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33 results on '"El-Khoueiry A.B."'

1. 122P Casdozokitug (casdozo, SRF388), a first-in-class IL-27 targeting antibody, as monotherapy (monotx) or in combination with pembrolizumab (pembro) in treatment-refractory non-small cell lung cancer (NSCLC)

Author

Marron, T.U., primary, Naing, A., additional, Mantia, C., additional, Pennell, N., additional, Kim, H.R., additional, Villaruz, L., additional, El-Khoueiry, A.B., additional, Gerber, D.E., additional, Qin, A., additional, Kim, T-Y., additional, Altan, M., additional, Gandhi, L., additional, Appleman, L.J., additional, Yoon, S., additional, Hill, J., additional, Reichert, V., additional, Masia, R., additional, Harshman, L., additional, Patnaik, A., additional, and Morgensztern, D., additional

Published
2023
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2. Nivolumab in sorafenib-naive and sorafenib-experienced patients with advanced hepatocellular carcinoma: 5-year follow-up from CheckMate 040

Author

El-Khoueiry, A.B., primary, Trojan, J., additional, Meyer, T., additional, Yau, T., additional, Melero, I., additional, Kudo, M., additional, Hsu, C., additional, Kim, T.-Y., additional, Choo, S.-P., additional, Kang, Y.-K., additional, Yeo, W., additional, Chopra, A., additional, Soleymani, S., additional, Yao, J., additional, Neely, J., additional, Tschaika, M., additional, Welling, T.H., additional, and Sangro, B., additional

Published
2023
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3. 783TiP Phase I study of HFB301001, a novel OX40 agonist monoclonal antibody, in patients with solid tumors selected via Drug Intelligence Science (DIS)

Author

Spira, A., primary, Mehra, R., additional, Mantia, C., additional, Babiker, H., additional, Borad, M., additional, Cervantes, A., additional, Garralda, E., additional, Mahipal, A., additional, Paz-Ares, L., additional, Hatzis, C., additional, Liu, A., additional, Raue, A., additional, Gan, J., additional, Adrian, F., additional, Manenti, L., additional, and El-Khoueiry, A.B., additional

Published
2022
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4. 754P A phase I/IIa dose escalation study of AFM24 in patients with epidermal growth factor receptor-expressing (EGFR) solid tumors: Results from phase I

Author

El-Khoueiry, A.B., primary, Lopez, J.S., additional, Saavedra, O., additional, Awad, M., additional, Thomas, J., additional, Tiu, C., additional, Garralda, E., additional, Rehbein, B., additional, Hintzen, G., additional, Pietzko, K., additional, Raab, C., additional, Rajkovic, E., additional, Ravenstijn, P., additional, Rivas, D., additional, and Emig, M., additional

Published
2022
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7. 712TiP A phase I/II multicenter, open-label, dose-escalation, safety, pharmacodynamic, and pharmacokinetic study of Q901 administered via intravenous infusion in adult patients with selected advanced solid tumors with a cohort expansion at the recommended phase II dose

Author

Alistar, A., Mahalingam, D., Barve, M., Borad, M., Babiker, H., Xie, H., Choi, B., Ahn, J., Choi, J., Ahn, K., Ryu, S., Kim, J., Yu, D., Lee, S-J., Jeon, B., Proniuk, S., Nam, K., and El-Khoueiry, A.B.

Published
2023
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10. 1016TiP LEAP-012 trial in progress: Pembrolizumab plus lenvatinib and transarterial chemoembolization (TACE) in patients with intermediate-stage hepatocellular carcinoma (HCC) not amenable to curative treatment

Author

Llovet, J.M., primary, El-Khoueiry, A.B., additional, Vogel, A., additional, Madoff, D.C., additional, Finn, R.S., additional, Ogasawara, S., additional, Ren, Z., additional, Mody, K., additional, Li, J. Jing, additional, Siegel, A.B., additional, Dubrovsky, L., additional, and Kudo, M., additional

Published
2020
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11. 525O A phase I dose escalation study of PRS-343, a HER2/4-1BB bispecific molecule, in patients with HER2-positive malignancies

