Phase II DeCOG-Study of Ipilimumab in Pretreated and Treatment-Naïve Patients with Metastatic Uveal Melanoma
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{"title"=>"Phase II DeCOG-study of ipilimumab in pretreated and treatment-naïve patients with metastatic uveal melanoma", "type"=>"journal", "authors"=>[{"first_name"=>"Lisa", "last_name"=>"Zimmer", "scopus_author_id"=>"36187647200"}, {"first_name"=>"Julia", "last_name"=>"Vaubel", "scopus_author_id"=>"36187497900"}, {"first_name"=>"Peter", "last_name"=>"Mohr", "scopus_author_id"=>"7102201924"}, {"first_name"=>"Axel", "last_name"=>"Hauschild", "scopus_author_id"=>"7005722750"}, {"first_name"=>"Jochen", "last_name"=>"Utikal", "scopus_author_id"=>"6601969918"}, {"first_name"=>"Jan", "last_name"=>"Simon", "scopus_author_id"=>"35433335800"}, {"first_name"=>"Claus", "last_name"=>"Garbe", "scopus_author_id"=>"7101929492"}, {"first_name"=>"Rudolf", "last_name"=>"Herbst", "scopus_author_id"=>"7102823087"}, {"first_name"=>"Alexander", "last_name"=>"Enk", "scopus_author_id"=>"55094698000"}, {"first_name"=>"Eckhart", "last_name"=>"Kämpgen", "scopus_author_id"=>"35519195600"}, {"first_name"=>"Elisabeth", "last_name"=>"Livingstone", "scopus_author_id"=>"24465712400"}, {"first_name"=>"Leonie", "last_name"=>"Bluhm", "scopus_author_id"=>"56545560700"}, {"first_name"=>"Rainer", "last_name"=>"Rompel", "scopus_author_id"=>"7004595503"}, {"first_name"=>"Klaus G.", "last_name"=>"Griewank", "scopus_author_id"=>"24481380300"}, {"first_name"=>"Michael", "last_name"=>"Fluck", "scopus_author_id"=>"8576906400"}, {"first_name"=>"Bastian", "last_name"=>"Schilling", "scopus_author_id"=>"18234206000"}, {"first_name"=>"Dirk", "last_name"=>"Schadendorf", "scopus_author_id"=>"56042878100"}], "year"=>2015, "source"=>"PLoS ONE", "identifiers"=>{"pui"=>"602884925", "sgr"=>"84924543977", "issn"=>"19326203", "pmid"=>"25761109", "scopus"=>"2-s2.0-84924543977", "doi"=>"10.1371/journal.pone.0118564", "isbn"=>"1932-6203 (Electronic)\\r1932-6203 (Linking)"}, "id"=>"43cf84c0-79ef-3e3a-870f-3c3570937c8a", "abstract"=>"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.", "link"=>"http://www.mendeley.com/research/phase-ii-decogstudy-ipilimumab-pretreated-treatmentna%C3%AFve-patients-metastatic-uveal-melanoma", "reader_count"=>38, "reader_count_by_academic_status"=>{"Unspecified"=>3, "Researcher"=>8, "Student > Doctoral Student"=>2, "Student > Ph. D. Student"=>3, "Student > Postgraduate"=>2, "Other"=>11, "Student > Master"=>5, "Student > Bachelor"=>2, "Lecturer > Senior Lecturer"=>1, "Professor"=>1}, "reader_count_by_user_role"=>{"Unspecified"=>3, "Researcher"=>8, "Student > Doctoral Student"=>2, "Student > Ph. D. Student"=>3, "Student > Postgraduate"=>2, "Other"=>11, "Student > Master"=>5, "Student > Bachelor"=>2, "Lecturer > Senior Lecturer"=>1, "Professor"=>1}, "reader_count_by_subject_area"=>{"Unspecified"=>4, "Biochemistry, Genetics and Molecular Biology"=>1, "Medicine and Dentistry"=>27, "Agricultural and Biological Sciences"=>4, "Chemistry"=>1, "Immunology and Microbiology"=>1}, "reader_count_by_subdiscipline"=>{"Medicine and Dentistry"=>{"Medicine and Dentistry"=>27}, "Chemistry"=>{"Chemistry"=>1}, "Immunology and Microbiology"=>{"Immunology and Microbiology"=>1}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>4}, "Biochemistry, Genetics and Molecular Biology"=>{"Biochemistry, Genetics and Molecular Biology"=>1}, "Unspecified"=>{"Unspecified"=>4}}, "reader_count_by_country"=>{"Italy"=>1}, "group_count"=>1}

