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Compares treatment options for Basal Cell Carcinoma
Official title Neoadjuvant Nivolumab + Relatlimab (Opdualag) Versus Nivolumab for Resectable High-Risk Basal Cell Carcinoma
ClinicalTrials.gov ID: NCT06624475
What this study is testing
What is Nivolumab?
Nivolumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for basal cell carcinoma.
Also referred to as Opdivo.
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
- This is a Phase 2 clinical trial with a 2:1 randomization comparing neoadjuvant Nivolumab + Relatlimab (Opdualag) vs neoadjuvant Nivolumab in patients with resectable high risk basal cell carcinoma (HR BCC)
- Phase 2: a mid-size study of how well it works
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
- Ability to understand and the willingness to sign a written informed consent document.
- Participants must have histologically or cytologically confirmed basal cell carcinoma.
- Participants must have high risk BCC as defined by size 20 mm or greater in the head and neck region or 40 mm or greater for the trunk/extremities.
- Participants must have surgically resectable BCC that is at increased risk for cosmetic disfigurement, functional defects, poor oncologic control, or...
- Participants must have treatment naive BCC.
You likely can't join if
- Is currently receiving any other investigational agents.
- Has participated in a study of an investigational product and received study treatment or used an investigational device within 4 weeks of the first...
- Hypersensitivity to Opdualag, nivolumab, or any of their excipients.
- Presence of untreated (symptomatic) central nervous system metastases.
- Presence of leptomeningeal metastatic disease.
- Treatment with any live / attenuated vaccine within 30 days of first study treatment.
See the full eligibility criteria
Who can join
- Ability to understand and the willingness to sign a written informed consent document.
- Participants must have histologically or cytologically confirmed basal cell carcinoma.
- Participants must have high risk BCC as defined by size 20 mm or greater in the head and neck region or 40 mm or greater for the trunk/extremities.
- Participants must have surgically resectable BCC that is at increased risk for cosmetic disfigurement, functional defects, poor oncologic control, or anticipated to require skin grafting or free flap reconstruction per...
- Participants must have treatment naive BCC.
- Aged 18 years or older.
- Eastern Cooperative Oncology Group Performance Status 0 or 1
- Demonstrates adequate organ function as defined below: Adequate bone marrow function
- Absolute neutrophil count ≥ 1,500/microliter
- Platelets ≥ 100,000/microliter Adequate hepatic function
- Total bilirubin \>1.5 x institutional upper limit of normal (except participants with Glibert Syndrome who must have a total bilirubin level of \<3.0xULN)
- Aspartate aminotransferase (AST or SGOT) ≤ 3 x institutional upper limit of normal
- Alanine transaminase (ALT or SGPT) ≤ 3 x institutional upper limit of normal Adequate renal function
- Creatinine clearance Calculated creatinine clearance (CrCl) \> 30 mL/min (using the Cockcroft Gault formula)
- Human immunodeficiency virus (HIV) infected individuals on effective anti retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Patients must not have had an AIDS defining...
- For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
- Individuals with a history of hepatitis C virus (HCV) infection must have been treated and cured. For individuals with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV...
- Concurrent malignancy (present during screening) requiring treatment or history o f prior malignancy active within 2 years prior to randomization (i.e., participants with a history of prior malignancy are eligible if...
- The effects of Opdualag on the on the developing human fetus are unknown. Therefore, the following criteria apply to participants in each study arm: Cohort 1 Opdualag: A woman of child bearing potential (WOCBP) is...
- Is not a WOCBP. OR
- Is a WOCB P and using a contraceptive method that is highly effective (with a failure rate of \<1% per year), with low user dependency, during the intervention period and for at least 5 months and agrees not to donate...
What rules you out
- Is currently receiving any other investigational agents.
- Has participated in a study of an investigational product and received study treatment or used an investigational device within 4 weeks of the first dose of study treatment.
- Hypersensitivity to Opdualag, nivolumab, or any of their excipients.
- Presence of untreated (symptomatic) central nervous system metastases.
- Presence of leptomeningeal metastatic disease.
- Treatment with any live / attenuated vaccine within 30 days of first study treatment.
- Radiation therapy within 2 weeks prior to first study treatment. Participants must have recovered (i.e., Grade ≤1 or at baseline) from radiation related toxicities prior to first study treatment.
- Participants with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) within 14 days or other immunosuppressive medications within 30 days of randomization. Note...
- Participants with an active, known, or suspected autoimmune disease. Note: Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or...
- Prior allogeneic tissue/solid organ transplant.
- Severe uncontrolled cardiac disease within 6 months of screening, including but not limited to poorly controlled hypertension , unstable angina, myocardial infarction, congestive heart failure (New York Heart...
- Any prior history of myocarditis and/or current diagnosis of myocarditis, regardless of etiology.
- Troponin T (TnT) or I (TnI) \> 2 x institutional upper limit of normal (ULN).
- Participants with TnT or TnI levels between \> 1× to 2× ULN will be permitted if repeat levels within 24 hours are ≤ 1× ULN. I f TnT or TnI levels are between \> 1× to 2× ULN within 24 hours, the participant must be...
- After cardiologist evaluation, the participant may be considered for randomization if the Investigator assesses a favorable benefit/risk.
- Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study treatment administration or that may interfere with the...
- Pregnant women are excluded from this study because Opdualag are immune checkpoint inhibitors with the potential for teratogenic o r abortifacient effects. Because there is an unknown but potential risk for adverse...
The study team makes the final eligibility decision.
Where it's taking place
- Irvine, California, United States
- La Jolla, California, United States
- San Francisco, California, United States
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 Irvine, California, United States; La Jolla, California, United States; San Francisco, California, United States. 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.