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Basal Cell CarcinomaPhase 2NEONNCT06624475

Neoadjuvant Nivolumab + Relatlimab (Opdualag) Versus Nivolumab for Resectable High-Risk Basal Cell Carcinoma

A Phase 2 study testing Nivolumab and Relatlimab plus Nivolumab in people with Basal Cell Carcinoma, run by University of California, San Diego at 3 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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) Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Basal Cell Carcinoma
What is being tested?
Nivolumab and Relatlimab plus Nivolumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
3 sitesUnited States
Study dates
21 Aug 2025to May 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to 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 investigator assessment.
  • Participants must have treatment naive BCC.
  • Aged 18 years or older.
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  • 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 opportunistic infection within the last year or a current CD4 count < 350 cells/microliter.
  • 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 viral load.
  • 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 treatment was completed at least 2 years before randomization and the patient has no evidence of disease). Participants with history of prior early stage basal/squamous cell skin cancer or non invasive or in situ cancers that have undergone definitive treatment at any time are also eligible.
  • 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 eligible to enroll if 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 the duration of treatment with Opdualag plus 5 half lives of study treatment for a total of 5 months post treatment completion and agrees not to donate eggs (ova, oocytes) for the purpose of re production for the same time period.
  • Cohort 2 nivolumab:
  • Women who are not of childbearing potential are exempt from contraceptive requirements.
  • Women participants must have documented proof that they are not of childbearing potential.
  • Women of child bearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 24 hours prior to the start of study treatment. An extension up to 72 hours prior to the start of study treatment is permissible in situations where results cannot be obtained within the standard 24 hour window. iv. Additional requirements for pregnancy testing during and after study intervention are located in the Schedule of Assessments.
  • The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. vi. WOCBP must agree to follow instructions for method(s) of contraception and as described below and included in the Informed Consent Form.
  • WOCBP are permitted to use hormonal contraception methods viii. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
  • 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 eggs (ova, oocytes) for the purpose of reproduction for the same time period.

Who cannot join

  • 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.
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  • 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: Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
  • 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 alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
  • 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 Association Class II or greater), pericarditis within the previous 6 months, cerebrovascular accident, or clinically significant uncontrolled cardiac arrhythmias.
  • 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 evaluated by a cardiologist. When repeat levels within 24 hours are not available, a repeat test should be conducted as soon as possible. If TnT or TnI repeat levels beyond 24 hours are < 2× ULN, the participant must be evaluated by a cardiologist.
  • 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 interpretation of study results and, in the judgement of the investigator, would make the patient an inappropriate candidate for the study.
  • 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 events in nursing infants secondary to treatment of the mother with Opdualag, breastfeeding should be discontinued if the mother is treated prior to initiating study treatment.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Catherine O'Neil, BS contact

858-822-5354

CancerCTO@health.ucsd.edu

United States3 sites, 3 recruiting

  • University of California, Irvine

    Irvine, California, 92868

    Mehir Tharani, 877-827-8839, ucstudy@uci.edu

    Recruiting

  • University of California, San Diego Moores Cancer Center

    La Jolla, California, 92093

    Catherine O'Neil, 858 822 5354, CancerCTO@health.ucsd.edu

    Soo Park, MD

    Recruiting

  • University of California, San Francisco

    San Francisco, California, 94158

    Sonia Contreras Martinez, (415) 714-4484, Sonia.ContrerasMartinez@ucsf.edu

    Adil Daud, MD

    Recruiting

Other trials in United States

About this study

Official title: Randomized Phase II Trial Neoadjuvant Nivolumab + Relatlimab (Opdualag) Versus Nivolumab for Resectable High-Risk Basal Cell Carcinoma

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)

Read the detailed description

Patients will be treated with 4 cycles of neoadjuvant Nivolumab + Relatlimab (Opdualag, cohort 1) or Nivolumab (cohort 2) given every 4 weeks followed by surgical resection. There will be an option to proceed directly to surgery after 2 cycles of therapy should patients have frank progression of disease based on clinical evaluation. There will also be an option to continue with Opdualag or Nivolumab beyond 4 cycles if there is ongoing clinical benefit per investigator discretion. If there is clinical evidence of a clinical complete response, patients may forgo surgery per investigator discretion. The primary outcome of pathologic response rate will be assessed at the time of resection. Patients will then be monitored for disease recurrence and other secondary outcomes.

Being tested
Nivolumab, Relatlimab plus Nivolumab
Medical subject headings
Carcinoma, Basal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NivolumabDrug

    Also called Opdivo

    Nivolumab is a fully humanized monoclonal antibody that binds to the Programmed Death-1 (PD-1) receptor, blocking its interactions with Programmed Death-Ligand 1 (PD-L1) and Programmed Death-Ligand 2 (PD-L2), and thus additionally inhibiting PD1-driven immune suppression. Nivolumab: 480 mg via intravenous administration (28 day cycle).

  • Relatlimab plus NivolumabDrug

    Also called Opdualag

    Relatlimab plus Nivolumab (Opdualag) is supplied as a single dose vial containing 480 mg of Nivolumab and 160 mg Relatlimab for intravenous administration (28 day cycle).

Study groups in NCT06624475
Study groupRoleWhat they receive
Cohort 1ExperimentalNivolumab 480 mg intravenous and Relatlimab 160 mg intravenous every 4 weeks, up to 4 cycles.
Receives: Drug: Relatlimab plus Nivolumab
Cohort 2ExperimentalNivolumab 480 mg intravenous every 4 weeks, up to 4 cycles.
Receives: Drug: Nivolumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathologic response rate

    The primary endpoint of this study is to evaluate the pathologic response rate (pathological complete response [pCR] plus major pathological response [MPR])) and the clinical complete response rate of Opdualag and Nivolumab in patients with resectable High-Risk Basal Cell Carcinoma.

    Measured: 2 years

  2. Clinical complete response rate

    Clinical complete response rate, per World Health Organization (WHO) Clinical Response Criteria for externally visible tumor(s) which can only be assessed clinically with bidimensional measurements.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2024
  2. Study start21 Aug 2025
  3. Primary completionMay 2028 (estimated)
  4. Study completionMay 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
2:1 randomization
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06624475
Sponsor's protocol ID
CA209-1451
Other IDs
810617
Acronym
NEON
Status last verified
Jul 2026
First submitted
4 Sep 2024
Last updated
28 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nivolumab and Relatlimab plus Nivolumab in people with Basal Cell Carcinoma, run by University of California, San Diego at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 32 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Catherine O'Neil, BS (858-822-5354, CancerCTO@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathologic response rate (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06624475.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.

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