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New cocktail aims to tackle returning brain tumors

NCT ID NCT03743662

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

39 people

The number who actually took part.

Started

Nov 2018

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Hartford Healthcare (Data Collection)

    Hartford, Connecticut, 06102, United States

  • Indiana University (Data Collection Only)

    Indianapolis, Indiana, 46202, United States

  • Lehigh Valley Health Network (Data Collection Only)

    Allentown, Pennsylvania, 18103, United States

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920, United States

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering Nassau

    Uniondale, New York, 11553, United States

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604, United States

  • University of Vermont Medical Center (Data Collection Only)

    Burlington, Vermont, 05401, United States

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