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Checkpoint Inhibitor
Anti-PD-1/LAG-3 (Opdualag/BMS-986213) for Melanoma (ClearMe Trial)
Phase 2
Recruiting
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, maximum of 6 years.
Awards & highlights
ClearMe Trial Summary
"This trial, called Clear-Me, is testing a new combination treatment (LAG3/PD-1 inhibitors) from Bristol-Myers Squibb to see if it works better than the standard
Who is the study for?
This trial is for patients with high-risk melanoma who have had surgery to remove their cancer. They must have detectable circulating tumor DNA (ctDNA) after the surgery. The study is open to various stages of melanoma, from Stage 2A up to Stage 4.Check my eligibility
What is being tested?
The Clear-Me trial compares two treatments: Opdualag, a combination therapy targeting LAG3 and PD-1 proteins on immune cells, versus Nivolumab alone, which targets only PD-1. Patients are randomly assigned to one of these treatments post-surgery.See study design
What are the potential side effects?
Potential side effects include immune-related reactions such as inflammation in different organs, skin issues like rash or itching, fatigue, flu-like symptoms and possible changes in hormone levels affecting thyroid or adrenal function.
ClearMe Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, maximum of 6 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, maximum of 6 years.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clearance of ctDNA at 12 months after starting adjuvant treatment. ctDNA clearance is defined as no detection of plasma ctDNA
Secondary outcome measures
Number and severity of treatment related adverse events according to CTCAE v5.0.
Recurrence-free survival (RFS)
Other outcome measures
Clearance of ctDNA
Measured changes of biomarker ctDNA
Methylation patterns of biomarker ctDNA using circulating free methylated DNA immunoprecipitation and sequencing (cfMeDIPseq) assay and correlation with ctDNA total variant allele frequency (VAF) detection.
+1 moreClearMe Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Anti-PD-1/LAG-3 (Opdualag/BMS-986213)Experimental Treatment2 Interventions
Group II: Anti-PD-1 ( Nivolumab)Active Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,476 Previous Clinical Trials
485,126 Total Patients Enrolled
17 Trials studying Melanoma
17,330 Patients Enrolled for Melanoma
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are currently undergoing treatment within this clinical trial?
"Affirmative. Information retrieved from clinicaltrials.gov highlights the ongoing recruitment status of this trial. Initially posted on March 18, 2024, and subsequently updated on March 15, 2024, the study aims to enroll a total of 54 participants across one designated site."
Answered by AI
What are the potential risks associated with Anti-PD-1/LAG-3 (Opdualag/BMS-986213) in individuals undergoing treatment?
"As we are conducting a Phase 2 trial for Anti-PD-1/LAG-3 (Opdualag/BMS-986213), our team at Power rates its safety as level 2. This signifies that while there is some existing safety data, efficacy remains unproven."
Answered by AI
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