drugset / Trial / NCT02383498

QUILT-3.011 Phase 2 Yeast-Brachyury Vaccine Chordoma

NCT02383498

RandomizedCrossoverQuadruple-blindTreatment

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.

Timeline

Start
2015-05-01
Primary completion
2019-09-01
Completion
2019-09-01

Drugs

EvaluationDrugModalityDoseRoute
Subject GI-6301 Vaccine

Indications