Anti-programmed-death-receptor-1 treatment with pembrolizumab in ipilimumab-refractory advanced melanoma: A randomised dose-comparison cohort of a phase 1 trial

The Lancet

Volumn 384, Issue 9948, 2014, Pages 1109-1117

  Robert, Caroline ^a   Ribas, Antoni ^b   Wolchok, Jedd D ^c   Hodi, F Stephen ^d   Hamid, Omid ^e   Kefford, Richard ^f,g   Weber, Jeffrey S ^h   Joshua, Anthony M ⁱ   Hwu, Wen Jen ^j   Gangadhar, Tara C ^k   Patnaik, Amita ^l   Dronca, Roxana ^m   Zarour, Hassane ⁿ   Joseph, Richard W ^o   Boasberg, Peter ^e   Chmielowski, Bartosz ^b   Mateus, Christine ^a   Postow, Michael A ^c   Gergich, Kevin ^p   Elassaiss Schaap, Jeroen ^p   Li, Xiaoyun Nicole ^p   Iannone, Robert ^p   Ebbinghaus, Scot W ^p   Kang, S Peter ^p   Daud, Adil ^q   more..

^a Universite Paris Sud   (France)

^b UNIVERSITY OF CALIFORNIA   (United States)

^c MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

^d DANA FARBER CANCER INSTITUTE   (United States)

^e Angeles Clinic and Research Institute   (United States)

^f MELANOMA INSTITUTE AUSTRALIA   (Australia)

^g UNIVERSITY OF SYDNEY   (Australia)

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

ⁱ PRINCESS MARGARET HOSPITAL   (Canada)

^j UNIVERSITY OF TEXAS   (United States)

^k UNIVERSITY OF PENNSYLVANIA   (United States)

^l South Texas Accelerated Research Therapeutics   (United States)

^m MAYO CLINIC   (United States)

ⁿ UNIVERSITY OF PITTSBURGH   (United States)

^o MAYO CLINIC   (United States)

^p MERCK RESEARCH LABORATORIES   (United States)

^q UNIVERSITY OF CALIFORNIA   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

IPILIMUMAB; PEMBROLIZUMAB; PROGRAMMED DEATH 1 RECEPTOR; ANTINEOPLASTIC AGENT; MONOCLONAL ANTIBODY;

ADULT; ADVANCED CANCER; ANEMIA; ARTICLE; AUTOIMMUNE HEPATITIS; BRAIN DISEASE; CANCER GROWTH; CONFUSION; CONTROLLED STUDY; CORTICOSTEROID THERAPY; DIARRHEA; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG TREATMENT FAILURE; DRUG WITHDRAWAL; DYSPNEA; FATIGUE; FEMALE; FOLLOW UP; HUMAN; HYPOPHYSITIS; HYPOXIA; MACULOPAPULAR RASH; MAJOR CLINICAL STUDY; MALE; MELANOMA; MIDDLE AGED; MULTICENTER STUDY; MUSCLE WEAKNESS; MUSCULOSKELETAL PAIN; PANCREATITIS; PERIPHERAL NEUROPATHY; PHASE 1 CLINICAL TRIAL; PNEUMONIA; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RASH; TREATMENT RESPONSE; ADOLESCENT; AGED; ANTAGONISTS AND INHIBITORS; CHEMICALLY INDUCED; CLINICAL TRIAL; COMPARATIVE STUDY; DOSE RESPONSE; DRUG ERUPTIONS; DRUG RESISTANCE; SKIN NEOPLASMS; TREATMENT OUTCOME; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC AGENTS; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ERUPTIONS; DRUG RESISTANCE, NEOPLASM; FATIGUE; FEMALE; HUMANS; MALE; MELANOMA; MIDDLE AGED; PROGRAMMED CELL DEATH 1 RECEPTOR; PRURITUS; SKIN NEOPLASMS; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84908354848     PISSN: 01406736     EISSN: 1474547X     Source Type: Journal    
DOI: 10.1016/S0140-6736(14)60958-2     Document Type: Article

References (33)

