Scholars@Duke

• Background
• 

  Education, Training, & Certifications

  • Hematology-Oncology Fellowship, Medicine, Duke University School of Medicine 2011 - 2014
  • Internal Medicine Residency, Medicine, Duke University School of Medicine 2008 - 2011
  • M.D., Duke University School of Medicine 2008
  • Ph.D., Duke University 2007
• 

  Previous Appointments & Affiliations

  • Medical Instructor in the Department of Medicine, Medicine, Medical Oncology, Medicine 2014 - 2017
• Research
• 

  Selected Grants

  • [NuTide:302] A Phase Ib/II open label study to assess the safety and pharmacokinetics of NUC-3373, a nucleotide analogue, given in combination with standard agents used in colorectal cancer treatment awarded by NuCana plc 2022 - 2027
  • [MK-6482-016] Pembrolizumab plus lenvatinib and belzutifan for specified solid tumors awarded by Merck Sharp & Dohme 2021 - 2026
  • A Phase 1b/2 Randomized Study of AVB-S6-500 plus Nab-paclitaxel and Gemcitabine in Patients with Locally Advanced, Recurrent, or Metastatic Pancreatic Adenocarcinoma awarded by Aravive, Inc 2021 - 2026
  • A Phase 1b/2 Open-Label Study of the Efficacy and Safety of Etigilimab (MPH313) Administered in Combination with Nivolumab to Subjects with Locally Advanced or Metastatic Solid Tumors awarded by Mereo BioPharma Group 2021 - 2026
  • A Phase 1 Study of SY-5609, an Oral, Selective CDK7 Inhibitor, in Adult Patients With Select Advanced Solid Tumors awarded by SYROS PHARMACEUTICALS 2021 - 2026
  • A Two-Part, Phase II, Multi-center Study of the ERK Inhibitor Ulixertinib (BVD-523) for Patients with Advanced Malignancies Harboring MEK or Atypical BRAF Alterations awarded by BioMed Valley Discoveries 2020 - 2025
  • Repare RP-3500-01 awarded by Repare Therapeutics 2020 - 2025
  • AMV564-301 awarded by Amphivena Therapeutics 2020 - 2025
  • A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR awarded by Incyte Corporation 2019 - 2024
  • A Phase 1b/2 Study to Evaluate the Safety, Pharmacokinetics, and Clinical Activity of Oleclumab (MEDI9447) with or without Durvalumab in Combination with Chemotherapy in Subjects with Metastatic Pancreatic Ductal Adenocarcinoma awarded by AstraZeneca LP 2018 - 2023
  • A Randomized, Phase 3 Study of Eryaspase in Combination with Chemotherapy versus Chemotherapy Alone as Second-Line Treatment in Patients with Pancreatic Adenocarcinoma TRYbeCA-1 ¿ TRial of erYaspase in pancreatic CAncer awarded by ERYTECH Pharma 2019 - 2023
  • BACCI: A Phase II Randomized, Double-Blind, Placebo-Controlled Study of Capecitabine Bevacizumab plus Atezolizumab versus Capecitabine Bevacizumab plus Placebo in Patients with Refractory Metastatic Colorectal Cancer awarded by Academic and Community Cancer Research United 2017 - 2023
  • Single-cell cytokine profiling in metastatic colorectal cancer patients receiving immunotherapy awarded by Mario Family Foundation 2022
  • A Randomized, Open-Label, Phase 2 Study of Nivolumab in Combination with Ipilimumab or Nivolumab Monotherapy in Participants with Advanced or Metastatic Solid Tumors of High Tumor Mutational Burden (TMB-H) awarded by Bristol-Myers Squibb Company 2019 - 2022
  • A Phase I open label dose escalation safety and tolerability study of INCB054828 in subjects with advanced malignancies awarded by Incyte Corporation 2015 - 2021
  • A platform study exploring the safety tolerability effects on the tumor microenvironment and efficacy of Pembroliumab (MK-3475) + INCB combination awarded by Incyte Corporation 2016 - 2021
  • A Randomized Phase 3 Study of AM0010 in Combination with FOLFOX Compared with FOLFOX Alone as Second-line Therapy in Patients with Metastatic Pancreatic Cancer that has Progressed During or Following a First-Line Gemcitabine Containing Regimen awarded by Eli Lilly and Company 2017 - 2020
  • A Phase 1/2 study of exploring the safety tolerablility and efficacy of Epacadostat in combination with Durvalumab in subjects with selected advanced solid tumors. awarded by Incyte Corporation 2016 - 2020
  • A Phase 1a Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of OMP-313M32 Administered as a Single Agent to Subjects With Locally Advanced or Metastatic Solid Tumors awarded by OncoMed Pharmaceuticals 2017 - 2020
  • A Phase 1/2 study of the safety, tolorability and efficacy of INCB24360 administered in combination with Nivolumab in select advanced cancers. awarded by Incyte Corporation 2015 - 2020
  • A Pilot Study Investigating the Effect of Atezolizumab Monotherapy and Atezolizumab plus Cobimetinib on the Tumoral Immunoprofile in Liver Metastases from Colorectal Cancer awarded by Genetech 2018
  • A Phase 2 proof of concept study of ACP-196 alone in combination with Pembrolizumab in subjects with advanced or metastatic pancreatic cancer. awarded by Acerta Pharma 2015 - 2018
  • A Multi center study of the Bruton's Tyrosine Kinase (BTK) inhibitor, Ibrutinib in combination with MEDI4736 awarded by Pharmacyclics, Inc. 2015 - 2018
  • Preclinical and Human Correlative Studies of a Novel Bruton Tyronsine Kinase Inhibitor in Pancreatic Cancer awarded by Department of Defense 2016 - 2017
• Publications & Artistic Works
• 

