drugset / Trial / NCT04966481
Palbociclib and Cetuximab Versus Cetuximab Monotherapy for Patients With CDKN2A-altered, HPV-unrelated Head and Neck Squamous Cell Carcinoma Who Experienced Disease Progression on a PD-1/L1 Inhibitor
Phase 3
Recruiting
81 enrolled
Washington University School of Medicine
Pfizer · collabThe Joseph Sanchez Foundation · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This multicenter, open-label, randomized phase 3 trial will determine if palbociclib and cetuximab (Arm 1) improves overall survival (OS) in comparison to cetuximab monotherapy (Arm 2) in patients with CDKN2A-altered, HPV-unrelated recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) who experienced disease progression on a PD-1/L1 inhibitor (given as monotherapy or in combination with other therapy).
Timeline
- Start
- 2022-04-06
- Primary completion
- 2028-02-28
- Completion
- 2028-02-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cetuximab | Monoclonal antibody | 250 mg/m2 | Intravenous |
| Subject | Palbociclib | Small molecule | 125 mg | Oral |