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2. Analysis of Radiation Therapy Quality Assurance in NRG Oncology RTOG 0848

Author

Tchelebi, Leila T., Winter, Kathryn A., Abrams, Ross A., Safran, Howard P., Regine, William F., McNulty, Susan, Wu, Abraham, Du, Kevin L., Seaward, Samantha A., Bian, Shelly X., Aljumaily, Raid, Shivnani, Anand, Knoble, Jeanna L., Crocenzi, Todd S., DiPetrillo, Thomas A., Roof, Kevin S., Crane, Christopher H., and Goodman, Karyn A.

Published
2024
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3. Immunologic and tumor responses of pegilodecakin with 5-FU/LV and oxaliplatin (FOLFOX) in pancreatic ductal adenocarcinoma (PDAC)

Author

Hecht, J Randolph, Papadopoulos, Kyriakos P, Falchook, Gerald S, Patel, Manish R, Infante, Jeffrey R, Aljumaily, Raid, Wong, Deborah J, Autio, Karen A, Wainberg, Zev A, Bauer, Todd M, Javle, Milind, Pant, Shubham, Bendell, Johanna, Hung, Annie, Ratti, Navneet, VanVlasselaer, Peter, Verma, Rakesh, Leveque, Joseph, Rao, Sujata, Oft, Martin, and Naing, Aung

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Immunology, Clinical Trials and Supportive Activities, Cancer, Pancreatic Cancer, Clinical Research, Digestive Diseases, Rare Diseases, 6.1 Pharmaceuticals, 6.2 Cellular and gene therapies, Evaluation of treatments and therapeutic interventions, Adult, Aged, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Pancreatic Ductal, Dose-Response Relationship, Drug, Fluorouracil, Humans, Interleukin-10, Kaplan-Meier Estimate, Leucovorin, Middle Aged, Neoplasm Staging, Organoplatinum Compounds, Pancreatic Neoplasms, Polyethylene Glycols, Progression-Free Survival, Response Evaluation Criteria in Solid Tumors, Metastatic pancreatic adenocarcinoma, Pegilodecakin, FOLFOX, Phase 1, IL-10, Pegylated IL-10, Pharmacology and Pharmaceutical Sciences, Oncology & Carcinogenesis, Oncology and carcinogenesis, Pharmacology and pharmaceutical sciences
Abstract

Background Treatment options for pancreatic ductal adenocarcinoma (PDAC) are limited and checkpoint blockade inhibitors have been disappointing in this disease. Pegilodecakin has demonstrated single agent anti-tumor activity in immune-sensitive tumors. Phase 1 and preclinical data indicate synergy of pegilodecakin with 5-FU and platins. We assessed the safety and activity of pegilodecakin+FOLFOX in patients with PDAC. Methods IVY (NCT02009449) was an open-label phase 1b trial in the United States. Here we report on all enrolled patients from cohort C. Heavily pretreated patients were treated with pegilodecakin (self-administered subcutaneously daily at 2.5, 5, or 10 μg/kg) + 5-flurouracil/leucovorin/oxaliplatin (FOLFOX), dosed per manufacturers prescribing information, until tumor progression. Eligible patients had measurable disease per immune-related response criteria (irRC), were ≥ 18 years of age, and had ECOG performance status of 0 or 1. Patients were evaluated for primary(safety) and secondary (tumor response per irRC) endpoints. Results From 5 August 2014-12 July 2016, 39 patients enrolled in cohort C. All patients were evaluable for safety. In this advanced population, regimen had manageable toxicities with no immune-related adverse events (irAEs) greater than grade 1. The most common grade 3/4/5 TEAEs were thrombocytopenia (21[53.8%] of 39) and anemia (17[43.6%] of 39). In evaluable PDAC patients, the best overall response of pegilodecakin+FOLFOX was 3(14%) with CRs in 2(9%) patients. Conclusions Pegilodecakin+FOLFOX had an acceptable tolerability profile in PDAC, with no substantial irAEs seen, and promising efficacy with the combination yielding a 2-year OS of 24% (95% CI 10-42). These data led to the phase 3 study with pegilodecakin+FOLFOX as second-line therapy of PDAC (SEQUOIA).

