We are analyzing https://link.springer.com/article/10.1007/s10637-016-0347-6.

Title:
Phase 1 study of pembrolizumab (MK-3475; anti-PD-1 monoclonal antibody) in Japanese patients with advanced solid tumors | Investigational New Drugs
Description:
Background This phase I study evaluated the safety and tolerability, pharmacokinetics and pharmacodynamics, immunogenicity, and antitumor activity of pembrolizumab in Japanese patients with advanced solid tumors. Methods Following an initial dose and a 28-day rest (cycle 1), pembrolizumab was administered as an intravenous infusion at escalating doses (2 or 10 mg/kg) every 2 weeks (Q2W) until disease progression or unacceptable toxicity. Adverse events (AEs) were assessed using CTCAE v4.0, and tumor response was assessed using both RECIST v1.1 and immune-related response criteria (irRC). Full pharmacokinetic sampling was performed during cycle 1. Results Three patients received pembrolizumab at 2.0 mg/kg and seven at 10 mg/kg. No dose-limiting toxicities were observed during cycle 1. Eighty percent of patients experienced drug-related AEs (mostly grade 1 or 2); the most common drug-related AEs were nausea, malaise, pyrexia, and aspartate aminotransferase/alanine transaminase (AST/ALT) elevations (n = 2 each). No drug-related grade 4 or 5 AEs occurred. Immune-related AEs comprised grade 3 ALT elevation (n = 1), grade 3 AST elevation (n = 1), grade 1 pneumonitis (n = 1), and grade 1 thyroid-stimulating hormone elevation (n = 1). The safety and pharmacokinetic profiles of Japanese patients were similar to those previously reported for Caucasian patients. A partial tumor response was observed in one patient with non-small-cell lung cancer (NSCLC) and in one patient with melanoma. Conclusions Pembrolizumab at both 2 and 10 mg/kg Q2W was well tolerated in Japanese patients with advanced solid tumors and showed encouraging anti-tumor activity against melanoma and NSCLC.
Website Age:
28 years and 1 months (reg. 1997-05-29).

Matching Content Categories {📚}

Education
Science
Health & Fitness

Content Management System {📝}

What CMS is link.springer.com built with?

Custom-built

No common CMS systems were detected on Link.springer.com, and no known web development framework was identified.

Traffic Estimate {📈}

What is the average monthly size of link.springer.com audience?

🌠 Phenomenal Traffic: 5M - 10M visitors per month

Based on our best estimate, this website will receive around 5,000,019 visitors per month in the current month.
However, some sources were not loaded, we suggest to reload the page to get complete results.

check SE Ranking
check Ahrefs
check Similarweb
check Ubersuggest
check Semrush

How Does Link.springer.com Make Money? {💸}

We don’t know how the website earns money.

While profit motivates many websites, others exist to inspire, entertain, or provide valuable resources. Websites have a variety of goals. And this might be one of them. Link.springer.com has a revenue plan, but it's either invisible or we haven't found it.

Keywords {🔍}

patients, pembrolizumab, study, article, mgkg, advanced, pubmed, grade, tumors, google, scholar, pdl, solid, tumor, cancer, cas, japanese, patient, melanoma, response, phase, aes, treatment, dose, cycle, observed, safety, activity, immune, days, nsclc, clinical, clin, data, antitumor, immunerelated, elevation, cells, expression, treated, antibody, full, disease, therapy, oncol, evaluated, doses, criteria, partial, evaluation,

Topics {✒️}

single-agent anti-programmed death-1 anti-programmed-death-receptor-1 treatment ny-eso-1-specific cd8+ article download pdf late-phase global studies small-cell lung cancer common drug-related aes anti-pd-1 monoclonal antibody paraffin-embedded tissue sections anti-tumor effector mechanisms pd-l1 significantly associates central nervous system pd-l1 22c3 antibody tumor-infiltrating immune cells aspartate aminotransferase/alanine transaminase dendritic cells enhances immune-related response criteria anti-pd-l1 therapy pd-l1/pd-1 pathway drug-related aes reported immune-related adverse events t-cell exhaustion terminal phase volume clinical trials based single-agent pembrolizumab administered ipilimumab-refractory advanced melanoma anti-drug antibody pd-l1-positive tumors pd-l1-negative tumors randomised dose-comparison cohort cytotoxic t-lymphocyte prior chemotherapy regimens privacy choices/manage cookies range 1–10 mg/kg overlapped humanized monoclonal antibody drug-related grade 4 programmed death-1 ligands 10 mg/kg generally increased immune-related aes immune-related aes [21 common aes related tumor-infiltrating cd8+ hisato kawakami full pharmacokinetic sampling renal cell carcinoma drug-related ae clinical trials terminal half-lives clin trials 4 pd-l1 expression

