High Grade GliomaPhase 2NCT05096481
PEP-CMV Vaccine Targeting CMV Antigen to Treat Newly Diagnosed Pediatric HGG and DIPG and Recurrent Medulloblastoma
A Phase 2 study testing PEP-CMV, Temozolomide and Tetanus Diphtheria Vaccine in people with High Grade Glioma and Diffuse Intrinsic Pontine Glioma, run by Nationwide Children's Hospital at 13 sites in United States.
Trial summary
This study will address the question of whether targeting CMV antigens with PEP-CMV can serve as a novel immunotherapeutic approach in pediatric patients with newly-diagnosed high-grade glioma (HGG) or diffuse intrinsic pontine glioma (DIPG) as well as recurrent medulloblastoma (MB). Read more about this study
- Who is it for?
- Ages 3 to 39 years
- Conditions the study is for
- High Grade Glioma, Diffuse Intrinsic Pontine Glioma, Recurrent Medulloblastoma
- What is being tested?
- PEP-CMV, Temozolomide and Tetanus Diphtheria Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 13 sitesUnited States
- Study dates
- 18 Jul 2024to 15 Jun 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 39 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
None listed.
Who cannot join
- Pregnancy or Breast-Feeding:
- Pregnant or breast-feeding women will not be entered on this study due to known or unknown risks of fetal and teratogenic adverse events as seen in animal/human studies. Pregnancy tests must be obtained in girls who are post-monarchal. Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
- Pregnancy Prevention Patients of childbearing or child fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study and for 3 months after drug cessation.
- Study Specific:
- Active infection requiring treatment
- Patients with malignancy related to HIV or solid organ transplant: known history of HIV, HBV surface antigen positivity or positive HCV antibody are not eligible. Viral testing is not required unless clinically indicated in patients without a known history
Show all 15Show fewer
- Known immunosuppressive disease
- Patients with active renal, cardiac (congestive cardiac failure, myocardial infarction, myocarditis), or moderate to severe pulmonary problems generally defined by need for medical intervention (e.g., oxygen, medications) and/or limiting activities of daily living (generally CTCAE Grade 2 or higher) or shortness of breath with limited exertion are not eligible. Pulmonary conditions include (but are not limited to) COPD, asthma, and hemi-pneumectomy
- Patients receiving concomitant immunosuppressive agents for medical conditions; inhaled corticosteroids for asthma are allowed.
- Patients receiving concomitant tumor-directed therapy
- Patients receiving any other investigational drug therapy.
- Patients on dexamethasone > 0.1 mg/Kg/day up to maximum dose of 4 mg/day or equivalent.
- Patients with any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction).
- Patients with inability to return for follow-up visits or obtain follow-up studies required to assess toxicity to therapy
- Patients at high risk for imminent neurologic decline due to extensive bulk disease, midline shift, or herniation on MRI. These patients should be discussed with the study chairs.
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
United States13 sites, 13 recruiting
- Recruiting
C.S. Mott Children's Hospital
Ann Arbor, Michigan, 48109
John Prensner, MD, 8669094449, prensner@med.umich.edu
- Recruiting
Children's Hospital Colorado
Aurora, Colorado, 80045
Holly Lindsay, MD, 720-777-0461, holly.lindsay@childrenscolorado.org
Holly Lindsay, MD
- Not yet recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Karen Wright, MD, 617.632.4309, KarenD_wright@dfci.harvard.edu
Karen Wright, MD
- Not yet recruiting
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Ashley Plant, MD, 312-227-4090, aplant@luriechildrens.org
Ashley Plant, MD
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Peter de Blank, MD, 513-517-2068, Peter.deBlank@cchmc.org
Peter de Blank, MD
- Recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205
Melinda Triplet, 614-722-6039, melinda.triplet@nationwidechildrens.org
Maryam Fouladi, MD
- Recruiting
Duke Cancer Center
Durham, North Carolina, 27710
Daniel Landi, MD, 919-684-5013, pedsneuronc@duke.edu
Daniel Landi, MD
- Recruiting
Texas Children's Hospital
Houston, Texas, 77030
Patricia Baxter, MD, 832-824-4681, pabaxter@txch.org
Patricia Baxter, MD
- Recruiting
Nicklaus Children's Hospital
Miami, Florida, 33155
Ziad Khatib, MD, 305-662-8360, ziad.khatib@nicklaushealth.org
- Not yet recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Michael J Fisher, MD, 215-590-5188, fisherm@email.chop.edu
Michael J Fisher, MD
- Recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
Sarah Leary, MD, 206-987-2106, sarah.leary@seattlechildrens.org
Sarah Leary, MD
- Recruiting
St. Louis Children's Hospital
St Louis, Missouri, 63110
Eric M Thompson, MD, pedshemonctrialreferral@wustl.edu
Eric M Thompson, MD
- Recruiting
Children's National Medical Center
Washington D.C., District of Columbia, 20010
Eugene Hwang, MD, 202-476-5046, ehwang@childrensnational.org
Eugene Hwang
About this study
Official title: Phase 2 Trial of a Novel Peptide Vaccine (PEP-CMV) Targeting CMV Antigen for Newly Diagnosed Pediatric High-grade Glioma and Diffuse Intrinsic Pontine Glioma and Recurrent Medulloblastoma
This study will address the question of whether targeting CMV antigens with PEP-CMV can serve as a novel immunotherapeutic approach in pediatric patients with newly-diagnosed high-grade glioma (HGG) or diffuse intrinsic pontine glioma (DIPG) as well as recurrent medulloblastoma (MB).
PEP-CMV is a vaccine mixture of a peptide referred to as Component A. Component A is a synthetic long peptide (SLP) of 26 amino acid residues from human pp65. The SLPs encode multiple potential class I, class II, and antibody epitopes across several haplotypes. Component A will be administered as a stable water:oil emulsion in Montanide ISA 51.
Funding Source - FDA OOPD
Read the detailed description
This phase II clinical trial will have 3 strata in order to assess the efficacy of a highly immunogenic CMV-directed peptide vaccines in children with (1) recurrent medulloblastoma (rMB), (2) newly-diagnosed high-grade gliomas (HGG) and (3) newly-diagnosed diffuse intrinsic pontine glioma (DIPG). Each stratum will run independently with a different endpoint and statistical design.
Within each stratum, the populations that may be used for analysis are defined as:
- Safety Analysis: Patients who receive at least 1 dose of the treatment will be used for safety analyses.
- Efficacy Analysis: Patients who receive at least 1 dose of the treatment will be used for efficacy analyses.
Stratum I: Patients with recurrent medulloblastoma with measurable disease (see eligibility) can be enrolled at any point following recurrence regardless of any prior therapy. For the purpose of this study, recurrence will be defined as a new lesion confirmed by biopsy or resection, positive cerebrospinal fluid (CSF) cytology, or recurrent/progressive tumor on MRI.
Strata II [CLOSED on 19Aug2026] and III: Patients with newly-diagnosed high-grade glioma [CLOSED on 19Aug2026] or DIPG may be enrolled any time within 42 days after completing radiation.
Cycle 1 (Induction cycle) is 77±2 days. Patients will receive one course of temozolomide 200 mg/m2/day x 5 days on Days 1-5 of cycle 1 and receive PEP-CMV vaccine intradermally at dose level 1 (250 μg/m2 ) on Days 21, 35 ±2 days, and 49 ±2 days. After the induction cycle which is 77 ± 2 days, each subsequent cycle is 28 days. Starting in cycle 2, PEP-CMV vaccine is administered intradermally every 28 days on day 1 of each course. Patient can continue to receive PEP-CMV every 28 days for a total of 24 cycles.
Patients will receive a tetanus (Td) booster (Td 5 flocculation units, Lf) at the time of enrollment. Immunotherapy begins with a Td pre-conditioning vaccine (Td 1 Lf, in 0.4 mL of saline) delivered i.d. at the RIGHT groin site of the vaccine injection 6-24 hours prior to the first vaccine on day 21.
The PEP-CMV vaccine will be administered as follows: 250 µg/m2 (up to a maximum of 500 µg) of Component A mixed with Montanide ISA-51 (1:1 volume ratio) intradermally administered half in the RIGHT groin and half in the LEFT groin.
- Being tested
- PEP-CMV, Temozolomide, Tetanus Diphtheria Vaccine
- Keywords
- High Grade Glioma, Diffuse Intrinsic Pontine Glioma, Recurrent Medulloblastoma, Immunotherapy
- Medical subject headings
- Glioma, Diffuse Intrinsic Pontine Glioma, Medulloblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEP-CMVBiological
The PEP-CMV vaccine will be administered as follows: 250 µg/m2 (up to a maximum of 500 µg) of Component A mixed with Montanide ISA-51 (1:1 volume ratio) intradermally administered half in the RIGHT groin and half in the LEFT groin.
