Efficacy of Nivolumab for Recurrent IDH Mutated High-Grade Gliomas

PHASE2CompletedINTERVENTIONAL
Enrollment

43

Participants

Timeline

Start Date

July 30, 2019

Primary Completion Date

December 2, 2020

Study Completion Date

August 18, 2021

Conditions
High Grade GliomaBrain Cancer
Interventions
DRUG

Nivolumab

"Nivolumab (Opdivo) is a potent human monoclonal antibody (mAb) of the IgG4 isotype designed to directly block the interaction between Programmed Cell Death 1 (PD-1) and its ligands, Programmed Death Ligand 1 (PD-L1) and PD-L2.~Nivolumab is administered by a 30 minutes intravenous infusion at dose of 240 mg every 2 (+/- 2 days) weeks for 8 cycles (4 months), followed by a dose of 480 mg administered by a 60 minutes intravenous infusion every 4 weeks (+/-3 days) (beginning at cycle 9) for a total therapy duration of 1 year (maximum 16 cycles of treatment) or until progression, death, unacceptable toxicity."

Trial Locations (7)

13000

AP-HM, La Timone, Hôpital Universitaire, Marseille

31000

IUCT Oncopole - CLCC Institut Claudius Regaud, Toulouse

33000

Groupe Hospitalier Saint-André, Bordeaux

44000

Institut de Cancérologie de l'Ouest (ICO) - site CLCC René Gauducheau, Nantes

60900

Hospices Civils de Lyon, Hôpital Pierre Wertheimer, Bron

Unknown

AP-HP - Groupe Hospitalier Pitié-Salpêtrière, Paris

AP-HP - Hôpital Saint-Louis, Paris

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

Assistance Publique - Hôpitaux de Paris

OTHER