Clinical Trials in Melanoma

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. 17: 367-402Angeles C.V. Wong S.L. Karakousis G.

The Landmark Series: Randomized Trials Examining Surgical Margins for Cutaneous Melanoma.

Ann Surg Oncol. 27: 3-12Cosimi A.B. Sober A.J. Mihm M.C. et al.

Conservative surgical management of superficially invasive cutaneous melanoma.

Cancer. 53: 1256-1259Balch 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. 43: 883-888Day C.L. Mihm M.C. Sober A.J. et al.

Narrower margins for clinical stage I malignant melanoma.

N Engl J Med. 306: 479-482Veronesi 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. 318: 1159-1162Veronesi U. Cascinelli N.

Narrow excision (1-cm margin). A safe procedure for thin cutaneous melanoma.

Arch Surg. 126: 438-441Balch 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. 7: 87-97Karakousis 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. 3: 446-452Balch 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. 218 (): 262-267Cohn-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. 89: 1495-1501Ringborg 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. 77: 1809-1814Utjés 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. 394: 471-477Gillgren 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. 378: 1635-1642Khayat 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. 97: 1941-1946Thomas J.M. Newton-Bishop J. A'Hern R. et al.

Excision margins in high-risk malignant melanoma.

N Engl J Med. 350: 757-766Hayes 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. 17: 184-192Cascinelli 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. 351: 793-796Balch 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. 224 (): 255-263Veronesi 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. 49: 2420-2430

The Landmark Series: MSLT-1, MSLT-2 and DeCOG (Management of Lymph Nodes).

Ann Surg Oncol. 27: 15-21Morton D.L. Thompson J.F. Cochran A.J. et al.

Sentinel-node biopsy or nodal observation in melanoma.

N Engl J Med. 355: 1307-1317Morton 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. 370: 599-609Leiter 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. 17: 757-767Ariyan C. Brady M.S. Gönen M. et al.

Positive nonsentinel node status predicts mortality in patients with cutaneous melanoma.

Ann Surg Oncol. 16: 186-190Faries M.B. Thompson J.F. Cochran A.J. et al.

Completion Dissection or Observation for Sentinel-Node Metastasis in Melanoma.

N Engl J Med. 376: 2211-2222Pucci C. Martinelli C. Ciofani G.

Innovative approaches for cancer treatment: current perspectives and new challenges.

Ecancermedicalscience. 13: 961Ascierto P.A. Kirkwood J.M. Grob J.J. et al.

The role of BRAF V600 mutation in melanoma.

J Transl Med. 10: 85Bhatia 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. 3: 24Sahni S. Valecha G. Sahni A.

Role of Anti-PD-1 Antibodies in Advanced Melanoma: The Era of Immunotherapy.

Cureus. 10: e3700

Combination therapy with BRAF and MEK inhibitors for melanoma: latest evidence and place in therapy.

Ther Adv Med Oncol. 8: 48-56Chapman P.B. Hauschild A. Robert C. et al.

Improved survival with vemurafenib in melanoma with BRAF V600E mutation.

N Engl J Med. 364: 2507-2516Ascierto 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. 31: 3205-3211Hauschild 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. 380: 358-365Sosman J.A. Kim K.B. Schuchter L. et al.

Survival in BRAF V600-mutant advanced melanoma treated with vemurafenib.

N Engl J Med. 366: 707-714Maio M. Lewis K. Demidov L. et al.

Adjuvant vemurafenib in resected, BRAF.

Lancet Oncol. 19: 510-520Long G.V. Hauschild A. Santinami M. et al.

Adjuvant Dabrafenib plus Trametinib in Stage III BRAF-Mutated Melanoma.

N Engl J Med. 377: 1813-1823Eggermont 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. 16: 522-530Eggermont 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. 22: 643-654Weber J. Mandala M. Del Vecchio M. et al.

Adjuvant Nivolumab versus Ipilimumab in Resected Stage III or IV Melanoma.

N Engl J Med. 377: 1824-1835Luke 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. 399: 1718-1729Grossman 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. : 9501Grossmann K.F. Othus M. Patel S.P. et al.

Adjuvant Pembrolizumab versus IFNα2b or Ipilimumab in Resected High-Risk Melanoma.

Cancer Discov. 12: 644-653Moncrieff 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. 25: 2541-2549

MelMART Trial: It's Now or Never.

Ann Surg Oncol. 25: 2493-2495

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.

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

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. 39

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