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

The Lancet Oncology

Volumn 16, Issue 4, 2015, Pages 375-384

  Weber, Jeffrey S ^a   D'Angelo, Sandra P ^b   Minor, David ^c   Hodi, F Stephen ^d   Gutzmer, Ralf ^e   Neyns, Bart ^f   Hoeller, Christoph ^g   Khushalani, Nikhil I ^h   Miller, Wilson H ⁱ   Lao, Christopher D ^j   Linette, Gerald P ^k   Thomas, Luc ^l   Lorigan, Paul ^m   Grossmann, Kenneth F ⁿ   Hassel, Jessica C ^o   Maio, Michele ^p   Sznol, Mario ^q   Ascierto, Paolo A ^r   Mohr, Peter ^s   Chmielowski, Bartosz ^t   Bryce, Alan ^u   Svane, Inge M ^v   Grob, Jean Jacques ^w   Krackhardt, Angela M ^x   Horak, Christine ^y   Lambert, Alexandre ^y   Yang, Arvin S ^y   Larkin, James ^z   more..

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

^b MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

^c California Pacific Center for Melanoma Research and Treatment   (United States)

^d DANA FARBER CANCER INSTITUTE   (United States)

^e HANNOVER MEDICAL SCHOOL   (Germany)

^f UNIVERSITY HOSPITAL BRUSSELS   (Belgium)

^g MEDICAL UNIVERSITY OF VIENNA   (Austria)

^h ROSWELL PARK CANCER INSTITUTE   (United States)

ⁱ MCGILL UNIVERSITY   (Canada)

^j UNIVERSITY OF MICHIGAN   (United States)

^k WASHINGTON UNIVERSITY   (United States)

^l HOSPICES CIVILS DE LYON   (France)

^m CHRISTIE HOSPITAL   (United Kingdom)

ⁿ UNIVERSITY OF UTAH   (United States)

^o GERMAN CANCER RESEARCH CENTER DKFZ   (Germany)

^p UNIVERSITY HOSPITAL OF SIENA   (Italy)

^q YALE CANCER CENTER   (United States)

^r NATIONAL CANCER INSTITUTE   (Italy)

^s Elbe Kliniken   (Germany)

^t UNIVERSITY OF CALIFORNIA   (United States)

^u MAYO CLINIC   (United States)

^v GENTOFTE UNIVERSITY HOSPITAL   (Denmark)

^w AIX MARSEILLE UNIVERSITY   (France)

^x TECHNICAL UNIVERSITY OF MUNICH   (Germany)

^y BRISTOL MYERS SQUIBB   (United States)

^z ROYAL MARSDEN HOSPITAL   (United Kingdom)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ANTINEOPLASTIC AGENT; B RAF KINASE; BRAF PROTEIN, HUMAN; CARBOPLATIN; CYTOTOXIC T LYMPHOCYTE ANTIGEN 4; IPILIMUMAB; MONOCLONAL ANTIBODY; NIVOLUMAB; PACLITAXEL;

ADULT; ADVERSE DRUG REACTION; AGED; ANTAGONISTS AND INHIBITORS; CANCER STAGING; CLINICAL TRIAL; CONTROLLED STUDY; DISEASE FREE SURVIVAL; FEMALE; GENETICS; HUMAN; IMMUNOLOGY; MALE; MELANOMA; MIDDLE AGED; MULTICENTER STUDY; PATHOLOGY; PHASE 3 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARBOPLATIN; CTLA-4 ANTIGEN; DISEASE-FREE SURVIVAL; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; FEMALE; HUMANS; MALE; MELANOMA; MIDDLE AGED; NEOPLASM STAGING; PACLITAXEL; PROTO-ONCOGENE PROTEINS B-RAF;

EID: 84931083080     PISSN: 14702045     EISSN: 14745488     Source Type: Journal    
DOI: 10.1016/S1470-2045(15)70076-8     Document Type: Article

References (30)

