a site of disease, and SUVmax \\> 10 at sites of measurable soft tissue disease ≥ 15mm (unless subject to factors explaining a lower uptake, e.g. respiratory motion, reconstruction artefact).\n11. Patients must have a life expectancy ≥ 6 months.\n12. Patients must have adequate bone marrow, hepatic and renal function, defined as:\n\n    1. Haemoglobin ≥ 100g\u002FL independent of transfusions (no red blood cell transfusion in last 4 weeks)\n    2. Absolute neutrophil count (ANC) ≥ 1.5 x 10\\^9\u002FL\n    3. Platelets ≥ 150 x 10\\^9\u002FL\n    4. Total bilirubin ≤ 1.5x upper limit of normal (ULN) except for patients with known Gilbert's syndrome, where this applies for the unconjugated bilirubin component\n    5. Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3x ULN if there is no evidence of liver metastasis or ≤ 5x ULN in the presence of liver metastases\n    6. Adequate renal function: patients must have a creatinine clearance estimated of ≥ 40mL\u002Fmin using the Cockcroft Gault equation (Appendix 3)\n13. Sexually active patients are willing to use medically acceptable forms of barrier contraception.\n14. Willing and able to comply with all study requirements, including all treatments and the timing and nature of all required assessments.\n15. At least 3 weeks since the completion of surgery or radiotherapy prior to registration.\n\nExclusion Criteria:\n\n1. Prior treatment with another radioisotope (i.e. PSMA radioligands, radium-223, strontium-89, samarium-153).\n2. Site(s) of discordant disease on PET imaging (Fluorodeoxyglucose \\[FDG\\]-positive and minimal PSMA-uptake).\n3. Other malignancies (in addition to the prostate cancer being treated on this study) within the previous 2-years prior to registration other than basal cell or squamous cell carcinomas of skin or other cancers that are unlikely to recur within 24 months.\n4. Symptomatic brain metastases or leptomeningeal metastases.\n5. Patients with symptomatic or impending cord compression unless appropriately treated beforehand and clinically stable for more than 4 weeks.\n6. Concurrent illness, including severe infection that may jeopardize the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety.",{"count":445,"type":21},42,[24,131],"This clinical trial will evaluate the safety and efficacy of \\[161Tb\\]Tb -PSMA-I\\&T in men with metastatic castration-resistant prostate cancer (mCRPC).",[449,450],"Prostate Cancer","Metastatic Castration-resistant Prostate Cancer",[452,453,454,455,456,457],"Prostate cancer","PSMA","mCRPC","PSMA-I&T","[161Tb]Tb","Terbium-161","2025-04-03",{"date":460,"type":41},"2025-04-06",{"date":462,"type":41},"2022-09-29",{"date":464,"type":21},"2026-12",{"name":47,"class":48},{"id":467,"slug":468,"hasResults":11,"nctId":469,"briefTitle":470,"officialTitle":471,"acronym":472,"eligibilityCriteria":473,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":474,"targetDuration":4,"studyType":22,"phases":476,"briefSummary":477,"conditions":478,"keywords":480,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":482,"lastUpdatePostDateStruct":483,"startDateStruct":485,"completionDateStruct":487,"leadSponsor":489,"locationsCount":49},"100443396","phase-1-parp-inhibitor-with-177lu-dota-octreotate-prrt-in-patients-with-neuroendocrine-tumours-100443396","NCT05053854","PARP Inhibitor With 177Lu-DOTA-Octreotate PRRT in Patients With Neuroendocrine Tumours","Phase 1 Trial of PARP Inhibitor Combined With 177Lu-DOTA-Octreotate Peptide Receptor Radionuclide Therapy (PRRT) in Patients With Metastatic NeuroEndocrine Tumor","PARLuNET","Inclusion Criteria:\n\n1. Patient must be \\> or equal to18 years of age and must have provided written informed consent.\n2. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2\n3. Histologically confirmed Grade 2 NET, Ki-67 of 3-20%, from pancreatic or intestinal origin.\n4. Patient clinically suitable for PRRT\n5. Tumor SSR uptake on GaTate PET\u002FCT higher than liver activity, ≥ modified Krenning 3 score\n6. No discordant FDG-avid disease on FDG PET\u002FCT\n7. No evidence of significant uncorrected carcinoid heart disease\n8. Patients must be willing and able to comply with the protocol for the duration of the study including undergoing treatment, scheduled assessments\n9. Patients must have adequate bone marrow, hepatic and renal function defined as:\n\n   * Haemoglobin ≥100 g\u002FL\n   * Absolute neutrophil count ≥1.5x109\u002FL\n   * Platelets ≥150 x109\u002FL\n   * Total bilirubin ≤1.5 x upper limit of normal (ULN)\n   * Aspartate transaminase (AST) (SGOT) and alanine transaminase (ALT) (SGPT)\n\n     ≤2.5 x ULN if there is no evidence of liver metastasis or ≤5 x ULN in the presence of liver metastases.\n   * Albumin ≥ 30 g\u002FL\n   * Adequate renal function: eGFR ≥ 50 ml\u002Fmin\n\nExclusion Criteria:\n\n1. Surgery or radiotherapy within \\\u003C3 weeks of registration. Patients must have recovered from any effects of any major surgery.\n2. Any prior exposure to peptide receptor radionuclide therapy (177Lu, 111In or 90Y labelled), PARPi, immunotherapy\n3. Uncontrolled intercurrent illness that is likely to impede participation and \u002For compliance\n4. Other malignancies unless curatively treated with no evidence of disease within previous 3-years other than adequately treated non-melanoma skin cancer or melanoma in situ.\n5. Previous or current history of myelodysplastic syndrome\u002Facute myeloid leukemia\n6. Patients unable to swallow orally administered medications or with gastrointestinal disorders likely to interfere with the absorption of the study medication.\n7. Use of strong P-gp inhibitors (eg, dronedarone, quinidine, ranolazine, verapamil, ketoconazole, itraconazole), P-gp inducers (eg, rifampin, tipranavir\u002Fritonavir), or BCRP inhibitors (eg, elacridar \\[GF120918\\]) should be avoided.\n8. Participation in another clinical study with an investigational product or another systemic therapy administered in the last 3 weeks (except short acting SSA).",{"count":475,"type":21},24,[24],"This phase 1 dose-escalation study is designed to evaluate the safety and tolerability of talazoparib in combination with 177Lu-DOTA-Octreotate peptide receptor radionuclide therapy (PRRT) in patients with metastatic pancreatic or midgut neuroendocrine tumour (NET).",[479],"Neuroendocrine Tumors",[481],"NET","2025-02-18",{"date":484,"type":41},"2025-02-20",{"date":486,"type":41},"2021-12-08",{"date":488,"type":21},"2029-06-30",{"name":47,"class":48},{"id":491,"slug":492,"hasResults":11,"nctId":493,"briefTitle":494,"officialTitle":495,"acronym":496,"eligibilityCriteria":497,"healthyVolunteers":11,"sex":17,"minAge":498,"maxAge":4,"enrollmentInfo":499,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":501,"conditions":502,"keywords":506,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":511,"lastUpdatePostDateStruct":512,"startDateStruct":514,"completionDateStruct":516,"leadSponsor":518,"locationsCount":49},"100454380","diagnosis-and-phenotype-characterisation-using-genomics-in-patients-with-inherited-bone-marrow-failure-ibmdx-study-100454380","NCT05196789","Diagnosis and Phenotype Characterisation Using Genomics in Patients With Inherited Bone Marrow Failure (IBMDx Study)","Diagnosis, Discovery and Novel Phenotype Characterisation Using Multimodal Genomics in Patients With Inherited Bone Marrow Failure and Related Disorders (IBMDx Study)","IBMDx","Inclusion Criteria:\n\n1. age ≥ 3 months\n2. able to give informed consent (or parent\u002Fguardian able to give informed consent)\n3. a clinicopathological diagnosis (or differential diagnosis) of inherited bone marrow failure syndrome or related disorder (IBMFS-RD) as per the study team\n\nExclusion Criteria:\n\n1. A clinicopathological diagnosis of an acquired bone marrow failure syndrome (including acquired aplastic anaemia and hypoplastic myelodysplastic syndrome) as per the study team\n2. Existing definitive genomic diagnosis for patient's haematological phenotype","3 Months",{"count":500,"type":21},350,"This project seeks to perform whole genome sequence (WGS) and whole transcriptome sequence (WTS) analysis on 350 patients with suspected inherited bone marrow failure syndromes and related disorder (IBMFS-RD) in order to increase the genomic diagnostic rate in IBMFS.",[503,504,505],"Inherited BMF Syndrome","Inherited Platelet Disorder","Hematologic Diseases",[507,508,509,510],"bone marrow failure syndrome","whole genome sequencing","hematological diseases","pancytopenia","2024-11-05",{"date":513,"type":41},"2024-11-07",{"date":515,"type":41},"2022-03-18",{"date":517,"type":21},"2025-12",{"name":47,"class":48},{"id":520,"slug":521,"hasResults":11,"nctId":522,"briefTitle":523,"officialTitle":524,"acronym":525,"eligibilityCriteria":526,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":527,"targetDuration":4,"studyType":22,"phases":528,"briefSummary":529,"conditions":530,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":532,"lastUpdatePostDateStruct":533,"startDateStruct":535,"completionDateStruct":537,"leadSponsor":539,"locationsCount":237},"100456322","phase-1-primelung-primary-radiotherapy-in-metastatic-lung-cancer---a-pilot-study-100456322","NCT05222087","PRIME_LUNG: Primary Radiotherapy In MEtastatic Lung Cancer - A Pilot Study","PRIME_LUNG: Primary Radiotherapy In MEtastatic Lung Cancer. A Pilot Study","PRIME_LUNG","Inclusion Criteria:\n\n* Have provided written informed consent for the trial.\n* Be ≥ 18 years of age on day of signing informed consent.\n* Newly diagnosed, metastatic (stage IV), non-small cell lung cancer (NSCLC), not amenable to curative surgery or curative radiotherapy\n* Histological or cytologically documented NSCLC\n* EGFR\u002FALK\u002FROS1 Wild-type\n* Primary disease suitable for radiotherapy and not requiring immediate palliative irradiation\n* ECOG 0-1\n\nExclusion Criteria:\n\n* Medically unfit for systemic therapy\n* EGFR\u002FALK\u002FROS1 mutation positive\n* Has had previous thoracic radiotherapy of \\> 36Gy in 12 fractions (or equivalent) within the 6 months prior to randomisation.\n* Has diagnosed and\u002For treated additional malignancy within 3 years prior to randomisation with the exception of: curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, curatively treated early-stage cervical cancer, breast cancer or prostate cancer with no evidence of active disease. Other exceptions may be considered following consultation with the principal investigator.\n* Has a history of (non-infectious) pneumonitis or current pneumonitis that requires active corticosteroids with a dose equivalent of prednisolone\\>10mg\u002Fd.\n* Has had any systemic anti-cancer therapy within 4 weeks prior to randomisation\n* A known diagnosis of idiopathic pulmonary fibrosis\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* Uncontrolled brain metastases defined as not amenable to surgery or stereotactic radiotherapy",{"count":329,"type":21},[24],"Outcome for patients diagnosed with advanced lung cancer remains poor; alternative treatment options are urgently needed. Studies in other metastatic cancers indicate radiotherapy to the primary tumour can improve outcomes. The investigators postulate this will also be observed in lung cancer patients. The aim of this pilot study is to assess the safety and feasibility of stereotactic ablative radiotherapy (SABR) to the lung primary prior to standard of care (SoC) systemic therapy in advanced non-small cell lung cancer (NSCLC). Forty patients with advanced (Stage IV) NSCLC will be recruited across the five Peter Mac campuses. Patients will be randomised to receive SoC systemic therapy with or without radiotherapy to the lung primary. Radiotherapy will be delivered before cycle 3 of SoC systemic therapy. Biospecimens will be collected for future translational research. The primary outcome of the study (feasibility of the protocol) will be assessed by the ability to deliver radiotherapy to the lung cancer primary, whilst meeting dose constraints. The study will also 1) evaluate proportion of patients who are willing to be randomised; 2) describe toxicity during the follow up period in each arm; 3) describe progression free survival.",[531],"NSCLC","2024-08-14",{"date":534,"type":41},"2024-08-15",{"date":536,"type":41},"2022-01-03",{"date":538,"type":21},"2025-04",{"name":47,"class":48},{"id":541,"slug":542,"hasResults":11,"nctId":543,"briefTitle":544,"officialTitle":544,"acronym":545,"eligibilityCriteria":546,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":547,"targetDuration":4,"studyType":22,"phases":548,"briefSummary":549,"conditions":550,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":552,"lastUpdatePostDateStruct":553,"startDateStruct":555,"completionDateStruct":557,"leadSponsor":559,"locationsCount":49},"100490482","phase-1-car-t-cell-therapy-in-relapsedrefractory-myeloma-with-extramedullary-disease---an-in-vivo-imaging-and-molecular-monitoring-study-100490482","NCT05666700","CAR-T