Pembrolizumab + IO102-103 for Head and Neck Cancer
(KIEO Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This research is being done to see if it is safe to give investigational combination of study drugs (Pembrolizumab and IO102-103) before surgery to people with surgically resectable (removable) newly diagnosed or recurrent metastatic SCCHN. This will be done by watching participants closely for possible side effects from Pembrolizumab and IO102-103. In addition, participants will be monitored for any delays to their surgery due to the study drugs.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive therapy or have received certain cancer treatments recently, you may need to discuss this with the trial team.
Is the combination of Pembrolizumab and IO102-103 safe for humans?
Pembrolizumab, also known as KEYTRUDA, has been used in various cancers and is generally considered safe, but it can cause serious side effects like pneumonia, liver inflammation, and thyroid problems. These side effects are related to its role as an immune checkpoint inhibitor, which can sometimes cause the immune system to attack healthy cells.12345
How does the drug Pembrolizumab + IO102-103 differ from other treatments for head and neck cancer?
Pembrolizumab is a drug that works by blocking a pathway that cancer cells use to hide from the immune system, and it is already used for certain head and neck cancers. The combination with IO102-103 is unique because it may enhance the immune response against cancer cells, potentially offering a new approach for patients who have not responded well to other treatments.12678
What data supports the effectiveness of the drug pembrolizumab for head and neck cancer?
Who Is on the Research Team?
Tanguy Seiwert, M.D.
Principal Investigator
Johns Hopkins University/Sidney Kimmel Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults with resectable head and neck squamous cell carcinoma who can consent to treatment and surgery. They must have good organ function, not be pregnant or breastfeeding, agree to use contraception, and have no severe heart conditions, active infections, recent cancer treatments or live vaccines. Those with certain other cancers or autoimmune diseases are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Neoadjuvant Treatment
Participants receive neoadjuvant Pembrolizumab and IO102-103 prior to surgery
Surgical Resection
Participants undergo surgical resection after neoadjuvant therapy
Adjuvant Treatment
Participants receive adjuvant Pembrolizumab and IO102-103 post-surgery
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- IO102-103
- Pembrolizumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead Sponsor
IO Biotech
Industry Sponsor
Merck Sharp & Dohme LLC
Industry Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University