BridgeMD
New treatment option for Diffuse Intrinsic Pontine Glioma
Official title rHSC-DIPGVax Plus Checkpoint Blockade for the Treatment of Newly Diagnosed DIPG and DMG
ClinicalTrials.gov ID: NCT04943848
What this study is testing
What is rHSC-DIPGVax?
rHSC-DIPGVax is an investigational medicine, being studied as a potential treatment for diffuse intrinsic pontine glioma.
Also referred to as vaccine.
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 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 18
You may be able to join if
- people with newly diagnosed typical or non-typical, biopsy-proven DIPG or DMG are eligible for study enrollment. Biopsy is not required for people...
- BSA \> or = 0.35m2 at the time of study enrollment
- Performance score: Karnofsky \>50% of people \>16 years of age and Lansky \> or = 50 for people \< or = 16 years of age. people who are unable to...
- 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)...
- Corticosteroids should be weaned as tolerated after radiation therapy with the goal of \< or = 0.5mg/kg/day for a minimum of 7 days prior to...
You likely can't join if
- Patients cannot receive temozolomide during radiation
- Disseminated disease
- people who have received any cancer therapy except for radiation
- Autoimmune or immune disorders
- Active respiratory disorder or infection
- Active viral infection
See the full eligibility criteria
- people with newly diagnosed typical or non-typical, biopsy-proven DIPG or DMG are eligible for study enrollment. Biopsy is not required for people with radiographically typical DIPG meeting imaging criteria. Biopsy is...
- BSA \> or = 0.35m2 at the time of study enrollment
- Performance score: Karnofsky \>50% of people \>16 years of age and Lansky \> or = 50 for people \< or = 16 years of age. people who are unable to walk because of paralysis but are up in a wheelchair will be considered...
- 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
- Corticosteroids should be weaned as tolerated after radiation therapy with the goal of \< or = 0.5mg/kg/day for a minimum of 7 days prior to enrollment.
- people must have measurable disease
- Patients cannot receive temozolomide during radiation
- Disseminated disease
- people who have received any cancer therapy except for radiation
- Autoimmune or immune disorders
- Active respiratory disorder or infection
- Active viral infection
The study team makes the final eligibility decision.
Where it's taking place
- Orange, California, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, 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, 12 months to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Orange, California, United States; Chicago, Illinois, United States; Boston, Massachusetts, 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.