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

NCT05344209 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2023-11-09

No results posted yet for this study

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.

Conditions

  • Oncology
  • NSCLC Stage IV
  • NSCLC, Stage III

Interventions

BIOLOGICAL

UV1

UV1 vaccine

DRUG

Sagramostim

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

DRUG

Anti-PD-1/PD-L1 treatment

either pembrolizumab, atezolizumab or cemiplimab

Sponsors & Collaborators

  • University Hospital, Akershus

    collaborator OTHER

  • Oslo University Hospital

    collaborator OTHER

  • Haukeland University Hospital

    collaborator OTHER

  • Helse Stavanger HF

    collaborator OTHER_GOV

  • Helse Fonna

    collaborator OTHER

  • Helse Nord-Trøndelag HF

    collaborator OTHER

  • St. Olavs Hospital

    collaborator OTHER

  • Alesund Hospital

    collaborator OTHER

  • Helse Forde

    collaborator OTHER

  • University Hospital of North Norway

    collaborator OTHER

  • Vestre Viken Hospital Trust

    lead OTHER

Principal Investigators

  • Odd Terje Brustugun, MD, PhD · Vestre Viken Health trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-12
Primary Completion
2025-07-01
Completion
2027-07-01

Countries

  • Norway

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05344209 on ClinicalTrials.gov