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 (May 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
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
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