Safety and clinical activity of pembrolizumab for treatment of recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-012): an open-label, multicentre, phase 1b trial

scientific article published on 27 May 2016

Safety and clinical activity of pembrolizumab for treatment of recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-012): an open-label, multicentre, phase 1b trial is …
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scholarly articleQ13442814

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P356DOI10.1016/S1470-2045(16)30066-3
P698PubMed publication ID27247226

P50authorTanguy Y SeiwertQ89776148
P2093author name stringJonathan D Cheng
Jared Weiss
Raanan Berger
Terrill McClanahan
Karl Heath
Barbara Burtness
Ranee Mehra
Christine Gause
Laura Q Chow
Jared Lunceford
Joseph Paul Eder
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Open-Label, Uncontrolled, Multicenter Phase II Study to Evaluate the Efficacy and Toxicity of Cetuximab As a Single Agent in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck Who Failed to Respond to Platinum-BaseQ57949385
P433issue7
P407language of work or nameEnglishQ1860
P921main subjectmulticenter clinical trialQ6934595
pembrolizumabQ13896859
head and neck squamous cell carcinomaQ18348812
metastatic squamous cell carcinomaQ18975728
P304page(s)956-965
P577publication date2016-05-27
P1433published inLancet Oncology CommissionQ13747613
P1476titleSafety and clinical activity of pembrolizumab for treatment of recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-012): an open-label, multicentre, phase 1b trial
P478volume17

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Q41994346PD-1 expression in head and neck squamous cell carcinomas derives primarily from functionally anergic CD4+ TILs in the presence of PD-L1+ TAMs
Q48017207PD-1 inhibitor-associated lichenoid inflammation with incidental suprabasilar acantholysis or vesiculation-Report of 4 cases
Q60960096PD-1/PD-L1 Axis, Rather Than High-Mobility Group Alarmins or CD8+ Tumor-Infiltrating Lymphocytes, Is Associated With Survival in Head and Neck Squamous Cell Carcinoma Patients Who Received Surgical Resection
Q55321107PD-1/PD-L1 pathway blockade works as an effective and practical therapy for cancer immunotherapy.
Q47105638PD-L1 expression and CD8+ tumor-infiltrating lymphocytes are associated with ALK rearrangement and clinicopathological features in inflammatory myofibroblastic tumors
Q52723008PD-L1 expression and presence of TILs in small intestinal neuroendocrine tumours.
Q64882611PD-L1-specific helper T-cells exhibit effective antitumor responses: new strategy of cancer immunotherapy targeting PD-L1 in head and neck squamous cell carcinoma.
Q41592956PD-L1: a novel prognostic biomarker in head and neck squamous cell carcinoma
Q58561615PD-Loma: a cancer entity with a shared sensitivity to the PD-1/PD-L1 pathway blockade
Q39146986PD1/PD-L1 inhibition as a potential radiosensitizer in head and neck squamous cell carcinoma: a case report
Q57472982Pan-tumor genomic biomarkers for PD-1 checkpoint blockade-based immunotherapy
Q38861925Patterns of Care in Adjuvant Therapy for Resected Oral Cavity Squamous Cell Cancer in Elderly Patients
Q90682159Pembrolizumab Induced Ocular Hypotony With Near Complete Vision Loss, Interstitial Pulmonary Fibrosis and Arthritis
Q54518660Pembrolizumab KEYNOTE-001: an adaptive study leading to accelerated approval for two indications and a companion diagnostic.
Q39193035Pembrolizumab for Platinum- and Cetuximab-Refractory Head and Neck Cancer: Results From a Single-Arm, Phase II Study.
Q64073848Pembrolizumab for recurrent/metastatic head and neck cancer: equally promising for Asian patients?
Q47641532Pembrolizumab for recurrent/metastatic head and neck squamous cell carcinoma in an Asian population.
Q49925686Pembrolizumab for the Treatment of Advanced Salivary Gland Carcinoma: Findings of the Phase 1b KEYNOTE-028 Study
Q49036770Pembrolizumab for the treatment of bladder cancer
Q55253213Pembrolizumab in Asia-Pacific patients with advanced head and neck squamous cell carcinoma: Analyses from KEYNOTE-012.
Q33757149Pembrolizumab in cervical cancer: latest evidence and clinical usefulness
Q52881938Pembrolizumab in recurrent advanced cervical squamous carcinoma.
Q47345366Pembrolizumab in the treatment of advanced urothelial cancer
Q90224620Pembrolizumab versus methotrexate, docetaxel, or cetuximab for recurrent or metastatic head-and-neck squamous cell carcinoma (KEYNOTE-040): a randomised, open-label, phase 3 study
Q39632681Pembrolizumab: first experience with recurrent primary central nervous system (CNS) tumors
Q42375254Perspectives in immunotherapy: meeting report from the "Immunotherapy Bridge", Napoli, November 30th 2016.
