NCT04263051

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

Evaluation of UCPVax Plus Nivolumab as Second Line Therapy in Advanced Non Small Cell Lung : a Randomized Non Comparative Phase II Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Centre Hospitalier Universitaire de Besancon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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).

Conditions

• Advanced Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	UCPVax + Nivolumab	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.
DRUG	standard chemotherapy	Second line chemotherapy at the choice of the investigator

Timeline

• Start date: 2020-09-09
• Primary completion: 2023-11-22
• Completion: 2024-11-28
• First posted: 2020-02-10
• Last updated: 2025-02-05

Locations

8 sites across 1 country: France