Clinical trial NCT04663126 - References

Melanoma — Feasibility of IV Tc-99m-tilmanocept for Imaging of M2-like TAMs in Metastatic Melanoma

Citation(s)

•   Azad AK, Rajaram MV, Metz WL, Cope FO, Blue MS, Vera DR, Schlesinger LS
  gamma-Tilmanocept, a New Radiopharmaceutical Tracer for Cancer Sentinel Lymph Nodes, Binds to the Mannose Receptor (CD206). J Immunol. 2015 Sep 1;195(5):2019-29. doi: 10.4049/jimmunol.1402005. Epub 2015 Jul 22.
•   Baker JL, Pu M, Tokin CA, Hoh CK, Vera DR, Messer K, Wallace AM
  Comparison of [(99m)Tc]tilmanocept and filtered [(99m)Tc]sulfur colloid for identification of SLNs in breast cancer patients. Ann Surg Oncol. 2015 Jan;22(1):40-5. doi: 10.1245/s10434-014-3892-2. Epub 2014 Jul 29.
•   Barsoum IB, Smallwood CA, Siemens DR, Graham CH
  A mechanism of hypoxia-mediated escape from adaptive immunity in cancer cells. Cancer Res. 2014 Feb 1;74(3):665-74. doi: 10.1158/0008-5472.CAN-13-0992. Epub 2013 Dec 13.
•   Bellon T, Martinez V, Lucendo B, del Peso G, Castro MJ, Aroeira LS, Rodriguez-Sanz A, Ossorio M, Sanchez-Villanueva R, Selgas R, Bajo MA
  Alternative activation of macrophages in human peritoneum: implications for peritoneal fibrosis. Nephrol Dial Transplant. 2011 Sep;26(9):2995-3005. doi: 10.1093/ndt/gfq771. Epub 2011 Feb 15.
•   Browne RH
  On the use of a pilot sample for sample size determination. Stat Med. 1995 Sep 15;14(17):1933-40. doi: 10.1002/sim.4780141709.
•   Cannarile MA, Weisser M, Jacob W, Jegg AM, Ries CH, Ruttinger D
  Colony-stimulating factor 1 receptor (CSF1R) inhibitors in cancer therapy. J Immunother Cancer. 2017 Jul 18;5(1):53. doi: 10.1186/s40425-017-0257-y.
•   Domingues B, Lopes JM, Soares P, Populo H
  Melanoma treatment in review. Immunotargets Ther. 2018 Jun 7;7:35-49. doi: 10.2147/ITT.S134842. eCollection 2018.
•   Falleni M, Savi F, Tosi D, Agape E, Cerri A, Moneghini L, Bulfamante GP
  M1 and M2 macrophages' clinicopathological significance in cutaneous melanoma. Melanoma Res. 2017 Jun;27(3):200-210. doi: 10.1097/CMR.0000000000000352.
•   Hodi FS, O'Day SJ, McDermott DF, Weber RW, Sosman JA, Haanen JB, Gonzalez R, Robert C, Schadendorf D, Hassel JC, Akerley W, van den Eertwegh AJ, Lutzky J, Lorigan P, Vaubel JM, Linette GP, Hogg D, Ottensmeier CH, Lebbe C, Peschel C, Quirt I, Clark JI, Wolchok JD, Weber JS, Tian J, Yellin MJ, Nichol GM, Hoos A, Urba WJ
  Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med. 2010 Aug 19;363(8):711-23. doi: 10.1056/NEJMoa1003466. Epub 2010 Jun 5. Erratum In: N Engl J Med. 2010 Sep 23;363(13):1290.
•   Julious, S
  A., Sample size of 12 per group rule of thumb for a pilot study. Pharmaceutical Statistics, 2005. 4(4): p. 287-291.
•   Kardan A, A
  B., Sanders J, Kissling A, Ralph D, Shuping J, Blue M, Hartings C, Hershey R, Ismail A, Gierach I, Bailey H, Spaulding A, Haynam M, Zubal G, Cope F., Evaluation of Intravenous Injection of Tc 99m Tilmanocept in Static Planar Gamma Emission Imaging and Fused SPECT/CT Imaging for Rheumatoid Arthritis [abstract]. Arthritis Rheumatol. , 2017. 69.
•   Kardan, A
  , et al., Intravenous 99mTc-tilmanocept in Planar and Fused SPECT/CT Imaging of Activated Macrophage Infiltration in Subjects with Active Rheumatoid Arthritis. Vol. 59. 2018.
•   Larkin J, Chiarion-Sileni V, Gonzalez R, Grob JJ, Cowey CL, Lao CD, Schadendorf D, Dummer R, Smylie M, Rutkowski P, Ferrucci PF, Hill A, Wagstaff J, Carlino MS, Haanen JB, Maio M, Marquez-Rodas I, McArthur GA, Ascierto PA, Long GV, Callahan MK, Postow MA, Grossmann K, Sznol M, Dreno B, Bastholt L, Yang A, Rollin LM, Horak C, Hodi FS, Wolchok JD
