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Clinical trials for metastatic melanoma

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https://www.readbyqxmd.com/read/29341833/immune-modified-response-evaluation-criteria-in-solid-tumors-imrecist-refining-guidelines-to-assess-the-clinical-benefit-of-cancer-immunotherapy
#1
F Stephen Hodi, Marcus Ballinger, Benjamin Lyons, Jean-Charles Soria, Mizuki Nishino, Josep Tabernero, Thomas Powles, David Smith, Axel Hoos, Chris McKenna, Ulrich Beyer, Ina Rhee, Gregg Fine, Nathan Winslow, Daniel S Chen, Jedd D Wolchok
Purpose Treating solid tumors with cancer immunotherapy (CIT) can result in unconventional responses and overall survival (OS) benefits that are not adequately captured by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. We describe immune-modified RECIST (imRECIST) criteria, designed to better capture CIT responses. Patients and Methods Atezolizumab data from clinical trials in non-small-cell lung cancer, metastatic urothelial carcinoma, renal cell carcinoma, and melanoma were evaluated. Modifications to imRECIST versus RECIST v1...
January 17, 2018: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/29341162/impact-of-genomics-on-the-surgical-management-of-melanoma
#2
REVIEW
P M Ferguson, G V Long, R A Scolyer, J F Thompson
BACKGROUND: Although surgery for early-stage melanoma offers the best chance of cure, recent advances in molecular medicine have revolutionized the management of late-stage melanoma, leading to significant improvements in clinical outcomes. Research into the genomic drivers of disease and cancer immunology has not only ushered in a new era of targeted and immune-based therapies for patients with metastatic melanoma, but has also provided new tools for monitoring disease recurrence and selecting therapeutic strategies...
January 2018: British Journal of Surgery
https://www.readbyqxmd.com/read/29336323/nivolumab-for-recurrent-cutaneous-squamous-cell-carcinoma-three-cases
#3
Veronika Blum, Beat Müller, Silvia Hofer, Esther Pardo, Kristin Zeidler, Joachim Diebold, Klaus Strobel, Christoph Brand, Stefan Aebi, Oliver Gautschi
Programmed cell death ligand 1 (PD-L1) is frequently expressed in cutaneous squamous cell cancer (CSCC) and preliminary data from an ongoing clinical trial suggest that programmed death receptor 1 (PD-1) checkpoint inhibitors may be useful to treat patients with metastatic non-melanoma skin cancer. To report a series of three patients with advanced CSCC treated with nivolumab, showing that commercially available PD-1 checkpoint inhibitors may be useful in non-melanoma skin cancer patients without access to a clinical trial...
January 16, 2018: European Journal of Dermatology: EJD
https://www.readbyqxmd.com/read/29324592/frequent-subclinical-macular-changes-in-combined-braf-mek-inhibition-with-high-dose-hydroxychloroquine-as-treatment-for-advanced-metastatic-braf-mutant-melanoma-preliminary-results-from-a-phase-i-ii-clinical-treatment-trial
#4
Akosua A Nti, Leona W Serrano, Harpal S Sandhu, Katherine E Uyhazi, Ilaina D Edelstein, Elaine J Zhou, Scott Bowman, Delu Song, Tara C Gangadhar, Lynn M Schuchter, Sheryl Mitnick, Alexander Huang, Charles W Nichols, Ravi K Amaravadi, Benjamin J Kim, Tomas S Aleman
PURPOSE: To assess the potential ocular toxicity of a combined BRAF inhibition (BRAFi) + MEK inhibition (MEKi) + hydroxychloroquine (HCQ) regime used to treat metastatic BRAF mutant melanoma. METHODS: Patients with stage IV metastatic melanoma and BRAF V600E mutations (n = 11, 31-68 years of age) were included. Treatment was with oral dabrafenib, 150 mg bid, trametinib, 2 mg/day, and HCQ, 400 mg to 600 mg bid. An ophthalmic examination, spectral domain optical coherence tomography, near-infrared and short-wavelength fundus autofluorescence, and static perimetry were performed at baseline, 1 month, and q/6 months after treatment...
