SWE-NEO: Swedish NEO-adjuvant trial comparing anti-PD-1 monotherapy to combined anti-CTLA-4/anti-PD-1 blockade in resectable stage III melanoma: study protocol for a phase III open-label multi-centre trial

Authors

  • Hildur Helgadottir Department of Oncology and Pathology, Karolinska Institutet, Stockholm; Theme Cancer, Karolinska University Hospital, 171 76 Stockholm, Sweden. https://orcid.org/0000-0002-0735-4771
  • Ana Carneiro Division of Oncology, Lund University Cancer Center, Department of Clinical Sciences, Lunds University, Lund, Sweden; Oncology Unit, Department of Hematology, Oncology and Radiation Physics, Skåne University Hospital Comprehensive Cancer Center, Skåne University Hospital, Lund, Sweden
  • Francesca Portelli Department of Oncology and Pathology, Karolinska Institutet, Stockholm, Sweden; Department of Clinical Pathology and Cancer Diagnostics, Karolinska University Hospital, Stockholm, Sweden https://orcid.org/0000-0002-3325-2357
  • Konstantinos Papadakis Department of Oncology and Pathology, Karolinska Institutet, Stockholm, Sweden https://orcid.org/0009-0009-1039-2873
  • Karl Björkström Department of Oncology and Pathology, Karolinska Institutet, Stockholm, Sweden; Theme Cancer, Karolinska University Hospital, Stockholm, Sweden https://orcid.org/0000-0002-9688-8870
  • Muyi Yang Department of Oncology and Pathology, Karolinska Institutet, Stockholm, Sweden
  • Iva Johansson Department of Clinical Pathology, Sahlgrenska University Hospital, Gothenburg, Sweden; Institute of Biomedicine, Sahlgrenska Academy, University of Gothenburg, Sweden https://orcid.org/0000-0002-9683-4637
  • Ingela Skogvall Svensson Department of Clinical Genetics, Pathology and Molecular Diagnostics, Skåne University Hospital, Region Skåne, Lund, Sweden
  • Allan Jazrawi Department of Plastic surgery and Craniofacial surgery, Karolinska University Hospital, Stockholm Sweden
  • Amanda Hallgren Center for Clinical Cancer Studies, Karolinska University Hospital, Stockholm Sweden
  • Katja Harbst Division of Oncology, Department of Clinical Science, Faculty of Medicine, Lund University, Lund, Sweden https://orcid.org/0000-0002-8225-1510
  • Rusana Bark Theme Cancer, Karolinska University Hospital, Stockholm, Sweden; Department of Clinical Sciences Intervention and Technology, Division of ENT Diseases, Karolinska Institutet, Stockholm, Sweden https://orcid.org/0000-0001-9325-2992
  • Suzanne Egyhazi Brage Department of Oncology and Pathology, Karolinska Institutet, Stockholm, Sweden https://orcid.org/0000-0002-0524-2346
  • Anders Berglund Epistat AB, Uppsala, Sweden https://orcid.org/0000-0003-3698-9861
  • Karolin Isaksson Department of Clinical Sciences, Surgery, Lund University, Lund, Sweden; Department of Surgery, Skåne University Hospital Kristianstad, Kristianstad, Sweden https://orcid.org/0000-0003-3690-5680
  • Stina Wickström Department of Oncology and Pathology, Karolinska Institutet, Stockholm, Sweden; Theme Cancer, Karolinska University Hospital, Stockholm, Sweden https://orcid.org/0000-0003-0349-4918
  • Jonas Nilsson Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden https://orcid.org/0000-0003-0346-6837
  • Lars Ny Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy at University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden; Department of Oncology, Sahlgrenska University Hospital, Gothenburg, Region Västra Götaland, Sweden https://orcid.org/0000-0003-3864-5958
  • Göran Jönsson Division of Oncology, Department of Clinical Science, Faculty of Medicine, Lund University, Lund, Sweden
  • Roger Olofsson Bagge Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Department of Surgery, Sahlgrenska University Hospital, Gothenburg, Region Västra Götaland, Sweden; Wallenberg Centre for Molecular and Translational Medicine, University of Gothenburg, Gothenburg, Sweden https://orcid.org/0000-0001-5795-0355

DOI:

https://doi.org/10.2340/1651-226X.2026.45174

Keywords:

Melanoma, Neoadjuvant therapy, immune checkpoint inhibitors, ipilimumab, nivolumab, PD-1, CTLA-4

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References

Long GV, Hauschild A, Santinami M, Atkinson V, Mandala M, Chiarion-Sileni V, et al. Adjuvant dabrafenib plus trametinib in stage III BRAF-mutated melanoma. N Engl J Med. 2017;377(19):1813–23.

https://doi.org/10.1056/NEJMoa1708539 DOI: https://doi.org/10.1056/NEJMoa1708539

Weber J, Mandala M, Del Vecchio M, Gogas HJ, Arance AM, Cowey CL, et al. Adjuvant nivolumab versus ipilimumab in resected stage III or IV melanoma. N Engl J Med. 2017;377(19):1824–35.

