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OncoMatch/Clinical Trials/NCT04697576

Intralesional Influenza Vaccine for the Treatment of Stage I-IV Melanoma

Is NCT04697576 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments for clinical stage i cutaneous melanoma ajcc v8.

Phase 1RecruitingCarlo ContrerasNCT04697576Data as of May 2026

Treatment: Ipilimumab · Nivolumab · Pembrolizumab · Quadrivalent Inactivated Influenza Vaccine · Nivolumab + RelatlimabThis phase I trial investigates the effects of influenza vaccine in treating patients with stage I-IV melanoma. While intramuscular administration of influenza vaccine provides immunization against the influenza virus, giving influenza vaccine directly into the tumor (intralesional) may decrease the size of the injected melanoma tumor, or the extent of the melanoma within the body.

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Extracted eligibility criteria

Cancer type

Melanoma

Disease stage

Required: Stage I, IA, IB, II, IIA, IIB, IIC, III, IV (AJCC v8)

clinical Stage I-III (Cohort #1), or Stage IV (Cohort #2) cutaneous melanoma

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Cannot have received: any melanoma therapy

Exception: prior surgical resection is permitted

Lab requirements

Blood counts

ANC ≥ 1.5 x 10^3/mm^3; Hemoglobin ≥ 9 g/dL; Platelet count ≥ 100 x 10^3/mm^3; Prothrombin time ≤ 1.5 x ULN

Kidney function

Creatinine clearance of ≥ 50 ml/min by Cockcroft-Gault equation

Liver function

AST/ALT ≤ 2.5 x ULN or ≤ 5 x ULN in patients with liver metastases; total bilirubin ≤ 1.5 x ULN (unconjugated bilirubin < 3 x ULN for patients with known Gilbert syndrome)

ANC ≥ 1.5 x 10^3/mm^3; Hemoglobin ≥ 9 g/dL; Platelet count ≥ 100 x 10^3/mm^3; AST/ALT ≤ 2.5 x ULN or ≤ 5 x ULN in patients with liver metastases; Prothrombin time ≤ 1.5 x ULN; Total bilirubin ≤ 1.5 x ULN (unconjugated bilirubin < 3 x ULN for patients with known Gilbert syndrome); Creatinine clearance of ≥ 50 ml/min by Cockcroft-Gault equation

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

US trial sites

  • Ohio State University Comprehensive Cancer Center · Columbus, Ohio

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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