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  • {"files"=>["https://ndownloader.figshare.com/files/1945014", "https://ndownloader.figshare.com/files/1945015", "https://ndownloader.figshare.com/files/1945016", "https://ndownloader.figshare.com/files/1945017"], "description"=>"<div><p>Purpose</p><p>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.</p><p>Patients and Methods</p><p>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.</p><p>Results</p><p>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.</p><p>Conclusions</p><p>Ipilimumab has very limited clinical activity in patients with metastatic UM. Toxicity was manageable when treated as per protocol-specific guidelines.</p><p>Trial Registration</p><p>ClinicalTrials.gov <a href=\"http://www.clinicaltrial.gov/ct2/show/NCT01355120?term=NCT01355120&rank=1\" target=\"_blank\">NCT01355120</a></p></div>", "links"=>[], "tags"=>["Metastatic Uveal Melanoma PurposeUp", "phase III trials", "metastatic UM", "disease control rate", "immunomodulating agent ipilimumab", "os", "ctc", "RECIST 1.1 criteria", "National Cancer Institute Common Toxicity Criteria", "cutaneous metastatic melanoma", "multicenter phase II study", "Dermatologic Cooperative Oncology Group", "ae", "nct", "3 week intervals"], "article_id"=>1332923, "categories"=>["Biological Sciences"], "users"=>["Lisa Zimmer", "Julia Vaubel", "Peter Mohr", "Axel Hauschild", "Jochen Utikal", "Jan Simon", "Claus Garbe", "Rudolf Herbst", "Alexander Enk", "Eckhart Kämpgen", "Elisabeth Livingstone", "Leonie Bluhm", "Rainer Rompel", "Klaus G. Griewank", "Michael Fluck", "Bastian Schilling", "Dirk Schadendorf"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0118564.s001", "https://dx.doi.org/10.1371/journal.pone.0118564.s002", "https://dx.doi.org/10.1371/journal.pone.0118564.s003", "https://dx.doi.org/10.1371/journal.pone.0118564.s004"], "stats"=>{"downloads"=>31, "page_views"=>10, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Phase_II_DeCOG_Study_of_Ipilimumab_in_Pretreated_and_Treatment_Na_239_ve_Patients_with_Metastatic_Uveal_Melanoma_/1332923", "title"=>"Phase II DeCOG-Study of Ipilimumab in Pretreated and Treatment-Naïve Patients with Metastatic Uveal Melanoma", "pos_in_sequence"=>0, "defined_type"=>4, "published_date"=>"2015-03-11 02:55:04"}
  • {"files"=>["https://ndownloader.figshare.com/files/1945008"], "description"=>"<p>Kaplan-Meier curves for overall survival (A) and progression-free survival (B) of treatment-naïve and pretreated patients with metastatic ocular melanoma who received ipilimumab 3 mg/kg.</p>", "links"=>[], "tags"=>["Metastatic Uveal Melanoma PurposeUp", "phase III trials", "metastatic UM", "disease control rate", "immunomodulating agent ipilimumab", "os", "ctc", "RECIST 1.1 criteria", "National Cancer Institute Common Toxicity Criteria", "cutaneous metastatic melanoma", "multicenter phase II study", "Dermatologic Cooperative Oncology Group", "ae", "nct", "3 week intervals"], "article_id"=>1332917, "categories"=>["Biological Sciences"], "users"=>["Lisa Zimmer", "Julia Vaubel", "Peter Mohr", "Axel Hauschild", "Jochen Utikal", "Jan Simon", "Claus Garbe", "Rudolf Herbst", "Alexander Enk", "Eckhart Kämpgen", "Elisabeth Livingstone", "Leonie Bluhm", "Rainer Rompel", "Klaus G. Griewank", "Michael Fluck", "Bastian Schilling", "Dirk Schadendorf"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0118564.g002", "stats"=>{"downloads"=>3, "page_views"=>81, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Kaplan_Meier_curves_for_overall_survival_A_and_progression_free_survival_B_of_treatment_na_239_ve_and_pretreated_patients_with_metastatic_ocular_melanoma_who_received_ipilimumab_3_mg_kg_/1332917", "title"=>"Kaplan-Meier curves for overall survival (A) and progression-free survival (B) of treatment-naïve and pretreated patients with metastatic ocular melanoma who received ipilimumab 3 mg/kg.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2015-03-11 02:55:04"}
