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Clinical trial metastatic melanoma

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https://www.readbyqxmd.com/read/29908991/mage-a3-immunotherapeutic-as-adjuvant-therapy-for-patients-with-resected-mage-a3-positive-stage-iii-melanoma-derma-a-double-blind-randomised-placebo-controlled-phase-3-trial
#1
Brigitte Dreno, John F Thompson, Bernard Mark Smithers, Mario Santinami, Thomas Jouary, Ralf Gutzmer, Evgeny Levchenko, Piotr Rutkowski, Jean-Jacques Grob, Sergii Korovin, Kamil Drucis, Florent Grange, Laurent Machet, Peter Hersey, Ivana Krajsova, Alessandro Testori, Robert Conry, Bernard Guillot, Wim H J Kruit, Lev Demidov, John A Thompson, Igor Bondarenko, Jaroslaw Jaroszek, Susana Puig, Gabriela Cinat, Axel Hauschild, Jelle J Goeman, Hans C van Houwelingen, Fernando Ulloa-Montoya, Andrea Callegaro, Benjamin Dizier, Bart Spiessens, Muriel Debois, Vincent G Brichard, Jamila Louahed, Patrick Therasse, Channa Debruyne, John M Kirkwood
BACKGROUND: Despite newly approved treatments, metastatic melanoma remains a life-threatening condition. We aimed to evaluate the efficacy of the MAGE-A3 immunotherapeutic in patients with stage IIIB or IIIC melanoma in the adjuvant setting. METHODS: DERMA was a phase 3, double-blind, randomised, placebo-controlled trial done in 31 countries and 263 centres. Eligible patients were 18 years or older and had histologically proven, completely resected, stage IIIB or IIIC, MAGE-A3-positive cutaneous melanoma with macroscopic lymph node involvement and an Eastern Cooperative Oncology Group performance score of 0 or 1...
June 13, 2018: Lancet Oncology
https://www.readbyqxmd.com/read/29906735/patterns-of-disease-control-and-survival-in-patients-with-melanoma-brain-metastases-undergoing-immune-checkpoint-blockade
#2
Laura Milsch, Anja Gesierich, Sophia Kreft, Elisabeth Livingstone, Lisa Zimmer, Matthias Goebeler, Dirk Schadendorf, Bastian Schilling
OBJECTIVES: Immune-checkpoint blockers (ICBs) significantly prolong overall survival (OS) in patients with advanced melanoma. Limited data are available on the efficacy and clinical benefit in patients with melanoma brain metastases (MBMs). The aim of this study was to determine whether ICB is active in an unselected cohort treated of patients with known brain metastases and if disease control correlates with the survival. METHODS: A total of 385 patients with metastatic malignant melanoma treated with ICB as monotherapy between 2005 and 2017 in two tertiary referral centres were included...
June 12, 2018: European Journal of Cancer
https://www.readbyqxmd.com/read/29889594/cytokines-in-the-treatment-of-cancer
#3
Kevin C Conlon, Milos D Miljkovic, Thomas A Waldmann
Cytokines are major regulators of innate and adaptive immunity that enable cells of the immune system to communicate over short distances. Cytokine therapy to activate the immune system of cancer patients has been an important treatment modality and continues to be a key contributor to current clinical cancer research. Interferon alpha (IFNα) is approved for adjuvant treatment of completely resected high-risk melanoma patients and several refractory malignancies. High-dose interleukin-2 (HDIL-2) is approved for treatment of metastatic renal cell cancer and melanoma, but both agents are currently less commonly used with the development of newer agents...
June 11, 2018: Journal of Interferon & Cytokine Research
https://www.readbyqxmd.com/read/29872563/targeting-gp100-and-trp-2-with-a-dna-vaccine-incorporating-t-cell-epitopes-with-a-human-igg1-antibody-induces-potent-t-cell-responses-that-are-associated-with-favourable-clinical-outcome-in-a-phase-i-ii-trial
#4
Poulam M Patel, Christian H Ottensmeier, Clive Mulatero, Paul Lorigan, Ruth Plummer, Hardev Pandha, Somaia Elsheikh, Efthymios Hadjimichael, Naty Villasanti, Sally E Adams, Michelle Cunnell, Rachael L Metheringham, Victoria A Brentville, Lee Machado, Ian Daniels, Mohamed Gijon, Drew Hannaman, Lindy G Durrant
A DNA vaccine, SCIB1, incorporating two CD8 and two CD4 epitopes from TRP-2/gp100 was evaluated in patients with metastatic melanoma. Each patient received SCIB1 via intramuscular injection with electroporation. The trial was designed to find the safest dose of SCIB1 which induced immune/clinical responses in patients with or without tumour. Fifteen patients with tumor received SCIB1 doses of 0.4-8 mg whilst 20 fully-resected patients received 2-8 mg doses. Twelve patients elected to continue immunization every 3 months for up to 39 months...
2018: Oncoimmunology
https://www.readbyqxmd.com/read/29866134/itraconazole-treatment-of-primary-malignant-melanoma-of-the-vagina-evaluated-using-positron-emission-tomography-and-tissue-cdna-microarray-a-case-report
#5
Kayo Inoue, Hiroshi Tsubamoto, Roze Isono-Nakata, Kazuko Sakata, Nami Nakagomi
BACKGROUND: Primary malignant melanoma of the vagina is extremely rare, with a poorer prognosis than cutaneous malignant melanoma. Previous studies have explored the repurposing of itraconazole, a common oral anti-fungal agent, for the treatment of various cancers. Here, we describe a patient with metastatic, unresectable vaginal malignant melanoma treated with 200 mg oral itraconazole twice a day in a clinical window-of-opportunity trial. CASE PRESENTATION: A 64-year-old Japanese woman with vaginal and inguinal tumours was referred to our institution...
June 4, 2018: BMC Cancer
https://www.readbyqxmd.com/read/29864718/vitamin-d-in-melanoma-controversies-and-potential-role-in-combination-with-immune-check-point-inhibitors
#6
REVIEW
Luigia Stefania Stucci, Stella D'Oronzo, Marco Tucci, Antonella Macerollo, Simone Ribero, Francesco Spagnolo, Elena Marra, Virginia Picasso, Laura Orgiano, Riccardo Marconcini, Francesco De Rosa, Lorenza di Guardo, Giulia Galli, Sara Gandini, Raffaele Palmirotta, Giuseppe Palmieri, Paola Queirolo, Francesco Silvestris
The role of vitamin D in melanoma is still controversial. Although several Authors described a correlation between vitamin D deficiency and poor survival in metastatic melanoma patients, clinical trials exploring the effects of vitamin D supplementation in this clinical setting were mostly inconclusive. However, recent evidence suggests that vitamin D exerts both anti-proliferative effects on tumor cells and immune-modulating activities, that have been widely explored in auto-immune disorders. On the one hand, vitamin D has been shown to inhibit T-helper17 lymphocytes, notoriously involved in the pathogenesis of immune-related adverse events (iAEs) which complicate immune-checkpoint inhibitor (ICI) treatment...
May 31, 2018: Cancer Treatment Reviews
https://www.readbyqxmd.com/read/29848375/an-update-on-the-society-for-immunotherapy-of-cancer-consensus-statement-on-tumor-immunotherapy-for-the-treatment-of-cutaneous-melanoma-version-2-0
#7
Ryan J Sullivan, Michael B Atkins, John M Kirkwood, Sanjiv S Agarwala, Joseph I Clark, Marc S Ernstoff, Leslie Fecher, Thomas F Gajewski, Brian Gastman, David H Lawson, Jose Lutzky, David F McDermott, Kim A Margolin, Janice M Mehnert, Anna C Pavlick, Jon M Richards, Krista M Rubin, William Sharfman, Steven Silverstein, Craig L Slingluff, Vernon K Sondak, Ahmad A Tarhini, John A Thompson, Walter J Urba, Richard L White, Eric D Whitman, F Stephen Hodi, Howard L Kaufman
BACKGROUND: Cancer immunotherapy has been firmly established as a standard of care for patients with advanced and metastatic melanoma. Therapeutic outcomes in clinical trials have resulted in the approval of 11 new drugs and/or combination regimens for patients with melanoma. However, prospective data to support evidence-based clinical decisions with respect to the optimal schedule and sequencing of immunotherapy and targeted agents, how best to manage emerging toxicities and when to stop treatment are not yet available...
May 30, 2018: Journal for Immunotherapy of Cancer
https://www.readbyqxmd.com/read/29847853/combination-controversies-checkpoint-inhibition-alone-or-in-combination-for-the-treatment-of-melanoma
#8
REVIEW
Allison Betof Warner, Michael A Postow
The immune checkpoint inhibitors ipilimumab, nivolumab, and pembrolizumab have dramatically improved outcomes for patients with metastatic melanoma; however, not all patients benefit from monotherapy with these agents. To address this issue, complementary combinations of immunotherapy are increasingly being explored as a strategy to improve outcomes. However, combinatorial approaches come with heightened risk of toxicity. In this review, we highlight combinations for which there are prospective data from clinical trials...
May 15, 2018: Oncology (Williston Park, NY)
https://www.readbyqxmd.com/read/29845338/establishment-of-adoptive-cell-therapy-with-tumor-infiltrating-lymphocytes-for-non-small-cell-lung-cancer-patients
#9
Ronny Ben-Avi, Ronit Farhi, Alon Ben-Nun, Marina Gorodner, Eyal Greenberg, Gal Markel, Jacob Schachter, Orit Itzhaki, Michal J Besser
Adoptive cell therapy (ACT) of tumor infiltration lymphocytes (TIL) yields promising clinical results in metastatic melanoma patients, who failed standard treatments. Due to the fact that metastatic lung cancer has proven to be susceptible to immunotherapy and possesses a high mutation burden, which makes it responsive to T cell attack, we explored the feasibility of TIL ACT in non-small cell lung cancer (NSCLC) patients. Multiple TIL cultures were isolated from tumor specimens of five NSCLC patients undergoing thoracic surgery...
May 29, 2018: Cancer Immunology, Immunotherapy: CII
https://www.readbyqxmd.com/read/29844573/melanoma-protective-antitumor-immunity-activated-by-catalytic-dna
#10
Hong Cai, Eun-Ae Cho, Yue Li, Jim Sockler, Christopher R Parish, Beng H Chong, Jarem Edwards, Tristan J Dodds, Peter M Ferguson, James S Wilmott, Richard A Scolyer, Gary M Halliday, Levon M Khachigian
Melanoma incidence is increasing worldwide, and although drugs such as BRAF/MEK small-molecule inhibitors and immune checkpoint antibodies improve patient outcomes, most patients ultimately fail these therapies and alternative treatment strategies are urgently needed. DNAzymes have recently undergone clinical trials with signs of efficacy and no serious adverse events attributable to the DNAzyme. Here we investigated c-Jun expression in human primary and metastatic melanoma. We also explored the role of T cell immunity in DNAzyme inhibition of primary melanoma growth and the prevention of growth in non-treated tumors after the cessation of treatment in a mouse model...
May 29, 2018: Oncogene
https://www.readbyqxmd.com/read/29803316/adoptive-cell-transfer-using-autologous-tumor-infiltrating-lymphocytes-in-gynecologic-malignancies
#11
REVIEW
Paul Mayor, Kristen Starbuck, Emese Zsiros
During the last decade, the field of cancer immunotherapy has been entirely transformed by the development of new and more effective treatment modalities with impressive response rates and the prospect of long survival. One of the major breakthroughs is adoptive cell transfer (ACT) based on autologous T cells derived from tumor-infiltrating lymphocytes (TILs). TIL-based ACT is a highly personalized cancer treatment. T cells are harvested from autologous fresh tumor tissues, and after ex vivo activation and extensive expansion, are reinfused to patients...
May 23, 2018: Gynecologic Oncology
https://www.readbyqxmd.com/read/29795041/reversal-of-resistance-in-targeted-therapy-of-metastatic-melanoma-lessons-learned-from-vemurafenib-braf-v600e-specific-inhibitor
#12
REVIEW
Antoni Xavier Torres-Collado, Jeffrey Knott, Ali R Jazirehi
Malignant melanoma is the most aggressive form of skin cancer and has a very low survival rate. Over 50% of melanomas harbor various BRAF mutations with the most common being the V600E. BRAFV600E mutation that causes constitutive activation of the MAPK pathway leading to drug-, immune-resistance, apoptosis evasion, proliferation, survival, and metastasis of melanomas. The ATP competitive BRAFV600E selective inhibitor, vemurafenib, has shown dramatic success in clinical trials; promoting tumor regression and an increase in overall survival of patients with metastatic melanoma...
