Actively Recruiting
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 2026-06-04
54
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether combining anti-LAG3 and anti-PD-1 drugs is more effective than anti-PD-1 alone in patients with high-risk melanoma who have detectable circulating tumor DNA (ctDNA) after surgery. This phase II study focuses on patients with stage 2B to 4 melanoma following definitive surgery. The study aims to understand if the combination treatment can better clear molecular residual disease, potentially lowering the risk of cancer recurrence. Participants will be randomly assigned to one of two groups: one receiving Opdualag (a combination of anti-LAG3 and anti-PD-1) and the other receiving Nivolumab (anti-PD-1 alone). Both treatments are given through intravenous infusion every four weeks. The randomization accounts for different melanoma stages to balance groups. About 270 patients will be screened to find at least 54 with detectable ctDNA who will proceed with treatment and follow-up. Throughout the study, participants will have their ctDNA levels monitored to assess clearance at 12 months after starting treatment. Researchers will also track recurrence-free survival at 12 and 36 months and monitor any treatment-related side effects for up to six years. Patients will undergo imaging scans and laboratory tests to ensure no detectable disease at the start and to evaluate their health during treatment. The study lasts several years, allowing thorough observation of long-term outcomes and safety.
CONDITIONS
Brief Title
Clear Me: Interception Trial to Detect and Clear Molecular Residual Disease in Patients With High-risk Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of screening or legal consent age
- Provided written informed consent before any study procedures
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 12 weeks
- Histologically confirmed cutaneous or mucosal melanoma
- High-risk melanoma stage 2B, 2C, 3A, 3B, 3C, 3D, or 4 fully resected
- Available archival tumor tissue for biomarker studies or tumor tissue from surgery after consent
- Candidate for definitive treatment including surgery and post-operative immunotherapy, with or without radiation
- No detectable disease by imaging (CT, MRI, PET-CT)
- Females of childbearing potential and non-sterilized males must use effective contraception during study and for 180 days after last dose
- Male participants must refrain from sperm donation during study and for 180 days after last dose
You will not qualify if you...
- Diagnosis of uveal melanoma
- Prior systemic anticancer therapy for melanoma or concurrent anticancer treatment
- Evidence of metastatic disease at staging
- History of allogeneic organ transplantation
- History of allergic reactions to anti-PD-1 or anti-LAG-3 compounds
- Active primary immunodeficiency
- Active autoimmune or inflammatory disorders, except certain controlled conditions like vitiligo, alopecia, stable hypothyroidism, controlled celiac disease, or inactive chronic skin conditions
- Active infections such as tuberculosis, hepatitis B or C (with some exceptions), or uncontrolled HIV
- Uncontrolled illnesses including heart failure, hypertension, coronary artery disease, lung disease, serious gastrointestinal conditions, or psychiatric/social conditions limiting study compliance
- History of other primary malignancies, with some exceptions for treated and low-risk cancers
- Mean QTc interval ≥ 500 msecs on ECG
- Prior nivolumab or relatlimab therapy
- Recent use of immunosuppressive medications, with specific exceptions
- Receipt of live vaccines within 30 days prior to study treatment
- Participation in another interventional clinical study within 28 days prior to randomization
- Inability to comply with study procedures or provide informed consent
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive intravenous treatment with Opdualag or Nivolumab every 4 weeks as part of the trial therapy.
Monthly visits for treatment administration
Duration - Up to 5 years after treatment ends
Participants are monitored for recurrence-free survival and treatment-related adverse events after completing treatment.
Visits at 12 months and 36 months post-treatment and additional check-ins as needed
Trial Site Locations
Total: 1 location
1
UHN- Princess Margaret Cancer Center
Toronto, Ontario, Canada, M5G 1Z5
Actively Recruiting
Research Team
A
Anna Spreafico, MD
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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