Phase 2 Study of Pembrolizumab With or Without UV1 Vaccine for First-Line Treatment of Advanced or Metastatic Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are investigating the safety and effectiveness of combining anti-PD-1PD-L1 treatment with UV1 vaccination compared to anti-PD-1PD-L1 treatment alone in patients with advanced or metastatic non-small cell lung cancer NSCLC who cannot have surgery. The phase 2 trial aims to improve progression-free survival in patients with stage IIIBIIIC or IV NSCLC by using these treatments. The study evaluates whether adding UV1 vaccination can provide additional benefit alongside standard anti-PD-1PD-L1 therapies. Participants are randomly assigned to receive either anti-PD-1PD-L1 treatment alone or combined with UV1 vaccination and sagramostim. The anti-PD-1PD-L1 treatment continues until disease progression or unacceptable side effects, up to two years. Patients in the UV1 vaccination group receive eight total injections the first dose on the same day as starting anti-PD-1PD-L1 treatment, three more within the next ten days, and one vaccination during treatment cycles two through five. During the study, participants undergo regular evaluations including imaging scans to measure tumor response according to RECIST 1.1 criteria. Researchers monitor progression-free survival over up to two years. Safety is continuously assessed and adverse events are tracked during treatment and for four months afterward. The study involves blood tests, tumor tissue analysis, and performance status assessments to evaluate organ function and overall health throughout participation.

Efficacy and Safety of Anti-PD-1/PD-L1 Treatment +/- UV1 Vaccination in Patients With Non-small Cell Lung Cancer