Cell Therapy in RelApsed\u002FRefractory Myeloma With ExtrameduLlary Disease - an in Vivo Imaging and Molecular Monitoring Study","CARAMEL","Inclusion Criteria:\n\nPatients must meet all the following criteria for study entry:\n\n1. Patient has provided written informed consent\n2. Patient is \\>18 years of age at the time of consent\n3. Patient has a documented diagnosis of MM according to the IMWG diagnostic criteria (Appendix 1)\n4. Measurable extramedullary disease by any imaging modality (at least one site of disease ≥1cm that has never received radiotherapy or has progressed following radiotherapy). Presence of biochemical measurable disease is not required\n5. Have received at least 2 prior lines of therapy including a PTI and an IMiD. Patient must have undergone at least 1 complete cycle of treatment for each line of therapy, unless PD was the best response to the line of therapy (Appendix 2) Note: induction with or without haematopoietic stem cell transplant, consolidation and maintenance therapy is considered a single line of therapy.\n6. Have an ECOG Performance Status score of 0 or 1 (Appendix 3)\n7. Have a life expectancy of ≥3 months, as judged by the Investigator\n8. Able to undergo apheresis for mononuclear cell collection\n9. Have clinical laboratory values meeting the following criteria within 7 days prior to registration (enrolment):\n\n   * Haemoglobin ≥80g\u002FL (recombinant human erythropoietin use is permitted)\n   * ANC ≥1 × 109\u002FL (prior growth factor support is permitted but must be without support in the 7 days prior to the laboratory test)\n   * Platelet count ≥50 × 109\u002FL\n   * Absolute lymphocyte count ≥0.3 × 109\u002FL\n   * AST ≤3.0× ULN\n   * ALT ≤3.0× ULN\n   * Total bilirubin ≤2.0× ULN; except in patients with congenital bilirubinaemia, such as Gilbert's syndrome (in which case direct bilirubin ≤2.0× ULN is required)\n   * Calculated CrCl ≥40mL\u002Fmin calculated by the Cockcroft-Gault formula (Appendix 4), nuclear medicine assessment or a 24-hour urine collection\n10. When a woman is of childbearing potential, the patient must commit either to abstaining continuously from heterosexual intercourse or agree to practice 2 methods of reliable birth control simultaneously. Where one of the methods is highly effective method of contraception (failure rate of \\\u003C1% per year when used consistently and correctly; see examples below) and one other effective method (i.e., male latex or synthetic condom, diaphragm, or cervical cap) and patient must agree to remain on both methods from the time of signing the PICF until at least 1 year after receiving a cilta-cel infusion (Appendix 5). Reliable contraception is indicated even where there has been a history of infertility, unless it is due to hysterectomy. WOCBP should be referred to a qualified provider of contraceptive methods, if needed. Examples of highly effective contraceptives include:\n\n    * User-independent methods: 1) implantable progestogen-only hormone contraception associated with inhibition of ovulation; 2) intrauterine device; intrauterine hormone-releasing system; 3) vasectomised partner\n    * User-dependent method: progestogen-only hormone contraception associated with inhibition of ovulation (oral or injectable)\n11. A man must commit either to abstaining continuously from heterosexual intercourse or a man who is sexually active with a WOCBP or a pregnant woman must agree to use a barrier method of contraception (e.g., latex or synthetic condom with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository) from the time of signing the PICF until at least 1 year after receiving a cilta-cel, even if they have undergone a successful vasectomy\n12. Women and men must agree not to donate eggs (ova, oocytes) or sperm, respectively, until at least 1 year after receiving a cilta-cel infusion\n13. Patient must be willing and able to adhere to the following lifestyle restrictions during the study to be eligible for participation:\n\n    * Refer to Section 8.6.3, Prohibited Therapies for details regarding prohibited and restricted therapy during the study\n    * Agree to follow all requirements that must be met during the study as noted in the Inclusion and Exclusion Criteria (e.g., contraceptive requirements)\n\nExclusion Criteria:\n\nPatients who meet any of the following criteria will be excluded from study entry:\n\n1. Known nickel or Pd sensitivity\n2. Weight \\>105 Kg and\u002For height \\>185 cm\n3. Known claustrophobia\n4. Prior treatment with CAR-T therapy directed at any target\n5. Received a cumulative dose of corticosteroids equivalent to ≥70mg of prednisone within the 7 days prior to planned apheresis\n6. Any prior therapy that is targeted to BCMA\n7. Vaccination with an investigational vaccine or live attenuated vaccine (except for COVID-19) within 4 weeks prior to planned conditioning\n8. Patient received any anti-tumour therapy as follows, prior to planned apheresis:\n\n   * Targeted therapy, epigenetic therapy, or treatment with an investigational drug or use of an invasive investigational medical device within 14 days or at least 5 half-lives, whichever is less\n   * Investigational vaccine within 4 weeks\n   * Monoclonal antibody treatment within 21 days\n   * Cytotoxic therapy within 14 days\n   * Radiotherapy within 14 days. However, if the radiation is given for palliative purposes and the radiation portal covered ≤5% of the bone marrow reserve, the patient is eligible irrespective of the end date of radiotherapy\n9. Active malignancies (i.e., progressing or requiring treatment change in the last 24 months) other than the disease being treated under study. The only allowed exceptions are:\n\n   * Non-muscle invasive bladder cancer treated within the last 24 months that is considered completely cured\n   * Skin cancer (non-melanoma or melanoma) treated within the last 24 months that is considered completely cured\n   * Non-invasive cervical cancer treated within the last 24 months that is considered completely cured\n   * Localised prostate cancer (N0M0):\n\n     * With a Gleason score of ≤6, treated within the last 24 months or untreated and under surveillance\n     * With a Gleason score of 3+4 that has been treated more than 6 months prior to full study screening and considered to have a very low risk of recurrence, or\n     * History of localised prostate cancer and receiving androgen deprivation therapy and considered to have a very low risk of recurrence\n   * Breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ, or history of localised breast cancer and receiving anti-hormonal agents and considered to have a very low risk of recurrence\n   * Malignancy that is considered cured with minimal risk of recurrence\n10. Plasma cell leukaemia at the time of screening (\\>2.0 x 109\u002FL plasma cells by standard differential), Waldenström's macroglobulinaemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary amyloid light-chain amyloidosis\n11. Contraindications or known life-threatening allergies, hypersensitivity, or intolerance to any of the study treatments (if known) or any of their excipients, including boron, mannitol, and dimethyl sulfoxide (refer to IB), or local product prescribing information for complete lists of excipients\n12. Pregnant or breast-feeding or planning to become pregnant while enrolled in this study or within 1 year after receiving cilta-cel infusion\n13. Plans to father a child while enrolled in this study or within 1 year after receiving cilta-cel infusion\n14. Stroke or seizure within 6 months prior to signing PICF\n15. Received either of the following:\n\n    * An allogenic stem cell transplant within 6 months before planned apheresis. Patients who received an allogeneic transplant must have stopped all immunosuppressive medications for 6 weeks without signs of graft-versus-host disease. Patients with active graft-versus-host disease are excluded\n    * An ASCT ≤12 weeks before planned apheresis\n16. Known active, or prior history of, CNS involvement or exhibits clinical signs of meningeal involvement of MM\n17. Any of the following criterion related to infectious diseases:\n\n    * Seropositive for HIV\n    * Hepatitis B infection: In the event the infection status is unclear, quantitative viral levels are necessary to determine the infection status (Appendix 6)\n    * Hepatitis C infection (defined as anti -HCV antibody positive or HCV-RNA positive) or known to have a history of hepatitis C NOTE: For patients with positive HCV antibody due to prior resolved disease can be enrolled, only if a confirmatory HCV RNA test is undetectable. For patients with known history of HCV infection, confirmation of sustained virologic response is required for study eligibility, defined as undetectable HCV RNA ≥24 weeks after completion of antiviral therapy.