Published
2021

4. Pegilodecakin combined with pembrolizumab or nivolumab for patients with advanced solid tumours (IVY): a multicentre, multicohort, open-label, phase 1b trial

Author

Naing, Aung, Wong, Deborah J, Infante, Jeffrey R, Korn, W Michael, Aljumaily, Raid, Papadopoulos, Kyriakos P, Autio, Karen A, Pant, Shubham, Bauer, Todd M, Drakaki, Alexandra, Daver, Naval G, Hung, Annie, Ratti, Navneet, McCauley, Scott, Van Vlasselaer, Peter, Verma, Rakesh, Ferry, David, Oft, Martin, Diab, Adi, Garon, Edward B, and Tannir, Nizar M

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Cancer, Lung, Clinical Trials and Supportive Activities, Clinical Research, Evaluation of treatments and therapeutic interventions, 6.2 Cellular and gene therapies, 6.1 Pharmaceuticals, Good Health and Well Being, Aged, Antibodies, Monoclonal, Humanized, Antineoplastic Agents, Immunological, Antineoplastic Combined Chemotherapy Protocols, Female, Humans, Interleukin-10, Male, Middle Aged, Neoplasms, Nivolumab, Polyethylene Glycols, Programmed Cell Death 1 Receptor, United States, Oncology & Carcinogenesis, Oncology and carcinogenesis
Abstract

BackgroundIL-10 has anti-inflammatory and CD8+ T-cell stimulating activities. Pegilodecakin (pegylated IL-10) is a first-in-class, long-acting IL-10 receptor agonist that induces oligoclonal T-cell expansion and has single-agent activity in advanced solid tumours. We assessed the safety and activity of pegilodecakin with anti-PD-1 monoclonal antibody inhibitors in patients with advanced solid tumours.MethodsWe did a multicentre, multicohort, open-label, phase 1b trial (IVY) at 12 cancer research centres in the USA. Patients were assigned sequentially into cohorts. Here, we report on all enrolled patients from two cohorts treated with pegilodecakin combined with anti-PD-1 inhibitors. Eligible patients were aged at least 18 years with histologically or cytologically confirmed advanced malignant solid tumours refractory to previous therapies, and an Eastern Cooperative Oncology Group performance status of 0 or 1. Patients with uncontrolled infectious diseases were excluded. Pegilodecakin was provided in single-use 3 mL vials and was self-administered subcutaneously by injection at home at 10 μg/kg or 20 μg/kg once per day in combination with pembrolizumab (2 mg/kg every 3 weeks or 200 mg every 3 weeks) or nivolumab (3 mg/kg every 2 weeks or 240 mg every 2 weeks or 480 mg every 4 weeks at the approved dosing), both of which were given intravenously at the study site. Patients received pembrolizumab or nivolumab with pegilodecakin until disease progression, toxicity necessitating treatment discontinuation, patient withdrawal of consent, or study end. The primary endpoints were safety and tolerability, assessed in all patients enrolled in the study who received any amount of study medication including at least one dose of pegilodecakin, and pharmacokinetics (previously published). Secondary endpoints included objective response by immune-related response criteria in all patients who were treated and had evaluable measurements. The study is active but no longer recruiting, and is registered with ClinicalTrials.gov, NCT02009449.FindingsBetween Feb 13, 2015, and Sept 12, 2017, 111 patients were enrolled in the two cohorts. 53 received pegilodecakin plus pembrolizumab, and 58 received pegilodecakin plus nivolumab. 34 (31%) of 111 patients had non-small-cell lung cancer, 37 (33%) had melanoma, and 38 (34%) had renal cell carcinoma; one (

