Actively Recruiting
Study of Intratumoral Injections of VLPONC-01 and Neoadjuvant Pembrolizumab in Head and Neck Squamous Cell Carcinoma
Led by VLP Therapeutics · Updated on 2026-01-20
41
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
V
VLP Therapeutics
Lead Sponsor
S
Stanford University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of a new treatment involving virus replicon particles (VRP) containing saRNA that encodes IL-12 in patients with head and neck squamous cell carcinoma (HNSCC). This Phase I open-label study also aims to compare tumor responses when using intratumoral injections of VLPONC-01 alone versus in combination with neoadjuvant pembrolizumab, an anti-PD-1 drug. The study explores changes in tumor microenvironment, cytokine levels, and cellular responses to understand treatment effects better. Participants will be assigned to one of three cohorts based on their cancer status and treatment plan. Cohort A includes patients with unresectable or recurrent/metastatic cancer who will receive four weekly intratumoral injections of VLPONC-01. Cohort C involves patients scheduled for tumor resection surgery who will receive four weekly injections of VLPONC-01 plus two intravenous doses of pembrolizumab three weeks apart before surgery or pembrolizumab alone. Follow-up safety visits occur 30 and 90 days after the final injection or surgery. Throughout the study, participants will undergo various assessments including monitoring for safety and tolerability from the first injection through 90 days post-treatment. Researchers will measure circulating IL-12 levels, VLPONC-01 presence in tumor tissue, and tumor response via imaging and pathology. Participants must comply with scheduled visits, treatments, lab tests, and other study procedures. The total participation duration varies depending on cohort and treatment schedule, with safety follow-ups extending up to 90 days after final therapy or surgery.
CONDITIONS
Brief Title
Intratumoral Delivery of Viral Replicon (saRNA) Particles Expressing IL-12 in Head and Neck Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Patients with unresectable or recurrent/metastatic head and neck cancer with at least one injectable tumor not scheduled for surgery (Cohort A)
- Patients scheduled for surgical tumor resection with at least one measurable resectable lesion (Cohort C)
- Prior treatment with platinum-based chemotherapy, 5-Fluorouracil, taxane chemotherapy, cetuximab, or gemcitabine for primary tumor
- Prior anti-PD-1 or PD-L1 therapy with confirmed progression after treatment
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Primary tumors suitable for intratumoral injection larger than 1 cm
- Adequate bone marrow and organ function
- Ability and willingness to provide informed consent
- Life expectancy greater than 12 weeks
- Willingness and ability to comply with study visits, treatments, and procedures
You will not qualify if you...
- Tumors not suitable for injection due to proximity to vital organs or neurovascular structures
- Women of childbearing potential without a negative pregnancy test or not using adequate contraception
- Expected to receive other anticancer medications prior to surgery whose toxicities have not resolved
- Participation in another investigational study within the last 30 days
- Uncontrolled illnesses unresponsive to treatment
- Use of immunosuppressive medication within 28 days before first injection (with some exceptions)
- Breastfeeding women
- History of allogenic organ transplant requiring immunosuppressives
- Active or uncontrolled infections including HIV or chronic hepatitis B or C
- Any condition interfering with study treatment evaluation or safety assessment
- Known hypersensitivity to immune therapy drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks for VLPONC-01 injections; pembrolizumab administered twice 3 weeks apart prior to surgery
Participants receive weekly intratumoral injections of VLPONC-01 and, for some groups, neoadjuvant pembrolizumab prior to surgery.
Weekly visits for VLPONC-01 injections and 2 IV pembrolizumab infusions prior to surgery
Duration - Single day
Participants scheduled for tumor resection surgery undergo the surgical procedure after completing neoadjuvant treatment.
1 surgery visit
Duration - Up to 90 days post final injection or surgery
Participants have follow-up safety visits to monitor for adverse effects after treatment and surgery.
Follow-up visits at approximately 30 and 90 days after final treatment or surgery
Trial Site Locations
Total: 1 location
1
Stanford University
Stanford, California, United States, 34305
Actively Recruiting
Research Team
C
Clinical Research Coordinator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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