Evidence map›Paper›PMID 41342548›Full record

Trial reportJapanese journal of clinical oncology2026

A phase II trial of nivolumab for patients with platinum-refractory recurrent or metastatic salivary gland cancer.

Yoshiaki Nagatani, Naomi Kiyota, Tomoko Yamazaki, Yukinori Asada, Masaaki Higashino, Hironaga Satake, Shogen Boku, Ari Nishimura, Hirokazu Uemura, Ichiro Ota and 13 more

Abstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Japanese journal of clinical oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 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.

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

6 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Article
  6. 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

23 authors.

Yoshiaki NagataniDepartment of Medical Oncology and Hematology, Kobe University Hospital, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan.ORCID 0009-0000-6153-6456
Naomi KiyotaDepartment of Medical Oncology and Hematology, Kobe University Hospital, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan.ORCID 0000-0001-8021-6116
Tomoko YamazakiDepartment of Head and Neck Oncology, Miyagi Cancer Center, 47-1 Nodayama, Medeshimashiode, Natori, Miyagi 981-1293, Japan.
Yukinori AsadaDepartment of Head and Neck Surgery, Miyagi Cancer Center, 47-1 Nodayama, Medeshimashiode, Natori, Miyagi 981-1293, Japan.
Masaaki HigashinoDepartment of Otorhinolaryngology, Head and Neck Surgery, Osaka Medical and Pharmaceutical University, 2-7 Daigaku-machi, Takatsuki 569-8686, Japan.
Hironaga SatakeDepartment of Medical Oncology, Kochi Medical School, Kohasu, Oko-Cho, Nankoku, Kochi 783-8505, Japan.ORCID 0000-0001-7629-6803
Shogen BokuCancer Treatment Center, Kansai Medical University Hospital, 2-3-1 Shinmachi, Hirakata, Osaka 573-1191, Japan.
Ari NishimuraDepartment of Otolaryngology-Head and Neck Surgery, Nara Medical University, 840 Shijo-cho, Kashihara, Nara 634-8522, Japan.
Hirokazu UemuraDepartment of Otolaryngology-Head and Neck Surgery, Nara Medical University, 840 Shijo-cho, Kashihara, Nara 634-8522, Japan.ORCID 0000-0001-7502-3619
Ichiro OtaDepartment of Otolaryngology-Head and Neck Surgery, Kindai University Nara Hospital, 1248-1 Otoda-cho, Ikoma, Nara 630-0293, Japan.
Katsunari YaneDepartment of Otolaryngology-Head and Neck Surgery, Kindai University Nara Hospital, 1248-1 Otoda-cho, Ikoma, Nara 630-0293, Japan.
Kaoru TanakaDepartment of Medical Oncology, Kindai University Faculty of Medicine, 377-2 Ohno-higashi, Osaka-Sayama, Osaka 589-8511, Japan.
Takuma OnoeDepartment of Medical Oncology, Hyogo Cancer Center, 13-70, Kitaouji-cho, Akashi, Hyogo 673-8588, Japan.
Yuji HirayamaDepartment of Head and Neck Surgery, Hyogo Cancer Center, 13-70, Kitaouji-cho, Akashi, Hyogo 673-8588, Japan.
Takahiro TsujikawaDepartment of Otolaryngology-Head and Neck Surgery, Kyoto Prefectural University of Medicine, 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan.
Hajime FujiwaraDepartment of Otorhinolaryngology-Head and Neck Surgery, Kobe University Graduate School of Medicine, 7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan.
Hikari ShimodaDepartment of Otorhinolaryngology-Head and Neck Surgery, Kobe University Graduate School of Medicine, 7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan.
Ken-Ichi NibuDepartment of Otorhinolaryngology-Head and Neck Surgery, Kobe University Graduate School of Medicine, 7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan.
Yoshinori ImamuraDepartment of Medical Oncology and Hematology, Kobe University Hospital, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan.
Shiro KimbaraDepartment of Medical Oncology and Hematology, Kobe University Hospital, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan.
Taiji KoyamaDepartment of Medical Oncology and Hematology, Kobe University Hospital, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan.
Yohei FunakoshiDepartment of Medical Oncology and Hematology, Kobe University Hospital, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan.ORCID 0000-0001-7793-5013
Hironobu MinamiDepartment of Medical Oncology and Hematology, Kobe University Hospital, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan.

Funding

Ministry of Education, Culture, Sports, Science and Technology, JapanScientific Research C 17K11384Scientific Research C 23K08963
6 · The paper itself

Abstract

backgroundSalivary gland cancer (SGC) is rare and has various histological types. This rarity and heterogeneity have hindered elucidation of the therapeutic contribution of systemic therapy, including immune checkpoint inhibitors, to recurrent or metastatic SGC (RM-SGC). The purpose of this trial was to investigate the efficacy and safety of nivolumab for platinum-refractory RM-SGC.

methodsThis phase II trial for platinum-refractory RM-SGC was conducted at nine centers. Nivolumab 240 mg was administered intravenously every 2 weeks. The primary endpoint was the objective response rate (ORR), and secondary endpoints were disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety.

resultsTwenty-four patients were enrolled between March 2018 and January 2022. The main histological types were salivary duct carcinoma (n = 10), adenoid cystic carcinoma (n = 6), and adenocarcinoma not otherwise specified (n = 5). The ORR was 8.3% (2/24, 80% CI, 2.2-20.6), with two partial responses in patients with salivary duct carcinoma. The DCR was 29.2% (7/24), while all of the other 17 patients (70.8%) showed progressive disease on first disease evaluation at 12 weeks. With a median follow-up of 21.2 months, median PFS and OS were 3.0 months (95% CI, 2.8-3.2) and 25.0 months (95% CI, 10.9-39.1), respectively. There were no new safety concerns with nivolumab monotherapy.

conclusionsThis phase II trial of nivolumab for patients with platinum-refractory RM-SGC did not meet its primary endpoint of ORR. Although nivolumab may be worth further development in salivary duct carcinoma, these results may raise concerns over nivolumab monotherapy for RM-SGC.

Indexed as

Antineoplastic Agents, ImmunologicalNeoplasm Recurrence, LocalNivolumabSalivary Gland NeoplasmsAdultAgedDrug Resistance, NeoplasmFemaleHumansMaleMiddle AgedNeoplasm MetastasisAntineoplastic Agents, ImmunologicalNivolumabimmune checkpoint inhibitornivolumabphase IIplatinum-refractorysalivary gland cancer

Identifiers

PMID41342548
PMCPMC13017010

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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.