A Longitudinal Assessment of Tumor Evolution in Patients With Brain Cancer

Conditions

• Newly Diagnosed High Grade Glioma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Temozolomide — DRUG
  concomitant and 5-day adjuvant temozolomide
• conformal brain radiation therapy — RADIATION
  standard radiation therapy for newly diagnosed glioblastoma
• Nivolumab — DRUG
  nivolumab 240 mg IV every 2 weeks for the first 28-day cycle, then option to modify to 480 mg IV every 4 weeks
• Ipilimumab — DRUG
  ipilimumab 1 mg/kg IV every 6 weeks (or every 8 weeks when nivolumab is administered every 4 weeks) for a maximum of 4 doses
• Bevacizumab — DRUG
  bevacizumab 5 mg/kg IV every 2 weeks (up to 10 mg/kg at treating physician's discretion)
• 5-day Temozolomide — DRUG
  150 mg/m\^2 oral, once daily on Days 1-5 of each 28-day cycle (stepwise titration every cycle up to 200 mg/m\^2 permitted)
• 5-day Temozolomide — DRUG
  100 mg/m\^2 oral, once daily on Days 2-6 of each 6 week course (stepwise titration every cycle up to 200 mg/m\^2 permitted)
• Lomustine — DRUG
  100 mg/m\^2 oral, on Day 1 of each 6 week course
• Nivolumab monotherapy — DRUG
  nivolumab 300 mg IV every 2 weeks for the first 28-day cycle, then option to modify to 480 mg IV every 4 weeks

Study Details

The purpose of this study is to test the safety and tolerability of the research study drugs nivolumab, ipilimumab, lomustine, bevacizumab, and temozolomide when used following surgery and before standard therapy with radiation and temozolomide in patients with newly diagnosed high grade glioma. Additional aims of the study are to: * Find out side effects (good and bad) of study drug combinations. * Evaluate any preliminary evidence of anticancer activity of study drug combinations . * Evaluate tumor characteristics by collecting brain tumor tissue samples. * Measure the amount of nivolumab and ipilimumab in biospecimens. * Look at biomarkers in biospecimens.

Key Dates

Start date

Mar 1, 2018

Status verified

Nov 2023

Primary completion

Sep 12, 2022

Completion

Oct 27, 2023

Study Design

Enrollment

49 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: 1 SOC (closed to enrollment)
  Standard conformal brain radiation therapy with concurrent and adjuvant temozolomide
• Experimental: 2 Nivo
  Nivolumab
• Experimental: 3 Nivo-Ipi (closed to enrollment)
  Nivolumab plus Ipilimumab
• Experimental: 4 Nivo-Ipi-CCNU-TMZ
  Nivolumab plus Ipilimumab plus Lomustine (CCNU) plus 5-day Temozolomide
• Experimental: 5 Nivo-Ipi-TMZ
  Nivolumab plus Ipilimumab plus 5-day Temozolomide
• Experimental: 6 Nivo-Ipi-Bev-TMZ
  Nivolumab plus Ipilimumab plus Bevacizumab plus 5-day Temozolomide

Primary Outcome Measure

Rate of dose limiting toxicities [ Time Frame: first 28 days of treatment ]

Locations (1)

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