IGV-001 Cell Immunotherapy for Glioblastoma

Phase-Based Progress Estimates
Westchester Medical Center, Valhalla, NYGlioblastoma+1 MoreIGV-001 Cell Immunotherapy - CombinationProduct
18 - 70
All Sexes
What conditions do you have?

Study Summary

This trial will compare a new treatment for glioblastoma to placebo to see if it extends survival.

Eligible Conditions
  • Glioblastoma

Treatment Effectiveness

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Up to 48 months

Month 36
Time to Definitive Deterioration Karnofsky Performance Status (KPS) Score
Up to 36 months
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of Participants With Clinically Significant Laboratory Assessment Abnormalities
Number of Participants With Clinically Significant Physical Examination Findings
Number of Participants With Clinically Significant Vital Signs Measurements
PFS in Participants With O6-methylguanine-DNA Methyltransferase (MGMT) With Methylation [MGMT+] and MGMT Without Methylation [MGMT-]
Progression-free Survival (PFS)
Time to Deterioration of Karnofsky Performance Status (KPS) Score
Up to 48 months
OS in Participants With MGMT+ and MGMT-
Overall Survival (OS)
Up to 6 months
PFS at 6 Months After Randomization (PFS6)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

1 of 2
1 of 2

Experimental Treatment

Non-Treatment Group

93 Total Participants · 2 Treatment Groups

Primary Treatment: IGV-001 Cell Immunotherapy · Has Placebo Group · Phase 2

IGV-001Experimental Group · 3 Interventions: IGV-001 Cell Immunotherapy, Standard of Care (SOC): Radiation Therapy, SOC: Temozolomide · Intervention Types: CombinationProduct, Procedure, Drug
PlaceboPlaceboComparator Group · 3 Interventions: Standard of Care (SOC): Radiation Therapy, SOC: Temozolomide, Placebo · Intervention Types: Procedure, Drug, CombinationProduct

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 48 months

Who is running the clinical trial?

ImvaxLead Sponsor

Eligibility Criteria

Age 18 - 70 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The tumor must be located in the upper part of the brain.

Frequently Asked Questions

Does the age restriction for this research allow individuals under 35 to participate?

"To be eligible for this trial, individuals must have surpassed the age of consent and yet not exceeded 70 years old." - Anonymous Online Contributor

Unverified Answer

What is the upper limit on participant enrollment in this experiment?

"This clinical trial is no longer accepting participants; its posting was initially published on December 1st 2022, and the page was last updated June 24th 2022. If you are seeking alternative studies, there are currently 442 trials for glioblastoma patients and 206 related to IGV-001 Cell Immunotherapy that remain open." - Anonymous Online Contributor

Unverified Answer

Would I be eligible to join this medical investigation?

"To be eligible for this medical trial, patients must have glioblastoma and fall within the age range of 18 to 70. The team is looking to enroll 93 people in total." - Anonymous Online Contributor

Unverified Answer

To what maladies is IGV-001 Cell Immunotherapy typically applied?

"IGV-001 Cell Immunotherapy is often prescribed to patients undergoing nitrosourea treatment, and can be employed in cases of advanced mycosis fungoides, refractory neuroblastoma, advance directives or treatments with limited efficacy." - Anonymous Online Contributor

Unverified Answer

What other research efforts have been conducted pertaining to IGV-001 Cell Immunotherapy?

"In 2002, the Memorial Sloan Kettering Cancer Center initiated its research into IGV-001 Cell Immunotherapy. Since then, 18614 clinical trials have been completed with 206 currently active ones concentrated in Philadelphia, Pennsylvania." - Anonymous Online Contributor

Unverified Answer

What is the breadth of this experiment's geographical distribution?

"At the moment, 34 medical trial sites are running this clinical study across America with Philadelphia, Newark and Boston being among them. To reduce travel time if you participate in the research, it is important to choose a nearby site location." - Anonymous Online Contributor

Unverified Answer

Is recruitment still taking place for this experiment?

"Contrary to the information hosted on clinicaltrials.gov, this medical trial is not enrolling patients as of now; it was first uploaded on December 1st 2022 and its record most recently updated June 24th 20212. However, there are 648 other trials actively recruiting participants at present." - Anonymous Online Contributor

Unverified Answer

Is this research novel or has it been conducted elsewhere?

"At present, there are 206 ongoing studies involving IGV-001 Cell Immunotherapy in 935 cities across 36 countries. This experimental drug first underwent clinical trials in 2002 under the auspices of Schering-Plough. Initially testing 60 patients during its Phase 2 approval process, 18614 further trials have been completed since then." - Anonymous Online Contributor

Unverified Answer

Has IGV-001 Cell Immunotherapy been given the stamp of approval by the FDA?

"This [immunotherapy](https://www.withpower.com/clinical-trials/immunotherapy) is still in the process of being evaluated for safety, so it was given a score of 2 on our rating scale. As this is only Phase 2 trial, there are some data points indicating its safety but no information on efficacy yet." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.