CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 28 enrolled
Drug / intervention
dendritic cell vaccination plus chemotherapybiological
Likely dose
dendritic cell vaccination plus chemotherapy 500 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02649829
NCT02649829Phase 2Completed
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First-line Immunotherapy Using Wilms' Tumor Protein 1 (WT1)-Targeted Dendritic Cell Vaccinations for Malignant Pleural Mesothelioma

University Hospital, Antwerp·interventional·Posted Jan 8, 2016·Updated Apr 29, 2025

In Brief

A Phase 2 clinical trial evaluating dendritic cell vaccination plus chemotherapy for Malignant Pleural Mesothelioma. Completed, enrolled 28 participants across 3 sites.

Detailed Summary

In this multicenter phase I/II trial, dendritic cells (DCs) loaded with the mesothelioma-associated tumor antigen WT1 will be used in conjunction with conventional chemotherapy for the frontline treatment of malignant pleural mesothelioma (MPM). The general objective is to provide the first-in-human experimental demonstration that the combination of platinum/pemetrexed-based chemotherapy with WT1-targeted DC vaccination is feasible and safe and enables the induction of both systemic and in situ mesothelioma-specific immune responses in patients with MPM.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalignant Pleural Mesothelioma
CountriesBelgium
CollaboratorsKom Op Tegen Kanker, Stichting tegen Kanker

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 8, 2016
Enrollment StartOct 3, 2017
Primary CompletionMar 9, 2025
TodayJul 2, 2026
Enrollment to primary: 7.4 yearsPosted 10.5 years ago

Interventions

dendritic cell vaccination plus chemotherapybiological

A. Chemoimmunotherapy: 1. four 3-weekly cycles of platinum/pemetrexed; on day 1 of each cycle, pemetrexed 500 mg/m2 should be administered as intravenous (IV) infusion over 10 minutes followed 30 minutes later by cisplatin 75 mg/m2 as IV over approximately 2 hours. 2. four intradermal vaccinations with 8-10 x 10e6 autologous WT1 mRNA-loaded DCs; at day 14+/- 3 days after the start of each chemotherapy cycle. B. Surgery: pleurectomy/decortication; in case of resectable disease, 4-6 weeks after start of the last chemotherapy cycle.