  • {"files"=>["https://ndownloader.figshare.com/files/1945007"], "description"=>"<p>Consort Diagram for DeCOG-study.</p>", "links"=>[], "tags"=>["Metastatic Uveal Melanoma PurposeUp", "phase III trials", "metastatic UM", "disease control rate", "immunomodulating agent ipilimumab", "os", "ctc", "RECIST 1.1 criteria", "National Cancer Institute Common Toxicity Criteria", "cutaneous metastatic melanoma", "multicenter phase II study", "Dermatologic Cooperative Oncology Group", "ae", "nct", "3 week intervals"], "article_id"=>1332916, "categories"=>["Biological Sciences"], "users"=>["Lisa Zimmer", "Julia Vaubel", "Peter Mohr", "Axel Hauschild", "Jochen Utikal", "Jan Simon", "Claus Garbe", "Rudolf Herbst", "Alexander Enk", "Eckhart Kämpgen", "Elisabeth Livingstone", "Leonie Bluhm", "Rainer Rompel", "Klaus G. Griewank", "Michael Fluck", "Bastian Schilling", "Dirk Schadendorf"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0118564.g001", "stats"=>{"downloads"=>1, "page_views"=>13, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Consort_Diagram_for_DeCOG_study_/1332916", "title"=>"Consort Diagram for DeCOG-study.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2015-03-11 02:55:04"}
  • {"files"=>["https://ndownloader.figshare.com/files/1945012"], "description"=>"<p>Abbreviations: ir, immune related; ALT, alanine aminotransferases; AST, aspartate aminotransferases.</p><p><sup>a</sup>Patients may have had more than one adverse event.</p><p>Adverse events.</p>", "links"=>[], "tags"=>["Metastatic Uveal Melanoma PurposeUp", "phase III trials", "metastatic UM", "disease control rate", "immunomodulating agent ipilimumab", "os", "ctc", "RECIST 1.1 criteria", "National Cancer Institute Common Toxicity Criteria", "cutaneous metastatic melanoma", "multicenter phase II study", "Dermatologic Cooperative Oncology Group", "ae", "nct", "3 week intervals"], "article_id"=>1332921, "categories"=>["Biological Sciences"], "users"=>["Lisa Zimmer", "Julia Vaubel", "Peter Mohr", "Axel Hauschild", "Jochen Utikal", "Jan Simon", "Claus Garbe", "Rudolf Herbst", "Alexander Enk", "Eckhart Kämpgen", "Elisabeth Livingstone", "Leonie Bluhm", "Rainer Rompel", "Klaus G. Griewank", "Michael Fluck", "Bastian Schilling", "Dirk Schadendorf"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0118564.t003", "stats"=>{"downloads"=>1, "page_views"=>9, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Adverse_events_/1332921", "title"=>"Adverse events.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2015-03-11 02:55:04"}
  • {"files"=>["https://ndownloader.figshare.com/files/1945010"], "description"=>"<p>Abbreviations: ECOG, Eastern Cooperative Oncology Group; LDH, lactate dehydrogenase</p><p>Patients characteristics.</p>", "links"=>[], "tags"=>["Metastatic Uveal Melanoma PurposeUp", "phase III trials", "metastatic UM", "disease control rate", "immunomodulating agent ipilimumab", "os", "ctc", "RECIST 1.1 criteria", "National Cancer Institute Common Toxicity Criteria", "cutaneous metastatic melanoma", "multicenter phase II study", "Dermatologic Cooperative Oncology Group", "ae", "nct", "3 week intervals"], "article_id"=>1332919, "categories"=>["Biological Sciences"], "users"=>["Lisa Zimmer", "Julia Vaubel", "Peter Mohr", "Axel Hauschild", "Jochen Utikal", "Jan Simon", "Claus Garbe", "Rudolf Herbst", "Alexander Enk", "Eckhart Kämpgen", "Elisabeth Livingstone", "Leonie Bluhm", "Rainer Rompel", "Klaus G. Griewank", "Michael Fluck", "Bastian Schilling", "Dirk Schadendorf"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0118564.t001", "stats"=>{"downloads"=>0, "page_views"=>15, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Patients_characteristics_/1332919", "title"=>"Patients characteristics.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2015-03-11 02:55:04"}
  • {"files"=>["https://ndownloader.figshare.com/files/1945011"], "description"=>"<p><sup>a</sup>Disease control rate refers to total number of patients with measurable disease and at least one tumor assessment (n = 34).</p><p>Best responses to treatment.</p>", "links"=>[], "tags"=>["Metastatic Uveal Melanoma PurposeUp", "phase III trials", "metastatic UM", "disease control rate", "immunomodulating agent ipilimumab", "os", "ctc", "RECIST 1.1 criteria", "National Cancer Institute Common Toxicity Criteria", "cutaneous metastatic melanoma", "multicenter phase II study", "Dermatologic Cooperative Oncology Group", "ae", "nct", "3 week intervals"], "article_id"=>1332920, "categories"=>["Biological Sciences"], "users"=>["Lisa Zimmer", "Julia Vaubel", "Peter Mohr", "Axel Hauschild", "Jochen Utikal", "Jan Simon", "Claus Garbe", "Rudolf Herbst", "Alexander Enk", "Eckhart Kämpgen", "Elisabeth Livingstone", "Leonie Bluhm", "Rainer Rompel", "Klaus G. Griewank", "Michael Fluck", "Bastian Schilling", "Dirk Schadendorf"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0118564.t002", "stats"=>{"downloads"=>2, "page_views"=>9, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Best_responses_to_treatment_/1332920", "title"=>"Best responses to treatment.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2015-03-11 02:55:04"}
