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      Pembrolizumab for the treatment of uveal melanoma: A case series

      brief-report
      1 , 1 , 2 , 1
      Rare Tumors
      SAGE Publications
      Uveal melanoma, anti-PD-1 treatment

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          Abstract

          Uveal melanoma is a rare disease. Up to 50% of the patients will develop metastases for which the treatment options are limited. No randomized controlled data for the treatment of uveal melanoma patients are available. In this study we describe the clinical course of nine uveal melanoma patients included in the pembrolizumab expanded access program (EAP) in Belgium. Nine uveal melanoma patients were treated in the EAP with 2mg/kg pembrolizumab every 3 weeks. Patients received pembrolizumab as first or second-line treatment. Baseline characteristics and tumor responses were prospectively collected. During a median follow-up of 40 weeks, the estimated median PFS was 18 weeks (95% CI 0.7–35) and median OS was 46 weeks (95% CI 33–59%). Four patients had stable disease (SD) for more than 20 weeks (PFS of 21, 22, and 27 weeks respectively) and 1 patient presented with SD for 119 weeks. No objective responses according to irRC were observed. One grade 3 hepatitis occurred which was reversible with the administration of high doses oral corticosteroids. Even though treatment with pembrolizumab is well tolerated, clinical benefit is disappointing. Nevertheless long-term diseases control can be achieved in selected cases

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          Cobimetinib combined with vemurafenib in advanced BRAFV600-mutant melanoma (coBRIM): updated efficacy results from a randomised, double-blind, phase 3 trial

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            Phase II DeCOG-Study of Ipilimumab in Pretreated and Treatment-Naïve Patients with Metastatic Uveal Melanoma

            Purpose Up to 50% of patients with uveal melanoma (UM) develop metastatic disease with limited treatment options. The immunomodulating agent ipilimumab has shown an overall survival (OS) benefit in patients with cutaneous metastatic melanoma in two phase III trials. As patients with UM were excluded in these studies, the Dermatologic Cooperative Oncology Group (DeCOG) conducted a phase II to assess the efficacy and safety of ipilimumab in patients with metastatic UM. Patients and Methods We undertook a multicenter phase II study in patients with different subtypes of metastatic melanoma. Here we present data on patients with metastatic UM (pretreated and treatment-naïve) who received up to four cycles of ipilimumab administered at a dose of 3 mg/kg in 3 week intervals. Tumor assessments were conducted at baseline, weeks 12, 24, 36 and 48 according to RECIST 1.1 criteria. Adverse events (AEs), including immune-related AEs were graded according to National Cancer Institute Common Toxicity Criteria (CTC) v.4.0. Primary endpoint was the OS rate at 12 months. Results Forty five pretreated (85%) and eight treatment-naïve (15%) patients received at least one dose of ipilimumab. 1-year and 2-year OS rates were 22% and 7%, respectively. Median OS was 6.8 months (95% CI 3.7–8.1), median progression-free survival 2.8 months (95% CI 2.5–2.9). The disease control rate at weeks 12 and 24 was 47% and 21%, respectively. Sixteen patients had stable disease (47%), none experienced partial or complete response. Treatment-related AEs were observed in 35 patients (66%), including 19 grade 3–4 events (36%). One drug-related death due to pancytopenia was observed. Conclusions Ipilimumab has very limited clinical activity in patients with metastatic UM. Toxicity was manageable when treated as per protocol-specific guidelines. Trial Registration ClinicalTrials.gov NCT01355120
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              Clinical outcomes in metastatic uveal melanoma treated with PD-1 and PD-L1 antibodies.

              Antibodies inhibiting the programmed death receptor 1 (PD-1) have demonstrated significant activity in the treatment of advanced cutaneous melanoma. The efficacy and safety of PD-1 blockade in patients with uveal melanoma has not been well characterized.
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                Author and article information

                Journal
                Rare Tumors
                Rare Tumors
                RTU
                sprtu
                Rare Tumors
                SAGE Publications (Sage UK: London, England )
                2036-3605
                2036-3613
                11 November 2020
                2020
                : 12
                : 2036361320971983
                Affiliations
                [1 ]Department of Medical Oncology, Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel, Brussels, Belgium
                [2 ]Dermatology, CHUV Lausanne university hospital, Lausanne, Switzerland
                Author notes
                [*]Yanina Jeanne Leona Jansen, Department of Medical Oncology, Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel, Laarbeeklaan 101, 1090 Brussels, Belgium. Email: yanina.jansen@ 123456uzbrussel.be
                Author information
                https://orcid.org/0000-0002-8322-9841
                Article
                10.1177_2036361320971983
                10.1177/2036361320971983
                7675863
                33240475
                51954685-464e-4e45-9e7d-c58ce9d65bff
                © The Author(s) 2020

                This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License ( https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page ( https://us.sagepub.com/en-us/nam/open-access-at-sage).

                History
                : 26 October 2019
                : 15 October 2020
                Categories
                Brief Report
                Custom metadata
                January-December 2020
                ts1

                Oncology & Radiotherapy
                uveal melanoma,anti-pd-1 treatment
                Oncology & Radiotherapy
                uveal melanoma, anti-pd-1 treatment

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