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
Qualifiers
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
Treatments tested in this trial
- M032
- Pembrolizumab
Treatment groups
28 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov