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Also known as Motolimod
VTX-2337 · 3 trials · 6 indications
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.
Comparison of duration of survival between the 2 treatment groups
| 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. |
| PLD 40 mg/m2 plus VTX-2337 | EXPERIMENTAL | The dosing schedule will be be based on a 28-day cycle. The starting dose schedule is PLD on Day 1 plus VTX-2337 on Day 3, Day 10, and Day 17 for the first 4 cycles. Starting with cycle 5, the dose regimen will be PLD on Day 1 plus VTX-2337 on Day 3 only, without additional doses of VTX-2337 on Days 10 and Day 17. |
| PLD 40 mg/m2 plus placebo | ACTIVE_COMPARATOR | The dosing schedule will be based on a 28-day cycle. The starting dose schedule is PLD on Day 1 plus placebo on Day 3, Day 10, and Day 17 for the first 4 cycles. Starting with cycle 5, the dose regimen will be PLD on Day 1 plus placebo on Day 3 only. |
| Name | Type | Description |
|---|---|---|
| VTX-2337 | DRUG | TLR8 Agonist |
| Carboplatin | DRUG | - |
| Cisplatin | DRUG | - |
| 5-fluorouracil | DRUG | - |
| Placebo | DRUG | - |
| pegylated liposomal doxorubicin (PLD) | 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...
VTX-2337 has been studied in oncology for advanced solid tumors, squamous cell carcinoma of the head and neck, and epithelial ovarian cancer. Clinical trials have evaluated it in recurrent or metastatic head and neck cancer and in recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
VTX-2337 is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is the sponsor associated with the clinical development program for this agent.
VTX-2337 has completed Phase 1 and Phase 2 clinical trials. It is an investigational agent and is not approved by the FDA. The Phase 1 study evaluated safety and pharmacology in patients with advanced cancer, while Phase 2 studies assessed it in head and neck and ovarian cancers.
VTX-2337 has been evaluated in three completed trials: NCT01836029 in recurrent or metastatic squamous cell carcinoma of the head and neck, NCT01666444 in recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal cancer, and NCT00688415 in advanced solid tumors and lymphoma.
VTX-2337 was studied in combination with chemotherapy plus cetuximab in patients with recurrent or metastatic squamous cell carcinoma of the head and neck. This was evaluated in the completed Phase 2 trial NCT01836029, which enrolled 195 patients in the United States.
VTX-2337 was studied in combination with pegylated liposomal doxorubicin in patients with recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal cancer. This was assessed in the completed Phase 2 trial NCT01666444, which enrolled 297 female patients aged 18 years and older.