Author

Ku, G., primary, Bendell, J.C., additional, Tolcher, A.W., additional, Hurvitz, S.A., additional, Krishnamurthy, A., additional, El-Khoueiry, A.B., additional, Patnaik, A., additional, Shroff, R.T., additional, Noonan, A., additional, Hahn, N.M., additional, Matrana, M., additional, Zettl, M., additional, Aviano, K., additional, Mar, L., additional, Jolicoeur, P., additional, Olwill, S., additional, Bruns, I., additional, and Piha-Paul, S., additional

Published
2020
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14. Outcomes based on albumin‐bilirubin (ALBI) grade in the phase III CELESTIAL trial of cabozantinib versus placebo in patients with advanced hepatocellular carcinoma (HCC)

Author

Chan, S.L., primary, Miksad, R., additional, Cicin, I., additional, Chen, Y., additional, Klumpen, H.J., additional, Kim, S., additional, Lin, Z.Z., additional, Youkstetter, J., additional, Sen, S., additional, Cheng, A.-L., additional, El-Khoueiry, A.B., additional, Meyer, T., additional, Kelley, R.K., additional, and Abou-Alfa, G.K., additional

Published
2019
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15. Outcomes based on plasma biomarkers for the phase III CELESTIAL trial of cabozantinib (C) versus placebo (P) in advanced hepatocellular carcinoma (aHCC)

Author

Rimassa, L., primary, Kelley, R.K., additional, Meyer, T., additional, Ryoo, B.-Y., additional, Merle, P., additional, Park, J.-W., additional, Blanc, J.-F., additional, Lim, H.Y., additional, Tran, A., additional, Borgman-Hagey, A.E., additional, Clary, D.O., additional, Wang, E., additional, Cheng, A.-L., additional, El-Khoueiry, A.B., additional, and Abou-Alfa, G.K., additional

Published
2019
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17. Outcomes by baseline alpha-fetoprotein (AFP) levels in the phase III CELESTIAL trial of cabozantinib (C) versus placebo (P) in previously treated advanced hepatocellular carcinoma (HCC)

Author

Kelley, R.K., primary, El-Khoueiry, A.B., additional, Meyer, T., additional, Rimassa, L., additional, Merle, P., additional, Chan, S.L., additional, Tran, A., additional, Parnis, F., additional, Tam, V.C., additional, Cattan, S., additional, Markby, D.W., additional, Clary, D.O., additional, Cheng, A.-L., additional, and Abou-Alfa, G.K., additional

Published
2018
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18. Pharmacodynamic (PD) changes in tumors and peripheral blood T cell receptor (TCR) repertoire in a phase I study combining OX40 (PF-04518600) and 4-1BB (utomilumab) agonistic monoclonal antibodies (mAbs)

Author

Hamid, O., primary, Hu-Lieskovan, S., additional, Ros, W., additional, Diab, A., additional, El-Khoueiry, A.B., additional, Thompson, J.A., additional, Eskens, F.A., additional, Spano, J.-P., additional, Angevin, E., additional, Rizvi, N.A., additional, Wasser, J.S., additional, Ott, P.A., additional, Chiappori, A., additional, Joh, T., additional, Krupka, H.I., additional, Potluri, S., additional, Wang, X., additional, Ganguli, B.J., additional, Chou, J., additional, and Doi, T., additional

Published
2018
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19. Preliminary results of the first-in-human, dose-finding PROCLAIM-CX-072 trial evaluating the PD-L1 probody therapeutic CX-072 in combination with ipilimumab (ipi) in patients (pts) with advanced solid tumors

Author

Plummer, R., primary, Sanborn, R.E., additional, de Vries, E.G.E., additional, Lorusso, P., additional, Arkenau, H.-T., additional, Uboha, N., additional, Wydmanski, J., additional, Fidler, M.J., additional, Boni, V., additional, Garcia-Corbacho, J., additional, Humphrey, R., additional, Will, M., additional, Autio, K.A., additional, El-Khoueiry, A.B., additional, Menke-van der Houven van Oordt, C.W., additional, and Thistlethwaite, F., additional

Published
2018
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20. Assessment of disease burden in the phase III CELESTIAL trial of cabozantinib (C) versus placebo (P) in advanced hepatocellular carcinoma (HCC)