https://doi.org/10.1056/NEJMoa1709030 DOI: https://doi.org/10.1056/NEJMoa1709030

Eggermont AMM, Blank CU, Mandala M, Long GV, Atkinson V, Dalle S, et al. Adjuvant pembrolizumab versus placebo in resected stage III melanoma. N Engl J Med. 2018;378(19):1789–801. https://doi.org/10.1056/NEJMoa1802357 DOI: https://doi.org/10.1056/NEJMoa1802357

Grossmann KF, Othus M, Patel SP, Tarhini AA, Sondak VK, Knopp MV, et al. Adjuvant pembrolizumab versus IFNalpha2b or ipilimumab in re-sected high-risk melanoma. Cancer Discov. 2022;12(3):644–53.

https://doi.org/10.1158/2159-8290.CD-21-1141 DOI: https://doi.org/10.1158/2159-8290.CD-21-1141

Wolchok JD, Chiarion-Sileni V, Rutkowski P, Cowey CL, Schadendorf D, Wagstaff J, et al. Final, 10-year outcomes with nivolumab plus ipili-mumab in advanced melanoma. N Engl J Med. 2025;392(1):11–22.

https://doi.org/10.1056/NEJMoa2407417 DOI: https://doi.org/10.1056/NEJMoa2407417

Long GV, Hauschild A, Santinami M, Kirkwood JM, Atkinson V, Mandala M, et al. Final results for adjuvant dabrafenib plus trametinib in stage III melanoma. N Engl J Med. 2024;391(18):1709–20.

https://doi.org/10.1056/NEJMoa2404139 DOI: https://doi.org/10.1056/NEJMoa2404139

Helgadottir H, Ny L, Ullenhag GJ, Falkenius J, Mikiver R, Bagge RO, et al. Survival after introduction of adjuvant treatment in stage III melano-ma: a nationwide registry-based study. J Natl Cancer Inst. 2023;115(9):1077–84.

https://doi.org/10.1093/jnci/djad081 DOI: https://doi.org/10.1093/jnci/djad081

Patel SP, Othus M, Chen Y, Wright GP, Jr, Yost KJ, Hyngstrom JR, et al. Neoadjuvant-adjuvant or adjuvant-only pembrolizumab in advanced melanoma. N Engl J Med. 2023;388(9):813–23.

https://doi.org/10.1056/NEJMoa2211437 DOI: https://doi.org/10.1056/NEJMoa2211437

Nelson A, Krabbe E, Bjorkstrom K, Huibers A, Jovanovic B, Blank CU, et al. Neoadjuvant immunotherapy for patients with resectable stage III/IV cutaneous melanoma – a Swedish retrospective real-world study (NEO-MEL). Eur J Cancer. 2025;224:115485.

https://doi.org/10.1016/j.ejca.2025.115485 DOI: https://doi.org/10.1016/j.ejca.2025.115485

Reijers ILM, Menzies AM, van Akkooi ACJ, Versluis JM, van den Heuvel NMJ, Saw RPM, et al. Personalized response-directed surgery and adjuvant therapy after neoadjuvant ipilimumab and nivolumab in high-risk stage III melanoma: the PRADO trial. Nat Med. 2022;28(6):1178–88.

https://doi.org/10.1038/s41591-022-01851-x DOI: https://doi.org/10.1038/s41591-022-01851-x

Blank CU, Lucas MW, Scolyer RA, van de Wiel BA, Menzies AM, Lopez-Yurda M, et al. Neoadju-vant nivolumab and ipilimumab in resectable stage III melanoma. N Engl J Med. 2024;391(18):1696–708.

https://doi.org/10.1056/NEJMoa2402604 DOI: https://doi.org/10.1056/NEJMoa2402604

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Published

2026-02-19

How to Cite

Helgadottir, H., Carneiro, A., Portelli, F., Papadakis, K., Björkström, K., Yang, M., … Olofsson Bagge, R. (2026). SWE-NEO: Swedish NEO-adjuvant trial comparing anti-PD-1 monotherapy to combined anti-CTLA-4/anti-PD-1 blockade in resectable stage III melanoma: study protocol for a phase III open-label multi-centre trial. Acta Oncologica, 65, 126–130. https://doi.org/10.2340/1651-226X.2026.45174

Issue

Vol. 65 (2026): Acta Oncologica

Section

Letter

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Copyright (c) 2026 Hildur Helgadottir, Ana Carneiro, Francesca Portelli, Konstantinos Papadakis, Karl Björkström, Muyi Yang, Iva Johansson, Ingela Skogvall Svensson, Allan Jazrawi, Amanda Hallgren, Katja Harbst, Rusana Bark, Suzanne Egyhazi Brage, Anders Berglund, Karolin Isaksson, Stina Wickström, Jonas Nilsson, Lars Ny, Göran Jönsson, Roger Olofsson Bagge

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This work is licensed under a Creative Commons Attribution 4.0 International License.