May 24, 2018: Cancers
https://www.readbyqxmd.com/read/29794999/targeted-tumor-therapy-remixed-an-update-on-the-use-of-small-molecule-drugs-in-combination-therapies
#13
REVIEW
Martina V Gatzka
Over the last decade, the treatment of tumor patients has been revolutionized by the highly successful introduction of novel targeted therapies, in particular small-molecule kinase inhibitors and monoclonal antibodies, as well as by immunotherapies. Depending on the mutational status, BRAF and MEK inhibitor combinations or immune checkpoint inhibitors are current first-line treatments for metastatic melanoma. However, despite great improvements of survival rates limitations due to tumor heterogeneity, primary and acquired therapy resistance, immune evasion, and economical considerations will need to be overcome...
May 24, 2018: Cancers
https://www.readbyqxmd.com/read/29790899/advances-in-the-systemic-treatment-of-melanoma-brain-metastases
#14
I C Glitza Oliva, G Schvartsman, H Tawbi
Of the solid tumor types that metastasize to the brain, melanoma has the highest propensity to form brain metastases. In addition, much remains unknown regarding the pathophysiology involved in melanoma cell extravasation through the blood-brain barrier, which enables interactions with the microenvironment, and melanoma cell transcriptomic responses to brain-specific cues. However, recent developments in targeted therapy and immunotherapy have generated considerable optimism regarding the treatment of metastatic melanoma...
May 22, 2018: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/29782381/high-baseline-neutrophil-to-lymphocyte-ratio-predicts-worse-outcome-in-patients-with-metastatic-braf-positive-melanoma-treated-with-braf-and-mek-inhibitors
#15
Paweł Teterycz, Paulina Jagodzińska-Mucha, Bożena Cybulska-Stopa, Anna Mariuk-Jarema, Katarzyna Kozak, Hanna Koseła-Paterczyk, Anna M Czarnecka, Marcin Rajczykowski, Robert Dziura, Łukasz Galus, Jacek Mackiewicz, Tomasz Świtaj, Anna Klimczak, Slawomir Falkowski, Rafał Suwiński, Marek Ziobro, Iwona Ługowska, Piotr Rutkowski
Neutrophil-to-lymphocyte ratio (NLR) has been shown to be prognostic in several solid malignancies. There are limited data regarding its value during novel therapies in patients with melanoma. The aim of the study was to assess the practical utility of this ratio in patients with BRAF-mutant melanoma treated with a combination of BRAF and MEK inhibitors (BRAFi/MEKi). We included 215 patients with inoperable or metastatic melanoma who underwent BRAFi/MEKi treatment between October 2015 and June 2017. Baseline NLR and other complete blood count-derived inflammatory markers were tested for association with overall survival and progression-free survival in univariate and multivariate models...
May 18, 2018: Melanoma Research
https://www.readbyqxmd.com/read/29774094/selumetinib-based-therapy-in-uveal-melanoma-patient-derived-xenografts
#16
Didier Decaudin, Rania El Botty, Béré Diallo, Gerald Massonnet, Justine Fleury, Adnan Naguez, Chloé Raymondie, Emma Davies, Aaron Smith, Joanne Wilson, Colin Howes, Paul D Smith, Nathalie Cassoux, Sophie Piperno-Neumann, Sergio Roman-Roman, Fariba Némati
The prognosis of metastatic uveal melanoma (UM) is among the worst of all human cancers. The identification of near-ubiquitous GNAQ/GNA11 mutations and the activation of MAPK signaling in UM have raised hopes of more effective, targeted therapies, based on MEK inhibition, for example. We evaluated the potential of drug combinations to increase the efficacy of the MEK inhibitor selumetinib (AZD6244, ARRY-142886), in UM cell lines and Patient-Derived Xenografts. We first evaluated the combination of selumetinib and DTIC...