1. PB Chapman, A Hauschild, C Robert et al. Improved survival with vemurafenib in melanoma with BRAF V600E mutation N Engl J Med 364 2011 2507 2516
2. A Hauschild, J-J Grob, LV Demidov et al. Dabrafenib in BRAF-mutated metastatic melanoma: a multicentre, open-label, phase 3 randomised controlled trial Lancet 380 2012 358 365
3. JA Sosman, KB Kim, L Schuchter et al. Survival in BRAF V600-mutant advanced melanoma treated with vemurafenib N Engl J Med 366 2012 707 714
4. V600K mutation-positive melanoma (BRIM-3): extended follow-up of a phase 3, randomised, open-label study Lancet Oncol 15 2014 323 332
5. KT Flaherty, C Robert, P Hersey et al. Improved survival with MEK inhibition in BRAF-mutated melanoma N Engl J Med 367 2012 107 114
6. PA Ascierto, JM Kirkwood, JJ Grob et al. The role of BRAF V600 mutation in melanoma J Transl Med 10 2012 85
7. KT Flaherty, JR Infante, A Daud et al. Combined BRAF and MEK inhibition in melanoma with BRAF V600 mutations N Engl J Med 367 2012 1694 1703
8. T Okazaki, S Chikuma, Y Iwai, S Fagarasan, T Honjo A rheostat for immune responses: the unique properties of PD-1 and their advantages for clinical application Nat Immunol 14 2013 1212 1218
9. Y Ishida, Y Agata, K Shibahara, T Honjo Induced expression of PD-1, a novel member of the immunoglobulin gene superfamily, upon programmed cell death EMBO J 11 1992 3887 3895
10. ME Keir, MJ Butte, GJ Freeman, AH Sharpe PD-1 and its ligands in tolerance and immunity Annu Rev Immunol 26 2008 677 704
11. DM Pardoll The blockade of immune checkpoints in cancer immunotherapy Nat Rev Cancer 12 2012 252 264
12. LM Francisco, PT Sage, AH Sharpe The PD-1 pathway in tolerance and autoimmunity Immunol Rev 236 2010 219 242
13. SL Topalian, FS Hodi, JR Brahmer et al. Safety, activity, and immune correlates of anti-PD-1 antibody in cancer N Engl J Med 366 2012 2443 2454
14. SL Topalian, M Sznol, DF McDermott et al. Survival, durable tumor remission, and long-term safety in patients with advanced melanoma receiving nivolumab J Clin Oncol 32 2014 1020 1030
15. O Hamid, C Robert, A Daud et al. Safety and tumor responses with lambrolizumab (anti-PD-1) in melanoma N Engl J Med 369 2013 134 144
16. C Robert, O Hamid, A Ribas et al. Updated clinical efficacy and safety of MK-3475 (anti-PD-1 monoclonal antibody) in advanced melanoma Pigment Cell Melanoma Res 26 2013 993 (abstr).
17. JS Weber, RR Kudchadkar, B Yu et al. Safety, efficacy, and biomarkers of nivolumab with vaccine in ipilimumab-refractory or -naive melanoma J Clin Oncol 31 2013 4311 4318
18. JD Wolchok, H Kluger, MK Callahan et al. Nivolumab plus ipilimumab in advanced melanoma N Engl J Med 369 2013 122 133
19. JR Brahmer, SS Tykodi, LQ Chow et al. Safety and activity of anti-PD-L1 antibody in patients with advanced cancer N Engl J Med 366 2012 2455 2465
20. O Hamid, JA Sosman, DP Lawrence et al. Clinical activity, safety, and biomarkers of MPDL3280A, an engineered PD-L1 antibody in patients with locally advanced or metastatic melanoma (mM) J Clin Oncol 31 2013 9010 (abstr).
21. JD Wolchok, A Hoos, S O'Day et al. Guidelines for the evaluation of immune therapy activity in solid tumors: immune-related response criteria Clin Cancer Res 15 2009 7412 7420
22. EA Eisenhauer, P Therasse, J Bogaerts et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1) Eur J Cancer 45 2009 228 247
23. C Clopper, E Pearson The use of confidence or fiducial limits illustrated in the case of the binomial Biometrika 26 1934 404 413
24. O Miettinen, M Nurminen Comparative analysis of two rates Statist Med 4 1985 213 226
25. JD Kalbfleisch, RL Prentice The statistical analysis of failure time data 1980 John Wiley & Sons New York
26. B Efron The Efficiency of Cox's Likelihood Function for Censored Data J Am Stat Assoc 72 1977 557 565
27. S Beal, LB Sheiner, A Boeckman, RJ Bauer NONMEM user's guides (1989-2009) 2009 Icon Development Solutions Ellicott City, MD
28. FS Hodi, SJ O'Day, DF McDermott et al. Improved survival with ipilimumab in patients with metastatic melanoma N Engl J Med 363 2010 711 723
29. M Nishino, A Giobbie-Hurder, M Gargano et al. Developing a common language for tumor response to immunotherapy: immune-related response criteria using unidimensional measurements Clin Cancer Res 19 2013 3936 3943
30. PA Ascierto, E Simeone, AM Grimaldi et al. Do BRAF inhibitors select for populations with different disease progression kinetics? J Transl Med 11 2013 61
31. A Ackerman, O Klein, DF McDermott et al. Outcomes of patients with metastatic melanoma treated with immunotherapy prior to or after BRAF inhibitors Cancer 120 2014 1695 1701
32. V Shahabi, G Whitney, O Hamid et al. Assessment of association between BRAF-V600E mutation status in melanomas and clinical response to ipilimumab Cancer Immunol Immunother 61 2012 733 737
33. JD Wolchok, H Kluger, MK Callahan et al. Nivolumab plus ipilimumab in advanced melanoma N Engl J Med 369 2013 122 133