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A 3+3 design tested different mogamulizumab doses with nivolumab every two weeks. Safety was assessed alongside depletion of FoxP3+ T cells in tumors. Sixteen patients were enrolled; grade 3–4 treatment-related adverse events occurred in six, and one death followed disease progression. Responses included partial and complete responses, with tumor CCR4+FoxP3+ T cell depletion and lymphocyte increases correlating with better prognosis.",{"@graph":69,"@context":123},[70,84,106],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":35,"@type":76,"position":81},"https://docshare.wps.com/document/healthcare/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/phase-i-study-on-neoadjuvant-combination-immunotherapy-with-mogamulizumab-and-nivolumab-for-solid-tumors/370414/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/phase-i-study-on-neoadjuvant-combination-immunotherapy-with-mogamulizumab-and-nivolumab-for-solid-tumors/370414.png","ImageObject",300,407,{"name":92,"@type":93},"Ophelia","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-10-31","2026-09-23",true,{"@type":102,"interactionType":103,"userInteractionCount":105},"InteractionCounter",{"@type":104},"ViewAction",14,{"@type":107,"mainEntity":108},"FAQPage",[109,115,119],{"name":110,"@type":111,"acceptedAnswer":112},"What was the purpose of this Phase I study?","Question",{"text":113,"@type":114},"To evaluate the safety and efficacy of preoperative combination therapy with mogamulizumab and nivolumab in patients with operable solid tumors.","Answer",{"name":116,"@type":111,"acceptedAnswer":117},"How were patients treated in the trial?",{"text":118,"@type":114},"Patients received preoperative nivolumab intravenously every two weeks for three doses, with mogamulizumab given weekly at different doses across cohorts (0.1, 0.3, or 1.0 mg/kg) for four doses.",{"name":120,"@type":111,"acceptedAnswer":121},"What were the key findings regarding efficacy and immune effects?",{"text":122,"@type":114},"The study observed tumor depletion of CCR4+FoxP3+ T cells in all patients, with lymphocyte increases in tumor tissue in 50% of patients. Clinical and pathological responses included partial and complete responses, and the lymphocyte increases correlated with better prognosis.","https://schema.org",{"og:url":83,"og:type":125,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":127,"canonical":83},"index,follow",{"doc_id":129,"site_id":62},370414,1790247284,{"code":4,"msg":5,"data":132},{"doc_id":129,"user_id":133,"nickname":92,"user_avatar":134,"doc_module":4,"category_id":34,"category_name":35,"doc_title":65,"doc_description":67,"doc_content":135,"file_id":136,"file_url":137,"file_type":138,"file_size":139,"view_count":105,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":140,"language":141,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":142,"faqs":143,"seo_title":144,"seo_description":67,"update_tm":145,"read_time":41},7971461741311,"https://ap-avatar.wpscdn.com/avatar/74000253aff267980c6?x-image-process=image/resize,m_fixed,w_180,h_180&k=1779345379180704826","Open access Original research  \n Phase I study on neoadjuvant  \ncombination immunotherapy with mogamulizumab and nivolumab for solid tumors  \nKoichi Jinushi,1,2 Takuro Saito  ,1,2 Koji Kurose,3 Susumu Suzuki  ,4,5 Takashi Kojima,6 Taishi Takahara,7 Tomoki Makino,1 Tetsuya Ogawa,8 Hiroyoshi Nishikawa  ,9,10,11 Kazuhiro Kakimi  ,12,13 Shinsuke Iida,14 Jun Nakajima,15 Yuichiro Doki,1 Mikio Oka  ,16 Ryuzo Ueda,10 Hisashi Wada2  \nTo cite: Jinushi K, Saito T, Kurose K, et al. Phase I study on neoadjuvant combination immunotherapy with mogamulizumab and nivolumab for solid tumors. Journal for ImmunoTherapy of Cancer 2025;13:e010634 . doi:10 . 1136/ jitc-2024-010634  \n► Additional supplemental material is published online only. To view, please visit the journal online ([https://doi.org/10.1136/](https://doi.org/10.1136/)[ ](https://doi.org/10.1136/)[jitc-2024-010634](jitc-2024-010634)) .  \nKJ and TS contributed equally.  \nRU and HW are joint senior authors.  \nAccepted 14 March 2025  \n© Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.  \nFor numbered affiliations see end of article.  \nCorrespondence to  \nProfessor Hisashi Wada; [hwada@gesurg.med.osaka-u](hwada@gesurg.med.osaka-u). [ac.jp](ac.jp)  \nABSTRACT  \nBackground Effector 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) inpatients with solid tumors.  \nMethods Patients 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+ (FoxP3+) T cells in the tumor.  \nResults 16 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+FoxP3+ T cells were depleted in the tumors of all patients and increases in lymphocytes in tumor tissue according to the tumor immune microenvironment classification were observed in 50% of the patients, which correlated with a better prognosis.  \nConclusions The preoperative combination of mogamulizumab and nivolumab was safely managed, exerted antitumor effects, and may be an effective option in the preoperative setting.  \nTrial registration number The present study was registered with ClinicalTrials.gov as NCT02946671 (registration date 2016-10-05) .   \nWHAT IS ALREADY KNOWN ON THIS TOPIC  \n\n| ⇒ The control of regulatory T cells (Tregs) may activate antitumor immunity. Mogamulizumab, a humanized IgG1 monoclonal antibody targeting anti-C-C chemokine receptor type 4, has been shown to deplete blood Tregs; however, its effects on tumorinfiltrating Tregs remain unclear.\u003Cbr>WHAT THIS STUDY ADDS |\n| --- |\n| ⇒ This clinical trial demonstrated that the neoadjuvant combination of mogamulizumab and nivolumab was safely managed and yielded favorable outcomes inpatients with operable solid tumors. Treg depletion was observed in both blood and tumors, and increases in lymphocytes in tumor tissue according to the tumor immune microenvironment classificat","cbCaicOARckLr9pm","https://ap.wps.com/l/cbCaicOARckLr9pm","pdf",929610,12,"English","# Abstract\n## Background\n## Methods\n## Results\n## Conclusions\n# Introduction\n## Immune checkpoint inhibition and Tregs\n# What is already known on this topic\n# What this study adds\n# How this study might affect research, practice or policy","[{\"question\":\"What was the purpose of this Phase I study?\",\"answer\":\"To evaluate the safety and efficacy of preoperative combination therapy with mogamulizumab and nivolumab in patients with operable solid tumors.\"},{\"question\":\"How were patients treated in the trial?\",\"answer\":\"Patients received preoperative nivolumab intravenously every two weeks for three doses, with mogamulizumab given weekly at different doses across cohorts (0.1, 0.3, or 1.0 mg/kg) for four doses.\"},{\"question\":\"What were the key findings regarding efficacy and immune effects?\",\"answer\":\"The study observed tumor depletion of CCR4+FoxP3+ T cells in all patients, with lymphocyte increases in tumor tissue in 50% of patients. Clinical and pathological responses included partial and complete responses, and the lymphocyte increases correlated with better prognosis.\"}]","Phase I study on neoadjuvant combination immunotherapy with mogamulizumab and nivolumab for solid tumors | PDF",1790188395]