Study on Pembrolizumab and IO102-103 Before Surgery for Head and Neck Cancer

Inclusion Criteria

• Be willing and able to provide written consent to participate in the trial.
• Be at least 18 years old.
• Have a type of head and neck cancer that can be surgically removed, typically at certain stages, but exceptions can be made for other suitable cases.
• Be a suitable candidate for surgery with the intent to cure the cancer.
• Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
• Agree to have a biopsy of the tumor before and during treatment.
• Have adequate organ function as determined by medical tests.
• Women of childbearing potential must have a negative pregnancy test before starting the study medication and agree to use two methods of birth control or be surgically sterile or abstain from heterosexual activity during the study and for 120 days after the last dose.
• Men must agree to use effective contraception or abstain from sexual activity during the study and for 120 days after the last dose.

Exclusion Criteria

• Women who are pregnant or have a positive pregnancy test before starting treatment.
• Have previously received certain types of cancer therapies, including anti-PD-1, anti-PD-L1, or similar agents.
• Have had systemic cancer treatment or radiation therapy recently.
• Have received a live vaccine within 30 days before starting the study drug.
• Are currently in another clinical trial or have used an investigational device recently.
• Have an immune deficiency or are on high-dose steroid therapy.
• Have another progressing cancer or have been treated for another cancer in the past two years, except for certain skin cancers or low-grade cancers.
• Have active brain metastases or cancer in the brain lining.
• Have severe allergies to Pembrolizumab or its ingredients.
• Have an active autoimmune disease requiring treatment in the past two years.
• Have a history of lung disease requiring steroids or current lung disease.
• Have an active infection needing treatment.
• Have a history of HIV, Hepatitis B, or Hepatitis C.
• Have any condition or treatment that might interfere with the study or is not in the participant's best interest.
• Have psychiatric or substance abuse disorders that would interfere with the study.
• Are pregnant, breastfeeding, or planning to have children during the study.
• Have had a tissue or organ transplant.
• Have certain heart conditions, such as heart failure or recent heart attack.