RecruitingBasal Cell Carcinoma

Nivolumab Alone or Plus Relatlimab or Ipilimumab for Patients With Locally-Advanced Unresectable or Metastatic Basal Cell Carcinoma

Eligible age

18+ yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

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About this study

This is a phase 2 trial assessing the efficacy of nivolumab, alone or in combination with relatlimab or ipilimumab in treating patients with locally-advanced unresectable or metastatic basal cell carcinoma.

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

You may qualify if…

✓ 1. Signed Written Informed Consent
✓ 1. Subjects must have signed and dated an Institutional Review Board (IRB)-approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care.
✓ 2. Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, and other requirements of the study.
✓ 2. Type of Participant and Target Disease Characteristics
✓ 1. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
✓ 2. Participants with histologically confirmed Basal Cell Carcinoma with disease that is considered by the investigator to be unresectable or metastatic.
✓ i) COHORT A: Patients with advanced BCC who are treatment-naïve (i.e., no prior hedgehog pathway inhibitors and T cell modulating agents) will receive anti-PD-1 (nivolumab) alone.
✓ ii) COHORT B: • Patients with advanced BCC who experience disease progression on anti-PD-1 (nivolumab) + anti-LAG-3 (relatlimab) will receive anti-PD-1 (nivolumab) + anti-CTLA-4 (ipilimumab).

You may not qualify if…

✕ 1. Medical Conditions
✕ 1. Pregnant or nursing women
✕ 2. Central nervous system metastases, unless stable for at least 4 weeks and no longer requiring steroid therapy.
✕ 3. Patients with an autoimmune disease or with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications may be permitted to enroll only after discussion with the study P.I.
✕ 4. Participants with human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS).
✕ 5. Viral hepatitis.
✕ i. Participants with active hepatitis B (positive hepatitis B surface antigen \[HBsAg\] or hepatitis C virus (HCV) (positive HCV RNA) are excluded.
✕ ii. Patients with past Hepatitis B virus (HBV) infection or resolved HBV infection (defined as the presence of hepatitis B core antibody \[HBcAb\] and the absence of HBsAg) are not ineligible, but HBV DNA quantification must be performed and results discussed with the P.I.

Where it's recruiting

Maryland

Baltimore

Source: ClinicalTrials.gov · NCT03521830 · last updated 2026-04-29