Protocol: SWOG – S2001
Please Note: Below is partial eligibility, for full eligibility requirement’s, please contact GHCI Research Department at (810) 762-8181, (810) 762-8079 and/or (810) 762-8038. Thank you!
Eligibility:
- Patient must have a histologic or cytologic diagnosis of pancreatic adenocarcinoma. Patients with neuroendocrine tumors, acinar cell and adenosquamous carcinomas are excluded.
- Patients must have one of the following mutations: germline mutation in BRCA 1 or 2 that was tested in a CLIA certified lab defined as positive and/or deleterious (that is, pathogenic or likely pathogenic variant). (NOTE: Patients with tumor somatic mutations are not eligible).
- Patient must have metastatic disease and received first line platinum-based chemotherapy (i.e. FOLFIRINOX, FOLFOX, or gemcitabine + cisplatin).
- Patients must have had a CT or MRI showing stable or responding disease on first line platinum-based chemotherapy within 30 days prior to registration.
- Patients must have received at least 16 weeks but no more than 24 weeks of first line platinum-based therapy for metastatic disease.
- Patients’ last chemotherapy treatment must be within 30 days prior to registration.
- Patients must not have had prior therapy with an anti-PD-1, anti-PD-L1, or antiPD-L2 agent, or any other immune checkpoint inhibitors.
- Patients must not have had prior therapy with PARP inhibitors.
- Zubrod performance status of 0-1.
- Patients must be ≥ 18 years old.
- Patients must be able to swallow and retain oral medications and have no known gastrointestinal disorders likely to interfere with absorption of the study medication.
- Participants with a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are
eligible for this trial provided it does not require concurrent therapy.