Evidence map›Paper›PMID 35656636›Full record

ArticleCancer science2022

A phase I study of the safety and efficacy of talimogene laherparepvec in Japanese patients with advanced melanoma.

Naoya Yamazaki, Taiki Isei, Yoshio Kiyohara, Hiroshi Koga, Takashi Kojima, Tatsuya Takenouchi, Kenji Yokota, Kenjiro Namikawa, Min Yi, Alissa Keegan and 1 more

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

Article in Cancer science, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03064763 (A Phase 1, Multi-center, Open-Label, Dose De-escalation Study to Evaluate the Safety and Efficacy of Talimogene Laherparepvec in Japanese Subjects With Unresectable Stage IIIB-IV Malignant Melanoma), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
1.2field-weighted citation impact, top 20% 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.

NCT03064763 phase1completednot on this map

A Phase 1, Multi-center, Open-Label, Dose De-escalation Study to Evaluate the Safety and Efficacy of Talimogene Laherparepvec in Japanese Subjects With Unresectable Stage IIIB-IV Malignant Melanoma

TypeinterventionalSponsorAmgenRan2017 to 2023Enrolled18ConditionsUnresectable Stage IIIB-IV Malignant MelanomaArmsTalimogene laherparepvec
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Review
  5. Review
  6. Review
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  8. 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

11 authors at 8 institutions in 2 countries.

Naoya YamazakiDepartment of Dermatologic Oncology, National Cancer Center Hospital, Tokyo, Japan.ORCID https://orcid.org/0000-0002-9638-0428
Taiki IseiDepartment of Dermatologic Oncology, Osaka International Cancer Institute, Osaka, Japan.
Yoshio KiyoharaDivision of Dermatology, Shizuoka Cancer Center Hospital, Shizuoka, Japan.
Hiroshi KogaDepartment of Dermatology, Shinshu University School of Medicine, Matsumoto, Nagano, Japan.
Takashi KojimaDepartment of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa-shi, Chiba, Japan.ORCID https://orcid.org/0000-0002-2554-8334
Tatsuya TakenouchiDivision of Dermatology, Niigata Cancer Center Hospital, Niigata-shi, Niigata, Japan.
Kenji YokotaDepartment of Dermatology, Nagoya University Hospital, Nagoya-shi, Aichi, Japan.
Kenjiro NamikawaDepartment of Dermatologic Oncology, National Cancer Center Hospital, Tokyo, Japan.ORCID https://orcid.org/0000-0003-2763-7346
Min YiAmgen Inc., Thousand Oaks, California, USA.
Alissa KeeganAmgen Inc., Thousand Oaks, California, USA.
Satoshi FukushimaDepartment of Dermatology and Plastic Surgery, Faculty of Life Sciences, Kumamoto University, Kumamoto, Japan.ORCID https://orcid.org/0000-0002-0622-7682
Amgen (United States) · USKumamoto University · JPNagoya University Hospital · JPNational Cancer Center Hospital East · JPNiigata Cancer Center Hospital · JPOsaka International Cancer Institute · JPShinshu University · JPShizuoka Cancer Center · JP

Funding

Amgen Inc.
6 · The paper itself

Abstract

Talimogene laherparepvec (T-VEC) is approved for the treatment of unresectable melanoma in the USA, Europe, and Australia. This phase I, multicenter, open-label, dose de-escalation study evaluated the safety and efficacy of T-VEC in Japanese patients with unresectable stage IIIB-IV melanoma. Eligible adult patients had histologically confirmed stage IIIB-IVM1c cutaneous melanoma, may have received prior systemic anticancer therapy, must have had ≥1 injectable lesion, serum lactate dehydrogenase ≤1.5x upper limit of normal, ECOG performance status of 0 or 1, and adequate hematologic, hepatic, and renal function. T-VEC was injected intralesionally (first dose, ≤4.0 ml of 10

Indexed as

Biological ProductsMelanomaOncolytic VirotherapySkin NeoplasmsAdultFemaleHerpesvirus 1, HumanHumansJapanMaleBiological Productstalimogene laherparepvecimmunotherapyJapanesemelanomaphase I clinical trialtalimogene laherparepvec

Identifiers

PMID35656636
PMCPMC9357627
OpenAlexW4281888560

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.