Viewing Study NCT04263051



Ignite Creation Date: 2024-05-06 @ 2:15 PM
Last Modification Date: 2024-10-26 @ 1:27 PM
Study NCT ID: NCT04263051
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2023-07-27
First Post: 2020-02-07

Brief Title: Evaluation of UCPVax Plus Nivolumab as Second Line Therapy in Advanced Non Small Cell Lung Cancer
Sponsor: Centre Hospitalier Universitaire de Besancon
Organization: Centre Hospitalier Universitaire de Besancon

Study Overview

Official Title: Evaluation of UCPVax Plus Nivolumab as Second Line Therapy in Advanced Non Small Cell Lung a Randomized Non Comparative Phase II Trial
Status: ACTIVE_NOT_RECRUITING
Status Verified Date: 2023-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: Optim-UCPVax
Brief Summary: 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 patients 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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
CA209-7CM OTHER Bristol-Myers Squibb None