Schema {🗺️}

WebPage:
      mainEntity:
         headline:Phase 1 study of pembrolizumab (MK-3475; anti-PD-1 monoclonal antibody) in Japanese patients with advanced solid tumors
         description: Background This phase I study evaluated the safety and tolerability, pharmacokinetics and pharmacodynamics, immunogenicity, and antitumor activity of pembrolizumab in Japanese patients with advanced solid tumors. Methods Following an initial dose and a 28-day rest (cycle 1), pembrolizumab was administered as an intravenous infusion at escalating doses (2 or 10 mg/kg) every 2 weeks (Q2W) until disease progression or unacceptable toxicity. Adverse events (AEs) were assessed using CTCAE v4.0, and tumor response was assessed using both RECIST v1.1 and immune-related response criteria (irRC). Full pharmacokinetic sampling was performed during cycle 1. Results Three patients received pembrolizumab at 2.0 mg/kg and seven at 10 mg/kg. No dose-limiting toxicities were observed during cycle 1. Eighty percent of patients experienced drug-related AEs (mostly grade 1 or 2); the most common drug-related AEs were nausea, malaise, pyrexia, and aspartate aminotransferase/alanine transaminase (AST/ALT) elevations (n = 2 each). No drug-related grade 4 or 5 AEs occurred. Immune-related AEs comprised grade 3 ALT elevation (n = 1), grade 3 AST elevation (n = 1), grade 1 pneumonitis (n = 1), and grade 1 thyroid-stimulating hormone elevation (n = 1). The safety and pharmacokinetic profiles of Japanese patients were similar to those previously reported for Caucasian patients. A partial tumor response was observed in one patient with non-small-cell lung cancer (NSCLC) and in one patient with melanoma. Conclusions Pembrolizumab at both 2 and 10 mg/kg Q2W was well tolerated in Japanese patients with advanced solid tumors and showed encouraging anti-tumor activity against melanoma and NSCLC.
         datePublished:2016-03-22T00:00:00Z
         dateModified:2016-03-22T00:00:00Z
         pageStart:347
         pageEnd:354
         sameAs:https://doi.org/10.1007/s10637-016-0347-6
         keywords:
            Pembrolizumab
            Anti-PD-1 therapy
            Pharmacokinetics
            Phase I study
            PD-L1
            Oncology
            Pharmacology/Toxicology
         image:
            https://media.springernature.com/lw1200/springer-static/image/art%3A10.1007%2Fs10637-016-0347-6/MediaObjects/10637_2016_347_Fig1_HTML.gif
            https://media.springernature.com/lw1200/springer-static/image/art%3A10.1007%2Fs10637-016-0347-6/MediaObjects/10637_2016_347_Fig2_HTML.gif
            https://media.springernature.com/lw1200/springer-static/image/art%3A10.1007%2Fs10637-016-0347-6/MediaObjects/10637_2016_347_Fig3_HTML.gif
         isPartOf:
            name:Investigational New Drugs
            issn:
               1573-0646
               0167-6997
            volumeNumber:34
            type:
               Periodical
               PublicationVolume
         publisher:
            name:Springer US
            logo:
               url:https://www.springernature.com/app-sn/public/images/logo-springernature.png
               type:ImageObject
            type:Organization
         author:
               name:Toshio Shimizu
               affiliation:
                     name:Kindai University Faculty of Medicine
                     address:
                        name:Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka-sayama, Japan
                        type:PostalAddress
                     type:Organization
               email:[email protected]
               type:Person
               name:Takashi Seto
               affiliation:
                     name:National Kyushu Cancer Center
                     address:
                        name:Department of Thoracic Oncology, National Kyushu Cancer Center, Fukuoka, Japan
                        type:PostalAddress
                     type:Organization
               type:Person
               name:Fumihiko Hirai
               affiliation:
                     name:National Kyushu Cancer Center
                     address:
                        name:Department of Thoracic Oncology, National Kyushu Cancer Center, Fukuoka, Japan
                        type:PostalAddress
                     type:Organization
               type:Person
               name:Mitsuhiro Takenoyama
               affiliation:
                     name:National Kyushu Cancer Center
                     address:
                        name:Department of Thoracic Oncology, National Kyushu Cancer Center, Fukuoka, Japan
                        type:PostalAddress
                     type:Organization
               type:Person
               name:Kaname Nosaki
               affiliation:
                     name:National Kyushu Cancer Center
                     address:
                        name:Department of Thoracic Oncology, National Kyushu Cancer Center, Fukuoka, Japan
                        type:PostalAddress
                     type:Organization
               type:Person
               name:Junji Tsurutani
               affiliation:
                     name:Kindai University Faculty of Medicine
                     address:
                        name:Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka-sayama, Japan
