Advertisement

Clinical Trials in Melanoma

Margins, Lymph Nodes, Targeted and Immunotherapy
Published:November 03, 2022DOI:https://doi.org/10.1016/j.soc.2022.07.005

      Keywords

      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribers receive full online access to your subscription and archive of back issues up to and including 2002.

      Content published before 2002 is available via pay-per-view purchase only.

      Subscribe:

      Subscribe to Surgical Oncology Clinics
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Coit D.G.
        • Thompson J.A.
        • Albertini M.R.
        • et al.
        Cutaneous Melanoma, Version 2.2019, NCCN Clinical Practice Guidelines in Oncology.
        J Natl Compr Canc Netw. 2019; 17: 367-402
        • Angeles C.V.
        • Wong S.L.
        • Karakousis G.
        The Landmark Series: Randomized Trials Examining Surgical Margins for Cutaneous Melanoma.
        Ann Surg Oncol. 2020; 27: 3-12
        • Cosimi A.B.
        • Sober A.J.
        • Mihm M.C.
        • et al.
        Conservative surgical management of superficially invasive cutaneous melanoma.
        Cancer. 1984; 53: 1256-1259
        • Balch C.M.
        • Murad T.M.
        • Soong S.J.
        • et al.
        Tumor thickness as a guide to surgical management of clinical stage I melanoma patients.
        Cancer. 1979; 43: 883-888
        • Day C.L.
        • Mihm M.C.
        • Sober A.J.
        • et al.
        Narrower margins for clinical stage I malignant melanoma.
        N Engl J Med. 1982; 306: 479-482
        • Veronesi U.
        • Cascinelli N.
        • Adamus J.
        • et al.
        Thin stage I primary cutaneous malignant melanoma. Comparison of excision with margins of 1 or 3 cm.
        N Engl J Med. 1988; 318: 1159-1162
        • Veronesi U.
        • Cascinelli N.
        Narrow excision (1-cm margin). A safe procedure for thin cutaneous melanoma.
        Arch Surg. 1991; 126: 438-441
        • Balch C.M.
        • Soong S.
        • Ross M.I.
        • et al.
        Long-term results of a multi-institutional randomized trial comparing prognostic factors and surgical results for intermediate thickness melanomas (1.0 to 4.0 mm). Intergroup Melanoma Surgical Trial.
        Ann Surg Oncol. 2000; 7: 87-97
        • Karakousis C.P.
        • Balch C.M.
        • Urist M.M.
        • et al.
        Local recurrence in malignant melanoma: long-term results of the multiinstitutional randomized surgical trial.
        Ann Surg Oncol. 1996; 3: 446-452
        • Balch C.M.
        • Urist M.M.
        • Karakousis C.P.
        • et al.
        Efficacy of 2-cm surgical margins for intermediate-thickness melanomas (1 to 4 mm). Results of a multi-institutional randomized surgical trial.
        Ann Surg. 1993; 218 ([discussion: 267–9]): 262-267
        • Cohn-Cedermark G.
        • Rutqvist L.E.
        • Andersson R.
        • et al.
        Long term results of a randomized study by the Swedish Melanoma Study Group on 2-cm versus 5-cm resection margins for patients with cutaneous melanoma with a tumor thickness of 0.8-2.0 mm.
        Cancer. 2000; 89: 1495-1501
        • Ringborg U.
        • Andersson R.
        • Eldh J.
        • et al.
        Resection margins of 2 versus 5 cm for cutaneous malignant melanoma with a tumor thickness of 0.8 to 2.0 mm: randomized study by the Swedish Melanoma Study Group.
        Cancer. 1996; 77: 1809-1814
        • Utjés D.
        • Malmstedt J.
        • Teras J.
        • et al.
        2-cm versus 4-cm surgical excision margins for primary cutaneous melanoma thicker than 2 mm: long-term follow-up of a multicentre, randomised trial.
        Lancet. 2019; 394: 471-477
        • Gillgren P.
        • Drzewiecki K.T.
        • Niin M.
        • et al.
        2-cm versus 4-cm surgical excision margins for primary cutaneous melanoma thicker than 2 mm: a randomised, multicentre trial.
        Lancet. 2011; 378: 1635-1642
        • Khayat D.
        • Rixe O.
        • Martin G.
        • et al.
