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An Investigational Immuno-therapy Study of Nivolumab Compared to Temozolomide, Each Given With Radiation Therapy, for Newly-diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer)
Phase 3 trial testing Nivolumab in Brain Cancer in 560 participants. Completed in 4 March 2022.
| Lead sponsor | Bristol-Myers Squibb |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 560 |
| Start date | 1 March 2016 |
| Primary completion | 17 January 2019 |
| Estimated completion | 4 March 2022 |
| Sites | 125 locations across Italy, Japan, Poland, Denmark, Netherlands, Russia, Belgium, Sweden |
Bristol-Myers Squibb — full company profile →
18 and older, any sex, with Brain Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
OS is defined as the time between the date of randomization and the date of death due to any cause. A participant who has not died will be censored at the last known alive date.
| Group | Value | 95% CI |
|---|---|---|
| Nivolumab + Radiation Therapy | 13.40 | 12.62 – 14.29 |
| Temozolomide + Radiation Therapy | 14.88 | 13.27 – 16.13 |
PFS was defined as the time from randomization to the date of the first documented tumor progression or death due to any cause. Participants who did not have disease progression or who did not die were censored at the date of last tumor assessment. Participants who did not have any on study tumor assessment and did not have tumor progression or die were censored at the randomization date. Participants who started any subsequent anti-cancer therapy without a prior reported progression were censored at the last tumor assessment prior to initiation of the subsequent anti-cancer therapy. Participa
| Group | Value | 95% CI |
|---|---|---|
| Nivolumab + Radiation Therapy | 6.01 | 5.65 – 6.21 |
| Temozolomide + Radiation Therapy | 6.21 | 5.98 – 6.90 |
The overall survival (OS) rate of (nivolumab + radiation therapy) and (temozolomide + radiation therapy) estimated as Kaplan-Meier probability of survival at 24 months. OS was defined as the time between the date of randomization and the date of death due to any cause. A participant who has not died was censored at the last known alive date.
| Group | Value | 95% CI |
|---|---|---|
| Nivolumab + Radiation Therapy | 10.6 | 7.3 – 14.6 |
| Temozolomide + Radiation Therapy | 21.2 | 16.5 – 26.3 |
OS was defined as the time between the date of randomization and the date of death due to any cause. A participant who has not died was censored at the last known alive date. Note: This outcome measure represents an updated version of the primary endpoint to include additional data collection that has occurred after the primary completion date (assessments were made until March 4, 2022).
| Group | Value | 95% CI |
|---|---|---|
| Nivolumab + Radiation Therapy | 13.34 | 12.55 – 14.16 |
| Temozolomide + Radiation Therapy | 14.92 | 13.27 – 16.10 |
Time frame: All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Nivolumab + Radiation Ther… | Temozolomide + Radiation T… |
|---|---|---|---|
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Seizure | Nervous system disorders | — | — |
| Tumour flare | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Epilepsy | Nervous system disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | — | — |
| Hemiparesis | Nervous system disorders | — | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — | — |
| Brain oedema | Nervous system disorders | — | — |
| Pyrexia | General disorders | — | — |
| General physical health deterioration | General disorders | — | — |
| Pneumonia | Infections and infestations | — | — |
| Glioblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Embolism | Vascular disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Hyperglycaemia | Metabolism and nutrition disorders | — | — |
| Deep vein thrombosis | Vascular disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Platelet count decreased | Investigations | — | — |
| Hyponatraemia | Metabolism and nutrition disorders | — | — |
| Muscular weakness | Musculoskeletal and connective tissue disorders | — | — |
| Aphasia | Nervous system disorders | — | — |
| Encephalopathy | Nervous system disorders | — | — |
| Reaction | System | Nivolumab + Radiation Ther… | Temozolomide + Radiation T… |
|---|---|---|---|
| Fatigue | General disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Alopecia | Skin and subcutaneous tissue disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Platelet count decreased | Investigations | — | — |
| Dizziness | Nervous system disorders | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — |
| Seizure | Nervous system disorders | — | — |
| Lymphocyte count decreased | Investigations | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — |
| Pyrexia | General disorders | — | — |
| Radiation skin injury | Injury, poisoning and procedural complications | — | — |
| Aphasia | Nervous system disorders | — | — |
| Insomnia | Psychiatric disorders | — | — |
| Asthenia | General disorders | — | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — |
| Lymphopenia | Blood and lymphatic system disorders | — | — |
| Gait disturbance | General disorders | — | — |
| Hemiparesis | Nervous system disorders | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Alanine aminotransferase increased | Investigations | — | — |
| Confusional state | Psychiatric disorders | — | — |
| Depression | Psychiatric disorders | — | — |
| Nasopharyngitis | Infections and infestations | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Weight decreased | Investigations | — | — |
| Memory impairment | Nervous system disorders | — | — |
| Somnolence | Nervous system disorders | — | — |
| Hypothyroidism | Endocrine disorders | — | — |
| Neutrophil count decreased | Investigations | — | — |
| Anxiety | Psychiatric disorders | — | — |
| Oedema peripheral | General disorders | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — |
| Neutropenia | Blood and lymphatic system disorders | — | — |
Most-reported serious reactions: Malignant neoplasm progression, Seizure, Tumour flare, Epilepsy, Headache, Pulmonary embolism, Hemiparesis, Thrombocytopenia.
Data from ClinicalTrials.gov NCT02617589 adverse events section.
The purpose of this study is to evaluate patients with glioblastoma that is MGMT-unmethylated (the MGMT gene is not altered by a chemical change). Patients will receive Nivolumab every two weeks in addition to radiation therapy, and then every four weeks. They will be compared to patients receiving standard therapy with temozolomide in addition to radiation therapy.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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