Evidence map›Paper›PMID 23666915›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2013

Four-year survival rates for patients with metastatic melanoma who received ipilimumab in phase II clinical trials.

J D Wolchok, J S Weber, M Maio, B Neyns, K Harmankaya, K Chin, L Cykowski, V de Pril, R Humphrey, C Lebbé

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03498196 (A Window of Opportunity Trial), which is not on this map. Cited by 104 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
104citing papers in PubMed, 3 pooled it
17.9field-weighted citation impact, top 1% 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.

NCT03498196 phase1 / phase2terminatednot on this mapstarted 2018, after this paper: background citation

A Window of Opportunity Trial: Avelumab in Non-metastatic Muscle Invasive Bladder Cancer (BL-AIR: Bladder Cancer-Avelumab for Invasive Resectable Disease)

TypeinterventionalSponsorBaylor College of MedicineRan2018 to 2019Enrolled1ConditionsBladder Cancer, Metastatic Bladder Cancer, Invasive Bladder CancerArmsAvelumab
3 · Its place in the literature

Who cites it

104 citing papers in PubMed, 3 syntheses or guidelines pooled it, 172 citations in OpenAlex.

  1. Pooled it
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  10. Five-year survival rates for treatment-naive patients with advanced melanoma who received ipilimumab plus dacarbazine in a phase III trial.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2015
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  11. Survival follow-up and ipilimumab retreatment of patients with advanced melanoma who received ipilimumab in prior phase II studies.Annals of oncology : official journal of the European Society for Medical Oncology · 2014
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  14. Survival, durable tumor remission, and long-term safety in patients with advanced melanoma receiving nivolumab.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2014
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44 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

10 authors at 8 institutions in 5 countries.

J D WolchokLudwig Institute of Cancer Research, Ludwig Center for Cancer Immunotherapy, Memorial Sloan-Kettering Cancer Center, New York, NY 10021, USA. wolchokj@mskcc.org
J S Weber
M Maio
B Neyns
K Harmankaya
K Chin
L Cykowski
V de Pril
R Humphrey
C Lebbé
Bristol-Myers Squibb (Belgium) · BEBristol-Myers Squibb (United States) · USMedical University of Vienna · ATMemorial Sloan Kettering Cancer Center · USMoffitt Cancer Center · USNetwork Italiano Per la Bioterapia Dei Tumori · ITUniversitair Ziekenhuis Brussel · BEUniversité Paris Cité · FR

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

backgroundThis analysis was carried out to evaluate the long-term survival of patients with metastatic melanoma who received ipilimumab, a fully human monoclonal antibody that binds to cytotoxic T-lymphocyte antigen-4, in clinical trials. PATIENTS AND

methodsPatients received ipilimumab in one of three completed phase II clinical trials (CA184-008, CA184-022, and CA184-007). Previously treated patients were enrolled in all studies, and treatment-naïve patients were also included in study CA184-007. Patients received ipilimumab at a dose of 10 mg/kg in studies CA184-008 and CA184-007, and at doses of 0.3, 3, or 10 mg/kg in study CA184-022. Ipilimumab was given every 3 weeks for four doses, and eligible patients could receive ipilimumab maintenance therapy every 12 weeks. In study CA184-022, patients could cross over to be retreated with ipilimumab at 10 mg/kg upon disease progression. Ongoing survival follow-up is conducted in a companion study, CA184-025.

resultsFour-year survival rates [95% confidence interval (95% CI)] for previously treated patients who received ipilimumab at 0.3, 3, or 10 mg/kg were 13.8% [6.1-22.5], 18.2% [9.5-27.6], and 19.7% [13.4-26.5] to 28.4% [13.9-44.2], respectively. In treatment-naïve patients who received ipilimumab at 10 mg/kg, 4-year survival rates were 37.7% [18.6-57.4] to 49.5% [23.8-75.4].

conclusionsThese results demonstrate durable survival in a significant proportion of patients with metastatic melanoma who received ipilimumab therapy.

Indexed as

Antibodies, MonoclonalCTLA-4 AntigenFollow-Up StudiesHumansImmunotherapyIpilimumabMelanomaSkin NeoplasmsSurvival RateTreatment OutcomeAntibodies, MonoclonalCTLA-4 AntigenIpilimumabcytotoxic T-lymphocyte antigen-4immunotherapyipilimumablong-term survivalmetastatic melanomasurvival rate

Identifiers

PMID23666915
PMCPMC4081656
OpenAlexW2121071739

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.