Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
VX15/2503+ avelumab · 1 trial · 1 indication
DLTs will be described and graded according to the Common Terminology Criteria Adverse Events version 4.03 (CTCAE v4.03) and according to the specific MedRA terms from immune mediated AEs
Safety assessments will be performed on a regular basis using physical examination, spontaneous AE reporting, scheduled and unscheduled laboratory assessments, and other diagnostic evaluations as indicated. Adverse events will be reported using the Common Terminology Criteria Adverse Events version 4.03 (CTCAE v4.03).
| Arm | Type | Description |
|---|---|---|
| VX15/2503 + avelumab | EXPERIMENTAL | VX15/2503 at a concentration of 5 mg/kg, 10 mg/kg or 20 mg/kg with a fixed dose of avelumab at 10 mg/kg, administered intravenously on a bi-weekly dosing cycle. |
| Name | Type | Description |
|---|---|---|
| VX15/2503 + avelumab | DRUG | Dose escalation will begin at 5 mg/kg of VX15/2503 and will increase up to 20 mg/kg with a constant dose of avelumab at 10 mg/kg. A recommended phase II dose of VX15/2503 will be determined and then utilized in the expansion phase with 10 mg/kg of avelumab. |
Inclusion Criteria: 1. Age \> 18 years. 2. Signed informed consent prior to the performance of any study-specific procedures, including fresh tumor biopsies. 3. Histologically or cytologically proven advanced (stage IIIB/IV) NSCLC subjects. Subjects in the Dose Escalation Phase must be immunotherap...
VX15/2503 plus avelumab is an investigational combination being studied for the treatment of advanced non-small cell lung cancer (NSCLC). The combination was evaluated in a Phase 1 clinical trial in patients with carcinoma, non-small-cell lung. It is not approved and remains in clinical development.
VX15/2503 plus avelumab is being developed by Merck KGaA, a biopharmaceutical company. The company's ticker symbol is MKGAF. The combination is in Phase 1 clinical development for advanced non-small cell lung cancer.
VX15/2503 plus avelumab is in Phase 1 clinical development. The combination is investigational and has not been approved by regulatory authorities. It is being studied for the treatment of advanced non-small cell lung cancer.
VX15/2503 plus avelumab was studied in a Phase 1 clinical trial with the identifier NCT03268057. The trial, titled "VX15/2503 in Combination With Avelumab in Advanced Non-small Cell Lung Cancer," enrolled 62 participants in the United States and has been completed.
VX15/2503 plus avelumab is not FDA approved. It is an investigational combination that has completed a Phase 1 clinical trial for advanced non-small cell lung cancer. The combination remains in clinical development and has not been approved for any use.