Evidence map›Paper›PMID 30515672›Full record

ArticleGastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association2019

Phase 1 trial of avelumab (anti-PD-L1) in Japanese patients with advanced solid tumors, including dose expansion in patients with gastric or gastroesophageal junction cancer: the JAVELIN Solid Tumor JPN trial.

Toshihiko Doi, Satoru Iwasa, Kei Muro, Taroh Satoh, Shuichi Hironaka, Taito Esaki, Tomohiro Nishina, Hiroki Hara, Nozomu Machida, Yoshito Komatsu and 4 more

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 34 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 3 pooled it
3.1field-weighted citation impact, top 6% 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.

NCT01943461 phase1completednot on this map

A Phase I Trial to Investigate the Tolerability, Safety, Pharmacokinetics, Biological and Clinical Activity of Avelumab (MSB0010718C) in Japanese Subjects With Metastatic or Locally Advanced Solid Tumors, With Expansion Part in Asian Subjects With Gastric Cancer

TypeinterventionalSponsorMerck KGaA, Darmstadt, GermanyRan2013 to 2019Enrolled57ConditionsSolid TumorsArmsAvelumab 3 mg/kg, Avelumab 10 mg/kg, Avelumab 20 mg/kg
NCT03966118 phase2unknown statusnot on this map

Avelumab + Paclitaxel/ Ramucirumab as Second Line Treatment in Gastro-esophageal Adenocarcinoma: a Phase II Trial of the AIO (The RAP-Trial)

TypeinterventionalSponsorP. C. Thuss-PatienceRan2019 to 2023Enrolled59ConditionsGastroesophageal Junction Adenocarcinoma, Adenocarcinoma of the StomachArmsAvelumab, Ramucirumab, Paclitaxel
3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 3 syntheses or guidelines pooled it, 57 citations in OpenAlex.

  1. Pooled it
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  3. Evaluation of the potential for QTc prolongation with avelumab.Cancer chemotherapy and pharmacology · 2019
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  9. Article
  10. Immunology and immunotherapy in gastric cancer.Clinical and experimental medicine · 2023
    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

14 authors at 12 institutions in 1 country.

Toshihiko DoiNational Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan. tdoi@east.ncc.go.jp.
Satoru IwasaNational Cancer Center Hospital, Chuo-ku, Tokyo, Japan.
Kei MuroAichi Cancer Center Hospital, Chikusa-ku, Nagoya, Japan.
Taroh SatohOsaka University Hospital, Suita, Osaka, Japan.
Shuichi HironakaChiba Cancer Center, Chuo-ku, Chiba, Japan.
Taito EsakiNational Kyushu Cancer Center, Minami-ku, Fukuoka, Japan.
Tomohiro NishinaShikoku Cancer Center, Matsuyama, Ehime, Japan.
Hiroki HaraSaitama Cancer Center, Kita, Adachi-gun, Saitama, Japan.
Nozomu MachidaShizuoka Cancer Center, Sunto-gun, Shizuoka, Japan.
Yoshito KomatsuHokkaido University Hospital, Kita-ku, Sapporo, Japan.
Yasuhiro ShimadaKochi Health Sciences Center, Kochi, Japan.
Satoshi OtsuOita University Hospital, Oita, Japan.
Shin ShimizuMerck Serono Co., Ltd, Tokyo, Japan.
Morihiro WatanabeMerck Serono Co., Ltd, Tokyo, Japan.
Merck (Japan) · JPNational Cancer Center Hospital East · JPAichi Cancer Center · JPChiba Cancer Center · JPHokkaido University Hospital · JPNational Hospital Organization Kyushu Cancer Center · JPOita University Hospital · JPOsaka University Hospital · JPSaitama Cancer Center · JPShikoku Cancer Center · JPShizuoka Cancer Center · JPUniversity of Kochi · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAvelumab is a human anti-PD-L1 IgG1 monoclonal antibody that has shown antitumor activity in several advanced cancers. We report results from JAVELIN Solid Tumor JPN, a phase 1 trial of avelumab in Japanese patients with advanced solid tumors with expansion in patients with advanced gastric cancer/gastroesophageal junction cancer.

methodsIn the dose-escalation part, eligible patients had various previously treated metastatic or advanced solid tumors. In the dose-expansion part, patients had stage IV gastric cancer/gastroesophageal junction adenocarcinoma and disease progression after prior therapy that included a platinum and fluoropyrimidine agent. Patients received avelumab every 2 weeks intravenously at 3, 10, or 20 mg/kg during dose escalation and 10 mg/kg during dose expansion.

resultsAmong 17 patients who received avelumab in the dose-escalation part, no dose-limiting toxicities occurred, and the maximum tolerated dose was not reached. 40 patients were enrolled in the dose-expansion part, of whom 21 (52.5%) had received ≥ 3 prior lines of therapy for advanced disease. In these patients, the objective response rate was 10.0% (95% CI, 2.8-23.7%) and median overall survival was 9.1 months (95% CI, 7.2-11.2 months). Three of 40 patients (7.5%) had a grade 3 treatment-related adverse event (alanine aminotransferase increase, anemia, and hyponatremia), and no grade ≥ 4 treatment-related adverse events occurred. Five patients (12.5%) had an immune-related adverse event (all grade 1/2).

conclusionsAvelumab showed acceptable safety in Japanese patients with advanced solid tumors and clinical activity in patients with advanced gastric cancer/gastroesophageal junction cancer and disease progression after chemotherapy.

Indexed as

AdenocarcinomaAdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedB7-H1 AntigenCohort StudiesDose-Response Relationship, DrugEsophageal NeoplasmsEsophagogastric JunctionFemaleFollow-Up StudiesHumansMaleMaximum Tolerated DoseMiddle AgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedavelumabB7-H1 AntigenCD274 protein, humanAvelumabGastric cancerJapanPD-L1Phase 1

Identifiers

PMID30515672
PMCPMC6570778
OpenAlexW2902391954

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.