CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 8 enrolled
Drug / intervention
Dendritic Cells for endometrial cancerbiological
Likely dose
Not stated in 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/NCT04212377
NCT04212377Phase 2Completed

An Exploratory Study: Dendritic Cells for Immunotherapy of Metastatic Endometrial Cancer Patients

Radboud University Medical Center·interventional·Posted Dec 27, 2019·Updated Jan 11, 2024

In Brief

A Phase 2 clinical trial evaluating Dendritic Cells for endometrial cancer for Endometrial Cancer. Completed, enrolled 8 participants across 1 site.

Detailed Summary

Prevention of infectious diseases through immunization is one of the greatest achievements of modern medicine. Nonetheless, considerable challenges remain for improving the efficacy of existing vaccines for therapeutic immunizations for diseases such as cancer. The investigators were amongst the first groups worldwide that introduced tumor antigen-loaded dendritic cell (DC)-based vaccines in the clinic1-3. Effective immune responses and favorable clinical outcomes have indeed been observed4-7. Thus far, mainly conventional in vitro generated monocyte-derived DCs (moDC) have been used in clinical trials worldwide. In the past 14 years the investigators have treated more than 375 patients and proven that DC therapy is feasible and non-toxic. The investigators observed that long lasting tumor specific T cell-mediated immunological responses are clearly linked to increased progression free survival as well as overall survival8. In conclusion, based on all these observations the investigators are convinced that pDC and myDC employ different, and probably more optimal mechanisms to combat cancer. In addition, based on in vitro data and preclinical studies that suggest that blood pDC and myDC act synergistically, the investigators hypothesize that the combination of myDC and pDC may induce stronger anti-tumor immune responses as compared to pDC or myDC alone, or moDC.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesNetherlands

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedDec 27, 2019
Enrollment StartApr 8, 2019
Primary CompletionMar 9, 2021
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 6.5 years ago

Interventions

Dendritic Cells for endometrial cancerbiological

Our study population consists of 8 mEC patients who receive carboplatin / paclitaxel chemotherapy in a weekly schedule on weeks 1, 2, 3 and weeks 5,6 and 7. In week 8, myeloid and plasmacytoid DC (nDC) are loaded with tumor lysate and MUC1 and survivin PepTivators, injected intranodally. An extensive immuno-motoring will be performed on all patients. Patients who show stable disease, partial response, or full response continue with extended three-week chemotherapy regimens with intranodal injections of nDC at weeks 17, 20, and 23.