Sequential administration of nivolumab and ipilimumab with a planned switch in patients with advanced melanoma (CheckMate 064): an open-label, randomised, phase 2 trial

The Lancet Oncology

Volumn 17, Issue 7, 2016, Pages 943-955

  Weber, Jeffrey S ^a,b   Gibney, Geoff ^b,c   Sullivan, Ryan J ^d   Sosman, Jeffrey A ^e   Slingluff, Craig L ^f   Lawrence, Donald P ^d   Logan, Theodore F ^g   Schuchter, Lynn M ^h   Nair, Suresh ⁱ   Fecher, Leslie ^g,j   Buchbinder, Elizabeth I ^k   Berghorn, Elmer ^l   Ruisi, Mary ^l   Kong, George ^l   Jiang, Joel ^l   Horak, Christine ^l   Hodi, F Stephen ^m  

^a NEW YORK UNIVERSITY MEDICAL CENTER   (United States)

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

^c GEORGETOWN UNIVERSITY   (United States)

^d MASSACHUSETTS GENERAL HOSPITAL   (United States)

^e VANDERBILT INGRAM CANCER CENTER   (United States)

^f UNIVERSITY OF VIRGINIA   (United States)

^g INDIANA UNIVERSITY SCHOOL OF MEDICINE   (United States)

^h UNIVERSITY OF PENNSYLVANIA   (United States)

ⁱ LEHIGH VALLEY HOSPITAL   (United States)

^j UNIVERSITY OF MICHIGAN   (United States)

^k BETH ISRAEL DEACONESS MEDICAL CENTER   (United States)

^l BRISTOL MYERS SQUIBB   (United States)

^m DANA FARBER CANCER INSTITUTE   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ALKALINE PHOSPHATASE; AMYLASE; ASPARTATE AMINOTRANSFERASE; IPILIMUMAB; NIVOLUMAB; TRIACYLGLYCEROL LIPASE; ANTINEOPLASTIC AGENT; MONOCLONAL ANTIBODY;

ABDOMINAL PAIN; ACUTE KIDNEY FAILURE; ACUTE PANCREATITIS; ADRENAL INSUFFICIENCY; ADULT; AGED; ARTHRALGIA; ARTICLE; AUTOIMMUNE DISEASE; BACKACHE; CANCER STAGING; CHILL; COLITIS; CONTINUOUS INFUSION; CONTROLLED STUDY; COUGHING; CROHN DISEASE; DECREASED APPETITE; DEHYDRATION; DEMYELINATING NEUROPATHY; DIARRHEA; DISEASE COURSE; DOSAGE SCHEDULE COMPARISON; DRUG FATALITY; DRUG SAFETY; DRUG SUBSTITUTION; DRUG WITHDRAWAL; DYSPNEA; ENCEPHALITIS; ENTEROCOLITIS; ERYTHRODERMA; FATIGUE; FEMALE; FEVER; FOLLOW UP; HEADACHE; HEARING IMPAIRMENT; HEART FAILURE; HEPATITIS; HUMAN; HYPERGLYCEMIA; HYPERTENSION; HYPERTRANSAMINASEMIA; HYPOPHYSITIS; HYPOTENSION; HYPOTHYROIDISM; INTERACTIVE VOICE RESPONSE SYSTEM; KIDNEY FAILURE; LEUKOPENIA; LIVER DISEASE; LYMPHOCYTOPENIA; MACULAR EDEMA; MACULOPAPULAR RASH; MAJOR CLINICAL STUDY; MALE; MELANOMA; MENTAL DEFICIENCY; MIDDLE AGED; MULTICENTER STUDY; MUSCLE SPASM; MUSCLE WEAKNESS; MYASTHENIA GRAVIS; NAUSEA; NEUTROPENIA; OPEN STUDY; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PNEUMONIA; POLYDIPSIA; PRIORITY JOURNAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RASH; RESPIRATORY FAILURE; SEQUENTIAL ANALYSIS; SIDE EFFECT; TREATMENT OUTCOME; TREATMENT RESPONSE; UNITED STATES; VITILIGO; VOMITING; CLINICAL TRIAL; DRUG ADMINISTRATION; PATHOLOGY; PROGNOSIS; SKIN NEOPLASMS; SURVIVAL RATE;

AGED; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; DRUG ADMINISTRATION SCHEDULE; FEMALE; FOLLOW-UP STUDIES; HUMANS; MALE; MELANOMA; MIDDLE AGED; NEOPLASM STAGING; PROGNOSIS; SKIN NEOPLASMS; SURVIVAL RATE;

EID: 84991110530     PISSN: 14702045     EISSN: 14745488     Source Type: Journal    
DOI: 10.1016/S1470-2045(16)30126-7     Document Type: Article