January 10, 2018: Retina
https://www.readbyqxmd.com/read/29306769/phase-ii-trial-of-ipilimumab-in-melanoma-patients-with-preexisting-humoural-immune-response-to-ny-eso-1
#5
G M Haag, I Zoernig, J C Hassel, N Halama, J Dick, N Lang, L Podola, J Funk, C Ziegelmeier, S Juenger, M Bucur, L Umansky, C S Falk, A Freitag, I Karapanagiotou-Schenkel, P Beckhove, A Enk, D Jaeger
BACKGROUND: Immune checkpoint therapy has dramatically changed treatment options in patients with metastatic melanoma. However, a relevant part of patients still does not respond to treatment. Data regarding the prognostic or predictive significance of preexisting immune responses against tumour antigens are conflicting. Retrospective data suggested a higher clinical benefit of ipilimumab in melanoma patients with preexisting NY-ESO-1-specific immunity. PATIENTS AND METHODS: Twenty-five patients with previously untreated or treated metastatic melanoma and preexisting humoural immune response against NY-ESO-1 received ipilimumab at a dose of 10 mg/kg in week 1, 4, 7, 10 followed by 3-month maintenance treatment for a maximum of 48 weeks...
January 4, 2018: European Journal of Cancer
https://www.readbyqxmd.com/read/29273043/psychometric-properties-of-the-fact-m-questionnaire-in-patients-with-merkel-cell-carcinoma
#6
REVIEW
Murtuza Bharmal, Fatoumata Fofana, Carla Dias Barbosa, Paul Williams, Lisa Mahnke, Alexia Marrel, Michael Schlichting
BACKGROUND: No validated disease-specific questionnaires exist to capture health-related quality of life (HRQoL) in patients with Merkel cell carcinoma (MCC). The Functional Assessment of Cancer Therapy - Melanoma (FACT-M) is validated in patients with melanoma, which shares many similarities with MCC. This paper reports the psychometric properties of the FACT-M in the metastatic MCC population. METHODS: Data were collected as part of a single-arm, open-label, multicenter trial involving patients with metastatic MCC who had failed at least one previous line of chemotherapy...
December 22, 2017: Health and Quality of Life Outcomes
https://www.readbyqxmd.com/read/29239192/-combined-regimens-in-immunotherapy
#7
B Melichar, M Spisarová
The advent of immunotherapy has changed our concept of how to manage metastatic disease. With the exception of relatively rare tumors, the treatment of metastatic cancer is still considered as palliative, and in systemic treatment immunotherapy is often selected, considering better tolerance. Immunotherapy opens the perspective of a long-term, possibly durable, response, and, in contrast to other approaches to targeted therapy, is active across a spectrum of tumors. Combined regimens that increase the efficacy, given the context, are thus of importance...
2017: Klinická Onkologie: Casopis Ceské a Slovenské Onkologické Spolecnosti
https://www.readbyqxmd.com/read/29239191/-advances-in-immunotherapy-of-malignant-melanoma
#8
I Krajsová
Development of immunotherapy has dramatically changed poor prognosis of metastatic malignant melanoma (MM). Inhibition of immune checkpoints represents a new effective treatment. Monoclonal antibodies against CTLA-4 ipilimumab and against PD-1 (programme death 1) nivolumab and pembrolizumab prolong progression free survival and overall survival (OS) in patients with advanced metastatic MM. Both achieved significant improvement in relapse-free survival and OS also in adjuvant setting. It looks like the efficacy of the combined immunotherapy of ipilimumab with anti-PD-1 antibodies is superior to the monotherapy, but combined therapy is accompanied by higher toxicity...
2017: Klinická Onkologie: Casopis Ceské a Slovenské Onkologické Spolecnosti
https://www.readbyqxmd.com/read/29208646/a-serum-protein-signature-associated-with-outcome-after-anti-pd1-therapy-in-metastatic-melanoma
#9
Mario Sznol, Ryan J Sullivan, Shauna Blackmon, Genevieve Boland, Harriet M Kluger, Ruth Halaban, Antonella Bacchiocchi, Paolo A Ascierto, Marilena Capone, Carlos Oliveira, Krista Meyer, Julia Grigorieva, Senait G Asmellash, Joanna Roder, Heinrich Roder, Jeffrey S Weber
A mass spectrometry analysis was performed using serum from patients receiving checkpoint inhibitors to define baseline protein signatures associated with outcome in metastatic melanoma. Pre-treatment serum was obtained from a development set of 119 melanoma patients on a trial of nivolumab with or without a multi-peptide vaccine and from patients receiving pembrolizumab, nivolumab, ipilimumab, or both nivolumab and ipilimumab. Spectra were obtained using matrix assisted laser desorption/ionization time of flight mass spectrometry...
December 5, 2017: Cancer Immunology Research
https://www.readbyqxmd.com/read/29200112/epidemiology-treatment-and-complications-of-central-nervous-system-metastases
#10
Amy A Pruitt
PURPOSE OF REVIEW: Neurologic problems resulting from systemic cancer metastases to brain parenchyma, dura, spinal cord, and leptomeninges are among the most common types of consultations addressed by neurologists. With patients surviving longer from systemic cancer, along with the rapidly evolving therapeutic options, the treatment of these devastating complications has become both more effective and more complicated. This article reviews current patterns of metastatic disease and the increasingly nuanced landscape of evolving therapies, their complications, and their impact on quality of survival...
