Could an immune stimulating drug enhance the effectiveness of an immune checkpoint inhibitor combined with radiation?
A combination including an investigational drug is being tested in pancreatic cancer that has spread beyond the pancreas or has not responded to prior chemotherapy treatment. This phase I trial will study the side effects of the new drug when given together with immunotherapy and radiation therapy.
A Different Approach to Stimulate the Immune System
SD-101 is an investigational drug that induces the activation of specific memory T helper cells, which promote anti-tumor T cell function. The clinical trial is looking to see if it also makes other immunotherapy drugs, such as the checkpoint inhibitor nivolumab, more effective.
Nivolumab works by reactivating T cells to attack the tumor. Immunotherapy with these types of drugs may help the body’s immune system recognize and attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors.
The phase I trial will investigate whether giving SD-101, nivolumab, and radiation therapy is safe and has any side effects in patients with pancreatic cancer. Researchers will also assess how well the treatment controls disease progression and survival for up to a year.
Who Can Participate
The trial is open for patients whose pancreatic cancer has progressed or not responded to standard chemotherapy, or for patients who could not tolerate the initial chemotherapy offered. Participants should also have at least one metastatic liver lesion amenable for radiation, intratumoral injection, and core biopsy, as well as at least one lesion outside the field of radiation.
Trial participants will undergo a rigorous combination including SD-101 injected directly into their tumor twice in the first cycle, and once during the following cycles; radiation therapy five times during the first cycle; and nivolumab intravenously once in the first cycle, then every two weeks for 24 months in the absence of disease progression or unacceptable toxicity.
We encourage you to consult your physicians for clinical trials that may be right for you. The website ClinicalTrials.gov provides more details about this trial as well as many others. You can visit the EmergingMed Trial Finder for a list of all active pancreatic cancer clinical trials.