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

NCT ID: NCT06624475

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-21
• Study Completion Date: 2028-05-31

Brief 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 BCC (HR BCC)

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.

Conditions

Basal Cell Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1

Nivolumab 480 mg IV and Relatlimab 160 mg IV. Every 4 weeks, up to 4 cycles

Group Type: EXPERIMENTAL

Relatlimab plus Nivolumab

Intervention Type: DRUG

Relatlimab plus Nivolumab (Opdualag) is supplied as a single dose vial containing 240 mg of Nivolumab and 80 mg. Relatlimab per 20 mL for intravenous administration ; 28 day cycle.

Cohort 2

Nivolumab 480 mg IV. Every 4 weeks, up to 4 cycles

Group Type: EXPERIMENTAL

Nivolumab

Intervention Type: DRUG

Nivolumab is a fully humanized monoclonal antibody that binds to the PD-1 receptor, blocking its interactions with PD-L1 and PD-L2, and thus additionally inhibiting PD1-driven immune suppression. Nivolumab 490 mg via IV administration 28 day cycle

Interventions

Nivolumab

Nivolumab is a fully humanized monoclonal antibody that binds to the PD-1 receptor, blocking its interactions with PD-L1 and PD-L2, and thus additionally inhibiting PD1-driven immune suppression. Nivolumab 490 mg via IV administration 28 day cycle

Intervention Type: DRUG

Relatlimab plus Nivolumab

Relatlimab plus Nivolumab (Opdualag) is supplied as a single dose vial containing 240 mg of Nivolumab and 80 mg. Relatlimab per 20 mL for intravenous administration ; 28 day cycle.

Intervention Type: DRUG

Other Intervention Names

Opdivo; Opdualag

Eligibility Criteria

Inclusion Criteria

1. Ability to understand and the willingness to sign a written informed consent document.

2. Participants must have histologically or cytologically confirmed basal cell carcinoma.

3. 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.

4. 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.

5. Participants must have treatment naive BCC.

6. Aged 18 years or older.

7. ECOG Performance Status 0 1

8. Demonstrates adequate organ function as defined below:

Adequate bone marrow function

1. Absolute neutrophil count ≥ 1,500/mcL

2. Platelets ≥ 100,000/mcL

Adequate hepatic function

3. Total bilirubin >1.5 x ULN (except participants with Glibert Syndrome who must have a total biliru bin level of <3.0xULN)

4. AST (SGOT) ≤ 3 x institutional upper limit of normal

5. ALT (SGPT) ≤ 3 x institutional upper limit of normal

Adequate renal function

6. Creatinine clearance Calculated creatinine clearance (CrCl) > 30 mL/min (using the Cockcroft Gault formula)

9. 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 las t year or a current CD4 count < 350 cells/uL.

10. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.

11. 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.

12. 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.

13. 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:

i. Women who are not of childbearing potential are exempt from contraceptive requirements.

ii. Women participants must have documented proof that they are not of childbearing potential.

iii. 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.

v. 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.

vii. 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:

1. Is not a WOCBP. OR

2. 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.

Exclusion Criteria

1. Is currently receiving any other investigational agents.

2. 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.

3. Hypersensitivity to Opdualag, nivolumab, or any of their excipients.

4. Presence of untreated (symptomatic) CNS metastases.

5. Presence of leptomeningeal metastatic disease.

6. Treatment with any live / attenuated vaccine within 30 days of first study treatment.

7. 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.

8. 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.

9. 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.

10. Prior allogeneic tissue/solid organ transplant.

11. 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.

12. Any prior history of myocarditis and/or current diagnosis of myocarditis, regardless of etiology.

13. Troponin T (TnT) or I (TnI) > 2 x institutional upper limit of normal (ULN).

1. 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.

2. After cardiologist evaluation, the participant may be considered for randomization if the Investigator assesses a favorable benefit/risk.

14. 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.

15. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Soo Park

Medical Oncologist, Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Soo Park, MD

Role: PRINCIPAL_INVESTIGATOR

UC San Diego Health - Moores Cancer Center

Locations

University of California, Irvine

Irvine, California, United States

Site Status: NOT_YET_RECRUITING

University of California, San Diego Moores Cancer Center

La Jolla, California, United States

Site Status: RECRUITING

University of California, San Francisco

San Francisco, California, United States

Site Status: NOT_YET_RECRUITING

Countries

United States

Central Contacts

Catherine O'Neil, BS

Role: CONTACT

CancerCTO@health.ucsd.edu

858-822-5354

Facility Contacts

Mehir Tharani

Role: primary

ucstudy@uci.edu

877-827-8839

Catherine O'Neil

Role: primary

CancerCTO@health.ucsd.edu

858 822 5354

Sonia Contreras Martinez

Role: primary

Sonia.ContrerasMartinez@ucsd.edu

(415) 714-4484

Other Identifiers

CA209-1451

Identifier Type: -

Identifier Source: org_study_id

810617

Identifier Type: OTHER

Identifier Source: secondary_id