[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Melanoma and Skin Cancer Trials Limited\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":100},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,71],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":4},"100548263","phase-2-neoadjuvant-pd-1-inhibitor-and-egfr-inhibitor-in-locally-advanced-cutaneous-squamous-cell-carcinoma-100548263",false,"NCT06418724","Neoadjuvant PD-1 Inhibitor and EGFR Inhibitor in Locally Advanced Cutaneous Squamous Cell Carcinoma","NEOPECS","Inclusion Criteria:\n\n1. Male or female \\> 18 years of age and able to comply with treatment, assessment and follow up\n2. Documentation of a locally advanced cutaneous squamous cell carcinoma diagnosis as evidenced by histopathology with available archival tissue. Locally Advanced cutaneous Squamous Cell Carcinoma (LASCC) defined as borderline resectable for surgery due to multiple recurrences, prior radiotherapy, large extension, bone erosion and\u002For deep infiltration beyond the subcutaneous tissue into muscle\u002Fnerve or, where curative resection may lead to unacceptable complications, morbidity or deformity, and ineligible for curative radiotherapy\n3. Measurable disease in accordance with iRECIST criteria OR clinically measurable disease \\>1cm by caliper measurement. Patients with synchronous primary cutaneous squamous cell carcinoma (cSCC) tumours will be eligible.\n4. Adequate bone marrow function with haemoglobin \\>100g\u002FL, absolute neutrophil count \\> 1.5 x 109\u002FL, platelets \\> 100 x 109\u002FL). Blood transfusion is allowable.\n5. Adequate hepatic function with total bilirubin levels \\\u003C1.5 upper limit normal range and Alanine aminotransferase (ALT) and AST levels \\\u003C2.5 level normal range.\n6. Adequate renal function with eGFR estimated with Cockcroft Gault formula \\>50mL\u002Fmin. Serum potassium levels 3.5 - 5.5 mmoL\u002FL, Serum magnesium levels 0.7 - 1.05 mmol\u002FL, Serum corrected calcium levels 2.15 - 2.55 mmol\u002FL\n7. Adequate performance status of Eastern Cooperative Oncology Group (ECOG) 0-1 as assessed by investigator\n8. Life expectancy of \\>6 months\n9. Able to provide written informed consent obtained from patient and ability for patient to comply with the requirements of the trial.\n\nExclusion Criteria:\n\n1. Distant metastatic disease (M1) including visceral or distant nodal metastases\n2. Prior receipt of checkpoint inhibitor therapy or anti-EGFR therapy for LASCC or any other malignancy\n3. Uncontrolled medical\u002Fpsychiatric co-morbidity as per investigator that may jeopardize the ability of the patient to undergo trial procedures with reasonable safety\n4. Uncontrolled autoimmune disease requiring active immune-suppression within 1 year of enrolment\n5. Corticosteroid use of \\>10mg daily of oral prednisone within 2 weeks of Cycle 1 Day 1 (C1D1)\n6. Known history of interstitial lung disease, non-infectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases.\n7. Uncontrolled infection with human immunodeficiency virus, hepatitis B, or hepatitis C infection; or has a diagnosis of immunodeficiency\n8. Transplant recipient\n9. Hepatitis C virus (HCV) and hepatitis B virus (HBV) testing will be performed at screening\n10. Controlled HIV infection (undetectable viral load (HIV RNA PCR) and Cluster of differentiation 4 (CD4) counts above 350 either spontaneously or on a stable antiviral regimen) is permitted. Monitoring will be performed per local standards.\n11. Controlled hepatitis B antibody positive infection (HBsAg+) is permitted providing a serum hepatitis B virus DNA PCR that is below the limit of detection and patient is receiving anti-viral therapy for hepatitis B. Periodic monitoring of HBV DNA is required. Anti-viral therapy for at least 6 months post the last dose of investigational study drug is required.\n12. Controlled hepatitis C virus antibody positive (HCV Ab+) is permitted (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy).\n13. History of another malignancy within 5 years prior to trial registration. A past history of adequately treated carcinoma-in-situ, basal cell carcinoma of skin, or superficial transitional cell carcinoma of the bladder is permitted. Patients with a history of other malignancies are eligible if they have been continuously disease free for at least 3 years after definitive primary treatment and low expected risk of recurrence.\n14. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with trial protocol and follow-up schedule, including alcohol and drug abuse.\n15. Pregnancy, lactation or inadequate contraception. Women must be post-menopausal, infertile or willing to use reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration. Men must have been surgically sterilized or willing to use double barrier contraception.