                        type:PostalAddress
                     type:Organization
               type:Person
               name:Hiroyasu Kaneda
               affiliation:
                     name:Kindai University Faculty of Medicine
                     address:
                        name:Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka-sayama, Japan
                        type:PostalAddress
                     type:Organization
               type:Person
               name:Tsutomu Iwasa
               affiliation:
                     name:Kindai University Faculty of Medicine
                     address:
                        name:Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka-sayama, Japan
                        type:PostalAddress
                     type:Organization
               type:Person
               name:Hisato Kawakami
               affiliation:
                     name:Kindai University Faculty of Medicine
                     address:
                        name:Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka-sayama, Japan
                        type:PostalAddress
                     type:Organization
               type:Person
               name:Kazuo Noguchi
               affiliation:
                     name:MSD K.K.
                     address:
                        name:MSD K.K., Tokyo, Japan
                        type:PostalAddress
                     type:Organization
               type:Person
               name:Takashi Shimamoto
               affiliation:
                     name:MSD K.K.
                     address:
                        name:MSD K.K., Tokyo, Japan
                        type:PostalAddress
                     type:Organization
               type:Person
               name:Kazuhiko Nakagawa
               affiliation:
                     name:Kindai University Faculty of Medicine
                     address:
                        name:Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka-sayama, Japan
                        type:PostalAddress
                     type:Organization
               type:Person
         isAccessibleForFree:1
         type:ScholarlyArticle
      context:https://schema.org
ScholarlyArticle:
      headline:Phase 1 study of pembrolizumab (MK-3475; anti-PD-1 monoclonal antibody) in Japanese patients with advanced solid tumors
      description: Background This phase I study evaluated the safety and tolerability, pharmacokinetics and pharmacodynamics, immunogenicity, and antitumor activity of pembrolizumab in Japanese patients with advanced solid tumors. Methods Following an initial dose and a 28-day rest (cycle 1), pembrolizumab was administered as an intravenous infusion at escalating doses (2 or 10 mg/kg) every 2 weeks (Q2W) until disease progression or unacceptable toxicity. Adverse events (AEs) were assessed using CTCAE v4.0, and tumor response was assessed using both RECIST v1.1 and immune-related response criteria (irRC). Full pharmacokinetic sampling was performed during cycle 1. Results Three patients received pembrolizumab at 2.0 mg/kg and seven at 10 mg/kg. No dose-limiting toxicities were observed during cycle 1. Eighty percent of patients experienced drug-related AEs (mostly grade 1 or 2); the most common drug-related AEs were nausea, malaise, pyrexia, and aspartate aminotransferase/alanine transaminase (AST/ALT) elevations (n = 2 each). No drug-related grade 4 or 5 AEs occurred. Immune-related AEs comprised grade 3 ALT elevation (n = 1), grade 3 AST elevation (n = 1), grade 1 pneumonitis (n = 1), and grade 1 thyroid-stimulating hormone elevation (n = 1). The safety and pharmacokinetic profiles of Japanese patients were similar to those previously reported for Caucasian patients. A partial tumor response was observed in one patient with non-small-cell lung cancer (NSCLC) and in one patient with melanoma. Conclusions Pembrolizumab at both 2 and 10 mg/kg Q2W was well tolerated in Japanese patients with advanced solid tumors and showed encouraging anti-tumor activity against melanoma and NSCLC.
      datePublished:2016-03-22T00:00:00Z
      dateModified:2016-03-22T00:00:00Z
      pageStart:347
      pageEnd:354
      sameAs:https://doi.org/10.1007/s10637-016-0347-6
      keywords:
         Pembrolizumab
         Anti-PD-1 therapy
         Pharmacokinetics
         Phase I study
         PD-L1
         Oncology
         Pharmacology/Toxicology
      image:
         https://media.springernature.com/lw1200/springer-static/image/art%3A10.1007%2Fs10637-016-0347-6/MediaObjects/10637_2016_347_Fig1_HTML.gif
         https://media.springernature.com/lw1200/springer-static/image/art%3A10.1007%2Fs10637-016-0347-6/MediaObjects/10637_2016_347_Fig2_HTML.gif
         https://media.springernature.com/lw1200/springer-static/image/art%3A10.1007%2Fs10637-016-0347-6/MediaObjects/10637_2016_347_Fig3_HTML.gif
      isPartOf:
         name:Investigational New Drugs
         issn:
            1573-0646
            0167-6997
         volumeNumber:34
         type:
            Periodical
            PublicationVolume
      publisher:
         name:Springer US
         logo:
            url:https://www.springernature.com/app-sn/public/images/logo-springernature.png
            type:ImageObject
         type:Organization
