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Influenza A Virus/Thailand/8/2022 (H3N2)-Like Strain (A/California/122/2022, San-022), Inactivated

This article discusses an innovative clinical trial investigating the use of an intratumoral flu vaccine in combination with pembrolizumab for patients with early-stage colorectal cancer. The study, known as the FLU-IMMUNE trial, aims to explore whether this unique approach can stimulate the immune system to fight cancer cells and potentially lead to tumor regression in patients with pMMR (proficient mismatch repair) type colorectal cancer.

Table of Contents

Overview of the Medication

INFLUENZA A VIRUS/THAILAND/8/2022 (H3N2)-LIKE STRAIN (A/CALIFORNIA/122/2022, SAN-022), INACTIVATED is a component of an influenza vaccine that is being studied for a novel use in cancer treatment[1]. This inactivated virus strain is typically used in flu vaccines to protect against influenza, but researchers are now exploring its potential in treating colorectal cancer when combined with immunotherapy.

Purpose and Target Condition

In this innovative approach, the flu vaccine containing this strain is being investigated for its potential to treat colorectal cancer, specifically in patients with non-metastatic pMMR (proficient mismatch repair) colorectal cancer[1]. The study aims to determine if combining a local flu vaccine treatment with immunotherapy can cause tumor regression in these patients.

Composition and Related Strains

The medication is part of a quadrivalent influenza vaccine that includes several inactivated virus strains[1]:

  • INFLUENZA A VIRUS/THAILAND/8/2022 (H3N2)-LIKE STRAIN (A/CALIFORNIA/122/2022, SAN-022), INACTIVATED
  • B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE)
  • INFLUENZA VIRUS B/AUSTRIA/1359417/2021-LIKE STRAIN (B/AUSTRIA/1359417/2021, BVR-26)
  • INFLUENZA A/VICTORIA/4897/2022 IVR-238 (H1N1), INACTIVATED
These strains are carefully selected to provide broad protection against different influenza virus types.

Administration and Dosage

In this clinical trial, the flu vaccine is administered intralesionally, which means it’s injected directly into the tumor[1]. This is a unique approach compared to the typical intramuscular injection used for flu prevention. The maximum daily and total dose amount is 0.5 mg/l or 0.5 ml, depending on the specific product formulation[1].

Current Clinical Trial

The medication is being studied in a clinical trial called the FLU-IMMUNE trial[1]. This trial aims to:

  1. Investigate whether the combination of local flu vaccine treatment and immunotherapy (pembrolizumab) causes tumor regression in patients with pMMR colorectal cancer.
  2. Assess specific safety events during the trial.
  3. Characterize the cancer-killing immune cells and functional changes in the tumor microenvironment.
The primary goal is to achieve a major pathological response in 50% or more of the patients, defined as less than 10% viable cells in the tumor[1].

Eligibility Criteria

To participate in this trial, patients must meet specific criteria[1], including:

  • Having confirmed localized pMMR stage I to III colorectal carcinoma
  • Being 18 years or older
  • Having adequate bone marrow, kidney, and liver function
  • Not having certain medical conditions or prior treatments that could interfere with the study
It’s important to note that this is not a complete list, and a healthcare provider should be consulted for full eligibility details.

Safety Considerations

As with any medical treatment, there are safety considerations[1]:

  • Patients with certain autoimmune disorders, active infections, or a history of severe allergic reactions to vaccines or their components are not eligible for the trial.
  • The trial excludes patients who have received certain types of immunotherapy in the past.
  • Pregnancy and breastfeeding are contraindications for participation in the trial.
These precautions are in place to ensure the safety of the participants and the integrity of the study results.

Future Implications

This innovative use of a flu vaccine component in cancer treatment represents a promising avenue in cancer immunotherapy[1]. If successful, it could open up new possibilities for treating colorectal cancer and potentially other types of cancer. However, it’s important to remember that this is still in the clinical trial phase, and more research is needed to establish its efficacy and safety in cancer treatment.

Aspect Details
Study Name FLU-IMMUNE trial
Main Objective Investigate tumor regression using intratumoral flu vaccine and pembrolizumab
Target Population Adults with early-stage pMMR colorectal cancer
Treatment Intratumoral Influvac Tetra (flu vaccine) + systemic Keytruda (pembrolizumab)
Primary Endpoint 50% or more patients achieving major pathological response
Secondary Objectives Safety assessment, immune cell characterization, tumor microenvironment analysis
Study Design Single arm combination intervention

FAQ

  • What is the main goal of the FLU-IMMUNE trial? The main goal of the FLU-IMMUNE trial is to investigate whether a combination of local flu vaccine treatment and immunotherapy (pembrolizumab) can cause tumor regression in patients with pMMR type colorectal cancer.
  • Who is eligible to participate in this clinical trial? Eligible participants include adults (18 years or older) with confirmed localized pMMR stage I to III colorectal cancer, who have an indication for elective curative intended surgery without neoadjuvant chemotherapy. They must also meet specific health criteria and agree to use contraception during the study period.
  • What treatments are being used in this study? The study combines two approved drugs: Influvac Tetra (a flu vaccine) administered intratumorally, and Keytruda (pembrolizumab) given systemically. This combination is novel but uses approved dosages of both drugs.
  • What is the primary endpoint of the study? The primary endpoint is to achieve a major pathological response (MPR) in 50% or more of the patients. MPR is defined as less than 10% viable cells in the tumor, corresponding to Mandard tumor regression grade 1-2 (MTRG).
  • Are there any specific exclusion criteria for this trial? Yes, some exclusion criteria include having an autoimmune disorder, previous treatment with certain immunotherapies, HIV or active hepatitis, recent use of live vaccines, and allergies to study drug components or influenza vaccines.

Ongoing Clinical Trials on Influenza A Virus/Thailand/8/2022 (H3N2)-Like Strain (A/California/122/2022, San-022), Inactivated

  • Study of Flu Vaccine and Pembrolizumab for Patients with Early Colorectal Cancer

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

  • Study on the Safety and Immune Response of a High-Dose Influenza Vaccine in Adults Aged 60 and Over, Comparing Trivalent Influenza Vaccine with a Drug Combination

    Not recruiting

    3 1 1 1
    Investigated drugs:
    Belgium Bulgaria Estonia Finland Spain

Glossary

  • pMMR: Proficient mismatch repair, a type of colorectal cancer that typically doesn't respond well to immunotherapy alone.
  • Intratumoral: Administered directly into the tumor.
  • Pembrolizumab: An immunotherapy drug that helps the immune system detect and fight cancer cells.
  • Neoadjuvant chemotherapy: Chemotherapy given before the main treatment, usually surgery.
  • Major pathological response (MPR): A significant reduction in viable cancer cells in the tumor after treatment.
  • ECOG performance status: A scale used to assess how a patient's disease affects their daily living abilities.
  • Glomerular filtration rate (GFR): A test used to check how well the kidneys are working.
  • Mandard tumor regression grade (MTRG): A system used to classify the response of a tumor to treatment.
  • Immunohistochemical analysis: A method used to detect specific proteins in tissues, often used to study immune cells in tumors.
  • Transcriptomic analyses: The study of all RNA molecules in a cell or tissue, which can provide information about gene activity.

References

  1. http://clinicaltrials.eu/trial/study-of-flu-vaccine-and-pembrolizumab-for-patients-with-early-colorectal-cancer/