Published
2019

5. Paradoxical effects of obesity on T cell function during tumor progression and PD-1 checkpoint blockade

Author

Wang, Ziming, Aguilar, Ethan G, Luna, Jesus I, Dunai, Cordelia, Khuat, Lam T, Le, Catherine T, Mirsoian, Annie, Minnar, Christine M, Stoffel, Kevin M, Sturgill, Ian R, Grossenbacher, Steven K, Withers, Sita S, Rebhun, Robert B, Hartigan-O’Connor, Dennis J, Méndez-Lagares, Gema, Tarantal, Alice F, Isseroff, R Rivkah, Griffith, Thomas S, Schalper, Kurt A, Merleev, Alexander, Saha, Asim, Maverakis, Emanual, Kelly, Karen, Aljumaily, Raid, Ibrahimi, Sami, Mukherjee, Sarbajit, Machiorlatti, Michael, Vesely, Sara K, Longo, Dan L, Blazar, Bruce R, Canter, Robert J, Murphy, William J, and Monjazeb, Arta M

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Immunology, Obesity, Clinical Research, Vaccine Related, Cancer, Immunization, Nutrition, Rare Diseases, Aging, Digestive Diseases, Aetiology, Development of treatments and therapeutic interventions, 5.1 Pharmaceuticals, 2.1 Biological and endogenous factors, Adult, Animals, Body Weight, Cell Line, Tumor, Cell Proliferation, Diet, Disease Progression, Female, Humans, Immunotherapy, Leptin, Male, Mice, Inbred C57BL, Mice, Obese, Middle Aged, Neoplasms, Programmed Cell Death 1 Receptor, Signal Transduction, Species Specificity, T-Lymphocytes, Tumor Burden, Medical and Health Sciences, Biomedical and clinical sciences, Health sciences
Abstract

The recent successes of immunotherapy have shifted the paradigm in cancer treatment, but because only a percentage of patients are responsive to immunotherapy, it is imperative to identify factors impacting outcome. Obesity is reaching pandemic proportions and is a major risk factor for certain malignancies, but the impact of obesity on immune responses, in general and in cancer immunotherapy, is poorly understood. Here, we demonstrate, across multiple species and tumor models, that obesity results in increased immune aging, tumor progression and PD-1-mediated T cell dysfunction which is driven, at least in part, by leptin. However, obesity is also associated with increased efficacy of PD-1/PD-L1 blockade in both tumor-bearing mice and clinical cancer patients. These findings advance our understanding of obesity-induced immune dysfunction and its consequences in cancer and highlight obesity as a biomarker for some cancer immunotherapies. These data indicate a paradoxical impact of obesity on cancer. There is heightened immune dysfunction and tumor progression but also greater anti-tumor efficacy and survival after checkpoint blockade which directly targets some of the pathways activated in obesity.

Published
2019

7. Comparing the rate of immunotherapy treatment change due to toxicity by sex

Author

Chua, Kevin J., primary, Kronstedt, Shane, additional, Kaldany, Alain, additional, Srivastava, Arnav, additional, Doppalapudi, Sai Krishnaraya, additional, Liu, Hao, additional, Tarhini, Ahmad A., additional, Gatti‐Mays, Margaret, additional, Gaughan, Elizabeth, additional, Hu‐Lieskovan, Siwen, additional, Aljumaily, Raid, additional, Nepple, Kenneth, additional, Schneider, Bryan, additional, Sterling, Joshua, additional, and Singer, Eric A., additional

Published
2024
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8. Trilaciclib dose selection: an integrated pharmacokinetic and pharmacodynamic analysis of preclinical data and Phase Ib/IIa studies in patients with extensive-stage small cell lung cancer

Author

Li, Chao, Hart, Lowell, Owonikoko, Taofeek K., Aljumaily, Raid, Rocha Lima, Caio Max, Conkling, Paul R., Webb, Roy Timothy, Jotte, Robert M., Schuster, Steven, Edenfield, William J., Smith, Deborah A., Sale, Mark, Roberts, Patrick J., Malik, Rajesh K., and Sorrentino, Jessica A.

Published
2021
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9. Myelopreservation with Trilaciclib in Patients Receiving Topotecan for Small Cell Lung Cancer: Results from a Randomized, Double-Blind, Placebo-Controlled Phase II Study

Author

Hart, Lowell L., Ferrarotto, Renata, Andric, Zoran G., Beck, J. Thaddeus, Subramanian, Janakiraman, Radosavljevic, Davorin Z., Zaric, Bojan, Hanna, Wahid T., Aljumaily, Raid, Owonikoko, Taofeek K., Verhoeven, Didier, Xiao, Jie, Morris, Shannon R., Antal, Joyce M., and Hussein, Maen A.

