Study on TG4001 and Avelumab for HPV16 Positive Recurrent or Metastatic Cancers

Inclusion Criteria

• Men and women aged 18 and older.
• Good overall health with a performance status of 0 or 1.
• Life expectancy of at least 3 months.
• Diagnosed with HPV-16 positive cancer that has spread or returned, such as cervical, vulvar, vaginal, penile, or anal cancer.
• Cancer cannot be removed by surgery or cured with radiation, and has shown progression.
• No more than one previous treatment for cancer that has spread or returned.
• Participants who have had cancer return within 6 months after previous treatment, cannot have platinum-based therapy, or refuse standard treatments are eligible.
• Limited liver disease if cancer has spread to the liver.
• Must provide a tumor sample from a biopsy.
• At least one tumor that can be measured by a CT scan.
• Adequate blood, liver, and kidney function.
• Negative pregnancy test for women who can have children.
• Use of effective birth control for both men and women during the study and for 3 months after the last treatment.

Exclusion Criteria

• Previous treatment with cancer immunotherapy or vaccines.
• Long-term use of steroids or immunosuppressive drugs unless stopped 2 weeks before the study, except for low-dose steroids for adrenal insufficiency.
• Cancer that has spread to the brain unless treated and stable for 4 weeks before the study.
• Other active cancers needing treatment.
• Previous cancers unless in complete remission for at least 2 years.
• Organ transplants, including stem cell transplants.
• Severe allergic reactions to monoclonal antibodies or similar drugs.
• Allergies to eggs, gentamycin, or similar compounds.
• Allergies to components of anti-PD-L1/PD-1 drugs.
• History of lung disease or pneumonitis.
• Active autoimmune diseases or immunodeficiency, except for controlled conditions like type I diabetes or hypothyroidism.
• Serious heart conditions or recent heart attacks.
• Uncontrolled high blood pressure or diabetes.
• Active infections.