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In a phase III trial (SUMIT) reported in the Journal of Clinical Oncology, Carvajal et al found that the addition of the oral MEK1/2 inhibitor selumetinib to dacarbazine did not significantly improve progression-free survival in patients with metastatic uveal melanoma. Study Details In the...
In the international phase III BRIM8 trial reported in The Lancet Oncology, Maio et al found inconclusive evidence of benefit of adjuvant vemurafenib treatment in patients with BRAF V600–mutant melanoma. Study Details In the double-blind trial, 498 patients with fully resected...
In a study reported in JAMA Oncology, Lee et al found that measurement of circulating tumor DNA (ctDNA) can help distinguish between pseudoprogression (radiologic progression prior to response) and true progression in patients with metastatic melanoma receiving anti–programmed cell death ...
The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies in melanoma. These studies focus on assessing response to checkpoint inhibitors; T-cell immunotherapy; combination therapies; adoptive cell therapy; combination therapy development; and...
The Skin Cancer Foundation, the leading nonprofit organization for public and professional skin cancer education, recently moved to a new office space at 205 Lexington Avenue in midtown Manhattan. The new office will allow the Foundation to grow its staff as it develops new patient support programs ...
In a study reported in The Lancet Oncology, McQuade et al found that obesity was associated with improved outcomes in treatment of metastatic melanoma with targeted therapy or immunotherapy—but not chemotherapy—with a survival benefit appearing to be restricted to obese male patients....
The number of U.S. cases of Merkel cell carcinoma is rising about six times faster than most other cancers, and at nearly twice the rate of melanoma. Paulson et al reported these findings in The Journal of the American Academy of Dermatology, which are based on research conducted at the University...
OBESE PATIENTS with metastatic melanoma who are treated with targeted or immune therapies live significantly longer than those with a normal body mass index (BMI), according to a study published in The Lancet Oncology of 1,918 patients in 6 independent clinical cohorts.1 This effect—referred to as ...
A pooled analysis by the U.S. Food and Drug Administration (FDA) has shown a benefit of treatment beyond progression, as defined by RECIST criteria, in many patients receiving anti–programmed cell death protein 1 (PD-1) antibodies for unresectable or metastatic melanoma. The analysis was ...
A pair of targeted therapies given before and after surgery for melanoma produced at least a sixfold increase in time to progression compared to standard-of-care surgery for patients with stage III disease, Amaria et al reported in The Lancet Oncology. Patients who had no sign of disease at surgery ...
Desmoplastic melanoma is a rare subtype of melanoma that is commonly found on sun-exposed areas, such as the head and neck, and usually seen in older patients. Treatment is difficult, as these tumors are often resistant to chemotherapy and lack actionable mutations commonly found in other types of...
As reported in the Journal of Clinical Oncology by Robert and colleagues, a high proportion of patients with metastatic melanoma achieving complete response on pembrolizumab (Keytruda) in the phase Ib KEYNOTE-001 trial maintained complete response for prolonged durations after treatment...
Increasing use of a potentially life-saving treatment for metastatic cancer is leaving too many vulnerable patients behind, according to a new study from Yale Cancer Center/Smilow Cancer Hospital published by Kann et al in JNCCN – Journal of the National Comprehensive Cancer Network. The...
On January 8, Merck and the European Organisation for Research and Treatment of Cancer (EORTC) announced that the phase III EORTC1325/KEYNOTE-054 trial investigating pembrolizumab (Keytruda) as monotherapy for surgically resected high-risk melanoma met its primary endpoint of recurrence-free...
In 2007, the International Agency for Research on Cancer classified shift work with circadian disruption or chronodisruption as a probable human carcinogen. Now, a meta-analysis investigating whether long-term shift work increases the risks of common cancers in women has found that, overall, night...
On December 22, the U.S. Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) and granted Priority Review designation to dabrafenib (Tafinlar) in combination with trametinib (Mekinist) for the adjuvant treatment of patients with stage III melanoma with BRAF V600E...
On December 20, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to the anti–programmed cell death protein 1 (PD-1) monoclonal antibody nivolumab (Opdivo) for the adjuvant treatment of patients with melanoma with involvement of lymph nodes, or in patients with...
CLINICIANS ARE now well acquainted with BRAF mutations in advanced melanoma, but there is more to genomics in this disease than identifying BRAF and prescribing a BRAF inhibitor. At the 2017 Debates and Didactics Conference, held at Sea Island, Georgia, Melinda L. Yushak, MD, MPH, of Emory...
MUCH PROGRESS has been made in the past decade in the treatment of patients with newly diagnosed metastatic melanoma. In the front-line setting, programmed cell death protein 1 (PD-1) monotherapy (nivolumab [Opdivo] and pembrolizumab [Keytruda]) and combined PD-1 plus cytotoxic...
On October 23, Novartis announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for dabrafenib (Tafinlar) in combination with trametinib (Mekinist) for the adjuvant treatment of patients with stage III melanoma with a BRAF V600 mutation following...
On October 16, Bristol-Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review its supplemental Biologics License Application (sBLA) for nivolumab (Opdivo) to treat patients with melanoma who are at high risk of disease recurrence following complete...
As reported by Long et al in the Journal of Clinical Oncology, a 5-year landmark analysis of patients receiving dabrafenib (Tafinlar) and trametinib (Mekinist) for BRAF V600–mutant metastatic melanoma shows persistent overall and progression-free survival benefits. Study Details The...
Research presented at the 9th World Congress of Melanoma supports the updated guideline recommendation that sentinel lymph node biopsy be performed in more patients newly diagnosed with melanoma, as it has the potential to save lives due to the information the procedure provides. This biopsy can...
OncoSec Medical Incorporated presented new clinical data on ImmunoPulse IL-12 (intratumoral pIL-12 [tavokinogene telseplasmid] with electroporation) at the 9th World Congress of Melanoma. “We are excited to share updated data from our phase II clinical monotherapy trial with ImmunoPulse ...
BerGenBio ASA announced that the randomized phase Ib/II clinical study of the Axl inhibitor BGB324 in combination with either the MAP kinase inhibitors trametinib (Mekinist) plus dabrafenib (Tafinlar) or the immune checkpoint inhibitor pembrolizumab (Keytruda) in patients with advanced melanoma is...
IN A LARGE single-institution study reported in the Journal of the National Comprehensive Cancer Network, Tobin Strom, MD, and colleagues found that regional radiotherapy was associated with a reduced risk of regional recurrence in patients with node-positive cutaneous melanoma, including those...
IN A RETROSPECTIVE pooled analysis of the CheckMate 069 and 067 studies reported in the Journal of Clinical Oncology, Dirk Schadendorf, MD, of the University Hospital Essen and the German Cancer Consortium, and colleagues found little difference in the efficacy of combined nivolumab (Opdivo) and...
In a retrospective analysis reported in JAMA Oncology, Georgina V. Long, MBBS, PhD, of the Melanoma Institute Australia, North Sydney, and colleagues found that a substantial proportion of patients with advanced melanoma derived benefit from continued nivolumab (Opdivo) treatment after Response...
BASED ON THE RESULTS of COMBI-AD1 and CheckMate 238,2 invited discussant Alexander Eggermont, MD, PhD, Professor of Oncology at Gustave Roussy in Paris, commented: “It’s a good day for melanoma!” In COMBI-AD, treatment with the combination of dabrafenib (Tafinlar) and trametinib (Mekinist)...
IN THE TREATMENT of malignant melanoma, immune checkpoint inhibitors are no longer just for metastatic disease, and the best type may be agents targeting the programmed cell death protein 1 (PD-1), according to results of CheckMate 238, presented at the European Society for Medical Oncology (ESMO)...
FOR PATIENTS with locally advanced, resectable melanoma harboring BRAF mutations, adjuvant treatment with BRAF/ MEK inhibition significantly improves overall survival, results of the COMBI-AD trial have shown. The study was presented at the European Society for Medical Oncology (ESMO) 2017...
A phase II study has shown that the addition of the oncolytic viral agent talimogene laherparepvec (Imlygic) to ipilimumab (Yervoy) significantly increased the response rate in patients with advanced unresectable melanoma. These findings were reported in the Journal of Clinical Oncology by Chesney...
An Italian single-center prospective cohort study suggests that adjuvant treatment with the beta-blocker propranolol significantly reduces the risk of melanoma recurrence in patients with stage IB to IIIA cutaneous disease. The findings were reported in JAMA Oncology by De Giorgi et al. Preclinical ...
THE PHASE III MSLT- II TRIAL showed that completion dissection was not associated with improved melanoma-specific overall survival vs observation in patients with sentinel-node metastasis, although a benefit was observed in regional disease control. The findings were reported in The New England...
IN WHAT APPEARS TO BE the largest blood-based biomarker study of a checkpoint inhibitor, an RNA transcript–based gene classifier was able to predict for melanoma patients’ response to tremelimumab. The study was recently published in the Journal for ImmunoTherapy of Cancer.1 “Our study, in many...
PROBABLY THE MOST IMPORTANT advance in the treatment of newly diagnosed primary melanoma has been the incorporation of sentinel lymph node biopsy as part of initial surgical management. The routine use of sentinel lymph node biopsy, often termed “sentinel lymphadenectomy,” in appropriately...
In a retrospective study reported in the Journal of Clinical Oncology, Sznol et al have provided a pooled safety profile of combination nivolumab (Opdivo) and ipilimumab (Yervoy) treatment in patients with advanced melanoma. Study Details The study included data from 448 patients from a phase Ib...
The phase III Checkmate 238 trial has shown improved recurrence-free survival with adjuvant nivolumab (Opdivo) vs ipilimumab (Yervoy) in patients with resected advanced melanoma. The findings were reported by Jeffrey Weber and colleagues in The New England Journal of Medicine. Study Details In the ...
The phase III COMBI-AD trial has shown a significant improvement in relapse-free survival with the combination of the BRAF inhibitor dabrafenib (Tafinlar) and the MEK inhibitor trametinib (Mekinist) vs placebo as adjuvant therapy in patients with resected stage III melanoma with BRAF V600E or V600K ...
The phase III Checkmate 238 trial has shown improved recurrence-free survival with adjuvant nivolumab (Opdivo) vs ipilimumab (Yervoy) in patients with resected advanced melanoma. The findings were reported by Weber and colleagues in The New England Journal of Medicine. Study Details In the...
THE PHASE III MSLT- II TRIAL showed that completion dissection was not associated with improved melanoma-specific overall survival vs observation in patients with sentinel-node metastasis, although a benefit was observed in regional disease control. The findings were reported in The New England...
DOES COMPLETE lymph node dissection for sentinel node–positive melanoma still have a role in the management of this disease? That’s debatable. Although it does not improve overall survival over observation alone, complete lymphadenectomy may have other benefits, according to a dialogue at the...
ASSUMING THE regimens evaluated in COMBI-AD and CheckMate 238 are both approved by the U.S. Food and Drug Administration for the treatment of high-risk resected melanoma, clinicians may be faced with a tough choice. ESMO experts and the study’s investigators weighed in on this issue in a lively...
FOR PATIENTS with malignant melanoma, the significant improvement in outcomes with targeted agents and antibodies against the programmed cell death protein 1 (PD-1) has now been observed in the adjuvant setting. Two landmark studies presented at the European Society for Medical Oncology (ESMO) 2017 ...
Overall survival outcomes in the phase III CheckMate 067 trial indicate improved survival with nivolumab (Opdivo)/ipilimumab (Yervoy) vs ipilimumab and with nivolumab vs ipilimumab in patients with previously untreated advanced melanoma. These findings were reported in The New England Journal of...
Combination targeted adjuvant therapy with dabrafenib (Tafinlar) and trametinib (Mekinist) doubles relapse-free survival in patients with stage III BRAF-mutant melanoma, according to late-breaking results from the COMBI-AD trial presented on September 11 at the European Society for Medical Oncology ...
Adjuvant nivolumab (Opdivo) is superior to standard-of-care ipilimumab (Yervoy) in patients with surgically resected stage III/IV melanoma who are at high risk of relapse, according to late-breaking results from the CheckMate 238 trial presented on September 11 at the European Society for Medical...
Jeffrey S. Weber, MD, PhD, of New York University’s Langone Medical Center, discusses study results on adjuvant therapy with nivolumab vs ipilimumab after complete resection of stage III/IV melanoma (Abstract LBA8).
Karl D. Lewis, MD, of the Anschutz Cancer Pavilion, discusses study findings on adjuvant vemurafenib in patients with completely resected BRAF V600–positive melanoma at high risk for recurrence (Abstract LBA7).
Caroline Robert, MD, PhD, of Gustave Roussy, characterizes complete responses in patients with advanced melanoma who received the combination of nivolumab and ipilimumab, or nivolumab or ipilimumab alone (Abstract 1213O).