Viral Replicon Particles for Head and Neck Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment for head and neck cancer to assess its safety and effectiveness. Researchers are testing a treatment that combines a virus-based injection (VRP-encapsulated saRNA encoding IL-12) with the cancer drug pembrolizumab. The goal is to determine if this combination can shrink tumors more effectively than the drug alone. Individuals with head and neck cancer, whose tumors can be injected or surgically removed, might be suitable for this trial. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you are currently receiving other anti-cancer medications or immunosuppressive drugs within 28 days before the first dose of the trial treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown pembrolizumab to be safe. The FDA has already approved it for treating certain types of head and neck cancer. Patients have received pembrolizumab in various situations, and it has generally been well-tolerated. Common side effects include fatigue and skin rash, but these are often manageable.
The VRP-encapsulated saRNA encoding IL-12 treatment is newer, requiring more research to fully understand its safety in humans. This trial is in an early phase, focusing primarily on safety assessment. Early trials typically start with small groups to closely monitor any side effects. Currently, there isn't enough data to draw conclusions about its safety. However, its presence in a clinical trial indicates researchers believe in its potential and are committed to thorough study.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for head and neck cancer because they use viral replicon particles (VRP) to deliver self-amplifying RNA (saRNA) that encodes the immune-stimulating protein IL-12 directly into tumors. This method is different from the standard care options like surgery, radiation, and chemotherapy, as it aims to boost the body's immune response specifically at the tumor site. Additionally, some treatment arms combine VRP with Pembrolizumab, an existing immunotherapy drug, which could enhance the overall effectiveness by targeting cancer cells in multiple ways. This innovative approach may offer a more targeted and potentially less toxic treatment option compared to traditional therapies.
What evidence suggests that this trial's treatments could be effective for head and neck cancer?
This trial will evaluate different treatment approaches for head and neck cancer. Some participants will receive pembrolizumab, which studies have shown can effectively treat head and neck squamous cell carcinoma. It has been proven to help patients live longer and delay cancer recurrence. Research indicates that adding pembrolizumab to standard treatments significantly improves patient outcomes.
Other participants will receive VRP-encapsulated saRNA encoding IL-12. Early animal studies suggest this treatment might control tumors better than some other methods. This approach uses a special kind of RNA (a molecule that helps make proteins) to activate the body's immune system to fight cancer cells. Although data collection from human studies is ongoing, this method shows promise in directly boosting the immune response against the tumor.46789Who Is on the Research Team?
Fred M Baik, MD
Principal Investigator
Stanford University
Are You a Good Fit for This Trial?
This trial is for individuals with specific types of head and neck cancers, including squamous cell carcinoma and esophageal carcinoma. Participants should have a tumor suitable for injection. Details on who can join are not fully provided here.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intratumoral injections of VLPONC-01, with some cohorts also receiving neoadjuvant pembrolizumab
Surgery
Participants in certain cohorts undergo tumor resection surgery after receiving treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment and surgery
What Are the Treatments Tested in This Trial?
Interventions
- Pembrolizumab
- VRP-encapsulated saRNA encoding IL-12
Find a Clinic Near You
Who Is Running the Clinical Trial?
VLP Therapeutics
Lead Sponsor
Stanford University
Collaborator