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2. Nivolumab versus docetaxel in previously treated advanced non-small-cell lung cancer (CheckMate 017 and CheckMate 057): 3-year update and outcomes in patients with liver metastases

Author

Vokes, E.E., Ready, N., Felip, E., Horn, L., Burgio, M.A., Antonia, S.J., Arén Frontera, O., Gettinger, S., Holgado, E., Spigel, D., Waterhouse, D., Domine, M., Garassino, M., Chow, L.Q.M., Blumenschein, G., Jr, Barlesi, F., Coudert, B., Gainor, J., Arrieta, O., Brahmer, J., Butts, C., Steins, M., Geese, W.J., Li, A., Healey, D., and Crinò, L.

Published
2018
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4. 1786O BMS-986012 (anti-fucosyl-monosialoganglioside-1 [fuc-GM1]) with carboplatin + etoposide + nivolumab (CE/NIVO) as first-line (1L) therapy in extensive-stage small cell lung cancer (ES-SCLC): Interim analysis (IA) of a randomized phase II study

Author

Kalinka, E., Bahce, I., Navarro Mendivil, A.F., Ready, N., Chu, Q.S-C., Sugawara, S., Sibille, A., Provencio Pulla, M., Johnson, M.L., Hiltermann, J.T.J.N., Ciuleanu, T-E., Dziadziuszko, R., Santo, A., Zhang, Y., Liu, Y., Sarmiento, R., Tannenbaum-Dvir, S., Ojalvo, L., Wu, J., and O'Byrne, K.J.

Published
2024
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6. 1664TiP A phase II randomized study of BMS-986012, an anti-fucosyl-GM1 monoclonal antibody, plus carboplatin, etoposide, and nivolumab (NIVO) as first-line (1L) therapy in patients with extensive-stage small cell lung cancer (ES-SCLC)

Author

Chu, Q., primary, Parikh, K., additional, Paz-Ares, L., additional, Navarro, A., additional, Markman, B., additional, Sarmiento, R., additional, Kollia, G., additional, He, C., additional, Sanghavi, K., additional, Chang, H., additional, Fischer, B., additional, Guha, U., additional, Tannenbaum-Dvir, S., additional, Wu, K., additional, Liu, Y., additional, and Ready, N., additional

Published
2021
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7. FP03.03 Clinical Activity of BMS-986012, an Anti-Fucosyl-GM1 Monoclonal Antibody, Plus Nivolumab in Small Cell Lung Cancer.

Author

Van Herpen C., Sibille A., Markman B., Clarke S., Juergens R., Acosta Rivera M., Kim D., Sanatani M., Tannenbaum-Dvir S., Basciano P., Lathers D., Urbanska K., Kollia G., He C., Dipiero A., Ready N., Chu Q., Leighl N., Surmont V., Andelkovic V., Rudin C., Snow S., Van Herpen C., Sibille A., Markman B., Clarke S., Juergens R., Acosta Rivera M., Kim D., Sanatani M., Tannenbaum-Dvir S., Basciano P., Lathers D., Urbanska K., Kollia G., He C., Dipiero A., Ready N., Chu Q., Leighl N., Surmont V., Andelkovic V., Rudin C., and Snow S.

Abstract

Introduction: In patients with extensive-stage small cell lung cancer (ES-SCLC), the addition of an anti-PD-L1 regimen to chemotherapy demonstrated limited benefit, with an increase in survival by 2 months (Horn et al. N Engl J Med. 2018;379:2220-2229). Therefore, future prospects for better outcomes in SCLC lie in novel medicines and new treatment combinations. Fucosyl-GM1 is a monosialoganglioside expressed in 50%-70% of SCLC with limited expression in normal tissues (Brezicka et al. APMIS. 1991;99:797-802; Brezicka et al. Tumour Biol. 1992;13:308-315). BMS-986012 is a nonfucosylated, fully human monoclonal antibody with high binding specificity for fucosyl-GM1 engineered to enhance antibody-dependent, cell-mediated cytotoxicity (Ponath et al. Clin Cancer Res. 2018;24:5178-5189). We previously reported that the combination of BMS-986012 and nivolumab in patients with relapsed/refractory SCLC was well tolerated and demonstrated preliminary antitumor activity (Chu et al. Ann Oncol. 2017;28(suppl 5). Abstract 1528PD). Here, we report updated safety and antitumor activity results from the phase 1/2 trial of the combination of BMS-986012 and nivolumab in patients with relapsed/refractory SCLC (NCT02247349). Method(s): Patients with relapsed/refractory SCLC who had not received prior checkpoint inhibitor (CPI) therapy received BMS-986012 400 or 1000 mg with nivolumab 360 mg intravenously every 3 weeks. The primary endpoint was safety. Secondary endpoints included investigator-assessed objective response rate (ORR), median duration of response (mDOR), median progression-free survival (mPFS), and pharmacokinetics. Median overall survival (mOS) was an exploratory endpoint. Result(s): As of July 22, 2020, 29 patients received BMS-986012 (400 mg, n=21; 1000 mg, n=8) with nivolumab, with a follow-up of 18.6 months (range, 0.6&-41.1 months). Median age of patients was 65 years (range, 46-79 years) and 52% were male; ECOG performance status was 0 (38%) or 1 (62%). The combinati