Author

Blanc, J.F., primary, Meyer, T., additional, Cheng, A.-L., additional, El-Khoueiry, A.B., additional, Cicin, I., additional, Chen, Y., additional, Bolondi, L., additional, Dadduzio, V., additional, Baron, A., additional, Lin, Z.-Z., additional, Adriani, J., additional, Kelly, R.K., additional, and Abou-Alfa, G.K., additional

Published
2018
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21. Outcomes by prior transarterial chemoembolization (TACE) in the phase III CELESTIAL trial of cabozantinib (C) versus placebo (P) in patients (pts) with advanced hepatocellular carcinoma (HCC)

Author

Yau, T., primary, Cheng, A.-L., additional, Meyer, T., additional, Ryoo, B.-Y., additional, Park, J.-W., additional, Klümpen, H.-J., additional, Lim, H.Y., additional, Kim, S., additional, Knox, J., additional, Patel, M., additional, El-Khoueiry, A.B., additional, Kelley, R.K., additional, and Abou-Alfa, G.K., additional

Published
2018
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26. 1184P - Pharmacodynamic (PD) changes in tumors and peripheral blood T cell receptor (TCR) repertoire in a phase I study combining OX40 (PF-04518600) and 4-1BB (utomilumab) agonistic monoclonal antibodies (mAbs)

Author

Hamid, O., Hu-Lieskovan, S., Ros, W., Diab, A., El-Khoueiry, A.B., Thompson, J.A., Eskens, F.A., Spano, J.-P., Angevin, E., Rizvi, N.A., Wasser, J.S., Ott, P.A., Chiappori, A., Joh, T., Krupka, H.I., Potluri, S., Wang, X., Ganguli, B.J., Chou, J., and Doi, T.

Published
2018
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30. 436P - Preliminary results of the first-in-human, dose-finding PROCLAIM-CX-072 trial evaluating the PD-L1 probody therapeutic CX-072 in combination with ipilimumab (ipi) in patients (pts) with advanced solid tumors

Author

Plummer, R., Sanborn, R.E., de Vries, E.G.E., Lorusso, P., Arkenau, H.-T., Uboha, N., Wydmanski, J., Fidler, M.J., Boni, V., Garcia-Corbacho, J., Humphrey, R., Will, M., Autio, K.A., El-Khoueiry, A.B., Menke-van der Houven van Oordt, C.W., and Thistlethwaite, F.

Published
2018
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31. Phase 3 Randomized, Double-Blind, Controlled Study of Cabozantinib (Xl184) Vs Placebo in Subjects with Hepatocellular Carcinoma Who Have Received Prior Sorafenib (Celestial) (Nct01908426)

Author

Abou-Alfa, G.K., primary, Cheng, A., additional, Meyer, T., additional, El-Khoueiry, A.B., additional, Ikeda, M., additional, Chun, H.G., additional, Furuse, J., additional, Knox, J., additional, Okusaka, T., additional, Colombo, M., additional, Merle, P., additional, Santoro, A., additional, Gallagher, D., additional, Janczewska, E., additional, Trojan, J., additional, Klumpen, H.J., additional, Cicin, I., additional, Ping, J., additional, Borgman-Hagey, A.E., additional, and Kelley, R.K., additional

Published
2014
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32. 742TiP - Phase 3 Randomized, Double-Blind, Controlled Study of Cabozantinib (Xl184) Vs Placebo in Subjects with Hepatocellular Carcinoma Who Have Received Prior Sorafenib (Celestial) (Nct01908426)

Author

Abou-Alfa, G.K., Cheng, A., Meyer, T., El-Khoueiry, A.B., Ikeda, M., Chun, H.G., Furuse, J., Knox, J., Okusaka, T., Colombo, M., Merle, P., Santoro, A., Gallagher, D., Janczewska, E., Trojan, J., Klumpen, H.J., Cicin, I., Ping, J., Borgman-Hagey, A.E., and Kelley, R.K.

Published
2014
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33. Efficacy and Safety of Nivolumab Plus Ipilimumab in Patients With Advanced Hepatocellular Carcinoma Previously Treated With Sorafenib

Author

Tae-You Kim, Jennifer J. Knox, Ho Yeong Lim, Ignacio Melero, Yoon-Koo Kang, Masatoshi Kudo, Francesco Tovoli, Chiun Hsu, Thomas Yau, Jaclyn Neely, Aiwu Ruth He, Ming Mo Hou, Bruno Sangro, Yun Shen, Tami Wisniewski, Jeffrey Anderson, Ana Matilla, Armando Santoro, Bassel F. El-Rayes, Anthony B. El-Khoueiry, Mirelis Acosta-Rivera, Yau T., Kang Y.-K., Kim T.-Y., El-Khoueiry A.B., Santoro A., Sangro B., Melero I., Kudo M., Hou M.-M., Matilla A., Tovoli F., Knox J.J., Ruth He A., El-Rayes B.F., Acosta-Rivera M., Lim H.-Y., Neely J., Shen Y., Wisniewski T., Anderson J., and Hsu C.

Subjects
Male, Sorafenib, Cancer Research, medicine.medical_specialty, Carcinoma, Hepatocellular, Randomization, Ipilimumab, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, 030212 general & internal medicine, ipilimumab, nivolumab, business.industry, Liver Neoplasms, Correction, hepatocellular carcinoma, Regimen, Oncology, Tolerability, Response Evaluation Criteria in Solid Tumors, 030220 oncology & carcinogenesis, immunotherapy, Nivolumab, business, medicine.drug
Abstract

Importance Most patients with hepatocellular carcinoma (HCC) are diagnosed with advanced disease not eligible for potentially curative therapies; therefore, new treatment options are needed. Combining nivolumab with ipilimumab may improve clinical outcomes compared with nivolumab monotherapy. Objective To assess efficacy and safety of nivolumab plus ipilimumab in patients with advanced HCC who were previously treated with sorafenib. Design, Setting, and Participants CheckMate 040 is a multicenter, open-label, multicohort, phase 1/2 study. In the nivolumab plus ipilimumab cohort, patients were randomized between January 4 and September 26, 2016. Treatment group information was blinded after randomization. Median follow-up was 30.7 months. Data cutoff for this analysis was January 2019. Patients were recruited at 31 centers in 10 countries/territories in Asia, Europe, and North America. Eligible patients had advanced HCC (with/without hepatitis B or C) previously treated with sorafenib. A total of 148 patients were randomized (50 to arm A and 49 each to arms B and C). Interventions Patients were randomized 1:1:1 to either nivolumab 1 mg/kg plus ipilimumab 3 mg/kg, administered every 3 weeks (4 doses), followed by nivolumab 240 mg every 2 weeks (arm A); nivolumab 3 mg/kg plus ipilimumab 1 mg/kg, administered every 3 weeks (4 doses), followed by nivolumab 240 mg every 2 weeks (arm B); or nivolumab 3 mg/kg every 2 weeks plus ipilimumab 1 mg/kg every 6 weeks (arm C). Main Outcomes and Measures Coprimary end points were safety, tolerability, and objective response rate. Duration of response was also measured (investigator assessed with the Response Evaluation Criteria in Solid Tumors v1.1). Results Of 148 total participants, 120 were male (81%). Median (IQR) age was 60 (52.5-66.5). At data cutoff (January 2019), the median follow-up was 30.7 months (IQR, 29.9-34.7). Investigator-assessed objective response rate was 32% (95% CI, 20%-47%) in arm A, 27% (95% CI, 15%-41%) in arm B, and 29% (95% CI, 17%-43%) in arm C. Median (range) duration of response was not reached (8.3-33.7+) in arm A and was 15.2 months (4.2-29.9+) in arm B and 21.7 months (2.8-32.7+) in arm C. Any-grade treatment-related adverse events were reported in 46 of 49 patients (94%) in arm A, 35 of 49 patients (71%) in arm B, and 38 of 48 patients (79%) in arm C; there was 1 treatment-related death (arm A; grade 5 pneumonitis). Conclusions and Relevance In this randomized clinical trial, nivolumab plus ipilimumab had manageable safety, promising objective response rate, and durable responses. The arm A regimen (4 doses nivolumab 1 mg/kg plus ipilimumab 3 mg/kg every 3 weeks then nivolumab 240 mg every 2 weeks) received accelerated approval in the US based on the results of this study. Trial Registration ClinicalTrials.gov Identifier:NCT01658878

Published
2020
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