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Nivolumab · 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 ...
Nivolumab is being studied for use in Metastatic Pancreatic Adenocarcinoma, specifically in patients with chemotherapy-refractory metastatic pancreatic cancer. It is part of a Phase 1 clinical trial that combines SD-101, Nivolumab, and radiation therapy to treat this condition.
Nivolumab is a monoclonal antibody that targets the PD-1 receptor on T cells, helping the immune system recognize and attack cancer cells. In the context of the Phase 1 trial, it is used in combination with SD-101 and radiation therapy for metastatic pancreatic adenocarcinoma.
Nivolumab is being developed by Dynavax Technologies Corporation, traded as DVAX on the stock exchange. The company is conducting a Phase 1 clinical trial for Nivolumab in combination with SD-101 and radiation therapy for metastatic pancreatic adenocarcinoma.
Nivolumab is in Phase 1 clinical development for metastatic pancreatic adenocarcinoma. The single trial, NCT04050085, has been completed with a total enrollment of 6 participants. It is an investigational drug and has not been approved for this indication.
Nivolumab is associated with one completed Phase 1 clinical trial, NCT04050085, titled 'SD-101, Nivolumab, and Radiation Therapy in Treating Patients With Chemotherapy-Refractory Metastatic Pancreatic Cancer.' The trial enrolled 6 participants in the United States and was not randomized or double-blinded.
No, Nivolumab is not the same as SD-101. In the clinical trial NCT04050085, Nivolumab is used in combination with SD-101 and radiation therapy. Nivolumab is a monoclonal antibody, while SD-101 is a separate investigational agent being tested alongside it.