References (22)

1. 1 Schadendorf, D, Hodi, FS, Robert, C, et al. Pooled analysis of long-term survival data from phase II and phase III trials of ipilimumab in unresectable or metastatic melanoma. J Clin Oncol 33 (2015), 1889–1894.
2. 2 Wang, C, Thudium, KB, Han, M, et al. In vitro characterization of the anti-PD-1 antibody nivolumab, BMS-936558, and in vivo toxicology in non-human primates. Cancer Immunol Res 2 (2014), 846–856.
3. 3 Robert, C, Long, GV, Brady, B, et al. Nivolumab in previously untreated melanoma without BRAF mutation. N Engl J Med 372 (2015), 320–330.
4. 4 Weber, JS, D'Angelo, SP, Minor, D, 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 16 (2015), 375–384.
5. 5 Okazaki, T, Chikuma, S, Iwai, Y, Fagarasan, S, Honjo, T, A rheostat for immune responses: the unique properties of PD-1 and their advantages for clinical application. Nat Immunol 14 (2013), 1212–1218.
6. 6 Larkin, J, Chiarion-Sileni, V, Gonzalez, R, et al. Combined nivolumab and ipilimumab or monotherapy in untreated melanoma. N Engl J Med 373 (2015), 23–34.
7. 7 Wolchok, JD, Kluger, H, Callahan, MK, et al. Nivolumab plus ipilimumab in advanced melanoma. N Engl J Med 369 (2013), 122–133.
8. 8 Postow, MA, Chesney, J, Pavlick, AC, et al. Nivolumab and ipilimumab versus ipilimumab in untreated melanoma. N Engl J Med 372 (2015), 2006–2017.
9. 9 Ji, RR, Chasalow, SD, Wang, L, et al. An immune-active tumor microenvironment favors clinical response to ipilimumab. Cancer Immunol Immunother 61 (2012), 1019–1031.
10. 10 Tarhini, AA, Edington, H, Butterfield, LH, et al. Immune monitoring of the circulation and the tumor microenvironment in patients with regionally advanced melanoma receiving neoadjuvant ipilimumab. PLoS One, 9, 2014, e87705.
11. 11 Taube, JM, Young, GD, McMiller, TL, et al. Differential expression of immune-regulatory genes associated with PD-L1 display in melanoma: implications for PD-1 pathway blockade. Clin Cancer Res 21 (2015), 3969–3976.
12. 12 Kluger H, Sznol M, Callahan MK, et al. Survival, response duration, and activity by BRAF mutation status in a phase 1 trial of nivolumab (anti-PD-1, BMS-936558, ONO-4538) and ipilimumab concurrent or sequenced therapy in advanced melanoma. 39th European Society for Medical Oncology Congress; Madrid, Spain; Sept 26–30, 2014.
13. 13 Eisenhauer, EA, Therasse, P, Bogaerts, J, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 45 (2009), 228–247.
14. 14 Phillips, T, Simmons, P, Inzunza, HD, et al. Development of an automated PD-L1 immunohistochemistry (IHC) assay for non-small cell lung cancer. Appl Immunohistochem Mol Morphol 23 (2015), 541–549.
15. 15 Hodi, FS, O'Day, SJ, McDermott, DF, et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med 363 (2010), 711–723.
16. 16 Robert, C, Thomas, L, Bondarenko, I, et al. Ipilimumab plus dacarbazine for previously untreated metastatic melanoma. N Engl J Med, 364, 2011, 251726.
17. 17 OPDIVO (nivolumab) [package insert], March 2015, Bristol-Myers Squibb Company, Princeton, NJ.
18. 18 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 28 (2010), 3167–3175.
19. 19 Qureshi, OS, Kaur, S, Hou, TZ, et al. Constitutive clathrin-mediated endocytosis of CTLA-4 persists during T cell activation. J Biol Chem 287 (2012), 9429–9440.
20. 20 Pentcheva-Hoang, T, Chen, L, Pardoll, DM, Allison, JP, Programmed death-1 concentration at the immunological synapse is determined by ligand affinity and availability. Proc Natl Acad Sci USA 104 (2007), 17765–17770.
21. 21 Shiratori, T, Miyatake, S, Ohno, H, et al. Tyrosine phosphorylation controls internalization of CTLA-4 by regulating its interaction with clathrin-associated adaptor complex AP-2. Immunity 6 (1997), 583–589.
22. 22 Robert, C, Schachter, J, Long, GV, et al. Pembrolizumab versus ipilimumab in advanced melanoma. N Engl J Med 372 (2015), 2521–2532.