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Clinical Trial NCT03743662 for Glioblastoma is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Memorial Sloan Kettering Cancer CenterNivolumab With Radiation Therapy and Bevacizumab for Recurrent MGMT Methylated Glioblastoma Phase 2 39
Clinical Trial NCT03743662 is designed to study Treatment for Glioblastoma. It is a Phase 2 interventional study that is active, not recruiting, having started on November 12, 2018, with plans to enroll 39 participants. Led by Memorial Sloan Kettering Cancer Center, it is expected to complete by November 1, 2026. The latest data from ClinicalTrials.gov was last updated on January 7, 2026.
Brief Summary
This study is being done to see if adding nivolumab to radiation therapy and bevacizumab can increase the effectiveness of the treatment for recurrent glioblastoma.
Official Title
A Phase II Trial of the PD-1 Antibody Nivolumab in Combination With Hypofractionated Re-irradiation and Bevacizumab for Recurrent MGMT Methylated Glioblastoma
Conditions
GlioblastomaOther Study IDs
- 18-400
NCT ID Number
Start Date (Actual)
2018-11-12
Last Update Posted
2026-01-07
Completion Date (Estimated)
2026-11
Enrollment (Estimated)
39
Study Type
Interventional
PHASE
Phase 2
Status
Active, not recruiting
Keywords
WHO grade IV
IDH wildtype
MGMT hypermethylation
18-400
nivolumab
recurrent glioblastoma
Memorial Sloan Kettering Cancer Center
IDH wildtype
MGMT hypermethylation
18-400
nivolumab
recurrent glioblastoma
Memorial Sloan Kettering Cancer Center
Primary Purpose
Treatment
Design Allocation
Non-Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalRecurrent Glioblastoma, No Surgery One cohort is for patients with recurrent GBM who are not undergoing surgical debulking as part of their treatment plan | Re-irradiation (RT) Re-RT will start on day 28 +/- 5 days for 5 fractions of 600cGy every other day over a 2-week period. Bevacizumab Bevacizumab if deemed beneficial by the investigator, will be started at the initiation of re-RT and continued for three doses in the medical arm. Patients in the surgical arm will omit the first bevacizumab dose to assure adequate wound healing after surgery and receive two doses. Bevacizumab will be dosed at 10mg/kg and given intravenously on day 28 (medical arm only), day 42 and day 56. Following day 56, further b...Show More Nivolumab Nivolumab will be started at enrollment and each patient will receive two doses of nivolumab prior to radiation.
Nivolumab will be dosed at 3mg/kg given intravenously before re-RT (day 1 +/- 5 and 14 +/- 5) and when given with bevacizumab if deemed beneficial by the investigator, (day 28 +/- 5 (medical arm only), day 42 +/- 5, and day 56 +/-5). Nivolumab will be dosed based on body weight while combined with re-radi...Show More |
ExperimentalRecurrent Glioblastoma, Surgery The second cohort is for patients with recurrent GBM who are undergoing surgery as part of their treatment. | Re-irradiation (RT) Re-RT will start on day 28 +/- 5 days for 5 fractions of 600cGy every other day over a 2-week period. Bevacizumab Bevacizumab if deemed beneficial by the investigator, will be started at the initiation of re-RT and continued for three doses in the medical arm. Patients in the surgical arm will omit the first bevacizumab dose to assure adequate wound healing after surgery and receive two doses. Bevacizumab will be dosed at 10mg/kg and given intravenously on day 28 (medical arm only), day 42 and day 56. Following day 56, further b...Show More Nivolumab Nivolumab will be started at enrollment and each patient will receive two doses of nivolumab prior to radiation.
Nivolumab will be dosed at 3mg/kg given intravenously before re-RT (day 1 +/- 5 and 14 +/- 5) and when given with bevacizumab if deemed beneficial by the investigator, (day 28 +/- 5 (medical arm only), day 42 +/- 5, and day 56 +/-5). Nivolumab will be dosed based on body weight while combined with re-radi...Show More Re-resection Re-resection will be performed in the surgical arm at day 14 (+/- 5 days). |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Overall survival | in participants with recurrent glioblastoma (first recurrence)treated with re-irradiation with concurrent nivolumab (as well as bevacizumab if the investigator feels that the patient benefits from the addition) followed by adjuvant nivolumab in two parallel cohorts. | 2 years |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
6 month progression-free survival | 6 months | |
Median progression-free survival | 2 years | |
Objective response rate | ORR using the iRANO criteria | 2 years |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
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
- 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).
Memorial Sloan Kettering Cancer Center739 active studies to exploreNo contact data.
11 Study Locations in 1 Countries
Connecticut
Hartford Healthcare (Data Collection), Hartford, Connecticut, 06102, United States
Indiana
Indiana University (Data Collection Only), Indianapolis, Indiana, 46202, United States
New Jersey
Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth, Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen, Montvale, New Jersey, 07645, United States
New York
Memorial Sloan Kettering Commack, Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester, Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center, New York, New York, 10065, United States
Memorial Sloan Kettering Nassau, Uniondale, New York, 11553, United States
Pennsylvania
Lehigh Valley Health Network (Data Collection Only), Allentown, Pennsylvania, 18103, United States
Vermont
University of Vermont Medical Center (Data Collection Only), Burlington, Vermont, 05401, United States