        Surgical margins in cutaneous melanoma (2 cm versus 5 cm for lesions measuring less than 2.1-mm thick).
        Cancer. 2003; 97: 1941-1946
        • Thomas J.M.
        • Newton-Bishop J.
        • A'Hern R.
        • et al.
        Excision margins in high-risk malignant melanoma.
        N Engl J Med. 2004; 350: 757-766
        • Hayes A.J.
        • Maynard L.
        • Coombes G.
        • et al.
        Wide versus narrow excision margins for high-risk, primary cutaneous melanomas: long-term follow-up of survival in a randomised trial.
        Lancet Oncol. 2016; 17: 184-192
        • Cascinelli N.
        • Morabito A.
        • Santinami M.
        • et al.
        Immediate or delayed dissection of regional nodes in patients with melanoma of the trunk: a randomised trial. WHO Melanoma Programme.
        Lancet. 1998; 351: 793-796
        • Balch C.M.
        • Soong S.J.
        • Bartolucci A.A.
        • et al.
        Efficacy of an elective regional lymph node dissection of 1 to 4 mm thick melanomas for patients 60 years of age and younger.
        Ann Surg. 1996; 224 ([discussion: 263–6]): 255-263
        • Veronesi U.
        • Adamus J.
        • Bandiera D.C.
        • et al.
        Delayed regional lymph node dissection in stage I melanoma of the skin of the lower extremities.
        Cancer. 1982; 49: 2420-2430
        • Bello D.M.
        • Faries M.B.
        The Landmark Series: MSLT-1, MSLT-2 and DeCOG (Management of Lymph Nodes).
        Ann Surg Oncol. 2020; 27: 15-21
        • Morton D.L.
        • Thompson J.F.
        • Cochran A.J.
        • et al.
        Sentinel-node biopsy or nodal observation in melanoma.
        N Engl J Med. 2006; 355: 1307-1317
        • Morton D.L.
        • Thompson J.F.
        • Cochran A.J.
        • et al.
        Final trial report of sentinel-node biopsy versus nodal observation in melanoma.
        N Engl J Med. 2014; 370: 599-609
        • Leiter U.
        • Stadler R.
        • Mauch C.
        • et al.
        Complete lymph node dissection versus no dissection in patients with sentinel lymph node biopsy positive melanoma (DeCOG-SLT): a multicentre, randomised, phase 3 trial.
        Lancet Oncol. 2016; 17: 757-767
        • Ariyan C.
        • Brady M.S.
        • Gönen M.
        • et al.
        Positive nonsentinel node status predicts mortality in patients with cutaneous melanoma.
        Ann Surg Oncol. 2009; 16: 186-190
        • Faries M.B.
        • Thompson J.F.
        • Cochran A.J.
        • et al.
        Completion Dissection or Observation for Sentinel-Node Metastasis in Melanoma.
        N Engl J Med. 2017; 376: 2211-2222
        • Pucci C.
        • Martinelli C.
        • Ciofani G.
        Innovative approaches for cancer treatment: current perspectives and new challenges.
        Ecancermedicalscience. 2019; 13: 961
        • Ascierto P.A.
        • Kirkwood J.M.
        • Grob J.J.
        • et al.
        The role of BRAF V600 mutation in melanoma.
        J Transl Med. 2012; 10: 85
        • Bhatia P.
        • Friedlander P.
        • Zakaria E.A.
        • et al.
        Impact of BRAF mutation status in the prognosis of cutaneous melanoma: an area of ongoing research.
        Ann Transl Med. 2015; 3: 24
        • Sahni S.
        • Valecha G.
        • Sahni A.
        Role of Anti-PD-1 Antibodies in Advanced Melanoma: The Era of Immunotherapy.
        Cureus. 2018; 10: e3700
        • Eroglu Z.
        • Ribas A.
        Combination therapy with BRAF and MEK inhibitors for melanoma: latest evidence and place in therapy.
        Ther Adv Med Oncol. 2016; 8: 48-56
        • Chapman P.B.
        • Hauschild A.
        • Robert C.
        • et al.
        Improved survival with vemurafenib in melanoma with BRAF V600E mutation.
        N Engl J Med. 2011; 364: 2507-2516
        • Ascierto P.A.
        • Minor D.
        • Ribas A.
        • et al.
        Phase II trial (BREAK-2) of the BRAF inhibitor dabrafenib (GSK2118436) in patients with metastatic melanoma.
        J Clin Oncol. 2013; 31: 3205-3211
        • Hauschild A.
        • Grob J.J.
        • Demidov L.V.
        • et al.
        Dabrafenib in BRAF-mutated metastatic melanoma: a multicentre, open-label, phase 3 randomised controlled trial.
        Lancet. 2012; 380: 358-365
        • Sosman J.A.
        • Kim K.B.
        • Schuchter L.
        • et al.
        Survival in BRAF V600-mutant advanced melanoma treated with vemurafenib.
        N Engl J Med. 2012; 366: 707-714
        • Maio M.
        • Lewis K.
        • Demidov L.
        • et al.
        Adjuvant vemurafenib in resected, BRAF.
        Lancet Oncol. 2018; 19: 510-520
        • Long G.V.
        • Hauschild A.
        • Santinami M.
        • et al.
        Adjuvant Dabrafenib plus Trametinib in Stage III BRAF-Mutated Melanoma.
        N Engl J Med. 2017; 377: 1813-1823
        • Eggermont A.M.
        • Chiarion-Sileni V.
        • Grob J.J.
        • et al.
        Adjuvant ipilimumab versus placebo after complete resection of high-risk stage III melanoma (EORTC 18071): a randomised, double-blind, phase 3 trial.
        Lancet Oncol. 2015; 16: 522-530
        • Eggermont A.M.M.
        • Blank C.U.
        • Mandalà M.
        • et al.
        Adjuvant pembrolizumab versus placebo in resected stage III melanoma (EORTC 1325-MG/KEYNOTE-054): distant metastasis-free survival results from a double-blind, randomised, controlled, phase 3 trial.
        Lancet Oncol. 2021; 22: 643-654
        • Weber J.
        • Mandala M.
        • Del Vecchio M.
        • et al.
        Adjuvant Nivolumab versus Ipilimumab in Resected Stage III or IV Melanoma.
        N Engl J Med. 2017; 377: 1824-1835
        • Luke J.J.
        • Rutkowski P.
        • Queirolo P.
        • et al.
        Pembrolizumab versus placebo as adjuvant therapy in completely resected stage IIB or IIC melanoma (KEYNOTE-716): a randomised, double-blind, phase 3 trial.
        Lancet. 2022; 399: 1718-1729
        • Grossman K.
        • Othus M.
        • Pratel S.
        • et al.
        Final analysis of overall survival (OS) and relapse-free-survival (RFS) in the intergroup S1404 phase III randomized trial comparing either high-dose interferon (HDI) or ipilimumab to pemnbrolizumab in patients with high-risk resected melanoma.
        J Clin Oncol. 2021; : 9501
        • Grossmann K.F.
        • Othus M.
        • Patel S.P.
        • et al.
        Adjuvant Pembrolizumab versus IFNα2b or Ipilimumab in Resected High-Risk Melanoma.
        Cancer Discov. 2022; 12: 644-653
        • Moncrieff M.D.
        • Gyorki D.
        • Saw R.
        • et al.
        1 Versus 2-cm Excision Margins for pT2-pT4 Primary Cutaneous Melanoma (MelMarT): A Feasibility Study.
        Ann Surg Oncol. 2018; 25: 2541-2549
        • Coit D.
        • Ariyan C.
        MelMART Trial: It's Now or Never.
        Ann Surg Oncol. 2018; 25: 2493-2495
      1. Bristol Myers Squibb. Press release: Bristol-Myers Squibb announces update on CheckMate-915 for Opdivo (nivolumab) plus Yervoy (ipilimumab) versus Opdivo alone in patients with resected high-risk melanoma and PD-L1 <1%. November 20th 2019. Available at: https://news.bms.com/news/details/2019/Bristol-Myers-Squibb-Announces-Update-on-CheckMate--915-for-Opdivo-nivolumab-Plus-Yervoy-ipilimumab-Versus-Opdivo-Alone-in-Patients-with-Resected-High-Risk-Melanoma-and-PD-L1-1/default.aspx.

      2. Neoadjuvant Ipilimumab Plus Nivolumab Versus Standard Adjuvant Nivolumab in Macroscopic Stage III Melanoma (NADINA). 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT04949113.

      3. A Study to Compare the Administration of Pembrolizumab After Surgery Versus Administration Both Before and After Surgery for High-Risk Melanoma. 2018. Available at: https://clinicaltrials.gov/ct2/show/NCT03698019.

        • Wilson M.
        • Geskin L.J.
        • Carvajal R.D.
        • et al.
        Adjuvant nivolumab in high-risk stage IIb/IIc melanoma patients: Results from investigator initiated clinical trial.
        J Clin Oncol. 2021; 39