December 2017: Continuum: Lifelong Learning in Neurology
https://www.readbyqxmd.com/read/29190182/checkpoint-inhibition-in-pediatric-hematologic-malignancies
#11
Kara L Davis, Archana M Agarwal, Anupam R Verma
Immune surveillance comprising of adaptive and innate immune systems is naturally designed to eliminate cancer development; overexpression of inhibitory receptors and their ligands prevent this check and lead to evasion and hence cancer progression and metastasis. The use of tumor-specific monoclonal antibodies (MAbs) targeting these checkpoint regulators is promising and has led to this novel field of cancer immunotherapy. The first antibody directed against cytotoxic T-lymphocyte associated protein 4 (CTLA-4), ipilimumab, showed promising results in clinical trials and was approved by the US Food and Drug Administration (FDA) for the treatment of metastatic melanoma in 2011...
November 30, 2017: Pediatric Hematology and Oncology
https://www.readbyqxmd.com/read/29181212/uncommon-braf-mutations-associated-with-durable-response-to-immunotherapy-in-patients-with-metastatic-melanoma
#12
Brenen P Swofford, Jade Homsi
Melanoma is a disease process which has been increasing in incidence over the past three decades and metastatic melanoma carries a poor prognosis. Through genetic studies of this disease, it has been determined that the BRAF V600 mutation plays a major role in the pathophysiology of the disease and this has led to the utilization of targeted therapy (BRAF and MEK inhibitors) in its treatment. Other BRAF mutations (non-V600 mutations) are rare in melanoma and targeted therapy is not indicated for patients with these mutations due to reduced response rates...
2017: Case Reports in Oncological Medicine
https://www.readbyqxmd.com/read/29180872/therapeutic-efficacy-and-safety-of-combined-braf-and-mek-inhibition-in-patients-with-malignant-melanoma-a-meta-analysis
#13
Peng Chen, Fuchao Chen, Benhong Zhou
Background: Recent clinical studies have shown that initial therapy with combined BRAF and mitogen-activated extracellular signal-regulated kinase (MEK) inhibition is more effective in metastatic melanoma than single-agent BRAF inhibitors. However, the response rates with single-agent BRAF are low. Thus, the objective of this study was to conduct a meta-analysis of randomized controlled trials to compare the efficacy and adverse events risk between mono-therapy and combination therapy...
2017: OncoTargets and Therapy
https://www.readbyqxmd.com/read/29180474/vitamin-c-sensitizes-melanoma-to-bet-inhibitors
#14
Gaofeng Wang, Sushmita Mustafi, Vladimir Camarena, Claude-Henry Volmar, Tyler C Huff, David W Sant, Shaun P Brothers, Zhao-Jun Liu, Claes Wahlestedt
Bromodomain and extra-terminal inhibitors (BETi) are promising cancer therapies, yet prominent side effects of BETi at effective doses have been reported in Phase I clinical trials. Here we screened a panel of small molecules targeting epigenetic modulators against human metastatic melanoma cells. Cells were pretreated with or without ascorbate (vitamin C), which promotes DNA demethylation and subsequently changes the sensitivity to drugs. Top hits were structurally unrelated BETi including JQ1, I-BET151, CPI-203, and BI-2536...
November 27, 2017: Cancer Research
https://www.readbyqxmd.com/read/29177235/metastatic-melanoma-patients-sensitivity-to-ipilimumab-cannot-be-predicted-by-tumor-characteristics
#15
Kara Rossfeld, Erinn M Hade, Alexandra Gangi, Matthew Perez, Emily N Kinsey, Joanna Grabska, Ashley Ederle, Jonathan Zager, April K Salama, Thomas E Olencki, Georgia M Beasley
Immune checkpoint inhibitors have dramatically changed the prognosis for patients with metastatic melanoma. However, not all patients respond to therapy and toxicities can be severe leaving need for reliable clinical predictive markers. Methods: We examined primary tumor characteristics including ulceration, BRAF mutation status, and Breslow depth in patients who subsequently developed stage IV disease and were treated with ipilimumab at 3 institutions. Patients in this study were not treated on clinical trials...
