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New treatment option for Glioblastoma Multiforme
Official title Study of Pembrolizumab and M032 (NSC 733972)
ClinicalTrials.gov ID: NCT05084430
What this study is testing
What is M032?
M032 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for glioblastoma multiforme.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This Phase I (Cohort I and Cohort II) and Phase II trial is designed to confirm the safety and tolerability of Pembrolizumab when given in conjunction with M032, an Oncolytic Herpes Simplex Virus (oHSV) that expresses IL-12 and perform the Phase II portion using a Recommended Phase 2 Dose (RP2D) of M032 (provided by the Phase I) when given in conjunction with Pembrolizumab for recurrent malignant glioma (glioblastoma multiforme, anaplastic astrocytoma, or glio-sarcoma).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Phase I/Cohort I: Participants are eligible to be included in the study only if all of the following criteria apply:
- Patients must have histologically or cytologically confirmed glioblastoma multiforme, anaplastic astrocytoma, or gliosarcoma, and is deemed a...
- Prior therapy: Patients must have failed external beam radio-therapy to the brain, and if eligible and tolerated, undergone appropriate treatment...
- Phase I/Cohort II or Phase II: Participants are eligible to be included in the study only if all of the following criteria apply:
- Patient must have MRI findings consistent with probable malignant glioma, have no previous diagnosis of glioma, and have had either no history of any...
You likely can't join if
- below:
- Age ≥18 years. Because no dosing or adverse event data are currently available on the use of M032 in patients \<16 years of age, children are...
- Karnofsky Performance Status (KPS) ≥70% (see Appendix B).
- Life expectancy of greater than 4 weeks.
- Preoperatively, the lesion must be ≥1.0 cm in diameter as determined by MRI.
- The effects of M032 on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate...
See the full eligibility criteria
- Phase I/Cohort I: Participants are eligible to be included in the study only if all of the following criteria apply:
- Patients must have histologically or cytologically confirmed glioblastoma multiforme, anaplastic astrocytoma, or gliosarcoma, and is deemed a potential candidate for resection of the recurrent tumor.
- Prior therapy: Patients must have failed external beam radio-therapy to the brain, and if eligible and tolerated, undergone appropriate treatment with temozolomide chemotherapy. All radiation and additional...
- Phase I/Cohort II or Phase II: Participants are eligible to be included in the study only if all of the following criteria apply:
- Patient must have MRI findings consistent with probable malignant glioma, have no previous diagnosis of glioma, and have had either no history of any surgery for brain tumor. The exception to this requirement is that...
- Should a patient in Phase I/Cohort II or Phase II be found on final pathologic diagnosis to not have a glioblastoma multiforme, anaplastic astrocytoma, or gliosarcoma, he/she will receive no other doses of M032 other...
- All patients, whether in Phase I/Cohort II or Phase II shall also be required to meet the following eligibility and be subject to the
- below:
- Age ≥18 years. Because no dosing or adverse event data are currently available on the use of M032 in patients \<16 years of age, children are excluded from this study but will be eligible for future pediatric phase 1...
- Karnofsky Performance Status (KPS) ≥70% (see Appendix B).
- Life expectancy of greater than 4 weeks.
- Preoperatively, the lesion must be ≥1.0 cm in diameter as determined by MRI.
- The effects of M032 on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for six months after receiving...
- Ability to understand and the willingness to sign a written informed con-sent document.
- Females of childbearing potential must not be pregnant; this will be con-firmed by a negative serum pregnancy test within 14 days prior to starting study treatment.
- Patients must have normal organ and marrow function as defined below:
- leukocytes……………………. \>3,000/μl
- absolute neutrophil count………. \>1,500/μl
- platelets…………………………... \>100,000/μl
- total bilirubin……………………. within normal institutional limits
- AST(SGOT)/ALT(SGPT)………… \<2.5 X institutional upper limit of normal creatinine within normal institutional limits Or
- creatinine clearance……………... \>60 mL/min/1.73 m2 for patients with creatinine levels above insti-tutional normal Exclusion Criteria: A Woman of Child Bearing Potential (WOCBP) who has a positive urine pregnancy test...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.