  Selected Publications

  • Academic Articles

    • Kenney, Cara, Tricia Kunst, Santhana Webb, Devisser Christina, Christy Arrowood, Seth M. Steinberg, Niharika B. Mettu, Edward J. Kim, and Udo Rudloff. “Phase II study of selumetinib, an orally active inhibitor of MEK1 and MEK2 kinases, in KRAS^G12R-mutant pancreatic ductal adenocarcinoma.” Investigational New Drugs 39, no. 3 (June 2021): 821–28. https://doi.org/10.1007/s10637-020-01044-8.
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    • Overman, Michael, Milind Javle, Richard E. Davis, Pankaj Vats, Chandan Kumar-Sinha, Lianchun Xiao, Niharika B. Mettu, et al. “Randomized phase II study of the Bruton tyrosine kinase inhibitor acalabrutinib, alone or with pembrolizumab in patients with advanced pancreatic cancer.” J Immunother Cancer 8, no. 1 (February 2020). https://doi.org/10.1136/jitc-2020-000587.
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    • Mettu, Niharika B., and James L. Abbruzzese. “Clinical Insights Into the Biology and Treatment of Pancreatic Cancer.” Journal of Oncology Practice 12, no. 1 (January 2016): 17–23. https://doi.org/10.1200/jop.2015.009092.
       Full Text  Open Access Copy
    • Mettu, Niharika B., Herbert Hurwitz, and David S. Hsu. “Use of molecular biomarkers to inform adjuvant therapy for colon cancer.” Oncology (Williston Park) 27, no. 8 (August 2013): 746–54.
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    • Mettu, N. B., H. Hurwitz, and D. S. Hsu. “Use of molecular biomarkers to inform adjuvant therapy for colon cancer.” Oncology (United States) 27, no. 8 (January 1, 2013).
    • Stanifer, John, Reema Mehta, Niharika Mettu, Jeffrey Sanders, and Noppon Setji. “Muehrcke's lines as a diagnostic clue to increased catabolism and a severe systemic disease state.” Am J Med Sci 342, no. 4 (October 2011): 331. https://doi.org/10.1097/MAJ.0b013e31821fb6d0.
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    • Mettu, Niharika B., Thomas B. Stanley, Mary A. Dwyer, Michelle S. Jansen, John E. Allen, Julie M. Hall, and Donald P. McDonnell. “The nuclear receptor-coactivator interaction surface as a target for peptide antagonists of the peroxisome proliferator-activated receptors.” Mol Endocrinol 21, no. 10 (October 2007): 2361–77. https://doi.org/10.1210/me.2007-0201.
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  • Conference Papers

    • Mettu, Niharika B., Donna Niedzwiecki, Christel Rushing, Andrew B. Nixon, Jingquan Jia, Sherri Haley, Wanda Honeycutt, Herbert Hurwitz, Johanna C. Bendell, and Hope Uronis. “A phase I study of gemcitabine + dasatinib (gd) or gemcitabine + dasatinib + cetuximab (GDC) in refractory solid tumors.” In Cancer Chemother Pharmacol, 83:1025–35, 2019. https://doi.org/10.1007/s00280-019-03805-6.
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