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.
Eligibility criteria
Qualifiers
Eastern Cooperative Oncology Group (ECOG) performance status 0-1, and adequate bone marrow and organ function.
Primary tumors should be amenable to intratumoral (IT) injection >1 cm diameter. This will be determined by the Protocol Director, or the surgeon involved.
Subjects with either a local recurrence or a new primary tumor will be allowed.
Age ≥ 18 years.
Disqualifiers
Tumors which are not feasible for injections include high risk lesions that are near vital organs or important neurovascular structures, as determined by the Protocol Director or involved surgeon.
Women of childbearing potential must have a negative serum β-hCG pregnancy test within 7 days prior to the administration of the first study treatment and/or urine pregnancy 48 hours prior to the administration of the first study treatment. Both sexually active women of childbearing potential and males (and their female partners) patients must agree to use two methods of effective contraception, one of them being a barrier method, or to abstain from sexual activity during the study and for at least 6 months after last dose of study drugs.
Patients expected to receive other anti-cancer medication such as, chemotherapy, immunotherapy, biologic therapy, targeted therapy, monoclonal antibodies, hormonal therapy (other than leuprolide or other GnRH agonists) prior to surgery and where all acute toxicity of prior treatments have not resolved.
Participation in another clinical study with an investigational product during the last 30 days.
Trial design
Treatments tested in this trial
VRP-encapsulated saRNA encoding IL-12 (1 x 10^9 viral particles per injection)
Pembrolizumab (KEYTRUDA®)
VRP-encapsulated saRNA encoding IL-12 (3 x 10^8 viral particles per injection)
Treatment groups
41 Participants
are divided into 4 treatment groups
Locations
1
Stanford University34305, StanfordCalifornia, United States