Ongoing Trials: A closer look at ECOG-ACRIN’s clinical trials for patients with pancreatic conditions

Pancreatic cancer forms in the tissues of the pancreas, an organ that helps the body digest food and balance blood sugar levels. It is the 10th most common cancer in the United States, yet it has one of the lowest survival rates. This is because the disease usually lacks early symptoms, making it difficult to detect. As a result, it is often diagnosed late, after it has spread beyond the pancreas, when treatment options are limited. Patients desperately need better screening methods and treatments.

This Pancreatic Cancer Awareness Month, we highlight two important clinical trials that aim to improve outcomes for patients. Click on the ‘learn more’ links for patient materials and eligibility requirements.

Non-cancerous pancreatic cysts

The EA2185 study is for patients with non-cancerous pancreatic cysts, or growths in the pancreas that are filled with fluid. Usually, these cysts cause no symptoms. They are most often found when someone undergoes abdominal imaging (like a CT or MRI scan) for another reason. While most cysts do not develop into cancerous tumors, a small percentage of them do. As a result, doctors recommend that all patients with cysts have regular imaging to watch for signs of cancer.

The purpose of the EA2185 study is to enhance regular imaging by also looking into the biology of cysts for signals of cancer, called biomarkers. Researchers are looking for blood-based biomarkers (such as proteins or DNA fragments) and imaging-based biomarkers (features on imaging scans). If the trial is successful, doctors in the future will be able to use these biomarkers to make earlier predictions of which patients are more likely to have their cysts turn into cancer.  

About 750 patients will take part in EA2185. All patients in the study will have regular imaging visits, and their scans will be collected by the research team. Many patients will also provide blood samples. All participants will be followed for approximately 5 years.

Learn more about EA2185 at ecog-acrin.org.

Early-stage pancreatic cancer with certain gene mutations

The EA2192/APOLLO trial is for patients who have completed surgery and chemotherapy for pancreatic cancer and have no evidence of remaining disease. Patients must also have one of the following gene mutations: BRCA1, BRCA2, or PALB2. The usual approach for these patients is observation, where their oncologist follows them on a regular basis for signs that the cancer has returned, but they receive no additional treatment. However, research suggests that the use of a drug called olaparib (oh-LA-puh-rib) after the usual therapy may help prevent the cancer from coming back. Olaparib is a type of drug called a PARP inhibitor.

The APOLLO study is exploring whether adding olaparib after the usual therapy improves results for patients with early-stage pancreatic cancer and a BRCA1, BRCA2, or PALB2 mutation. Olaparib is approved by the US Food and Drug Administration to treat several other types of cancer, including pancreatic cancer that has spread and has these mutations. It is taken as a pill.

About 152 patients will enroll in APOLLO. They will be randomly assigned by a computer to receive either olaparib or a placebo. Participants will be twice as likely to receive olaparib as a placebo. APOLLO is a double-blind study, meaning that neither patients nor their doctors will know which group they belong to. It is important to note that placebos are never used in place of the usual cancer treatment. In this trial, they are used in the observational arm to help eliminate bias.

Researchers will compare both groups of patients, looking to see if the new approach is better at preventing the cancer from coming back. All patients in the study will be followed for up to 10 years.

Learn more about APOLLO at ecog-acrin.org.