1. Ishida Y, Agata Y, Shibahara K, Honjo T Induced expression of PD-1, a novel member of the immunoglobulin gene superfamily, upon programmed cell death. EMBO J 1992, 11:3887-3895.
2. Freeman GJ, Long AJ, Iwai Y, et al. Engagement of the PD-1 immunoinhibitory receptor by a novel B7 family member leads to negative regulation of lymphocyte activation. J Exp Med 2000, 192:1027-1034.
3. Keir ME, Liang SC, Guleria I, et al. Tissue expression of PD-L1 mediates peripheral T cell tolerance. J Exp Med 2006, 203:883-895.
4. Nishimura H, Nose M, Hiai H, Minato N, Honjo T Development of lupus-like autoimmune diseases by disruption of the PD-1 gene encoding an ITIM motif-carrying immunoreceptor. Immunity 1999, 11:141-151.
5. Nishimura H, Okazaki T, Tanaka Y, et al. Autoimmune dilated cardiomyopathy in PD-1 receptor-deficient mice. Science 2001, 291:319-322.
6. Dong H, Strome SE, Salomao DR, et al. Tumor-associated B7-H1 promotes T-cell apoptosis: a potential mechanism of immune evasion. Nat Med 2002, 8:793-800.
7. Brahmer JR, Drake CG, Wollner I, 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, 28:3167-3175.
8. Topalian SL, Hodi FS, Brahmer JR, et al. Safety, activity, and immune correlates of anti-PD-1 antibody in cancer. N Engl J Med 2012, 366:2443-2454.
9. Lipson EJ, Sharfman WH, Drake CG, et al. Durable cancer regression off-treatment and effective reinduction therapy with an anti-PD-1 antibody. Clin Cancer Res 2013, 19:462-468.
10. Topalian SL, Sznol M, McDermott DF, et al. Survival, durable tumor remission, and long-term safety in patients with advanced melanoma receiving nivolumab. J Clin Oncol 2014, 32:1020-1030.
11. Weber JS, Kudchadkar RR, Yu B, et al. Safety, efficacy, and biomarkers of nivolumab with vaccine in ipilimumab-refractory or -naive melanoma. J Clin Oncol 2013, 31:4311-4318.
12. Hamid O, Robert C, Daud A, et al. Safety and tumor responses with lambrolizumab (anti-PD-1) in melanoma. N Engl J Med 2013, 369:134-144.
13. Robert C, Ribas A, Wolchok JD, et al. Anti-programmed-death-receptor-1 treatment with pembrolizumab in ipilimumab-refractory advanced melanoma: a randomised dose-comparison cohort of a phase 1 trial. Lancet 2014, 384:1109-1117.
14. Robert C, Long GV, Brady B, et al. Nivolumab in previously untreated melanoma without BRAF mutation. N Engl J Med 2015, 372:320-330.
15. Ansell SM, Lesokhin AM, Borello I, et al. PD-1 blockade with nivolumab in relapsed or refractory Hodgkin's lymphoma. N Engl J Med 2015, 372:311-319.
16. Powles T, Vogelzang NJ, Fine GD, et al. Inhibition of PD-L1 by MPDL3280A and clinical activity in pts with metastatic urothelial bladder cancer (UBC). J Clin Oncol 2014, 32(suppl):5S. (abstr 5011).
17. Seiwert TY, Burtness B, Weiss J, et al. A phase Ib study of MK-3475 in patients with human papillomavirus (HPV)-associated and non-HPV-associated head and neck (H/N) cancer. J Clin Oncol 2014, 32(suppl):5S. (abstr 6011).
18. Hamanishi J, Mandai M, Ikeda T, et al. Efficacy and safety of anti-PD-1 antibody (nivolumab: BMS-936558, ONO-4538) in patients with platinum-resistant ovarian cancer. J Clin Oncol 2014, 32(suppl):5S. (abstr 5511).
19. Wolchok JD, Kluger H, Callahan MK, et al. Nivolumab plus ipilimumab in advanced melanoma. N Engl J Med 2013, 369:122-133.
20. Eisenhauer EA, Therasse P, Bogaert J, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 2009, 45:228-247.
21. Wolchok JD, Hoos A, O'Day S, et al. Guidelines for the evaluation of immune therapy activity in solid tumors: immune-related response criteria. Clin Cancer Res 2009, 15:7412-7420.
22. Nishino M, Giobbie-Hurder A, Gargano M, Suda M, Ramaiya NH, Hodi FS Developing a common language for tumor response to immunotherapy: immune-related response criteria using unidimensional measurements. Clin Cancer Res 2013, 19:3936-3943.
23. Hodi FS, Ribas A, Daud A, et al. Evaluation of immune-related response criteria (irRC) in patients (pts) with advanced melanoma (MEL) treated with the anti-PD-1 monoclonal antibody MK-3475. J Clin Oncol 2014, 32(suppl):5S. (abstr 3006).
24. Armand P, Nagler A, Weller EA, et al. Disabling immune tolerance by programmed death-1 blockade with pidilizumab after autologous hematopoietic stem-cell transplantation for diffuse large B-cell lymphoma: results of an international phase II trial. J Clin Oncol 2013, 31:4199-4206.
25. Brahmer JR, Tykodi SS, Chow LQ, et al. Safety and activity of anti-PD-L1 antibody in patients with advanced cancer. N Engl J Med 2012, 366:2455-2465.
26. Segal NH, Antonia SJ, Brahmer JR, et al. Preliminary data from a multi-arm expansion study of MEDI4736, an anti-PD-L1 antibody. J Clin Oncol 2014, 32(suppl):5S. (abstr 3002).
27. Herbst RS, Gordon MS, Fine GD, et al. A study of MPDL3280A, an engineered PD-L1 antibody in patients with locally advanced or metastatic tumors. J Clin Oncol 2013, 31(suppl). (abstr 3000).
28. Ribas A, Puzanov I, Dummer R, et al. A randomized controlled comparison of pembrolizumab and chemotherapy in patients with ipilimumab-refractory melanoma. 2015 Society for Melanoma Research Annual Meeting; Zurich, Switzerland; Nov 13-16, 2014.
29. Robert C, Schadendorf D, Messina M, Hodi FS, O'Day S Efficacy and safety of retreatment with ipilimumab in patients with pretreated advanced melanoma who progressed after initially achieving disease control. Clin Cancer Res 2013, 19:2232-2239. for the MDX010-20 investigators.
30. Weber J, Kahler K, Hauschild A Management of immune-related adverse events and kinetics of response with ipilimumab. J Clin Oncol 2012, 30:2691-2697.