Published
2021

8. FP03.03 Clinical Activity of BMS-986012, an Anti–Fucosyl-GM1 Monoclonal Antibody, Plus Nivolumab in Small Cell Lung Cancer

Author

Chu, Q., primary, Leighl, N., additional, Surmont, V., additional, Van Herpen, C., additional, Sibille, A., additional, Markman, B., additional, Clarke, S., additional, Juergens, R., additional, Acosta Rivera, M., additional, Andelkovic, V., additional, Rudin, C., additional, Snow, S., additional, Kim, D., additional, Sanatani, M., additional, Tannenbaum-Dvir, S., additional, Basciano, P., additional, Lathers, D., additional, Urbanska, K., additional, Kollia, G., additional, He, C., additional, Dipiero, A., additional, and Ready, N., additional

Published
2021
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11. CheckMate 817: First-Line Nivolumab plus Ipilimumab in Patients with ECOG PS 2 and Other Special Populations with Advanced NSCLC

Author

Barlesi, F., Audigier-Valette, C., Felip, E., Ciuleanu, T., Jao, K., Rijavec, E., Urban, L., Aucoin, J., Zannori, C., Vermaelen, K., Frontera, O. A., Ready, N., Fontecedro, A. Curioni, Linardou, H., Poddubskaya, E., Fischer, J., Iordan, I., Groen, H., Pillai, R., Li, S., Fiore, J., Chang, H., Acevedo, A., and Paz-Ares, L.

Subjects
nivolumab, ipilimumab, NSCLC
Published
2019

12. Durvalumab for recurrent or metastatic head and neck squamous cell carcinoma : Results from a single-arm, phase II study in patients with ≥25% tumour cell PD-L1 expression who have progressed on platinum-based chemotherapy

Author

Zandberg, D. P., Algazi, A. P., Jimeno, A., Good, J. S., Fayette, J., Bouganim, N., Ready, N. E., Clement, P. M., Even, C., Jang, R. W., Wong, S., Keilholz, Ulrich, Gilbert, J., Fenton, M., Braña, Irene, Henry, S., Remenar, E., Papai, Z., Siu, L. L., Jarkowski, A., Armstrong, Jon M., Asubonteng, K., Fan, J., Melillo, G., Mesía, R., Universitat Autònoma de Barcelona, Institut Català de la Salut, [Zandberg DP] University of Pittsburgh Medical Center, Hillman Cancer Center, Pittsburgh, PA, USA. [Algazi AP] University of California San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, USA. [Jimeno A] Division of Medical Oncology, University of Colorado School of Medicine, Aurora, CO, USA. [Good JS] Institute of Head and Neck Studies and Education, Queen Elizabeth Hospital, Birmingham, UK. [Fayette J] Clinical Oncology, Cancer Center Centre Léon Bérard, University of Lyon, Lyon, France. [Bouganim N] Department of Oncology, McGill University Health Centre, Montreal, QC, Canada. [Braña I] Oncologia Mèdica, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. Universitat Autònoma de Barcelona, Barcelona, Spain, Hospital Universitari Vall d'Hebron, Vall d'Hebron Barcelona Hospital Campus, UCL - (MGD) Service d'oncologie médicale, and UCL - SSS/IREC/MONT - Pôle Mont Godinne

Subjects
Male, 0301 basic medicine, Cancer Research, Survival rate, Durvalumab, medicine.medical_treatment, MULTICENTER, Phases of clinical research, Cap - Càncer, neoplasias::neoplasias por tipo histológico::neoplasias glandulares y epiteliales::carcinoma::carcinoma de células escamosas::carcinoma de células escamosas de cabeza y cuello [ENFERMEDADES], Other subheadings::Other subheadings::/drug therapy [Other subheadings], Gastroenterology, B7-H1 Antigen, Antineoplastic Agents, Immunological, 0302 clinical medicine, Neoplasms::Neoplasms by Site::Head and Neck Neoplasms [DISEASES], Quimioteràpia, Monoclonal, Head and neck cancer, Càncer de cap, aminoácidos, péptidos y proteínas::proteínas::proteínas sanguíneas::inmunoproteínas::inmunoglobulinas::anticuerpos::anticuerpos monoclonales [COMPUESTOS QUÍMICOS Y DROGAS], AGENT, Aged, 80 and over, Antibodies, Monoclonal, Middle Aged, Prognosis, OPEN-LABEL, CANCER, CETUXIMAB, METHOTREXATE, Survival Rate, Oncology, Head and Neck Neoplasms, Lymphatic Metastasis, 030220 oncology & carcinogenesis, Female, Immunotherapy, Life Sciences & Biomedicine, Adult, medicine.medical_specialty, HPV, Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores], Antibodies, GEFITINIB, Head cancer, Coll - Càncer, Young Adult, 03 medical and health sciences, Internal medicine, Biomarkers, Tumor, medicine, Humans, Chemotherapy, neoplasias::neoplasias por localización::neoplasias de cabeza y cuello [ENFERMEDADES], Adverse effect, PEMBROLIZUMAB, Aged, Salvage Therapy, Science & Technology, Recurrent or metastatic, Squamous Cell Carcinoma of Head and Neck, business.industry, International Agencies, medicine.disease, Neck cancer, Head and neck squamous-cell carcinoma, Càncer de coll, 030104 developmental biology, Neoplasms::Neoplasms::Neoplasms by Site::Head and Neck Neoplasms::Squamous Cell Carcinoma of Head and Neck [DISEASES], Neoplasm Recurrence, Local, business, Amino Acids, Peptides, and Proteins::Proteins::Blood Proteins::Immunoproteins::Immunoglobulins::Antibodies::Antibodies, Monoclonal [CHEMICALS AND DRUGS], Anticossos monoclonals, Follow-Up Studies
Abstract

Anticossos; Immunoteràpia; Càncer de cap i coll Anticuerpos; Inmunoterapia; Cáncer de cabeza y cuello Antibodies; Immunotherapy; Head and neck cancer Background Patients with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) progressing on platinum-based chemotherapy have poor prognoses and limited therapeutic options. Programmed cell death-1 (PD-1) and its ligand 1 (PD-L1) are frequently upregulated in HNSCC. The international, multi-institutional, single-arm, phase II HAWK study ( NCT02207530 ) evaluated durvalumab monotherapy, an anti-PD-L1 monoclonal antibody, in PD-L1-high patients with platinum-refractory R/M HNSCC. Patients and methods Immunotherapy-naïve patients with confirmed PD-L1-high tumour cell expression (defined as patients with ≥25% of tumour cells expressing PD-L1 [TC ≥ 25%] using the VENTANA PD-L1 [SP263] Assay) received durvalumab 10 mg/kg intravenously every 2 weeks for up to 12 months. The primary end-point was objective response rate; secondary end-points included progression-free survival (PFS) and overall survival (OS). Results Among evaluable patients (n = 111), objective response rate was 16.2% (95% confidence interval [CI], 9.9–24.4); 29.4% (95% CI, 15.1–47.5) for human papillomavirus (HPV)-positive patients and 10.9% (95% CI, 4.5–21.3) for HPV-negative patients. Median PFS and OS for treated patients (n = 112) was 2.1 months (95% CI, 1.9–3.7) and 7.1 months (95% CI, 4.9–9.9); PFS and OS at 12 months were 14.6% (95% CI, 8.5–22.1) and 33.6% (95% CI, 24.8–42.7). Treatment-related adverse events were 57.1% (any grade) and 8.0% (grade ≥3); none led to death. At data cut-off, 24.1% of patients remained on treatment or in follow-up. Conclusion Durvalumab demonstrated antitumour activity with acceptable safety in PD-L1-high patients with R/M HNSCC, supporting its ongoing evaluation in phase III trials in first- and second-line settings. In an ad hoc analysis, HPV-positive patients had a numerically higher response rate and survival than HPV-negative patients. This study was supported by AstraZeneca.

Published
2019

13. CheckMate 817 : nivolumab + ipilimumab en première ligne chez des patients atteints d’un cancer bronchique non à petites cellules (CBNPC) avancé avec un ECOG PS 2 et autres populations particulières

Author

Barlesi, F., primary, Audigier-Valette, C., additional, Felip, E., additional, Ciuleanu, T.E., additional, Jao, K., additional, Rijavec, E., additional, Urban, L., additional, Aucoin, J.S., additional, Zannori, C., additional, Vermaelen, K., additional, Frontera, O.A., additional, Ready, N., additional, Curioni Fontecedro, A., additional, Linardou, H., additional, Poddubskaya, E., additional, Fischer, J.R., additional, Iordan, I., additional, Groen, H., additional, Pillai, R., additional, Li, S., additional, Fiore, J., additional, Chang, H., additional, Acevedo, A., additional, and Paz-Ares, L., additional

Published
2020
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14. Five-year outcomes from the randomized, phase 3 trials CheckMate 017/057: nivolumab vs docetaxel in previously treated NSCLC

Author

Lind, M., primary, Gettinger, S., additional, Borghaei, H., additional, Brahmer, J., additional, Chow, L., additional, Burgio, M., additional, De Castro Carpeno, J., additional, Pluzanski, A., additional, Arrieta, O., additional, Frontera, O. Aren, additional, Chiari, R., additional, Butts, C., additional, Wojcik-Tomaszewska, J., additional, Coudert, B., additional, Garassino, M., additional, Ready, N., additional, Felip, E., additional, Garcia, M. Alonso, additional, Waterhouse, D., additional, Domine, M., additional, Barlesi, F., additional, Antonia, S., additional, Wohlleber, M., additional, Gerber, D., additional, Czyzewicz, G., additional, Spigel, D., additional, Crino, L., additional, Eberhardt, W., additional, Li, A., additional, Marimuthu, S., additional, and Vokes, E., additional

Published
2020
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15. Résultats à 5 ans des essais cliniques randomisés de phase III CheckMate (CM) 017/057 : nivolumab vs docétaxel dans le cancer bronchique non à petites cellules (CBNPC) avancé après un traitement antérieur

Author

Gettinger, S., primary, Borghaei, H., additional, Brahmer, J., additional, Chow, L.Q.M., additional, Burgio, M.A., additional, De Castro Carpeno, J., additional, Pluzanski, A., additional, Arrieta, O., additional, Aren Frontera, O., additional, Chiari, R., additional, Butts, C., additional, Wojcik-Tomaszewska, J., additional, Coudert, B., additional, Chiara Garassino, M., additional, Ready, N., additional, Felip, E., additional, Alonso Garcia, M., additional, Waterhouse, D., additional, Domine, M., additional, Barlesi, F., additional, Antonia, S., additional, Wohlleber, M., additional, Gerber, D.E., additional, Czyzewicz, G., additional, Spigel, D.R., additional, Crino, L., additional, Eberhardt, W.E.E., additional, Li, A., additional, Marimuthu, S., additional, and Vokes, E.E., additional

Published
2020
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16. CheckMate 817: Safety of Flat-Dose Nivolumab Plus Weight-Based Ipilimumab for the First-line (1L) Treatment of Advanced NSCLC

Author

Paz-Ares, L., Urban, L., Audigier-Valette, C., Grossi, F., Jao, K., Aucoin, J., Linardou, H., Poddubskaya, E. Vladimirovna, Fischer, J., Fontecedro, A. Curioni, Groen, H., Vermaelen, K., Bourhaba, M., Kowalski, D., Pillai, R., Spigel, D., Ahmed, S., Hu, W., Vickery, D., Fiore, J., Ready, N., Guided Treatment in Optimal Selected Cancer Patients (GUTS), and Damage and Repair in Cancer Development and Cancer Treatment (DARE)

Subjects
Nivolumab, Ipilimumab, non-small cell lung cancer
Published
2018

17. Nivolumab Plus Low-Dose IPILIMUMAB as First-Line Treatment of Advanced NSCLC: Overall Survival Analysis of Checkmate 817

Author

Barlesi, F., primary, Audigier-Valette, C., additional, Felip, E., additional, Ciuleanu, T.-E., additional, Jao, K., additional, Rijavec, E., additional, Urban, L., additional, Aucoin, J.-S., additional, Zannori, C., additional, Vermaelen, K., additional, Frontera, O. Arén, additional, Ready, N., additional, Curioni, A., additional, Linardou, H., additional, Poddubskaya, E., additional, Fischer, J.R., additional, Pillai, R., additional, Li, S., additional, Acevedo, A., additional, and Paz-Ares, L., additional

Published
2019
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19. OA14.04 Five-Year Outcomes From the Randomized, Phase 3 Trials CheckMate 017/057: Nivolumab vs Docetaxel in Previously Treated NSCLC

Author

Gettinger, S., primary, Borghaei, H., additional, Brahmer, J., additional, Chow, L., additional, Burgio, M., additional, De Castro Carpeno, J., additional, Pluzanski, A., additional, Arrieta, O., additional, Frontera, O. Aren, additional, Chiari, R., additional, Butts, C., additional, Wojcik-Tomaszewska, J., additional, Coudert, B., additional, Garassino, M., additional, Ready, N., additional, Felip, E., additional, Garcia, M. Alonso, additional, Waterhouse, D., additional, Domine, M., additional, Barlesi, F., additional, Antonia, S., additional, Wohlleber, M., additional, Gerber, D., additional, Czyzewicz, G., additional, Spigel, D., additional, Crino, L., additional, Eberhardt, W., additional, Li, A., additional, Marimuthu, S., additional, and Vokes, E., additional

Published
2019
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20. OA04.02 CheckMate 817: First-Line Nivolumab + Ipilimumab in Patients with ECOG PS 2 and Other Special Populations with Advanced NSCLC

Author

Barlesi, F., primary, Audigier-Valette, C., additional, Felip, E., additional, Ciuleanu, T., additional, Jao, K., additional, Rijavec, E., additional, Urban, L., additional, Aucoin, J., additional, Zannori, C., additional, Vermaelen, K., additional, Frontera, O.A., additional, Ready, N., additional, Fontecedro, A. Curioni, additional, Linardou, H., additional, Poddubskaya, E., additional, Fischer, J., additional, Iordan, I., additional, Groen, H., additional, Pillai, R., additional, Li, S., additional, Fiore, J., additional, Chang, H., additional, Acevedo, A., additional, and Paz-Ares, L., additional

Published
2019
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21. Nivolumab (nivo) plus ipilimumab (ipi), nivo, or placebo (pbo) as maintenance therapy in patients (pts) with extensive disease small cell lung cancer (ED-SCLC) after first-line (1L) platinum-based chemotherapy (chemo): Results from the double-blind, randomized phase III CheckMate 451 study

Author

Owonikoko, T.K., primary, Kim, H.R., additional, Govindan, R., additional, Ready, N., additional, Reck, M., additional, Peters, S., additional, Dakhil, S.R., additional, Navarro, A., additional, Rodriguez-Cid, J., additional, Schenker, M., additional, Lee, J.S., additional, Gutierrez, V., additional, Percent, I., additional, Morgensztern, D., additional, Fairchild, J., additional, Baudelet, C., additional, and Park, K., additional

Published
2019
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22. CheckMate 817: Safety of flat-dose nivolumab (nivo) plus weight-based ipilimumab (ipi) for the first lie (1 L) treatment of advanced non-small cell lung cancer (NSCLC)

Author

Fischer, JR, additional, Paz-Ares, L, additional, Urban, L, additional, Audigier-Valette, C, additional, Grossi, F, additional, Jao, K, additional, Aucoin, JS, additional, Linardou, H, additional, Vladimirovna Poddubskaya, E, additional, Cuiioni Fontecedro, A, additional, Groen, HJM, additional, Vermaelen, K, additional, Bourhaba, M, additional, Kowalski, D, additional, Narayana Pillai, R, additional, Spigel, DR, additional, Ahmed, S, additional, Hu, W, additional, Vickery, D, additional, Fiore, J, additional, and Ready, N, additional

Published
2019
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23. Efficacy and safety of rovalpituzumab tesirine in patients with DLL3-expressing, ≥ 3rd line small cell lung cancer: Results from the phase 2 TRINITY study

Author

Carbone, DP, additional, Morgensztern, D, additional, Le Moulec, S, additional, Santana-Davila, R, additional, Ready, N, additional, Hann, CL, additional, Glisson, BS, additional, Dowlati, A, additional, Rudin, CM, additional, Lally, S, additional, Yalamanchili, S, additional, Wolf, J, additional, Govindan, R, additional, and Besse, B, additional

Published
2019
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24. P1.01-02 Long-Term Outcomes with First-Line Nivolumab Plus Ipilimumab in Advanced NSCLC: 3-Year Follow-Up from CheckMate 012

Author

Antonia, S., primary, Gettinger, S., additional, Borghaei, H., additional, Goldman, J.W., additional, Brahmer, J., additional, Ready, N., additional, Gerber, D., additional, Chow, L., additional, Juergens, R., additional, Laurie, S., additional, Shepherd, F., additional, Li, X., additional, Li, A., additional, Geese, W., additional, and Hellmann, M., additional

Published
2018
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25. P1.01-79 CheckMate 817: Safety of Flat-Dose Nivolumab Plus Weight-Based Ipilimumab for the First-line (1L) Treatment of Advanced NSCLC

Author

Paz-Ares, L., primary, Urban, L., additional, Audigier-Valette, C., additional, Grossi, F., additional, Jao, K., additional, Aucoin, J., additional, Linardou, H., additional, Vladimirovna Poddubskaya, E., additional, Fischer, J., additional, Curioni Fontecedro, A., additional, Groen, H., additional, Vermaelen, K., additional, Bourhaba, M., additional, Kowalski, D., additional, Pillai, R., additional, Spigel, D., additional, Ahmed, S., additional, Hu, W., additional, Vickery, D., additional, Fiore, J., additional, and Ready, N., additional

Published
2018
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26. Susceptibility loci of CNOT6 in the general mRNA degradation pathway and lung cancer risk-A re-analysis of eight GWASs

Author

Zhou, F.S., Wang, Y., Liu, H., Ready, N., Han, Y., Hung, R.J., Brhane, Y., McLaughlin, J., Brennan, P., Bickeböller, H., Rosenberger, A., Houlston, R.S., Caporaso, N., Landi, M.T., Brüske, I., Risch, A., Ye, Y., Wu, X., Christiani, D.C., Goodman, G., Chen, C., Amos, C.I., and Qingyi, W.

Subjects
Lung Neoplasms, RNA Stability, Quantitative Trait Loci, Polymorphism, Single Nucleotide, Linkage Disequilibrium, Article, Gene Expression Regulation, Neoplastic, Lung Cancer Risk, Molecular Epidemiology, Pathway Analysis, Exoribonucleases, Humans, Genetic Predisposition to Disease, RNA, Messenger, Lung, Genome-Wide Association Study
Abstract

PURPOSE: mRNA degradation is an important regulatory step for controlling gene expression and cell functions. Genetic abnormalities involved in mRNA degradation genes were found to be associated with cancer risk. Therefore, we systematically investigated the roles of genetic variants in the general mRNA degradation pathway in lung cancer risk. EXPERIMENTAL DESIGN: Meta-analyses were conducted using summary data from six lung cancer genome-wide association studies (GWASs) from the Transdisciplinary Research in Cancer of the Lung and additional two GWASs from Harvard University and deCODE in the International Lung Cancer Consortium. Expression quantitative trait loci analysis (eQTL) was used for in silico functional validation of the identified significant susceptibility loci. RESULTS: This pathway-based analysis included 6,816 single nucleotide polymorphisms (SNP) in 68 genes in 14,463 lung cancer cases and 44,188 controls. In the single-locus analysis, we found that 20 SNPs were associated with lung cancer risk with a false discovery rate threshold of

Published
2016

27. Factor analysis of authority behaviour inventory

Author

Ahmed, S.M.S., Boyce, A., and Ready, N.

Subjects
Factor analysis -- Research, Authoritarianism (Personality trait) -- Research, Psychology and mental health
Abstract

A factor analysis of the responses from 185 subjects to Rigby's (1987) Authority Behaviour Inventory Scale allowed other estimates of homogeneity. The results suggest that the scale is highly heterogeneous for the sample of 185 Canadian students.

Published
1991

28. 113 - Five-year outcomes from the randomized, phase 3 trials CheckMate 017/057: nivolumab vs docetaxel in previously treated NSCLC

Author

Lind, M., Gettinger, S., Borghaei, H., Brahmer, J., Chow, L., Burgio, M., De Castro Carpeno, J., Pluzanski, A., Arrieta, O., Frontera, O. Aren, Chiari, R., Butts, C., Wojcik-Tomaszewska, J., Coudert, B., Garassino, M., Ready, N., Felip, E., Garcia, M. Alonso, Waterhouse, D., Domine, M., Barlesi, F., Antonia, S., Wohlleber, M., Gerber, D., Czyzewicz, G., Spigel, D., Crino, L., Eberhardt, W., Li, A., Marimuthu, S., and Vokes, E.

Published
2020
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29. P3.07-012 Nivolumab Versus Docetaxel in Patients With Previously Treated Advanced Non-Small Cell Lung Cancer and Liver Metastases

Author

Crinò, L., primary, Horn, L., additional, Felip, E., additional, Frontera, O. Arén, additional, Burgio, M., additional, Waterhouse, D., additional, Blumenschein, G., additional, Barlesi, F., additional, Garassino, M., additional, Holgado, E., additional, Antonia, S., additional, Spigel, D., additional, Gainor, J., additional, Gettinger, S., additional, Geese, W., additional, Li, A., additional, Healey, D., additional, and Ready, N., additional

Published
2017
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30. Durvalumab for recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC): Preliminary results from a single-arm, phase 2 study

Author

Zandberg, D., primary, Algazi, A., additional, Jimeno, A., additional, Good, J.S., additional, Fayette, J., additional, Bouganim, N., additional, Ready, N., additional, Clement, P.M., additional, Goswmi, T., additional, Jarkowski, A., additional, Armstrong, J.M., additional, Asubonteng, K., additional, Melillo, G., additional, and Mesía, R., additional

Published
2017
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31. Initial results of BMS-986012, a first-in-class fucosyl-GM1 mAb, in combination with nivolumab, in pts with relapsed/refractory (rel/ref) small-cell lung cancer (SCLC)

Author

Chu, Q.S.-C., primary, van Herpen, C., additional, Leighl, N.B., additional, Markman, B., additional, Clarke, S., additional, Juergens, R.A., additional, Basciano, P., additional, Lathers, D., additional, Tannenbaum-Dvir, S., additional, Urbanska, K., additional, Kollia, G., additional, Darby, C., additional, Williams, D., additional, Kolaitis, G., additional, and Ready, N., additional

Published
2017
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33. First-Line Nivolumab in Stage IV or Recurrent Non-Small-Cell Lung Cancer.

Author

Carbone, D.P., Reck, M., Paz-Ares, L., Creelan, B., Horn, L., Steins, M., Felip, E., Heuvel, M. van den, Ciuleanu, T.E., Badin, F., Ready, N., Hiltermann, T.J.N., Nair, S., Juergens, R., Peters, S., Minenza, E., Wrangle, J.M., Rodriguez-Abreu, D., Borghaei, H., umenschein GR, J.r. Bl, Villaruz, L.C., Havel, L., Krejci, J., rral Jaime, J. Co, Chang, H., Geese, W.J., Bhagavatheeswaran, P., Chen, A.C., Socinski, M.A., Carbone, D.P., Reck, M., Paz-Ares, L., Creelan, B., Horn, L., Steins, M., Felip, E., Heuvel, M. van den, Ciuleanu, T.E., Badin, F., Ready, N., Hiltermann, T.J.N., Nair, S., Juergens, R., Peters, S., Minenza, E., Wrangle, J.M., Rodriguez-Abreu, D., Borghaei, H., umenschein GR, J.r. Bl, Villaruz, L.C., Havel, L., Krejci, J., rral Jaime, J. Co, Chang, H., Geese, W.J., Bhagavatheeswaran, P., Chen, A.C., and Socinski, M.A.

Abstract

Item does not contain fulltext, BACKGROUND: Nivolumab has been associated with longer overall survival than docetaxel among patients with previously treated non-small-cell lung cancer (NSCLC). In an open-label phase 3 trial, we compared first-line nivolumab with chemotherapy in patients with programmed death ligand 1 (PD-L1)-positive NSCLC. METHODS: We randomly assigned, in a 1:1 ratio, patients with untreated stage IV or recurrent NSCLC and a PD-L1 tumor-expression level of 1% or more to receive nivolumab (administered intravenously at a dose of 3 mg per kilogram of body weight once every 2 weeks) or platinum-based chemotherapy (administered once every 3 weeks for up to six cycles). Patients receiving chemotherapy could cross over to receive nivolumab at the time of disease progression. The primary end point was progression-free survival, as assessed by means of blinded independent central review, among patients with a PD-L1 expression level of 5% or more. RESULTS: Among the 423 patients with a PD-L1 expression level of 5% or more, the median progression-free survival was 4.2 months with nivolumab versus 5.9 months with chemotherapy (hazard ratio for disease progression or death, 1.15; 95% confidence interval [CI], 0.91 to 1.45; P=0.25), and the median overall survival was 14.4 months versus 13.2 months (hazard ratio for death, 1.02; 95% CI, 0.80 to 1.30). A total of 128 of 212 patients (60%) in the chemotherapy group received nivolumab as subsequent therapy. Treatment-related adverse events of any grade occurred in 71% of the patients who received nivolumab and in 92% of those who received chemotherapy. Treatment-related adverse events of grade 3 or 4 occurred in 18% of the patients who received nivolumab and in 51% of those who received chemotherapy. CONCLUSIONS: Nivolumab was not associated with significantly longer progression-free survival than chemotherapy among patients with previously untreated stage IV or recurrent NSCLC with a PD-L1 expression level of 5% or more. Overall survival was s

Published
2017

34. A phase 1/2 trial of a monoclonal antibody targeting fucosyl GM1 in relapsed/refractory small cell lung cancer (SCLC): Safety and preliminary efficacy.

Author

Basciano P., Ready N., Jackson J., Williams D., Kolaitis G., Phillips P., Kollia G., Rudin C., Krug L., Leighl N., Markman B., Chu Q.S-C., Fracasso P.M., Lathers D., Basciano P., Ready N., Jackson J., Williams D., Kolaitis G., Phillips P., Kollia G., Rudin C., Krug L., Leighl N., Markman B., Chu Q.S-C., Fracasso P.M., and Lathers D.

Abstract

Background: Fucosyl-GM1 (Fuc-GM1), a ganglioside with abundant yet restricted expression on the cell surface of SCLCs, is a potential target for therapeutic approaches. Here we present preliminary results from a Phase 1/2 study of BMS-986012, a first-in-class fully human IgG1 monoclonal antibody with enhanced ADCC that specifically binds to Fuc-GM1, for the treatment of SCLC. Method(s): Patients ( pts) with relapsed/refractory SCLC after at least one line of prior therapy were enrolled. BMS-986012 was administered IV at flat doses of 70, 160, 400, and 1000 mg every 3 weeks (wk) during dose escalation. Pharmacokinetics (PK) and anti-drug antibodies (ADA) were assessed during cycle 1. Result(s): Twenty-nine pts were treated across all doses. Median age was 63 yr (range: 26-81); 55% were female; 95% had a smoking history. Pts had received up to five lines of prior therapy; 52% had one prior line; 48% had 2 or more two prior lines. Nine pts were platinum refractory (<=3 mo from end of first line therapy to progression). No dose limiting toxicities or treatment-related grade 4 or 5 adverse events occurred. Treatment-related adverse events occurring in >10% of pts were pruritus, decreased appetite, and rash. Preliminary PK analysis suggests a linear dose-exposure relationship (Table). No ADAs were detected. One confirmed complete response (CR; duration 53 wk; 70 mg dose level) and one confirmed partial response (PR; duration 17 wk; 400 mg dose level) were observed. Stable disease (SD) was reported in 4 pts. The CR and 2 SD occurred among the 9 platinum refractory pts. Conclusion(s): BMS-986012 demonstrates a manageable safety profile and resulted in objective responses in relapsed SCLC, including platinum refractory pts. Preliminary PK analysis showed dose-proportional and linear increase in exposure with moderate to high variability. Dose expansion is currently enrolling at 400 and 1000 mg.

Published
2017

35. Initial results of BMS-986012, a first-in-class fucosyl-GM1 mAb, in combination with nivolumab, in pts with relapsed/refractory (rel/ ref) small-cell lung cancer (SCLC).

Author

Darby C., Kollia G., Williams D., Ready N., Kolaitis G., Chu Q.S-C., Van Herpen C., Leighl N.B., Markman B., Clarke S., Juergens R.A., Basciano P., Lathers D., Tannenbaum-Dvir S., Urbanska K., Darby C., Kollia G., Williams D., Ready N., Kolaitis G., Chu Q.S-C., Van Herpen C., Leighl N.B., Markman B., Clarke S., Juergens R.A., Basciano P., Lathers D., Tannenbaum-Dvir S., and Urbanska K.

Abstract

Background: Given the burden of comorbidities, lack of curative agents, and high mortality in pts with SCLC, novel treatment options with limited toxicity are needed. BMS-986012 is a first-in-class, fully human mAb with enhanced antibody-dependent cellmediated cytotoxicity that binds to fucosyl-GM1, a ganglioside highly expressed on SCLC. BMS-986012 monotherapy is well tolerated and has shown evidence of antitumor activity in some pts with rel/ref SCLC in a phase 1/2 study (NCT02247349; Chu et al. Ann Oncol. 2016;27(6 suppl) [abstract 1427PD]). Here we present initial results of BMS-986012 + nivolumab (anti-programmed death-1 mAb) in pts with rel/ref SCLC (NCT02247349). Method(s): Pts with SCLC who relapsed after or were refractory to first-line therapy received BMS-986012 400 or 1000 mg +nivolumab 360 mg IV Q3W. Dose escalation was based on a modified toxicity probability interval design. Primary objectives were safety and tolerability and determination of dose-limiting toxicities (DLT) and maximum tolerated dose. Secondary objectives included pharmacokinetics, antitumor activity, and immunogenicity. Result(s): To date, 16 pts received BMS-986012 (400 mg, n=8; 1000 mg, n=8)+nivolumab. Demographic and safety data are based on 14 pts treated as of the April 3, 2017 cutoff. Median age was 64 y (range, 49-79 y), ECOG status was 0 (29%) or 1 (71%), and all pts were current (29%) or former (71%) smokers. All pts had prior platinum-based first-line therapy. The most common treatment-related AEs (TRAEs) were generalized pruritus (71%), vulvovaginal pruritus (21%), and dry skin (21%). Only 2 pts, both treated with 1000/360 mg, had G3/4 TRAEs (G3 pruritus with G4 lipase increase; G3 hepatic failure [DLT; led to discontinuation]). As of May 1, 2017, 4 of the 16 pts evaluable for efficacy achieved partial responses (2 unconfirmed). Updated efficacy data as well as data from ongoing biomarker analyses will be presented. Conclusion(s): BMS-986012 in combination with nivolumab is

Published
2017

36. Susceptibility loci of CNOT6 in the general mRNA degradation pathway and lung cancer risk-A re-analysis of eight GWASs.

Author

Zhou, F, Wang, Y, Liu, H, Ready, N, Han, Y, Hung, RJ, Brhane, Y, McLaughlin, J, Brennan, P, Bickeböller, H, Rosenberger, A, Houlston, RS, Caporaso, N, Landi, MT, Brüske, I, Risch, A, Ye, Y, Wu, X, Christiani, DC, Goodman, G, Chen, C, Transdisciplinary Research in Cancer of the Lung (TRICL) Research Team, Amos, CI, Wei, Q, Zhou, F, Wang, Y, Liu, H, Ready, N, Han, Y, Hung, RJ, Brhane, Y, McLaughlin, J, Brennan, P, Bickeböller, H, Rosenberger, A, Houlston, RS, Caporaso, N, Landi, MT, Brüske, I, Risch, A, Ye, Y, Wu, X, Christiani, DC, Goodman, G, Chen, C, Transdisciplinary Research in Cancer of the Lung (TRICL) Research Team, Amos, CI, and Wei, Q

Published
2017

38. LBA1_PR - Nivolumab (nivo) plus ipilimumab (ipi), nivo, or placebo (pbo) as maintenance therapy in patients (pts) with extensive disease small cell lung cancer (ED-SCLC) after first-line (1L) platinum-based chemotherapy (chemo): Results from the double-blind, randomized phase III CheckMate 451 study

Author

Owonikoko, T.K., Kim, H.R., Govindan, R., Ready, N., Reck, M., Peters, S., Dakhil, S.R., Navarro, A., Rodriguez-Cid, J., Schenker, M., Lee, J.S., Gutierrez, V., Percent, I., Morgensztern, D., Fairchild, J., Baudelet, C., and Park, K.

Published
2019
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39. A phase 1/2 trial of a monoclonal antibody targeting fucosyl GM1 in relapsed/refractory small cell lung cancer (SCLC): Safety and preliminary efficacy

Author

Chu, Q.S.-C., primary, Markman, B., additional, Leighl, N., additional, Krug, L., additional, Rudin, C., additional, Lathers, D., additional, Basciano, P., additional, Fracasso, P.M., additional, Kollia, G., additional, Phillips, P., additional, Kolaitis, G., additional, Williams, D., additional, Jackson, J., additional, and Ready, N., additional

Published
2016
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41. Long-term outcomes with nivolumab (Nivo) vs docetaxel (Doc) in patients (Pts) with advanced (Adv) NSCLC: CheckMate 017 and CheckMate 057 2-y update

Author

Barlesi, F., primary, Steins, M., additional, Horn, L., additional, Ready, N., additional, Felip, E., additional, Borghaei, H., additional, Spigel, D.R., additional, Arrieta, O., additional, Antonia, S.J., additional, Fayette, J., additional, Rizvi, N., additional, Crinò, L., additional, Reck, M., additional, Eberhardt, W.E., additional, Hellmann, M., additional, Geese, W.J., additional, Li, A., additional, Healey, D., additional, Brahmer, J.R., additional, and Paz-Ares, L., additional

Published
2016
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42. NSCLC, metastatic CheckMate 026: A phase 3 trial of nivolumab vs investigator's choice (IC) of platinum-based doublet chemotherapy (PT-DC) as first-line therapy for stage iv/recurrent programmed death ligand 1 (PD-L1)−positive NSCLC

Author

Socinski, M., primary, Creelan, B., additional, Horn, L., additional, Reck, M., additional, Paz-Ares, L., additional, Steins, M., additional, Felip, E., additional, van den Heuvel, M., additional, Ciuleanu, T.E., additional, Badin, F., additional, Ready, N., additional, Hiltermann, T.J.N., additional, Nair, S., additional, Juergens, R., additional, Peters, S., additional, Minenza, E., additional, Geese, W.J., additional, Bhagavatheeswaran, P., additional, Chen, A., additional, and Carbone, D.P., additional

Published
2016
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49. LBA7_PR - NSCLC, metastatic CheckMate 026: A phase 3 trial of nivolumab vs investigator's choice (IC) of platinum-based doublet chemotherapy (PT-DC) as first-line therapy for stage iv/recurrent programmed death ligand 1 (PD-L1)−positive NSCLC

Author

Socinski, M., Creelan, B., Horn, L., Reck, M., Paz-Ares, L., Steins, M., Felip, E., van den Heuvel, M., Ciuleanu, T.E., Badin, F., Ready, N., Hiltermann, T.J.N., Nair, S., Juergens, R., Peters, S., Minenza, E., Geese, W.J., Bhagavatheeswaran, P., Chen, A., and Carbone, D.P.

Published
2016
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