Clear Me: Interception Trial to Detect and Clear Molecular Residual Disease in Patients With High-risk Melanoma

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 gr

Trial Details

NCT ID
NCT06319196
Phase
PHASE2
Sponsor
University Health Network, Toronto
Status
RECRUITING
Cancer Type
Mucosal Melanoma Melanoma
Interventions
  • Opdualag
  • Nivolumab
Locations (sample)
  • Toronto, Ontario, Canada|43.70643,-79.39864

Key Eligibility Criteria

  • Age ≥ 18 years at the time of screening or age of consent according to law.
  • Written informed consent and any locally required authorization (e.g., data privacy) obtained from the subject prior to performing any protocol-rel…
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Must have a life expectancy of at least 12 weeks.

For full eligibility, visit ClinicalTrials.gov.

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