[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100527705":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":34,"responsibleParty":53,"collaborators":55,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":32,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":32,"enrollmentInfo":68,"targetDuration":32,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":32,"overallStatus":36,"whyStopped":32,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Melanoma Institute Australia","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Neoadjuvant Treatment","EXPERIMENTAL","Nivolumab and relatlimab will be administered in a fixed dose combination (FDC). The FDC product contains nivolumab and relatlimab in a protein-mass ratio of 3:1 (nivolumab 240 mg and relatlimab 80 mg): in a 20 mL concentrate solution per single vial. The dose and dosing regimen for this study is nivolumab 480 mg and relatlimab 160 mg - 2 vials per infusion. This was primarily based on the observed benefit\u002Frisk profile observed in metastatic melanoma patients from Study CA224-020 pharmacokinetics (PK), pharmacodynamics, and extensive nivolumab monotherapy clinical experience. In addition, the Phase 2\u002F3 Study CA224-047 established this dose as active in unresectable and metastatic melanoma.\n\nThis study is open label and single arm, with all patients scheduled to receive two doses of nivolumab and relatlimab FDC prior to surgery on days 1 and 29.",[13],"Drug: Nivolumab 240 mg \u002F Relatlimab 80 mg in a fixed dose combination",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Nivolumab 240 mg \u002F Relatlimab 80 mg in a fixed dose combination","Dual inhibition of the distinct LAG3 and PD-1 checkpoint pathways",[9],[21],"Opdualag",[23],{"name":24,"affiliation":25,"role":26},"Georgina V Long","Melanoma Instiute Australia","PRINCIPAL_INVESTIGATOR",[28],{"name":29,"role":30,"phone":31,"phoneExt":32,"email":33},"Monica Osorio","CONTACT","+ 61 2 9911 7296",null,"monica.osorio@melanoma.org.au",[35],{"facility":5,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"RECRUITING","Wollstonecraft","New South Wales","2065","Australia","AU",{"type":43,"coordinates":44},"Point",[45,46],151.18981,-33.8328,{"lat":46,"lon":45},[49,51],{"name":29,"role":30,"phone":50,"phoneExt":32,"email":33},"+612 9911 7296",{"name":52,"role":26,"phone":32,"phoneExt":32,"email":32},"Georgina V. Long",{"type":54,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[56],{"name":57,"class":58},"Bristol-Myers Squibb","INDUSTRY","100527705","phase-2-neoadjuvant-nivolumab-and-relatlimab-in-merkel-cell-carcinoma-100527705",false,"NCT06151236","Neoadjuvant Nivolumab and Relatlimab in Merkel Cell Carcinoma","A Phase 2, Open Label, Single Arm Clinical Trial of Neoadjuvant Nivolumab and Relatlimab in Stage I To III Resectable Merkel Cell Carcinoma","Inclusion Criteria:\n\n1. Aged ≥ 18 years\n2. Written consent\n3. Histologically confirmed, resectable Merkel cell carcinoma with AJCC (8th ed) clinical or pathological stage I (≥ 10 mm), IIA, or IIB or III disease\n4. In-transit metastases are permitted if they are completely resectable\n5. Measurable disease according to RECIST 1.1 criteria\n6. Previous radiotherapy permitted if there is RECIST-measurable progression of disease since the completion of radiotherapy\n7. At least one of either, archival tissue from a primary or nodal MCC lesion (if applicable) for the current diagnosis and\u002For a newly obtained core biopsy of a lesion which has not been previously irradiated.\n8. ECOG 0-1\n9. Adequate organ function on blood pathology\n10. Life expectancy \\>12 months\n11. Female patients to use effective contraception during study treatment and for 5 months after last dose.\n\nExclusion Criteria:\n\n1. Clinical, radiographic or pathological evidence of distant metastases\n2. Contraindication to nivolumab and \u002F or relatlimab\n3. Prior anti-PD-1, CTLA-4, PDL-1 or LAG 3 antibody exposure, or an agent directed to another stimulatory or co-inhibitory T-cell receptor for any disease or any chemotherapy or experimental local or systemic drug treatment\n4. Active autoimmune disease or requirement for chronic steroid therapy other than hormone replacement therapy\n5. A diagnosis of immunodeficiency or chronic steroid therapy \\>10 mg OD prednisone or equivalent\n6. Additional malignancy active within past 3 years; patients with chronic lymphocytic leukaemia can be included in this study.\n7. Uncontrolled cardiovascular disease or history of myocarditis\n8. Has had an allogenic tissue\u002Fsolid organ transplant\n9. Troponin T (TnT) or I (TnI) \\>2 × institutional ULN\n10. Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis or current interstitial lung disease\n11. Has an active infection requiring systemic therapy\n12. Active Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection.\n13. Known HIV\n14. Pregnant or breast feeding females\n15. Concurrent medical or social conditions that may prevent the patient attending assessments or procedures per schedule","ALL","18 Years",{"count":69,"type":70},20,"ESTIMATED","INTERVENTIONAL",[73],"PHASE2","The goal of this clinical trial is to test neoadjuvant dual immunotherapy in Merkel cell carcinoma with the aim to improve recurrence-free survival",[76],"Merkel Cell Carcinoma","2026-02-12",{"date":79,"type":80},"2026-02-17","ACTUAL",{"date":82,"type":80},"2024-03-11",{"date":84,"type":70},"2034-04",{"name":5,"class":6},1]