Nivolumab + Radiation + Bevacizumab for Glioblastoma
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Memorial Sloan Kettering Cancer Center
No Placebo Group
Prior Safety Data
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?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.
Eligibility Criteria
Adults with confirmed grade IV glioblastoma, IDH wildtype, MGMT hypermethylation, who've had surgery and chemo with temozolomide followed by radiation. They must show signs of recurrence but have a relatively small tumor (≤5cm), good performance status, and normal organ function. Excluded are those with multiple recurrences, certain heart conditions or infections, active autoimmune diseases requiring recent treatment, pregnancy/breastfeeding intentions within trial period, MRI incompatibility or prior treatments conflicting with the study drugs.Inclusion Criteria
I have been treated with radiation and temozolomide.
My bone marrow is working well.
I am mostly able to care for myself and carry out daily activities.
I am 18 years old or older.
My tumor is 5 cm or smaller and shows up on contrast imaging.
My tumor biopsy shows MGMT hypermethylation.
My glioblastoma is grade IV and IDH wildtype.
I have had the largest possible surgery to remove my tumor.
I have had one round of radiation therapy before.
My cancer has come back, as shown by tests or scans.
Exclusion Criteria
I have not had a heart attack or unstable chest pain in the last year.
My tumor is larger than 5 cm and shows up on contrast imaging.
I have a wound, ulcer, or bone fracture that hasn’t healed.
I have been treated with bevacizumab before.
I have a history of lung inflammation not caused by an infection.
I haven't had a peptic ulcer, abdominal issues like fistula, perforation, or abscess in the last 6 months.
I have moderate to severe heart failure.
My high blood pressure is not controlled by medication.
My cancer recurrence is located below the tentorium in my brain.
I am not allergic to nivolumab, bevacizumab, or their ingredients.
I have an active tuberculosis infection.
My brain tumor has an IDH mutation.
I have been treated with immune checkpoint inhibitors.
I am currently on medication for an infection.
I haven't needed systemic treatment for an autoimmune disease in the last 2 years.
I need high doses of steroids daily to manage my condition.
My cancer has returned more than once after initial treatment.
I have been diagnosed with an immunodeficiency condition, such as HIV or AIDS.
Treatment Details
The trial tests if adding nivolumab to standard re-irradiation therapy and bevacizumab improves outcomes for recurrent glioblastoma patients. It's exploring whether this combination can better control tumor growth compared to current methods.
2Treatment groups
Experimental Treatment
Group I: Recurrent Glioblastoma, SurgeryExperimental Treatment4 Interventions
The second cohort is for patients with recurrent GBM who are undergoing surgery as part of their treatment.
Group II: Recurrent Glioblastoma, No SurgeryExperimental Treatment3 Interventions
One cohort is for patients with recurrent GBM who are not undergoing surgical debulking as part of their treatment plan
Bevacizumab is already approved in European Union, United States, Japan, Canada for the following indications:
🇪🇺 Approved in European Union as Avastin for:
- Colorectal cancer
- Breast cancer
- Non-small cell lung cancer
- Renal cell carcinoma
- Ovarian cancer
🇺🇸 Approved in United States as Avastin for:
- Colorectal cancer
- Non-small cell lung cancer
- Glioblastoma
- Renal cell carcinoma
- Cervical cancer
- Ovarian cancer
🇯🇵 Approved in Japan as Avastin for:
- Colorectal cancer
- Non-small cell lung cancer
- Breast cancer
- Renal cell carcinoma
- Ovarian cancer
🇨🇦 Approved in Canada as Avastin for:
- Colorectal cancer
- Non-small cell lung cancer
- Breast cancer
- Renal cell carcinoma
- Ovarian cancer
Find a clinic near you
Research locations nearbySelect from list below to view details:
Memoral Sloan Kettering Basking RidgeBasking Ridge, NJ
Memorial Sloan Kettering MonmouthMiddletown, NJ
Memorial Sloan Kettering BergenMontvale, NJ
Memorial Sloan Kettering Basking RidgeBasking Ridge, NJ
More Trial Locations
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Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor