NCT03647423

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

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

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: ImmunityBio, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Chordoma
• Unresectable Malignant Neoplasm

Interventions

Type	Name	Description
BIOLOGICAL	Aldoxorubicin Hydrochloride	Aldoxorubicin Hydrochloride HCI
BIOLOGICAL	ALT-803	Recombinant human super agonist interleukin-15 (IL-15) complex
BIOLOGICAL	ETBX-051	Ad5 \[E1-, E2b-\]-Brachyury
BIOLOGICAL	ETBX-061	Ad5 \[E1-, E2b-\]-mucin 1 \[MUC1\]
BIOLOGICAL	GI-6301	Brachyury yeast
BIOLOGICAL	haNK	haNK™, NK-92 \[CD16.158V, ER IL-2\]
DRUG	Avelumab	injection
DRUG	Cetuximab	Injection
DRUG	Cyclophosphamide	Capsules
RADIATION	SBRT	Stereotactic body radiation therapy

Timeline

• Start date: 2018-08-31
• Primary completion: 2020-08-31
• Completion: 2021-12-28
• First posted: 2018-08-27
• Last updated: 2025-02-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study