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Now Enrolling: The APOLLO clinical trial is studying an additional treatment option after standard therapy for certain patients with pancreatic cancer

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Patients with non-metastatic pancreatic cancer may be eligible to participate in the APOLLO (EA2192) trial if they carry a BRCA1, BRCA2, or PALB2 mutation.

The usual approach for patients with non-metastatic pancreas cancer is a combination of surgery and chemotherapy; in select cases, patients may also receive radiation. After these standard-of-care therapies are completed, the usual approach is observation: patients are followed by their oncologist for evidence that the cancer has returned, but they receive no additional treatment. The APOLLO study is examining whether treatment with the oral medication olaparib delays cancer recurrence when compared with observation.

The APOLLO trial is studying a way to personalize, or tailor, treatment in certain patients based on their genetic profiles. About 4%-8% of all pancreas cancers may be driven by an inherited BRCA1, BRCA2, or PALB2 gene mutation. Olaparib is in a class of drugs known as PARP inhibitors. Research suggests that the addition of PARP inhibitors such as olaparib, after standard treatment, may be beneficial for patients with these mutations. It is hoped that APOLLO will shed light on whether treatment with olaparib is better, the same, or worse than the usual approach of observation.

“A recent trial for patients with BRCA-related breast cancer showed that treatment with olaparib increased the length of time patients survived without any signs or symptoms of their cancer returning,” said Kim Reiss Binder, MD, lead researcher for APOLLO. “With the APOLLO study, we are looking to see if olaparib does the same thing for patients with BRCA- or PALB2-related pancreatic cancer.”

To be eligible for the phase II APOLLO study, a patient must have a BRCA1, BRCA2, or PALB2 mutation detected in saliva, blood, and/or tumor tissue samples. Participants must have completed their standard-of-care surgery and therapies, and have no evidence of remaining disease. Eligible patients will be randomly selected by a computer to one of two study groups. Two-thirds will be in the group that receives treatment with olaparib (a pill taken twice a day for 1 year). One-third will be in the group that receives a twice-daily placebo pill, also for 12 months, which looks like the study drug but contains no medication. The use of placebos in clinical trials helps prevent bias. Placebos are never used in place of standard-of-care cancer treatment, but they are sometimes used when an experimental drug is added to the standard-of-care approach. APOLLO is a double-blind study; thus, neither patients nor their doctors will know to which group they are assigned.

The study’s primary objective is to determine the relapse-free survival benefit from the addition of maintenance olaparib after completion of chemotherapy. Approximately 152 patients will participate in APOLLO. All study participants, regardless of the group to which they are assigned, will be monitored by their physician every 8 weeks for up to 10 years.

This study is led by Kim Reiss Binder, MD of the University of Pennsylvania.

Learn more about the EA2192 study at ecog-acrin.org.

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