Q64118745Perspectives of Induction With Chemo and/or Immune Check Point Inhibition in Head and Neck Organ Preservation Treatment
Q60908672Phase I/II trial of Durvalumab plus Tremelimumab and stereotactic body radiotherapy for metastatic head and neck carcinoma
Q92801272Phase IB/II Trial of Lenvatinib Plus Pembrolizumab in Patients With Advanced Renal Cell Carcinoma, Endometrial Cancer, and Other Selected Advanced Solid Tumors
Q55000623Plasma-derived Exosomes Reverse Epithelial-to-Mesenchymal Transition after Photodynamic Therapy of Patients with Head and Neck Cancer.
Q92060396Potential of Pembrolizumab in Metastatic or Recurrent Head and Neck Cancer: Evidence to Date
Q55012383Precision Medicine in Head and Neck Cancer: Myth or Reality?
Q52591781Precision Therapy of Head and Neck Squamous Cell Carcinoma.
Q97884890Preclinical models of head and neck squamous cell carcinoma for a basic understanding of cancer biology and its translation into efficient therapies
Q58579220Predicting 90-Day Mortality in Locoregionally Advanced Head and Neck Squamous Cell Carcinoma after Curative Surgery
Q95591987Preface: More than two decades of modern tumor immunology
Q89450684Preface: More than two decades of modern tumor immunology
Q91284516Preface: More than two decades of modern tumor immunology
Q41041538Pretreatment antigen-specific immunity and regulation - association with subsequent immune response to anti-tumor DNA vaccination
Q96612904Prevalence of PD-L1 expression in head and neck squamous precancerous lesions: a systematic review and meta-analysis
Q41633683Profile of pembrolizumab in the treatment of head and neck squamous cell carcinoma: design development and place in therapy
Q92696861Prognostic and clinicopathological value of PD-L1 in colorectal cancer: a systematic review and meta-analysis
Q33884484Prognostic score in patients with recurrent or metastatic carcinoma of the head and neck treated with cetuximab and chemotherapy
Q33788235Prognostic value of programmed cell death ligand 1 expression in patients with head and neck cancer: A systematic review and meta-analysis
Q47122217Programmed cell death ligand 1 as a biomarker in head and neck cancer
Q55311366Programmed cell death-1 and programmed cell death ligand-1 antibodies-induced dysthyroidism.
Q59805349Progresses and Perspectives of Anti-PD-1/PD-L1 Antibody Therapy in Head and Neck Cancers
Q49180652Protein methyltransferases and demethylases dictate CD8+ T-cell exclusion in squamous cell carcinoma of the head and neck
Q41339254Pseudoprogression in microsatellite instability-high colorectal cancer during treatment with combination T cell mediated immunotherapy: a case report and literature review
Q54723806Putting T cells to work-outsourcing neoantigen detection in head and neck cancers?
Q56892940RANKL blockade improves efficacy of PD1-PD-L1 blockade or dual PD1-PD-L1 and CTLA4 blockade in mouse models of cancer
Q55491553Radiation therapy and PD-1/PD-L1 blockade: the clinical development of an evolving anticancer combination.
Q92306377Radioimmunotherapy for the treatment of head and neck cancer
Q59606033Radiotherapy plus EGFR inhibitors: synergistic modalities.
Q52602002Radiotherapy-induced anti-tumor immune response and immune-related adverse events in a case of recurrent nasopharyngeal carcinoma undergoing anti-PD-1 immunotherapy.
Q91729359Randomized phase III KEYNOTE-045 trial of pembrolizumab versus paclitaxel, docetaxel, or vinflunine in recurrent advanced urothelial cancer: results of >2 years of follow-up
Q49797507Rational Design for Cervical Cancer Therapeutics: Cellular and Non-Cellular Based Strategies on the Horizon for Recurrent, Metastatic or Refractory Cervical Cancer.
Q90440765Rational combination with PDK1 inhibition overcomes cetuximab resistance in head and neck squamous cell carcinoma
Q64091122Real-world systemic therapy treatment patterns for squamous cell carcinoma of the head and neck in Canada
Q39107022Redirecting the focus of cancer immunotherapy to premalignant conditions
Q52725238Regulation and Function of the PD-L1 Checkpoint.
Q88442150Reirradiation of head and neck cancer using modern highly conformal techniques
Q41348852Resistance to CTLA-4 checkpoint inhibition reversed through selective elimination of granulocytic myeloid cells
Q47876963Response of advanced stage recurrent lymphoepithelioma-like carcinoma to nivolumab.
