Nivolumab With Radiation Therapy and Bevacizumab for Recurrent MGMT Methylated Glioblastoma

Conditions

• Glioblastoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Re-irradiation (RT) — RADIATION
  Re-RT will start on day 28 +/- 5 days for 5 fractions of 600cGy every other day over a 2-week period.
• Bevacizumab — DRUG
  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 bevacizumab doses can be given every two weeks at the discretion of the treating physician.
• Nivolumab — DRUG
  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-radiation and bevacizumab for safety considerations to reduce adverse events. Single agent nivolumab will be given at 240mg flat dose every 2 weeks thereafter until disease progression, withdrawal, adverse event, or death.
• Re-resection — PROCEDURE
  Re-resection will be performed in the surgical arm at day 14 (+/- 5 days).

Study Details

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.

Key Dates

Start date

Nov 12, 2018

Status verified

Jan 2026

Primary completion

Nov 30, 2026

Completion

Nov 30, 2026

Study Design

Enrollment

39 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Recurrent Glioblastoma, No Surgery
  One cohort is for patients with recurrent GBM who are not undergoing surgical debulking as part of their treatment plan
• Experimental: Recurrent Glioblastoma, Surgery
  The second cohort is for patients with recurrent GBM who are undergoing surgery as part of their treatment.

Primary Outcome Measure

Overall survival [ Time Frame: 2 years ]

Locations (11)

Find similar trials in Hartford, CT

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