Phase I/II study of metastatic melanoma patients treated with nivolumab who had progressed after ipilimumab

Cancer Immunology Research

Volumn 4, Issue 4, 2016, Pages 345-353

  Weber, Jeffrey ^b   Gibney, Geoffrey ^c   Kudchadkar, Ragini ^d   Yu, Bin ^a   Cheng, Pingyan ^a   Martinez, Alberto J ^a   Kroeger, Jodie ^a   Richards, Allison ^a   McCormick, Lori ^a   Moberg, Valerie ^a   Cronin, Heather ^a   Zhao, Xiuhua ^a   Schell, Michael ^a   Chen, Yian Ann ^a  

^a H LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE   (United States)

^b NEW YORK UNIVERSITY MEDICAL CENTER   (United States)

^c GEORGETOWN UNIVERSITY   (United States)

^d EMORY UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ALKALINE PHOSPHATASE; ASPARTATE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE ISOENZYME 2; B RAF KINASE; CREATININE; IPILIMUMAB; NIVOLUMAB; PEPTIDE VACCINE; PREDNISONE; TRIACYLGLYCEROL LIPASE; ANTINEOPLASTIC AGENT; BIOLOGICAL MARKER; MONOCLONAL ANTIBODY;

ACNE; ADRENAL INSUFFICIENCY; ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALKALINE PHOSPHATASE BLOOD LEVEL; ALLERGIC REACTION; ANEMIA; ANOREXIA; ARTHRALGIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BRAIN METASTASIS; CANCER GROWTH; CANCER OF UNKNOWN PRIMARY SITE; CANCER REGRESSION; CHILL; COHORT ANALYSIS; COLITIS; CONFUSION; CONSTIPATION; COUGHING; CREATININE BLOOD LEVEL; CUTANEOUS MELANOMA; DIARRHEA; DISEASE SEVERITY; DRY EYE; DRY SKIN; DYSPNEA; EDEMA; ENDOCRINE DISEASE; ERYTHEMA MULTIFORME; EYE MELANOMA; FATIGUE; FEMALE; FEVER; FLOW CYTOMETRY; FLU LIKE SYNDROME; FOLLOW UP; GASTROINTESTINAL DISEASE; HEADACHE; HUMAN; HUMAN CELL; HYPERGLYCEMIA; HYPERHIDROSIS; HYPERTHYROIDISM; HYPONATREMIA; HYPOTHYROIDISM; IMMUNOPATHOLOGY; INFUSION RELATED REACTION; INJECTION SITE REACTION; LEUKOCYTE COUNT; LIMB PAIN; LONG TERM SURVIVAL; LYMPHOCYTE COUNT; MACULOPAPULAR RASH; MAJOR CLINICAL STUDY; MALE; METASTATIC MELANOMA; MIDDLE AGED; MUCOSA INFLAMMATION; MUSCLE WEAKNESS; MYALGIA; MYELOID-DERIVED SUPPRESSOR CELL; NAUSEA; NEUTROPHIL COUNT; OVERALL SURVIVAL; PAIN; PANCREATITIS; PERIPHERAL BLOOD MONONUCLEAR CELL; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PNEUMONIA; PROGRESSION FREE SURVIVAL; PRURITUS; SIDE EFFECT; SKIN DISEASE; STOMACH PAIN; SURVIVAL RATE; TREATMENT DURATION; TREATMENT RESPONSE; TRIACYLGLYCEROL LIPASE BLOOD LEVEL; VOMITING; WEIGHT REDUCTION; XEROSTOMIA; AGED; BONE MARROW CELL; CANCER STAGING; CLINICAL TRIAL; DISEASE COURSE; DRUG RESISTANCE; IMMUNOLOGY; IMMUNOPHENOTYPING; KAPLAN MEIER METHOD; MELANOMA; METABOLISM; METASTASIS; MORTALITY; MULTIMODALITY CANCER THERAPY; PATHOLOGY; RETREATMENT; TREATMENT OUTCOME;

ADULT; AGED; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC AGENTS; BIOMARKERS; COHORT STUDIES; COMBINED MODALITY THERAPY; DISEASE PROGRESSION; DRUG RESISTANCE, NEOPLASM; FEMALE; HUMANS; IMMUNOPHENOTYPING; KAPLAN-MEIER ESTIMATE; MALE; MELANOMA; MIDDLE AGED; MYELOID CELLS; NEOPLASM METASTASIS; NEOPLASM STAGING; RETREATMENT; TREATMENT OUTCOME;

EID: 85016509105     PISSN: 23266066     EISSN: 23266074     Source Type: Journal    
DOI: 10.1158/2326-6066.CIR-15-0193     Document Type: Article