  • {"files"=>["https://ndownloader.figshare.com/files/1945009"], "description"=>"<p>(A) LDH level (<2-fold upper level norm (ULN) versus ≥ 2xULN). LDH < 2xULN: median OS: 9.3 months (95% CI 7.0–11.6); LDH ≥ 2xULN: median OS 2.5 months (95% CI 1.5–5.7). (B) the number of ipilimumab doses (<4 versus 4). 4 doses: median OS: 9.1 months (95% CI 6.7–13.9); < 4 doses: median OS: 2.8 monhts (95% CI 1.5–6.3). (C) ALC (<1000/μl versus ≥1000/μl). ALC ≥1000/μl: median OS: 8.6 (95% CI 7.0–14.5); ALC <1000/μl: median OS: 3.1 (95% CI 2.2–11.5).</p>", "links"=>[], "tags"=>["Metastatic Uveal Melanoma PurposeUp", "phase III trials", "metastatic UM", "disease control rate", "immunomodulating agent ipilimumab", "os", "ctc", "RECIST 1.1 criteria", "National Cancer Institute Common Toxicity Criteria", "cutaneous metastatic melanoma", "multicenter phase II study", "Dermatologic Cooperative Oncology Group", "ae", "nct", "3 week intervals"], "article_id"=>1332918, "categories"=>["Biological Sciences"], "users"=>["Lisa Zimmer", "Julia Vaubel", "Peter Mohr", "Axel Hauschild", "Jochen Utikal", "Jan Simon", "Claus Garbe", "Rudolf Herbst", "Alexander Enk", "Eckhart Kämpgen", "Elisabeth Livingstone", "Leonie Bluhm", "Rainer Rompel", "Klaus G. Griewank", "Michael Fluck", "Bastian Schilling", "Dirk Schadendorf"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0118564.g003", "stats"=>{"downloads"=>6, "page_views"=>63, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Kaplan_Meier_curves_for_overall_survival_stratified_by_the_lactate_dehydrogenase_LDH_level_before_the_first_dose_of_ipilimumab_A_the_number_of_ipilimumab_doses_B_and_the_absolute_lymphocyte_count_ALC_before_the_third_dose_week_7_of_ipilimumab_C_/1332918", "title"=>"Kaplan-Meier curves for overall survival stratified by the lactate dehydrogenase (LDH) level before the first dose of ipilimumab (A), the number of ipilimumab doses (B), and the absolute lymphocyte count (ALC) before the third dose (week 7) of ipilimumab (C).", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2015-03-11 02:55:04"}

PMC Usage Stats | Further Information

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  • {"unique-ip"=>"28", "full-text"=>"32", "pdf"=>"7", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"1", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2019", "month"=>"1"}
  • {"unique-ip"=>"22", "full-text"=>"22", "pdf"=>"7", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"4", "cited-by"=>"0", "year"=>"2018", "month"=>"11"}
  • {"unique-ip"=>"18", "full-text"=>"21", "pdf"=>"10", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"4", "supp-data"=>"1", "cited-by"=>"0", "year"=>"2018", "month"=>"9"}
  • {"unique-ip"=>"24", "full-text"=>"27", "pdf"=>"11", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2018", "month"=>"12"}
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  • {"unique-ip"=>"19", "full-text"=>"26", "pdf"=>"12", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"3", "cited-by"=>"0", "year"=>"2018", "month"=>"5"}
  • {"unique-ip"=>"28", "full-text"=>"26", "pdf"=>"7", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"11", "cited-by"=>"0", "year"=>"2018", "month"=>"6"}
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Relative Metric

{"start_date"=>"2015-01-01T00:00:00Z", "end_date"=>"2015-12-31T00:00:00Z", "subject_areas"=>[]}
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