Multicenter Phase 1b Trial Testing the Neoadjuvant Combination of Domatinostat, Nivolumab and Ipilimumab in IFN-gamma Signature-low and IFN-gamma Signature-high RECIST 1.1-measurable Stage III Cutaneous or Unknown Primary Melanoma

Condition:   Malignant Melanoma Stage III Interventions:   Drug: Domatinostat;   Drug: Nivolumab;   Drug: Ipilimumab Sponsors:   The Netherlands Cancer Institute;   4SC Not yet recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials

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Authors: Read RL, Thompson JF Abstract Introduction: Melanoma in-transit metastases (ITMs) occur between the primary tumor site and the regional node field. Most patients with ITMs have a poor prognosis. The treatment of ITMs can be simple if surgical excision is possible, but challenging when ITMs are advanced, multiple or recurrent and impacting quality of life.Areas covered: The management of ITM is still evolving. Patients who are disease-free after surgical excision of ITMs are today candidates for adjuvant systemic treatment to reduce recurrence risk. Some who have multiple or advanced ITMs may achieve long-t...
Source: Expert Review of Clinical Pharmacology - Category: Drugs & Pharmacology Tags: Expert Rev Clin Pharmacol Source Type: research
AbstractPurpose of ReviewThis review describes the evolving role of surgery in stage III and IV melanoma.Recent FindingsSurgery has been the first option to cure melanoma patients at initial diagnosis of metastatic spread: a complete surgical excision of the disease either in stage III or IV has been the gold standard for decades. A positive sentinel node biopsy (SNB) has been followed by a complete lymph node dissection (CLND) since the early stages of modern surgical oncology. However, since two randomized trials have indicated that a CLND does not improve survival in patients with a positive SNB, a CLND is no longer con...
Source: Current Oncology Reports - Category: Cancer & Oncology Source Type: research
CONCLUSION: irPR features are consistent across tumor types and treatment settings. Standardized, pan-tumor immune-mediated pathologic response criteria (irPRC) are defined and associated specimen-handling considerations are described. Future, prospective studies are merited to validate irPRC in larger datasets and to associate pathologic features with long-term patient outcomes. PMID: 31672770 [PubMed - as supplied by publisher]
Source: Clinical Cancer Research - Category: Cancer & Oncology Authors: Tags: Clin Cancer Res Source Type: research
This article aims to highlight the current era of integrated multidisciplinary care of patients with advanced melanoma by outlining current approved therapies, including immunotherapy, targeted therapy, radiation therapy, and other strategies used in both the adjuvant and the neoadjuvant setting as well as the evolving role of surgical intervention in the changing landscape of advanced melanoma.
Source: Surgical Clinics of North America - Category: Surgery Authors: Source Type: research
Condition:   Malignant Melanoma Stage III Interventions:   Drug: Domatinostat;   Drug: Nivolumab;   Drug: Ipilimumab Sponsors:   The Netherlands Cancer Institute;   4SC Not yet recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
ConclusionsThe 18-mo FU confirms that durable RFS can be achieved with 2 cycles of neoadj IPI+NIVO without any additional adjuvant therapy. Pathologic response remains the strongest marker for RFS. TMB and IFN-y signature might serve as baseline markers identifying pts benefiting from neoadj IPI+NIVO. Neoadj 2 cycles IPI1+NIVO3 should be tested in a randomized phase III study versus adjuvant therapy.Clinical trial identificationNCT02977052.Legal entity responsible for the studyNetherlands Cancer Institute.FundingBMS.DisclosureE.A. Rozeman: Travel / Accommodation / Expenses: NanoString; Travel / Accommodation / Expenses: MS...
Source: Annals of Oncology - Category: Cancer & Oncology Source Type: research
We examined the impact of neo T-VEC in resectable metastatic melanoma.MethodsPts with resectable stage IIIB-IVM1a melanoma and ≥ 1 injectable cutaneous, subcutaneous or nodal lesions were randomized 1:1 to 6 doses/12 wks of neo T-VEC then surg (Arm 1) vs surg alone (Arm 2). T-VEC was given until surg, no remaining injectable tumors or intolerance. The primary endpoint per protocol was recurrence-free survival (RFS) at 2-y rs, with events defined as first of local, regional or distant recurrence or death due to any cause after surg in the ITT set. Per protocol, pts who withdrew prior to surg or had a non-R0 resection wer...
Source: Annals of Oncology - Category: Cancer & Oncology Source Type: research
No abstract available
Source: Oncology Times - Category: Cancer & Oncology Tags: News Source Type: research
Public Workshop
Source: FDA Center for Drug Evaluation and Research - What's New - Category: Drugs & Pharmacology Authors: Source Type: news
John Fruehauf, M.D., PhD,discusses the International Neoadjuvant Melanoma Consortuim. Author: Annual-Meeting Added: 08/21/2019
Source: Oncology Tube - Category: Cancer & Oncology Source Type: podcasts
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