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Nivolumab Plus Standard Dose Bevacizumab Versus Nivolumab Plus Low Dose Bevacizumab in GBM
Phase 2 trial testing Nivolumab in Glioblastoma in 90 participants. Participants enrolled and being followed up; not accepting new ones.
| Lead sponsor | David Peereboom |
|---|---|
| Phase | Phase 2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 90 |
| Start date | 21 May 2018 |
| Primary completion | 30 December 2020 |
| Estimated completion | 30 June 2025 |
| Sites | 2 locations across United States |
David Peereboom — 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.
OS-12 is the percentage of participants in the analysis population who remain alive for at least twelve months following initiation of study therapy. Participants without efficacy evaluation data or without survival data will be censored at Day 1
| Group | Value | 95% CI |
|---|---|---|
| Nivolumab + Standard Dose Bevacizumab | 41.1 | 26.1 – 56.1 |
| Nivolumab + Low Dose Bevacizumab | 37.7 | 23.1 – 52.4 |
The percentage of participants in the analysis population who remain progression-free for at least six months following initiation of study therapy. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions Participants without efficacy evaluation data or without survival data will be censored at Day 1
| Group | Value | 95% CI |
|---|---|---|
| Nivolumab + Standard Dose Bevacizumab | 46.7 | 32.1 – 61.2 |
| Nivolumab + Low Dose Bevacizumab | 44.6 | 29.4 – 59.8 |
OS, as defined as number of participants alive from beginning of treatment up to 6 six months Participants without efficacy evaluation data or without survival data will be censored at Day 1
| Group | Value | 95% CI |
|---|---|---|
| Nivolumab + Standard Dose Bevacizumab | 75.1 | 62.3 – 87.9 |
| Nivolumab + Low Dose Bevacizumab | 57.4 | 42.9 – 71.9 |
OS, as defined as the percentage of participants alive from beginning of treatment up to 18 months. Participants without efficacy evaluation data or without survival data will be censored at Day 1
| Group | Value | 95% CI |
|---|---|---|
| Nivolumab + Standard Dose Bevacizumab | 30.9 | 15.7 – 46.1 |
| Nivolumab + Low Dose Bevacizumab | 22.5 | 8.5 – 36.5 |
Proportion of participants in the analysis population who have complete response (CR) or partial response (PR) using Radiologic Assessment in Neuro-Oncology criteria (RANO) criteria. Participants without efficacy evalaluation data or survival data censored at day 1. Participants without measurable disease will not be included.
| Group | Value | 95% CI |
|---|---|---|
| Nivolumab + Standard Dose Bevacizumab | 18 | |
| Nivolumab + Low Dose Bevacizumab | 16 |
Median time from allocation to first documented disease progression per RANO or death due to any cause, whichever occurs first. Those without efficacy eval. data or survival data censored at day 1 RANO - progressive disease: * (\>) 25% increase in sum of products of perpendicular diameters of measurable lesions (over best response \[smallest tumor size\] or baseline if no decrease) on stable/increasing corticosteroid doses * Any new measurable lesion that when added to change in initial tumor(s) exceeds 25% increase in x-sectional area. * Clear clinical deterioration not attributable to caus
| Group | Value | 95% CI |
|---|---|---|
| Nivolumab + Standard Dose Bevacizumab | 4.1 | 3.2 – 7.0 |
| Nivolumab + Low Dose Bevacizumab | 5.6 | 3.7 – 6.8 |
Time from first RANO response to disease progression in participants who achieve a PR or better Participants without efficacy evaluation data or without survival data will be censored at Day 1
| Group | Value | 95% CI |
|---|---|---|
| Nivolumab + Standard Dose Bevacizumab | 5.2 | 3.5 – 6.6 |
| Nivolumab + Low Dose Bevacizumab | 5.2 | 3.4 – 6.8 |
Time frame: Adverse events were collected while participants were on study up to 3 years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Nivolumab + Standard Dose … | Nivolumab + Low Dose Bevac… |
|---|---|---|---|
| Generalized Muscle Weakness | Musculoskeletal and connective tissue disorders | — | — |
| Fatigue | General disorders | — | — |
| Other Neurologic | Nervous system disorders | — | — |
| Hypertension | Cardiac disorders | — | — |
| Cognitive | Nervous system disorders | — | — |
| Deep vein thrombosis | Cardiac disorders | — | — |
| Pulmonary Embolism | Cardiac disorders | — | — |
| Infection | General disorders | — | — |
| Gait Imbalance | Musculoskeletal and connective tissue disorders | — | — |
| Headaches | Nervous system disorders | — | — |
| Seizure | Nervous system disorders | — | — |
| Liver Function Abnormal | Gastrointestinal disorders | — | — |
| Lipase Increase | Investigations | — | — |
