QUILT-3.011 Phase 2 Yeast-Brachyury Vaccine Chordoma

Phase 2

Completed

• Conditions: Chordoma
• Interventions: Biological: GI-6301 Vaccine (Yeast- Brachyury); Other: Placebo; Radiation: Radiotherapy; Device: wGT3X-BT Actigraph

• Registration Number: NCT02383498
• Lead Sponsor: NantCell, Inc.

Brief Summary

This is a phase 2 clinical trial to determine whether the yeast-brachyury vaccine GI-6301 improves the effectiveness of radiation for patients with localized chordoma. Chordoma patients with inoperable or residual tumor who do not have metastases and are planning to be treated with definitive (\>70Gy) radiation were enrolled. Patients were randomized to receive radiation plus the vaccine or radiation plus a blinded placebo. The study compared the outcomes of patients treated with radiation with and without the vaccine to determine whether the vaccine can increase the chances of shrinking the tumor and/or preventing further tumor growth.

Detailed Description

Chordoma is a rare disease, affecting about 3,000 people in the United States. There have been indications of clinical benefit in patients with chordoma enrolled on the phase I trial of GI-6301.

PRIMARY OBJECTIVE: To determine if there is a difference in overall response rate (ORR) defined as complete response (CR) or partial response (PR) by RECIST 1.1 after up to 24 months among patients with Chordoma who are treated with radiation plus placebo vs. radiation plus vaccine.

Study Timeline

• Study First Submitted: 2015-03-04
• Study First Submitted QC: 2015-03-06
• Study First Posted: 2015-03-09
• Study Start: 2015-05-01
• Primary Completion: 2019-09-01
• Study Completion: 2019-09-01
• Status Verified: 2019-10
• Results First Submitted: 2024-04-17
• Results First Submitted QC: 2024-05-17
• Last Update Submitted: 2024-05-17
• Results First Posted: 2024-05-20
• Last Update Posted: 2024-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Radiotherapy	Radiation + Placebo + Actigraph
GI-6301 Vaccine	GI-6301 Vaccine (Yeast- Brachyury)	Radiation + GI-6301 Vaccine + Actigraph
GI-6301 Vaccine	wGT3X-BT Actigraph	Radiation + GI-6301 Vaccine + Actigraph
Placebo	Placebo	Radiation + Placebo + Actigraph
GI-6301 Vaccine	Radiotherapy	Radiation + GI-6301 Vaccine + Actigraph
Placebo	wGT3X-BT Actigraph	Radiation + Placebo + Actigraph

Primary Outcome Measures

Name	Time	Method
Overall Response Rate	Up to 24 months	Difference in overall response rate among patients with Chordoma who are treated with radiation plus placebo vs. radiation plus vaccine.; Overall response rate (ORR) defined as complete response (CR) or partial response (PR) by RECIST 1.1 in the irradiated tumor site after up to 24 months among patients with Chordoma who are treated with radiation plus vaccine vs. radiation plus placebo; Complete response (CR; disappearance of all target lesions and no new lesions) or partial response (PR; \>=30% decrease in the sum of the greatest diameter).

Trial Locations

Locations (1)

NIH Clinical Center; 🇺🇸 Bethesda, Maryland, United States