Phase 2b Study of Combination Immunotherapy for Newly Diagnosed Glioblastoma Patients

Sponsor: Imvax

Sponsor score: 0

ClinicalTrials ID:NCT04485949

This clinical trial is testing a new combination immunotherapy treatment to see if it can help patients with newly diagnosed glioblastoma live longer without their cancer getting worse, compared to a placebo.

Patient Parameters

Program Overview

The study aims to find out if a new combination immunotherapy treatment, called IGV-001, can help patients with newly diagnosed glioblastoma (a type of brain cancer) live longer and prevent the cancer from worsening, compared to a placebo treatment.

Eligibility Criteria

Inclusion Criteria

  • Have a good level of daily functioning, with a Karnofsky performance score of 70 or higher.
  • Recently diagnosed with glioblastoma, a type of brain cancer, based on a doctor's assessment.
  • Have a brain MRI scan showing a measurable tumor before surgery, with at least one tumor measuring 4 cm² in two different directions.
  • The tumor must be located in the upper part of the brain.
  • Have good bone marrow and organ function based on screening tests.

Exclusion Criteria

  • Have cancer affecting both sides of the brain, multiple tumor sites, or tumors in the brain stem or cerebellum.
  • Have had any previous surgery or treatment for glioma.
  • Have a history of glioma or another cancer within the last 3 years, unless it was treated and cured, except for certain skin cancers or early-stage cervical or breast cancer.
  • Have a severe immune system condition, like HIV with low CD4+ cell count, or an active autoimmune disease like Crohn's disease.
  • Have active heart disease or a history of heart problems.
  • Are taking part in another treatment study or have taken an experimental drug recently.
  • Have received a live vaccine within 30 days before the study.
  • Have active and untreated infections like hepatitis B, hepatitis C, or HIV.
  • Are using Tumor Treating Fields or Optune® therapy.

Locations

FACILITYZIPCITYSTATE
Mayo Clinic - Jacksonville32224JacksonvilleFlorida
Tufts Medical Center02111BostonMassachusetts
Henry Ford Health System48202DetroitMichigan
Dartmouth Hitchcock Medical Center03756LebanonNew Hampshire
John Theurer Cancer Center At Hackensack UMC07601HackensackNew Jersey
Jersey Shore University Medical Center07753Neptune CityNew Jersey
Northwell Health at North Shore University Hospital11030ManhassetNew York
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center10021New YorkNew York
Icahn School of Medicine at Mount Sinai10029New YorkNew York
Columbia University Medical Center10032New YorkNew York

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