      author:
            name:Toshio Shimizu
            affiliation:
                  name:Kindai University Faculty of Medicine
                  address:
                     name:Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka-sayama, Japan
                     type:PostalAddress
                  type:Organization
            email:[email protected]
            type:Person
            name:Takashi Seto
            affiliation:
                  name:National Kyushu Cancer Center
                  address:
                     name:Department of Thoracic Oncology, National Kyushu Cancer Center, Fukuoka, Japan
                     type:PostalAddress
                  type:Organization
            type:Person
            name:Fumihiko Hirai
            affiliation:
                  name:National Kyushu Cancer Center
                  address:
                     name:Department of Thoracic Oncology, National Kyushu Cancer Center, Fukuoka, Japan
                     type:PostalAddress
                  type:Organization
            type:Person
            name:Mitsuhiro Takenoyama
            affiliation:
                  name:National Kyushu Cancer Center
                  address:
                     name:Department of Thoracic Oncology, National Kyushu Cancer Center, Fukuoka, Japan
                     type:PostalAddress
                  type:Organization
            type:Person
            name:Kaname Nosaki
            affiliation:
                  name:National Kyushu Cancer Center
                  address:
                     name:Department of Thoracic Oncology, National Kyushu Cancer Center, Fukuoka, Japan
                     type:PostalAddress
                  type:Organization
            type:Person
            name:Junji Tsurutani
            affiliation:
                  name:Kindai University Faculty of Medicine
                  address:
                     name:Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka-sayama, Japan
                     type:PostalAddress
                  type:Organization
            type:Person
            name:Hiroyasu Kaneda
            affiliation:
                  name:Kindai University Faculty of Medicine
                  address:
                     name:Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka-sayama, Japan
                     type:PostalAddress
                  type:Organization
            type:Person
            name:Tsutomu Iwasa
            affiliation:
                  name:Kindai University Faculty of Medicine
                  address:
                     name:Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka-sayama, Japan
                     type:PostalAddress
                  type:Organization
            type:Person
            name:Hisato Kawakami
            affiliation:
                  name:Kindai University Faculty of Medicine
                  address:
                     name:Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka-sayama, Japan
                     type:PostalAddress
                  type:Organization
            type:Person
            name:Kazuo Noguchi
            affiliation:
                  name:MSD K.K.
                  address:
                     name:MSD K.K., Tokyo, Japan
                     type:PostalAddress
                  type:Organization
            type:Person
            name:Takashi Shimamoto
            affiliation:
                  name:MSD K.K.
                  address:
                     name:MSD K.K., Tokyo, Japan
                     type:PostalAddress
                  type:Organization
            type:Person
            name:Kazuhiko Nakagawa
            affiliation:
                  name:Kindai University Faculty of Medicine
                  address:
                     name:Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka-sayama, Japan
                     type:PostalAddress
                  type:Organization
            type:Person
      isAccessibleForFree:1
["Periodical","PublicationVolume"]:
      name:Investigational New Drugs
      issn:
         1573-0646
         0167-6997
      volumeNumber:34
Organization:
      name:Springer US
      logo:
         url:https://www.springernature.com/app-sn/public/images/logo-springernature.png
         type:ImageObject
      name:Kindai University Faculty of Medicine
      address:
         name:Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka-sayama, Japan
         type:PostalAddress
      name:National Kyushu Cancer Center
      address:
         name:Department of Thoracic Oncology, National Kyushu Cancer Center, Fukuoka, Japan
         type:PostalAddress
      name:National Kyushu Cancer Center
      address:
         name:Department of Thoracic Oncology, National Kyushu Cancer Center, Fukuoka, Japan
         type:PostalAddress
      name:National Kyushu Cancer Center
      address:
         name:Department of Thoracic Oncology, National Kyushu Cancer Center, Fukuoka, Japan
         type:PostalAddress
      name:National Kyushu Cancer Center
      address:
         name:Department of Thoracic Oncology, National Kyushu Cancer Center, Fukuoka, Japan
         type:PostalAddress
      name:Kindai University Faculty of Medicine
      address:
         name:Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka-sayama, Japan