Published
2021
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11. Analysis of Radiation Therapy Quality Assurance in NRG Oncology RTOG 0848

Author

Tchelebi, Leila T., primary, Winter, Kathryn A., additional, Abrams, Ross A., additional, Safran, Howard P., additional, Regine, William F., additional, McNulty, Susan, additional, Wu, Abraham, additional, Du, Kevin L., additional, Seaward, Samantha A., additional, Bian, Shelly X., additional, Aljumaily, Raid, additional, Shivnani, Anand, additional, Knoble, Jeanna L., additional, Crocenzi, Todd S., additional, DiPetrillo, Thomas A., additional, Roof, Kevin S., additional, Crane, Christopher H., additional, and Goodman, Karyn A., additional

Published
2023
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14. Abstract CT163: A phase II basket trial of dual anti-CTLA-4 and anti-PD-1 blockade in rare tumors (DART) SWOG S1609: the small cell carcinoma of the ovary, hypercalcemic type cohort

Author

Chae, Young Kwang, primary, Othus, Megan, additional, Patel, Sandip P., additional, Aljumaily, Raid, additional, Win, Khine Z., additional, Pejovic, Tanya, additional, Thomas, Sajeve S., additional, Robinson, William R., additional, Chung, Liam Il-Young, additional, McLeod, Christine M., additional, Chen, Helen X., additional, Sharon, Elad, additional, Streicher, Howard, additional, Ryan, Christopher W., additional, Blanke, Charles D., additional, and Kurzrock, Razelle, additional

Published
2023
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15. Supplementary Table 1 from Safety and Clinical Activity of MEDI1873, a Novel GITR Agonist, in Advanced Solid Tumors

Author

Balmanoukian, Ani S., primary, Infante, Jeffrey R., primary, Aljumaily, Raid, primary, Naing, Aung, primary, Chintakuntlawar, Ashish V., primary, Rizvi, Naiyer A., primary, Ross, Helen J., primary, Gordon, Michael, primary, Mallinder, Philip R., primary, Elgeioushi, Nairouz, primary, González-García, Ignacio, primary, Standifer, Nathan, primary, Cann, Jennifer, primary, Durham, Nicholas, primary, Rahimian, Shahram, primary, Kumar, Rakesh, primary, and Denlinger, Crystal S., primary

Published
2023
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16. Supplementary Figures from Phase I Basket Study of Taselisib, an Isoform-Selective PI3K Inhibitor, in Patients with PIK3CA-Mutant Cancers

Author

Jhaveri, Komal, primary, Chang, Matthew T., primary, Juric, Dejan, primary, Saura, Cristina, primary, Gambardella, Valentina, primary, Melnyk, Anton, primary, Patel, Manish R., primary, Ribrag, Vincent, primary, Ma, Cynthia X., primary, Aljumaily, Raid, primary, Bedard, Philippe L., primary, Sachdev, Jasgit C., primary, Dunn, Lara, primary, Won, Helen, primary, Bond, John, primary, Jones, Surai, primary, Savage, Heidi M., primary, Scaltriti, Maurizio, primary, Wilson, Timothy R., primary, Wei, Michael C., primary, and Hyman, David M., primary

Published
2023
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17. Data from Safety and Clinical Activity of MEDI1873, a Novel GITR Agonist, in Advanced Solid Tumors

Author

Balmanoukian, Ani S., primary, Infante, Jeffrey R., primary, Aljumaily, Raid, primary, Naing, Aung, primary, Chintakuntlawar, Ashish V., primary, Rizvi, Naiyer A., primary, Ross, Helen J., primary, Gordon, Michael, primary, Mallinder, Philip R., primary, Elgeioushi, Nairouz, primary, González-García, Ignacio, primary, Standifer, Nathan, primary, Cann, Jennifer, primary, Durham, Nicholas, primary, Rahimian, Shahram, primary, Kumar, Rakesh, primary, and Denlinger, Crystal S., primary

Published
2023
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18. Supplementary Figure 4 from Safety and Clinical Activity of MEDI1873, a Novel GITR Agonist, in Advanced Solid Tumors

