Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
pepinemab+ pembrolizumab · 1 trial · 1 indication
TEAE's are defined as Adverse Events (AEs) with onset after date-time of first dose, or medical conditions present prior to the start of IMP but increased in severity or relationship after date-time of first dose of IMP.
Review number of subjects with incidence of laboratory abnormalities based on hematology, clinical chemistry, and urinalysis test results with consideration to ECG, vital sign measurements and physical examinations.
To be determined by the ORR of the combination pepinemab and pembrolizumab first-line treatment in patients with R/M HNSCC. This is defined as complete response (CR) or PR according to RECIST 1.1 from the first dose until documented confirmed disease progression.
| Arm | Type | Description |
|---|---|---|
| pepinemab + pembrolizumab | EXPERIMENTAL | Pepinemab will be administered at 20 mg/kg (with possible dose modifications to 15 mg/kg or 10 mg/kg, if the initial 20 mg/kg dose of pepinemab is determined not to be well tolerated) in combination with a fixed dose of 200 mg pembrolizumab, administered in separate IV infusions, Q3W. |
| Name | Type | Description |
|---|---|---|
| pepinemab + pembrolizumab | DRUG | The Safety Run-in phase will begin at 20 mg/kg pepinemab with a fixed dose of 200 mg pembrolizumab. The dose of pepinemab may be reduced to 15 mg/kg or 10 mg/kg with a fixed dose of 200 mg pembrolizumab if the initial pepinemab dose of 20 mg/kg is found to not be well tolerated. Once a recommended phase II dose of pepinemab is determined it will be utilized in the Dose Expansion phase in combination with 200 mg pembrolizumab. |
Inclusion Criteria: 1. Subjects must be ≥18 years of age. 2. Subjects or their legal representative must be able to provide written informed consent to participate in the trial prior to the performance of any study-specific procedures. 3. Subjects must have histologically or cytologically confirmed...
Pepinemab plus pembrolizumab is being studied for the treatment of recurrent or metastatic squamous cell carcinoma of the head and neck (HNSCC). The combination is an investigational regimen in clinical development, and it has not been approved by the FDA for this or any other indication.
Merck & Company, Inc. (NYSE: MRK) is developing pepinemab in combination with pembrolizumab. The combination is being evaluated in an early-stage clinical trial for recurrent or metastatic squamous cell carcinoma of the head and neck.
Pepinemab plus pembrolizumab is in Phase 1 clinical development. A Phase 1 trial of the combination in recurrent or metastatic squamous cell carcinoma of the head and neck has been completed, but the regimen remains investigational and has not been approved.
Pepinemab plus pembrolizumab has been studied in one clinical trial, NCT04815720, titled "Pepinemab in Combination With Pembrolizumab in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck." This Phase 1 trial enrolled 49 participants in the United States and has been completed.
No, pepinemab plus pembrolizumab is a combination regimen that includes both pepinemab and pembrolizumab. It is distinct from pembrolizumab monotherapy. The combination is being investigated for recurrent or metastatic squamous cell carcinoma of the head and neck.