About this trial
This is a phase I, open label, plus expansion clinical trial evaluating the safety and tolerability of rHSC-DIPGVax in combination with BALSTILIMAB and ZALIFRELIMAB. rHSC-DIPGVax is an off-the-shelf neo-antigen heat shock protein containing 16 peptides reflecting neo-epitopes found in the majority of DIPG and DMG tumors. Newly diagnosed patients with DIPG and DMG who have completed radiation six to ten weeks prior to enrollment are eligible.
Eligibility criteria
Qualifiers
Subjects with newly diagnosed typical or non-typical, biopsy-proven DIPG or DMG are eligible for study enrollment. Biopsy is not required for subjects with radiographically typical DIPG meeting imaging criteria. Biopsy is required for DMG's and non-radiographically typical DIPG. Histone mutation must be confirmed by pathology report. Radiographically typical DIPG defined as a tumor with a pontine epicenter and diffuse involvement of more than 2/3 of the pons.
BSA > or = 0.35m2 at the time of study enrollment
Performance score: Karnofsky >50% of subjects >16 years of age and Lansky > or = 50 for subjects < or = 16 years of age. Subjects who are unable to walk because of paralysis but are up in a wheelchair will be considered ambulatory for the purpose of assessing the performance score.
Must start radiation therapy within 42 days from date of diagnostic imaging. C1D1 must be within 42 days to 70 days post radiation (6-10 weeks). Patients CANNOT receive temozolomide during radiation
Disqualifiers
Patients cannot receive temozolomide during radiation
Disseminated disease
Subjects who have received any cancer therapy except for radiation
Autoimmune or immune disorders
Trial design
Treatments tested in this trial
- rHSC-DIPGVax
- Balstilimab
- Zalifrelimab
Treatment groups
Locations
3Sponsors and collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
Lead sponsor
Dana-Farber Cancer Institute
Collaborator
Children's Hospital of Orange County
Collaborator
University of Calgary
Collaborator