Author

Balmanoukian, Ani S., primary, Infante, Jeffrey R., primary, Aljumaily, Raid, primary, Naing, Aung, primary, Chintakuntlawar, Ashish V., primary, Rizvi, Naiyer A., primary, Ross, Helen J., primary, Gordon, Michael, primary, Mallinder, Philip R., primary, Elgeioushi, Nairouz, primary, González-García, Ignacio, primary, Standifer, Nathan, primary, Cann, Jennifer, primary, Durham, Nicholas, primary, Rahimian, Shahram, primary, Kumar, Rakesh, primary, and Denlinger, Crystal S., primary

Published
2023
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19. Supplementary Figure 1 from Safety and Clinical Activity of MEDI1873, a Novel GITR Agonist, in Advanced Solid Tumors

Author

Balmanoukian, Ani S., primary, Infante, Jeffrey R., primary, Aljumaily, Raid, primary, Naing, Aung, primary, Chintakuntlawar, Ashish V., primary, Rizvi, Naiyer A., primary, Ross, Helen J., primary, Gordon, Michael, primary, Mallinder, Philip R., primary, Elgeioushi, Nairouz, primary, González-García, Ignacio, primary, Standifer, Nathan, primary, Cann, Jennifer, primary, Durham, Nicholas, primary, Rahimian, Shahram, primary, Kumar, Rakesh, primary, and Denlinger, Crystal S., primary

Published
2023
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20. Supplementary Figure 3 from Safety and Clinical Activity of MEDI1873, a Novel GITR Agonist, in Advanced Solid Tumors

Author

Balmanoukian, Ani S., primary, Infante, Jeffrey R., primary, Aljumaily, Raid, primary, Naing, Aung, primary, Chintakuntlawar, Ashish V., primary, Rizvi, Naiyer A., primary, Ross, Helen J., primary, Gordon, Michael, primary, Mallinder, Philip R., primary, Elgeioushi, Nairouz, primary, González-García, Ignacio, primary, Standifer, Nathan, primary, Cann, Jennifer, primary, Durham, Nicholas, primary, Rahimian, Shahram, primary, Kumar, Rakesh, primary, and Denlinger, Crystal S., primary

Published
2023
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21. Supplementary Figure 2 from Safety and Clinical Activity of MEDI1873, a Novel GITR Agonist, in Advanced Solid Tumors

Author

Balmanoukian, Ani S., primary, Infante, Jeffrey R., primary, Aljumaily, Raid, primary, Naing, Aung, primary, Chintakuntlawar, Ashish V., primary, Rizvi, Naiyer A., primary, Ross, Helen J., primary, Gordon, Michael, primary, Mallinder, Philip R., primary, Elgeioushi, Nairouz, primary, González-García, Ignacio, primary, Standifer, Nathan, primary, Cann, Jennifer, primary, Durham, Nicholas, primary, Rahimian, Shahram, primary, Kumar, Rakesh, primary, and Denlinger, Crystal S., primary

Published
2023
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33. Tolerability and antitumor activity of cemiplimab, a human monoclonal anti–PD-1, as monotherapy in patients with pretreated non-small cell lung cancer (NSCLC): Data from the Phase 1 NSCLC expansion cohort

Author

Moreno, Victor, primary, Garrido, Pilar, additional, Papadopoulos, Kyriakos P., additional, De Miguel Luken, Maria Jose, additional, Gil-Martin, Marta, additional, Aljumaily, Raid, additional, Rosen, Lee S., additional, Rietschel, Petra, additional, Mohan, Kosalai K., additional, Yoo, Suk-Young, additional, Stankevich, Elizabeth, additional, Lowy, Israel, additional, and Fury, Matthew G., additional

Published
2021
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34. Pegilodecakin as monotherapy or in combination with anti‐PD‐1 or tyrosine kinase inhibitor in heavily pretreated patients with advanced renal cell carcinoma: Final results of cohorts A, G, H and I of IVY Phase I study

