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NCT number NCT03495921
Study type Interventional
Source Gradalis, Inc.
Contact Gladice Wallraven
Phone 214-442-8124
Email info@gradalisinc.com
Status Not yet recruiting
Phase Phase 3
Start date June 15, 2018
Completion date July 1, 2022

Clinical Trial Summary

This is a two-part, multicenter, 1:1 randomized Phase III study of intradermal autologous Vigil immunotherapy (1.0 x 10e6 cells/injection cells/injection; minimum of 4 to a maximum of 12 administrations) in combination with irinotecan and temozolomide in subjects with metastatic Ewing's sarcoma Family of Tumors (ESFT) refractory or intolerant to 1 prior line of chemotherapy. Participants undergoing a standard surgical procedure (e.g., tumor biopsy or palliative resection) may have tumor tissue harvested for manufacture of investigational product.


Clinical Trial Description

Participants will be managed in an outpatient setting. Hematologic function, liver enzymes, renal function and electrolytes will be monitored. Blood for immune function analyses including IFN╬│-ELISPOT analysis of cytotoxic T cell activation in response to autologous tumor antigens will be collected at tissue procurement, post-procurement screening and Day 15 (prior to Vigil administration when applicable) at Cycles 2, 4, end of treatment, and every 6 months thereafter. Blood for ctDNA analysis will be collected prior to chemotherapy administration at baseline, Cycle 2 - Week 1 Day 1, Cycle 4 - Week 1 Day 1, and EOT.


Study Design


Related Conditions & MeSH terms


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