Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02383498 | QUILT-3.011 Phase 2 Yeast-Brachyury Vaccine Chordoma | PHASE2 | COMPLETED | 24 | — | — | May 1, 2015 | Sep 1, 2019 | May 20, 2024 | 1 | United States |
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).
| Arm | Type | Description |
|---|---|---|
| GI-6301 Vaccine | EXPERIMENTAL | Radiation + GI-6301 Vaccine + Actigraph |
| Placebo | PLACEBO_COMPARATOR | Radiation + Placebo + Actigraph |
| Name | Type | Description |
|---|---|---|
| Placebo | OTHER | Placebo will consist of USP-grade or equivalent 0.9% Sodium Chloride for Injection. Doses of placebo will be drawn into labeled syringes by an independent, unblinded pharmacist or designee. |
| GI-6301 Vaccine (Yeast- Brachyury) | BIOLOGICAL | GI-6301 Vaccine is a heat-killed, recombinant yeast-based vaccine engineered to express the transcription factor, Brachyury. The Brachyury gene is used to transfect the parental yeast strain (S. cerevisiae W303 - a haploid strain with known mutations from wildtype yeast) to produce the final recombinant vaccine product. |
| Radiotherapy | RADIATION | Standard of care |
| wGT3X-BT Actigraph | DEVICE | wGT3X-BT is small, non-invasive, portable watch accelerometer worn on the subject's wrist for Cycle 1 through Cycle 9 |
* INCLUSION CRITERIA: Participants must meet the following criteria for participation: 1. Diagnosis: Patients must have histologically confirmed chordoma by the Laboratory of Pathology, NCI, which is localized (no evidence of metastatic disease), unresectable and they must have planned radiation t...