  Combined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma. N Engl J Med. 2015 Jul 2;373(1):23-34. doi: 10.1056/NEJMoa1504030. Epub 2015 May 31. Erratum In: N Engl J Med. 2018 Nov 29;379(22):2185.
•   Madore J, Vilain RE, Menzies AM, Kakavand H, Wilmott JS, Hyman J, Yearley JH, Kefford RF, Thompson JF, Long GV, Hersey P, Scolyer RA
  PD-L1 expression in melanoma shows marked heterogeneity within and between patients: implications for anti-PD-1/PD-L1 clinical trials. Pigment Cell Melanoma Res. 2015 May;28(3):245-53. doi: 10.1111/pcmr.12340. Epub 2014 Dec 22.
•   McGranahan N, Furness AJ, Rosenthal R, Ramskov S, Lyngaa R, Saini SK, Jamal-Hanjani M, Wilson GA, Birkbak NJ, Hiley CT, Watkins TB, Shafi S, Murugaesu N, Mitter R, Akarca AU, Linares J, Marafioti T, Henry JY, Van Allen EM, Miao D, Schilling B, Schadendorf D, Garraway LA, Makarov V, Rizvi NA, Snyder A, Hellmann MD, Merghoub T, Wolchok JD, Shukla SA, Wu CJ, Peggs KS, Chan TA, Hadrup SR, Quezada SA, Swanton C
  Clonal neoantigens elicit T cell immunoreactivity and sensitivity to immune checkpoint blockade. Science. 2016 Mar 25;351(6280):1463-9. doi: 10.1126/science.aaf1490. Epub 2016 Mar 3.
•   Obeid JM, Erdag G, Smolkin ME, Deacon DH, Patterson JW, Chen L, Bullock TN, Slingluff CL
  PD-L1, PD-L2 and PD-1 expression in metastatic melanoma: Correlation with tumor-infiltrating immune cells and clinical outcome. Oncoimmunology. 2016 Sep 20;5(11):e1235107. doi: 10.1080/2162402X.2016.1235107. eCollection 2016.
•   Porcheray F, Viaud S, Rimaniol AC, Leone C, Samah B, Dereuddre-Bosquet N, Dormont D, Gras G
  Macrophage activation switching: an asset for the resolution of inflammation. Clin Exp Immunol. 2005 Dec;142(3):481-9. doi: 10.1111/j.1365-2249.2005.02934.x.
•   Qian BZ, Pollard JW
  Macrophage diversity enhances tumor progression and metastasis. Cell. 2010 Apr 2;141(1):39-51. doi: 10.1016/j.cell.2010.03.014.
•   Ribas A, Puzanov I, Dummer R, Schadendorf D, Hamid O, Robert C, Hodi FS, Schachter J, Pavlick AC, Lewis KD, Cranmer LD, Blank CU, O'Day SJ, Ascierto PA, Salama AK, Margolin KA, Loquai C, Eigentler TK, Gangadhar TC, Carlino MS, Agarwala SS, Moschos SJ, Sosman JA, Goldinger SM, Shapira-Frommer R, Gonzalez R, Kirkwood JM, Wolchok JD, Eggermont A, Li XN, Zhou W, Zernhelt AM, Lis J, Ebbinghaus S, Kang SP, Daud A
  Pembrolizumab versus investigator-choice chemotherapy for ipilimumab-refractory melanoma (KEYNOTE-002): a randomised, controlled, phase 2 trial. Lancet Oncol. 2015 Aug;16(8):908-18. doi: 10.1016/S1470-2045(15)00083-2. Epub 2015 Jun 23.
•   Robert C, Long GV, Brady B, Dutriaux C, Maio M, Mortier L, Hassel JC, Rutkowski P, McNeil C, Kalinka-Warzocha E, Savage KJ, Hernberg MM, Lebbe C, Charles J, Mihalcioiu C, Chiarion-Sileni V, Mauch C, Cognetti F, Arance A, Schmidt H, Schadendorf D, Gogas H, Lundgren-Eriksson L, Horak C, Sharkey B, Waxman IM, Atkinson V, Ascierto PA
  Nivolumab in previously untreated melanoma without BRAF mutation. N Engl J Med. 2015 Jan 22;372(4):320-30. doi: 10.1056/NEJMoa1412082. Epub 2014 Nov 16.
•   Sharma P, Hu-Lieskovan S, Wargo JA, Ribas A
  Primary, Adaptive, and Acquired Resistance to Cancer Immunotherapy. Cell. 2017 Feb 9;168(4):707-723. doi: 10.1016/j.cell.2017.01.017.
•   Siveen KS, Kuttan G
  Role of macrophages in tumour progression. Immunol Lett. 2009 Apr 27;123(2):97-102. doi: 10.1016/j.imlet.2009.02.011. Epub 2009 Mar 9.
•   Snyder A, Makarov V, Merghoub T, Yuan J, Zaretsky JM, Desrichard A, Walsh LA, Postow MA, Wong P, Ho TS, Hollmann TJ, Bruggeman C, Kannan K, Li Y, Elipenahli C, Liu C, Harbison CT, Wang L, Ribas A, Wolchok JD, Chan TA
  Genetic basis for clinical response to CTLA-4 blockade in melanoma. N Engl J Med. 2014 Dec 4;371(23):2189-2199. doi: 10.1056/NEJMoa1406498. Epub 2014 Nov 19. Erratum In: N Engl J Med. 2018 Nov 29;379(22):2185.
•   Stein M, Keshav S, Harris N, Gordon S
  Interleukin 4 potently enhances murine macrophage mannose receptor activity: a marker of alternative immunologic macrophage activation. J Exp Med. 1992 Jul 1;176(1):287-92. doi: 10.1084/jem.176.1.287.
•   Sun Z, Fourcade J, Pagliano O, Chauvin JM, Sander C, Kirkwood JM, Zarour HM
  IL10 and PD-1 Cooperate to Limit the Activity of Tumor-Specific CD8+ T Cells. Cancer Res. 2015 Apr 15;75(8):1635-44. doi: 10.1158/0008-5472.CAN-14-3016. Epub 2015 Feb 26.
•   Svensson-Arvelund J, Mehta RB, Lindau R, Mirrasekhian E, Rodriguez-Martinez H, Berg G, Lash GE, Jenmalm MC, Ernerudh J
  The human fetal placenta promotes tolerance against the semiallogeneic fetus by inducing regulatory T cells and homeostatic M2 macrophages. J Immunol. 2015 Feb 15;194(4):1534-44. doi: 10.4049/jimmunol.1401536. Epub 2015 Jan 5.
•   Sznol M, Chen L
  Antagonist antibodies to PD-1 and B7-H1 (PD-L1) in the treatment of advanced human cancer. Clin Cancer Res. 2013 Mar 1;19(5):1021-34. doi: 10.1158/1078-0432.CCR-12-2063.
•   Tumeh PC, Harview CL, Yearley JH, Shintaku IP, Taylor EJ, Robert L, Chmielowski B, Spasic M, Henry G, Ciobanu V, West AN, Carmona M, Kivork C, Seja E, Cherry G, Gutierrez AJ, Grogan TR, Mateus C, Tomasic G, Glaspy JA, Emerson RO, Robins H, Pierce RH, Elashoff DA, Robert C, Ribas A
  PD-1 blockade induces responses by inhibiting adaptive immune resistance. Nature. 2014 Nov 27;515(7528):568-71. doi: 10.1038/nature13954.
•   Varasteh Z, Hyafil F, Anizan N, Diallo D, Aid-Launais R, Mohanta S, Li Y, Braeuer M, Steiger K, Vigne J, Qin Z, Nekolla SG, Fabre JE, Doring Y, Le Guludec D, Habenicht A, Vera DR, Schwaiger M
  Targeting mannose receptor expression on macrophages in atherosclerotic plaques of apolipoprotein E-knockout mice using 111In-tilmanocept. EJNMMI Res. 2017 Dec;7(1):40. doi: 10.1186/s13550-017-0287-y. Epub 2017 May 3.
•   Wallace AM, Han LK, Povoski SP, Deck K, Schneebaum S, Hall NC, Hoh CK, Limmer KK, Krontiras H, Frazier TG, Cox C, Avisar E, Faries M, King DW, Christman L, Vera DR
  Comparative evaluation of [(99m)tc]tilmanocept for sentinel lymph node mapping in breast cancer patients: results of two phase 3 trials. Ann Surg Oncol. 2013 Aug;20(8):2590-9. doi: 10.1245/s10434-013-2887-8. Epub 2013 Mar 17.
•   Wolchok JD, Kluger H, Callahan MK, Postow MA, Rizvi NA, Lesokhin AM, Segal NH, Ariyan CE, Gordon RA, Reed K, Burke MM, Caldwell A, Kronenberg SA, Agunwamba BU, Zhang X, Lowy I, Inzunza HD, Feely W, Horak CE, Hong Q, Korman AJ, Wigginton JM, Gupta A, Sznol M
  Nivolumab plus ipilimumab in advanced melanoma. N Engl J Med. 2013 Jul 11;369(2):122-33. doi: 10.1056/NEJMoa1302369. Epub 2013 Jun 2. Erratum In: N Engl J Med. 2018 Nov 29;379(22):2185.
•   Zhu Y, Knolhoff BL, Meyer MA, Nywening TM, West BL, Luo J, Wang-Gillam A, Goedegebuure SP, Linehan DC, DeNardo DG
  CSF1/CSF1R blockade reprograms tumor-infiltrating macrophages and improves response to T-cell checkpoint immunotherapy in pancreatic cancer models. Cancer Res. 2014 Sep 15;74(18):5057-69. doi: 10.1158/0008-5472.CAN-13-3723. Epub 2014 Jul 31.

Pilot Study to Test the Feasibility of IV Injected Tc-99m-tilmanocept for Imaging of M2-like Tumour Associated Macrophages in Metastatic Melanoma

Details for clinical trial NCT04663126