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

36 Participants
are divided into 4 treatment groups

Locations

3
Children's Health Orange County (CHOC)92868, OrangeCalifornia, United States
Ann and Robert H. Lurie Children's Hospital of Chicago60611, ChicagoIllinois, United States
Dana-Farber Boston Children's Cancer and Blood Disorders Center02215, BostonMassachusetts, United States

Sponsors 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