\n16. Sexually active men and women of childbearing potential who are unwilling to practice highly effective contraception prior to the start of the first treatment, during the study, and for at least 6 months after the last dose of investigational drug.","ALL","18 Years",{"count":19,"type":20},27,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The NEOPECS trial is a phase II prospective, single-arm, non-randomised interventional trial for patients with borderline resectable locally advanced cutaneous squamous cell carcinoma with a 6-participant safety lead in to ensure safety of the combination in the neoadjuvant setting across 3 sites in Australia.",[26],"Locally Advanced Cutaneous Squamous Cell Carcinoma",[28,29,30,31,32,33],"immunotherapy","neoadjuvant therapy","PD-1 inhibitor","EGFR inhibitor","cetuximab","cemiplimab","NOT_YET_RECRUITING","2026-03-23",{"date":37,"type":38},"2026-03-27","ACTUAL",{"date":40,"type":20},"2026-07-30",{"date":42,"type":20},"2030-12-01",{"name":44,"class":45},"Melanoma and Skin Cancer Trials Limited","OTHER",{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},"100528672","phase-1-bevacizumab-and-icis--hsrt-in-symptomatic-melanoma-brain-metastases-100528672","NCT06163820","Bevacizumab and ICIs + hSRT in Symptomatic Melanoma Brain Metastases","Bevacizumab and Immune chEckpoint Inhibitors Plus Hypofractionated Stereotactic radioTherapy for the Treatment of sympTomatic mElanoma bRain Metastases.","BETTER","Inclusion Criteria:\n\n* 1\\. Histologically (or cytologically) proven metastatic melanoma, with radiologically confirmed brain metastases.\n* 2\\. Symptomatic from brain metastases at the time of study enrolment, or brain metastases that requires corticosteroids for the management of neurological symptoms.\n* 3\\. Intracranial lesions amenable to hypofractionated stereotactic radiotherapy. These are defined as all intracranial melanoma lesions greater or equal to 5 mm in diameter, all intracranial lesions that are causing symptoms, and all intracranial lesions located in the eloquent areas of the brain.\n* 4\\. World Health Organisation (WHO) performance status of 0 - 2\n* 5\\. At least one brain metastasis has to be symptomatic.\n* 6\\. Laboratory tests required: Haemoglobin (Hb) ≥ 9.0 g\u002FdL Absolute neutrophil count ≥ 1 x 109\u002FL Platelet count ≥ 100 x 109\u002FL Either: Serum bilirubin ≤ 1.5 x upper limit of normal (ULN) (Patients with isolated hyperbilirubinaemia due to Gilbert's syndrome are allowed.) Or: Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 2.5 x (ULN) unless raised due to tumour in which case up to 5 x ULN is permissible Creatinine clearance ≥ 40 mL\u002Fmin (Cockcroft-Gault or MDRD are acceptable)\n* 7\\. Age ≥ 18 years\n* 8\\. Able to provide informed written consent (signed and dated), attend trial site for study visits and be capable of co-operating with treatment and follow-up\n\nExclusion Criteria:\n\n* 1\\. Prior radiotherapy to the brain\n* 2\\. Active concurrent malignancy requiring systemic anti-cancer therapy within the last 2 years. Patients with any malignancy treated with curative intent and no evidence of disease will be eligible for this trial.\n* 3\\. Prior systemic therapy for melanoma, unless given in the neoadjuvant or adjuvant setting for extracranial disease only, completed more than \\>6 months prior to enrolment in this trial and if administered with radiological proof of the absence of brain metastases\n* 4\\. Inability to undergo MRI of the brain\n* 5\\. Definitive leptomeningeal disease. Patients with equivocal leptomeningeal disease may be included on the trial after discussion with CPI.\n* 6\\. Female patients who are pregnant or lactating. Patients who are able to become pregnant, must return a negative serum or urine pregnancy test before enrolment and agree to use two forms of contraception (one effective form plus a barrier method) \\[oral, injected or implanted hormonal contraception and condom; intra-uterine device and condom; diaphragm with spermicidal gel and condom\\] or agree to sexual abstinence, effective from signing the consent form, throughout the trial and for six months after any treatment for melanoma, radiotherapy or immunotherapy, are considered eligible.\n* 7\\. Male patients with partners of child-bearing potential (unless they agree to take measures not to father children by using a barrier method of contraception or to sexual abstinence effective from the first administration of bevacizumab, throughout the trial and for six months afterwards after treatment the end-of-trial visit. Men with partners of child-bearing potential must also be willing to ensure that their partner uses an effective method of contraception for the same duration for example, hormonal contraception, intrauterine device, diaphragm with spermicidal gel or sexual abstinence). Men with pregnant or lactating partners must be advised to use barrier method contraception to prevent exposure of the foetus or neonate. Abstinence is only considered to be an acceptable method of contraception when this is in line with the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.