Precision radiation of immune checkpoint therapy resistant melanoma metastases (PROMMEL study): study protocol for a phase II open-label multicenter trial

References

• Sung H, Ferlay J, Siegel R, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA A Cancer J Clin. 2021;71(3):209–249.
   PubMed Web of Science ®Google Scholar
• Socialstyrelsen. Statistics on Cancer Incidence 2020 Socialstyrelsen: Socialstyrelsen; 2021. [Available from: www.socialstyrelsen.se/statistik-och-data/statistik/statistikamnen/cancer/.
   Google Scholar
• Middleton MR, Grob JJ, Aaronson N, et al. Randomized phase III study of temozolomide versus dacarbazine in the treatment of patients with advanced metastatic malignant melanoma. J Clin Oncol. 2000;18(1):158–166.
   PubMed Web of Science ®Google Scholar
• Robert C, Grob JJ, Stroyakovskiy D, et al. Five-Year outcomes with dabrafenib plus trametinib in metastatic melanoma. N Engl J Med. 2019;381(7):626–636.
   PubMed Web of Science ®Google Scholar
• Robert C, Schachter J, Long GV, et al. Pembrolizumab versus ipilimumab in advanced melanoma. N Engl J Med. 2015;372(26):2521–2532.
   PubMed Web of Science ®Google Scholar
• Dummer R, Ascierto PA, Gogas HJ, et al. Encorafenib plus binimetinib versus vemurafenib or encorafenib in patients with BRAF-mutant melanoma (COLUMBUS): a multicentre, open-label, randomised phase 3 trial. Lancet Oncol. 2018;19(5):603–615.
   PubMed Web of Science ®Google Scholar
• Robert C, Long GV, Brady B, et al. Nivolumab in previously untreated melanoma without BRAF mutation. N Engl J Med. 2015;372(4):320–330.
   PubMed Web of Science ®Google Scholar
• Davies H, Bignell GR, Cox C, et al. Mutations of the BRAF gene in human cancer. Nature. 2002;417(6892):949–954.
   PubMed Web of Science ®Google Scholar
• Long GV, Stroyakovskiy D, Gogas H, et al. Combined BRAF and MEK inhibition versus BRAF inhibition alone in melanoma. N Engl J Med. 2014;371(20):1877–1888.
   PubMed Web of Science ®Google Scholar
• Hamid O, Robert C, Daud A, et al. Five-year survival outcomes for patients with advanced melanoma treated with pembrolizumab in KEYNOTE-001. Ann Oncol. 2019;30(4):582–588.
   PubMed Web of Science ®Google Scholar
• Atkins M, Lee S, Chmielowski B, et al. DREAMseq (doublet, randomized evaluation in advanced melanoma sequencing): a phase III trial—ECOG-ACRIN EA6134. J Clin Oncol. 2021;39(36_suppl):356154–356154.
   Web of Science ®Google Scholar
• Wolchok JD, Chiarion-Sileni V, Gonzalez R, et al. Long-Term outcomes with nivolumab plus ipilimumab or nivolumab alone versus ipilimumab in patients with advanced melanoma. J Clin Oncol. 2022;40(2):127–137.
   PubMed Web of Science ®Google Scholar
• Larkin J, Chiarion-Sileni V, Gonzalez R, et al. Five-Year survival with combined nivolumab and ipilimumab in advanced melanoma. N Engl J Med. 2019;381(16):1535–1546.
   PubMed Web of Science ®Google Scholar
• Larkin J, Chiarion-Sileni V, Gonzalez R, et al. Combined nivolumab and ipilimumab or monotherapy in untreated melanoma. N Engl J Med. 2015;373(1):23–34.
   PubMed Web of Science ®Google Scholar
• Ascierto PA, Dummer R, Gogas HJ, et al. Update on tolerability and overall survival in COLUMBUS: landmark analysis of a randomised phase 3 trial of encorafenib plus binimetinib vs vemurafenib or encorafenib in patients with BRAF V600-mutant melanoma. Eur J Cancer. 2020;126:33–44.
   PubMed Web of Science ®Google Scholar
• Mahadevan A, Patel VL, Dagoglu N. Radiation therapy in the management of malignant melanoma. Oncology. 2015;29(10):743–751.
   PubMed Web of Science ®Google Scholar
• Rogers SJ, Puric E, Eberle B, et al. Radiotherapy for melanoma: More than DNA damage. Dermatol Res Pract. 2019;2019:9435389.
   PubMedGoogle Scholar
• Song CW, Kim MS, Cho LC, et al. Radiobiological basis of SBRT and SRS. Int J Clin Oncol. 2014;19(4):570–578.
   PubMed Web of Science ®Google Scholar
• Franceschini D, Franzese C, De Rose F, et al. Role of extra cranial stereotactic body radiation therapy in the management of stage IV melanoma. Br J Radiol. 2017;90(1077):20170257.
   PubMedGoogle Scholar
• Grimaldi AM, Simeone E, Giannarelli D, et al. Abscopal effects of radiotherapy on advanced melanoma patients who progressed after ipilimumab immunotherapy. Oncoimmunology. 2014;3:e28780.
   PubMed Web of Science ®Google Scholar
• Liniker E, Menzies AM, Kong BY, et al. Activity and safety of radiotherapy with anti-PD-1 drug therapy in patients with metastatic melanoma. Oncoimmunology. 2016;5(9):e1214788.
