Universal Cancer Peptide-based Vaccination in Metastatic NSCLC
NCT02818426 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 82
Last updated 2025-01-09
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.
Conditions
- Metastatic Non-small Cell Lung Cancer
Interventions
- DRUG
-
UCPVax
Sponsors & Collaborators
-
Invectys
collaborator INDUSTRY -
Centre Hospitalier Universitaire de Besancon
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 89 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-04-20
- Primary Completion
- 2022-08-30
- Completion
- 2024-12-31
Countries
- France
Study Locations
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