[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575055":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":32,"centralContacts":36,"locations":42,"responsibleParty":116,"collaborators":12,"id":118,"slug":119,"hasResults":120,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":124,"eligibilityCriteria":125,"healthyVolunteers":120,"sex":126,"minAge":127,"maxAge":12,"enrollmentInfo":128,"targetDuration":12,"studyType":131,"phases":132,"briefSummary":134,"conditions":135,"keywords":137,"overallStatus":45,"whyStopped":12,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":157},{"fullName":5,"class":6},"Melanoma Institute Australia","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A: Concurrent stereotactic body radiotherapy + Immune checkpoint inhibitor(s)","EXPERIMENTAL","Concurrent stereotactic body radiotherapy (SBRT) with standard of care immune checkpoint inhibitor(s) (ICI).\n\nPatients will receive a minimum SBRT biologically effective dose (BED) of 48Gy10 to all sites of metastatic disease between cycle 1 and cycle 3 of immunotherapy. The interval between cycles 1 and 3 will depend on the prescribed immunotherapy regimen that is standard of care at each participating site.\n\nStandard of care 1st line immunotherapy, as decided by the treating clinician and in accordance with the current listing on the Australian Register of Therapeutic Goods (ARTG) or applicable international regulatory agency will be administered concurrently",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Arm B: Immune checkpoint inhibitor(s)","ACTIVE_COMPARATOR","Immunotherapy alone\n\nStandard of care 1st line immunotherapy, as decided by the treating clinician and in accordance with the current listing on the Australian Register of Therapeutic Goods (ARTG) or applicable international regulatory agency will be administered alone.",[18],"Drug: Immunotherapy alone",[20,23],{"type":6,"name":21,"description":22,"armGroupLabels":12,"otherNames":12},"Stereotactic Body Radiotherapy (extracranial) concurrent with Immunotherapy","Radiotherapy A minimum SBRT biologically effective dose (BED) of 48Gy10 to all sites of extracranial metastatic disease should be administered between cycle 1 and cycle 3 of standard of care immunotherapy.\n\nImmunotherapy All patients will receive standard of care 1st line immunotherapy as decided by the treating clinician and in accordance with the current listing on the Australian Register of Therapeutic Goods (ARTG) or applicable international regulatory agency.\n\nOther Names:\n\nImmune checkpoint inhibitor Standard of care immunotherapy First line treatment",{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Immunotherapy alone","All patients will receive standard of care 1st line immunotherapy as decided by the treating clinician and in accordance with the current listing on the Australian Register of Therapeutic Goods (ARTG) or applicable international regulatory agency.",[14],[29,30,31],"Immune checkpoint inhibitor","Standard of care immunotherapy","First line treatment",[33],{"name":34,"affiliation":5,"role":35},"Angela Hong","STUDY_CHAIR",[37],{"name":38,"role":39,"phone":40,"phoneExt":12,"email":41},"Monica Osorio","CONTACT","+61 2 9911 7296","monica.osorio@melanoma.org.au",[43,61,75,88,101],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Westmead Hospital","RECRUITING","Westmead","New South Wales","2145","Australia","AU",{"type":52,"coordinates":53},"Point",[54,55],150.98768,-33.80383,{"lat":55,"lon":54},[58],{"name":59,"role":60,"phone":12,"phoneExt":12,"email":12},"Tim Wang","PRINCIPAL_INVESTIGATOR",{"facility":5,"status":45,"city":62,"state":47,"zip":63,"country":49,"countryCode":50,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Wollstonecraft","2065",{"type":52,"coordinates":65},[66,67],151.18981,-33.8328,{"lat":67,"lon":66},[70,74],{"name":71,"role":39,"phone":72,"phoneExt":12,"email":73},"Maria Gonzalez","+612 9911 7200","maria.gonzalez@melanoma.org.au",{"name":34,"role":60,"phone":12,"phoneExt":12,"email":12},{"facility":76,"status":45,"city":77,"state":78,"zip":79,"country":49,"countryCode":50,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Princess Alexandra Hospital","Woolloongabba","Queensland","4102",{"type":52,"coordinates":81},[82,83],153.03655,-27.48855,{"lat":83,"lon":82},[86],{"name":87,"role":60,"phone":12,"phoneExt":12,"email":12},"Mark Pinkham",{"facility":89,"status":45,"city":90,"state":91,"zip":92,"country":49,"countryCode":50,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"The Alfred Hospital","Melbourne","Victoria","3004",{"type":52,"coordinates":94},[95,96],144.96332,-37.814,{"lat":96,"lon":95},[99],{"name":100,"role":60,"phone":12,"phoneExt":12,"email":12},"Jeremy Ruben",{"facility":102,"status":45,"city":103,"state":104,"zip":105,"country":106,"countryCode":107,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"Princess Margaret Cancer Centre","Toronto","Ontario","M5G 2C4","Canada","CA",{"type":52,"coordinates":109},[110,111],-79.39864,43.70643,{"lat":111,"lon":110},[114],{"name":115,"role":60,"phone":12,"phoneExt":12,"email":12},"Philip