Evaluation of UCPVax Plus Nivolumab as Second Line Therapy in Advanced Non Small Cell Lung Cancer

Sponsor
Centre Hospitalier Universitaire de Besancon
Study ID
NCT04263051
Phase
PHASE2
Status
Completed

Conditions

  • Advanced Non-small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • UCPVax + Nivolumab — DRUG
    UCPVax will be administrated at day 1 of week 1 ; 2 ; 3 ; 5 ; 6 ; 7 and then week 13 and every 2 months until months 12. Nivolumab will be administrated at the dose of 480 mg at day 1 and then every 4 weeks until disease progression or unacceptable toxicity according to label. At the end of COMBO phase, nivolumab will be continued every 4 weeks for maximum 24 months from the first administration, until disease progression or unacceptable toxicity according to standard of care.
  • standard chemotherapy — DRUG
    Second line chemotherapy at the choice of the investigator

Study Details

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).

Key Dates

Start date
Sep 9, 2020
Status verified
Jan 2025
Primary completion
Nov 22, 2023
Completion
Nov 28, 2024

Study Design

Enrollment
60 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: UCPVax + Nivolumab
    UCPVax vaccine (0,5 mg) Nivolumab (480 mg)
  • Other: Standard second line chemotherapy
    Standard second line chemotherapy at the choice of the investigator. This arm will permit to assess the good calibration of the hypothesis on the experimental arm.

Primary Outcome Measure

6 months Progression-Free Survival (PFS) rate [ Time Frame: 6 months after the date of initiation of treatment (1st day of 1st cycle of chemotherapy) ]

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