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NCT03452579 · ClinicalTrials.gov registry record · Phase 2
Nivolumab Plus Standard Dose Bevacizumab Versus Nivolumab Plus Low Dose Bevacizumab in GBM
A Phase 2 study of Glioblastoma, sponsored by David Peereboom.
- Active
- Registry status
- Phase 2
- Development phase
- 90
- Enrollment target
- 2
- Study locations
NCT03452579: Active Phase 2 study of Glioblastoma, sponsored by David Peereboom.
NCT03452579 is a Phase 2 study of Glioblastoma that is active but no longer recruiting, run by David Peereboom. The registered enrollment target is 90 participants, below the 108-participant average among 199 other Glioblastoma trials with a reported enrollment target (17% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03452579, a Phase 2 study of Glioblastoma, is active but no longer recruiting, sponsored by David Peereboom.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 90 participants
- Enrollment target
- 2
- Study locations
Study Summary
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).
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Nivolumab
- DRUG Standard Dose Bevacizumab
- DRUG Low Dose Bevacizumab
Study Locations (2)
Massachusetts
- Dana-Farber Cancer Institute - Boston
Ohio
- Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2018-05-21 |
| Est. Completion | 2025-06-30 |
| Phase | Phase 2 |
What the registry record for NCT03452579 still lists
NCT03452579 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 108-participant average among 199 other Glioblastoma trials with a reported enrollment target (17% lower).
The record links to 1 condition, with Glioblastoma appearing as the primary indexed condition, and to 3 interventions - of which Nivolumab is the first listed.
NCT03452579 reports a single indexed study location in Massachusetts, Ohio.
Frequently Asked Questions
What is clinical trial NCT03452579 about?
NCT03452579 is a clinical study titled "Nivolumab Plus Standard Dose Bevacizumab Versus Nivolumab Plus Low Dose Bevacizumab in GBM". 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)...
What is the current status of trial NCT03452579?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2018-05-21. Estimated completion is 2025-06-30.
What conditions does trial NCT03452579 study?
This clinical trial studies the following conditions: Glioblastoma.
What interventions are being tested in trial NCT03452579?
The interventions under investigation include: Nivolumab (DRUG), Standard Dose Bevacizumab (DRUG), Low Dose Bevacizumab (DRUG).
Who is sponsoring clinical trial NCT03452579?
This trial is sponsored by David Peereboom, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03452579 being conducted?
This trial has 2 study locations across Massachusetts, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03452579's enrollment target sits among peer trials
90 51st of 199 higher than 148 of 199 other Glioblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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