protocolSection identificationModule nctId: NCT06319196, orgStudyIdInfo id: Clear Me, briefTitle: Clear Me: Interception Trial to Detect and Clear Molecular Residual Disease in Patients With High-risk Melanoma, acronym: ClearMe, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-02-15, completionDateStruct date: 2030-02-15, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: University Health Network, Toronto, class: OTHER, descriptionModule briefSummary: Clear-Me is a biomarker-driven phase II study that tests whether the combination anti- lymphocyte-activation gene-3 (LAG3)/anti-programmed cell death protein 1(PD-1) inhibition Bristol-Myers Squibb (BMS986213) is superior to anti-PD-1 inhibition in patients with detectable circulating tumor deoxyribonucleic acid (ctDNA) following definitive surgery for high risk melanoma. Patients will be allocated to either Arm A or Arm B via the process of randomization. The randomization process will be stratified according to stage (Stage 2A/2B/3A/3B/3C/3D or 4), to ensure absolute balance between stage groups. The investigators are choosing only 1 stratification factor, disease stage, as the investigators consider stage being the most significant prognosticating variable. Each stage represents a biologically distinct entity with varying recurrence rate outcomes. Block randomization will be performed to ensure equal sample sizes in the combination and monotherapy arms. At least 54 patients will be included in the randomized part of the study. The investigators are expecting approximately 20% of the patients to have detectable ctDNA after definite surgery. Therefore, approximately 270 patients are expected to be enrolled and tested for ctDNA in the entire study., conditionsModule conditions: Cutaneous Melanoma, conditions: Melanoma Stage IV, conditions: Mucosal Melanoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 54, type: ESTIMATED, armsInterventionsModule interventions name: Opdualag, interventions name: Nivolumab, outcomesModule primaryOutcomes measure: Clearance of ctDNA at 12 months after starting adjuvant treatment. ctDNA clearance is defined as no detection of plasma ctDNA, secondaryOutcomes measure: Recurrence-free survival (RFS), secondaryOutcomes measure: Number and severity of treatment related adverse events according to CTCAE v5.0., otherOutcomes measure: Clearance of ctDNA, otherOutcomes measure: Measured changes of biomarker ctDNA, otherOutcomes measure: Methylation patterns of biomarker ctDNA using circulating free methylated DNA immunoprecipitation and sequencing (cfMeDIPseq) assay and correlation with ctDNA total variant allele frequency (VAF) detection., otherOutcomes measure: Quality of life assessment using Quality of Life Questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UHN- Princess Margaret Cancer Center, status: RECRUITING, city: Toronto, state: Ontario, zip: M5G 1Z5, country: Canada, contacts name: Anna Spreafico, MD, role: CONTACT, phone: 416-946-2263, email: anna.spreafico@uhn.ca, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False