Study of Pembrolizumab and M032 (NSC 733972)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alabama at Birmingham
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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 single-agent trials.
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.
Trial design
Design model
Sequential
Treatments tested in this trial
M032
DrugStarting at week four, patients will undergo treatment on the same day, and every three weeks thereafter, with intravenous infusion of 200mg of Pembrolizumab . A total of 3 combined doses of Pembrolizumab and M032 will be given.
Pembrolizumab
DrugStarting at week four, patients will undergo treatment on the same day, and every three weeks thereafter, with intravenous infusion of 200mg of Pembrolizumab . A total of 3 combined doses of Pembrolizumab and M032 will be given.
Treatment groups
28 Participants
are divided into 2 treatment groupsGroup A: Recurrent MGExperimental treatment 2 interventions
Group B: Newly Diagnosed MGExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Overall Survival at 12 and 24 months
Overall Survival at 12 and 24 months allows for a quantifiable outcome that should be straightforward to compare to historical data in this patient population.
Time frame
12-24 months2
Progression Free Survival at 6 months (PFS-6)
PFS-6 evaluates all treated patients at 6 months after baseline MRI and determines the percentage of patients who have not progressed by either imaging or neurologic evaluation. The iRA-NO criteria will be utilized to determine progression for this trial. PFS-6 will also be compared to historical controls for each cohort.
Time frame
6 months3
Overall Survival (OS)
OS will be determined for each cohort of patients and compared to historical controls for that cohort. .
Time frame
3 years4
Progression Free Survival (PFS)
PFS will be determined by MRI and neurologic evaluation using the iRANO criteria. PFS utilizes an historical approach to determining if progression has occurred and is helpful measure to compare this current study to historical studies. An important limitation in the assessment of PFS centers on the fact that patients may not get imaging or neurologic examinations done at an optimal or consistent time; as such, another approach, PFS-6, has been adopted in some studies. PFS-6 evaluates all treated patients at 6 months after baseline MRI and determines the percentage of patients who have not progressed by either imaging or neurologic evaluation. The iRANO criteria will be utilized to determine progression for this trial. PFS and OS will be compared to historical controls for each cohort.
Time frame
3 yearsSponsors and contacts
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Source ClinicalTrials.gov