Nivolumab for Recurrent or Progressive IDH Mutant Gliomas

Part of paid clinical trials in Miami, Florida.

Sponsor
Fabio Iwamoto, MD
Study ID
NCT03557359
Phase
PHASE2
Status
Completed

Conditions

  • Gliomas

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
    Nivolumab (Opdivo®) is a human monoclonal antibody (HuMAb; immunoglobulin G4 (IgG4)- S228P) that targets the PD-1 cluster of differentiation 279 (CD279) cell surface membrane receptor.

Study Details

The objective of this study is to determine response rates (partial and complete responses) to nivolumab of recurrent or progressive IDH mutant (grades 2, 3 or 4) gliomas with prior exposure to alkylating agents.

Key Dates

Start date
Jun 12, 2018
Status verified
Jun 2026
Primary completion
Sep 20, 2022
Completion
Feb 11, 2025

Study Design

Enrollment
35 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab
    Nivolumab 240 mg will be given every 2 weeks for 8 cycles. Beginning with Cycle 9, nivolumab 480 mg will be given every 4 weeks for a total therapy duration of 2 years, or until progressive disease, unacceptable toxicity, or withdrawal of consent. Nivolumab will be administered as a 30-minute infusion. A finite treatment duration with immune therapies in this participant population remains an area of ongoing research; therefore the treatment duration chosen was 2 years.

Primary Outcome Measure

Overall Response Rate [ Time Frame: Throughout treatment duration or until progressive disease, unacceptable toxicity, or withdrawal of consent, up to 2 years ]

Locations (4)

FacilityCityStateZIPSite coordinators
Miami Cancer CenterMiamiFlorida33176-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Columbia University Medical CenterNew YorkNew York10032-
Weill Cornell Medical CollegeNew YorkNew York10065-

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