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QUILT-3.091 NANT Chordoma Vaccine vs Radiation in Subjects With Unresectable Chordoma.

Chordoma Clinical Trial

Official title:
QUILT-3.091 NANT Chordoma Vaccine: A Randomized Phase 1b/2 Trial of the NANT Chordoma Vaccine vs. Radiation in Subjects With Unresectable Chordoma.

Clinical Trial Summary

QUILT 3.091 Chordoma Vaccine: Phase 1B/2 NANT Chordoma Vaccine vs Radiation in Subjects with Unresectable Chordoma.

Clinical Trial Description

The NANT Chordoma Vaccine regimen will be administered in 2 phases, an induction and a maintenance phase. Subjects will continue induction treatment for up to 1 year. Those who have a confirmed complete response (CR) in the induction phase will enter the maintenance phase of the study. Subjects who experience ongoing stable disease (SD) or an ongoing partial response (PR) at 1 year may enter the maintenance phase at the Investigator's and Sponsor's discretion. Subjects may remain in the maintenance phase of the study for up to 1 year. In the randomized component of the phase 2 portion of the study, the control arm will be treated with radiation according to established SoC protocols as determined by the Investigator. In the phase 2 single-arm component of the study, subjects will be enrolled in the first stage of Simon's two-stage optimal design. If the study proceeds to the second stage of Simon's two-stage optimal design, additional subjects will be enrolled in the second stage. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03647423
Study type Interventional
Source ImmunityBio, Inc.
Contact
Status Withdrawn
Phase Phase 1/Phase 2
Start date August 31, 2018
Completion date August 30, 2022
View Details
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