APOLLO (EA2192): A Randomized Phase II Double-Blind Study of Olaparib versus Placebo Following Adjuvant Chemotherapy in Patients with Resected Pancreatic Cancer and a Pathogenic BRCA1, BRCA2 or PALB2 Mutation

Inclusion Criteria: Resected pancreatic cancer w/o evidence of disease recurrence
Received ≥3mo multi-agent chemotherapy in the perioperative setting
Within 8 weeks of therapy completion
Pathogenic germline or somatic variant in BRCA or PALB2 (by local lab; confirmed by central review)
If variant identified in tissue, agreement to undergo germline testing

Exclusion Criteria: Any history of progressive disease during platinum therapy
Uncontrolled gastrointestinal disorder that would interfere with the absorption of olaparib
History of MDS/AML

Pilot Study of a Multimodal Prehabilitation Pancreatic Cancer Program

Inclusion Criteria: Adults age 18 years or older. Diagnosed within 8 weeks with upfront resectable, borderline resectable, or locally advanced unresectable PDAC as defined by the National Comprehensive Cancer Network (NCCN). Planning to undergo TNT at MGH. Planning to receive modified FOLFIRINOX for neoadjuvant chemotherapy. Planning to undergo surgical resection of PDAC at MGH. Verbal fluency in English.

Exclusion Criteria: Adults age 18 years or older. Diagnosed within 8 weeks with upfront resectable, borderline resectable, or locally advanced unresectable PDAC as defined by the National Comprehensive Cancer Network (NCCN). Planning to undergo TNT at MGH. Planning to receive modified FOLFIRINOX for neoadjuvant chemotherapy. Planning to undergo surgical resection of PDAC at MGH. Verbal fluency in English.

Alliance A021806: A Phase III Trial of Perioperative Versus Adjuvant Chemotherapy for Resectable Pancreatic Cancer

Inclusion Criteria: PRE-REGISTRATION: Pathology: Histologic or cytologic proof of pancreatic adenocarcinoma or adenosquamous carcinoma TNM Stage: Tx-4, N0-1, M0 (M0 disease does not include spread to distant lymph nodes and organs) Resectable Primary Tumor: Local radiographic reading must be consistent with resectable disease defined as the following on 1) arterial and venous phase contrast-enhanced abdominal/pelvic CT scan or abdominal/pelvic magnetic resonance imaging (MRI) scan and 2) chest CT: No involvement or abutment of the celiac artery, common hepatic artery, superior mesenteric artery, or replaced right hepatic artery (if applicable) Less than 180 degree interface between tumor and vessel wall of the portal vein or superior mesenteric vein, and patent portal vein/splenic vein confluence No evidence of metastatic disease Measurable disease or non-measurable disease o Non-measurable disease is defined as cytologic or histologic confirmation of adenocarcinoma of adenosquamous carcinoma by fine needle aspiration or core-biopsy of the pancreas without measurable disease by radiographic imaging REGISTRATION: Confirmation of resectable disease by real-time central imaging review by the Alliance Imaging Core Lab at Imaging and Radiation Oncology Core (IROC) Ohio Determined to be appropriate candidate for curative-intent pancreatectomy by surgeon intending to perform the resection No prior radiation therapy, chemotherapy, targeted therapy, investigational therapy, or surgery for pancreatic cancer Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic, and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test done =< 14 days prior to registration is required Eastern Cooperative Oncology Group (ECOG) performance status 0-1 Total Neuropathy Score < 2 Absolute neutrophil count (ANC) >= 1,500/uL Platelet count >= 100,000/uL Total bilirubin =< 1.5 x upper limit of normal (ULN) (If obstructive jaundice is present, then biliary drainage must be initiated and total bilirubin =< 3.0) Creatinine =< 1.5 x ULN OR calculated (Calc.) creatinine clearance >= 30 mL/min (Calculated using the Cockcroft-Gault equation) No known Gilbert’s Syndrome or known homozygosity for UGAT1A1*28 polymorphism No comorbid conditions that would prohibit curative-intent pancreatectomy Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug prior to registration Chronic concomitant treatment with strong inducers of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inducers must discontinue the drug prior to registration

Exclusion Criteria: Confirmation of resectable disease by real-time central imaging review by the Alliance Imaging Core Lab at IROC Ohio. Determined to be appropriate candidate for curative-intent pancreatectomy by surgeon intending to perform the resection.

