NCT02818426

Universal Cancer Peptide-based Vaccination in Metastatic NSCLC

Anticancer Therapeutic Vaccination Using Telomerase-derives Universal Cancer Peptides in Metastatic Non Small Cell Lung Cancer : A Phase I/II Study

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Centre Hospitalier Universitaire de Besancon · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

UCPVAx is a therapeutic vaccine based on the telomerase-derived UCP designed to induce strong TH1 CD4 T cell responses in cancer patients. Three doses of UCPVax (0,25 mg, 0,5 mg and 1 mg) will be tested in this phase I/II study by using Continuous Reassessment Method (CRML) dose escalation design model. The phase I is a dose escalation study designed to evaluate safety of use of UCPVax and to estimate its Maximum Tolerated Dose (MTD). The phase II is a dose deescalation designed to evaluate the immunogenicity of UCPVax according to the dose level.

Detailed description

UCPVax study is a prospective multicenter phase I/II study: 54 patients with metastatic NSCLC will be enrolled in 5 centers in France. A translational research program will be performed to better define the eligibility criteria and predictive biomarkers needed for randomized phase II and Phase III trials.

Conditions

• Metastatic Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	UCPVax

Timeline

• Start date: 2016-04-20
• Primary completion: 2022-08-30
• Completion: 2024-12-31
• First posted: 2016-06-29
• Last updated: 2025-01-09

Locations

5 sites across 1 country: France