Evidence map›Paper›PMID 28283736›Full record

ArticleCancer chemotherapy and pharmacology2017

Phase 1b study of pembrolizumab (MK-3475; anti-PD-1 monoclonal antibody) in Japanese patients with advanced melanoma (KEYNOTE-041).

Naoya Yamazaki, Tatsuya Takenouchi, Manabu Fujimoto, Hironobu Ihn, Hiroshi Uchi, Takashi Inozume, Yoshio Kiyohara, Hisashi Uhara, Kazuhiko Nakagawa, Hiroshi Furukawa and 4 more

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

Article in Cancer chemotherapy and pharmacology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02180061 (Phase Ib Study of MK-3475 in Subjects With Advanced Melanoma), which is not on this map. Cited by 58 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
58citing papers in PubMed, 8 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.

NCT02180061 phase1completednot on this map

Phase Ib Study of MK-3475 in Subjects With Advanced Melanoma

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2014 to 2017Enrolled42ConditionsMelanomaArmsPembrolizumab
3 · Its place in the literature

Who cites it

58 citing papers in PubMed, 8 syntheses or guidelines pooled it.

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  9. Trial
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  11. Benefit of immune checkpoint inhibitors as adjuvant treatment for acral melanomas.Journal of the European Academy of Dermatology and Venereology : JEADV · 2026
    Article
  12. Review
  13. Article
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  18. Impact of Treatment Delay in Head and Neck Mucosal Melanoma on Overall Patient Survival.Journal of neurological surgery. Part B, Skull base · 2024
    Article
  19. Article
  20. Optimal strategy in managing advanced melanoma.The Journal of dermatology · 2024
    Review
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

14 authors.

Naoya YamazakiDepartment of Dermatologic Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan. nyamazaki@ncc.go.jp.
Tatsuya TakenouchiDepartment of Dermatology, Niigata Cancer Center Hospital, Niigata, Japan.
Manabu FujimotoDepartment of Dermatology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.
Hironobu IhnDepartment of Dermatology and Plastic Surgery, Faculty of Life Sciences, Kumamoto University, Kumamoto, Japan.
Hiroshi UchiDepartment of Dermatology, Kyushu University School of Medicine, Fukuoka, Japan.
Takashi InozumeDepartment of Dermatology, Faculty of Medicine, University of Yamanashi, Yamanashi, Japan.
Yoshio KiyoharaDepartment of Dermatology, Shizuoka Cancer Center, Shizuoka, Japan.
Hisashi UharaDepartment of Dermatology, Sapporo Medical University School of Medicine, Sapporo, Japan.
Kazuhiko NakagawaDepartment of Medical Oncology, Kindai University Faculty of Medicine, Osaka-sayama, Japan.
Hiroshi FurukawaDepartment of Plastic and Reconstructive Surgery, Graduate School of Medicine, Hokkaido University, Sapporo, Japan.
Hidefumi WadaDepartment of Dermatology, Yokohama City University School of Medicine, Yokohama, Japan.
Kazuo NoguchiMSD K.K., Tokyo, Japan.
Takashi ShimamotoMSD K.K., Tokyo, Japan.
Kenji YokotaDepartment of Dermatology, Nagoya University Graduate School of Medicine, Nagoya, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThis phase I b study evaluated the safety and anti-tumor activity of pembrolizumab in Japanese patients with advanced melanoma.

methodsPembrolizumab (2 mg/kg) was given every 3 weeks (Q3W) for up to 2 years or until confirmed progression or unacceptable toxicity. The tumor response was assessed as per the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by both investigator review and central review.

resultsForty-two patients with advanced melanoma received pembrolizumab. A primary cutaneous histology was observed in 34 patients (81.0%), while a primary mucosal histology was observed in 8 patients (19.0%). Thirty-four patients (81.0%) experienced treatment-related adverse events (AEs). The most common treatment-related AEs were pruritus, maculopapular rash, malaise, and hypothyroidism. Grade 3-5 treatment-related AEs occurred in 8 patients (19.0%). The only grade 3-5 treatment-related AE reported in at least two patients was anemia. There were two treatment-related deaths (unknown cause and cerebral hemorrhage). Among the 37 evaluable patients, the confirmed overall response rates (ORRs) determined by central review were 24.1% (95% CI 10.3-43.5) for cutaneous melanoma and 25.0% (95% CI 3.2-65.1) for mucosal melanoma. The responses were durable, and the median duration of response was not reached in either population. The median overall survival (OS) was not reached, with a 12-month OS of 82.7% for cutaneous melanoma and 51.4% for mucosal melanoma.

conclusionThe safety profile of pembrolizumab in Japanese patients was similar to that reported in the previous clinical studies. Pembrolizumab provided promising anti-tumor activity in Japanese patients with advanced melanoma.

Indexed as

AdultAgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsAsian PeopleCutaneous Malignant MelanomaDisease-Free SurvivalFemaleHumansMaleMelanomaMiddle AgedProgrammed Cell Death 1 ReceptorSkinAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsPDCD1 protein, humanpembrolizumabProgrammed Cell Death 1 ReceptorAnti-PD-1 therapyImmunotherapyJapanese patientsMelanomaPembrolizumab

Identifiers

PMID28283736
PMCPMC5364262

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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.