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2. Early Onset Intrahepatic Cholangiocarcinoma: Clinical Characteristics, Oncological Outcomes, and Genomic/Transcriptomic Features

Author

Tsilimigras, Diamantis I., Han, Xu, Guglielmi, Alfredo, Aldrighetti, Luca, Weiss, Matthew, Bauer, Todd W., Alexandrescu, Sorin, Poultsides, George A., Maithel, Shishir K., Marques, Hugo P., Martel, Guillaume, Pulitano, Carlo, Shen, Feng, Chaucy, François, Koerkamp, Bas Groot, Endo, Itaru, Sasaki, Kazunari, Aucejo, Federico, Zhang, Xu-Feng, Zhu, Hua, and Pawlik, Timothy M.

Published
2024
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3. Benchmarks in Liver Resection for Intrahepatic Cholangiocarcinoma

Author

Alaimo, Laura, Endo, Yutaka, Catalano, Giovanni, Ruzzenente, Andrea, Aldrighetti, Luca, Weiss, Matthew, Bauer, Todd W., Alexandrescu, Sorin, Poultsides, George A., Maithel, Shishir K., Marques, Hugo P., Martel, Guillaume, Pulitano, Carlo, Shen, Feng, Cauchy, François, Koerkamp, Bas Groot, Endo, Itaru, Kitago, Minoru, and Pawlik, Timothy M.

Published
2024
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5. First-in-human phase 1/1b study to evaluate sitravatinib in patients with advanced solid tumors

Author

Bauer, Todd, Cho, Byong Chul, Heist, Rebecca, Bazhenova, Lyudmila, Werner, Theresa, Goel, Sanjay, Kim, Dong-Wan, Adkins, Douglas, Carvajal, Richard D, Alva, Ajjai, Eaton, Keith, Wang, Judy, Liu, Yong, Yan, Xiaohong, Christensen, Jamie, Neuteboom, Saskia, Chao, Richard, and Pant, Shubham

Subjects
Lung, Cancer, Clinical Research, Lung Cancer, Rare Diseases, 6.1 Pharmaceuticals, 6.2 Cellular and gene therapies, Evaluation of treatments and therapeutic interventions, