Evidence map›Paper›PMID 26541511›Full record

Trial reportJournal of translational medicine2015

Open-label, multicenter, single-arm phase II DeCOG-study of ipilimumab in pretreated patients with different subtypes of metastatic melanoma.

Lisa Zimmer, Thomas K Eigentler, Felix Kiecker, Jan Simon, Jochen Utikal, Peter Mohr, Carola Berking, Eckhart Kämpgen, Edgar Dippel, Rudolf Stadler and 8 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Journal of translational medicine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01355120 (THE IPI - Multibasket Trial in Advanced Melanoma), which is not on this map. Cited by 41 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
41citing papers in PubMed, 10 pooled it
4.0field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01355120 phase2completednot on this map

THE IPI - Multibasket Trial in Advanced Melanoma: Prospective Clinical Phase II Multibasket Study in Melanoma Patients With Advanced Disease (DeCOG MM-PAL11)

TypeinterventionalSponsorProf. Dr. med. Dirk SchadendorfRan2011 to 2013Enrolled171ConditionsOcular MelanomaArmsIpilimumab
3 · Its place in the literature

Who cites it

41 citing papers in PubMed, 10 syntheses or guidelines pooled it, 79 citations in OpenAlex.

  1. Pooled it
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  11. Trial
  12. Article
  13. Mucosal Melanoma: An Overview of Recent Therapies.Current pharmaceutical design · 2026
    Review
  14. Review
  15. Article
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  20. Primary Oral Mucosal Melanoma: A Case Series.Journal of maxillofacial and oral surgery · 2022
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors at 14 institutions in 1 country.

Lisa ZimmerDepartment of Dermatology, University Hospital, University Duisburg-Essen, Essen, Germany. lisa.zimmer@uk-essen.de.
Thomas K EigentlerDepartment of Dermatology, Center for Dermatooncology, University Medical Center Tübingen, Tübingen, Germany. thomas.eigentler@med.uni-tuebingen.de.
Felix KieckerDepartment of Dermatology and Allergy, Skin Cancer Center, Charité-Universitätsmedizin Berlin, Berlin, Germany. felix.kiecker@charite.de.
Jan SimonDepartment of Dermatology, Venereology and Allergology, University Hospital Leipzig, Leipzig, Germany. Jan.simon@medizin.uni-leipzig.de.
Jochen UtikalSkin Cancer Unit, German Cancer Research Center (DKFZ), Heidelberg, Germany. jochen.utikal@umm.de.
Peter MohrDepartment of Dermatology, Elbekliniken Stade Buxtehude, Buxtehude, Germany. peter.mohr@elbekliniken.de.
Carola BerkingDepartment of Dermatology and Allergy, Ludwig-Maximilian University, Munich, Germany. carola.berking@med.uni-muenchen.de.
Eckhart KämpgenDepartment of Dermatology, Dermatologikum Berlin, Berlin, Germany. Kaempgen@dermatologikum-berlin.de.
Edgar DippelDepartment of Dermatology, Klinikum Ludwigshafen, Skin Cancer Center Rheinpfalz, Ludwigshafen, Germany. dippele@klilu.de.
Rudolf StadlerDepartment of Dermatology, Medical Centre Minden, Minden, Germany. rudolf.stadler@muehlenkreiskliniken.de.
Axel HauschildUniversity Department of Dermatology, Kiel, Germany. ahauschild@dermatology.uni-kiel.de.
Michael FluckDepartment of Dermatology Hornheide, Münster, Germany. michael.fluck@fachklinik-hornheide.de.
Patrick TerheydenDepartment of Dermatology, University of Lübeck, Lübeck, Germany. patrick.terheyden@uksh.de.
Rainer RompelDepartment of Dermatology, Clinical Centre Kassel, Kassel, Germany. rompel@klinikum-kassel.de.
Carmen LoquaiDepartment of Dermatology, University Medical Center, Johannes Gutenberg-University, Mainz, Germany. Carmen.Loquai@unimedizin-mainz.de.
Zeinab AssiDepartment of Dermatology, Center for Dermatooncology, University Medical Center Tübingen, Tübingen, Germany. zeinab.jradi.assi@gmail.com.
Claus GarbeDepartment of Dermatology, Center for Dermatooncology, University Medical Center Tübingen, Tübingen, Germany. claus.garbe@uni-tuebingen.de.
Dirk SchadendorfDepartment of Dermatology, University Hospital, University Duisburg-Essen, Essen, Germany. dirk.schadendorf@uk-essen.de.
University of Tübingen · DEUniversity of Duisburg-Essen · DECharité - Universitätsmedizin Berlin · DEDermatologikum Hamburg · DEElbe Kliniken Stade-Buxtehude · DEFachklinik Hornheide · DEJohannes Gutenberg University Mainz · DEJohannes Wesling Klinikum Minden · DEKiel University · DEKlinikum Ludwigshafen · DELeipzig University · DELudwig-Maximilians-Universität München · DEUniversity Hospital Heidelberg · DEUniversity of Lübeck · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIpilimumab is an approved immunotherapy that has shown an overall survival benefit in patients with cutaneous metastatic melanoma in two phase III trials. As results of registrational trials might not answer all questions regarding safety and efficacy of ipilimumab in patients with advanced melanoma seen in daily clinical practice, the Dermatologic Cooperative Oncology Group conducted a phase II study to assess the efficacy and safety of ipilimumab in patients with different subtypes of metastatic melanoma. PATIENTS AND

methodsWe undertook a multicenter phase II study in melanoma patients irrespective of location of the primary melanoma. Here we present data on patients with pretreated metastatic cutaneous, mucosal and occult melanoma 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.

results103 pretreated patients received at least one dose of ipilimumab, including 83 cutaneous, seven mucosal and 13 occult melanomas. 1-year OS rates for cutaneous, mucosal and occult melanoma were 38 %, 14 % and 27 %, respectively. Median OS was 6.8 months (95 % CI 5.3-9.9) for cutaneous, 9.6 months (95 % CI 1.6-11.1) for mucosal, and 9.9 months (lower 95 % CI 2.3, upper 95 % CI non-existent) for occult melanoma. Overall response rates for cutaneous, mucosal and occult melanoma were 16 %, 17 % and 11 %, respectively. Eleven patients had partial response (16 %) and ten patients experienced stable disease (14 %), none achieved a complete response. Treatment-related AEs were observed in 71 patients (69 %), including 20 grade 3-4 events (19 %). No new and unexpected safety findings were noted.

conclusionsIpilimumab is a treatment option for pretreated patients with advanced cutaneous melanoma seen in daily routine. Toxicity was manageable when treated as per protocol-specific guidelines.

trial registrationClinical Trials.gov NCT01355120.

Indexed as

AdultAgedAged, 80 and overAntibodies, MonoclonalAntineoplastic AgentsBiomarkers, TumorCutaneous Malignant MelanomaFemaleHumansIpilimumabKaplan-Meier EstimateMaleMelanomaMiddle AgedRemission InductionSkin NeoplasmsAntibodies, MonoclonalAntineoplastic AgentsBiomarkers, TumorIpilimumab

Identifiers

PMID26541511
PMCPMC4635983
OpenAlexW2114747879

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.