Author

Tannir, Nizar M., primary, Papadopoulos, Kyriakos P., additional, Wong, Deborah J., additional, Aljumaily, Raid, additional, Hung, Annie, additional, Afable, Manuel, additional, Kim, Jong Seok, additional, Ferry, David, additional, Drakaki, Alexandra, additional, Bendell, Johanna, additional, and Naing, Aung, additional

Published
2021
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36. Phase I Basket Study of Taselisib, an Isoform-Selective PI3K Inhibitor, in Patients withPIK3CA-Mutant Cancers

Author

Jhaveri, Komal, primary, Chang, Matthew T., additional, Juric, Dejan, additional, Saura, Cristina, additional, Gambardella, Valentina, additional, Melnyk, Anton, additional, Patel, Manish R., additional, Ribrag, Vincent, additional, Ma, Cynthia X., additional, Aljumaily, Raid, additional, Bedard, Philippe L., additional, Sachdev, Jasgit C., additional, Dunn, Lara, additional, Won, Helen, additional, Bond, John, additional, Jones, Surai, additional, Savage, Heidi M., additional, Scaltriti, Maurizio, additional, Wilson, Timothy R., additional, Wei, Michael C., additional, and Hyman, David M., additional

Published
2021
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37. Safety and Clinical Activity of MEDI1873, a Novel GITR Agonist, in Advanced Solid Tumors

Author

Balmanoukian, Ani S., primary, Infante, Jeffrey R., additional, Aljumaily, Raid, additional, Naing, Aung, additional, Chintakuntlawar, Ashish V., additional, Rizvi, Naiyer A., additional, Ross, Helen J., additional, Gordon, Michael, additional, Mallinder, Philip R., additional, Elgeioushi, Nairouz, additional, González-García, Ignacio, additional, Standifer, Nathan, additional, Cann, Jennifer, additional, Durham, Nicholas, additional, Rahimian, Shahram, additional, Kumar, Rakesh, additional, and Denlinger, Crystal S., additional

Published
2020
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38. Myelopreservation with Trilaciclib in Patients Receiving Topotecan for Small Cell Lung Cancer: Results from a Randomized, Double-Blind, Placebo-Controlled Phase II Study

Author

Hart, Lowell L., primary, Ferrarotto, Renata, additional, Andric, Zoran G., additional, Beck, J. Thaddeus, additional, Subramanian, Janakiraman, additional, Radosavljevic, Davorin Z., additional, Zaric, Bojan, additional, Hanna, Wahid T., additional, Aljumaily, Raid, additional, Owonikoko, Taofeek K., additional, Verhoeven, Didier, additional, Xiao, Jie, additional, Morris, Shannon R., additional, Antal, Joyce M., additional, and Hussein, Maen A., additional

Published
2020
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40. Avelumab as second-line therapy for metastatic, platinum-treated urothelial carcinoma in the phase Ib JAVELIN Solid Tumor study: 2-year updated efficacy and safety analysis

Author

Apolo, Andrea B, primary, Ellerton, John A, additional, Infante, Jeffrey R, additional, Agrawal, Manish, additional, Gordon, Michael S, additional, Aljumaily, Raid, additional, Gourdin, Theodore, additional, Dirix, Luc, additional, Lee, Keun-Wook, additional, Taylor, Matthew H, additional, Schöffski, Patrick, additional, Wang, Ding, additional, Ravaud, Alain, additional, Manitz, Juliane, additional, Pennock, Gregory, additional, Ruisi, Mary, additional, Gulley, James L, additional, and Patel, Manish R, additional

Published
2020
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41. Immunologic and tumor responses of pegilodecakin with 5-FU/LV and oxaliplatin (FOLFOX) in pancreatic ductal adenocarcinoma (PDAC)

Author

Hecht, J. Randolph, primary, Papadopoulos, Kyriakos P., additional, Falchook, Gerald S., additional, Patel, Manish R., additional, Infante, Jeffrey R., additional, Aljumaily, Raid, additional, Wong, Deborah J., additional, Autio, Karen A., additional, Wainberg, Zev A., additional, Bauer, Todd M., additional, Javle, Milind, additional, Pant, Shubham, additional, Bendell, Johanna, additional, Hung, Annie, additional, Ratti, Navneet, additional, VanVlasselaer, Peter, additional, Verma, Rakesh, additional, Leveque, Joseph, additional, Rao, Sujata, additional, Oft, Martin, additional, and Naing, Aung, additional

