Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TLR9 Agonist SD-101 · 1 trial · 3 indications
Adverse events, serious adverse events, and clinical laboratory values outside normal limits will be listed for each patient and summarized by body system and dose level in frequency tables. Severity will be graded by Common Terminology Criteria for Adverse Events version 5.0.
| Arm | Type | Description |
|---|---|---|
| Treatment (SD-101, radiation therapy, nivolumab) | EXPERIMENTAL | Patients receive TLR9 agonist SD-101 intratumorally on days 1 and 8 of cycle 1 and day 1 of cycles 2-5. Treatment repeats every 2 weeks for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo radiation therapy on days 1, 3, 5, 8, and 10 of cycle 1. Patients also receive nivolumab IV over 30 minutes on day 2. Cycles with nivolumab repeat every 2 weeks for 24 months in the absence of disease progression or unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| Nivolumab | BIOLOGICAL | Given IV |
| Radiation Therapy | RADIATION | Undergo radiation therapy |
| TLR9 Agonist SD-101 | DRUG | Given intratumorally |
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 - 2 * Able and willing to provide written informed consent * Pathology confirmed pancreatic adenocarcinoma by histology or cytology * Life expectancy \>= 3 months * Progression during or after greater than ...