TemozolomideDrug
Also called TMZ
Patients will receive one course of temozolomide 200 mg/m2/day x 5 days on Days 1-5 of cycle 1
Tetanus Diphtheria VaccineBiological
Also called Td
Patients will receive a tetanus (Td) booster (Td 5 flocculation units, Lf) at the time of enrollment. Immunotherapy begins with a Td pre-conditioning vaccine (Td 1 Lf, in 0.4 mL of saline) delivered i.d. at the RIGHT groin site of the vaccine injection 6-24 hours prior to the first vaccine on day 21.
| Study group | Role | What they receive |
|---|---|---|
| PEP-CMV | Experimental | Participants will receive standard chemotherapy with temozolomide for five days, followed by the study vaccine, PEP-CMV, on day 21. Participants will receive a tetanus diphtheria (Td) booster vaccine and a small dose Td preconditioning vaccine to prepare their immune system to receive their first PEP-CMV vaccine. Participants will receive the first 3 PEP-CMV vaccines every 2 weeks, and after the third vaccine, the rest of the vaccines will be given monthly. The first cycle is 77 days and all subsequent cycles are 28 days. The PEP-CMV vaccine may be received for up to 24 cycles. Receives: Biological: PEP-CMV; Drug: Temozolomide; Biological: Tetanus Diphtheria Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
4-mo PFS in patients with recurrent medulloblastoma
To determine the progression-free survival (PFS) at 4 months in pediatric or young adult patients with recurrent medulloblastoma treated with PEP-CMV.
Measured: 4 months
1-yr OS in patients with newly diagnosed DIPG
To estimate the 1-year Overall Survival (OS) distribution in patients with newly diagnosed DIPG treated with radiotherapy followed by PEP-CMV
Measured: one year
1-yr PFS in patients with newly diagnosed HGG
To estimate the 1-year Progression Free Survival (PFS) distribution in patients with newly diagnosed HGG treated with radiotherapy followed by PEP-CMV
Measured: one year
Secondary outcomes (3)
ORR in patients with recurrent medulloblastoma
To determine the objective response rate (ORR) = partial response (PR) + complete response (CR) in patients with recurrent medulloblastoma treated with PEP-CMV
Measured: From Day 1 of treatment through 30 days following end of protocol treatment
PFS in patients with recurrent medulloblastoma
To determine the 1-year Progression Free Survival (PFS) in patients with recurrent Medulloblastoma treated with PEP-CMV.
Measured: one year
OS in patients with newly diagnosed HGG by PEP-CMV
To determine the 2-year Overall Survival (OS) in patients newly diagnosed with HGG treated with PEP-CMV.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start18 Jul 2024
- Primary completion15 Jun 2028 (estimated)
- Study completion15 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Grade GliomaStudies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University
- Responsible party
- Sponsor
- Investigators
- Daniel Landi, MD, Study chair, Duke Cancer CenterEric M Thompson, MD, Study chair, Washington University - St. Louis Children's HospitalMaryam Fouladi, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05096481
- Sponsor's protocol ID
- CONNECT1906
- Other IDs
- R01FD007283
- Status last verified
- Aug 2026
- First submitted
- 15 Oct 2021
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Trial of a Novel Peptide Vaccine (PEP-CMV) Targeting CMV Antigen for Newly Diagnosed Pediatric High-grade Glioma and Diffuse Intrinsic Pontine Glioma and Recurrent Medulloblastoma
- ClinicalTrials.gov ID
- NCT05096481
- Acronym / sponsor ID
- CONNECT1906
- Keywords
- High Grade Glioma, Diffuse Intrinsic Pontine Glioma, Recurrent Medulloblastoma, Immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Collaborators
- Duke University
- Study start
- 18 Jul 2024 (actual)
- Primary completion
- 15 Jun 2028 (estimated)
- Study completion
- 15 Jun 2030 (estimated)
- First posted
- 27 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will address the question of whether targeting CMV antigens with PEP-CMV can serve as a novel immunotherapeutic approach in pediatric patients with newly-diagnosed high-grade glioma (HGG) or diffuse intrinsic pontine glioma (DIPG) as well as recurrent medulloblastoma (MB).
PEP-CMV is a vaccine mixture of a peptide referred to as Component A. Component A is a synthetic long peptide (SLP) of 26 amino acid residues from human pp65. The SLPs encode multiple potential class I, class II, and antibody epitopes across several haplotypes. Component A will be administered as a stable water:oil emulsion in Montanide ISA 51.
Funding Source - FDA OOPD
Detailed description
This phase II clinical trial will have 3 strata in order to assess the efficacy of a highly immunogenic CMV-directed peptide vaccines in children with (1) recurrent medulloblastoma (rMB), (2) newly-diagnosed high-grade gliomas (HGG) and (3) newly-diagnosed diffuse intrinsic pontine glioma (DIPG). Each stratum will run independently with a different endpoint and statistical design.
Within each stratum, the populations that may be used for analysis are defined as:
- Safety Analysis: Patients who receive at least 1 dose of the treatment will be used for safety analyses.
- Efficacy Analysis: Patients who receive at least 1 dose of the treatment will be used for efficacy analyses.
Stratum I: Patients with recurrent medulloblastoma with measurable disease (see eligibility) can be enrolled at any point following recurrence regardless of any prior therapy. For the purpose of this study, recurrence will be defined as a new lesion confirmed by biopsy or resection, positive cerebrospinal fluid (CSF) cytology, or recurrent/progressive tumor on MRI.