References (33)

1. Brahmer JR, Drake CG, Wollner I, Powderly J, Picus J, Sharfman WH, et al. Phase I study of single-agent anti-programmed death-1 (MDX-1106) in refractory solid tumors: Safety, clinical activity, pharmacodynamics, and immunologic correlates. J Clin Oncol 2010;28:3167-75.
2. Topalian SL, Hodi FS, Brahmer JR, Gettinger SN, Smith DC, McDermott D F, et al. Safety, activity, and immune correlates of anti-PD-1 antibody in cancer. N Engl J Med 2012;366:2443-53.
3. Weber JS, D'Angelo SP, Minor D, Hodi FS, Gutzmer R, Neyns B, et al. Nivolumab versus chemotherapy in patients with advanced melanoma who progressed after anti-CTLA-4 treatment (CheckMate 037): A randomised, controlled, open-label, phase 3 trial. Lancet Oncol 2015;16: 375-84.
4. Robert C, Long GV, Brady B, Dutriaux C, Maio M, Mortier L, et al. Nivolumab in previously untreated melanoma without BRAF mutation. N Engl J Med 2015;372:320-30.
5. Sznol M, Kluger HM, Hodi FS, McDermott DF, Carvajal RD, Lawrence DP, et al. Survival and long-term follow-up of safety and response in patients (pts)with advanced melanoma (MEL) in a phase I trial of nivolumab (anti- PD-1; BMS-936558; ONO-4538). J Clin Oncol 2013;31:549s(suppl; abstr CRA9006).
6. Topalian SL, Sznol M, McDermott DF, Kluger HM, Carvajal RD, Sharfman WH, et al. Survival, durable tumor remission, and long-term safety in patients with advanced melanoma receiving nivolumab. J Clin Oncol 2014;32:1020-30.
7. Hamid O, Robert C, Daud A, Hodi FS, Hwu WJ, Kefford R, et al. Safety and tumor responses with lambrolizumab (anti-PD-1) in melanoma. N Engl J Med 2013;369:134-44.
8. Patnaik A, Kang SP, Rasco D, Papadopoulos KP, Elassaiss-Schaap J, Beeram M, et al., Phase I study of pembrolizumab (MK-3475; Anti-PD-1 Monoclonal Antibody) in patients with advanced solid tumors. Clin Cancer Res 2015;21:4286-93.
9. Taube JM, Anders RA, Young GD, Xu H, Sharma R, McMiller TL et al Colocalization of inflammatory response with B7-H1 expression in human melanocytic lesions supports an adaptive resistance mechanism of immune escape. Sci Transl Med 2012;4:127-37.
10. Taube JM, Klein A, Brahmer JR, Xu H, Pan X, Kim JH, et al. Association of PD-1, PD-1 ligands, and other features of the tumor immune microenvironment with response to anti-PD-1 therapy. Clin Cancer Res 2014;20: 5064-74.
11. Tumeh PC, Harview CL, Yearley JH, Shintaku IP, Taylor EJ, Robert L, et al., PD-1 blockade induces responses by inhibiting adaptive immune resistance. Nature 2014;515:568-71.
12. Taube JM, Young GD, McMiller TL, Chen S, Salas JT, Pritchard TS, et al. Differential expression of immune-regulatory genes associated with PD-L1 display in melanoma: implications for PD-1 pathway blockade. Clin Cancer Res 2015;21:3969-76.
13. Weber JS, Kudchadkar RR, Yu B, Gallenstein D, Horak CE, Inzunza HD, et al., Safety, efficacy, and biomarkers of nivolumab with vaccinein ipilimumab-refractory or -naive melanoma. J Clin Oncol 2013;31: 4311-8.
14. Wolchok JD, Hoos A, O'Day S, Weber JS, Hamid O, Lebbe C, et al. Guidelines for the evaluation of immune therapy activity in solid tumors: immune-related response criteria. Clin Cancer Res 2009;15: 7412-20.
15. Gabrilovich DI, Ostrand-Rosenberg S, Bronte V. Coordinated regulation of myeloid cells by tumours. Nat Rev Immunol 2012;12:253-68.
16. Freeman-Keller M, Weber JS. Nivolumab in resected and unresectable melanoma: immune-related adverse events and association with survival outcomes. J Clin Oncol 33, 2015(suppl; abstr 9028).
17. Ansell SM, Lesokhin AM, Borrello I, Halwani A, Scott EC, Gutierrez M, et al. PD-1 blockade with nivolumab in relapsed or refractory Hodgkin's lymphoma. N Engl J Med 2015;372:311-9.