         type:PostalAddress
      name:Kindai University Faculty of Medicine
      address:
         name:Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka-sayama, Japan
         type:PostalAddress
      name:Kindai University Faculty of Medicine
      address:
         name:Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka-sayama, Japan
         type:PostalAddress
      name:Kindai University Faculty of Medicine
      address:
         name:Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka-sayama, Japan
         type:PostalAddress
      name:MSD K.K.
      address:
         name:MSD K.K., Tokyo, Japan
         type:PostalAddress
      name:MSD K.K.
      address:
         name:MSD K.K., Tokyo, Japan
         type:PostalAddress
      name:Kindai University Faculty of Medicine
      address:
         name:Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka-sayama, Japan
         type:PostalAddress
ImageObject:
      url:https://www.springernature.com/app-sn/public/images/logo-springernature.png
Person:
      name:Toshio Shimizu
      affiliation:
            name:Kindai University Faculty of Medicine
            address:
               name:Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka-sayama, Japan
               type:PostalAddress
            type:Organization
      email:[email protected]
      name:Takashi Seto
      affiliation:
            name:National Kyushu Cancer Center
            address:
               name:Department of Thoracic Oncology, National Kyushu Cancer Center, Fukuoka, Japan
               type:PostalAddress
            type:Organization
      name:Fumihiko Hirai
      affiliation:
            name:National Kyushu Cancer Center
            address:
               name:Department of Thoracic Oncology, National Kyushu Cancer Center, Fukuoka, Japan
               type:PostalAddress
            type:Organization
      name:Mitsuhiro Takenoyama
      affiliation:
            name:National Kyushu Cancer Center
            address:
               name:Department of Thoracic Oncology, National Kyushu Cancer Center, Fukuoka, Japan
               type:PostalAddress
            type:Organization
      name:Kaname Nosaki
      affiliation:
            name:National Kyushu Cancer Center
            address:
               name:Department of Thoracic Oncology, National Kyushu Cancer Center, Fukuoka, Japan
               type:PostalAddress
            type:Organization
      name:Junji Tsurutani
      affiliation:
            name:Kindai University Faculty of Medicine
            address:
               name:Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka-sayama, Japan
               type:PostalAddress
            type:Organization
      name:Hiroyasu Kaneda
      affiliation:
            name:Kindai University Faculty of Medicine
            address:
               name:Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka-sayama, Japan
               type:PostalAddress
            type:Organization
      name:Tsutomu Iwasa
      affiliation:
            name:Kindai University Faculty of Medicine
            address:
               name:Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka-sayama, Japan
               type:PostalAddress
            type:Organization
      name:Hisato Kawakami
      affiliation:
            name:Kindai University Faculty of Medicine
            address:
               name:Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka-sayama, Japan
               type:PostalAddress
            type:Organization
      name:Kazuo Noguchi
      affiliation:
            name:MSD K.K.
            address:
               name:MSD K.K., Tokyo, Japan
               type:PostalAddress
            type:Organization
      name:Takashi Shimamoto
      affiliation:
            name:MSD K.K.
            address:
               name:MSD K.K., Tokyo, Japan
               type:PostalAddress
            type:Organization
      name:Kazuhiko Nakagawa
      affiliation:
            name:Kindai University Faculty of Medicine
            address:
               name:Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka-sayama, Japan
               type:PostalAddress
            type:Organization
PostalAddress:
      name:Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka-sayama, Japan
      name:Department of Thoracic Oncology, National Kyushu Cancer Center, Fukuoka, Japan
      name:Department of Thoracic Oncology, National Kyushu Cancer Center, Fukuoka, Japan
      name:Department of Thoracic Oncology, National Kyushu Cancer Center, Fukuoka, Japan
      name:Department of Thoracic Oncology, National Kyushu Cancer Center, Fukuoka, Japan
      name:Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka-sayama, Japan
      name:Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka-sayama, Japan
      name:Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka-sayama, Japan
      name:Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka-sayama, Japan
      name:MSD K.K., Tokyo, Japan
      name:MSD K.K., Tokyo, Japan
      name:Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka-sayama, Japan

External Links {🔗}(136)

Analytics and Tracking {📊}

Google Tag Manager

Libraries {📚}

Clipboard.js
Prism.js

CDN Services {📦}

Crossref

4.43s.

LINK . SPRINGER . COM {}