Evidence map›Paper›PMID 26410424›Full record

Trial reportCancer chemotherapy and pharmacology2015

Phase II study of ipilimumab monotherapy in Japanese patients with advanced melanoma.

N Yamazaki, Y Kiyohara, H Uhara, S Fukushima, H Uchi, N Shibagaki, A Tsutsumida, S Yoshikawa, R Okuyama, Y Ito and 1 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer chemotherapy and pharmacology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01990859 (Phase 2 Study of Ipilimumab in Japanese Subjects With Unresectable or Metastatic Melanoma), which is not on this map. Cited by 35 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 7 pooled it
3.6field-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.

NCT01990859 phase2completednot on this map

Phase 2 Study of Ipilimumab in Japanese Subjects With Unresectable or Metastatic Melanoma

TypeinterventionalSponsorBristol-Myers SquibbRan2013 to 2015Enrolled20ConditionsMelanomaArmsIpilimumab
3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 7 syntheses or guidelines pooled it, 63 citations in OpenAlex.

  1. Pooled it
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  3. Guideline
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  12. Article
  13. Optimal strategy in managing advanced melanoma.The Journal of dermatology · 2024
    Review
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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

11 authors at 7 institutions in 2 countries.

N YamazakiDepartment of Dermatologic Oncology, National Cancer Center Hospital, Tokyo, Japan.
Y KiyoharaDermatology Division, Shizuoka Cancer Center, Shizuoka, Japan.
H UharaDepartment of Dermatology, Shinshu University School of Medicine, Matsumoto, Japan.
S FukushimaDepartment of Dermatology and Plastic Surgery, Faculty of Life Sciences, Kumamoto University, Kumamoto, Japan.
H UchiDepartment of Dermatology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
N ShibagakiDepartment of Dermatology, University of Yamanashi Hospital, Yamanashi, Japan.
A TsutsumidaDepartment of Dermatologic Oncology, National Cancer Center Hospital, Tokyo, Japan.
S YoshikawaDermatology Division, Shizuoka Cancer Center, Shizuoka, Japan.
R OkuyamaDepartment of Dermatology, Shinshu University School of Medicine, Matsumoto, Japan.
Y ItoResearch and Development, Bristol-Myers K.K., 6-5-1, Nishishinjuku, Shinjuku-ku, Tokyo, 1631328, Japan.
T TokudomeResearch and Development, Bristol-Myers K.K., 6-5-1, Nishishinjuku, Shinjuku-ku, Tokyo, 1631328, Japan. takuto0806@gmail.com.
National Cancer Center · USShinshu University · JPShizuoka Cancer Center · JPBristol-Myers Squibb (Japan) · JPKumamoto University · JPKyushu University · JPUniversity of Yamanashi Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeIpilimumab is designed to block cytotoxic T-lymphocyte antigen-4 to augment antitumor T cell responses. In studies of predominantly Caucasian patients with advanced melanoma, ipilimumab was associated with durable response, long-term survival benefit, and a manageable safety profile. This phase II study assessed the safety of ipilimumab in Japanese patients with unresectable stage III or IV melanoma.

methodsPatients received ipilimumab 3 mg/kg every 3 weeks for four doses. The database lock for the original analysis was in August 2014. Overall survival, progression-free survival, and data on deaths were based on an updated, follow-up analysis (database lock April 2015).

resultsData are reported from 20 patients. Fifteen patients (75 %) received all four doses of ipilimumab during induction. Twelve patients (60 %) had at least one drug-related adverse event (AE), and no patients discontinued due to a drug-related AE. There were no deaths related to study drug. The most common drug-related AEs were rash (n = 7), pyrexia (n = 3), increased aspartate aminotransferase (AST; n = 3), and increased alanine aminotransferase (ALT; n = 3). Twelve patients (60 %) reported immune-related AEs (irAEs); most frequent were skin (n = 9) and liver (n = 3) disorders. Grade 3 irAEs were ALT and AST elevation (n = 2) and diabetes mellitus (n = 1). Two patients had a partial response and two had stable disease, yielding a 20 % disease control rate. Median overall survival and progression-free survival were 8.71 and 2.74 months, respectively.

conclusionIpilimumab 3 mg/kg had a manageable AE profile in this Japanese patient population with clinical outcomes similar to that in Caucasian patients. CLINICALTRIALS. GOV IDENTIFIER: NCT01990859.

Indexed as

AdultAgedAntibodies, MonoclonalAntibody FormationAntineoplastic AgentsChemical and Drug Induced Liver InjuryCTLA-4 AntigenDisease-Free SurvivalDrug EruptionsExanthemaFemaleFeverFollow-Up StudiesHumansImmunologic FactorsIpilimumabAntibodies, MonoclonalAntineoplastic AgentsCTLA-4 AntigenCTLA4 protein, humanImmunologic FactorsIpilimumabImmune-checkpoint inhibitorIpilimumabJapanese patientsMelanomaPhase II study

Identifiers

PMID26410424
PMCPMC4612321
OpenAlexW2130723808

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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.