\n* 8\\. Haemorrhage encompassing \\>50% of any lesion that is \\>10 mm in diameter (excluding surrounding oedema). A modern susceptibility-sensitive MRI sequence such as SWI is mandatory.\n* 9\\. Brain metastases greater than 5 cm in maximal diameter\n* 10\\. Increasing corticosteroid dose for 48 hours prior to initiation of study therapy OR current dexamethasone-equivalent dose of \\>8 mg per day\n* 11\\. Major thoracic or abdominal surgery within 28 days prior to initiation of trial treatment\n* 12\\. Neurosurgery within 14 days prior to initiation of trial treatment\n* 13\\. Active or history of severe auto-immune disease requiring systemic anti-inflammatory therapy. Patients with well-controlled auto-immune diseases not requiring systemic anti-inflammatory therapy may be included after consultation with the CPI. Severe auto-immune respiratory disease will be excluded from the trial.\n* 14\\. History of inflammatory bowel disease\n* 15\\. Requirement for ongoing concurrent systemic immunosuppressive therapy (other than corticosteroids).\n* 16\\. History of intra-abdominal inflammatory process within 6 months prior to initiation of trial treatment, including but not limited to peptic ulcer disease, diverticular disease or colitis.\n* 17\\. History of abdominal or trachea-oesophageal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months prior to initiation of trial treatment\n* 18\\. History of intestinal obstruction and\u002For clinical signs or symptoms of gastrointestinal obstruction including sub-occlusive disease related to the underlying disease or requirement for routine parenteral hydration, parenteral nutrition or tube feeding within 6 months prior to initiation of trial treatment\n* 19\\. Any Grade ≥3 haemorrhage or bleeding event within 28 days of trial treatment initiation. Patients presenting with haemorrhagic brain metastases that have been adequately treated with neurosurgery are not excluded under this criterion but remain subject to criterion 12 pertaining to timing of neurosurgery.\n* 20\\. Current use of full-dose anticoagulation or thrombolytic therapy within 10 days of initiation of trial treatment\n* 21\\. Evidence of bleeding diatheses or significant coagulopathy\n* 22\\. History of inadequately controlled arterial hypertension (systolic BP ≥160 mm Hg or diastolic BP ≥100 mm Hg despite maximal medical therapy); prior history of hypertensive crises or hypertensive encephalopathy\n* 23\\. Concurrent congestive heart failure, prior history of NYHA class III\u002F IV cardiac disease, prior history of cardiac ischaemia or prior history of cardiac arrhythmia\n* 24\\. Concurrent participation in another interventional clinical trial or intention to do so. Concurrent participation in an observational trial is acceptable.\n* 25\\. Any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical trial.",{"count":55,"type":20},46,[57,23],"PHASE1","Single arm phase I\u002FII trial to evaluate the safety and efficacy of the combination of bevacizumab, with ipilimumab plus nivolumab, and hypofractionated stereotactic radiotherapy (hSRT) in patients with symptomatic melanoma brain metastases (MBM).",[60],"Melanoma Brain Metastases","RECRUITING","2025-05-08",{"date":64,"type":38},"2025-05-13",{"date":66,"type":20},"2025-05-31",{"date":68,"type":20},"2026-01-30",{"name":44,"class":45},1,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},"100351824","melanoma-margins-trial-ii-1cm-v-2cm-wide-surgical-excision-margins-for-ajcc-stage-ii-primary-cutaneous-melanoma-100351824","NCT03860883","Melanoma Margins Trial-II: 1cm v 2cm Wide Surgical Excision Margins for AJCC Stage II Primary Cutaneous Melanoma","Melanoma Margins Trial-II - A Phase III, Multi-centre Randomised Controlled Trial Investigating 1cm v 2cm Wide Surgical Excision Margins for AJCC Stage II Primary Cutaneous Melanoma (02.18 MelMarT-II)","MelMarT-II","Inclusion Criteria:\n\nPatients may be included in the study if they meet ALL of the following criteria:\n\n1. 1\\. Patients must have a Stage II primary invasive cutaneous melanoma (pT2b-pT4b, AJCC 8th edition) with Breslow thickness \\>1.0mm to 2.0mm; \\>2.0mm to 4.0mm or \\>4.0mm with ulceration, or \\>2.0mm to 4.0mm; or \\>4.0mm without ulceration (Table 1) as determined by diagnostic biopsy (narrow excision, incision, shave or punch biopsy) and subsequent histopathological analysis.\n2. Must have a primary melanoma that is cutaneous (including head, neck, trunk, extremity, scalp, palm or sole).\n3. An uninterrupted 2cm margin must be technically feasible around biopsy scar or primary melanoma.\n4. 4\\. Surgical intervention (which refers to the staging -SLNB and WLE as these are both to be done on the same day) must be completed within 120 days of the original diagnosis. Surgical intervention must also be performed within 28 days of randomisation.\n5. Patients must be 18 years or older at time of consent.\n6. Patient must be able to give informed consent and comply with the treatment protocol and follow up plan.\n7. Life expectancy of at least 5 years from the time of diagnosis, not considering the melanoma in question, as determined by the PI.\n8. Patients must have an ECOG performance score between 0 and 1 at screening.\n9. A survivor of prior cancer is eligible provided that ALL of the following criteria are met and documented:\n\n   * The patient has undergone potentially curative therapy for all prior malignancies,\n   * There has been no evidence of recurrence of any prior malignancies for at least FIVE years (with the exception of successfully treated uterine\u002Fcervical or non-melanoma skin cancers (SCCs\u002FBCCs) with no evidence of recurrence), and\n   * The patient is deemed by their treating physician to be at low risk of recurrence from previous malignancies.\n\nExclusion Criteria:\n\nPatients will be excluded from the study for ANY of the following reasons:\n\n1. Uncertain diagnosis of melanoma i.e., so-called 'melanocytic lesion of unknown malignant potential'.\n2. Patient has already undergone WLE at the site of the primary index lesion.\n3. Patient unable or ineligible to undergo staging SLNB of the primary index lesion.\n4. Perineural invasion or neurotropic melanoma: Neurotropism or perineural invasion in any type of melanoma is an exclusion. Perineural invasion does not include entrapment of nerves within the main primary tumour mass.\n5. Desmoplastic melanoma: with any patient where pathology determines melanoma as PURE desmoplastic (as per WHO definition of \\>90% desmoplasia), they are not eligible for this study. However melanomas with less than 90% desmoplasia or mixed desmoplastic subtypes are eligible unless there is neurotropism present (perineural invasion).\n6. Microsatellitosis (a nest of metastatic tumour cells found to be growing away from the primary tumour) as per AJCC 8th edition definition is an exclusion.\n7. Subungual melanoma\n8. Patient has already undergone a local flap reconstruction of the defect after excision of the primary and determination of an accurate excision margin is impossible.\n9. History of previous or concurrent (i.e. \\>1 primary melanoma) invasive melanoma.\n10. Melanoma located distal to the metacarpophalangeal joint; on the tip of the nose; the eyelids or on the ear; genitalia, perineum or anus; mucous membranes or internal viscera.\n11. Physical, clinical, radiographic or pathologic evidence of satellite, in-transit, regional, or distant metastatic melanoma.\n12. Patient has undergone surgery on a separate occasion to clear the lymph nodes of the probable draining lymphatic field, including -SLNB, of the index melanoma.\n13. Any additional solid tumour or hematologic malignancy during the past 5 years (with exception of non- melanoma skin cancers (T1 skin lesions of squamous cell carcinoma (SCCs), basal cell carcinoma (BCCs)), or uterine\u002Fcervical cancer).\n14. Melanoma-related operative procedures not corresponding to criteria described in the protocol.\n15. Planned adjuvant radiotherapy to the primary melanoma site after wide local excision is not permitted as part of the protocol and any patients given this treatment would be excluded from the study.\n16. History of organ transplantation.\n17. Oral or parenteral immunosuppressive agents (not topical or inhaled steroids) at enrolment or within 6 months prior to enrolment.\n\nPregnancy is not a specific exclusion criterion for this trial, though it may not be clinically appropriate to perform a wide excision and SLNB until the pregnancy has been completed, which may exclude the patient due to violation of inclusion criterion 4. We would advise careful counselling of the patient prior to enrolling the patient, which would include a discussion at the treating centre's multidisciplinary team meeting or tumour board. We would strongly advise contacting the central trial office to discuss the case prior to enrolling on the study.",{"count":80,"type":20},2998,[82],"NA","Patients with a primary invasive melanoma are recommended to undergo excision of the primary lesion with a wide margin. There is evidence that less radical margins of excision may be just as safe. This is a randomised controlled trial of 1 cm versus 2 cm margin of excision of the primary lesion for adult patients with stage II primary invasive cutaneous melanomas (AJCC 8th edition) to determine differences in disease-free survival. A reduction in margins is expected to improve patient quality of life.",[85],"Cutaneous Melanoma, Stage II",[87,88,89,90],"Malignant","Melanoma","Cancer","Surgery","2024-11-25",{"date":93,"type":38},"2024-11-27",{"date":95,"type":38},"2019-12-17",{"date":97,"type":20},"2034-12-31",{"name":44,"class":45},192,""]