A Randomized, Multicenter, Controlled, Unblinded Study to Assess the Safety and Efficacy of the NanoKnife® System for the Ablation of Unresectable Stage 3 Pancreatic Adenocarcinoma AND REGISTRY TO EVALUATE EFFECTIVENESS AND SAFETY OF THE NANOKNIFE SYSTEM FOR THE ABLATION OF STAGE 3 PANCREATIC ADENOCARCINOMA

Inclusion Criteria: RCT: 1. Provision of signed and dated informed consent form. 2. Subject is 18 years of age and older. 3. Subject has a diagnosis of unresectable Stage 3 pancreatic adenocarcinoma cancer cytologically or pathologically confirmed per American Joint Committee on Cancer (AJCC) staging criteria. 4. Subject has a tumor evaluated as Stage 3 according to National Comprehensive Cancer Network (NCCN) guidelines, based on radiographic imaging or exploratory surgery. 5. Maximum axial and anterior to posterior tumor dimension of ≤3.5cm, after receiving three months of treatment with the modified FOLFIRINOX regimen. 6. Subject has received 3 months of treatment with the modified FOLFIRINOX regimen. 7. Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 8. Subject has an American Society of Anesthesiologists (ASA) classification of physical health status of 1, 2, 3 or 4. Registry: 1. Provisions of signed and dated informed consent form 2. Patient is 18 years of age and older 3. Patient has a diagnosis of Stage 3 PC cytologically or pathologically confirmed per American Joint Committee on Cancer (AJCC) staging criteria 4. Patient has a tumor evaluated as Stage 3 according to National Comprehensive Cancer Network (NCCN) guidelines, based on radiographic imaging or exploratory surgery 5. Maximum axial and anterior to posterior tumor dimension of ≤3.5cm after SOC 6. Patient has received 3 months of SOC per each participating institution’s guidelines 7. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 8. Patient has an American Society of Anesthesiologists (ASA) classification of physical health status of 1, 2, 3 or 4 9. Patients at IRE sites who are deemed eligible for IRE and receive ablation using the NanoKnife System 10. Patient shows no evidence of disease progression based on NCCN guidelines after completing three (3) months of SOC

Exclusion Criteria: RCT: 1. Subjects who are or may be pregnant as determined by a positive pregnancy test or breastfeeding or male or female subjects of reproductive potential who are not willing to employ highly effective birth control from screening to 6 months after the last dose of chemotherapy. 2. Subjects who are unable to tolerate general anesthetic with full skeletal muscle blockade. 3. Subjects who are actively bleeding, anticoagulated, coagulopathy, or have any of the following hematology results: hemoglobin less than 10 g/dL without the support of growth factors or transfusions; absolute neutrophil count less than 1500 cells/mL; or platelet count less than 100,000. 4. Subjects with the presence of implanted cardiac pacemakers, defibrillators, electronic devices or implanted devices with metal parts in the thoracic cavity at the time of IRE. 5. Subjects with history of epilepsy or other neurological disease. 6. Subjects with renal, cardiac, liver, or hematological abnormalities of concern to the investigator. 7. Subjects with Stage 3, 4, or 5 chronic kidney disease. 8. Subjects receiving IRE for margin accentuation. 9. Subjects who at 3 months after FOLFIRINOX treatment have evidence of disease progression. 10. Participation in another interventional trial for pancreatic cancer. 11. Subjects who did not meet study defined criteria for adequacy of induction treatment at the end of the 3 months. Registry: 1. Participation in an interventional trial for pancreatic cancer during the study data collection period 2. Pregnant or lactating patients or male or female patients of reproductive potential who are not willing to employ highly effective birth control from screening to 6 months after the last dose of chemotherapy 3. Patients who are unable to tolerate general anesthetic with full skeletal muscle blockade 4. Patients with the presence of implanted cardiac pacemakers, defibrillators, electronic devices or implanted devices with metal parts in the thoracic cavity at the time of IRE.

Brief Summary:
This phase II trial studies the side effects and how well the combination of binimetinib and encorafenib work in treating patients with pancreatic cancer with a somatic BRAF V600E mutation. Binimetinib and encorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving binimetinib and encorafenib may work better compared to the usual treatment in treating patients with pancreatic cancer and a somatic BRAF V600E mutation.

A Multi-center Trial to Evaluate Multiple Regimens in Metastatic Pancreatic Cancer

Precision Promise is a multi-center, seamless Phase 2/3 platform trial designed to evaluate multiple regimens in metastatic pancreatic cancer. The goal of the platform is to find effective therapies for pancreatic cancer. The platform will rapidly and efficiently test multiple novel drugs and combinations compared to standard of care therapy in first and second metastatic patients. Bayesian response-adaptive randomization will be used to assign patients to arms based on their performance in subtypes of the disease. The primary endpoint is overall survival.

The Pancreas Center at Columbia University Irving Medical Center – Multiple Trials Available 

Oregon Health & Science University Brenden-Colson Center – Multiple Trials Available