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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07172256 | CUE-101with Pembrolizumab for LA-HPV+HNSCCs | PHASE2 | NOT YET_RECRUITING | 30 | — | — | Apr 1, 2026 | Feb 1, 2031 | Apr 15, 2026 | 1 | United States |
This outcome measure evaluates the immune response by quantifying the presence of HPV-16 E711-20-specific CD8+ T cells in the peripheral blood at the conclusion of neoadjuvant treatment. The assessment will involve collecting blood samples from participants and analyzing them for the presence and quantity of these specific CD8+ T cells using immunological assays. The primary endpoint is the change in the number of HPV-16 E711-20-specific CD8+ T cells from baseline to the end of the treatment period.
| Arm | Type | Description |
|---|---|---|
| Neoadjuvant CUE-101 | EXPERIMENTAL | Neoadjuvant therapy followed by definitive surgical resection |
| Neoadjuvant Pembro | EXPERIMENTAL | Pembrolizumab Neoadjuvant therapy followed by definitive surgical resection |
| Neoadjuvant CUE-101 + Pembro | EXPERIMENTAL | CUE-101+Pembrolizumab as neoadjuvant therapy followed by definitive surgical resection |
| Name | Type | Description |
|---|---|---|
| CUE-101 | DRUG | CUE-101 will be administered by IV infusion with a commercially available syringe pump or IV infusion pump over 60 minutes on Day 1 and Day 21 after all procedures and assessments are completed. It will be administered at a dosage level of 4 mg/kg x 2 |
| Pembrolizumab | DRUG | Pembrolizumab will be administered on Day 1 and Day 21 after all procedures and assessments are completed according to the Study Calendar. Pembrolizumab will be administered as a dose of 200 mg using a 30-minute (- 5 min/+10 min) IV infusion. |
Inclusion Criteria: * Participants must have histologically or cytologically confirmed new diagnosis of locally advanced, non-metastatic, head and neck squamous cell carcinoma of the oropharynx (cT1-4 N0-N3 M0) * Participants must be deemed unresectable by a head and neck surgeon for one or more of...