Clinical trial · Interventional
Stereotactic Radiosurgery With Nivolumab and Valproate in Patients With Recurrent Glioblastoma
A Pilot Study to Evaluate the Feasibility of the Combined Use of Stereotactic Radiosurgery With Nivolumab and Concurrent Valproate in Patients With Recurrent Glioblastoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The pharmaceutical company (BMS) would no longer provide nivolumab for the study, so the study was terminated early.
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the safety and feasibility of the immunotherapeutic agent nivolumab given in combination with gamma knife therapy and valproate in patients with recurrent glioblastoma, a common and lethal type of brain cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nivolumab | Drug | Nivolumab | ALIAS |
| Stereotactic Radiosurgery | Radiation | — | UNRESOLVED |
| Valproate | Drug | Valproic Acid | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Nivolumab & Valproate Following G.K.
- description
- Subjects will begin a valproate regimen prior to undergoing stereotactic radiosurgery (gamma knife) on a single lesion. Following the surgery, subjects will receive nivolumab every 2 weeks and daily valproate.
- interventionNames
- Radiation: Stereotactic Radiosurgery
- Drug: Nivolumab
- Drug: Valproate
Primary outcomes (2)
- measure
- Feasibility based on number of subjects who complete 4 doses of nivolumab
- timeFrame
- At 3 months following radiosurgery
- description
- Feasibility of the radiosurgery and drug combination will be determined based on the number of subjects who complete at least 4 doses of nivolumab.
- measure
- Incidence of adverse events
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed malignant, recurrent glioblastoma or gliosarcoma * Subject must have adequate organ function * Subject must still be able to care for most of his or her personal needs Exclusion Criteria: * Subject is pregnant * Subject has extracranial metastatic or leptomeningeal disease * Subject has an additional malignancy that is progressing or requires active treatment, exceptions being basal cell and squamous cell carcinomas of the skin, indolent prostate cancer, chronic lymphocytic leukemia, or in situ cervical cancer * Subject has received chemotherapy, biological therapy, or had surgery 4 weeks prior to beginning the study * Subject has had radiation therapy within 10 weeks prior to entering beginning the study * Subject has had prior therapy with bevacizumab * Subject has had previous treatment with carmustine wafer except when administered as first-line treatment no less than six months prior to beginning the study * Subject requires escalating supraphysiologic doses of corticosteroids greater than 2 mg of dexamethasone or an equivalent * Active autoimmune disease requiring systemic treatment within the past 3 months or any syndrome that requires immunosuppressive agents * Interstitial lung disease or active, non-infectious pneumonitis * Evidence of greater than Grade 1 CNS hemorrhage or greater than Grade 3 venous thromboembolism * History of uncontrolled cardiac disease * Subject unable or unwilling to have a head contrast enhanced MRI
References
Publications (0)
Data not yet available