Clinical Trial

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

Study acronym: MESOVAX
Active, Not Recruiting Phase 1
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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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2018-05-23; most recent amendment 2024-09-30.
Status change: Recruiting → Active, Not Recruiting 2024-09-30
Status change: Not Yet Recruiting → Recruiting 2020-04-20
Trial Details
NCT Number NCT03546426
Lead Sponsor Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Conditions Mesothelioma, Malignant, PD-L1 Negative, Advanced Cancer, Progressive Disease
Enrollment 18 participants
Start Date 2019-12-12
Primary Completion 2027-01 (estimated)
Study Completion 2028-09 (estimated)
Updated on ClinicalTrials.gov 2024-10-01