AzTrials
AzTrials

Recurrent GlioblastomaPhase 1NEO-GLITIPNINCT06097975

A Clinical Trial on Combined (Neo-)Adjuvant Intravenous Plus Intracranial Administration of Ipilimumab and Nivolumab in Recurrent Glioblastoma

A Phase 1 study testing Neo-adjuvant nivolumab and ipililumab IV + adjuvant nivolumab and ipililumab IV, Neurosurgery and intracavitary injection nivolumab and ipililumab and Adjuvant nivolumab IV + nivolumab and ipililumab intracavitary in people with Recurrent Glioblastoma, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The goal of this phase I interventional study is to determine the safety and feasibility of the proposed investigational (neo-)adjuvant treatment regimen in patients with resectable reccurent glioblastoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Recurrent Glioblastoma
What is being tested?
Neo-adjuvant nivolumab and ipililumab IV + adjuvant nivolumab and ipililumab IV, Neurosurgery and intracavitary injection nivolumab and ipililumab and Adjuvant nivolumab IV + nivolumab and ipililumab intracavitary
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteBelgium
Study dates
15 Mar 2024to 1 Dec 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult
  1. Subjects must have signed and dated an approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care
  2. Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, tumor biopsies, and other requirements of the study.
  3. Histopathological diagnosis of glioblastoma (= IDHwt, WHO grade IV astrocytoma of the central nervous system (Louis, Perry et al. 2021).
  4. Diagnosis of resectable glioblastoma recurrence and/or progression following prior standard of care treatment (surgery for resectable lesions, radiation therapy and temozolomide chemotherapy). Recurrence/progression is defined as significant [according to the investigators assessment] growth and/or recurrence of the glioblastoma tumor mass on sequential MRI of the brain;
  5. The following disease characteristics should be present:
  6. Presence of a measurable tumor lesion that is characterized by gadolinium enhancement on T1-MRI of the brain (with a longest diameter of > 10 mm and a perpendicular diameter of >5mm).
  7. No evidence of clinically relevant spontaneous intra-tumor hemorrhage on baseline MRI-imaging or in the prior disease history;
  8. No ventriculo-peritoneal drain:
  9. No contraindication for evaluation by gadolinium enhanced MRI, 18FFET-PET/CT of the brain or whole-body contrast enhanced CT;
  10. ECOG performance status score of 0, 1 or 2;
  11. An interval of at least 4 months (: 16 weeks) after the end of postoperative radiation therapy for glioblastoma unless progression is confirmed on an MRI of the brain obtained > 4 week after the first observation of progression; and with an interval of at least 4 weeks after the last administration of temozolomide;
  12. Male or female, 18 years of age or older;
  13. Resolution of all acute treatment related adverse effects of prior surgical procedures, radiotherapy and temozolomide to NCI CTCAEv4.0 grade 0 or 1 except for alopecia;
  14. Adequate organ function as defined by the following criteria:
  15. Total serum bilirubin < 1.5 x ULN (patients with Gilbert's disease exempt who should have bilirubin < 2x ULN)
  16. AST and ALT < 2.5 x upper limit of normal (ULN);
  17. Serum creatinine ≤1.5 x ULN or calculated creatinine clearance ≥60 mL/min
  18. Absolute neutrophil count (ANC) > 1500/mm³ without growth factor support
  19. Platelets > 75 000 cells/mm³
  20. Hemoglobin ≥9 g/dL (which may be obtained by transfusion or growth factor support)
  21. FT4 hormone levels within normal range;
  22. No prior treatment on a nivolumab and/or ipilimumab trial;
  23. No prior treatment with an anti-CTLA-4 or anti-PD-1/-L1 targeted therapy;
  24. No gastrointestinal abnormalities including:
  25. Inability to take oral medication.
  26. Requirement for intravenous alimentation.
  27. Prior surgical procedures affecting absorption including gastric resection.
  28. Treatment for active peptic ulcer disease in the past 6 months.
  29. Malabsorption syndromes.
  30. Active gastrointestinal bleeding, unrelated to cancer, as evidenced by hematemesis, hematochezia or melena in the past 3 months without evidence of resolution documented by endoscopy or colonoscopy;
  31. No evidence of pre-existing uncontrolled hypertension as documented by baseline blood pressure reading. The baseline systolic blood pressure reading must be ≤140 mm Hg, and the baseline diastolic blood pressure readings must be ≤90 mm Hg. If baseline blood pressure reading exceeds the inclusion values a second blood pressure reading (taken at least 1 hour apart) must be documented in order to confirm the absence of uncontrolled hypertension. Patients whose hypertension is controlled by antihypertensive therapies are eligible;
  32. No concurrent treatment:
  33. In another therapeutic clinical trial;
  34. No requirement for permanent therapeutic anticoagulation therapy.
  35. Subjects with active, known, or suspected autoimmune disease are not eligible. Subjects with type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll;
  36. Subjects requiring systemic treatment with either corticosteroids (> 8 mg daily methylprednisolone equivalent) or other immunosuppressive medications within 14 days of study enrollment. Inhaled or topical steroids are permitted in the absence of active autoimmune disease;
  37. No active uncontrolled seizure disorder;
  38. No myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure or any unstable arrhythmia, cerebrovascular accident or transient ischemic attack, within the 12 months prior to study drug administration.;
  39. No known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness;
  40. No serious uncontrolled medical disorder or active infection that would impair their ability to receive study treatment;
  41. No history of a malignancy (other than glioma) except those treated with curative intent for skin cancer (other than melanoma) or in situ breast or cervical cancer or those treated with curative intent for any other cancer with no evidence of disease for 5 years;
  42. No other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study;
  43. No dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol;
  44. Female patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception measures during the period of therapy, which should be continued for at least 5 months following the last dose of nivolumab as indicated in the SmPC. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrollment and pregnancy testing should be conducted within 24h prior to the first dose of immune checkpoint inhibitors and thereafter monthly and at the end of systemic exposure. The definition of effective contraception will be included in the Informed consent form. Women must not be breastfeeding at initiation of screening.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • UZ Brussel

