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Neoadjuvant Pembrolizumab and IO102-103 for Squamous Cell Carcinoma of the Head and Neck (SCCHN).

Study acronym: KIEO
StatusActive, Not Recruiting
PhasePhase 2
Started2023-12-14
View on ClinicalTrials.gov ↗

Amendment history

2026-09-23
Enrollment closed, study ongoing
2026-02-27
Study Status, Study Design v7
Enrollment target15→30
2026-02-26
3 amendments v4-v6
3 re-verifications since 2024-02-12, no change to tracked fields
2024-01-11
Study Status v3
Start dateestimated 2023-12-01→confirmed 2023-12-14
2023-11-16
Study Status v2
Start date2023-10-16→2023-12-01
2023-10-12
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2026-09-01→2026-10-16
Completion date2028-09-01→2028-10-16
Start date2023-09-01→2023-10-16
Study sites1→5
2023-08-02
Original filing
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.
Trial Details
NCT Number NCT05977907
Lead Sponsor Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators: IO Biotech, Merck Sharp & Dohme LLC
Conditions Head and Neck Squamous Cell Carcinoma
Enrollment 30 participants
Start Date 2023-12-14
Primary Completion 2026-10-16 (estimated)
Study Completion 2028-10-16 (estimated)
Updated on ClinicalTrials.gov 2026-09-22