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PEP-CMV vaccine · 1 trial · 4 indications
An unacceptable toxicity will be defined as any life-threatening toxicity ≥ Grade 3 that is possibly, probably, or definitely related to the PEP CMV vaccine. There are exceptions listed in the protocol
| Arm | Type | Description |
|---|---|---|
| Phase I Stratum I: Temozolomide + Nivolumab + PEP-CMV vaccine + Td booster | EXPERIMENTAL | Patients with newly-diagnosed high-grade glioma or DMG may be enrolled any time within 42 days after completing radiation. Cycle 1 (Induction cycle) is 77±2 days. Will receive 1 course of temozolomide 200 mg/m\^2/day x 5 days on Days 1-5 of cycle 1 \& receive PEP-CMV vaccine at dose level 1 (250 μg/m\^2) on Days 21, 35 ±2 days, and 49 ±2 days. After the induction cycle, each subsequent cycle is 28 days. Starting in cycle 2, PEP-CMV vaccine is administered every 28 days on day 1 of each course. Patient can continue to receive PEP-CMV every 28 days until recurrence/progression (up to 10 years). Patients 18 and older will receive a tetanus (Td) booster at the time of enrollment. Immunotherapy begins with a Td pre-conditioning vaccine delivered 6-24 hours prior to the first vaccine on day 21. Patients will also receive nivolumab 3 mg/kg IV on day 14±1 day then every 14 days ±2 days thereafter. |
| Phase I Stratum II: Temozolomide + Nivolumab + PEP-CMV vaccine + Td booster | EXPERIMENTAL | Patients with recurrent/progressive HGG or DMG with measurable disease can be enrolled at any point following recurrence regardless of any prior therapy. Cycle 1 (Induction cycle) is 77±2 days. Will receive 1 course of temozolomide 200 mg/m\^2/day x 5 days on Days 1-5 of cycle 1 \& receive PEP-CMV vaccine at dose level 1 (250 μg/m\^2) on Days 21, 35 ±2 days, and 49 ±2 days. After the induction cycle, each subsequent cycle is 28 days. Starting in cycle 2, PEP-CMV vaccine is administered every 28 days on day 1 of each course. Patient can continue to receive PEP-CMV every 28 days until recurrence/progression (up to 10 years). Patients 18 and older will receive a tetanus (Td) booster at the time of enrollment. Immunotherapy begins with a Td pre-conditioning vaccine delivered 6-24 hours prior to the first vaccine on day 21. Patients will also receive nivolumab 3 mg/kg IV on day 14±1 day then every 14 days ±2 days thereafter. |
| Phase I Stratum III: Temozolomide + Nivolumab + PEP-CMV vaccine + Td booster | EXPERIMENTAL | Patients with recurrent/progressive MB or EPN with measurable disease can be enrolled at any point following recurrence regardless of any prior therapy. Cycle 1 (Induction cycle) is 77±2 days. Will receive 1 course of temozolomide 200 mg/m\^2/day x 5 days on Days 1-5 of cycle 1 \& receive PEP-CMV vaccine at dose level 1 (250 μg/m\^2) on Days 21, 35 ±2 days, and 49 ±2 days. After the induction cycle, each subsequent cycle is 28 days. Starting in cycle 2, PEP-CMV vaccine is administered every 28 days on day 1 of each course. Patient can continue to receive PEP-CMV every 28 days until recurrence/progression (up to 10 years). Patients 18 and older will receive a tetanus (Td) booster at the time of enrollment. Immunotherapy begins with a Td pre-conditioning vaccine delivered 6-24 hours prior to the first vaccine on day 21. Patients will also receive nivolumab 3 mg/kg IV on day 14±1 day then every 14 days ±2 days thereafter. |
| Phase II: Temozolomide + Nivolumab + PEP-CMV vaccine + Td booster | EXPERIMENTAL | Cycle 1 (Induction cycle) is 77±2 days. Will receive 1 course of temozolomide 200 mg/m\^2/day x 5 days on Days 1-5 of cycle 1 \& receive PEP-CMV vaccine at dose level 1 (250 μg/m\^2) on Days 21, 35 ±2 days, and 49 ±2 days. After the induction cycle, each subsequent cycle is 28 days. Starting in cycle 2, PEP-CMV vaccine is administered every 28 days on day 1 of each course. Patient can continue to receive PEP-CMV every 28 days until recurrence/progression. Patients 18 and older will receive a tetanus (Td) booster at the time of enrollment. Immunotherapy begins with a Td pre-conditioning vaccine delivered 6-24 hours prior to the first vaccine on day 21. Patients will also receive nivolumab 3 mg/kg IV on day 14±1 day then every 14 days ±2 days thereafter. |
| Name | Type | Description |
|---|---|---|
| PEP-CMV vaccine | BIOLOGICAL | Intra-dermally administered half in the RIGHT groin and half in the LEFT groin. |
| Tetanus booster | BIOLOGICAL | Td 5 flocculation units, Lf |
| Nivolumab | BIOLOGICAL | Administered intravenously |
| Temozolomide | DRUG | Administered orally |
Inclusion Criteria for All Patients: * Patients must be ≥4 and ≤25 years of age (inclusive) at the time of study enrollment * Metastatic Disease: Patients with M+ disease are eligible. * Adequate bone marrow function defined as: * ANC (Absolute neutrophil count) ≥ 1000/µl. * Platelets ≥ 75,000...
The PEP-CMV vaccine is an investigational cancer vaccine being studied for use in Diffuse Midline Glioma, a type of brain tumor. It is also being evaluated in related conditions including Diffuse Midline High-grade Glioma, Medulloblastoma, and Ependymoma. The vaccine is currently in Phase 1 clinical development and is not yet approved.
The PEP-CMV vaccine is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting clinical trials to evaluate the vaccine's safety and efficacy in patients with certain brain tumors, including Diffuse Midline Glioma.
The PEP-CMV vaccine is in Phase 1 clinical development. It is an investigational therapy, meaning it has not been approved by regulatory authorities. The ongoing Phase 1 trial is designed to assess the vaccine's safety and tolerability in patients with newly diagnosed or recurrent brain tumors.
The PEP-CMV vaccine is being studied in a single Phase 1 clinical trial with the identifier NCT06639607. This trial is enrolling 68 participants and is currently not yet recruiting. The study is evaluating the vaccine in combination with nivolumab for patients with newly diagnosed or recurrent Diffuse Midline Glioma, high-grade glioma, medulloblastoma, and ependymoma.
The PEP-CMV vaccine is a monoclonal antibody-based therapy. It is designed to target specific components of the immune system to help fight cancer. The vaccine is being studied in combination with nivolumab, another immunotherapy agent, to potentially enhance the immune response against brain tumors.
The PEP-CMV vaccine is a therapeutic cancer vaccine, not a preventive vaccine like those for infectious diseases. It is designed to treat existing cancers by stimulating the immune system to attack tumor cells. It is currently being tested in a clinical trial setting and is not available for general use.