Published
2020
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42. Abstract CT301: A phase Ib study to evaluate RO7198457, an individualized Neoantigen Specific immunoTherapy (iNeST), in combination with atezolizumab in patients with locally advanced or metastatic solid tumors

Author

Lopez, Juanita S., primary, Camidge, Ross, additional, Iafolla, Marco, additional, Rottey, Sylvie, additional, Schuler, Martin, additional, Hellmann, Matthew, additional, Balmanoukian, Ani, additional, Dirix, Luc, additional, Gordon, Michael, additional, Sullivan, Ryan, additional, Henick, Brian S., additional, Drake, Charles, additional, Wong, Kit, additional, LoRusso, Patricia, additional, Ott, Patrick, additional, Fong, Lawrence, additional, Schiza, Aglaia, additional, Yachnin, Jeffery, additional, Ottensmeier, Christian, additional, Braiteh, Fadi, additional, Bendell, Johanna, additional, Leidner, Rom, additional, Fisher, George, additional, Jerusalem, Guy, additional, Molenaar-Kuijsten, Laura, additional, Schmidt, Marcus, additional, Laurie, Scott A., additional, Aljumaily, Raid, additional, Rittmeyer, Achim, additional, Gort, Eelke, additional, Melero, Ignacio, additional, Mueller, Lars, additional, Sabado, Rachel, additional, Twomey, Patrick, additional, Huang, Jack, additional, Yadav, Manesh, additional, Zhang, Jingbin, additional, Mueller, Felicitas, additional, Derhovanessian, Evelyna, additional, Sahin, Ugur, additional, Türeci, Özlem, additional, and Powles, Thomas, additional

Published
2020
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43. INDUCE-1: Report on safety run-in cohorts combining Inducible T-cell co-stimulatory receptor (ICOS) agonist GSK3359609 (GSK609) with platinum+5-FU chemotherapy (5-FU/plat), with or without pembrolizumab (PE), for the treatment of advanced solid tumors.

Author

Massarelli, Erminia, primary, Balmanoukian, Ani Sarkis, additional, Vieito, Maria, additional, Le Tourneau, Christophe, additional, Hernandez-Guerrero, Tatiana, additional, Trigo, Jose Manuel, additional, Aljumaily, Raid, additional, Chisamore, Michael Jon, additional, Rogan, Debra, additional, Sung, Ruby, additional, Henry, Courtney, additional, Turner, David, additional, Yadavilli, Sapna, additional, Franco, Sonia, additional, Ellis, Catherine Elizabeth, additional, Ballas, Marc S., additional, Hoos, Axel, additional, and Rischin, Danny, additional

Published
2020
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44. A phase III trial-in-progress called REPLATINUM that compares RRx-001 + a platinum doublet to a platinum doublet in third-line or beyond small cell lung cancer.

Author

Morgensztern, Daniel, primary, Huang, Chao Hui, additional, Rolfo, Christian Diego, additional, Ruckdeschel, John C., additional, Dragnev, Konstantin H., additional, Aljumaily, Raid, additional, Hauke, Ralph J., additional, Mekhail, Tarek, additional, Fidler, Mary J., additional, Hamm, John Turner, additional, and Chiappori, Alberto, additional

Published
2020
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45. Pegilodecakin as monotherapy or in combination with anti-PD-1 or tyrosine kinase inhibitor in heavily pretreated patients with advanced renal cell carcinoma (RCC): Updated results from phase I/Ib IVY study.

Author

Naing, Aung, primary, Papadopoulos, Kyriakos P., additional, Wong, Deborah J.L., additional, Aljumaily, Raid, additional, Hung, Annie, additional, Afable, Manuel, additional, Kim, Jong Seok, additional, Ferry, David, additional, Drakaki, Alexandra, additional, Bendell, Johanna C., additional, and Tannir, Nizar M., additional

Published
2020
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46. Effect of trilaciclib, a CDK 4/6 inhibitor, on myelosuppression in patients with previously treated extensive-stage small cell lung cancer receiving topotecan.

