Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03688178 | DC Migration Study to Evaluate TReg Depletion In GBM Patients With and Without Varlilumab | PHASE2 | ACTIVE NOT_RECRUITING | 43 | — | — | Aug 26, 2020 | Mar 1, 2026 | Apr 15, 2025 | 1 | United States |
OS is defined as the time in months between randomization and death, or last follow-up if alive (Groups 1 and 2). Kaplan-Meier methods will be used to estimate median OS
Percentage of patients with unacceptable toxicity (all Groups)
Change between baseline and nadir before the 2nd cycle of TMZ (Combined Groups 1 and 2, Group 3)
| Arm | Type | Description |
|---|---|---|
| Gr1: DC vaccine (DC pre-conditioning) | EXPERIMENTAL | Patients will receive TMZ at a target dose of 150-200 mg/m\^2/d for 5 days every 4 (+2) weeks for up to 12 cycles. DC vaccines will be administered in equal amounts to both inguinal regions. DC vaccines #1-3 occur every 2 weeks and all subsequent vaccines (up to 10) occur monthly. Group 1 patients will receive autologous unpulsed DC vaccines administered to a single side of the groin and saline administered to the contralateral side the day prior to the 4th DC vaccine as pre-conditioning. |
| Gr2: DC Vaccine (Td pre-conditioning) | EXPERIMENTAL | Patients will receive TMZ at a target dose of 150-200 mg/m\^2/d for 5 days every 4 (+2) weeks for up to 12 cycles. DC vaccines will be administered in equal amounts to both inguinal regions. DC vaccines #1-3 occur every 2 weeks and all subsequent vaccines (up to 10) occur monthly. Group 2 patients will receive a single dose of Td toxoid administered to a single side of the groin and saline administered to the contralateral side the day prior to the 4th DC vaccine, which is always given bilaterally at the groin site. |
| Gr3:DC Vaccine+varlilumab(Td pre-conditioning) | EXPERIMENTAL | Patients will receive TMZ at a target dose of 150-200 mg/m\^2/d for 5 days every 4 (+2) weeks for up to 12 cycles. DC vaccines will be administered in equal amounts to both inguinal regions. DC vaccines #1-3 occur every 2 weeks and all subsequent vaccines (up to 10) occur monthly. Group 3 patients will receive the first 3 DC vaccines every 2 weeks, same as Groups 1 and 2, but they will also receive varlilumab intraveneously (IV) 7 days before vaccine #1 and again at the same visit as vaccine #1, as well as 7 days before every DC vaccine except vaccine #2. Prior to the 4th vaccine, patients will receive a single dose of Td toxoid administered to a single side of the groin and saline administered to the contralateral side. |
| Name | Type | Description |
|---|---|---|
| Human CMV pp65-LAMP mRNA-pulsed autologous DCs | BIOLOGICAL | 2x10\^7 human CMV pp65-LAMP mRNA-pulsed autologous DCs are given intradermally and bilaterally at the groin site (divided equally to both inguinal regions). Patients will receive up to a total of 10 DC vaccines. |
| Temozolomide | DRUG | Temozolomide is a standard chemotherapy given to all enrolled patients at a targeted dose of 150-200mg/m2/d for 5 days every 4 (+ 2) weeks for up to 12 cycles (patients with unmethylated MGMT gene promoter will receive only cycle 1) |
| Varlilumab | BIOLOGICAL | Varlilumab is an agonist anti-CD27 monoclonal antibody |
| Td | BIOLOGICAL | A single dose of Td toxoid (1 flocculation unit, Lf, in 0.4 mLs) administered to a single side of the groin given intradermally |
| Unpulsed DCs | BIOLOGICAL | Patients in Group I will receive 1 x 10\^6 autologous unpulsed DCs in saline administered to a single side of the groin intradermally 1 day before the fourth vaccine. |
Inclusion Criteria: * Age ≥18 years of age. * Glioblastoma with definitive resection prior to enrollment, with residual radiographic contrast enhancing disease on the post-operative CT or MRI of \<1 cm in maximal diameter in any plane. * Able to receive SOC RT/TMZ for approximately 6 weeks duration...