Evidence map›Paper›PMID 40180420›Full record

ArticleJournal for immunotherapy of cancer2025

Phase I study on neoadjuvant combination immunotherapy with mogamulizumab and nivolumab for solid tumors.

Koichi Jinushi, Takuro Saito, Koji Kurose, Susumu Suzuki, Takashi Kojima, Taishi Takahara, Tomoki Makino, Tetsuya Ogawa, Hiroyoshi Nishikawa, Kazuhiro Kakimi and 6 more

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

Article in Journal for immunotherapy of cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02946671 (Phase I Study of Pre-operative Combination Therapy With Mogamulizumab), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing 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.

NCT02946671 phase1completednot on this map

Phase I Study of Pre-operative Combination Therapy With Mogamulizumab (Anti-CCR4) and Nivolumab (Anti-PD-1) Against Solid Cancer Patients

TypeinterventionalSponsorOsaka UniversityRan2016 to 2020Enrolled16ConditionsGastric Cancer, Esophageal Cancer, Lung Cancer, Renal CancerArmsMogamulizumab, Nivolumab
3 · Its place in the literature

Who cites it

9 citing papers in PubMed.

  1. Review
  2. Review
  3. Regulatory T cells in cancer and inflammation.Signal transduction and targeted therapy · 2026
    Review
  4. Review
  5. Review
  6. Review
  7. [Guardians of Immune Tolerance: Regulatory T Cells].Sichuan da xue xue bao. Yi xue ban = Journal of Sichuan University. Medical science edition · 2025
    Review
  8. Progress of immune checkpoint inhibitors in gastric cancer.World journal of gastrointestinal oncology · 2025
    Review
  9. 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

16 authors.

Koichi Jinushi *Department of Gastroenterological Surgery, Osaka University School of Medicine Graduate School of Medicine, Suita, Osaka Prefecture, Japan.
Takuro Saito *Department of Gastroenterological Surgery, Osaka University School of Medicine Graduate School of Medicine, Suita, Osaka Prefecture, Japan.ORCID http://orcid.org/0000-0002-1733-5064
Koji KuroseDepartment of Respiratory Medicine, Kawasaki Medical School, Kurashiki, Japan.
Susumu SuzukiResearch Creation Support Center, Aichi Medical University, Nagakute, Aichi, Japan.ORCID http://orcid.org/0000-0002-1466-8824
Takashi KojimaDepartment of Gastroenterology and Gastrointestinal Oncology, National Cancer Center-Hospital East, Kashiwa, Chiba, Japan.
Taishi TakaharaDepartment of Surgical Pathology, Aichi Medical University Hospital, Nagakute, Aichi Prefecture, Japan.
Tomoki MakinoDepartment of Gastroenterological Surgery, Osaka University School of Medicine Graduate School of Medicine, Suita, Osaka Prefecture, Japan.
Tetsuya OgawaDepartment of Otorhinolaryngology-Head and Neck Surgery, Aichi Medical University School of Medicine, Nagakute, Japan.
Hiroyoshi NishikawaDivision of Cancer Immunology, National Cancer Center Japan, Chuo, Tokyo, Japan.ORCID http://orcid.org/0000-0001-6563-9807
Kazuhiro KakimiDepartment of Immunology, Kindai University Faculty of Medicine Graduate School of Medical Sciences, sayama, Osaka, Japan.ORCID http://orcid.org/0000-0003-2631-3040
Shinsuke IidaDepartment of Hematology and Oncology, Nagoya City University Graduate School of Medical Sciences and Medical School, Nagoya, Aichi Prefecture, Japan.
Jun NakajimaDepartment of Thoracic Surgery, The University of Tokyo, Bunkyo-ku, Tokyo, Japan.
Yuichiro DokiDepartment of Gastroenterological Surgery, Osaka University School of Medicine Graduate School of Medicine, Suita, Osaka Prefecture, Japan.
Mikio OkaDepartment of Immuno-Oncology, Kawasaki Medical School, Kurashiki, Japan.ORCID http://orcid.org/0000-0002-7914-5768
Ryuzo UedaDepartment of Immunology, Nagoya University Graduate School of Medicine Faculty of Medicine, Nagoya, Aichi Prefecture, Japan.
Hisashi WadaDepartment of Immunology, Nagoya University Graduate School of Medicine, Nagoya, Japan hwada@gesurg.med.osaka-u.ac.jp.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEffector regulatory T cells expressing C-C chemokine receptor 4 (CCR4) suppress antitumor immune responses. We conducted a phase I clinical trial to evaluate the safety and efficacy of preoperative combination therapy with mogamulizumab (an anti-CCR4 antibody) and nivolumab (an anti-programmed death-1 antibody) in patients with solid tumors.

methodsPatients with operable solid tumors were enrolled in a 3+3 design, with preoperative nivolumab (3.0 mg/kg) administered intravenously every 2 weeks three times and mogamulizumab at 0.1 mg/kg (cohort 1), 0.3 mg/kg (cohort 2), or 1.0 mg/kg (cohort 3) every week four times. The primary endpoints were safety and the effects of depleting Forkhead box P3

results16 patients were enrolled between June 2016 and April 2020, including those with renal (n=7), lung (n=5), esophageal (n=3), and oral (n=1) cancers. Grade 3-4 treatment-related adverse events were observed in 6 of 16 patients, with lymphopenia (25%) and maculopapular rash (13%) being the most frequent. Grade 5 interstitial pneumonia was observed in one patient; however, the cause of death was disease progression. There were three partial responses (PRs) (one lung and two esophageal cancers) among clinical responses and one complete response (one lung cancer) and nine PRs (five kidney, two lung, and two esophageal cancers) among pathological responses. CCR4

conclusionsThe preoperative combination of mogamulizumab and nivolumab was safely managed, exerted antitumor effects, and may be an effective option in the preoperative setting. TRIAL REGISTRATION NUMBER: The present study was registered with ClinicalTrials.gov as NCT02946671 (registration date 2016-10-05).

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsImmunotherapyNeoadjuvant TherapyNeoplasmsNivolumabAdultAgedFemaleHumansMaleMiddle AgedAntibodies, Monoclonal, HumanizedmogamulizumabNivolumabAntibodyImmunotherapySolid tumorT regulatory cell - Treg

Identifiers

PMID40180420
PMCPMC11966984

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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.