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New treatment option for Cutaneous Melanoma
Official title Clear Me: Interception Trial to Detect and Clear Molecular Residual Disease in Patients With High-risk Melanoma
ClinicalTrials.gov ID: NCT06319196
What this study is testing
What is Opdualag?
Opdualag is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for cutaneous melanoma.
Also referred to as BMS-986213.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years at the time of screening or age of consent according to law.
- Written informed consent and any locally required authorization (e.g., data privacy) obtained from the subject prior to performing any...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Must have a life expectancy of at least 12 weeks.
- Histologically confirmed cutaneous or mucosal melanoma.
You likely can't join if
- Diagnosis of uveal melanoma.
- Any prior systemic anticancer therapy for melanoma. Any concurrent anticancer treatment. Concurrent use of hormonal therapy for non-cancer-related...
- Evidence of metastatic disease at surgical and radiological staging.
- History of allogeneic organ transplantation.
- History of allergic reactions or hypersensitivity attributed to compounds of similar chemical or biologic composition to anti-PD-1 or anti-LAG-3 or...
- History of active primary immunodeficiency.
See the full eligibility criteria
Who can join
- Age ≥ 18 years at the time of screening or age of consent according to law.
- Written informed consent and any locally required authorization (e.g., data privacy) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Must have a life expectancy of at least 12 weeks.
- Histologically confirmed cutaneous or mucosal melanoma.
- High risk melanoma people with disease staging for which adjuvant immunotherapy has been proven to reduce the risk of relapse versus observation (disease stage: 2B, 2C, 3A, 3B, 3C, 3D, 4 fully resected).
- Archival tumor formalin-fixed, paraffin-embedded (FFPE) specimens for correlative biomarker studies are required (1 H\&E and 10 unstained 5 microns slides). If surgery is going to be performed after signing consent...
- Patient is a candidate for definitive treatment: including surgery, and post-operative adjuvant immunotherapy with or without radiation for local control.
- No detectable disease via imaging (CT scan, MRI, with or without Positron emission tomography (PET) CT scan). Table 4.1.2-1 : Criteria for adequate organ and Marrow function
- Females of childbearing potential who are sexually active with a non-sterilized male partner must use at least one highly effective method of contraception (see Section 8.1.1 for definition of females of childbearing...
- Non-sterilized male people who are sexually active with a female partner of childbearing potential must use a male condom with spermicide from screening to 180 days after receipt of the final dose of study treatment. It...
What rules you out
- Diagnosis of uveal melanoma.
- Any prior systemic anticancer therapy for melanoma. Any concurrent anticancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is allowed.
- Evidence of metastatic disease at surgical and radiological staging.
- History of allogeneic organ transplantation.
- History of allergic reactions or hypersensitivity attributed to compounds of similar chemical or biologic composition to anti-PD-1 or anti-LAG-3 or any of their excipients.
- History of active primary immunodeficiency.
- Active autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease], immune related diverticulitis [prior diverticulitis in the context of diverticulosis is allowed...
- Participants with vitiligo or alopecia
- Participants with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement
- Any chronic skin condition that does not require systemic therapy. Participants without active disease in the last 1 year may be included but only after consultation with the Principal Investigator
- Participants with celiac disease controlled by diet alone
- Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice), hepatitis B (known...
- Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, clinically relevant coronary artery disease or history of...
- History of another primary malignancy except for:
- Malignancy treated with curative intent and with no known active disease ≥ 3 years before the first dose of study treatment and of low potential risk for recurrence.
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
- Adequately treated carcinoma in situ without evidence of disease.
- Participants with a history of prostate cancer (tumor/node/metastasis stage) of Stage ≤ T2cN0M0 without biochemical recurrence or progression and who in the opinion of the investigator are not deemed to require active...
- Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 500 msecs calculated from three ECGs.
- Prior nivolumab or relatlimab therapy.
- Current or prior use of immunosuppressive medication within 14 days before the first dose of study intervention. The following are exceptions to this criterion (see Section 4.7.1.1):
- Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra-articular injection)
- Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
- Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication)
- Receipt of live attenuated vaccine within 30 days prior to the first dose of study intervention. Note: Participants should not receive live vaccine whilst receiving study intervention and up to 30 days after the last...
- Participation in another clinical study with an investigational product administered in the last 28 days prior to randomization or concurrent enrollment in another clinical study, unless the study is an observational...
- Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions and requirements.
- For women only - currently pregnant (confirmed with positive pregnancy test) or breastfeeding.
- people who are unable to willingly provide consent or are unable to comply with the protocol procedures.
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.