Evidence map›Paper›PMID 39905323›Full record

ArticleBMC cancer2025

Safety and efficacy of oral cancer vaccine B440 in patients with PD-1/PD-L1 inhibitor-resistant advanced urothelial cancer: a study protocol for a phase 1 multicenter, open-label, single-arm clinical trial.

Junya Furukawa, Yasumasa Kakei, Sae Murakami, Hiroshi Kita, Hideto Ueki, Takuto Hara, Jun Teishima, Nobuyuki Hinata, Hideaki Miyake, Masato Fujisawa and 1 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. 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

11 authors.

Junya FurukawaDepartment of Urology, Kobe University Graduate School of Medicine, Kobe, Japan.
Yasumasa KakeiDepartment of Clinical and Translational Research Center, Kobe University Hospital, Kobe, Japan. ykakei@med.kobe-u.ac.jp.
Sae MurakamiDepartment of Clinical and Translational Research Center, Kobe University Hospital, Kobe, Japan.
Hiroshi KitaDepartment of Clinical and Translational Research Center, Kobe University Hospital, Kobe, Japan.
Hideto UekiDepartment of Urology, Kobe University Graduate School of Medicine, Kobe, Japan.
Takuto HaraDepartment of Urology, Kobe University Graduate School of Medicine, Kobe, Japan.
Jun TeishimaDepartment of Urology, Kobe University Graduate School of Medicine, Kobe, Japan.
Nobuyuki HinataDepartment of Urology, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.
Hideaki MiyakeDepartment of Urology, Kobe University Graduate School of Medicine, Kobe, Japan.
Masato FujisawaDepartment of Urology, Kobe University Graduate School of Medicine, Kobe, Japan.
Toshiro ShirakawaDepartment of Urology, Kobe University Graduate School of Medicine, Kobe, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis is a multicenter, open-label, single-arm clinical trial to evaluate the safety and efficacy of oral cancer vaccine B440 in patients with PD-1/PD-L1 inhibitor-resistant advanced urothelial cancer.

methodsThe trial will be performed at three university hospitals in Japan. The target number of patients will be 12. The patients will be treated orally with B440 once daily for 5 days followed by 2 days for four consecutive courses (4 weeks, 20 treatments). The low-dose group will receive 800 mg (4 capsules) per dose and the high-dose group will receive 1,600 mg (8 capsules) per dose. The primary outcome will be the number and incidence of DLT cases the start of treatment and Day 28. Secondary outcomes are the presence or absence of a response, the best overall response and PFS. DISCUSSION: If this trial shows B440 to be safe and effective, it may lead to a late phase randomized controlled trial in advanced urothelial cancer. Ultimately, we hope to provide a new treatment option for such patients.

trial registrationJapan Registry of Clinical Trials (jRCT) identifier: jRCT2051220143. Registered on December 27, 2022.

Indexed as

Cancer VaccinesUrologic NeoplasmsAdministration, OralAdultAgedB7-H1 AntigenClinical Trials, Phase I as TopicDrug Resistance, NeoplasmFemaleHumansImmune Checkpoint InhibitorsJapanMaleMiddle AgedMulticenter Studies as TopicProgrammed Cell Death 1 ReceptorB7-H1 AntigenCancer VaccinesCD274 protein, humanImmune Checkpoint InhibitorsPDCD1 protein, humanProgrammed Cell Death 1 Receptoradvanced urothelial cancerB440Clinical trialICIPhase 1WT-1 protein

Identifiers

PMID39905323
PMCPMC11792616

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Registered trials

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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.