OncoMatch/Clinical Trials/NCT06736379
Intratumoral Delivery of Viral Replicon (saRNA) Particles Expressing IL-12 in Head and Neck Cancer
Is NCT06736379 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments including VRP-encapsulated saRNA encoding IL-12 (1 x 10^9 viral particles per and VRP-encapsulated saRNA encoding IL-12 (3 x 10^8 viral particles per for head and neck cancers- squamous cell.
Treatment: VRP-encapsulated saRNA encoding IL-12 (1 x 10^9 viral particles per · Pembrolizumab (KEYTRUDA®) · VRP-encapsulated saRNA encoding IL-12 (3 x 10^8 viral particles per — The goal of this clinical trial is to assess the safety and tolerability of a virus replicon particle (VRP) encapsulated saRNA encoding IL-12 when injected into in head and neck cancer patients. The main questions being addressed are: The safety and tolerability of intratumoral (IT) injections of VRP-encapsulated saRNA encoding IL-12 (VLPONC-01) The tumor response to IT injections of VLPONC-01 The tumor response due to the combination of IT injections of VLPONC-01 and system IV administration of neoadjuvant pembrolizumab (anti-PD-1) treatment Researchers will compare neoadjuvant pembrolizumab alone to the combination therapy to see if the combination enhances tumor responses.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
Cancer type
Head and Neck Squamous Cell Carcinoma
Tumor Agnostic
Biomarker criteria
Allowed: ALK rearrangement
Allowed: EGFR activating mutation
Disease stage
Required: Stage I, II, III, IVA, IVB (AJCC, 8th Edition)
clinical stage I-IVb (cT1-4, N0-3) (AJCC, 8th Edition)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy — locally advanced or metastatic
Subjects must have received a platinum containing chemotherapy regimen
Must have received: antimetabolite (5-Fluorouracil) — locally advanced or metastatic
5-Fluorouracil chemotherapy
Must have received: taxane — locally advanced or metastatic
taxane based chemotherapy
Must have received: EGFR-targeted therapy (cetuximab) — locally advanced or metastatic
cetuximab
Must have received: antimetabolite (gemcitabine) — locally advanced or metastatic
gemcitabine
Must have received: anti-PD-1 therapy
Subjects must have received an anti-PD-1/ PD-L1 as monotherapy or in combination with chemotherapy. Subjects must have progressed following therapy with at least one PD-1 or PD-L1 checkpoint inhibitor
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1,500/mcL; Platelets ≥ 100,000/mcL; Hemoglobin ≥ 8.0 g/dL (transfusion/intervention allowed to achieve Hgb ≥ 8.0 g/dL)
Liver function
Total bilirubin ≤2x institutional upper limit of normal (ULN); AST(SGOT) or ALT(SGPT) ≤ 3.0x institutional ULN
Have acceptable organ and marrow function defined as follows: Absolute neutrophil count ≥ 1,500/mcL Platelets ≥ 100,000/mcL Hemoglobin ≥ 8.0 g/dL (Note: use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dL is acceptable) Total bilirubin ≤2x institutional upper limit of normal (ULN) AST(SGOT) or ALT(SGPT) ≤ 3.0x institutional ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Stanford University · Stanford, California
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06736379 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received platinum-based chemotherapy and antimetabolite.
What disease stage is eligible?
Stage I or II or III or IVA or IVB is required.
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