Last reviewed · How we verify
Phase 2 Multicenter Study Investigating the Tolerability and Efficacy of UV1 Vaccine in Patients With Recurrent or Metastatic PD-L1 Positive (CPS≥1) Head and Neck Squamous Cell Carcinoma Planned for First-line Treatment With Pembrolizumab (FOCUS)
The primary objective of this study is to determine the clinical performance of UV1 vaccination as add on to standard pembrolizumab treatment in patients with recurrent or metastatic PD-L1 positive (CPS \>=1) head and neck squamous cell carcinoma. Secondary objectives are to determine the efficacy in terms of overall survival ,objective response rate and duration of response. Moreover, this study will explore patient subgroups most likely deriving benefit from a targeted immunotherapy approach combining a checkpoint inhibitor with a cancer vaccine and help to establish liquid biopsy tumor monitoring in HNSCC.
Details
| Lead sponsor | Martin-Luther-Universität Halle-Wittenberg |
|---|---|
| Phase | Phase 2 |
| Status | UNKNOWN |
| Enrolment | 75 |
| Start date | 2021-08-02 |
| Completion | 2025-02 |
Conditions
- Head and Neck Squamous Cell Carcinoma
Interventions
- UV1
- Sargramostim for Injection
- Pembrolizumab injection
Primary outcomes
- Progression free survival rate — 6 months after first administration of study medication
according to iRECIST
Countries
Germany