Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PEPIDH1M vaccine+ vorasidenib · 1 trial · 1 indication
The proportion of patients with an unacceptable toxicity
The time between initiation of cycle 1 vorasidenib and first documentation of disease progression or death
| Arm | Type | Description |
|---|---|---|
| PEPIDH1M vaccine + vorasidenib | EXPERIMENTAL | Patients will receive vaccination with 0.5 mL of Td (tetanus and diphtheria toxoids) intramuscularly into the deltoid muscle. Patients will then receive vorasidenib 40mg orally once a day for 28 days. After two cycles of 28-day vorasidenib and at the start of the 3rd cycle of vorasidenib, patients will receive the PEPIDH1M vaccine intradermally (i.d.) to alternating groin regions on the following schedule: vaccine #1, day 1; vaccine #2, day 15. The day before vaccine #1, patients will receive a vaccine site pre-conditioning injection of a single dose of Td toxoid. This will be administered twelve hours to one day prior to receiving PEPIDH1M vaccine i.d. to the RIGHT groin area. Vaccines #3 and #4 will be given on day 1 and day 15 of cycle 4. Starting on 6th cycle of 28-day vorasidenib, subjects will receive PEPIDH1M vaccine (i.d. to alternating groin regions) every 28 days on day 1 for vaccine #5-#12. Patients will receive up to a total of 14 cycles of vorasidenib. |
| Name | Type | Description |
|---|---|---|
| PEPIDH1M vaccine + vorasidenib | DRUG | Patients will receive vaccination with 0.5 mL of Td (tetanus and diphtheria toxoids) intramuscularly into the deltoid muscle. Patients will then receive vorasidenib 40mg orally once a day for 28 days. After two cycles of 28-day vorasidenib and at the start of the 3rd cycle of vorasidenib, patients will receive the PEPIDH1M vaccine intradermally (i.d.) to alternating groin regions on the following schedule: vaccine #1, day 1; vaccine #2, day 15. The day before vaccine #1, patients will receive a vaccine site pre-conditioning injection of a single dose of Td toxoid. This will be administered twelve hours to one day prior to receiving PEPIDH1M vaccine i.d. to the RIGHT groin area. Vaccines #3 and #4 will be given on day 1 and day 15 of cycle 4. Starting on 6th cycle of 28-day vorasidenib, subjects will receive PEPIDH1M vaccine (i.d. to alternating groin regions) every 28 days on day 1 for vaccine #5-#12. Patients will receive up to a total of 14 cycles of vorasidenib. |
Inclusion Criteria: 1. Age ≥ 18 years 2. IDH1R132H expression in primary tumor 3. Clinical and/or radiographic, progressive Grade 2-3 glioma with greater than 2 cm of non-enhancing disease in one plane. 4. 1st recurrence only 5. Signed informed consent 6. For females of child-bearing potential, neg...
PEPIDH1M vaccine + vorasidenib is an investigational combination therapy being studied for the treatment of low grade glioma of the brain, a type of brain tumor. It is currently in Phase 1 clinical development and has not been approved by the FDA.
The combination of PEPIDH1M vaccine and vorasidenib is designed to target IDH1 mutations in low grade gliomas. The vaccine component is tumor-specific and aims to elicit an immune response against IDH1 mutant tumor cells, while vorasidenib is a small molecule inhibitor that targets the mutant IDH1 enzyme.
PEPIDH1M vaccine + vorasidenib is being developed by Tango Therapeutics, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol TNGX.
PEPIDH1M vaccine + vorasidenib is currently in Phase 1 clinical development. It is an investigational therapy and has not yet received FDA approval. The ongoing Phase 1 trial is actively recruiting participants.
PEPIDH1M vaccine + vorasidenib is being evaluated in a Phase 1 clinical trial with the identifier NCT05609994. The trial, titled 'ViCToRy: Vorasidenib in Combination With Tumor Specific Peptide Vaccine for Recurrent IDH1 Mutant Lower Grade Gliomas,' is recruiting patients in the United States and aims to enroll 48 participants.
Yes, PEPIDH1M vaccine + vorasidenib is also known as PEPIDH1M vaccine + vorasidenib. These names refer to the same investigational combination therapy being developed by Tango Therapeutics for low grade glioma.