Author

Hart, Lowell L., primary, Andric, Zoran Gojko, additional, Hussein, Maen A., additional, Ferrarotto, Renata, additional, Beck, J. Thaddeus, additional, Subramanian, Janakiraman, additional, Radosavljevic, Davorin Z., additional, Jovanovic, Dragana, additional, Pachipala, Krishna Kishore, additional, Samarzija, Miroslav, additional, Zaric, Bojan, additional, Hanna, Wahid Tewfik, additional, Aljumaily, Raid, additional, Owonikoko, Taofeek Kunle, additional, Malik, Rajesh K., additional, Morris, Shannon R., additional, Johnson, Misha L., additional, Yang, Zhao, additional, Adler, Steven, additional, and Spigel, David R., additional

Published
2019
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47. A phase Ib study of prexasertib, a checkpoint kinase (CHK1) inhibitor, and LY3023414, a dual inhibitor of class I phosphatidylinositol 3-kinase (PI3K) and the mammalian target of rapamycin (mTOR) in patients with advanced solid tumors.

Author

Hong, David S., primary, Moore, Kathleen N., additional, Bendell, Johanna C., additional, Karp, Daniel D., additional, Wang, Judy Sing-Zan, additional, Ulahannan, Susanna Varkey, additional, Johnson, Melissa Lynne, additional, Aljumaily, Raid, additional, Hynes, Scott, additional, Callies, Sophie, additional, Decker, Rodney, additional, LaBell, Elizabeth, additional, Niland, Michele, additional, Wang, Xuejing Aimee, additional, Bence Lin, Aimee, additional, and Patel, Manish R., additional

Published
2019
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48. Tolerability and antitumor activity of cemiplimab, a human monoclonal anti-PD-1, in patients with non-small cell lung cancer (NSCLC): Interim data from a phase I dose escalation and NSCLC expansion cohort.

Author

Moreno, Victor, primary, Calvo, Emiliano, additional, Olmedo Garcia, Maria Eugenia, additional, Gil-Martin, Marta, additional, Aljumaily, Raid, additional, Papadopoulos, Kyriakos P., additional, Rosen, Lee S., additional, Rietschel, Petra, additional, Mohan, Kosalai Kal, additional, Li, Jingjin, additional, Stankevich, Elizabeth, additional, Rowlands, Tracey, additional, Feng, Minjie, additional, and Fury, Matthew G., additional

Published
2019
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49. Avelumab treatment for metastatic urothelial carcinoma in the phase Ib JAVELIN Solid Tumor Study: Updated safety and efficacy analysis with ≥ two years of follow-up.

Author

Apolo, Andrea B., primary, Ellerton, John Allan, additional, Infante, Jeffrey R., additional, Agrawal, Manish, additional, Gordon, Michael S., additional, Aljumaily, Raid, additional, Britten, Carolyn D., additional, Dirix, Luc, additional, Lee, Keun-Wook, additional, Taylor, Matthew H., additional, Schoffski, Patrick, additional, Wang, Ding, additional, Ravaud, Alain, additional, Xiong, Junyuan, additional, Rosen, Galit, additional, Gulley, James L., additional, and Patel, Manish R., additional

Published
2019
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50. Pegilodecakin Combined with Anti-PD-1 Monoclonal Antibodies for Patients with Advanced Renal Cell Carcinoma (IVY): A Multicentre, Open-Label, Phase 1b Trial

Author

Naing, Aung, primary, Infante, Jeffrey R., additional, Wong, Deborah J., additional, Korn, Michael W., additional, Aljumaily, Raid, additional, Papadopoulos, Kyriakos P., additional, Autio, Karen A., additional, Pant, Shubham, additional, Bauer, Todd M., additional, Drakaki, Alexandra, additional, Daver, Naval G., additional, Hung, Annie, additional, Ratti, Navneet, additional, McCauley, Scott, additional, Van Vlasselaer, Peter, additional, Verma, Rakesh, additional, Ferry, David, additional, Oft, Martin, additional, and Tannir, Nizar M., additional

Published
2019
Full Text
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