Evidence map›Paper›PMID 25761109›Full record

Trial reportPloS one2015

Phase II DeCOG-study of ipilimumab in pretreated and treatment-naïve patients with metastatic uveal melanoma.

Lisa Zimmer, Julia Vaubel, Peter Mohr, Axel Hauschild, Jochen Utikal, Jan Simon, Claus Garbe, Rudolf Herbst, Alexander Enk, Eckhart Kämpgen and 7 more

Registry-linked trialAbstract readClinical Trial, Phase IIHistorical ArticleMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in PloS one, 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 124 papers, 14 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
124citing papers in PubMed, 14 pooled it
–field-weighted citation impact
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

124 citing papers in PubMed, 14 syntheses or guidelines pooled it.

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  15. Nivolumab and Ipilimumab in Metastatic Uveal Melanoma: Results From a Single-Arm Phase II Study.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2021
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  20. Gene Therapy Strategies for Uveal Melanoma: Adeno-associated Virus Delivery Challenges and Translational Opportunities.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026
    Review

64 more citing papers are in PubMed but not listed here.

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

17 authors.

Lisa ZimmerDepartment of Dermatology, University Hospital, University Duisburg-Essen, Essen, Germany.
Julia VaubelDepartment of Dermatology, University Hospital, University Duisburg-Essen, Essen, Germany.
Peter MohrDepartment of Dermatology, Buxtehude, Germany.
Axel HauschildUniversity Department of Dermatology, Kiel, Germany.
Jochen UtikalSkin Cancer Unit, German Cancer Research Center (DKFZ), Heidelberg, Germany; Department of Dermatology, Venereology and Allergology, University Medical Center Mannheim, Ruprecht-Karl University of Heidelberg, Mannheim, Germany.
Jan SimonUniversity Department of Dermatology, Leipzig, Germany.
Claus GarbeUniversity Department of Dermatology, Tübingen, Germany.
Rudolf HerbstDepartment of Dermatology, Erfurt, Germany.
Alexander EnkDepartment of Dermatology, University Hospital, Ruprecht-Karl University of Heidelberg, Heidelberg, Germany.
Eckhart KämpgenDepartment of Dermatology, University Hospital, Erlangen, Germany.
Elisabeth LivingstoneDepartment of Dermatology, University Hospital, University Duisburg-Essen, Essen, Germany.
Leonie BluhmDepartment of Dermatology, Buxtehude, Germany.
Rainer RompelDepartment of Dermatology, Kassel, Germany.
Klaus G GriewankDepartment of Dermatology, University Hospital, University Duisburg-Essen, Essen, Germany.
Michael FluckDepartment of Dermatology Hornheide, Münster, Germany.
Bastian SchillingDepartment of Dermatology, University Hospital, University Duisburg-Essen, Essen, Germany.
Dirk SchadendorfDepartment of Dermatology, University Hospital, University Duisburg-Essen, Essen, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeUp 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

methodsWe 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.

resultsForty 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.

conclusionsIpilimumab has very limited clinical activity in patients with metastatic UM. Toxicity was manageable when treated as per protocol-specific guidelines.

trial registrationClinicalTrials.gov NCT01355120.

Indexed as

AdultAgedAged, 80 and overAntibodies, MonoclonalAntineoplastic AgentsFemaleHistory, AncientHumansIpilimumabKaplan-Meier EstimateMelanomaMiddle AgedProportional Hazards ModelsTreatment OutcomeUveal NeoplasmsAntibodies, MonoclonalAntineoplastic AgentsIpilimumab

Identifiers

PMID25761109
PMCPMC4356548

What OpenQuestion holds

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LicenceCC BY
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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.