   PubMed Web of Science ®Google Scholar
• Aboudaram A, Modesto A, Chaltiel L, et al. Concurrent radiotherapy for patients with metastatic melanoma and receiving anti-programmed-death 1 therapy: a safe and effective combination. Melanoma Res. 2017;27(5):485–491.
   PubMed Web of Science ®Google Scholar
• Funck-Brentano E, Baghad B, Fort M, et al. Efficacy of late concurrent hypofractionated radiotherapy in advanced melanoma patients failing anti-PD-1 monotherapy. Int J Cancer. 2020;147(6):1707–1714.
   PubMedGoogle Scholar
• Seegenschmiedt MH, Keilholz L, Altendorf-Hofmann A, et al. Palliative radiotherapy for recurrent and metastatic malignant melanoma: prognostic factors for tumor response and long-term outcome: a 20-year experience. Int J Radiat Oncol Biol Phys. 1999;44(3):607–618.
   PubMed Web of Science ®Google Scholar
• Chicas-Sett R, Morales-Orue I, Castilla-Martinez J, et al. Stereotactic ablative radiotherapy combined with immune checkpoint inhibitors reboots the immune response assisted by immunotherapy in metastatic lung cancer: a systematic review. Int J Mol Sci. 2019;20(9):2173.
   Google Scholar
• Eriksson D, Stigbrand T. Radiation-induced cell death mechanisms. Tumour Biol. 2010;31(4):363–372.
   PubMedGoogle Scholar
• Lugade AA, Sorensen EW, Gerber SA, et al. Radiation-induced IFN-gamma production within the tumor microenvironment influences antitumor immunity. J Immunol. 2008;180(5):3132–3139.
   PubMed Web of Science ®Google Scholar
• Twyman-Saint Victor C, Rech AJ, Maity A, et al. Radiation and dual checkpoint blockade activate non-redundant immune mechanisms in cancer. Nature. 2015;520(7547):373–377.
   PubMed Web of Science ®Google Scholar
• Brooks ED, Chang JY. Time to abandon single-site irradiation for inducing abscopal effects. Nat Rev Clin Oncol. 2019;16(2):123–135.
   PubMed Web of Science ®Google Scholar
• Demaria S, Ng B, Devitt ML, et al. Ionizing radiation inhibition of distant untreated tumors (abscopal effect) is immune mediated. Int J Radiat Oncol Biol Phys. 2004;58(3):862–870.
   PubMed Web of Science ®Google Scholar
• Abuodeh Y, Venkat P, Kim S. Systematic review of case reports on the abscopal effect. Curr Probl Cancer. 2016;40(1):25–37.
   PubMed Web of Science ®Google Scholar
• Roger A, Finet A, Boru B, et al. Efficacy of combined hypo-fractionated radiotherapy and anti-PD-1 monotherapy in difficult-to-treat advanced melanoma patients. Oncoimmunology. 2018;7(7):e1442166.
   PubMed Web of Science ®Google Scholar
• Wang D, Zhang X, Gao Y, et al. Research progress and existing problems for abscopal effect. Cancer Manag Res. 2020;12:6695–6706.
   PubMed Web of Science ®Google Scholar
• Dewan MZ, Galloway AE, Kawashima N, et al. Fractionated but not single-dose radiotherapy induces an immune-mediated abscopal effect when combined with anti-CTLA-4 antibody. Clin Cancer Res. 2009;15(17):5379–5388.
   PubMed Web of Science ®Google Scholar
• Filatenkov A, Baker J, Mueller AM, et al. Ablative tumor radiation can change the tumor immune cell microenvironment to induce durable complete remissions. Clin Cancer Res. 2015;21(16):3727–3739.
   PubMed Web of Science ®Google Scholar
• Wang SJ, Jhawar SR, Rivera-Nunez Z, et al. The association of radiation dose-fractionation and immunotherapy use with overall survival in metastatic melanoma patients. Cureus. 2020;12(6):e8767.
   PubMedGoogle Scholar
• Cox BW, Spratt DE, Lovelock M, et al. International spine radiosurgery consortium consensus guidelines for target volume definition in spinal stereotactic radiosurgery. Int J Radiat Oncol Biol Phys. 2012;83(5):e597–e605.
   PubMed Web of Science ®Google Scholar
• Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009;45(2):228–247.
   PubMed Web of Science ®Google Scholar
• Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials. 1989;10(1):1–10.
   PubMedGoogle Scholar
• Basler L, Gabryś HS, Hogan SA, et al. Radiomics, tumor volume, and blood biomarkers for early prediction of pseudoprogression in patients with metastatic melanoma treated with immune checkpoint inhibition. Clin Cancer Res. 2020;26(16):4414–4425.
   PubMed Web of Science ®Google Scholar
• Lee JH, Long GV, Menzies AM, et al. Association between circulating tumor DNA and pseudoprogression in patients with metastatic melanoma treated with anti-Programmed cell death 1 antibodies. JAMA Oncol. 2018;4(5):717–721.
   PubMed Web of Science ®Google Scholar
• Chan AW, Tetzlaff JM, Gotzsche PC, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586.
   PubMed Web of Science ®Google Scholar