Wong",{"type":117,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR","100575055","phase-2-stereotactic-ablative-radiotherapy-xrt-and-immunotherapy-for-oligometastatic-extracranial-melanoma-100575055",false,"NCT06767306","Stereotactic Ablative Radiotherapy (XRT) and Immunotherapy for Oligometastatic Extracranial Melanoma","A Phase II, Multicentre, Non-Comparative, Randomised Controlled Trial of Stereotactic Ablative Body Radiotherapy and Immunotherapy Versus Immunotherapy Alone in Patients With Treatment Naïve Oligometastatic Extracranial Melanoma","AXIOM","Inclusion Criteria:\n\n* Female or male patients, age 18 or older\n* Willing to provide signed informed consent\n* Life expectancy \\> 6 months\n* First presentation of AJCC Stage IV (any N, M1a, M1b, M1c), histologically confirmed cutaneous, acral or unknown primary melanoma with one to five extracranial metastases detected on CT and whole body PET-CT, and considered unresectable\n* A primary lesion and \u002F or up to 4 in-transit metastases(is) (ITM) in addition to distant metastases(is) are permitted and will be counted in the maximum number of permitted baseline lesions\n* Prior surgery for symptomatic disease (e.g. small bowel obstruction) for this first presentation of Stage IV melanoma is permitted, provided the total number of remaining extracranial metastases is ≤ 5 (NOT including the resected lesion). No more than one excised metastatic lesion is permitted\n* At least one metastasis should be measurable as a target lesion per RECIST version 1.1\n* No evidence of cerebral metastases on MRI brain (CT brain is acceptable if there is contraindication to MRI)\n* All lesions can be treated with a minimum SBRT biologically effective dose (BED) of 48Gy\n* Able to tolerate treatment with immunotherapy as determined by the medical oncologist\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days of randomisation\n\nExclusion Criteria:\n\n* Ocular or mucosal melanoma\n* Serious or unstable medical co-morbidities or other conditions that could interfere with the patient's safety, consent, or compliance\n* Patients for whom there is a definite and immediate indication for radiotherapy (e.g., spinal cord compression, rapidly progressing disease associated with clinical signs and symptoms)\n* Prior radiotherapy for Stage IV disease (prior adjuvant radiotherapy to primary site or nodal field (Stage I-III disease) is permitted, however adjuvant-treated sites must not be included in the baseline lesions\n* Inability to treat all disease sites with SBRT as determined by radiation oncologist\n* Prior systemic drug therapy for melanoma, unless given in the neoadjuvant or adjuvant setting for Stage I-III disease\n* Any contraindication to the planned standard of care immunotherapy regimen per regulatory approved product information\n* For patients with liver metastases - moderate\u002Fsevere liver dysfunction\n* A known history of another malignancy or concurrent malignancy unless the patient is disease-free for a minimum of 1 year, is completely treated and is at low risk of recurrence\n* Pregnant or breastfeeding females","ALL","18 Years",{"count":129,"type":130},129,"ESTIMATED","INTERVENTIONAL",[133],"PHASE2","The purpose of this research is to evaluate the addition of radiotherapy to the standard immunotherapy drugs that are given to patients with advanced or metastatic melanoma that has spread to other parts of the body. Radiotherapy uses x-rays to target and kill melanoma cells and immunotherapy works by activating the body's own immune system to seek out and fight melanoma cells. Both of these treatments are commonly given to patients with advanced melanoma and other cancers. Both treatments are usually given separately but can also be given together. The aim of this research is to find out if giving radiotherapy and immunotherapy together is better than giving immunotherapy alone.\n\nThe type of radiotherapy to be used in this project is known as 'stereotactic' body radiotherapy or SBRT (also known as stereotactic body ablative radiotherapy, SABR). SBRT targets the radiation very precisely at the metastatic deposits in the body. This method protects the healthy areas near the melanoma. SBRT works by delivering a high dose of radiation precisely to the areas of melanoma which causes the melanoma cells to break apart and eventually die. SBRT is given in 'fractions' which means the high dose is given in small measures over several days, depending on the number and size of metastases.",[136],"Melanoma Metastatic",[138,139,140,141,142,143,144,145,146,147],"SABR","stereotactic body radiotherapy","Stereotactic Ablative Body Radiotherapy","SABRT","Immunotherapy","Immune Checkpoint Inhibitors","Oligometastases","Extracranial","Quality of life","Biomarkers","2026-05-03",{"date":150,"type":151},"2026-05-07","ACTUAL",{"date":153,"type":151},"2025-03-06",{"date":155,"type":130},"2033-04-01",{"name":5,"class":6},5]