Q64235743Results of the extended analysis for cancer treatment (EXACT) trial: a prospective translational study evaluating individualized treatment regimens in oncology
Q92358620Risk of immune-related diarrhea with PD-1/PD-L1 inhibitors in different cancer types and treatment regimens
Q92538625Role of Tumor-Mediated Dendritic Cell Tolerization in Immune Evasion
Q58573986Routine surveillance scanning in HNSCC: Lung screening CT scans have value but head and neck scans do not
Q49902128STINGel: Controlled release of a cyclic dinucleotide for enhanced cancer immunotherapy.
Q58082830Safety and Efficacy of Durvalumab With or Without Tremelimumab in Patients With PD-L1-Low/Negative Recurrent or Metastatic HNSCC: The Phase 2 CONDOR Randomized Clinical Trial
Q53837214Safety and Efficacy of Pembrolizumab Monotherapy in Patients With Previously Treated Advanced Gastric and Gastroesophageal Junction Cancer: Phase 2 Clinical KEYNOTE-059 Trial.
Q39084242Safety and activity of pembrolizumab in patients with locally advanced or metastatic urothelial cancer (KEYNOTE-012): a non-randomised, open-label, phase 1b study
Q64066298Safety and antitumor activity of the anti-PD-1 antibody pembrolizumab in patients with advanced, PD-L1-positive papillary or follicular thyroid cancer
Q47164715Safety of checkpoint inhibitors for cancer treatment: strategies for patient monitoring and management of immune-mediated adverse events
Q38809582Safety of drug treatments for head and neck cancer
Q88654117Safety, anti-tumour activity, and pharmacokinetics of fixed-dose SHR-1210, an anti-PD-1 antibody in advanced solid tumours: a dose-escalation, phase 1 study
Q90304312Second infield re-irradiation with a resulting cumulative equivalent dose (EQD2max ) of >180 Gy for patients with recurrent head and neck cancer
Q52655048Semaphorin 4D in human head and neck cancer tissue and peripheral blood: A dense fibrotic peri-tumoral stromal phenotype.
Q91015143Sequential therapy of neoadjuvant biochemotherapy with cetuximab, paclitaxel, and cisplatin followed by cetuximab-based concurrent bioradiotherapy in high-risk locally advanced oral squamous cell carcinoma: Final analysis of a phase 2 clinical trial
Q92632643Serious immune-related adverse events in patients with head and neck cancer after checkpoint blockade: Systematic review
Q52651819Severe immune mucositis and esophagitis in metastatic squamous carcinoma of the larynx associated with pembrolizumab.
Q52617485Simultaneous targeting of EGFR, HER2, and HER4 by afatinib overcomes intrinsic and acquired cetuximab resistance in head and neck squamous cell carcinoma cell lines.
Q97539835Squamous Cell Carcinoma: An Update on Diagnosis and Treatment
Q55457406Stereotactic Body Radiotherapy Treatment for Recurrent, Previously Irradiated Head and Neck Cancer.
Q91717183Syngeneic animal models of tobacco-associated oral cancer reveal the activity of in situ anti-CTLA-4
Q38971558Systemic Treatment in HPV-Induced Recurrent or Metastatic HNSCC.
Q38744053Systemic therapy for head and neck squamous cell carcinoma: Historical perspectives and recent breakthroughs
Q52596337T Cell Dysfunction in Cancer.
Q47132997T cell-targeting nanoparticles focus delivery of immunotherapy to improve antitumor immunity
Q55644910TPF induction chemotherapy increases PD-L1 expression in tumour cells and immune cells in head and neck squamous cell carcinoma.
Q64927095Targeted Therapies and Immune-Checkpoint Inhibition in Head and Neck Squamous Cell Carcinoma: Where Do We Stand Today and Where to Go?
Q38851114Targeted Therapy in Head and Neck Cancer: An Update on Current Clinical Developments in Epidermal Growth Factor Receptor-Targeted Therapy and Immunotherapies
Q49961144Targeted therapies for targeted populations: Anti-EGFR treatment for EGFR amplified gastroesophageal adenocarcinoma
Q90620359Targeting cancer stem cells in squamous cell carcinoma
Q38819982Targeting the PD-1 pathway in pediatric solid tumors and brain tumors
Q39384440The "Achilles Heel" of Cancer and Its Implications for the Development of Novel Immunotherapeutic Strategies.
Q91021396The 100 most cited manuscripts in head and neck cancer: a bibliometric analysis
Q64084618The Double-Edged Sword-How Human Papillomaviruses Interact With Immunity in Head and Neck Cancer
Q38686682The PD-1/PD-L1 axis and human papilloma virus in patients with head and neck cancer after adjuvant chemoradiotherapy: A multicentre study of the German Cancer Consortium Radiation Oncology Group (DKTK-ROG).
Q99549310The Prognostic Significance of Immune-Related Metabolic Enzyme MTHFD2 in Head and Neck Squamous Cell Carcinoma
Q37516448The Role of the Tumor Vasculature in the Host Immune Response: Implications for Therapeutic Strategies Targeting the Tumor Microenvironment
Q91895909The Society for Immunotherapy of Cancer consensus statement on immunotherapy for the treatment of squamous cell carcinoma of the head and neck (HNSCC)
Q64986397The Synergistic Effect of Immune Checkpoint Blockade and Radiotherapy in Recurrent/Metastatic Sinonasal Cancer.
Q92691192The changing therapeutic landscape of head and neck cancer
Q92767428The effects and safety of PD-1/PD-L1 inhibitors on head and neck cancer: A systematic review and meta-analysis
Q38811007The immune microenvironment of HPV-negative oral squamous cell carcinoma from never-smokers and never-drinkers patients suggests higher clinical benefit of IDO1 and PD1/PD-L1 blockade.
Q53359622The immune molecular landscape of the B7 and TNFR immunoregulatory ligand-receptor families in head and neck cancer: A comprehensive overview and the immunotherapeutic implications.
Q52932010The latest prospects of investigational drugs for head and neck cancer.
Q52678178The molecular landscape of head and neck cancer.
Q92463703The potential mechanism, recognition and clinical significance of tumor pseudoprogression after immunotherapy
Q64052653The promise of Immuno-oncology: implications for defining the value of cancer treatment
Q89339593The promise of immunostimulatory antibodies in head and neck cancer
Q54980315The promise of immunotherapy in head and neck squamous cell carcinoma: combinatorial immunotherapy approaches.
Q59469171The rationale for including immune checkpoint inhibition into multimodal primary treatment concepts of head and neck cancer.
Q89046053The role of protein methyltransferases as potential novel therapeutic targets in squamous cell carcinoma of the head and neck
Q50921394The second wave of immune checkpoint inhibitor tsunami: advance, challenges and perspectives.
Q92128972The society for immunotherapy of cancer consensus statement on immunotherapy for the treatment of advanced renal cell carcinoma (RCC)
Q46518643Therapeutic Implications of the Genetic Landscape of Head and Neck Cancer.
Q50606627Time dependent pharmacokinetics of pembrolizumab in patients with solid tumor and its correlation with best overall response.
Q58608193Time to abandon single-site irradiation for inducing abscopal effects
Q57816910Toxicity Reduction in the Treatment of HPV Positive Oropharyngeal Cancer: Emerging Combined Modality Approaches
Q37664203Transient immunological and clinical effectiveness of treating mice bearing premalignant oral lesions with PD-1 antibodies
Q99583798Translating KEYNOTE-048 into practice recommendations for head and neck cancer
Q90300273Treatment-Related Adverse Events of PD-1 and PD-L1 Inhibitors in Clinical Trials: A Systematic Review and Meta-analysis
Q47393365Trial watch: Immune checkpoint blockers for cancer therapy
Q52681592Tumor Immunology and Immunotherapy for Head and Neck Squamous Cell Carcinoma.
Q89525448Tumor immune microenvironment in head and neck cancers
Q92199854Tumour flare reaction in cancer treatments: a comprehensive literature review
Q50545401Two immune-enhanced molecular subtypes differ in inflammation, checkpoint signaling and outcome of advanced head and neck squamous cell carcinoma.
Q95282869Update on oral and oropharyngeal cancer staging - International perspectives
Q47095527Update on squamous cell carcinoma of the head and neck: ASCO annual meeting 2017.
Q92037447Upregulation of PD-L1 and PD-L2 in neck node metastases of head and neck squamous cell carcinoma
Q39194722Utility of PD-L1 immunohistochemistry assays for predicting PD-1/PD-L1 inhibitor response
Q38661479What's new in small cell lung cancer - extensive disease? An overview on advances of systemic treatment in 2016.
Q99632545[Development of programmed death receptor-1 and programmed death receptor-1 ligand in oral squamous cell carcinoma]
Q64979501[HPV - A different view on Head and Neck Cancer].
Q51318731[Immunotherapeutic studies of head and neck tumors : Highlights of the 2016 ASCO Annual Meeting].
Q51319375[Immunotherapy for HNSCC : Quo vadis?].
Q58606996[Immunotherapy highlights of the ASCO annual meeting 2018 for head and neck cancers]
Q90322062[Oncoimmunology in old age]
Q52815753[Preclinical models in head and neck tumors : Evaluation of cellular and molecular resistance mechanisms in the tumor microenvironment].
Q64889726mTOR Signalling in Head and Neck Cancer: Heads Up.
Q90688840p16 status and choice of chemotherapy in the KEYNOTE-040 study

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