Clear Me: Interception Trial to Detect and Clear Molecular Residual Disease in Patients With High-risk Melanoma
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek co najmniej 18 lat
- •Potwierdzona histologicznie czerniak skóry lub błon śluzowych
- •Czerniak wysokiego ryzyka na etapie, dla którego leczenie immunologiczne zmniejsza ryzyko powrotu choroby (stadium 2B, 2C, 3A, 3B, 3C, 3D, 4 całkowicie usunięte)
- •Brak choroby widocznej w badaniach obrazowych (CT, MRI, PET-CT)
- •Kandydat do operacji i leczenia immunologicznego po operacji
- •Ogólny stan zdrowia pozwalający na uczestnictwo w badaniu (ECOG 0-1)
- •Spodziewana długość życia co najmniej 12 tygodni
- •Dostępne próbki guza z operacji do badań laboratoryjnych
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- October 13, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
UHN- Princess Margaret Cancer Center
Toronto, Canada
Trial contact
Anna Spreafico, MD
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 10/14/2026.
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