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Avelumab With Hypofractionated Radiation Therapy in Adults With Isocitrate Dehydrogenase (IDH) Mutant Glioblastoma
Phase 2 trial testing Avelumab in Glioblastoma in 6 participants. Completed in 29 August 2019.
| Lead sponsor | NYU Langone Health |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 6 |
| Start date | 17 March 2017 |
| Primary completion | 29 August 2019 |
| Estimated completion | 29 August 2019 |
| Sites | 4 locations across United States |
NYU Langone Health — full company profile →
18 and older, any sex, with Glioblastoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Subjects are evaluable for DLTs (defined in section 5.2.1.2) if they have received at least one dose of Avelumab, have completed HFRT per protocol and have completed safety assessments over the entire DLT evaluation period (days 1 through 28).
| Group | Value | 95% CI |
|---|---|---|
| Avelumab and Hypofractionated Radiation Therapy(HFRT) | 0 |
PFS, defined as the time between treatment initiation and first occurrence of disease progression or death, will be censored at last follow-up if the patient remained alive without disease progression
| Group | Value | 95% CI |
|---|---|---|
| Avelumab and Hypofractionated Radiation Therapy(HFRT) | 4.2 | 1.4 – 5.7 |
OS will be determined from the time of treatment initiation until the time of death, with OS being censored at last follow-up if the patient remained alive
| Group | Value | 95% CI |
|---|---|---|
| Avelumab and Hypofractionated Radiation Therapy(HFRT) | 10.1 | 6.8 – 12 |
PFS, defined as the time between treatment initiation and first occurrence of disease progression or death, will be censored at last follow-up if the patient remained alive without disease progression
| Group | Value | 95% CI |
|---|---|---|
| Avelumab and Hypofractionated Radiation Therapy(HFRT) | 4.2 | 1.4 – 5.7 |
Time frame: 12 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Avelumab and Hypofractiona… |
|---|---|---|
| Edema cerebral | Nervous system disorders | — |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | — |
| Encephalopathy | Nervous system disorders | — |
| Infusion related reaction | General disorders | — |
| Other, radiation vasculopathy | Vascular disorders | — |
| Hyponatremia | Metabolism and nutrition disorders | — |
| Reaction | System | Avelumab and Hypofractiona… |
|---|---|---|
| White blood cell decreased | Investigations | — |
| Nausea | Gastrointestinal disorders | — |
| CD4 lymphocytes decreased | Investigations | — |
| Vomiting | Gastrointestinal disorders | — |
| Urinary tract infection | Infections and infestations | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — |
| Pyramidal tract syndrome | Nervous system disorders | — |
| Platelet count decreased | Investigations | — |
| Paresthesia | Nervous system disorders | — |
| Headache | Nervous system disorders | — |
| Fall | Injury, poisoning and procedural complications | — |
| Depression | Psychiatric disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Aspartate aminotransferase increased | Investigations | — |
| Anxiety | Psychiatric disorders | — |
| Anemia | Blood and lymphatic system disorders | — |
| Alopecia | Skin and subcutaneous tissue disorders | — |
| Alanine aminotransferase increased | Investigations | — |
| Vaginal dryness | Reproductive system and breast disorders | — |
| Urinary urgency | Renal and urinary disorders | — |
| Urinary retention | Renal and urinary disorders | — |
| Urinary incontinence | Renal and urinary disorders | — |
| Spasticity | Nervous system disorders | — |
| Somnolence | Nervous system disorders | — |
| Sun burn | Skin and subcutaneous tissue disorders | — |
| Sinus tachycardia | Cardiac disorders | — |
| Sinus pain | Nervous system disorders | — |
| Sinus disorder | Respiratory, thoracic and mediastinal disorders | — |
| Sinus bradycardia | Cardiac disorders | — |
| Seizure | Nervous system disorders | — |
| Psychosis | Psychiatric disorders | — |
| Pain | General disorders | — |
| Non-cardiac chest pain | General disorders | — |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — |
| Memory impairment | Nervous system disorders | — |
| Hypothyroidism | Endocrine disorders | — |
| Hypotension | Vascular disorders | — |
| Hypophosphatemia | Metabolism and nutrition disorders | — |
Most-reported serious reactions: Edema cerebral, Generalized muscle weakness, Encephalopathy, Infusion related reaction, Other, radiation vasculopathy, Hyponatremia.
Data from ClinicalTrials.gov NCT02968940 adverse events section.
The purpose of this study is to test how safe and effective treatment with the combination of Avelumab and radiation is for IDH mutant gliomas that have transformed to glioblastoma after chemotherapy.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing