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| EXAMINATION | - LONG G V ET AL, "Assessment of nivolumab exposure and clinical safety of 480 mg every 4 weeks flat-dosing schedule in patients with cancer.", ANNALS OF ONCOLOGY : OFFICIAL JOURNAL OF THE EUROPEAN SOCIETY FOR MEDICAL ONCOLOGY 01 11 2018, (20181101), vol. 29, no. 11, ISSN 1569-8041, pages 2208 - 2213, XP055651364 | |
| INTERNATIONAL-SEARCH-REPORT | - MARZUKA ALEXANDER ET AL, "Melanoma Treatments: Advances and Mechanisms.", JOURNAL OF CELLULAR PHYSIOLOGY NOV 2015, (20150422), vol. 230, no. 11, doi:10.1002/jcp.25019, ISSN 1097-4652, pages 2626 - 2633, XP002759396 [X] 1-51 * page 2631, column l, paragraph 2 - column r, paragraph 3 * | |
| INTERNATIONAL-SEARCH-REPORT | - MAHONEY KATHLEEN M ET AL, "The Next Immune-Checkpoint Inhibitors: PD-1/PD-L1 Blockade in Melanoma.", CLINICAL THERAPEUTICS 1 APR 2015, (20150401), vol. 37, no. 4, ISSN 1879-114X, pages 764 - 782, XP055285031 [X] 1-51 * page 771, column l, paragraph 2 - page 774, column r, paragraph 1 * | |
| INTERNATIONAL-SEARCH-REPORT | - BOWYER S ET AL, "Efficacy and toxicity of treatment with the anti-CTLA-4 antibody ipilimumab in patients with metastatic melanoma after prior anti-PD-1 therapy.", BRITISH JOURNAL OF CANCER 10 MAY 2016, (20160510), vol. 114, no. 10, ISSN 1532-1827, pages 1084 - 1089, XP002759397 [T] * the whole document * | |
| INTERNATIONAL-SEARCH-REPORT | - JEDD D. WOLCHOK ET AL, "Nivolumab plus Ipilimumab in Advanced Melanoma", NEW ENGLAND JOURNAL OF MEDICINE, (20130711), vol. 369, no. 2, doi:10.1056/NEJMoa1302369, ISSN 0028-4793, pages 122 - 133, XP055182024 [X] 1-51 * page 124, column r, paragraph 2 * * page 128, column r, paragraph 4 - page 130, column r, paragraph 3 * | |
| INTERNATIONAL-SEARCH-REPORT | - G. K. PHILIPS ET AL, "Therapeutic uses of anti-PD-1 and anti-PD-L1 antibodies", INTERNATIONAL IMMUNOLOGY., GB, (20141016), vol. 27, no. 1, doi:10.1093/intimm/dxu095, ISSN 0953-8178, pages 39 - 46, XP055217958 [X] 1-51 * page 44, column r, paragraph 2 - page 45, column l, paragraph 2; table 1 * | |
| INTERNATIONAL-SEARCH-REPORT | - P. A. ASCIERTO ET AL, "Biomarkers for Immunostimulatory Monoclonal Antibodies in Combination Strategies for Melanoma and Other Tumor Types", CLINICAL CANCER RESEARCH, (20130301), vol. 19, no. 5, doi:10.1158/1078-0432.CCR-12-2982, ISSN 1078-0432, pages 1009 - 1020, XP055124339 [I] 1-51 * the whole document * | |
| INTERNATIONAL-SEARCH-REPORT | - P. A. OTT ET AL, "CTLA-4 and PD-1/PD-L1 Blockade: New Immunotherapeutic Modalities with Durable Clinical Benefit in Melanoma Patients", CLINICAL CANCER RESEARCH, (20131001), vol. 19, no. 19, doi:10.1158/1078-0432.CCR-13-0143, ISSN 1078-0432, pages 5300 - 5309, XP055200528 [X] 1-51 * page 5306, column l, paragraph 2 - column r, paragraph 1 * * page 5307, column l, paragraph 2 - column r * | |
| INTERNATIONAL-SEARCH-REPORT | - PAOLO A ASCIERTO ET AL, "The additional facet of immunoscore: immunoprofiling as a possible predictive tool for cancer treatment", JOURNAL OF TRANSLATIONAL MEDICINE, BIOMED CENTRAL, LONDON, GB, (20130303), vol. 11, no. 1, doi:10.1186/1479-5876-11-54, ISSN 1479-5876, page 54, XP021142097 [X] 1-51 * page 3/4, line 10 - line 17 * | |
| OPPOSITION | - "A Dose Escalation and Cohort Expansion Study of Anti-CD27 (Varlilumab) and Anti-PD-1 (Nivolumab) in Advanced Tumors ", History of Changes for Study: NCT02335918, (20160415), URL: https://clinicaltrials.gov/ct2/history/NCT02335918?A=1&B=17&C=merged#StudyPageTop, XP055909210 | - |
| OPPOSITION | - "A Dose Frequency Optimization,Trial of Nivolumab 240 mg Every 2 Weeks vs Nivolumab 480 mg Every 4 Weeks in Advanced or Metastatic Non-small Cell Lung Cancer Who Received 4 Months of Nivolumab at 3 mg/kg or 240 mg (CheckMate 384)", History of Changes for Study: NCT02713867, (20160426), URL: https://clinicaltrials.gov/ct2/history/NCT02713867?A=6&B=6&C=merged#StudyPageTop, XP055909451 | - |
| OPPOSITION | - "A Dose Frequency Optimization,Trial of Nivolumab 240 mg Every 2 Weeks vs Nivolumab 480 mg Every 4 Weeks in Subjects With Advanced or Metastatic Non-small Cell Lung Cancer Who Received Up to 12 Months of Nivolumab at 3 mg/kg or 240 mg Every 2 Weeks (CheckMate 384)", ClinicalTrials.gov Identifier: NCT02713867, (20160321), URL: https://clinicaltrials.gov/ct2/show/NCT02713867, XP055909208 | - |
| OPPOSITION | - "An Investigational Immuno-therapy Study to Assess the Safety, Tolerability and Effectiveness of Anti-LAG-3 With and Without Anti-PD-1 in the Treatment of Solid Tumors", ClinicalTrials.gov Identifier: NCT01968109, (20131023), URL: https://clinicaltrials.gov/ct2/show/NCT01968109, XP055909073 | - |
| OPPOSITION | - Anonymous, "An Open-Label Phase II Study of Nivolumab in Adult Participants With Recurrent High-Grade Meningioma", ClinicalTrials.gov, (20160107), pages 1 - 8, ClinicalTrials.gov, URL: https://clinicaltrials.gov/ct2/show/NCT02648997, (20220105), XP055876276 | - |
| OPPOSITION | - Anonymous, "CheckMate 067: Nivo + Ipi and Nivo Alone Superior to Ipi in Previously Untreated Advanced Melanoma", CCO Independent Conference Highlights of the 2015 ASCO Annual Meeting, (20150602), XP055909365 | - |
| OPPOSITION | - Anonymous, "DAKO Autostainer, User Guide, Document Number 0003106", DAKO, (20070301), pages 1 - 2, XP055876285 | - |
| OPPOSITION | - Anonymous, "Guidance for Industry Exposure-Response Relationships — StudyDesign, Data Analysis, and Regulatory Applications", U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologies Evaluation and Research (CBER, (20030401), pages 1 - 28, XP055894618 | - |
| OPPOSITION | - Anonymous, "History of changes for study : NCT01844505", ClinicalTrials.gov archive, (20150420), pages 1 - 14, ClinicalTrials.gov archive, URL: https://clinicaltrials.gov/ct2/history/NCT01844505?V_36=View#StudyPageTop, (20220223), XP055894626 | - |
| OPPOSITION | - Anonymous, "OPDIVO (nivolumab) injection, for intravenous use", HIGHLIGHTS OF PRESCRIBING INFORMATION, (20150901), pages 1 - 34, XP055894620 | - |
| OPPOSITION | - Anonymous, "OPDIVO (nivolumab) injection, for intravenous use ", Highlights of Prescribing Information, (20180301), pages 1 - 74, XP055909215 | - |
| OPPOSITION | - Anonymous, "Phase II Anti-PD1 Epigenetic Therapy Study in NSCLC. (NA 00084192)", ClimcalTrials.gov, (20130826), pages 1 - 7, ClimcalTrials.gov, URL: https://clinicaltrials.gov/ct2/show/NCT01928576, (20220105), XP055876275 | - |
| OPPOSITION | - Anonymous, "Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously TreatedAdvanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC)(CheckMate 017)", ClinicalTrials.gov, (20120717), pages 1 - 11, ClinicalTrials.gov, URL: ClinicalTrials.gov/NCT01642004, (20220105), XP055876280 | - |
| OPPOSITION | - Anonymous, "Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously TreatedMetastatic Non-squamous NSCLC (CheckMateO57)", ClinicalTrials.gov, (20120828), pages 1 - 10, ClinicalTrials.gov, URL: ClinicalTrials.gov/NCT01673867, (20220105), XP055876281 | - |
| OPPOSITION | - Anonymous, "Study of Nivolumab (BMS-936558) Compared With Dacarbazine in Untreated,Unresectable, or Metastatic Melanoma (CheckMate 066) ", ClinicalTrials.gov, (20121106), pages 1 - 8, XP055876284 | - |
| OPPOSITION | - Anonymous, "Study of Nivolumab (BMS-936558) Compared With Dacarbazine in Untreated,Unresectable, or Metastatic Melanoma (CheckMate 066)", ClinicalTrials.gov, (20121106), pages 1 - 8, XP055876286 | - |
| OPPOSITION | - Anonymous, "Study of Nivolumab (BMS-936558) vs. Everolimus in Pre-Treated Advanced orMetastatic Clear-cell Renal Cell Carcinoma (CheckMate 025)", ClinicalTrials.gov, (20120820), pages 1 - 10, XP055876283 | - |
| OPPOSITION | - Anonymous, "SUMMARY OF PRODUCT CHARACTERISTICS : YERVOY 5 mg/ml concentrate for solution for infusion", Report, (20160421), page 66, XP055876274 | - |
| OPPOSITION | - "Anti-PD 1 Brain Collaboration for Patients With Melanoma Brain Metastases (ABC)", ClinicalTrials.gov Identifier: NCT02374242, (20150227), URL: https://clinicaltrials.gov/ct2/show/NCT02374242, XP055909062 | - |
| OPPOSITION | - "ASCO 2015: Phase III Study Finds Nivolumab Improves Progression-Free Survival, Especially When Combined With Ipilimumab, in Advanced Melanoma", The ASCO Post, (20150601), URL: https://ascopost.com/News/28604, XP055909400 | - |
| OPPOSITION | - "A Single-Arm, Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) for Subjects With Histologically Confirmed Stage III (Unresectable) or Stage IV Melanoma Progressing Post Prior Treatment Containing an Anti-CTLA4 Monoclonal Antibody (CheckMate 172) ", ClinicalTrials.gov Identifier: NCT02156804, (20140605), URL: https://clinicaltrials.gov/ct2/show/NCT02156804, (20220405), XP055909037 | - |
| OPPOSITION | - "A Study to Compare BMS-936558 to the Physician's Choice of Either Dacarbazine or Carboplatin and Paclitaxel in Advanced Melanoma Patients That Have Progressed Following Anti-CTLA-4 Therapy (CheckMate 037) ", ClinicalTrials.gov Identifier: NCT01721746, (20121106), URL: https://clinicaltrials.gov/ct2/show/NCT01721746, XP055909042 | - |
| OPPOSITION | - Berking Carola, "ASCO 2015 - Neues aus der Dermato-Onkologie", Trillium Krebsmedizin, (20150101), vol. 24, no. 4, pages 214 - 217, XP055909392 | - |
| OPPOSITION | - Bristol Myers Squibb, "European Commission Approves Expanded Use of Opdivo (Reg) (nivolumab) to Include Previously Treated Metastatic Non-Squamous Non-Small Cell Lung Cancer", (20160406), pages 1 - 4, URL: https://news.bms.com/news/details/2016/European-Commission-Approves-Expanded- Use-of-Opdivo-nivolumab-to-Include-Previously-Treated-Metastatic-Non-Squamous- Non-Small- Cell -Lung-Cancer/default.aspx, (20211220), XP055874888 | - |
| OPPOSITION | - Center For Drug Evaluation And Research, "Clinical Pharmacology and Biopharmaceutics Review(s)", FDA's Drug Approval Package for Opdivo (nivolumab) 125554Orig1s000, (20150121), pages 1 - 58, XP055908991 | - |
| OPPOSITION | - Ema Chmp, "Opdivo", Assessment report - EMEA/CHMP/76688/2015, (20150423), pages 1 - 130, XP055908981 | - |
| OPPOSITION | - European Medicines Agency Ema, "Assessment report OPDIVO International non-proprietary name: Nivolumab", (20150924), pages 1 - 78, XP055874846 | - |
| OPPOSITION | - FLIES et al., "Blockade of the B7-H1/PD-1 Pathway for Cancer Immunotherapy", Yale J Biol Med, (20110000), vol. 84, no. 4, pages 409 - 21, XP002711444 | - |
| OPPOSITION | - Helwick Caroline, "CheckMate 067: Dual Checkpoint Blockade Proves Effective in Advanced Melanoma ", The ASCO Post, (20150610), URL: https://ascopost.com/issues/june-10-2015/checkmate-067-dual-checkpoint-blockade-proves-effective-in-advanced-melanoma/, XP055909393 | - |
| OPPOSITION | - Hughes Debra, "Nivolumab Significantly Improves Outcomes in Advanced Melanoma ", Cancer Therapy Advisor, (20150531), URL: https://www.cancertherapyadvisor.com/home/news/conference-coverage/american-society-of-clinical-oncology-asco/asco-2015/nivolumab-significantly-improves-outcomes-in-advanced-melanoma/, XP055909399 | - |
| OPPOSITION | - Olafsen Tove, Shannon J.Sirk, David J.Betting, Vania E.Kenanova, Karl B.Bauer, Waldemar Ladno, Andrew A.Raubitschek, John M.Timmerman, Anna M.Wu, "ImmunoPET imaging of B-cell lymphomausing ,24l-anti-CD20 scFv dimers (diabodies)", Protein Engineering , Design & Selection, (20100401), vol. 23, no. 4, pages 243 - 249, XP055894615 | - |
| OPPOSITION | - "Phase 3 Study of Nivolumab or Nivolumab Plus Ipilimumab Versus Ipilimumab Alone in Previously Untreated Adva (CheckMate-067)", ClinicalTrials.gov Identifier: NCT01844505, (20130501), URL: https://clinicaltrials.gov/ct2/show/NCT01844505, XP055438971 | - |
| OPPOSITION | - "Safety Study of Anti-LAG-3 With and Without Anti-PD-1 in the Treatment of Solid Tumors", History of Changes for Study: NCT01968109, (20141006), URL: https://clinicaltrials.gov/ct2/history/NCT01968109?A=1&B=8&C=merged#StudyPageTop, XP055909127 | - |
| OPPOSITION | - Scott Lesley J, "Nivolumab: A Review in Advanced Melanoma", Drugs, (20150729), vol. 75, no. 12, pages 1413 - 1424, XP055874892 | - |
| OPPOSITION | - "Small Cell Lung Carcinoma Trial With Nivolumab and IpiliMUmab in LImited Disease (STIMULI)", History of Changes for Study: NCT02046733, (20151006), URL: https://clinicaltrials.gov/ct2/history/NCT02046733?A=1&B=6&C=merged#StudyPageTop, XP055909122 | - |
| OPPOSITION | - "Study of Nivolumab (BMS-936558) Compared With Dacarbazine in Untreated, Unresectable, or Metastatic Melanoma (CheckMate 066)", ClinicalTrials.gov Identifier: NCT01721772, (20121106), URL: https://clinicaltrials.gov/ct2/show/NCT01721772, XP055876284 | - |
| OPPOSITION | - Topalian Suzanne Louise, Julie R Brahmer, F.Stephen Hodl, David F Mc.Dermott, David C. Smith, Scott N. Gettinger Et Al., "Anti-PD-1 (BMS-936558, MDX-1106) in patients with advancedsolid tumors: Clinical activity, safety, and a potential biomarker for response. (Abstract CR2509)", Journal of Clinical Oncology, (20120101), vol. 30, no. 18, pages 1 - 1, XP055876279 | - |
| OPPOSITION | - Wang X., G. Bajaj, Y. Feng, M. Gupta, S.Agrawal, A. Yang J. Park, A. Roy, "CHARACTERIZATION OF EXPOSURE-RESPONSE (E-R) RELATIONSHIPFOR NIVOLUMAB IN SUBJECTS WITH ADVANCED MELANOMA PROGRESSING POST ANTI-CTLA4- Abstract PI-073", Clin. Pharmacol. Ther., (20150211), vol. 97, no. S11, pages S41 - S42, XP055894634 | - |
| OPPOSITION | - Byrum Stephanie, Nathan L. Avaritt, Samuel G. Mackintosh, Josie M. Munkberg Brian D. Badgwell, Wang L. Cheung*, And Alan J. Tackett, "A Quantitative Proteomic Analysis of FFPE Melanoma", J. Cutan. Pathol., (20111101), vol. 38, no. 11, doi:10.1111/j.l600-0560.201L01761.x, pages 933 - 936, XP055876273 | |
| OPPOSITION | - Jules Gadiot; Anna I. Hooijkaas; Andrew D. M. Kaiser; Harm van Tinteren; Hester van Boven; Christian Blank, "Overall survival and PD‐L1 expression in metastasized malignant melanoma", Cancer, American cancer society , Philadelphia , PA, US, US , (20101129), vol. 117, no. 10, doi:10.1002/cncr.25747, ISSN 0008-543X, pages 2192 - 2201, XP071127140 | |
| OPPOSITION | - Zhao X., Shen J., Ivaturi V., Gopalakrishnan M., Feng Y., Schmidt B.J., Statkevich P., Goodman V., Gobburu J., Bello A., Roy A., Agrawal S., "Model-based evaluation of the efficacy and safety of nivolumab once every 4 weeks across multiple tumor types", Annals of Oncology, NL , (20200201), vol. 31, no. 2, doi:10.1016/j.annonc.2019.10.015, ISSN 0923-7534, pages 302 - 309, XP055909419 | |
| OPPOSITION | - Kathleen M. Mahoney, Gordon J. Freeman, David F. Mcdermott, "The Next Immune-Checkpoint Inhibitors: PD-1/PD-L1 Blockade in Melanoma", Clinical Therapeutics, AMSTERDAM, NL, (20150401), vol. 37, no. 4, doi:10.1016/j.clinthera.2015.02.018, ISSN 0149-2918, pages 764 - 782, XP055285031 | |
| OPPOSITION | - Meng Xiangjiao; Huang Zhaoqin; Teng Feifei; Xing Ligang; Yu Jinming, "Predictive biomarkers in PD-1/PD-L1 checkpoint blockade immunotherapy", Cancer Treatment Reviews, AMSTERDAM, NL , (20151110), vol. 41, no. 10, doi:10.1016/j.ctrv.2015.11.001, ISSN 0305-7372, pages 868 - 876, XP029315381 | |
| OPPOSITION | - Belum V.R.; Benhuri B.; Postow M.A.; Hellmann M.D.; Lesokhin A.M.; Segal N.H.; Motzer R.J.; Wu S.; Busam K.J.; Wolchok J.D.; Lacouture M.E., "Characterisation and management of dermatologic adverse events to agents targeting the PD-1 receptor", European Journal of Cancer, Amsterdam NL , (20160401), vol. 60, doi:10.1016/j.ejca.2016.02.010, ISSN 0959-8049, pages 12 - 25, XP029534274 | |
| OPPOSITION | - Jeffrey S Weber,et al, "Nivolumab versus chemotherapy in patients with advanced melanoma who progressed after anti-CTLA-4 treatment (CheckMate 037): a randomised, controlled, open-label, phase 3 trial", The Lancet Oncology, ELSEVIER, AMSTERDAM, NL, AMSTERDAM, NL , (20150401), vol. 16, no. 4, doi:10.1016/S1470-2045(15)70076-8, ISSN 1470-2045, pages 375 - 384, XP055553053 | |
| OPPOSITION | - Haidong Dong, Scott E. Strome, Diva R. Salomao, Hideto Tamura, Fumiya Hirano, Dallas B. Flies, Patrick C. Roche, Jun Lu, Gefeng Zhu, Koji Tamada, Vanda A. Lennon, Esteban Celis & Lieping Chen, "Tumor-associated B7-H1 promotes T-cell apoptosis: a potential mechanism of immune evasion.", Nature Medicine, New York, (20020624), vol. 8, no. 8, doi:10.1038/nm730, ISSN 1078-8956, pages 793 - 800, XP002397368 | |
| OPPOSITION | - Suzanne L Topalian, M D, F Stephen Hodi, M D, Julie R Brahmer, M D, Scott N Gettinger, M D, David C Smith, M D, David F Mcdermott, M D, John D Powderly, M D, Richard D Carvajal, M D, Jeffrey A Sosman, M D, Michael B Atkins, M D, Philip D Leming, M D, David R Spigel, M D, Scott J Antonia, M D, Ph D, Leora Horn, M D, Charles G Drake, M D, Ph D, Drew M Pardoll, M D, Ph D, Lieping Chen, M D, Ph D, William H Sharfman, M D, Robert A Anders, M D, Ph D, Janis M Taube, M D, Tracee L Mcmiller, M S, Haiying Xu, B A, Alan J Korman, Ph D, Maria Jure-Kunkel, Ph D, Shruti Agrawal, Ph D, Daniel Mcdonald, M B A, Georgia D Kollia, Ph D, Ashok Gupta, M D, Ph D, Jon M Wigginton, M D, Mario Sznol, M D A Bs, T R Ac, S L T, J R B, C G D, D M P, W H S, R A A, J M T, S J A, Bristol-Myers Squibb, Ca Milpitas, A J K ), Nj, M J, -K, S A, D M, G D K, A G, "Safety, activity, and immune correlates of anti-PD-1 antibody in cancer", The New England journal of medicine, US , (20120628), vol. 366, no. 26, doi:10.1056/NEJMoa1200690, ISSN 0028-4793, pages 2443 - 2454, XP055098235 | |
| OPPOSITION | - TOPALIAN SUZANNE L ET AL, "Safety, activity, and immune correlates of anti-PD-1 antibody in cancer.", New England Journal of Medicine, US , (20120628), vol. 366, no. 26, doi:10.1056/NEJMoa1200690, ISSN 1533-4406, pages 2443 - 2454, XP002767416 | |
| OPPOSITION | - Michael A. Postow, Jason Chesney, Anna C. Pavlick, Caroline Robert, Kenneth Grossmann, David McDermott, Gerald P. Linette, Nicolas Meyer, Jeffrey K. Giguere, Sanjiv S. Agarwala, Montaser Shaheen, Marc S. Ernstoff, David Minor, April K. Salama, Matthew Taylor, Patrick A. Ott, Linda M. Rollin, Christine Horak, Paul Gagnier, Jedd D. Wolchok, and F. Stephen Hodi, "Nivolumab and ipilimumab versus ipilimumab in untreated melanoma", The New England journal of medicine, US , (20150521), vol. 372, doi:10.1056/NEJMoa1414428, ISSN 0028-4793, pages 2006 - 2017, XP002761464 | |
| OPPOSITION | - James Larkin, Vanna Chiarion-Sileni, Rene Gonzalez, Jean Jacques Grob, C. Lance Cowey, Christopher D. Lao, Dirk Schadendorf, Reinhard Dummer, Michael Smylie, Piotr Rutkowski, Pier F. Ferrucci, Andrew Hill, John Wagstaff, Matteo S. Carlino, John B. Haanen, Michele Maio, Ivan Marquez-Rodas, Grant A. Mcarthur, Paolo A. Ascierto, Georgina V. Long, Margaret K. Callahan, Michael A. Postow, Kenneth Grossmann, Mario Sznol, Brigitte Dreno, Lars Bastholt, Arvin Yang, Linda M. Rollin, Christine Horak, F. Stephen Hodi, Jedd D. Wolchok, "Combined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma", The New England journal of medicine, Massachusetts Medical Society, US, US , (20150702), vol. 373, no. 1, doi:10.1056/NEJMoa1504030, ISSN 0028-4793, pages 23 - 34, XP055553658 | |
| OPPOSITION | - James Larkin, Vanna Chiarion-Sileni, Rene Gonzalez, Jean Jacques Grob, C. Lance Cowey, Christopher D. Lao, Dirk Schadendorf, Reinhard Dummer, Michael Smylie, Piotr Rutkowski, Pier F. Ferrucci, Andrew Hill, John Wagstaff, Matteo S. Carlino, John B. Haanen, Michele Maio, Ivan Marquez-Rodas, Grant A. Mcarthur, Paolo A. Ascierto, Georgina V. Long, Margaret K. Callahan, Michael A. Postow, Kenneth Grossmann, Mario Sznol, Brigitte Dreno, Lars Bastholt, Arvin Yang, Linda M. Rollin, Christine Horak, F. Stephen Hodi, Jedd D. Wolchok, "Combined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma", The New England journal of medicine, US , (20150702), vol. 373, no. 1, doi:10.1056/NEJMoa1504030, ISSN 0028-4793, pages 23 - 34, XP055316141 | |
| OPPOSITION | - Larkin James, Vanna Chiarion-Sileni, Rene Gonzalez, Jean Jacques Grob, C. Lance Cowey, Christopher D. Lao, Dirk Schadendorf, Reinhard Dummer, Michael Smylie, Piotr Rutkowski, Pier F. Ferrucci, Andrew Hill, John Wagstaff, Matteo S. Carlino, John B. Haanen, Michele Maio, Ivan Marquez-Rodas, Grant A. Mcarthur, Paolo A. Ascierto, Georgina V. Long, Margaret K. Callahan, Michael A. Postow, Kenneth Grossmann, Mario Sznol, Brigitte Dreno, Lars Bastholt, Arvin Yang, Linda M. Rollin, Christine Horak, F. Stephen Hodi, Jedd D. Wolchok, "Combined Nivolumab and Ipilimumab or Monotherapy in Previously Untreated Melanoma", N. Engl. J. Med. (Suppl.), (20150702), vol. 373, no. 1, doi:10.1056/NEJMoa1504030, pages 1 - 1, XP055876277 | |
| OPPOSITION | - Julie Brahmer, Karen L. Reckamp, Paul Baas, Lucio Crinò, Wilfried E.E. Eberhardt, Elena Poddubskaya, Scott Antonia, Adam Pluzanski, Everett E. Vokes, Esther Holgado, David Waterhouse, Neal Ready, Justin Gainor, Osvaldo Arén Frontera, Libor Havel, Martin Steins, Marina C. Garassino, Joachim G. Aerts, Manuel Domine, Luis Paz-Ares, Martin Reck, Christine Baudelet, Christopher T. Harbison, Brian Lestini, David R. Spigel, "Nivolumab versus Docetaxel in Advanced Squamous-Cell Non–Small-Cell Lung Cancer", The New England journal of medicine, US , (20150709), vol. 373, no. 2, doi:10.1056/NEJMoa1504627, ISSN 0028-4793, pages 123 - 135, XP055391742 | |
| OPPOSITION | - J. Hamanishi, M. Mandai, M. Iwasaki, T. Okazaki, Y. Tanaka, K. Yamaguchi, T. Higuchi, H. Yagi, K. Takakura, N. Minato, T. Honjo, S. Fujii, "Programmed cell death 1 ligand 1 and tumor-infiltrating CD8+ T lymphocytes are prognostic factors of human ovarian cancer", Proceedings of the National Academy of Sciences, National Academy of Sciences, (20070227), vol. 104, no. 9, doi:10.1073/pnas.0611533104, ISSN 00278424, pages 3360 - 3365, XP055030513 | |
| OPPOSITION | - Katelyn E. McCabe and Anna M. Wu, "Positive progress in immunoPET--not just a coincidence", CANCER BIOTHERAPY AND RADIOPHARMACEUTICALS., LIEBERT., US, US , (20100601), vol. 25, no. 3, doi:10.1089/cbr.2010.0776, pages 253 - 261, XP009150571 | |
| OPPOSITION | - ZHAO X ET AL, "Assessment of nivolumab benefit-risk profile of a 240-mg flat dose relative to a 3-mg/kg dosing regimen in patients with advanced tumors.", Annals of Oncology, GB , (20170801), vol. 28, no. 8, doi:10.1093/annonc/mdx235, ISSN 1569-8041, pages 2002 - 2008, XP002789767 | |
| OPPOSITION | - G V Long, S S Tykodi, J G Schneider, C Garbe, G Gravis, M Rashford, S Agrawal, E Grigoryeva, A Bello, A Roy, L Rollin, X Zhao, "Assessment of nivolumab exposure and clinical safety of 480 mg every 4 weeks flat-dosing schedule in patients with cancer", Annals of Oncology, Kluwer Dordrecht, NL, NL , (20180000), vol. 29, doi:10.1093/annonc/mdy408, ISSN 0923-7534, pages 2213 - 2218, XP055651364 | |
| OPPOSITION | - G V Long, S S Tykodi, J G Schneider, C Garbe, G Gravis, M Rashford, S Agrawal, E Grigoryeva, A Bello, A Roy, L Rollin, X Zhao, "Assessment of nivolumab exposure and clinical safety of 480 mg every 4 weeks flat-dosing schedule in patients with cancer", Annals of Oncology, NL , (2018), vol. 29, no. 11, doi:10.1093/annonc/mdy408, ISSN 0923-7534, pages 2208 - 2213, XP055651364 | |
| OPPOSITION | - Bi Y., Liu J., Furmanski B., Zhao H., Yu J., Osgood C., Ward A., Keegan P., Booth B.P., Rahman A., Wang Y., "Model-informed drug development approach supporting approval of the 4-week (Q4W) dosing schedule for nivolumab (Opdivo) across multiple indications: a regulatory perspective", Annals of Oncology, NL , (20190401), vol. 30, no. 4, doi:10.1093/annonc/mdz037, ISSN 0923-7534, pages 644 - 651, XP055909420 | |
| OPPOSITION | - G. K. Philips, M. Atkins, "Therapeutic uses of anti-PD-1 and anti-PD-L1 antibodies", International Immunology, GB , (20150101), vol. 27, no. 1, doi:10.1093/intimm/dxu095, ISSN 0953-8178, pages 39 - 46, XP055217958 | |
| OPPOSITION | - PHILIPS et al., "Therapeutic uses of anti-PD-1 and anti-PD-L1 antibodies", Int Immunol, (20140000), vol. 27, no. 1, doi:10.1093/intimm/dxu095, pages 39 - 46, XP055217958 | |
| OPPOSITION | - J. Condeelis, R. Weissleder, "In Vivo Imaging in Cancer", Cold Spring Harbor Perspectives in Biology, (20101201), vol. 2, no. 12, doi:10.1101/cshperspect.a003848, pages a003848 - a003848, XP055652019 | |
| OPPOSITION | - Toutain P. L., Bousquet-Melou A., "Plasma terminal half-life", JOURNAL OF VETERINARY PHARMACOLOGY AND THERAPEUTICS, GB , (20041201), vol. 27, no. 6, doi:10.1111/j.1365-2885.2004.00600.x, ISSN 0140-7783, pages 427 - 439, XP055909101 | |
| OPPOSITION | - P. A. Ascierto, M. Kalos, D. A. Schaer, M. K. Callahan, J. D. Wolchok, "Biomarkers for Immunostimulatory Monoclonal Antibodies in Combination Strategies for Melanoma and Other Tumor Types", Clinical Cancer Research, (20130301), vol. 19, no. 5, doi:10.1158/1078-0432.CCR-12-2982, ISSN 10780432, pages 1009 - 1020, XP055124339 | |
| OPPOSITION | - P. A. Ott, F. S. Hodi, C. Robert, "CTLA-4 and PD-1/PD-L1 Blockade: New Immunotherapeutic Modalities with Durable Clinical Benefit in Melanoma Patients", Clinical Cancer Research, (20131001), vol. 19, no. 19, doi:10.1158/1078-0432.CCR-13-0143, ISSN 10780432, pages 5300 - 5309, XP055200528 | |
| OPPOSITION | - PATEL et al., "PD-L1 Expression as a Predictive Biomarker in Cancer Immunotherapy", Mol Cancer Ther., (20150218), vol. 14, no. 4, doi:10.1158/1535-7163.MCT-14-0983, pages 847 - 856, XP055567991 | |
| OPPOSITION | - Diane D. Wang, Shuzhong Zhang, Hong Zhao, Angela Y. Men, Kourosh Parivar, "Fixed Dosing Versus Body Size-Based Dosing of Monoclonal Antibodies in Adult Clinical Trials", The Journal of clinical pharmacology, LIPPINCOTT CO, HAGERSTOWN, MD, US, US , (20090901), vol. 49, no. 9, doi:10.1177/0091270009337512, ISSN 0091-2700, pages 1012 - 1024, XP055393361 | |
