OncoMatch/Clinical Trials/NCT04697576
Intralesional Influenza Vaccine for the Treatment of Stage I-IV Melanoma
Is NCT04697576 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments for clinical stage i cutaneous melanoma ajcc v8.
Treatment: Ipilimumab · Nivolumab · Pembrolizumab · Quadrivalent Inactivated Influenza Vaccine · Nivolumab + Relatlimab — This 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
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)
Demographics
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 →Frequently asked questions
Is NCT04697576 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior any melanoma therapy disqualifies patients from enrollment.
What disease stage is eligible?
Stage I or IA or IB or II or IIA or IIB or IIC or III or IV is required.
Is there an age limit?
Yes. Patients must be 99 years or younger.
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 qualifyRelated pages