A Phase 2b Clinical Study With a Combination Immunotherap... | NCT04485949

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IGV-001	Experimental	Participants will be implanted with biodiffusion chambers containing IGV-001 on Day 1 and explanted on Day 3 (at approximately 48 hours following implantation). After 6 weeks, participants will receive radiotherapy (RT) per institutional standards for 5 days per week along with temozolomide 75 mg/m^2 orally, once daily (QD) for up to 12 weeks followed by temozolomide 150 to 200 mg/m^2, orally, on Days 1 to 5 of each 28-day cycle for up to 6 cycles (Week 41).	Combination Product: IGV-001 Cell Immunotherapy Procedure: Standard of Care (SOC): Radiation Therapy Drug: SOC: Temozolomide
Placebo	Placebo Comparator	Participants will be implanted with biodiffusion chambers containing placebo on Day 1 and explanted on Day 3 (at approximately 48 hours following implantation). After 6 weeks, participants will receive RT per institutional standards for 5 days per week along with temozolomide 75 mg/m^2 orally, QD for up to 12 weeks followed by temozolomide 150 to 200 mg/m^2, orally, on Days 1 to 5 of each 28-day cycle for up to 6 cycles (Week 41).	Combination Product: Placebo Procedure: Standard of Care (SOC): Radiation Therapy Drug: SOC: Temozolomide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IGV-001 Cell Immunotherapy	Combination Product	IGV-001, an immunotherapeutic product that combines personalized whole tumor-derived cells with an antisense oligonucleotide (IMV-001) in implantable biodiffusion chambers.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-free Survival (PFS)	PFS is defined as the time from randomization to first progression, as determined by the central radiology review group blinded to the study treatment arm, or death.	Up to 36 months

Secondary Outcomes

Measure	Description	Time Frame
Overall Survival (OS)	OS is defined as the time from randomization to death due to any cause.	Up to 48 months
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Device Events (ADE), and Unexpected Adverse Device Events (ADR)

Other Outcomes

Measure	Description	Time Frame
Time to Deterioration of Karnofsky Performance Status (KPS) Score	Time to KPS deterioration is defined as the time from screening to the first date of deterioration of the KPS score. Deterioration of KPS is defined as a stable or increasing steroid dose-dependent stabilization of a KPS score of <70 over 2 consecutive visits at least 4 weeks apart. KPS is an 11-level score which ranges between 0 (death) to 100 (complete healthy status); a higher score represents a higher ability to perform daily tasks.

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

Has a Karnofsky performance scale (KPS) score ≥ 70 at screening
Has a new diagnosis of GBM (WHO GRADE III or Grade IV GBM) based on the treating neurosurgeon's best clinical judgement
Has a diagnostic contrast-enhanced magnetic resonance imaging (MRI) scan with fluid attenuated inversion-recovery (FLAIR) sequence of the brain at screening. Participants must have a confirmed measurable disease pre-operatively with at least 1 lesion measuring a total bi-perpendicular product of 4 centimeter square (cm^2) in 2 different planes (axial, sagittal, or coronal)
The tumor must be located in the supratentorial compartment
Has adequate bone marrow and organ function at screening

Key Exclusion Criteria:

Has bi-hemispheric disease, multicentric disease, or disease burden involving the brain stem or cerebellum based on MRI post-gadolinium enhancement
Has received any previous surgical resection or any anticancer intervention for glioma
Has any history of glioma, a concurrent malignancy, or malignancy within 3 years of randomization, unless definitive therapy is completed, with the exception of basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast that has completed curative therapy
Has any severe immunocompromised condition (eg, human immunodeficiency virus (HIV) with a cluster of differentiation [CD] 4+ cell count <200*10^6/liter [L]) or any active uncontrolled autoimmune disease (eg, Crohn's disease)
Has an active cardiac disease or a history of cardiac dysfunction
Is receiving any other investigational agent(s) or has received an investigational agent within 30 days or 5 half-lives of investigational agent use, whichever is longer, prior to screening
Is partaking in another interventional study. Participants who are partaking in an observational study are eligible
Has received a live vaccine within 30 days of screening
Has active and uncontrolled/untreated hepatitis B virus (HBV), hepatitis C virus (HCV), HIV, or any other active infections that, in the Investigator's opinion, would impair or prohibit a participant's participation in this study.
Is receiving treatment with Tumor Treating Fields or Optune®

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic - Jacksonville		Jacksonville	Florida	32224	United States
Tufts Medical Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38060340	Derived	Lee IY, Hanft S, Schulder M, Judy KD, Wong ET, Elder JB, Evans LT, Zuccarello M, Wu J, Aulakh S, Agarwal V, Ramakrishna R, Gill BJ, Quinones-Hinojosa A, Brennan C, Zacharia BE, Silva Correia CE, Diwanji M, Pennock GK, Scott C, Perez-Olle R, Andrews DW, Boockvar JA. Autologous cell immunotherapy (IGV-001) with IGF-1R antisense oligonucleotide in newly diagnosed glioblastoma patients. Future Oncol. 2024 Mar;20(10):579-591. doi: 10.2217/fon-2023-0702. Epub 2023 Dec 7.
38017340

ID	Term
D001254	Astrocytoma
D005910	Glioma
D018302	Neoplasms, Neuroepithelial
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D009375	Neoplasms, Glandular and Epithelial
D009380	Neoplasms, Nerve Tissue

ID	Term
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation