In short
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.
At a glance
- 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
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. 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. 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: 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. 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.
Current Clinical Trial
The medication is being studied in a clinical trial called the FLU-IMMUNE trial. This trial aims to: Investigate whether the combination of local flu vaccine treatment and immunotherapy (pembrolizumab) causes tumor regression in patients with pMMR colorectal cancer. Assess specific safety events during the trial. 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.
Eligibility Criteria
To participate in this trial, patients must meet specific criteria, 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: 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. 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.