Strata II [CLOSED on 19Aug2026] and III: Patients with newly-diagnosed high-grade glioma [CLOSED on 19Aug2026] or DIPG may be enrolled any time within 42 days after completing radiation.
Cycle 1 (Induction cycle) is 77±2 days. Patients will receive one course of temozolomide 200 mg/m2/day x 5 days on Days 1-5 of cycle 1 and receive PEP-CMV vaccine intradermally at dose level 1 (250 μg/m2 ) on Days 21, 35 ±2 days, and 49 ±2 days. After the induction cycle which is 77 ± 2 days, each subsequent cycle is 28 days. Starting in cycle 2, PEP-CMV vaccine is administered intradermally every 28 days on day 1 of each course. Patient can continue to receive PEP-CMV every 28 days for a total of 24 cycles.
Patients will receive a tetanus (Td) booster (Td 5 flocculation units, Lf) at the time of enrollment. Immunotherapy begins with a Td pre-conditioning vaccine (Td 1 Lf, in 0.4 mL of saline) delivered i.d. at the RIGHT groin site of the vaccine injection 6-24 hours prior to the first vaccine on day 21.
The PEP-CMV vaccine will be administered as follows: 250 µg/m2 (up to a maximum of 500 µg) of Component A mixed with Montanide ISA-51 (1:1 volume ratio) intradermally administered half in the RIGHT groin and half in the LEFT groin.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PEP-CMV | Experimental | Biological: PEP-CMV, Drug: Temozolomide, Biological: Tetanus Diphtheria VaccineParticipants will receive standard chemotherapy with temozolomide for five days, followed by the study vaccine, PEP-CMV, on day 21. Participants will receive a tetanus diphtheria (Td) booster vaccine and a small dose Td preconditioning vaccine to prepare their immune system to receive their first PEP-CMV vaccine. Participants will receive the first 3 PEP-CMV vaccines every 2 weeks, and after the third vaccine, the rest of the vaccines will be given monthly. The first cycle is 77 days and all subsequent cycles are 28 days. The PEP-CMV vaccine may be received for up to 24 cycles. |
Who may qualify
- Ages
- 3 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (15 listed)
- Pregnancy or Breast-Feeding:
- Study Specific:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEP-CMVThe PEP-CMV vaccine will be administered as follows: 250 µg/m2 (up to a maximum of 500 µg) of Component A mixed with Montanide ISA-51 (1:1 volume ratio) intradermally administered half in the RIGHT groin and half in the LEFT groin. | Biological | PEP-CMV |
| TemozolomideAlso: TMZPatients will receive one course of temozolomide 200 mg/m2/day x 5 days on Days 1-5 of cycle 1 | Drug | PEP-CMV |
| Tetanus Diphtheria VaccineAlso: TdPatients will receive a tetanus (Td) booster (Td 5 flocculation units, Lf) at the time of enrollment. Immunotherapy begins with a Td pre-conditioning vaccine (Td 1 Lf, in 0.4 mL of saline) delivered i.d. at the RIGHT groin site of the vaccine injection 6-24 hours prior to the first vaccine on day 21. | Biological | PEP-CMV |
Primary outcome
4-mo PFS in patients with recurrent medulloblastoma
Time frame: 4 months
To determine the progression-free survival (PFS) at 4 months in pediatric or young adult patients with recurrent medulloblastoma treated with PEP-CMV.
1-yr OS in patients with newly diagnosed DIPG
Time frame: one year
To estimate the 1-year Overall Survival (OS) distribution in patients with newly diagnosed DIPG treated with radiotherapy followed by PEP-CMV
1-yr PFS in patients with newly diagnosed HGG
Time frame: one year
To estimate the 1-year Progression Free Survival (PFS) distribution in patients with newly diagnosed HGG treated with radiotherapy followed by PEP-CMV
3 secondary outcomes
ORR in patients with recurrent medulloblastoma
Time frame: From Day 1 of treatment through 30 days following end of protocol treatment
PFS in patients with recurrent medulloblastoma
Time frame: one year
OS in patients with newly diagnosed HGG by PEP-CMV
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel Landi, MD study chair
Duke Cancer Center
Eric M Thompson, MD study chair
Washington University - St. Louis Children's Hospital
Maryam Fouladi, MD principal investigator
Nationwide Children's Hospital
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PEP-CMV, Temozolomide and Tetanus Diphtheria Vaccine in people with High Grade Glioma and Diffuse Intrinsic Pontine Glioma, run by Nationwide Children's Hospital at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kelsey H Troyer, PhD (6147223284, kelsey.troyer@nationwidechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
4-mo PFS in patients with recurrent medulloblastoma (time frame: 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.