PMID- 27528724
OWN - NLM
STAT- MEDLINE
DCOM- 20170912
LR  - 20200502
IS  - 1527-7755 (Electronic)
IS  - 0732-183X (Print)
IS  - 0732-183X (Linking)
VI  - 34
IP  - 29
DP  - 2016 Oct 10
TI  - Safety, Antitumor Activity, and Immune Activation of Pegylated Recombinant Human 
      Interleukin-10 (AM0010) in Patients With Advanced Solid Tumors.
PG  - 3562-3569
LID - 10.1200/JCO.2016.68.1106 [doi]
AB  - Purpose Interleukin-10 (IL-10) stimulates the expansion and cytotoxicity of 
      tumor-infiltrating CD8+ T cells and inhibits inflammatory CD4+ T cells. 
      Pegylation prolongs the serum concentration of IL-10 without changing the 
      immunologic profile. This phase I study sought to determine the safety and 
      antitumor activity of AM0010. Patients and Methods Patients with selected 
      advanced solid tumors were treated with AM0010 in a dose-escalation study, which 
      was followed by a renal cell cancer (RCC) dose-expansion cohort. AM0010 was 
      self-administered subcutaneously at doses of 1 to 40 mug/kg once per day. Primary 
      end points were safety and tolerability; clinical activity and immune activation 
      were secondary end points. Results In the dose-escalation and -expansion cohorts, 
      33 and 18 patients, respectively, were treated with daily subcutaneous injection 
      of AM0010. AM0010 was tolerated in a heavily pretreated patient population. 
      Treatment-related adverse events (AEs) included anemia, fatigue, 
      thrombocytopenia, fever, and injection site reactions. Grade 3 to 4 
      nonhematopoietic treatment-related AEs, including rash (n = 2) and transaminitis 
      (n = 1), were observed in five of 33 patients. Grade 3 to 4 anemia or 
      thrombocytopenia was observed in five patients. Most treatment-related AEs were 
      transient or reversible. AM0010 led to systemic immune activation with elevated 
      immune-stimulatory cytokines and reduced transforming growth factor beta in the 
      serum. Partial responses were observed in one patient with uveal melanoma and 
      four of 15 evaluable patients with RCC treated at 20 mug/kg (overall response 
      rate, 27%). Prolonged stable disease of at least 4 months was observed in four 
      patients, including one with colorectal cancer with disease stabilization for 20 
      months. Conclusion AM0010 has an acceptable toxicity profile with early evidence 
      of antitumor activity, particularly in RCC. These data support the further 
      evaluation of AM0010 both alone and in combination with other immune therapies 
      and chemotherapies.
FAU - Naing, Aung
AU  - Naing A
AD  - Aung Naing, Rivka R. Colen, David S. Hong, and Nizar M. Tannir, MD Anderson 
      Cancer Center, Houston; Kyriakos P. Papadopoulos and Drew R. Rasco, START Center 
      for Cancer Care, San Antonio, TX; Karen A. Autio, Memorial Sloan Kettering Cancer 
      Center, New York, NY; Patrick A. Ott, Dana-Farber Cancer Institute, Boston, MA; 
      Manish R. Patel, Sarah Cannon Research Institute/Florida Cancer Specialists, 
      Sarasota, FL; Deborah J. Wong, University of California Los Angeles, Los Angeles; 
      Melinda Whiteside, John B. Mumm, Ivan H. Chan, Peter Van Vlasselaer, and Martin 
      Oft, ARMO BioSciences, Redwood City, CA; Gerald S. Falchook, Sarah Cannon 
      Research Institute at HealthONE, Denver, CO; Shubham Pant, Oklahoma University, 
      Oklahoma City, OK; and Johanna C. Bendell, Todd M. Bauer, and Jeffrey R. Infante, 
      Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN.
