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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01836029 | Chemotherapy Plus Cetuximab in Combination With VTX-2337 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck | PHASE2 | COMPLETED | 195 | — | — | Oct 14, 2013 | Sep 19, 2016 | Oct 29, 2019 | 53 | United States |
PFS was based on central assessment by a blinded independent radiologist per immune related response evaluation criteria for solid tumors (irRECIST) and was summarized and displayed by treatment arm using Kaplan-Meier methods. Treatments were compared using a stratified log-rank test controlling for randomization stratification factors. The hazard ratio between the 2 treatment arms, as well as the associated one-sided 90% CI and p-value, were presented using a Cox proportional hazards regression model.
| Arm | Type | Description |
|---|---|---|
| chemotherapy and cetuximab plus VTX-2337 | EXPERIMENTAL | VTX-2337 (3.0 mg/m2) will be administered on Day 8 and Day 15 of a 21-day cycle for 6 cycles, followed by dosing on Days 8 and 22 of 28-day cycles until disease progression. Cisplatin (100 mg/m2) OR carboplatin (AUC 5 mg/mL/min) will be administered on Day 1 of a 21-day cycle for a maximum of 6 cycles. 5-FU (1000 mg/m2) will be administered on Days 1-4 of a 21-day cycle for a maximum of 6 cycles. Cetuximab (initial dose: 400 mg/m2; remaining doses: 250 mg/m2) will be administered weekly until disease progression. |
| chemotherapy and cetuximab plus placebo | ACTIVE_COMPARATOR | Placebo (3.0 mg/m2) will be administered on Day 8 and Day 15 of a 21-day cycle for 6 cycles, followed by dosing on Days 8 and 22 of 28-day cycles until disease progression. Cisplatin (100 mg/m2) OR carboplatin (AUC 5 mg/mL/min) will be administered on Day 1 of a 21-day cycle for a maximum of 6 cycles. 5-FU (1000 mg/m2) will be administered on Days 1-4 of a 21-day cycle for a maximum of 6 cycles. Cetuximab (initial dose: 400 mg/m2; remaining doses: 250 mg/m2) will be administered weekly until disease progression. |
| Name | Type | Description |
|---|---|---|
| VTX-2337 | DRUG | TLR8 Agonist |
| Carboplatin | DRUG | - |
| Cisplatin | DRUG | - |
| 5-fluorouracil | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: * Ability and willingness to provide written informed consent * Histologically or cytologically confirmed squamous cell carcinoma of the head and neck * Locoregionally recurrent or metastatic disease that has not previously been treated with systemic therapy of recurrent or meta...