Protocol: SWOG – S2001

SCHEMA 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:

1. Patient must have a histologic or cytologic diagnosis of pancreatic adenocarcinoma. Patients with neuroendocrine tumors, acinar cell and adenosquamous carcinomas are excluded.
2. 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).
3. Patient must have metastatic disease and received first line platinum-based chemotherapy (i.e. FOLFIRINOX, FOLFOX, or gemcitabine + cisplatin).
4. 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.
5. Patients must have received at least 16 weeks but no more than 24 weeks of first line platinum-based therapy for metastatic disease.
6. Patients’ last chemotherapy treatment must be within 30 days prior to registration.
7. 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.
8. Patients must not have had prior therapy with PARP inhibitors.
9. Zubrod performance status of 0-1.
10. Patients must be ≥ 18 years old.
11. 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.
12. 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.

Protocol: ECOG – EA2192

SCHEMA EA2192

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:

Step 0 Pre- Registration:

1. Patients must be at least 18 years of age.
2. ECOG Performance Status 0-2.
3. Patient must have a diagnosis of pancreatic cancer and have successfully undergone a curative intent surgical resection and must have no evidence of recurrent disease as determined by the investigator.  NOTE: This includes patients with adenocarcinoma, acinar carcinoma, squamous cell carcinoma adenosquamous and variants thereof. Patients with neuroendocrine tumors are excluded from enrolling.
4. Patient must be planning to receive, be receiving or be within 8 weeks of having completed at least three combined months (i.e., 12 weeks) of perioperative (neoadjuvant, adjuvant or a combination of both) systemic, multi-agent chemotherapy.Patients may have had up to 6 months of perioperative systemic therapy as deemed appropriate by their primary treating medical team (patients can have received radiation or chemoradiation in addition to this 6 month course).
5. Patient must have a known pathogenic or likely pathogenic germline or somatic mutation in BRCA1, BRCA2, or PALB2, as determined by a Clinical Laboratory Improvement Amendments (CLIA) certified or equivalently-accredited laboratory. Mutations must be considered pathogenic or likely pathogenic

Step 1 Registration:

1. Patient must have undergone at least 3 combined months (i.e., 12 weeks) of perioperative (neoadjuvant, adjuvant or a combination of both) systemic, multi-agent chemotherapy. Patients may have had up to 6 months of perioperative systemic therapy as deemed appropriate by their primary treating medical team (patients can have received radiation or chemoradiation in addition to this 6 months course).
2. If mutation in BRCA1, BRCA2 or PALB2 was identified in tumor tissue and the patient has not previously undergone germline testing, the patient must agree to undergo germline testing.
3. Patient must have no evidence of recurrent or metastatic pancreatic cancer at the time of randomization as documented by baseline scans obtained ≤ 4 weeks prior to randomization.
4. Patient must not have previously had evidence of progressive pancreatic cancer while receiving platinum-based therapy.
5. Patient must be ≥ 21 days (three weeks) from their last treatment (including chemotherapy or radiotherapy) but ≤ 56 days (eight weeks) from their last treatment. Patients who have received neoadjuvant and/or adjuvant radiotherapy are eligible.
6. Patient must not have had major surgery within 2 weeks prior to randomization and patients must have recovered from any effects of any major surgery.

Protocol: ECOG – EA2186

SCHEMA EA2186

Please Note: Below is a partial list  of eligibility, please contact GHCI Research Department at (810) 762-8181, (810) 762-8079 or (810) 762-8038. Thank you!

Eligibility:

1. Patient must have newly diagnosed untreated biopsy proven metastatic adenocarcinoma of the pancreas. However, previous surgery, adjuvant chemotherapy and/or radiation therapy will be allowed, provided radiation therapy is completed at least 2 weeks prior to registration and adjuvant therapy was administered more than 6 months prior to registration. Patients with the following histology are excluded: Acinar cell; Adenosquamous carcinoma.
2. Patients must be at least or equal to 70 years of age.
3. ECOG Performance Status 0-2.
4. Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this protocol. HIV (+) patients who are on ritonavir or/and cobicistat-based regimen must be switched to alternative ART.
5. Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this protocol, patients should be class 2B or better.
6. Patient must have measurable disease.