18 and older, any sex, with Glioblastoma. 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.
Overall Survival at 12 Months (OS12)Primary· 12 months
Overall survival is defined as the time from study entry to death from any cause. OS12 is the percentage of subjects who are alive 12 months after study entry. Data for subjects who are lost to follow up prior to documented death will be counted as deaths at the last assessment date when the subject is known to be alive.
Group
Value
95% CI
Bavituximab + Standard of Care Radiation + Temozolomide
72.7
59 – 90
Radiographic Response RateSecondary· every 3 months for 5 years
Radiographic response (RR) is defined as a complete response or partial response per RANO (Response assessment in neuro-oncology) criteria with incorporation of iRANO (immunotherapy response assessment for neuro-oncology) criteria. The radiographic response rate is the percentage of subjects who achieved radiographic response as defined above.
Group
Value
95% CI
Bavituximab + Standard of Care Radiation + Temozolomide
4
Progression Free Survival (PFS)Secondary· every 3 months for up to 5 years
Progression free survival is defined as the time of study entry to time of disease progression, or death due to any cause. Data for subjects who are lost to follow up will be censored at the date when the subject is last known to be alive. PFS results below are reported up to the data cutoff in May 2021.
Group
Value
95% CI
Bavituximab + Standard of Care Radiation + Temozolomide
6.9
6.2 – 9.7
Overall Survival (OS)Secondary· Up to 5 years
Overall survival is defined as the time of study entry to death from any cause. Data for subjects who are lost to follow up will be censored at the date when the subject is last known to be alive. OS results below are reported up to the data cutoff in May 2021.
Group
Value
95% CI
Bavituximab + Standard of Care Radiation + Temozolomide
15.4
13.3 – 23.6
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 5 years, starting at date of first treatment administration..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Bavituximab + Standard of Care Radiation + Temozolomide
Serious: 9/36 (25%)
Deaths: 29/36
Serious adverse events (18 terms)
Reaction
System
Bavituximab + Standard of …
Seizure
Nervous system disorders
—
Hydrocephalus
Nervous system disorders
—
Somnolence
Nervous system disorders
—
Cognitive disturbance
Nervous system disorders
—
General disorders and administration site conditions - Other, specify
General disorders
—
Nervous system disorders - Other, specify
Nervous system disorders
—
Renal and urinary disorders - Other, specify
Renal and urinary disorders
—
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
—
Blood and lymphatic system disorders - Other, specify
Blood and lymphatic system disorders
—
Confusion
Psychiatric disorders
—
Eye disorders - Other, specify
Eye disorders
—
Fever
General disorders
—
Gastritis
Gastrointestinal disorders
—
General disorders and administration site conditions - Other, specify
This research study is studying a combination of drugs with radiation as a possible treatment for Glioblastoma.
The drugs involved in this study are:
* Bavituximab
* Temozolomide
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04373785 — NG101m Adjuvant Therapy in Glioblastoma Patients
· Phase 1, PHASE2
· not yet recruiting
NCT06448286 — PH Weighted Chemical Exchange Saturation Transfer MRI-Based Surgical Resection to Improve Survival in Patients With Glio
· Phase 3
· not yet recruiting
NCT07492680 — A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic S
· Phase 2
· not yet recruiting
NCT07452458 — Temporally-Modulated Pulsed Radiation Therapy Versus Standard Radiation Therapy for the Treatment of Newly Diagnosed, ID
· Phase 3
· not yet recruiting
NCT06639607 — PEP-CMV + Nivolumab for Newly Diagnosed Diffuse Midline Glioma/High-grade Glioma and Recurrent Diffuse Midline Glioma/Hi
· Phase 1, PHASE2
· not yet recruiting
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Currently open trials in the same condition.
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· recruiting
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· recruiting
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NCT07410676 — EBNK-001 Allogeneic NK Cells With Low-Dose IL-15 ± Pembrolizumab in Advanced Solid Tumors
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· recruiting
Other Massachusetts General Hospital trials
Trials by the same sponsor.
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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 Massachusetts General Hospital
Last refreshed: 16 May 2024
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/NCT03139916.