Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06319196

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

Led by University Health Network, Toronto · Updated on 2025-12-03

54

Participants Needed

1

Research Sites

207 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years of age or older at screening
  • Provide written informed consent before any study procedures
  • ECOG performance status of 0 or 1
  • Life expectancy of at least 12 weeks
  • Histologically confirmed cutaneous or mucosal melanoma
  • High-risk melanoma stages 2B, 2C, 3A, 3B, 3C, 3D, or fully resected stage 4
  • Available tumor tissue samples for biomarker studies
  • Candidate for definitive treatment including surgery and post-operative immunotherapy
  • No detectable disease by imaging (CT, MRI, PET CT scans)
  • Females of childbearing potential must use effective contraception from screening to 180 days after last treatment dose
  • Non-sterilized males sexually active with females of childbearing potential must use condoms with spermicide from screening to 180 days after last treatment dose
Not Eligible

You will not qualify if you...

  • Diagnosis of uveal melanoma
  • Previous systemic anticancer therapy for melanoma or concurrent anticancer treatment
  • Evidence of metastatic disease at staging
  • History of allogeneic organ transplantation
  • Allergic reactions or hypersensitivity to anti-PD-1, anti-LAG-3, or similar compounds
  • History of active primary immunodeficiency
  • Active autoimmune or inflammatory disorders, except specified stable conditions
  • Active infections including tuberculosis, hepatitis B or C (with exceptions)
  • Uncontrolled illnesses that increase risk or limit consent ability
  • History of other primary malignancies except certain treated cancers without active disease
  • QTcF interval ≥ 500 msecs on ECG
  • Prior treatment with nivolumab or relatlimab
  • Recent use of immunosuppressive medications except specified exceptions
  • Live attenuated vaccine within 30 days prior to first dose
  • Participation in another investigational clinical study within 28 days prior to randomization
  • Unlikely to comply with study procedures or restrictions
  • Pregnant or breastfeeding women
  • Unable to provide informed consent or comply with protocol procedures

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

UHN- Princess Margaret Cancer Center

Toronto, Ontario, Canada, M5G 1Z5

Actively Recruiting

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Research Team

A

Anna Spreafico, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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