April 24, 2018: Oncotarget
https://www.readbyqxmd.com/read/29762855/real-world-treatment-practice-in-patients-with-advanced-melanoma-in-the-nivolumab-era-five-novel-italian-case-reports-and-a-literature-review
#17
R Depenni, C De Rossi, M De Tursi, R Marconcini, T Troiani
OBJECTIVE: The approval of the anti-PD1 antibody nivolumab has provided a significant therapeutic opportunity in the landscape of metastatic melanoma. In pivotal clinical trials, nivolumab improved clinical outcomes with a great safety profile. However, in real-world practice, the majority of the population with metastatic melanoma does meet one or more eligibility criteria of pivotal trials, since they have an ECOG-PS ≥ 2 or active/untreated known brain metastases. Waiting for larger real-wold studies that are currently lacking, but would be crucial to confirm the efficacy of nivolumab in challenging patients and to detect rare adverse events that could not be noticed in pivotal trials, this review collects both literature and unpublished case reports on nivolumab treatment in metastatic melanoma...
April 2018: European Review for Medical and Pharmacological Sciences
https://www.readbyqxmd.com/read/29762449/time-to-procedure-nuclear-imaging-and-clinicopathological-characteristics-as-predictive-factors-for-sentinel-lymph-node-metastasis-in-cutaneous-melanoma-a-single-center-analysis
#18
Ljiljana Jaukovic, Milica Rajović, Lidija Kandolf Sekulovic, Marija Radulovic, Nenad Stepic, Zeljko Mijuskovic, Nenad Petrov, Boris Ajdinovic
OBJECTIVE: Sentinel lymph node (SLN) biopsy is a widely accepted staging procedure for cutaneous melanoma patients who are at risk of clinically occult nodal metastases. Numerous predictive factors for regional lymph node metastases have been identified; however, few have been found to be reproducibly significant. Also, the role of blue dye in identification was questioned in recent trials. Time to procedure was also found to be predictive of SLN positivity, but this was not confirmed in other studies...
May 14, 2018: Annals of Plastic Surgery
https://www.readbyqxmd.com/read/29750749/vemurafenib-in-braf-mutant-metastatic-melanoma-patients-in-real-world-clinical-practice-prognostic-factors-associated-with-clinical-outcomes
#19
Maartje G Schouwenburg, Anouk Jochems, Brenda Leeneman, Margreet G Franken, Alfons J M van den Eertwegh, John B A G Haanen, Michiel C T van Zeijl, Maureen J Aarts, Alexander C J van Akkooi, Franchette W P J van den Berkmortel, Willeke A M Blokx, Jan Willem B de Groot, Geke A P Hospers, Ellen Kapiteijn, Rutger H Koornstra, Wim H Kruit, Marieke W J Louwman, Djura Piersma, Rozemarijn S van Rijn, Karijn P M Suijkerbuijk, Albert J Ten Tije, Gerard Vreugdenhil, Michel W J M Wouters, Jacobus J M van der Hoeven
The aim of this population-based study was to identify the factors associated with clinical outcomes in vemurafenib-treated patients and to evaluate outcomes across subgroups of patients with different risk profiles. Data were retrieved from the Dutch Melanoma Treatment Registry. Time to next treatment (TTNT) and overall survival (OS) of all metastatic melanoma patients who received vemurafenib between 2012 and 2015 were assessed using Kaplan-Meier estimates. A risk score was developed on the basis of all prognostic factors associated with TTNT and OS derived from multivariable Cox regression analyses...
May 10, 2018: Melanoma Research
https://www.readbyqxmd.com/read/29738114/oncogenic-signaling-in-uveal-melanoma
#20
REVIEW
John J Park, Russell J Diefenbach, Anthony M Joshua, Richard F Kefford, Matteo S Carlino, Helen Rizos
Uveal melanoma is the most common primary cancer of the eye, and despite rapidly emerging insights into the molecular profile of this disease, prognosis of patients with metastatic uveal melanoma remains poor with mortality rates unchanged in over 35 years. Early genetic events activate G protein-coupled receptor signaling in nearly all uveal tumors via mutually exclusive mutations in the GNAQ, GNA11, CYSLTR2, or PLCB4 genes. A multitude of signaling cascades downstream of G protein activation, including protein kinase C and mitogen-activated protein kinase activity, are actionable, and many ongoing clinical trials are targeting these pathways...
May 8, 2018: Pigment Cell & Melanoma Research
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