RecruitingPhase 2NCT05344209

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

A Randomized Phase II, Open-label, Multicenter Study Investigating Efficacy and Safety of Pembrolizumab +/- UV1 Vaccination as First Line Treatment in Patients With Inoperable Advanced or Metastatic Non-small Cell Lung Cancer


Sponsor

Vestre Viken Hospital Trust

Enrollment

138 participants

Start Date

Aug 12, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a personalized cancer vaccine called UV1 (which targets telomerase, a protein highly active in cancer cells) to standard pembrolizumab immunotherapy improves outcomes for patients with advanced non-small cell lung cancer (NSCLC). **You may be eligible if...** - You have stage IIIB/IIIC or stage IV non-small cell lung cancer that cannot be treated with curative intent - Your tumor shows high PD-L1 expression (≥50%) and you are eligible for pembrolizumab as first-line treatment - You have not previously received immunotherapy - You have at least one measurable tumor lesion on imaging **You may NOT be eligible if...** - Your PD-L1 expression is below 50% - You have active autoimmune disease or are on immunosuppressive medications - You have brain metastases that are untreated or unstable - You have received prior immunotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALUV1

UV1 vaccine

DRUGSagramostim

for stimulation of local dendritic cell population to take up the vaccine and to mature into professional APCs

DRUGAnti-PD-1/PD-L1 treatment

either pembrolizumab, atezolizumab or cemiplimab


Locations(1)

Vestre Viken Health Trust

Drammen, Akershus, Norway

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NCT05344209


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