drugset / Trial / NCT05344209
Efficacy and Safety of Anti-PD-1/PD-L1 Treatment +/- UV1 Vaccination in Patients With Non-small Cell Lung Cancer
Phase 2
Recruiting
138 enrolled
Vestre Viken Hospital Trust
Alesund Hospital · collabHaukeland University Hospital · collabHelse Fonna · collabHelse Forde · collabHelse Nord-Trøndelag HF · collabHelse Stavanger HF · collabOslo University Hospital · collabSt. Olavs Hospital · collabUniversity Hospital of North Norway · collabUniversity Hospital, Akershus · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
A Randomized, Multicenter Study Investigating Efficacy and Safety of anti-PD-1/PD-L1-treatment +/- UV1 vaccination as first line treatment in patients with inoperable advanced or metastatic non-small cell lung cancer. The objective of the phase 2 study is to induce a meaningful Progression-Free Survival (PFS) benefit in patients with stage IIIB/IIIC or stage IV NSCLC by treating with anti-PD-1/PD-L1 treatment and UV1 vaccination versus anti-PD-1/PD-L1 treatment alone.
Timeline
- Start
- 2022-08-12
- Primary completion
- 2025-07-01
- Completion
- 2027-07-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atezolizumab | Monoclonal antibody | — | — |
| Subject | Cemiplimab | Monoclonal antibody | — | — |
| Subject | Pembrolizumab | Monoclonal antibody | — | — |
| Subject | Sagramostim | Unknown | 75 ug | — |
| Subject | UV1 | Peptide | 300 ug | — |