FAU - Papadopoulos, Kyriakos P
AU  - Papadopoulos KP
AD  - Aung Naing, Rivka R. Colen, David S. Hong, and Nizar M. Tannir, MD Anderson 
      Cancer Center, Houston; Kyriakos P. Papadopoulos and Drew R. Rasco, START Center 
      for Cancer Care, San Antonio, TX; Karen A. Autio, Memorial Sloan Kettering Cancer 
      Center, New York, NY; Patrick A. Ott, Dana-Farber Cancer Institute, Boston, MA; 
      Manish R. Patel, Sarah Cannon Research Institute/Florida Cancer Specialists, 
      Sarasota, FL; Deborah J. Wong, University of California Los Angeles, Los Angeles; 
      Melinda Whiteside, John B. Mumm, Ivan H. Chan, Peter Van Vlasselaer, and Martin 
      Oft, ARMO BioSciences, Redwood City, CA; Gerald S. Falchook, Sarah Cannon 
      Research Institute at HealthONE, Denver, CO; Shubham Pant, Oklahoma University, 
      Oklahoma City, OK; and Johanna C. Bendell, Todd M. Bauer, and Jeffrey R. Infante, 
      Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN.
FAU - Autio, Karen A
AU  - Autio KA
AD  - Aung Naing, Rivka R. Colen, David S. Hong, and Nizar M. Tannir, MD Anderson 
      Cancer Center, Houston; Kyriakos P. Papadopoulos and Drew R. Rasco, START Center 
      for Cancer Care, San Antonio, TX; Karen A. Autio, Memorial Sloan Kettering Cancer 
      Center, New York, NY; Patrick A. Ott, Dana-Farber Cancer Institute, Boston, MA; 
      Manish R. Patel, Sarah Cannon Research Institute/Florida Cancer Specialists, 
      Sarasota, FL; Deborah J. Wong, University of California Los Angeles, Los Angeles; 
      Melinda Whiteside, John B. Mumm, Ivan H. Chan, Peter Van Vlasselaer, and Martin 
      Oft, ARMO BioSciences, Redwood City, CA; Gerald S. Falchook, Sarah Cannon 
      Research Institute at HealthONE, Denver, CO; Shubham Pant, Oklahoma University, 
      Oklahoma City, OK; and Johanna C. Bendell, Todd M. Bauer, and Jeffrey R. Infante, 
      Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN.
FAU - Ott, Patrick A
AU  - Ott PA
AD  - Aung Naing, Rivka R. Colen, David S. Hong, and Nizar M. Tannir, MD Anderson 
      Cancer Center, Houston; Kyriakos P. Papadopoulos and Drew R. Rasco, START Center 
      for Cancer Care, San Antonio, TX; Karen A. Autio, Memorial Sloan Kettering Cancer 
      Center, New York, NY; Patrick A. Ott, Dana-Farber Cancer Institute, Boston, MA; 
      Manish R. Patel, Sarah Cannon Research Institute/Florida Cancer Specialists, 
      Sarasota, FL; Deborah J. Wong, University of California Los Angeles, Los Angeles; 
      Melinda Whiteside, John B. Mumm, Ivan H. Chan, Peter Van Vlasselaer, and Martin 
      Oft, ARMO BioSciences, Redwood City, CA; Gerald S. Falchook, Sarah Cannon 
      Research Institute at HealthONE, Denver, CO; Shubham Pant, Oklahoma University, 
      Oklahoma City, OK; and Johanna C. Bendell, Todd M. Bauer, and Jeffrey R. Infante, 
      Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN.
FAU - Patel, Manish R
AU  - Patel MR
AD  - Aung Naing, Rivka R. Colen, David S. Hong, and Nizar M. Tannir, MD Anderson 
      Cancer Center, Houston; Kyriakos P. Papadopoulos and Drew R. Rasco, START Center 
      for Cancer Care, San Antonio, TX; Karen A. Autio, Memorial Sloan Kettering Cancer 
      Center, New York, NY; Patrick A. Ott, Dana-Farber Cancer Institute, Boston, MA; 
      Manish R. Patel, Sarah Cannon Research Institute/Florida Cancer Specialists, 
      Sarasota, FL; Deborah J. Wong, University of California Los Angeles, Los Angeles; 
      Melinda Whiteside, John B. Mumm, Ivan H. Chan, Peter Van Vlasselaer, and Martin 
      Oft, ARMO BioSciences, Redwood City, CA; Gerald S. Falchook, Sarah Cannon 
      Research Institute at HealthONE, Denver, CO; Shubham Pant, Oklahoma University, 
      Oklahoma City, OK; and Johanna C. Bendell, Todd M. Bauer, and Jeffrey R. Infante, 
      Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN.
FAU - Wong, Deborah J
AU  - Wong DJ
AD  - Aung Naing, Rivka R. Colen, David S. Hong, and Nizar M. Tannir, MD Anderson 
      Cancer Center, Houston; Kyriakos P. Papadopoulos and Drew R. Rasco, START Center 
      for Cancer Care, San Antonio, TX; Karen A. Autio, Memorial Sloan Kettering Cancer 
      Center, New York, NY; Patrick A. Ott, Dana-Farber Cancer Institute, Boston, MA; 
      Manish R. Patel, Sarah Cannon Research Institute/Florida Cancer Specialists, 
      Sarasota, FL; Deborah J. Wong, University of California Los Angeles, Los Angeles; 
      Melinda Whiteside, John B. Mumm, Ivan H. Chan, Peter Van Vlasselaer, and Martin 
      Oft, ARMO BioSciences, Redwood City, CA; Gerald S. Falchook, Sarah Cannon 
      Research Institute at HealthONE, Denver, CO; Shubham Pant, Oklahoma University, 
      Oklahoma City, OK; and Johanna C. Bendell, Todd M. Bauer, and Jeffrey R. Infante, 
      Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN.
FAU - Falchook, Gerald S
AU  - Falchook GS
AD  - Aung Naing, Rivka R. Colen, David S. Hong, and Nizar M. Tannir, MD Anderson 
      Cancer Center, Houston; Kyriakos P. Papadopoulos and Drew R. Rasco, START Center 
      for Cancer Care, San Antonio, TX; Karen A. Autio, Memorial Sloan Kettering Cancer 
      Center, New York, NY; Patrick A. Ott, Dana-Farber Cancer Institute, Boston, MA; 
      Manish R. Patel, Sarah Cannon Research Institute/Florida Cancer Specialists, 
      Sarasota, FL; Deborah J. Wong, University of California Los Angeles, Los Angeles; 
      Melinda Whiteside, John B. Mumm, Ivan H. Chan, Peter Van Vlasselaer, and Martin 
      Oft, ARMO BioSciences, Redwood City, CA; Gerald S. Falchook, Sarah Cannon 
      Research Institute at HealthONE, Denver, CO; Shubham Pant, Oklahoma University, 
      Oklahoma City, OK; and Johanna C. Bendell, Todd M. Bauer, and Jeffrey R. Infante, 
      Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN.
FAU - Pant, Shubham
AU  - Pant S
AD  - Aung Naing, Rivka R. Colen, David S. Hong, and Nizar M. Tannir, MD Anderson 
      Cancer Center, Houston; Kyriakos P. Papadopoulos and Drew R. Rasco, START Center 
      for Cancer Care, San Antonio, TX; Karen A. Autio, Memorial Sloan Kettering Cancer 
      Center, New York, NY; Patrick A. Ott, Dana-Farber Cancer Institute, Boston, MA; 
      Manish R. Patel, Sarah Cannon Research Institute/Florida Cancer Specialists, 
      Sarasota, FL; Deborah J. Wong, University of California Los Angeles, Los Angeles; 
      Melinda Whiteside, John B. Mumm, Ivan H. Chan, Peter Van Vlasselaer, and Martin 
      Oft, ARMO BioSciences, Redwood City, CA; Gerald S. Falchook, Sarah Cannon 
      Research Institute at HealthONE, Denver, CO; Shubham Pant, Oklahoma University, 
      Oklahoma City, OK; and Johanna C. Bendell, Todd M. Bauer, and Jeffrey R. Infante, 
      Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN.
FAU - Whiteside, Melinda
AU  - Whiteside M
AD  - Aung Naing, Rivka R. Colen, David S. Hong, and Nizar M. Tannir, MD Anderson 
      Cancer Center, Houston; Kyriakos P. Papadopoulos and Drew R. Rasco, START Center 
      for Cancer Care, San Antonio, TX; Karen A. Autio, Memorial Sloan Kettering Cancer 
      Center, New York, NY; Patrick A. Ott, Dana-Farber Cancer Institute, Boston, MA; 
      Manish R. Patel, Sarah Cannon Research Institute/Florida Cancer Specialists, 
      Sarasota, FL; Deborah J. Wong, University of California Los Angeles, Los Angeles; 
      Melinda Whiteside, John B. Mumm, Ivan H. Chan, Peter Van Vlasselaer, and Martin 
      Oft, ARMO BioSciences, Redwood City, CA; Gerald S. Falchook, Sarah Cannon 
      Research Institute at HealthONE, Denver, CO; Shubham Pant, Oklahoma University, 
      Oklahoma City, OK; and Johanna C. Bendell, Todd M. Bauer, and Jeffrey R. Infante, 
      Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN.
FAU - Rasco, Drew R
AU  - Rasco DR
AD  - Aung Naing, Rivka R. Colen, David S. Hong, and Nizar M. Tannir, MD Anderson 
      Cancer Center, Houston; Kyriakos P. Papadopoulos and Drew R. Rasco, START Center 
      for Cancer Care, San Antonio, TX; Karen A. Autio, Memorial Sloan Kettering Cancer 
      Center, New York, NY; Patrick A. Ott, Dana-Farber Cancer Institute, Boston, MA; 
      Manish R. Patel, Sarah Cannon Research Institute/Florida Cancer Specialists, 
      Sarasota, FL; Deborah J. Wong, University of California Los Angeles, Los Angeles; 
      Melinda Whiteside, John B. Mumm, Ivan H. Chan, Peter Van Vlasselaer, and Martin 
      Oft, ARMO BioSciences, Redwood City, CA; Gerald S. Falchook, Sarah Cannon 
      Research Institute at HealthONE, Denver, CO; Shubham Pant, Oklahoma University, 
      Oklahoma City, OK; and Johanna C. Bendell, Todd M. Bauer, and Jeffrey R. Infante, 
      Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN.
FAU - Mumm, John B
AU  - Mumm JB
AD  - Aung Naing, Rivka R. Colen, David S. Hong, and Nizar M. Tannir, MD Anderson 
      Cancer Center, Houston; Kyriakos P. Papadopoulos and Drew R. Rasco, START Center 
      for Cancer Care, San Antonio, TX; Karen A. Autio, Memorial Sloan Kettering Cancer 
      Center, New York, NY; Patrick A. Ott, Dana-Farber Cancer Institute, Boston, MA; 
      Manish R. Patel, Sarah Cannon Research Institute/Florida Cancer Specialists, 
      Sarasota, FL; Deborah J. Wong, University of California Los Angeles, Los Angeles; 
      Melinda Whiteside, John B. Mumm, Ivan H. Chan, Peter Van Vlasselaer, and Martin 
      Oft, ARMO BioSciences, Redwood City, CA; Gerald S. Falchook, Sarah Cannon 
      Research Institute at HealthONE, Denver, CO; Shubham Pant, Oklahoma University, 
      Oklahoma City, OK; and Johanna C. Bendell, Todd M. Bauer, and Jeffrey R. Infante, 
      Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN.
FAU - Chan, Ivan H
AU  - Chan IH
AD  - Aung Naing, Rivka R. Colen, David S. Hong, and Nizar M. Tannir, MD Anderson 
      Cancer Center, Houston; Kyriakos P. Papadopoulos and Drew R. Rasco, START Center 
      for Cancer Care, San Antonio, TX; Karen A. Autio, Memorial Sloan Kettering Cancer 
      Center, New York, NY; Patrick A. Ott, Dana-Farber Cancer Institute, Boston, MA; 
      Manish R. Patel, Sarah Cannon Research Institute/Florida Cancer Specialists, 
      Sarasota, FL; Deborah J. Wong, University of California Los Angeles, Los Angeles; 
      Melinda Whiteside, John B. Mumm, Ivan H. Chan, Peter Van Vlasselaer, and Martin 
      Oft, ARMO BioSciences, Redwood City, CA; Gerald S. Falchook, Sarah Cannon 
      Research Institute at HealthONE, Denver, CO; Shubham Pant, Oklahoma University, 
      Oklahoma City, OK; and Johanna C. Bendell, Todd M. Bauer, and Jeffrey R. Infante, 
      Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN.
FAU - Bendell, Johanna C
AU  - Bendell JC
AD  - Aung Naing, Rivka R. Colen, David S. Hong, and Nizar M. Tannir, MD Anderson 
      Cancer Center, Houston; Kyriakos P. Papadopoulos and Drew R. Rasco, START Center 
      for Cancer Care, San Antonio, TX; Karen A. Autio, Memorial Sloan Kettering Cancer 
      Center, New York, NY; Patrick A. Ott, Dana-Farber Cancer Institute, Boston, MA; 
      Manish R. Patel, Sarah Cannon Research Institute/Florida Cancer Specialists, 
      Sarasota, FL; Deborah J. Wong, University of California Los Angeles, Los Angeles; 
      Melinda Whiteside, John B. Mumm, Ivan H. Chan, Peter Van Vlasselaer, and Martin 
      Oft, ARMO BioSciences, Redwood City, CA; Gerald S. Falchook, Sarah Cannon 
      Research Institute at HealthONE, Denver, CO; Shubham Pant, Oklahoma University, 
      Oklahoma City, OK; and Johanna C. Bendell, Todd M. Bauer, and Jeffrey R. Infante, 
      Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN.
FAU - Bauer, Todd M
AU  - Bauer TM
AD  - Aung Naing, Rivka R. Colen, David S. Hong, and Nizar M. Tannir, MD Anderson 
      Cancer Center, Houston; Kyriakos P. Papadopoulos and Drew R. Rasco, START Center 
      for Cancer Care, San Antonio, TX; Karen A. Autio, Memorial Sloan Kettering Cancer 
      Center, New York, NY; Patrick A. Ott, Dana-Farber Cancer Institute, Boston, MA; 
      Manish R. Patel, Sarah Cannon Research Institute/Florida Cancer Specialists, 
      Sarasota, FL; Deborah J. Wong, University of California Los Angeles, Los Angeles; 
      Melinda Whiteside, John B. Mumm, Ivan H. Chan, Peter Van Vlasselaer, and Martin 
      Oft, ARMO BioSciences, Redwood City, CA; Gerald S. Falchook, Sarah Cannon 
      Research Institute at HealthONE, Denver, CO; Shubham Pant, Oklahoma University, 
      Oklahoma City, OK; and Johanna C. Bendell, Todd M. Bauer, and Jeffrey R. Infante, 
      Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN.
FAU - Colen, Rivka R
AU  - Colen RR
AD  - Aung Naing, Rivka R. Colen, David S. Hong, and Nizar M. Tannir, MD Anderson 
      Cancer Center, Houston; Kyriakos P. Papadopoulos and Drew R. Rasco, START Center 
      for Cancer Care, San Antonio, TX; Karen A. Autio, Memorial Sloan Kettering Cancer 
      Center, New York, NY; Patrick A. Ott, Dana-Farber Cancer Institute, Boston, MA; 
      Manish R. Patel, Sarah Cannon Research Institute/Florida Cancer Specialists, 
      Sarasota, FL; Deborah J. Wong, University of California Los Angeles, Los Angeles; 
      Melinda Whiteside, John B. Mumm, Ivan H. Chan, Peter Van Vlasselaer, and Martin 
      Oft, ARMO BioSciences, Redwood City, CA; Gerald S. Falchook, Sarah Cannon 
      Research Institute at HealthONE, Denver, CO; Shubham Pant, Oklahoma University, 
      Oklahoma City, OK; and Johanna C. Bendell, Todd M. Bauer, and Jeffrey R. Infante, 
      Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN.
FAU - Hong, David S
AU  - Hong DS
AD  - Aung Naing, Rivka R. Colen, David S. Hong, and Nizar M. Tannir, MD Anderson 
      Cancer Center, Houston; Kyriakos P. Papadopoulos and Drew R. Rasco, START Center 
      for Cancer Care, San Antonio, TX; Karen A. Autio, Memorial Sloan Kettering Cancer 
      Center, New York, NY; Patrick A. Ott, Dana-Farber Cancer Institute, Boston, MA; 
      Manish R. Patel, Sarah Cannon Research Institute/Florida Cancer Specialists, 
      Sarasota, FL; Deborah J. Wong, University of California Los Angeles, Los Angeles; 
      Melinda Whiteside, John B. Mumm, Ivan H. Chan, Peter Van Vlasselaer, and Martin 
      Oft, ARMO BioSciences, Redwood City, CA; Gerald S. Falchook, Sarah Cannon 
      Research Institute at HealthONE, Denver, CO; Shubham Pant, Oklahoma University, 
      Oklahoma City, OK; and Johanna C. Bendell, Todd M. Bauer, and Jeffrey R. Infante, 
      Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN.
FAU - Van Vlasselaer, Peter
AU  - Van Vlasselaer P
AD  - Aung Naing, Rivka R. Colen, David S. Hong, and Nizar M. Tannir, MD Anderson 
      Cancer Center, Houston; Kyriakos P. Papadopoulos and Drew R. Rasco, START Center 
      for Cancer Care, San Antonio, TX; Karen A. Autio, Memorial Sloan Kettering Cancer 
      Center, New York, NY; Patrick A. Ott, Dana-Farber Cancer Institute, Boston, MA; 
      Manish R. Patel, Sarah Cannon Research Institute/Florida Cancer Specialists, 
      Sarasota, FL; Deborah J. Wong, University of California Los Angeles, Los Angeles; 
      Melinda Whiteside, John B. Mumm, Ivan H. Chan, Peter Van Vlasselaer, and Martin 
      Oft, ARMO BioSciences, Redwood City, CA; Gerald S. Falchook, Sarah Cannon 
      Research Institute at HealthONE, Denver, CO; Shubham Pant, Oklahoma University, 
      Oklahoma City, OK; and Johanna C. Bendell, Todd M. Bauer, and Jeffrey R. Infante, 
      Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN.
FAU - Tannir, Nizar M
AU  - Tannir NM
AD  - Aung Naing, Rivka R. Colen, David S. Hong, and Nizar M. Tannir, MD Anderson 
      Cancer Center, Houston; Kyriakos P. Papadopoulos and Drew R. Rasco, START Center 
      for Cancer Care, San Antonio, TX; Karen A. Autio, Memorial Sloan Kettering Cancer 
      Center, New York, NY; Patrick A. Ott, Dana-Farber Cancer Institute, Boston, MA; 
      Manish R. Patel, Sarah Cannon Research Institute/Florida Cancer Specialists, 
      Sarasota, FL; Deborah J. Wong, University of California Los Angeles, Los Angeles; 
      Melinda Whiteside, John B. Mumm, Ivan H. Chan, Peter Van Vlasselaer, and Martin 
      Oft, ARMO BioSciences, Redwood City, CA; Gerald S. Falchook, Sarah Cannon 
      Research Institute at HealthONE, Denver, CO; Shubham Pant, Oklahoma University, 
      Oklahoma City, OK; and Johanna C. Bendell, Todd M. Bauer, and Jeffrey R. Infante, 
      Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN.
FAU - Oft, Martin
AU  - Oft M
AD  - Aung Naing, Rivka R. Colen, David S. Hong, and Nizar M. Tannir, MD Anderson 
      Cancer Center, Houston; Kyriakos P. Papadopoulos and Drew R. Rasco, START Center 
      for Cancer Care, San Antonio, TX; Karen A. Autio, Memorial Sloan Kettering Cancer 
      Center, New York, NY; Patrick A. Ott, Dana-Farber Cancer Institute, Boston, MA; 
      Manish R. Patel, Sarah Cannon Research Institute/Florida Cancer Specialists, 
      Sarasota, FL; Deborah J. Wong, University of California Los Angeles, Los Angeles; 
      Melinda Whiteside, John B. Mumm, Ivan H. Chan, Peter Van Vlasselaer, and Martin 
      Oft, ARMO BioSciences, Redwood City, CA; Gerald S. Falchook, Sarah Cannon 
      Research Institute at HealthONE, Denver, CO; Shubham Pant, Oklahoma University, 
      Oklahoma City, OK; and Johanna C. Bendell, Todd M. Bauer, and Jeffrey R. Infante, 
      Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN.
FAU - Infante, Jeffrey R
AU  - Infante JR
AD  - Aung Naing, Rivka R. Colen, David S. Hong, and Nizar M. Tannir, MD Anderson 
      Cancer Center, Houston; Kyriakos P. Papadopoulos and Drew R. Rasco, START Center 
      for Cancer Care, San Antonio, TX; Karen A. Autio, Memorial Sloan Kettering Cancer 
      Center, New York, NY; Patrick A. Ott, Dana-Farber Cancer Institute, Boston, MA; 
      Manish R. Patel, Sarah Cannon Research Institute/Florida Cancer Specialists, 
      Sarasota, FL; Deborah J. Wong, University of California Los Angeles, Los Angeles; 
      Melinda Whiteside, John B. Mumm, Ivan H. Chan, Peter Van Vlasselaer, and Martin 
      Oft, ARMO BioSciences, Redwood City, CA; Gerald S. Falchook, Sarah Cannon 
      Research Institute at HealthONE, Denver, CO; Shubham Pant, Oklahoma University, 
      Oklahoma City, OK; and Johanna C. Bendell, Todd M. Bauer, and Jeffrey R. Infante, 
      Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN.
LA  - eng
SI  - ClinicalTrials.gov/NCT02009449
GR  - P30 CA008748/CA/NCI NIH HHS/United States
GR  - UL1 TR000371/TR/NCATS NIH HHS/United States
PT  - Clinical Trial, Phase I
PT  - Journal Article
PL  - United States
TA  - J Clin Oncol
JT  - Journal of clinical oncology : official journal of the American Society of 
      Clinical Oncology
JID - 8309333
RN  - 0 (AM0010)
RN  - 0 (Cytokines)
RN  - 0 (Interleukin-8)
RN  - 0 (Recombinant Proteins)
RN  - 0 (Transforming Growth Factor beta)
RN  - 130068-27-8 (Interleukin-10)
RN  - 207137-56-2 (Interleukin-4)
RN  - 3WJQ0SDW1A (Polyethylene Glycols)
RN  - 82115-62-6 (Interferon-gamma)
RN  - Uveal melanoma
SB  - IM
CIN - J Clin Oncol. 2016 Oct 10;34(29):3576-3578. PMID: 27573656
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Anemia/chemically induced
MH  - Carcinoma, Renal Cell/drug therapy
MH  - Cytokines/*blood
MH  - Drug Eruptions/etiology
MH  - Exanthema/chemically induced
MH  - Fatigue/chemically induced
MH  - Female
MH  - Fever/chemically induced
MH  - Humans
MH  - Injections, Subcutaneous/adverse effects
MH  - Interferon-gamma/blood
MH  - Interleukin-10/*adverse effects/immunology/pharmacokinetics/therapeutic use
MH  - Interleukin-4/blood
MH  - Interleukin-8/blood
MH  - Kidney Neoplasms/drug therapy
MH  - Male
MH  - Melanoma/drug therapy
MH  - Middle Aged
MH  - Neoplasms/*drug therapy/pathology
MH  - Polyethylene Glycols/*adverse effects/pharmacokinetics/therapeutic use
MH  - Recombinant Proteins/adverse effects/immunology/pharmacokinetics/therapeutic use
MH  - Thrombocytopenia/chemically induced
MH  - Transforming Growth Factor beta/blood
MH  - Uveal Neoplasms/drug therapy
MH  - Young Adult
PMC - PMC5657013
COIS- Authors' disclosures of potential conflicts of interest are found in the article 
      online at www.jco.org. Author contributions are found at the end of this article.
EDAT- 2016/08/17 06:00
MHDA- 2017/09/13 06:00
PMCR- 2017/10/10
CRDT- 2016/08/17 06:00
PHST- 2016/08/17 06:00 [pubmed]
PHST- 2017/09/13 06:00 [medline]
PHST- 2016/08/17 06:00 [entrez]
PHST- 2017/10/10 00:00 [pmc-release]
AID - JCO.2016.68.1106 [pii]
AID - 681106 [pii]
AID - 10.1200/JCO.2016.68.1106 [doi]
PST - ppublish
SO  - J Clin Oncol. 2016 Oct 10;34(29):3562-3569. doi: 10.1200/JCO.2016.68.1106.