Merkel cell carcinoma
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|Kaufman et al. 2016 (JAVELIN)||Phase II||31.8% (95.9% CI 21.9–43.1%)|
- Avelumab (Bavencio) 10 mg/kg IV over 60 minutes once on day 1
Per Kaufman et al. 2016 (JAVELIN)
- H1-antihistamine, such as diphenhydramine (dose & route not given) 30 to 60 minutes prior to each dose of avelumab
- Paracetamol/acetaminophen (dose not given) 30 to 60 minutes prior to each dose of avelumab
- The Avelumab package insert suggests "Premedicate with acetaminophen and an antihistamine for the first 4 infusions and subsequently as needed."
14-day cycles, given until progression of disease or unacceptable toxicity
- Kaufman HL, Russell J, Hamid O, Bhatia S, Terheyden P, D'Angelo SP, Shih KC, Lebbé C, Linette GP, Milella M, Brownell I, Lewis KD, Lorch JH, Chin K, Mahnke L, von Heydebreck A, Cuillerot JM, Nghiem P. Avelumab in patients with chemotherapy-refractory metastatic Merkel cell carcinoma: a multicentre, single-group, open-label, phase 2 trial. Lancet Oncol. 2016 Oct;17(10):1374-1385. link to original article contains verified protocol PubMed content property of HemOnc.org
- Abstract: Howard Kaufman, Jeffery Scott Russell, Omid Hamid, Shailender Bhatia, Patrick Terheyden, Sandra P. D'Angelo, Kent C. Shih, Celeste Lebbe, Gerald P Linette, Michele Milella, Isaac Brownell, Karl D. Lewis, Jochen H. Lorch, Kevin M. Chin, Lisa Mahnke, Anja von Heydebreck, Jean-Marie Cuillerot, Paul Nghiem. Avelumab (MSB0010718C; anti-PD-L1) in patients with metastatic Merkel cell carcinoma previously treated with chemotherapy: Results of the phase 2 JAVELIN Merkel 200 trial. 2016 ASCO Annual Meeting abstract 9508. link to abstract
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|Nghiem et al. 2016||Phase II||56% (95% CI 35-76%)|
- Pembrolizumab (Keytruda) 2 mg/kg IV once on day 1
21-day cycles for up to 2 years or until CR, progression, or intolerable toxicity
- Nghiem PT, Bhatia S, Lipson EJ, Kudchadkar RR, Miller NJ, Annamalai L, Berry S, Chartash EK, Daud A, Fling SP, Friedlander PA, Kluger HM, Kohrt HE, Lundgren L, Margolin K, Mitchell A, Olencki T, Pardoll DM, Reddy SA, Shantha EM, Sharfman WH, Sharon E, Shemanski LR, Shinohara MM, Sunshine JC, Taube JM, Thompson JA, Townson SM, Yearley JH, Topalian SL, Cheever MA. PD-1 Blockade with Pembrolizumab in Advanced Merkel-Cell Carcinoma. N Engl J Med. 2016 Jun 30;374(26):2542-52. Epub 2016 Apr 19. link to original article link to PMC article contains verified protocol PubMed