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Clinical Trial Protocol

KEYNOTE – D36: Personalized Immunotherapy with a Neoepitope Vaccine, EVX-01 and Pembrolizumab in Advanced Melanoma

ORCID Icon, ORCID Icon, ORCID Icon, , , , ORCID Icon, & show all
Pages 3473-3480 | Received 11 Jul 2022, Accepted 11 Aug 2022, Published online: 01 Sep 2022

References

  • Hamid O , RobertC, DaudAet al. Five-year survival outcomes for patients with advanced melanoma treated with pembrolizumab in KEYNOTE-001. Ann. Oncol.30(4), 582–588 (2019).
  • Larkin J , Chiarion-SileniV, GonzalezRet al. Five-year survival with combined nivolumab and ipilimumab in advanced melanoma. N. Engl. J. Med.381(16), 1535–1546 (2019).
  • Robert C , SchachterJ, LongGvet al. Pembrolizumab versus ipilimumab in advanced melanoma. N. Engl. J. Med.372(26), 2521–2532 (2015).
  • Hamid O , RobertC, DaudAet al. Long-term outcomes in patients with advanced melanoma who had initial stable disease with pembrolizumab in KEYNOTE-001 and KEYNOTE-006. Eur. J. Cancer157, 391–402 (2021).
  • Gubin MM , ZhangX, SchusterHet al. Checkpoint blockade cancer immunotherapy targets tumour-specific mutant antigens. Nature515(7528), 577–581 (2014).
  • van Rooij N , van BuurenMM, PhilipsDet al. Tumor exome analysis reveals neoantigen-specific T-cell reactivity in an ipilimumab-responsive melanoma. J. Clin. Oncol.31(32), 439–442 (2013).
  • Lu Y-C , YaoX, LiYFet al. Mutated PPP1R3B is recognized by T cells used to treat a melanoma patient who experienced a durable complete tumor regression. J. Immunol.190(12), 6034–6042 (2013).
  • Zhou J , DudleyME, RosenbergSA, RobbinsPF. Persistence of multiple tumor-specific T-cell clones is associated with complete tumor regression in a melanoma patient receiving adoptive cell transfer therapy. Journal of Immunotherapy28(1), 53–62 (2005).
  • Keskin DB , AnandappaAJ, SunJet al. Neoantigen vaccine generates intratumoral T cell responses in phase Ib glioblastoma trial. Nature565(7738), 234–239 (2019).
  • Ott PA , HuZ, KeskinDBet al. An immunogenic personal neoantigen vaccine for patients with melanoma. Nature547(7662), 217–221 (2017).
  • Ralli M , BotticelliA, ViscontiICet al. Immunotherapy in the treatment of metastatic melanoma: current knowledge and future directions. J. Immunol. Res.2020, 9235638 (2020).
  • Sahin U , DerhovanessianE, MillerMet al. Personalized RNA mutanome vaccines mobilize poly-specific therapeutic immunity against cancer. Nature547(7662), 222–226 (2017).
  • Ott PA , Hu-LieskovanS, ChmielowskiBet al. A phase Ib trial of personalized neoantigen therapy plus anti-PD-1 in patients with advanced melanoma, non-small cell lung cancer, or bladder cancer. Cell183(2), 347–362 (2020).
  • Mørk SK , KadivarM, BolKFet al. Personalized therapy with peptide-based neoantigen vaccine (EVX-01) including a novel adjuvant, CAF®09b, in patients with metastatic melanoma. OncoImmunology11(1), 2023255 (2022).
  • Guo Y , LeiK, TangL. Neoantigen vaccine delivery for personalized anticancer immunotherapy. Front. Immunol.9, 1499 (2018).
  • Eisenhauer EA , TherasseP, BogaertsJet al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur. J. Cancer45(2), 228–247 (2009).
  • Amin MB , EdgeSB, GreeneFLet al. American Joint Committee on Cancer (AJCC). Cancer J. Clin.67(2), 93–99 (2017).
  • Seymour L , BogaertsJ, PerroneAet al. iRECIST: guidelines for response criteria for use in trials testing immunotherapeutics. Lancet Oncol.18(3), e143–e152 (2017).