\n18. Serious underlying medical or psychiatric condition or disease, that is likely to interfere with study procedures or results, or that in the opinion of the Investigator would constitute a hazard for participating in this study, such as:\n\n    * Requirement of continuous supplemental oxygen\n    * Evidence of active viral or bacterial infection, requiring systemic antimicrobial therapy, or uncontrolled systemic fungal infection\n    * Active autoimmune disease\n    * Overt clinical evidence of dementia or altered mental status\n    * Any history of Parkinson's disease or other neurodegenerative disorder\n    * Clinically significant cardiac conditions, such as:\n\n      * NYHA Class III or IV congestive heart failure (Appendix 7) Short title: CARAMEL Page 60 of 128 Version: 1.0 Date: 17th November 2022\n      * Myocardial infarction or coronary-artery-bypass graft ≤6 months prior to planned apheresis\n      * History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration\n      * History of severe non-ischemic cardiomyopathy\n      * Impaired cardiac function (LVEF \\\u003C45%) as assessed by ECHO or MUGA scan performed ≤8 weeks before planned apheresis\n19. Major operations or surgical procedures within 2 weeks prior to bridging therapy, or has surgery planned during the study or within 2 weeks after study treatment administration Note: patients with planned surgical procedures to be conducted under local anaesthesia may participate.\n20. Frailty index of ≥ 2 according to Myeloma Geriatric Assessment score (Appendix 8)\n21. Any issue that would impair the ability of the patient to receive or tolerate the planned treatment, to understand informed consent or any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the patient (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments",{"count":278,"type":21},[24],"This clinical trial will investigate the in vivo trafficking of cilta-cel in extramedullary myeloma using 64Cu Super Paramagnetic Iron Oxide Nanoparticle (64Cu SPION) and Positron Emission Tomography-Magnetic Resonance Imaging (PET-MRI)",[551],"Extramedullary Myeloma","2024-04-10",{"date":554,"type":41},"2024-04-11",{"date":556,"type":41},"2023-12-08",{"date":558,"type":21},"2027-01",{"name":47,"class":48},{"id":561,"slug":562,"hasResults":11,"nctId":563,"briefTitle":564,"officialTitle":565,"acronym":566,"eligibilityCriteria":567,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":568,"targetDuration":4,"studyType":22,"phases":570,"briefSummary":571,"conditions":572,"keywords":574,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":576,"lastUpdatePostDateStruct":577,"startDateStruct":579,"completionDateStruct":581,"leadSponsor":583,"locationsCount":49},"100483068","metabolic-phenotypes-in-melanoma-100483068","NCT05570227","Metabolic Phenotypes in Melanoma","Identification of Metabolic Phenotypes Associated With Prognosis and Therapeutic Response in Patients With Melanoma","MetaMel","Inclusion Criteria:\n\n1. Patient has provided written informed consent\n2. Male or female aged 18 years or older at written informed consent\n3. Presence of a known melanoma lesion requiring surgical excision or biopsy\n4. Patient is willing and able to comply with the protocol for the duration of the study including undergoing biopsies and receiving a stable isotope infusion (where applicable)\n\nExclusion Criteria:\n\nPatients who meet any of the following criteria will be excluded from receiving a \\[U-13C\\]Glucose infusion:\n\n1. Diabetes mellitus\n2. Pregnancy or breast feeding\n3. Patients unable to comply with study procedures and follow up in the opinion of the investigator",{"count":569,"type":21},240,[96],"This is a single centre, correlative, longitudinal, biomarker study that aims to describe the metabolic features of human melanoma using mass spectrometry.",[573],"Melanoma",[575],"Metabolism","2023-07-03",{"date":578,"type":41},"2023-07-06",{"date":580,"type":41},"2023-06-27",{"date":582,"type":21},"2027-10",{"name":47,"class":48},""]