Trial of Combination Tumor Treating Fields (TTF; Optune), Nivolumab Plus/Minus Ipilimumab for Recurrent Glioblastoma

Part of paid clinical trials in Miami, Florida.

Sponsor
Baptist Health South Florida
Study ID
NCT03430791
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab 240 mg IV — DRUG
    Nivolumab IV 240mg IV every 2 weeks for maximum of 24 months.
  • Nivolumab 3 mg/kg — DRUG
    Nivolumab IV 3mg/kg every 2 weeks for maximum of 24 months.
  • Ipilimumab 1 mg/kg — DRUG
    Ipilimumab IV 1 mg/kg every 6 weeks for maximum of 4 doses.
  • NovoTTF200A (Optune) — DEVICE
    A device to be worn continuously for a goal of 75% of the time, ranging from 18 hours daily nonstop or 22 hours daily with 2-3 days off monthly.

Study Details

Phase I/II trial in which participants with recurrent glioblastoma will receive a combination of tumor treating fields(portable device), nivolumab with or without ipilimumab.

Key Dates

Start date
Dec 5, 2018
Status verified
Nov 2022
Primary completion
May 29, 2020
Completion
Jan 27, 2021

Study Design

Enrollment
5 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab Monotherapy
    Nivolumab 240 mg IV every 2 weeks for maximum of 24 months. TTF (Optune) for max of 24 months
  • Experimental: Nivolumab+Ipilimumab
    Nivolumab 3 mg/kg IV with ipilimumab then 240 mg every 2 weeks for maximum of 24 months. Ipilimumab 1 mg/kg IV every 6 weeks maximum of 4 times. NovoTTF200A (Optune) TTF for maximum 24 months

Primary Outcome Measure

Objective Response Rate According to Modified iRANO Criteria [ Time Frame: 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Miami Cancer Institute at Baptist Health, Inc.MiamiFlorida33176-

Find similar trials in Miami, FL

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
Miami Cancer Institute at Baptist Health, Inc.· Miami, FL

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