Loading clinical trials...
Loading clinical trials...
Evaluation of UCPVax Plus Nivolumab as Second Line Therapy in Advanced Non Small Cell Lung : a Randomized Non Comparative Phase II Trial
Lung cancer is the most commonly diagnosed malignancy and the leading cause of cancer-related mortality both in men and women worldwide. The past few years have demonstrated great progress in the field of tumor immunotherapy through agents that address mechanisms of immune escape notably, so called immune checkpoint inhibitors (ICB). Indeed, ICB have emerged as a fatal weapon in the anticancer treatment arsenal. Anti-PD-1 and anti-PD-L1 antibodies have shown promising results in several cancers including Non-small Cell Lung Cancer (NSCLC) patients. Although such ICB extend patient's survival compared with conventional systemic therapies, they fail to control cancer progression in a significant proportion of patients which can reach up to 50-60% in NSCLC. Recent literature highlights a range of factors involved in the heterogeneous responses and failures to ICB therapies. The challenge is how can ICB treatment efficacy be extended to majority patients? To respond to this question, to increase the success of immunotherapy, immuno-oncology community develops combinations approaches. The aim of these project is to evaluate the efficacy of Nivolumab plus a novel CD4Th1 inducer anti-cancer vaccine in NSCLC patients. Nivolumab (NIVO), which is an anti-PD-1 antibody, has shown promising results in 2nd line treatment for advanced NSCLC. UCPVax is a therapeutic anti-cancer vaccine based on the telomerase-derived helper peptides designed to induce strong TH1 CD4 T cell responses in cancer patients (NCT02818426).
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
CHU of Besançon
Besançon, France
CHU Bordeaux
Bordeaux, France
Centre Georges François Leclerc
Dijon, France
Institut de Cancérologie Privé CCGM
Montpellier, France
CH Mulhouse
Mulhouse, France
CHU de Nîmes
Nîmes, France
Institut Jean Godinot
Reims, France
Institut de Cancérologie de l'Ouest
Saint-Herblain, France
Start Date
September 9, 2020
Primary Completion Date
November 22, 2023
Completion Date
November 28, 2024
Last Updated
February 5, 2025
60
ACTUAL participants
UCPVax + Nivolumab
DRUG
standard chemotherapy
DRUG
Lead Sponsor
Centre Hospitalier Universitaire de Besancon
Collaborators
NCT06731413
NCT07356544
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions