Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05977907 | Neoadjuvant Pembrolizumab and IO102-103 for Squamous Cell Carcinoma of the Head and Neck (SCCHN). | PHASE2 | RECRUITING | 30 | — | — | Dec 14, 2023 | Oct 16, 2028 | Mar 3, 2026 | 5 | United States |
To determine rate of pathologic treatment response ≥50% (pTR-2) / immune-related pathologic response criteria (irPRC) ≥ 50% rate to neoadjuvant pembrolizumab plus IO102-IO103 in SCCHN
| Arm | Type | Description |
|---|---|---|
| Single Cohort | EXPERIMENTAL | Neoadjuvant Pembrolizumab ( 400mg IV infusion x1) + IO102-103 ( Subcutaneous injection weekly x6) Adjuvant Pembrolizumab ( 400 mg IV infusion Every 6 weeks x8) + IO102-103 ( Subcutaneous injection every 3 week x6 then every 6 weeks x5) |
| Name | Type | Description |
|---|---|---|
| Pembrolizumab | DRUG | Pembrolizumab is an investigational drug in this study |
| IO102-103 | DRUG | IO102-103 is an investigational drug in this study. |
Inclusion Criteria: * Be willing and able to provide written informed consent/assent for the trial. * Be 18 years of age on day of signing informed consent. * Patients with non-bulky/non-bulky squamous cell carcinomas of the head and neck, with an indication for surgical therapy. 1. Surgically r...