New cocktail aims to tackle returning brain tumors
NCT ID NCT03743662
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase II trial tests whether adding the immunotherapy drug nivolumab to re-irradiation and bevacizumab can help people with recurrent glioblastoma live longer. The study includes 39 participants whose tumors have a specific genetic marker (MGMT methylated). The goal is to see if this combination is more effective than standard treatments for this aggressive brain cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- nivolumab (a drug that helps the immune system fight cancer)
- What this could lead to
- If successful, this could offer a new treatment option for people with recurrent glioblastoma, potentially extending survival.
- What could go wrong
- This is a small, early-phase trial (39 people) with no control group, so results may not be definitive. The combination also carries risks like immune-related side effects and bleeding from bevacizumab.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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39 people
The number who actually took part.
- Started
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Nov 2018
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Histologic confirmed glioblastoma (WHO grade IV), IDH wildtype confirmed by DNA sequencing * MGMT hypermethylation in archival tumor biopsy, determined by any CLIAapproved, DNA-based assay * Prior maximal feasible surgical resection of biopsy * Prior treatment with radiation and temozolomide chemotherapy * Pathologic and/or Radiographic evidence of recurrent disease * Circumscribed enhancing tumor ≤ 5.0 cm in largest diameter (T1 post contrast) * 1 prior course of radiation therapy * Age ≥ 18 years * Karnofsky performance status ≥ 70% or ECOG 0 or 1 * Adequate bone marrow function * Hemoglobin ≥ 10g/dL * Absolute neutrophil count ≥ 1,500/mm 3 * Absolute lymphocyte count ≥ 200/mm 3 * Platelet count ≥ 100,000/mm3 * Adequate liver function * Bilirubin \<1.5 times upper limit normal (ULN) * AST and ALT ≤ 3 times ULN * Alkaline phosphatase ≤ 2 times ULN * Adequate renal function * BUN and Creatinine \<1.5 times ULN Exclusion Criteria: * Infratentorial location of the recurrence * IDH mutated glioblastoma * More than one prior tumor recurrence after standard first-line therapy * Prior radiation to the brain within ≤ 4 months * Circumscribed enhancing tumor \>5.0 cm in largest diameter (T1 post contrast) * Pulmonary embolus or deep vein thrombosis within preceding 2 months * Grade 2 or greater congestive heart failure * Unstable angina, myocardial infarction within past 12 months * Peptic ulcer, abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within past 6 months * Nonhealing wound, ulcer or bone fracture * Prior spontaneous CNS hemorrhage (as determined from clinical history, CT, or MRI) * Uncontrollable hypertension * Requiring escalating or chronic supraphysiologic doses of corticosteroids (\> 4 mg dexamethasone daily) for control of disease at the time of registration * Previous or current treatment with an anti-CTLA-4, anti-PD-1, anti-PD-L1, or anti-PDL2 agent. * Previous or current treatment with bevacizumab * Hypersensitivity to nivolumab or bevacizumab or any of its excipients * Diagnosis of immunodeficiency, including Human Immunodeficiency Virus (HIV) or acquired immunodeficiency syndrome (AIDS) * Known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected). * Known history of active TB (Bacillus Tuberculosis) * Known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. * Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. * Known history of, or any evidence of active, non-infectious pneumonitis. * Active infection requiring systemic therapy. * Pregnancy or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment. * Unable to undergo MRI of the brain (i.e. pacemaker or any other contraindication for MRIs).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hartford Healthcare (Data Collection)
Hartford, Connecticut, 06102, United States
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Indiana University (Data Collection Only)
Indianapolis, Indiana, 46202, United States
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Lehigh Valley Health Network (Data Collection Only)
Allentown, Pennsylvania, 18103, United States
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Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920, United States
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Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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Memorial Sloan Kettering Commack
Commack, New York, 11725, United States
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Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Nassau
Uniondale, New York, 11553, United States
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Memorial Sloan Kettering Westchester
Harrison, New York, 10604, United States
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University of Vermont Medical Center (Data Collection Only)
Burlington, Vermont, 05401, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a trio of repurposed drugs shrink recurrent brain tumors?
- Can an existing drug boost bevacizumab against recurrent brain cancer?
- One extra radiation dose after standard brain cancer therapy: can it boost the immune system?
- Radioactive tracer lights up Oxygen-Starved brain tumors
- Can a common virus vaccine help fight brain cancer?
- Radioactive tiles target brain tumors in frail patients