| OPPOSITION | - WANG et al., "Fixed Dosing Versus Body Size-Based Dosing of Monoclonal Antibodies in Adult Clinical Trials", J Clin Pharmacol, (20090000), vol. 49, no. 9, doi:10.1177/0091270009337512, pages 1012 - 24, XP055393361 | |
| OPPOSITION | - Barbee Meagan S., Adebayo Ogunniyi, Troy Z. Horvat And Thu-Oanh Dang, "Current Status and Future Directions of the Immune Checkpoint Inhibitors Ipilimumab, Pembrolizumab, and Nivolumab in Oncology", Annals of Pharmacotherapy, (20150101), vol. 49, no. 8, doi:10.1177/1060028015586218, pages 907 - 937, XP055909444 | |
| OPPOSITION | - Stefani Spranger, Thomas Gajewski, "Rational combinations of immunotherapeutics that target discrete pathways", Journal for ImmunoTherapy of Cancer, BioMed Central, London, GB, GB , (20130101), vol. 1, no. 1, doi:10.1186/2051-1426-1-16, ISSN 2051-1426, page 16, XP055237414 | |
| OPPOSITION | - BRAHMER et al., "Phase I Study of Single-Agent Anti-Programmed Death-1 (MDX- 1106) in Refractory Solid Tumors: Safety, Clinical Activity, Pharmacodynamics, and Immunologic Correlates", J Clin Oncol, (20100000), vol. 28, no. 19, doi:10.1200/JCO.2009.26.7609, pages 3167 - 75, XP055124332 | |
| OPPOSITION | - Grosso Joseph, Christine E. Horak, David Inzunza, Diana M. Cardona, Jason S. Simon, Ashok Kumar Gupta, Vindira Sankar, Jong-Soon Park, Georgia Kollia, Janis M. Taube, Robert Anders, Maria Jure-Kunkel, Jim Novotny, Jr., Clive R. Taylor, Xiaoling Zhang, Therese Phillips, Pauline Simmons, John Cogswell, "Association of tumor PD-L1 expression and immune biomarkers with clinical activity in patients (pts) with advanced solid tumors treated with nivolumab (anti-PD-1; BMS-936558; ONO-4538) ", Journal of Clinical Oncology - Meeting Abstract | 2013 ASCO Annual Meeting I, (20130520), vol. 31, no. 15_suppl, doi:10.1200/jco.2013.31.15_suppl.3016, page 3016, XP055909353 | |
| OPPOSITION | - S. L. Topalian, M. Sznol, D. F. Mcdermott, H. M. Kluger, R. D. Carvajal, W. H. Sharfman, J. R. Brahmer, D. P. Lawrence, M. B. Atkins, J. D. Powderly, P. D. Leming, E. J. Lipson, I. Puzanov, D. C. Smith, J. M. Taube, J. M. Wigginton, G. D. Kollia, A. Gupta, D. M. Pardoll, J. A. Sosman, F. S. Hodi, "Survival, Durable Tumor Remission, and Long-Term Safety in Patients With Advanced Melanoma Receiving Nivolumab", Journal of Clinical Oncology, US , (20140401), vol. 32, no. 10, doi:10.1200/JCO.2013.53.0105, ISSN 0732-183X, pages 1020 - 1030, XP055218601 | |
| OPPOSITION | - M. A. Postow, M. K. Callahan, J. D. Wolchok, "Immune Checkpoint Blockade in Cancer Therapy", Journal of Clinical Oncology, US , (20150610), vol. 33, no. 17, doi:10.1200/JCO.2014.59.4358, ISSN 0732-183X, pages 1974 - 1982, XP055320016 | |
| OPPOSITION | - BAI et al., "A Guide to Rational Dosing of Monoclonal Antibodies", Clin Pharmacokinet, (20120000), vol. 51, no. 2, doi:10.2165/11596370-000000000-00000, pages 119 - 35, XP009184175 | |
| OPPOSITION | - Bai Shuang; Jorga Karin; Xin Yan; Jin Denise; Zheng Yanan; Damico-Beyer Lisa A; Gupta Manish; Tang Meina; Allison David E; Lu Dan; Zhang Yi; Joshi Amita; Dresser Mark J, "A Guide to Rational Dosing of Monoclonal Antibodies", CLINICAL PHARMACOKINETICS., ADIS INTERNATIONAL LTD., AUCKLAND, NZ, NZ , (20120101), vol. 51, no. 2, doi:10.2165/11596370-000000000-00000, ISSN 0312-5963, pages 119 - 135, XP009184175 | |
| OPPOSITION | - TSAI et al., Human Vaccines & Immunotherapeutics, (20141100), vol. 10, no. 11, pages 3111 - 3116, XP055700180 | |
| OPPOSITION | - PRICHARD, "Overview of Automated Immunohistochemistry", Arch Pathol Lab Med, (20140000), vol. 138, no. 12, doi:10.5858/arpa.2014-0083-RA, pages 1578 - 82, XP055326004 | |
