A Phase I/II Study of Nivolumab, Ipilimumab and Plinabulin in Patients With Recurrent Small Cell Lung Cancer

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

September 6, 2018

Primary Completion Date

September 25, 2023

Study Completion Date

July 1, 2024

Conditions
Lung CancerSCLC
Interventions
DRUG

Nivolumab

A fully human immunoglobulin (Ig) G4 monoclonal antibody directed against the negative immunoregulatory human cell surface receptor programmed death-1 (PD-1,PCD-1,) with immune checkpoint inhibitory and antineoplastic activities.

DRUG

Plinabulin

Plinabulin (BPI-2358) is a synthetic, low molecular weight, new chemical entity originally developed by Nereus Pharmaceuticals, Inc., and now by BeyondSpring Pharmaceuticals, Inc. It belongs to the diketopiperazine class of compounds with a chemical name 2, 5-piperazinedione, 3-\[\[5-(1,1-dimethylethyl)-1H-imidazol-4-yl\[methylene\]-6-(phenylmethylene)-, (3Z,6Z) (trivial name t-butyl-dehydrophenylahistin).

DRUG

Ipilimumab

Ipilimumab is a monoclonal antibody that works to activate the immune system by targeting CTLA-4, a protein receptor that downregulates the immune system.

Trial Locations (8)

33612

Moffitt Cancer Center, Tampa

37403

Erlanger Health System, Chattanooga

46202

Indiana University Melvin and Bren Simon Cancer Center, Indianapolis

48202

Henry Ford Health System, Detroit

55455

University of Minnesota, Minneapolis

60612

University of Illinois Cancer Center, Chicago

91010

City of Hope, Duarte

08903

Rutgers Cancer Institute of New Jersey, New Brunswick

All Listed Sponsors
collaborator

BeyondSpring Pharmaceuticals Inc.

INDUSTRY

collaborator

Bristol-Myers Squibb

INDUSTRY

collaborator

Rutgers Cancer Institute of New Jersey

OTHER

lead

Salma Sabbour

OTHER

NCT03575793 - A Phase I/II Study of Nivolumab, Ipilimumab and Plinabulin in Patients With Recurrent Small Cell Lung Cancer | Biotech Hunter | Biotech Hunter