OncoMatch/Clinical Trials/NCT03521830
Nivolumab Alone or Plus Relatlimab or Ipilimumab for Patients With Locally-Advanced Unresectable or Metastatic Basal Cell Carcinoma
Is NCT03521830 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Nivolumab and Ipilimumab for basal cell carcinoma.
Treatment: Nivolumab · Ipilimumab · Relatlimab — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Cancer type
Tumor Agnostic
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: hedgehog pathway inhibitor
Exception: Cohort A only
COHORT A: Patients with advanced BCC who are treatment-naïve (i.e., no prior hedgehog pathway inhibitors and T cell modulating agents)
Cannot have received: T cell modulating agent
Exception: Cohort A only
COHORT A: Patients with advanced BCC who are treatment-naïve (i.e., no prior hedgehog pathway inhibitors and T cell modulating agents)
Cannot have received: T cell modulating agent (anti-CTLA-4, anti-PD-L1, anti-LAG-3, anti-KIR)
Patients may not have received prior T cell modulating agents for BCC (e.g., anti-CTLA-4, anti-PD-L1, anti-LAG-3, anti-KIR, etc.)
Lab requirements
Blood counts
White Blood Cells ≥ 2000/μL; Neutrophils ≥ 1500/μL; Platelets ≥ 100 x 10³/μL; Hemoglobin ≥ 9.0 g/dL
Kidney function
Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL/minute (using Cockcroft/Gault formula)
Liver function
AST and ALT ≤ 3 x ULN, except in patients with liver metastases whose values may be ≤ 5 x ULN; Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome who may have total bilirubin ≤ 3.0 mg/dL)
Screening laboratory values... White Blood Cells ≥ 2000/μL; Neutrophils ≥ 1500/μL; Platelets ≥ 100 x 10³/μL; Hemoglobin ≥ 9.0 g/dL; Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL/minute (using Cockcroft/Gault formula); AST and ALT ≤ 3 x ULN, except in patients with liver metastases whose values may be ≤ 5 x ULN; Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome who may have total bilirubin ≤ 3.0 mg/dL)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Johns Hopkins Hospital · Baltimore, Maryland
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT03521830 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior hedgehog pathway inhibitor, T cell modulating agent, T cell modulating agent disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify