Participants must not have melanoma or NSCLC. FluMist®) are live attenuated vaccines and are not allowed. J Clin Oncol. J Clin Oncol. Participants with unknown or missing response information will be treated as non-responders. 2019 Feb;152(2):243-250. doi: 10.1016/j.ygyno.2018.11.017. 2018 Aug 1;29(8):1807-1813. doi: 10.1093/annonc/mdy232. Ott PA, Bang YJ, Berton-Rigaud D, Elez E, Pishvaian MJ, Rugo HS, Puzanov I, Mehnert JM, Aung KL, Lopez J, Carrigan M, Saraf S, Chen M, Soria JC. Keynote to PowerPoint Converter. Pembrolizumab prolongs overall survival and has a favourable benefit-to-risk profile in patients with previously treated, PD-L1-positive, advanced non-small-cell lung cancer. Apple Newsroom is the source for news about Apple. Hansen AR, Massard C, Ott PA, Haas NB, Lopez JS, Ejadi S, Wallmark JM, Keam B, Delord JP, Aggarwal R, Gould M, Yang P, Keefe SM, Piha-Paul SA. Epub 2017 Mar 11. J Clin Oncol. Epub 2017 May 10. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02054806. Individual Participant Data (IPD) Sharing Statement: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf, http://engagezone.msd.com/ds_documentation.php, Best Overall Response Using Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) [ Time Frame: Up to 24 months ], Progression Free Survival (PFS) [ Time Frame: Up to 24 months ], Overall Survival (OS) [ Time Frame: Up to 24 months ], Duration of Response (DOR) in Participants Who Achieve Partial Response (PR) or Better [ Time Frame: Up to 24 months ], Histologically or cytologically documented locally-advanced and/or metastatic solid malignancy that is incurable, and has failed prior standard therapy or for which standard therapy is not appropriate, Have measurable disease based on Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1), Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1, Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication, Male participants of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study medication through 120 days after the last dose of study medication, Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment, Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment, Prior anti-cancer therapy with a monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or not recovered from adverse events due to mAbs administered more than 4 weeks earlier, Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks (12 weeks for measurable sites of central nervous system [CNS] disease) prior to study Day 1 or not recovered from adverse events due to a previously administered agent, Known additional malignancy that is progressing or requires active treatment excepting basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cervical cancer, Known active CNS metastases and/or carcinomatous meningitis, Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e. KEYNOTE-426 is an ongoing, phase 3, randomised, open-label trial in treatment-naive advanced renal cell carcinoma, being done in 129 sites (hospitals and cancer centres) in 16 countries (appendix pp 2–6). BigSpeak Speakers Bureau works with top virtual keynote speakers such as Marc Randolph, Molly Bloom, Magic Johnson, Matthew Luhn, James Clear, and other top business keynote speakers. Any advanced solid tumor that has failed at least one line of therapy and is TMB-H (≥10 mut/Mb, F1CDx assay), excluding dMMR/MSI-H tumors. Pembrolizumab for the treatment of programmed death-ligand 1-positive advanced carcinoid or pancreatic neuroendocrine tumors: Results from the KEYNOTE-028 study. Keywords provided by Merck Sharp & Dohme Corp.: Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number): Why Should I Register and Submit Results? Gynecol Oncol. A Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. You have reached the maximum number of saved studies (100). PLoS One. Talk with your doctor and family members or friends about deciding to join a study. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. These data establish pembrolizumab as a new treatment option for this population and validate the use of PD-L1 selection. Genetic and Rare Diseases Information Center, Merck Oncology Clinical Trials Information. Frenel JS, Le Tourneau C, O'Neil B, Ott PA, Piha-Paul SA, Gomez-Roca C, van Brummelen EMJ, Rugo HS, Thomas S, Saraf S, Rangwala R, Varga A. Lancet Oncol. Choosing to participate in a study is an important personal decision. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) Read press releases, get updates, watch video and download images. Marabelle A, Fakih M, Lopez J, Shah M, Shapira-Frommer R, Nakagawa K, Chung HC, Kindler HL, Lopez-Martin JA, Miller WH Jr, Italiano A, Kao S, Piha-Paul SA, Delord JP, McWilliams RR, Fabrizio DA, Aurora-Garg D, Xu L, Jin F, Norwood K, Bang YJ. • Virtual Keynote Address • Up to 21 hours CPE credit ... (Advanced) $1,950 $ Up to 10 firm attendees (Premium) $3,050 $ Less Early Bird Discount per package (3/31/21) -$100 per package. [Epub ahead of print]. 2020 Jul 1;126(13):3021-3030. doi: 10.1002/cncr.32883. Epub 2018 Dec 3. The trial protocol is available in the appendix. Thanks to our advanced conversion technology the quality of the output PowerPoint document will be exactly the same as if it was saved through the latest iWork suite from Apple. Ann Oncol. OS was defined as the time from randomization to death due to any cause. 2017 Dec 20;35(36):4035-4041. doi: 10.1200/JCO.2017.74.5471. Association of tumour mutational burden with outcomes in patients with advanced solid tumours treated with pembrolizumab: prospective biomarker analysis of the multicohort, open-label, phase 2 KEYNOTE-158 study. $ Virtual Registration Fee: In-Person Conference Registration Fee: ClinicalTrials.gov Identifier: NCT02628067, Interventional Keywords provided by Merck Sharp & Dohme Corp.: Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number): Why Should I Register and Submit Results? Please remove one or more studies before adding more. Reardon DA, Kim TM, Frenel JS, Simonelli M, Lopez J, Subramaniam DS, Siu LL, Wang H, Krishnan S, Stein K, Massard C. Treatment with pembrolizumab in programmed death ligand 1-positive recurrent glioblastoma: Results from the multicohort phase 1 KEYNOTE-028 trial. BigSpeak is your one-stop source for diversity speakers, leadership keynote speakers, teamwork motivational speakers, and all of the best inspirational speakers. Lancet Oncol. 2017 Aug 1;35(22):2535-2541. doi: 10.1200/JCO.2017.72.5952. 2020 May 1;26(9):2124-2130. doi: 10.1158/1078-0432.CCR-19-3014. 2020 Oct;21(10):1353-1365. doi: 10.1016/S1470-2045(20)30445-9. Safety and antitumor activity of the anti-PD-1 antibody pembrolizumab in patients with recurrent carcinoma of the anal canal. 2018 Jun 15;24(12):2804-2811. doi: 10.1158/1078-0432.CCR-17-3452. Epub 2017 Aug 24. Listing a study does not mean it has been evaluated by the U.S. Federal Government. I didn't simply ask these questions over and Epub 2020 Apr 22. Doi T, Piha-Paul SA, Jalal SI, Saraf S, Lunceford J, Koshiji M, Bennouna J. Has had an allogenic tissue/solid organ transplant. (CRC participants will have a histologically proven locally advanced unresectable or metastatic CRC which is dMMR/MSI-H that has received 2 prior lines of therapy.) OS is presented. Association of tumour mutational burden with outcomes in patients with advanced solid tumours treated with pembrolizumab: prospective biomarker analysis of the multicohort, open-label, phase 2 KEYNOTE-158 study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. doi: 10.1371/journal.pone.0189848. Information provided by (Responsible Party): Participants receive pembrolizumab 10 mg/kg, intravenously (IV), on Day 1 of every 2-week dosing cycle for up to 24 months. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02628067. Featuring remarkable people communicating passionately and persuasively, TED Talks provide the ELT classroom with inspiring ideas and an unparalleled source of authentic language input. Pembrolizumab for the treatment of programmed death-ligand 1-positive advanced carcinoid or pancreatic neuroendocrine tumors: Results from the KEYNOTE-028 study. Mehnert JM, Varga A, Brose MS, Aggarwal RR, Lin CC, Prawira A, de Braud F, Tamura K, Doi T, Piha-Paul SA, Gilbert J, Saraf S, Thanigaimani P, Cheng JD, Keam B. 2019 Jun 10;37(17):1470-1478. doi: 10.1200/JCO.18.01265. ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ at any time during the trial. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Participants with any advanced solid tumor that has failed at least one line of therapy and is Tumor- Mutational Burden-High (TMB-H), excluding participants with mismatch repair deficient (dMMR/MSI-H) tumors. Epub 2020 Sep 10. 2019 Feb 1;37(4):318-327. doi: 10.1200/JCO.2018.78.2276. 2020 Oct;21(10):1353-1365. doi: 10.1016/S1470-2045(20)30445-9. a sample unit from the Student's Book and the accompanying audio tracks; a sample unit from the Workbook and the accompanying audio tracks Has received a live vaccine within 30 days of planned start of study medication. Lancet Oncol. Cohen RB, Delord JP, Doi T, Piha-Paul SA, Liu SV, Gilbert J, Algazi AP, Damian S, Hong RL, Le Tourneau C, Day D, Varga A, Elez E, Wallmark J, Saraf S, Thanigaimani P, Cheng J, Keam B. Pembrolizumab for the Treatment of Advanced Salivary Gland Carcinoma: Findings of the Phase 1b KEYNOTE-028 Study. Pembrolizumab in Patients With Extensive-Stage Small-Cell Lung Cancer: Results From the Phase Ib KEYNOTE-028 Study. Responses will be determined by independent central radiologic review, with confirmatory assessment as required per RECIST 1.1.  (Clinical Trial), Phase IB Study of Pembrolizumab (MK-3475) in Subjects With Select Advanced Solid Tumors, 18 Years and older   (Adult, Older Adult). 2018 Jan 1;36(1):61-67. doi: 10.1200/JCO.2017.74.9846. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Cancer. 2017 Dec 20;35(36):4050-4056. doi: 10.1200/JCO.2017.73.3675. Pembrolizumab for advanced prostate adenocarcinoma: findings of the KEYNOTE-028 study. Study record managers: refer to the Data Element Definitions if submitting registration or results information. DOR, defined in the subset of participants with a CR or PR, based on RECIST 1.1 as assessed by independent central radiologic review, as the time from first documented evidence of CR or PR until the first documented sign of disease progression or death due to any cause, whichever occurs first. PATIENTS AND METHODS In this open-label, phase III study, we randomly assigned (1:1) 628 patients with advanced/metastatic squamous cell carcinoma or adenocarcinoma of the esophagus, that progressed after one prior therapy, to pembrolizumab 200 mg … Marabelle A, Le DT, Ascierto PA, Di Giacomo AM, De Jesus-Acosta A, Delord JP, Geva R, Gottfried M, Penel N, Hansen AR, Piha-Paul SA, Doi T, Gao B, Chung HC, Lopez-Martin J, Bang YJ, Frommer RS, Shah M, Ghori R, Joe AK, Pruitt SK, Diaz LA Jr. Efficacy of Pembrolizumab in Patients With Noncolorectal High Microsatellite Instability/Mismatch Repair-Deficient Cancer: Results From the Phase II KEYNOTE-158 Study. Epub 2017 Nov 2. Alley EW, Lopez J, Santoro A, Morosky A, Saraf S, Piperdi B, van Brummelen E. Clinical safety and activity of pembrolizumab in patients with malignant pleural mesothelioma (KEYNOTE-028): preliminary results from a non-randomised, open-label, phase 1b trial. Safety and Antitumor Activity of Pembrolizumab in Advanced Programmed Death Ligand 1-Positive Endometrial Cancer: Results From the KEYNOTE-028 Study. Read our, ClinicalTrials.gov Identifier: NCT02054806, Interventional Epub 2019 Apr 3. Convert .KEY to .PPT or .PPTX files online using CloudConvert! Choosing to participate in a study is an important personal decision. J Clin Oncol. Mehnert JM, Bergsland E, O'Neil BH, Santoro A, Schellens JHM, Cohen RB, Doi T, Ott PA, Pishvaian MJ, Puzanov I, Aung KL, Hsu C, Le Tourneau C, Hollebecque A, Élez E, Tamura K, Gould M, Yang P, Stein K, Piha-Paul SA. CloudConvert is an online document and presentation converter. There is no limit to the number of prior treatment regimens, Can supply tumor tissue for study analyses (dependent on tumor type), Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale within 3 days prior to first dose of pembrolizumab, Female participants of childbearing potential must be willing to use adequate contraception for the course of the study through 120 days after the last dose of study treatment, Male participants with partners of must childbearing potential must be willing to use adequate contraception for the course of the study through 120 days after the last dose of study treatment, Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of study treatment, Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment, Active autoimmune disease that has required systemic treatment in the past 2 years, Prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or not recovered from an adverse event caused by mAbs administered more than 4 weeks earlier, Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks of study Day 1 or not recovered from adverse events caused by a previously administered agent, Known additional malignancy within 2 years prior to enrollment with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or curatively resected in situ cancers, Known active central nervous system (CNS) metastases and/or carcinomatous meningitis, Has known glioblastoma multiforme of the brain stem, History of non-infectious pneumonitis that required steroids or current pneumonitis, Active infection requiring systemic therapy, Known psychiatric or substance abuse disorders that would interfere with the participant's ability to cooperate with the requirements of the study, Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment, Previously participated in any other pembrolizumab (MK-3475) study, or received prior therapy with an anti-programmed cell death (PD)-1, anti-PD-Ligand 1 (anti-PD-L1), anti-PD-Ligand 2 (anti-PD-L2), or any other immunomodulating mAb or drug specifically targeting T-cell co-stimulation or checkpoint pathways, Known history of Human Immunodeficiency Virus (HIV), Received live vaccine within 30 days of planned start of study treatment, Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients, Known history of active tuberculosis (TB, Bacillus tuberculosis). J Clin Oncol. eCollection 2017. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Individual Participant Data (IPD) Sharing Statement: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf, http://engagezone.msd.com/ds_documentation.php. Thanks to our advanced conversion technology the quality of the output will be exactly the same as if the file was saved through the latest Microsoft Office 2019 suite. Keynote Speakers, Business Speakers and Motivational Speakers – use search filters below to find the best keynote speakers and create personalized MyCatalogs. BMC Cancer. If a participant does not have a documented date of progression or death, PFS will be censored at the date of the last adequate assessment.  (Clinical Trial), A Clinical Trial of Pembrolizumab (MK-3475) Evaluating Predictive Biomarkers in Subjects With Advanced Solid Tumors (KEYNOTE 158), 18 Years and older   (Adult, Older Adult), Call for Information (Investigational Site 0018), Call for Information (Investigational Site 0202), Los Angeles, California, United States, 90033, Call for Information (Investigational Site 0017), Los Angeles, California, United States, 90048, Call for Information (Investigational Site 0015), Call for Information (Investigational Site 0011), Baltimore, Maryland, United States, 21231, Call for Information (Investigational Site 0005), Rockville, Maryland, United States, 20850, Call for Information (Investigational Site 0207), Boston, Massachusetts, United States, 02114, Call for Information (Investigational Site 0010), Boston, Massachusetts, United States, 02215, Call for Information (Investigational Site 0209), Call for Information (Investigational Site 0008), New Brunswick, New Jersey, United States, 08903, Call for Information (Investigational Site 0004), Contact: Australian Medical Information Centre    61 2 8988 8428, Contact: Medical Information Centre Centre d'information medicale Merck Canada Inc.    514-428-8600 / 1-800-567-2594, Contact: Francesca Carvajal    57 1219109011090, Contact: German Medical Information Center    49 800 673 673 673, Contact: Barbara Capaccetti    39 06361911, Contact: Japan Call Center    81-3-6272-1957, Contact: Jongho Ahn    82-2-331-2000 2015, Contact: Caroline Doornebos    31 23 515 3362, Contact: Tony Johansson    47 32 20 75 20, Contact: Tatiana Serebriakova    74959167100, EXT.366, Contact: Lourdes Lopez-Bravo    (0034) 913210654. Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Objective Response Rate (ORR) [ Time Frame: Up to approximately 2 years ], Duration of Response (DOR) [ Time Frame: Up to approximately 2 years ], Progression Free Survival (PFS) [ Time Frame: Up to approximately 2 years ], Overall Survival (OS) [ Time Frame: Up to approximately 2 years ], Biliary Adenocarcinoma (gallbladder or biliary tree (intrahepatic or extrahepatic cholangiocarcinoma) except Ampulla of Vater cancers), Neuroendocrine Tumors (well- and moderately-differentiated) of the lung, appendix, small intestine, colon, rectum, or pancreas, Endometrial Carcinoma (sarcomas and mesenchymal tumors are excluded), Salivary Gland Carcinoma (sarcomas and mesenchymal tumors are excluded), Any advanced solid tumor, with the exception of colorectal carcinoma (CRC), which is Microsatellite Instability (MSI)-High (MSI-H) OR, Any advanced solid tumor (including Colorectal Carcinoma [CRC]) which is Mismatch Repair Deficient (dMMR)/MSI-H in participants from mainland China who are of Chinese descent. The percentage of participants who experience a CR or PR based on modified RECIST 1.1 will be presented. J Clin Oncol. Ott PA, Bang YJ, Piha-Paul SA, Razak ARA, Bennouna J, Soria JC, Rugo HS, Cohen RB, O'Neil BH, Mehnert JM, Lopez J, Doi T, van Brummelen EMJ, Cristescu R, Yang P, Emancipator K, Stein K, Ayers M, Joe AK, Lunceford JK. Cancer. U.S. Department of Health and Human Services. Epub 2017 Nov 8. U.S. Department of Health and Human Services, The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Clin Cancer Res. Keynote For Windows free download - Apple Keynote, Windows Media Player, Viber for Windows, and many more programs Ann Oncol. 2020 Jan 1;38(1):1-10. doi: 10.1200/JCO.19.02105. Information provided by (Responsible Party): In this study, participants with multiple types of advanced (unresectable and/or metastatic) solid tumors who have progressed on standard of care therapy will be treated with pembrolizumab (MK-3475). Epub 2018 Mar 20. 2017 Dec 28;12(12):e0189848. The first version was made available to the public in 2003 as Keynote 1.0 and was designed to compete with Microsoft's Powerpoint presentation software which formed part of Microsoft Office. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Clin Cancer Res. 2020 Jul 1;126(13):3021-3030. doi: 10.1002/cncr.32883. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Updated Analysis of KEYNOTE-024: Pembrolizumab Versus Platinum-Based Chemotherapy for Advanced Non–Small-Cell Lung Cancer With PD-L1 Tumor Proportion Score ... advanced NSCLC without EGFR/ALK aber-rations, despite crossover from … The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Participants who are alive, have not progressed, have not initiated new anti-cancer treatment, and have not been determined to be lost to follow-up are considered ongoing responders at the time of analysis. Epub 2019 Nov 4. Ott PA, Piha-Paul SA, Munster P, Pishvaian MJ, van Brummelen EMJ, Cohen RB, Gomez-Roca C, Ejadi S, Stein M, Chan E, Simonelli M, Morosky A, Saraf S, Emancipator K, Koshiji M, Bennouna J. Keynote is a multi-syllabus ELT course for working adults and students that uses inspirational TED Talks to teach English.