Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Dendritic Cell Tumor Cell Lysate Vaccine · 1 trial · 1 indication
Two-sample T-test with Bonferroni adjustment will be used to compare the increase number of expanded TCR clones after dendritic cell (DC) vaccination with PD-1 blockade in Group A versus (vs) DC vaccination with a placebo in Group B.
Adverse events will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. All patients who receive any amount of pembrolizumab/placebo or ATL-DC vaccination will be evaluable for toxicity, serious adverse events (SAEs), and events of clinical interest (ECIs).
| Arm | Type | Description |
|---|---|---|
| Group A (pembrolizumab, ATL-DC, poly ICLC) | EXPERIMENTAL | Beginning 14 days prior to scheduled surgery, patients receive pembrolizumab IV over 30 minutes. After surgery, patients receive pembrolizumab IV over 30 minutes on day 1. Cycle repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive ATL-DC ID with poly ICLC IM every 2 weeks for up to 3 doses in the absence of disease progression or unacceptable toxicity. |
| Group B (placebo, ATL-DC, poly ICLC) | ACTIVE_COMPARATOR | Beginning 14 days prior to scheduled surgery, patients receive placebo IV. After surgery, patients receive placebo IV on day 1. Cycle repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive ATL-DC ID with poly ICLC IM every 2 weeks for up to 3 doses in the absence of disease progression or unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| Dendritic Cell Tumor Cell Lysate Vaccine | BIOLOGICAL | Given ID |
| Pembrolizumab | BIOLOGICAL | Given IV |
| Placebo Administration | OTHER | Given IV |
| Poly ICLC | DRUG | Given IM |
Inclusion Criteria: * Participants with histologically confirmed diagnosis of surgically accessible recurrent/progressive glioblastoma will be enrolled in this study * Be at first or second relapse (Note: relapse is defined as progression following initial therapy, i.e., radiation +/- chemotherapy....