| Upper Resipratory Infection | Respiratory, thoracic and mediastinal disorders | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — |
| Hyperglycemia | Investigations | — | — |
| Abnormal LFT | Gastrointestinal disorders | — | — |
| ALT Increase | Blood and lymphatic system disorders | — | — |
| Neutrophil decreased | Blood and lymphatic system disorders | — | — |
| Pain | General disorders | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Abnormal Electrolytes | Investigations | — | — |
| Immune System Other Cerebrit | Investigations | — | — |
| Serum Amylase Increased | Investigations | — | — |
| Intracranial Hemorrhage | Nervous system disorders | — | — |
| Reaction | System | Nivolumab + Standard Dose … | Nivolumab + Low Dose Bevac… |
|---|---|---|---|
| Fatigue | General disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Abnormal Electrocytes | Investigations | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Proteinuria | Renal and urinary disorders | — | — |
| Hypertension | Cardiac disorders | — | — |
| Lipase Increased | Investigations | — | — |
| Seizure | Nervous system disorders | — | — |
| General Muscle Weakness | Investigations | — | — |
| Bleed | Blood and lymphatic system disorders | — | — |
| Body pain/stiffness | Musculoskeletal and connective tissue disorders | — | — |
| Other-neurologic | Nervous system disorders | — | — |
| Flu Symptoms | General disorders | — | — |
| Platelet count decreased | Blood and lymphatic system disorders | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — |
| Hyperglycemia | Investigations | — | — |
| ALT increased | Blood and lymphatic system disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Behavioral Side effect | Nervous system disorders | — | — |
| Cough | General disorders | — | — |
| AST increased | Investigations | — | — |
| Serum amylase increased | Investigations | — | — |
| Infection | General disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Joint Pain | Musculoskeletal and connective tissue disorders | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — |
| Chest Pain | Cardiac disorders | — | — |
| Weight loss | General disorders | — | — |
| Abdominal Discomfort | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Hypothroidism | Investigations | — | — |
| Insomnia | General disorders | — | — |
| Dysphagia | Gastrointestinal disorders | — | — |
| Hiccups/hoarseness | Respiratory, thoracic and mediastinal disorders | — | — |
| Eye Discomfort | Eye disorders | — | — |
Most-reported serious reactions: Generalized Muscle Weakness, Fatigue, Other Neurologic, Hypertension, Cognitive, Deep vein thrombosis, Pulmonary Embolism, Infection.
Data from ClinicalTrials.gov NCT03452579 adverse events section.
The purpose of this study is to test the effectiveness (how well the drug works), safety and tolerability of an investigational drug called nivolumab (also known as BMS-936558) in glioblastoma (a malignant tumor, or GBM), when added to bevacizumab. Nivolumab is an antibody (a kind of human protein) that is being tested to see if it will allow the body's immune system to work against glioblastoma tumors. Opdivo (nivolumab ) is currently FDA approved in the United States for melanoma (a type of skin cancer), non-small cell lung cancer, renal cell cancer (a type of kidney cancer), Hodgkin's lymphoma but is not approved in glioblastoma. nivolumab may help your immune system detect and attack cancer cells. Bevacizumab is a drug which works on the blood vessel that supply the tumor and potentially can starve the tumor by cutting off the blood supply to these tumors. Bevacizumab is commercially available and FDA approved for individuals with recurrent glioblastoma. This study has two study groups. Arm 1 will receive the study drug nivolumab 240mg and bevacizumab 10 mg (standard dose) every 2 weeks and Arm 2 will receive the study drug nivolumab 240 mg and bevacizumab 3 mg (low dose) every 2 weeks. A process will be used to assign participants, by chance, to one of the study groups. Neither participants nor doctors can choose which group participants are in. This is done by chance because no one knows if one study group is better or worse than the other. 90 total participants are expected to participate in this study (45 participants in each arm). Your total participation in this study from the time you have signed the informed consent to your last visit, including follow-up visits, may be more than three years (depending on what effect the treatment has on your cancer, and how well you tolerate the treatment).
8 peer-reviewed publications reference this trial (live from Europe PMC):
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