18. Gettinger SN, Horn L, Gandhi L, Spigel DR, Antonia SJ, Rizvi NA, et al. Overall survival and long-term safety of nivolumab (Anti-Programmed Death 1 Antibody, BMS-936558, ONO-4538) in patients with previously treated advanced non-small-cell lung cancer. J Clin Oncol 2015; 33:2004-12.
19. McDermott DF, Drake CG, Sznol M, Choueiri TK, Powderly JD, Smith DC, et al. Survival, durable response, and long-term safety in patients with previously treated advanced renal cell carcinoma receiving nivolumab. J Clin Oncol 2015;33:2013-20.
20. Garon EB, Rizvi NA, Hui R, Leighl N, Balmanoukian AS, Eder JP, et al. KEYNOTE-001 Investigators. Pembrolizumab for the treatment of nonsmall- cell lung cancer. N Engl J Med 2015;372:2018-28.
21. Rizvi NA, Mazieres J, Planchard D, Stinchcombe TE, Dy GK, Antonia SJ, et al. Activity and safety of nivolumab, an anti-PD-1 immune checkpoint inhibitor, for patients with advanced, refractory squamous non-small-cell lung cancer (CheckMate 063): A phase 2, single-arm trial. Lancet Oncol 2015;16:257-65.
22. Poschke I, Mougiakakos D, Hansson J, Masucci GV, Kiessling R. Immature immunosuppressive CD14HLA-DR-/low cells in melanoma patients are Stat3hi and overexpress CD80, CD83, and DC-sign. Cancer Res 2010;70: 4335-520.
23. Gros A, Turcotte S, Wunderlich JR, AhmadzadehM, Dudley ME, Rosenberg SA. Myeloid cells obtained from the blood but not from the tumor can suppress T-cell proliferation in patients with melanoma. Clin Cancer Res 2012;18:5212-23.
24. Kitano S, Postow MA, Ziegler CG, Kuk D, Panageas KS, Cortez C, et al. Computational algorithm-driven evaluation of monocytic myeloidderived suppressor cell frequency for prediction of clinical outcomes. Cancer Immunol Res 2014;2:812-21.
25. Pico de Coa~na Y, Poschke I, Gentilcore G, Mao Y, Nystrom M, Hansson J, et al. Ipilimumab treatment results in an early decrease in the frequency of circulating granulocytic myeloid-derived suppressor cells as well as their Arginase1 production. Cancer Immunol Res 2013;1:158-62.
26. Tarhini AA, Edington H, Butterfield LH, Lin Y, Shuai Y, Tawbi H, et al. Immune monitoring of the circulation and the tumor microenvironment in patients with regionally advanced melanoma receiving neoadjuvant ipilimumab. PLoS One 2014;9:e87705.
27. Meyer C, Cagnon L, Costa-Nunes CM, Baumgaertner P, Montandon N, Leyvraz L, et al. Frequencies of circulating MDSC correlate with clinical outcome of melanoma patients treated with ipilimumab. Cancer Immunol Immunother 2014;63:247-57.
28. Weide B, Martens A, Zelba H, Stutz C, Derhovanessian E, Di Giacomo AM, et al. Myeloid-derived suppressor cells predict survival of patients with advancedmelanoma: comparisonwith regulatory T cells and NY-ESO-1- or Melan-A-specific T cells. Clin Cancer Res 2014;20:1601-9.
29. Zhao F, Hoechst B, Dufy A, Gamrekelashvili J, Fioravanti S, Manns MP, et al. S100A9: A new marker for monocytic human myeloid derived suppressor cells. Immunology 2012;136:176-83.
30. Wolchok JD, Kluger H, Callahan MK, Postow MA, Rizvi NA, Lesokhin AM, et al. Nivolumab plus ipilimumab in advanced melanoma. N Engl J Med 2013;369:122-33.
31. Postow MA, Chesney J, Pavlick AC, Robert C, Grossmann K, McDermott D, et al. Nivolumab and ipilimumab versus ipilimumab in untreated melanoma. N Engl J Med 2015;372:2006-17.
32. Larkin J, Chiarion-Sileni V, Gonzalez R, Grob J-J, Cowey L, Lao CD, et al. Combined nivolumab and ipilimumab or monotherapy in previously untreated melanoma. N Engl J Med 2015.
33. Lipson EJ, Sharfman WH, Drake CG, Wollner I, Taube JM, Anders RA, et al. Durable cancer regression off-treatment and effective reinduction therapy with an anti-PD-1 antibody. Clin Cancer Res 2013;19:462-8.