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

Sponsor
University Health Network, Toronto
Study ID
NCT06319196
Phase
PHASE2
Status
Recruiting
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Conditions

  • Cutaneous Melanoma
  • Melanoma Stage IV
  • Mucosal Melanoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Opdualag — DRUG
    Opdualag vial IV every 4 weeks (Q4W)
  • Nivolumab — DRUG
    Nivolumab 480mg IV Q4W

Study Details

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.

Key Dates

Start date
Aug 27, 2026
Status verified
Jun 2026
Primary completion
Feb 15, 2027
Completion
Feb 15, 2030

Study Design

Enrollment
54 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Anti-PD-1/LAG-3 (Opdualag/BMS-986213)
  • Active Comparator: Anti-PD-1 ( Nivolumab)

Primary Outcome Measure

Clearance of ctDNA at 12 months after starting adjuvant treatment. ctDNA clearance is defined as no detection of plasma ctDNA [ Time Frame: 12 months after starting adjuvant treatment. ]

Central Contacts

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