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Poster display session

3937 - PIVOT-02: A Phase 1/2, Open-label, Multicenter, Dose Escalation and Dose Expansion Study of NKTR-214 and Nivolumab in Patients with Select, Locally Advanced or Metastatic Solid Tumor Malignancies.


10 Sep 2017


Poster display session


Clinical Research;  Cancers in Adolescents and Young Adults (AYA);  Immunotherapy


Adi Diab


Annals of Oncology (2017) 28 (suppl_5): v403-v427. 10.1093/annonc/mdx376


A. Diab1, M.E. Hurwitz2, N. Tannir3, C. Bernatchez1, C. Haymaker1, S.E. Bentebibel1, B.D. Curti4, M.K.K. Wong1, I. Gergel5, M. Tagliaferri6, J. Zalevsky7, U. Hoch8, S. Aung6, M. Imperiale6, D. Cho9, S.S. Tykodi10, I. Puzanov11, H. Kluger12, P. Hwu1, M. Sznol13

Author affiliations

  • 1 Department Of Melanoma Medical Oncology, MD Anderson Cancer Center, 77030-4095 - Houston/US
  • 2 Department Of Internal Medicine, Division Of Medical Oncology, Yale School of Medicine, New Haven/US
  • 3 Genitourinary Medical Oncology, MD Anderson Cancer Center, 77030-4095 - Houston/US
  • 4 Department Of Genitourinary Oncology Research, Providence Cancer Center and Earle A. Chiles Research Institute, Portland/US
  • 5 Department Of Drug Development, Nektar Therapeutics, San Francisco/US
  • 6 Department Of Clinical Development, Nektar Therapeutics, 94158 - San Francisco/US
  • 7 Department Of Biology & Preclinical Development, Nektar Therapeutics, San Francisco/US
  • 8 Department Of Clinical Pharmacology, Nektar Therapeutics, 94115 - San Francisco/US
  • 9 Department Of Medical Oncology, NYU Medical Oncology Associates, New York/US
  • 10 Department Of Medical Oncology, University of Washington and Fred Hutchinson Cancer Research Center, Seattle/US
  • 11 Department Of Medical Oncology, Roswell Park Cancer Institute, Buffalo/US
  • 12 Department Of Medical Oncology, Yale Breast Center, 6519 - New Haven/US
  • 13 Department Of Medical Oncology, Yale University School of Medicine Medical Oncology, New Haven/US


Abstract 3937


Abundance and functional quality of tumor infiltrating lymphocytes are positively linked with tumor response and improved survival with checkpoint inhibitors. NKTR-214 is a CD122-biased agonist that targets the IL2 pathway and is designed to provide sustained signaling through the heterodimeric IL2 receptor pathway (IL2Rβɣ) to preferentially activate and expand NK and effector CD8+ T cells over CD4+ T regulatory cells within the tumor microenvironment. NKTR-214 has been administered to 28 patients with advanced cancers. NKTR-214 as a single agent demonstrated a substantial increase in both CD8+ T and NK cells within the tumor microenvironment in patients with prior immune checkpoint therapy (Bernatchez et al 2016). Given the favorable safety profile and strong biomarker data, a trial combining NKTR-214 and nivolumab was initiated.

Trial design

PIVOT-02 is a phase 1/2 open-label trial in patients (pts) with locally advanced or metastatic melanoma (mM), non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), urothelial carcinoma, or triple-negative breast cancer (TNBC). The primary objectives are to evaluate safety and tolerability, determine the recommended phase 2 dose (RP2D), and assess tumor response by RECIST 1.1. In an outpatient setting, NKTR-214 is administered at dose levels of 0.003, 0.006 and 0.009 mg/kg in combination with nivolumab at two flat dose schedules of either 240 mg @ q2w or 360 mg @ q3w. As of May 8, 17 pts (7 mM, 8 RCC, and 2 NSCLC) have been enrolled into 4 cohorts in the dose-escalation phase. In the dose-expansion phase, approximately 250 pts will be enrolled in five tumor types and eight indications; immunotherapy naïve patients and patients who are relapsed/refractory to checkpoint therapy are being studied separately. Extensive blood and tumor tissue samples are being collected to measure immune activation using immunophenotyping including flow cytometry, immunohistochemistry (IHC), T cell clonality and gene expression analyses. Enrollment is ongoing.

Clinical trial identification


Legal entity responsible for the study

Nektar Therapeutics


Nektar Therapeutics


A. Diab: Consulting or Advisory Role - Celgene; CureVac; Nektar Research Funding - Celgene (Inst); Idera (Inst); Nektar (Inst); Pfizer (Inst) Travel, Accommodations, Expenses – Nektar. M.E. Hurwitz: Employment - Pfizer Consulting or Advisory Role – Nektar. N. Tannir: Honoraria - Bristol-Myers Squibb; Exelixis; GSK; Nektar; Novartis; Pfizer Advisory Role - Bristol-Myers Squibb; Exelixis; GSK; Nektar; Novartis Research Funding - Bristol-Myers Squibb; Epizyme; Exelixis; Novartis Travel - Bristol-Myers Squibb; Exelixis; GSK; Nektar; Novartis; Pfizer. C. Bernatchez: Employment - Lexicon (I) Stock - Lexicon (I) Advisory Role - Lion Biotechnologies Research Funding - Idera; Nektar Patents - Patent pending on BTLA as a marker for better CD8 T cells for adoptive immunotherapy. C. Haymaker: Cara L. Haymaker Research Funding - Idera; Nektar. B.D. Curti: Honoraria - Prometheus Speakers\' Bureau - Prometheus Research Funding - Bristol-Myers Squibb; Galectin Therapeutics; MedImmune; Prometheus; Viralytics Travel, Accommodations, Expenses - Agonox; MedImmune; Nektar; Prometheus. I. Gergel: Employment - Nektar Leadership - Corium International; Nektar Stock and Other Ownership Interests - Corium International; Nektar. M. Tagliaferri: Employment - Nektar Travel, Accommodations, Expenses - Nektar J. Zalevsky: Employment - Nektar. U. Hoch, S. Aung, M. Imperiale: Employment - Nektar Stock and Other Ownership Interests - Nektar D. Cho: Honoraria - Bristol-Myers Squibb; Exelixis; Roche/Genentech Consulting or Advisory Role - Pfizer; Prometheus. S.S. Tykodi: Consulting or Advisory Role - Amgen; Prometheus Research Funding - Argos Therapeutics (Inst); Bristol-Myers Squibb (Inst); Exelixis (Inst); Genentech (Inst); GlaxoSmithKline (Inst); Prometheus (Inst). I. Puzanov: Consulting or Advisory Role - Amgen; Bristol-Myers Squib; Roche/Genentech. H. Kluger: Honoraria - Merck Consulting or Advisory Role - Alexion Pharmaceuticals; Prometheus; Regeneron Research Funding - Merck (Inst) Travel, Accommodations, Expenses - Bristol-Myers Squib P. Hwu: Stock and Other Ownership Interests - immatics; Lion Biotechnologies Consulting or Advisory Role - Lion Biotechnologies Research Funding - Bristol-Myers Squibb (Inst); Genentech (Inst). M. Sznol: Stock -Adaptive Bio; Amphivena; Intensity Thera Advisor -Adaptimmune; Alexion; Amgen; AstraZeneca; Biodesix; Bristol-Myers Squibb; Genentech; Immune Design; Janssen; Kyowa; Lilly; Lion Bios; Lycera; MSD; Merus; Modulate; Nektar; Novartis; Pfizer; Symphogen; Theravance. All other authors have declared no conflicts of interest.

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