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  • MC1841: Phase II Study of Niraparib and TSR-042 in Patients with Germline or Somatic BRCA1/2 and PALB2-related Pancreatic Cancer Rochester, Minn., Jacksonville, Fla., Scottsdale/Phoenix, Ariz. In our own data sequencing 3,000 patients with pancreatic cancer, approximately 3% of pancreatic cancer patients harbor germline mutations in DNA repair genes such as BRCA1/2 and PALB2, and are therefore potential candidates for PARP-inhibitor therapy. In addition, somatic mutations in Homologous Recombination Repair (HRR) genes can confer sensitivity as well, and have been reported to double the number of patients potentially eligible for such therapy. The Keynote-162 study of niraparib and pembrolizumab has validated this approach, with early reports of impressive efficacy. Although unselected trials in pancreatic cancer with immunotherapy alone have yet to be successful, we hypothesize that induced genetic variation with PARP inhibition disrupting the tumor microenvironment and increasing neoepitope expression can sensitize tumors to immune checkpoint inhibition. We have developed preliminary data with RNAseq suggesting that potent PARP inhibition is associated with gain of novel mutations in pancreas cell lines, even compared to cisplatin alone, or irinotecan alone. We propose that a combination of PARP inhibition and anti-PD1 therapy has valuable therapeutic potential in pancreatic cancer. HRR deficient pancreatic cancer has largely been defined to date based on mutations in well-established genes such as BRCA1/2 and PALB2. However, more DNA repair associated genes are becoming associated with risk for pancreatic cancer and may well impact tumor phenotype. The goal would be to evaluate the combination of niraparib and TSR-042 in patients with germline or somatic mutations in BRCA1/2 or PALB2.
  • MMP1602: Single Arm Phase II Study of Ipilimumab and Nivolumab as Adjuvant Therapy for Resected Mucosal Melanoma (SALVO Study). HCRN: MEL16-252 Rochester, Minn.

    The trial is a single arm phase II clinical trial of Ipilimumab and Nivolumab in patients with resected mucosal melanoma. Ipilimumab (1 mg/kg) and Nivolumab (3 mg/kg) will be administered day 1 of a 21-day cycle in cycles 1-4 and then nivolumab 480 mg will be administered day 1 of a 28-day cycle for cycles 5-15 or until disease recurrence.

  • Pilot Study of Development of Xenografts from Pancreatic Cancer Patients to Ascertain Sensitivity to PARP Inhibitors and Other Therapies Targeting DNA Repair Rochester, Minn.

    The purpose of this study is to learn more about pancreatic cancer genetics in association with response to drug therapy. Pancreatic cancer has identifiable genetic (DNA) changes, yet for many it is not known whether these affect response to cancer drugs.

     

     

  • S1922, Randomized Phase II Selection Study of Ramucirumab and Paclitaxel Versus FOLFIRI in Refractory Small Bowel Adenocarcinoma Rochester, Minn. This phase II trial studies how well ramucirumab and paclitaxel or the FOLFIRI regimen (leucovorin calcium, fluorouracil, and irinotecan hydrochloride) work in treating patients with small bowel cancers that have spread extensively to other anatomic sites (advanced) or are no longer responding to treatment (refractory). Ramucirumab is a monoclonal antibody that attaches to and inhibits a molecule called VEGFR-2. This may restrain new blood vessel formation therefore reducing nutrient supply to tumor which may interfere with tumor cell growth and expansion. Drugs used in chemotherapy, such as paclitaxel, leucovorin calcium, fluorouracil, and irinotecan hydrochloride work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving Ramucirumab plus paclitaxel or FOLFIRI, may be helpful in treating advanced or refractory small bowel cancers and may help patients live longer.

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