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Vb10.16

This article discusses a clinical trial investigating the use of VB10.16, a novel drug, in combination with pembrolizumab for patients with HPV16-positive head and neck squamous cell carcinoma. The study aims to assess the safety, effectiveness, and immune response of this combination therapy in patients with recurrent or metastatic cancer that cannot be treated with local therapy. The trial consists of two phases: a dose escalation phase to determine the optimal dose and a dose expansion phase to further evaluate the treatment’s efficacy and safety.

Table of Contents

What is VB10.16?

VB10.16 is a new type of immunotherapy drug being developed to treat certain types of cancer[1]. It is classified as a therapeutic vaccine, which means it’s designed to stimulate the immune system to fight existing cancer cells rather than prevent disease like traditional vaccines do.

How does VB10.16 work?

VB10.16 works by targeting specific proteins (E6 and E7) produced by the human papillomavirus type 16 (HPV16)[1]. These proteins are often found in certain types of cancer cells. By helping the immune system recognize and attack cells with these proteins, VB10.16 aims to fight the cancer.

What condition does VB10.16 treat?

VB10.16 is being studied for the treatment of HPV16-positive oropharyngeal head and neck squamous cell carcinoma (HNSCC)[1]. This is a type of cancer that:

  • Affects the oropharynx (the middle part of the throat, including the back of the tongue, tonsils, and soft palate)
  • Is caused by HPV16 infection
  • Has returned after previous treatment (recurrent) or has spread to other parts of the body (metastatic)
  • Cannot be removed by surgery

Current research on VB10.16

VB10.16 is currently being studied in a clinical trial that combines it with another immunotherapy drug called pembrolizumab[1]. This trial aims to:

  1. Find the safest and most effective dose of VB10.16
  2. Evaluate how well VB10.16 and pembrolizumab work together to fight cancer
  3. Assess the safety of this combination treatment
  4. Measure how the immune system responds to VB10.16

Who can participate in the VB10.16 trial?

The trial is open to patients who meet specific criteria[1], including:

  • Adults 18 years or older
  • Diagnosed with HPV16-positive oropharyngeal HNSCC that is recurrent or metastatic
  • Cancer that cannot be cured by local treatments
  • Have at least one measurable tumor
  • Good overall health status

There are also several factors that may prevent someone from participating in the trial, such as certain medical conditions, previous treatments, or pregnancy[1].

Potential benefits and risks

As with any experimental treatment, there are potential benefits and risks to participating in the VB10.16 trial[1]: Potential benefits:

  • Access to a new treatment that may be more effective than current options
  • Close monitoring by healthcare professionals
  • Contributing to medical research that may help future patients
Potential risks:
  • Side effects from the treatment, which may be severe or unexpected
  • The treatment may not be effective for everyone
  • Time commitment for hospital visits and tests

It’s important to discuss these potential benefits and risks with your healthcare provider to determine if participating in the VB10.16 trial is right for you.

Aspect Details
Study Type Phase 1/2a, open-label, dose-finding trial
Main Objective Evaluate safety, immunogenicity, and anti-tumor activity of VB10.16 with pembrolizumab
Target Population Patients with unresectable recurrent or metastatic HPV16-positive oropharyngeal HNSCC
Treatment VB10.16 (varying doses) combined with fixed-dose pembrolizumab
Study Phases Dose Escalation (3 cohorts: 3mg, 6mg, 9mg VB10.16) and Dose Expansion (2 cohorts)
Primary Endpoints Safety (DLTs, adverse events), ORR, T-cell responses
Secondary Endpoints DCR, DOR, PFS, OS, immunogenicity
Key Eligibility Criteria ≥18 years, confirmed HPV16+ oropharyngeal HNSCC, measurable disease, adequate organ function
Key Exclusion Criteria Prior immunotherapy, active autoimmune disease, uncontrolled infections

FAQ

  • What is VB10.16 and how does it work? VB10.16 is an investigational drug designed to target HPV16-positive cancers. It works by stimulating the immune system to recognize and attack cancer cells that express HPV16 proteins. When combined with pembrolizumab, an immunotherapy drug, it may enhance the body's ability to fight cancer.
  • Who is eligible to participate in this clinical trial? Eligible participants are adults (18 years or older) with confirmed HPV16-positive oropharyngeal head and neck squamous cell carcinoma that is recurrent or metastatic and cannot be cured by local therapy. Patients must have measurable disease and meet specific health criteria, including adequate organ function and performance status.
  • What are the main objectives of this clinical trial? The main objectives are to determine the safety and optimal dose of VB10.16 when combined with pembrolizumab, evaluate the anti-tumor activity and clinical efficacy of the combination, and assess the immune response generated by the treatment.
  • How is the trial structured? The trial is divided into two main phases: a dose escalation phase to determine the safe and effective dose of VB10.16, and a dose expansion phase to further evaluate the treatment's efficacy and safety in a larger group of patients. Patients will receive VB10.16 in combination with a fixed dose of pembrolizumab.
  • What are the potential benefits and risks of participating in this trial? Potential benefits include access to a novel combination therapy that may be effective against HPV16-positive head and neck cancer. Risks may include side effects from the treatment, which will be closely monitored throughout the trial. It's important to note that as this is an experimental treatment, its effectiveness and all potential risks are not yet fully known.

Ongoing Clinical Trials on Vb10.16

  • Study on the Safety and Effectiveness of VB10.16 and Pembrolizumab for Patients with HPV16-Positive Head and Neck Cancer

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia France Germany Hungary Norway Poland +1

Glossary

  • HPV16: Human Papillomavirus type 16, a specific strain of HPV known to cause certain types of cancer, including some head and neck cancers.
  • Head and Neck Squamous Cell Carcinoma (HNSCC): A type of cancer that begins in the squamous cells that line the moist surfaces inside the head and neck, such as the mouth, nose, and throat.
  • Pembrolizumab: An immunotherapy drug that helps the immune system detect and fight cancer cells by blocking a protein called PD-1.
  • Recurrent cancer: Cancer that has returned after a period of time during which the cancer could not be detected.
  • Metastatic cancer: Cancer that has spread from its original site to other parts of the body.
  • Immunogenicity: The ability of a substance to provoke an immune response in the body.
  • Dose-limiting toxicity (DLT): Side effects of a drug that are severe enough to prevent an increase in dose or require a decrease in dose.
  • Objective Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • Progression-free survival (PFS): The length of time during and after treatment that a patient lives with the disease but it does not get worse.
  • Overall survival (OS): The length of time from the start of treatment that patients are still alive.

References

  1. http://clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-vb10-16-and-pembrolizumab-for-patients-with-hpv16-positive-head-and-neck-cancer/