A Phase 2b Clinical Study With a Combination Immunotherapy in Newly Diagnosed Patients With Glioblastoma

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

93

Participants

Timeline

Start Date

March 20, 2023

Primary Completion Date

April 30, 2026

Study Completion Date

July 31, 2027

Conditions
Glioblastoma
Interventions
COMBINATION_PRODUCT

IGV-001 Cell Immunotherapy

IGV-001, an immunotherapeutic product that combines personalized whole tumor-derived cells with an antisense oligonucleotide (IMV-001) in implantable biodiffusion chambers.

COMBINATION_PRODUCT

Placebo

Placebo in implantable biodiffusion chambers containing a predetermined inactive solution.

PROCEDURE

Standard of Care (SOC): Radiation Therapy

Radiation therapy administered per institutional standards.

DRUG

SOC: Temozolomide

Temozolomide administered orally.

Trial Locations (23)

10021

David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center, New York

10029

Icahn School of Medicine at Mount Sinai, New York

10032

Columbia University Medical Center, New York

10065

Weill Cornell Medicine, New York

10075

Lenox Hill Hospital, New York

10467

Montefiore Medical Center, The Bronx

10595

Westchester Medical Center, Valhalla

11030

Northwell Health at North Shore University Hospital, Manhasset

17033

The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center, Hershey

19107

Thomas Jefferson University, Philadelphia

19130

University of Pennsylvania, Philadelphia

26506

West Virginia University, Morgantown

27599

University of North Carolina (UNC) - Chapel Hill, Chapel Hill

32224

Mayo Clinic - Jacksonville, Jacksonville

43201

The Ohio State University (OSU) Wexner Medical Center, Columbus

45229

UC Health, Cincinnati

48202

Henry Ford Health System, Detroit

53705

University of Wisconsin - Madison, Madison

02111

Tufts Medical Center, Boston

03756

Dartmouth Hitchcock Medical Center, Lebanon

07601

John Theurer Cancer Center At Hackensack UMC, Hackensack

07753

Jersey Shore University Medical Center, Neptune City

02903

Rhode Island Hospital, Providence

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Imvax

INDUSTRY

NCT04485949 - A Phase 2b Clinical Study With a Combination Immunotherapy in Newly Diagnosed Patients With Glioblastoma | Biotech Hunter | Biotech Hunter