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OncoMatch/Clinical Trials/NCT03690986

VX15/2503 in Combination With Ipilimumab or Nivolumab in Patients With Head and Neck Cancer

Is NCT03690986 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including VX15/2503 and Ipilimumab for squamous cell carcinoma of the head and neck.

Phase 1RecruitingEmory UniversityNCT03690986Data as of May 2026

Treatment: VX15/2503 · Ipilimumab · NivolumabThis phase I trial studies how well anti-semaphorin 4D (SEMA4D) monoclonal antibody VX15/2503 (VX15/2503) with or without ipilimumab and/or nivolumab work in treating patients with stage I-IVA head and neck squamous cell cancer. Monoclonal antibodies, such as VX15/2503, ipilimumab, and nivolumab, may interfere with the ability of tumor cells to grow and spread.

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Extracted eligibility criteria

Cancer type

Head and Neck Squamous Cell Carcinoma

Biomarker criteria

Allowed: CDKN2A p16 positive and negative allowed

p16 positive and negative allowed

Disease stage

Required: Stage I, II, III, IVA

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: any treatment for hnscc

Lab requirements

Blood counts

Absolute neutrophil count ≥ 1,500 cells/µL; Platelets ≥ 100,000/µL; Hemoglobin ≥ 9.0g/dL (may receive prbc transfusion)

Kidney function

Serum creatinine ≤ 1.5 x ULN; Calculated creatinine clearance of ≤ 50 mL/min

Liver function

Total bilirubin ≤ 1.5 x ULN; AST and ALT ≤ 2.5 x ULN; Albumin ≥ 3.0 g/dL

Absolute neutrophil count ≥ 1,500 cells/µL; Platelets ≥ 100,000/µL; Hemoglobin ≥ 9.0g/dL (may receive packed red blood cell [prbc] transfusion); Total bilirubin ≤ 1.5 x ULN; AST and ALT ≤ 2.5 x ULN; Albumin ≥ 3.0 g/dL; Serum creatinine ≤ 1.5 x ULN; Calculated creatinine clearance of ≤ 50 mL/min

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Emory University Hospital Midtown · Atlanta, Georgia

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