drugset / Trial / NCT03546426

Pembrolizumab Plus Autologous Dendritic Cell Vaccine in Patients with PD-L1 Negative Advanced Mesothelioma Who Have Failed Prior Therapies

NCT03546426

NaSingle-groupOpen-labelTreatment

Summary

Pembrolizumab plus autologous dendritic cell vaccine in patients with PD-L1 negative advanced mesothelioma who have failed prior therapies.This is an exploratory, single-arm, open-label, phase 1b clinical trial. Patients will receive pembrolizumab 200 mg and autologous dendritic cell vaccine every 3 weeks for the first 6 cycles, followed by pembrolizumab 200 mg every 3 weeks until confirmed progression or for a maximum of 2 years (see Figure 1 Study Schema). After each vaccine administration patients will receive IL-2 3 MU s.c. for 5 days, from day +2 to day +6.

Timeline

Start
2019-12-12
Primary completion
2027-01
Completion
2028-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous
Subject autologous dendritic cells Cell therapy 1e+07 cells Other
Background aldesleukin Protein / enzyme biologic 3e+06 iu Subcutaneous