October 2017: International Journal of Surgery. Oncology
https://www.readbyqxmd.com/read/29177094/safety-and-immunogenicity-of-mage-a3-cancer-immunotherapeutic-with-dacarbazine-in-patients-with-mage-a3-positive-metastatic-cutaneous-melanoma-an-open-phase-i-ii-study-with-a-first-assessment-of-a-predictive-gene-signature
#16
Jean-Jacques Grob, Laurent Mortier, Lionel D'Hondt, Florent Grange, Jean Francois Baurain, Brigitte Dréno, Céleste Lebbe, Caroline Robert, Anne Dompmartin, Bart Neyns, Marc Gillet, Jamila Louahed, Silvija Jarnjak, Frédéric F Lehmann
Background: We assessed safety, immunogenicity and clinical activity of recombinant MAGE-A3 antigen combined with AS15 immunostimulant (MAGE-A3 immunotherapeutic) in association with dacarbazine in patients with metastatic melanoma. Methods: In this open-label, phase I/II, uncontrolled multicentre trial conducted in Belgium and France, patients with MAGE-A3-positive melanoma received up to 24 doses of MAGE-A3 immunotherapeutic (four cycles) coadministered with eight doses of dacarbazine...
2017: ESMO Open
https://www.readbyqxmd.com/read/29157311/peripheral-and-local-predictive-immune-signatures-identified-in-a-phase-ii-trial-of-ipilimumab-with-carboplatin-paclitaxel-in-unresectable-stage-iii-or-stage-iv-melanoma
#17
Rahima Jamal, Réjean Lapointe, Eftihia Cocolakis, Paméla Thébault, Shirin Kazemi, Jennifer E Friedmann, Jeanne Dionne, Jean-François Cailhier, Karl Bélanger, Jean-Pierre Ayoub, Huy Le, Caroline Lambert, Jida El-Hajjar, Léon C van Kempen, Alan Spatz, Wilson H Miller
BACKGROUND: Checkpoint blockade with ipilimumab provides long-term survival to a significant proportion of patients with metastatic melanoma. New approaches to increase survival and to predict which patients will benefit from treatment are needed. This phase II trial combined ipilimumab with carboplatin/paclitaxel (CP) to assess its safety, efficacy, and to search for peripheral and tumor-based predictive biomarkers. METHODS: Thirty patients with untreated unresectable/metastatic melanoma were treated with ipilimumab and CP...
November 21, 2017: Journal for Immunotherapy of Cancer
https://www.readbyqxmd.com/read/29157300/prospects-for-combined-use-of-oncolytic-viruses-and-car-t-cells
#18
REVIEW
Adam Ajina, John Maher
With the approval of talimogene laherparepvec (T-VEC) for inoperable locally advanced or metastatic malignant melanoma in the USA and Europe, oncolytic virotherapy is now emerging as a viable therapeutic option for cancer patients. In parallel, following the favourable results of several clinical trials, adoptive cell transfer using chimeric antigen receptor (CAR)-redirected T-cells is anticipated to enter routine clinical practice for the management of chemotherapy-refractory B-cell malignancies. However, CAR T-cell therapy for patients with advanced solid tumours has proved far less successful...
November 21, 2017: Journal for Immunotherapy of Cancer
https://www.readbyqxmd.com/read/29155424/immune-checkpoint-inhibitors-in-sarcomas-in-quest-of-predictive-biomarkers
#19
Robin Veenstra, Marie Kostine, Anne-Marie Cleton-Jansen, Noel Fcc de Miranda, Judith Vmg Bovée
Sarcomas are a rare group of tumors of mesenchymal origin. Metastatic sarcomas are often difficult to treat and unresponsive to standard radio- and chemotherapy, resulting in a poor survival rate for patients. Novel treatments with immune checkpoint inhibitors have been proven to prolong survival of patients with a variety of cancers, including metastatic melanoma, lung, and renal cell carcinoma. Since immune checkpoint inhibitors could provide a novel treatment option for patients with sarcomas, clinical trials investigating their efficacy in these group of tumors are ongoing...
November 20, 2017: Laboratory Investigation; a Journal of Technical Methods and Pathology
https://www.readbyqxmd.com/read/29149136/mapk-pathway-targeted-therapies-care-and-management-of-unique-toxicities-in-patients-with-advanced-melanoma%C3%A2
#20
Krista M Rubin
BACKGROUND: Agents targeting the MAPK pathway, including inhibitors of BRAF and MEK, have dramatically transformed the treatment landscape for patients with BRAF-mutant metastatic melanoma. Although generally well tolerated, targeted agents were associated with unique toxicities.
. OBJECTIVES: This article aims to provide nurses with an overview of the key toxicities and associated management strategies of the characteristic adverse event (AE) profile associated with agents targeting the MAPK pathway...
December 1, 2017: Clinical Journal of Oncology Nursing
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