2 and older, any sex, with Ewing Sarcoma or Ewing Family of Tumors. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression Free Survival (PFS)Primary· From date of randomization until the date of first documented progression (assessed up to 3 years).
Progression Free Survival (PFS) is defined as the time from randomization to the event of disease recurrence/progression according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria (version 1.1) for target lesions and assessed CT/MRI by local investigator.
Group
Value
95% CI
Group A: Vigil in Combination With Irinotecan and Temozolomide
2.8
2.7 – NA
Group B: Irinotecan and Temozolomide
9.1
2.8 – NA
Overall Survival (OS)Secondary· From date of randomization until date of death from any cause, whichever came first (assessed up to 3 years).
OS is defined as time from randomization to death or to the date of last follow-up. The date of last follow-up confirming survival will be used as the censoring date for subjects who are alive and/or do not have a known date of death.
Group
Value
95% CI
Group A: Vigil in Combination With Irinotecan and Temozolomide
16.1
14.6 – NA
Group B: Irinotecan and Temozolomide
3.3
3.3 – NA
Overall Response Rate (ORR)Secondary· 6 months after treatment with Vigil.
ORR is defined as the proportion of participants who have prolonged stable disease or a partial or complete response or complete response to therapy according to RECIST 1.1.
Group
Value
95% CI
Group A: Vigil in Combination With Irinotecan and Temozolomide
0
Group B: Irinotecan and Temozolomide
0
Vigil Manufacture Success Rate: Number of Participants Eligible for Treatment on the Main Study.Secondary· From manufacturing start date until 4 weeks post manufacturing for each tissue procurement (assessed up to 17 months).
Participants were considered eligible for treatment, if the tissue submitted to Gradalis met all criteria, including manufacturing product release criteria.
Group
Value
95% CI
Total Number of Tissue Procurements
4
Adverse events — posted to ClinicalTrials.gov
Time frame: SAEs and Other Adverse Events: following procurement of the subject's tissue for tissue manufacture and for up to 30 days following the last study treatment, a duration of approximately 12 months. All-cause Mortality: from randomization date and until death or protocol termination, up to 3 years..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Group A: Vigil in Combination With Irinotecan and Temozolomide
The goal of this clinical trial was to compare participants with first relapse or refractory Ewing's sarcoma when treated with investigational product (Vigil) in addition to the standard treatment of irinotecan and temozolomide compared to the standard treatment of irinotecan and temozolomide alone. The main question it aimed to answer is "Will participants who receive Vigil in addition to irinotecan and temozolomide have a prolonged time to progression and improved quality of life compared to the participants who receive irinotecan and temozolomide alone?".
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT03073525 — A Trial of Atezolizumab and Vigil in Patients With Advanced Gynecological Cancers
· Phase 2
· completed
NCT02725489 — Pilot Study of Durvalumab and Vigil in Advanced Women's Cancers
· Phase 2
· completed
NCT02511132 — A Two-part Phase IIb Trial of Vigil (Bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Immunotherapy) in Ewing's S
· Phase 2
· completed
NCT03842865 — Expanded Access of Vigil in Solid Tumors
· temporarily not available
Other recruiting trials for Ewing Sarcoma
Currently open trials in the same condition.
NCT07297979 — Evaluation of Xaluritamig in Adults, Adolescents and Children With Relapsed or Refractory Ewing Sarcoma (EWS)
· Phase 1
· recruiting
NCT07222735 — Hypofractionated Radiation in Combination With B7-H3-CAR T Cells for Pediatric Patients With Relapsed/Refractory Sarcoma
· Phase 1
· recruiting
NCT07197554 — A Phase 1/1B Study of ST-01156, a Small Molecule RBM39 Degrader, in Patients With Advanced Solid Malignancies
· Phase 1
· recruiting
NCT07188532 — Biologically-Adapted, Dose-Escalated Radiotherapy for the Treatment of Ewing Sarcoma, BEAR Trial
· NA
· recruiting
NCT07141862 — Fertility Preservation in Children With Solid Tumors: Detection of Residual Disease by a Sensitive Method
· recruiting
Other Gradalis, Inc. trials
Trials by the same sponsor.
NCT03073525 — A Trial of Atezolizumab and Vigil in Patients With Advanced Gynecological Cancers
· Phase 2
· completed
NCT02511132 — A Two-part Phase IIb Trial of Vigil (Bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Immunotherapy) in Ewing's S
· Phase 2
· completed
NCT01309230 — A Trial of FANG™ Vaccine for Participants With Ovarian Cancer
· Phase 2
· completed
NCT03842865 — Expanded Access of Vigil in Solid Tumors
· temporarily not available
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Gradalis, Inc.
Last refreshed: 26 April 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03495921.