    Brussels, Brussels Capital, 1090

Other trials in Belgium

About this study

Official title: A Phase I Clinical Trial on Combined (Neo-)Adjuvant Intravenous Plus Intracranial Administration of Ipilimumab and Nivolumab in Recurrent Glioblastoma

The goal of this phase I interventional study is to determine the safety and feasibility of the proposed investigational (neo-)adjuvant treatment regimen in patients with resectable reccurent glioblastoma.

Participants will:

  • receive neo-adjuvant administration of intravenous immunotherapy
  • followed by a maximal safe neurosurgical resection
  • afterwards, immunotherapy will be injected into the brain tissue
  • followed by insertion of an Ommaya reservoir
  • postoperatively, administration of immunotherapy will be continued
Being tested
Neo-adjuvant nivolumab and ipililumab IV + adjuvant nivolumab and ipililumab IV, Neurosurgery and intracavitary injection nivolumab and ipililumab, Adjuvant nivolumab IV + nivolumab and ipililumab intracavitary
Medical subject headings
Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neo-adjuvant nivolumab and ipililumab IV + adjuvant nivolumab and ipililumab IVDrug

    Participants will receive neo-adjuvant administration of intravenous immunotherapy on day 1 + day 22: ipilimumab + nivolumab IV.

  • Neurosurgery and intracavitary injection nivolumab and ipililumabProcedure or surgery

    The neo-adjuvant therapy will be followed by a maximal safe surgery resection of the glioblastoma. Immunotherapy (nivolumab + ipililumab) will be injected into the brain tissue, followed by insertion of an Ommaya reservoir

  • Adjuvant nivolumab IV + nivolumab and ipililumab intracavitaryDrug

    Postoperatively, administration of immunotherapy will be continued, on day 15 postoperatively and every 2 weeks thereafter patients will receive nivolumab IV as well as ipililumab + nivolumab intracavitary.

Study groups in NCT06097975
Study groupRoleWhat they receive
Experimental armExperimentalNot described
Receives: Drug: Neo-adjuvant nivolumab and ipililumab IV + adjuvant nivolumab and ipililumab IV; Procedure: Neurosurgery and intracavitary injection nivolumab and ipililumab; Drug: Adjuvant nivolumab IV + nivolumab and ipililumab intracavitary

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determine the safety and feasibility of the proposed investigational (neo-)adjuvant treatment regimen in patients with resectable recurrent glioblastoma.

    Incidence of treatment related adverse events (TRAE). TRAE will be collected on a continuous basis. Type, frequency and severity (graded according to the CTCAEv5) will be reported descriptively.

    Measured: 1 year

Secondary outcomes (1)

  1. Estimate anti-tumor responses of the proposed investigational (neo-)adjuvant treatment regimen.

    Objective response rate (ORR, according to iRANO criteria) following 4 weeks of neo-adjuvant therapy.

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2023
  2. Study start15 Mar 2024
  3. Primary completion1 Jun 2027 (estimated)
  4. Study completion1 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06097975
Sponsor's protocol ID
2023-BN-001
Acronym
NEO-GLITIPNI
Status last verified
Sep 2026
First submitted
5 Oct 2023
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Neo-adjuvant nivolumab and ipililumab IV + adjuvant nivolumab and ipililumab IV, Neurosurgery and intracavitary injection nivolumab and ipililumab and Adjuvant nivolumab IV + nivolumab and ipililumab intracavitary in people with Recurrent Glioblastoma, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine the safety and feasibility of the proposed investigational (neo-)adjuvant treatment regimen in patients with resectable recurrent glioblastoma. (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06097975.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in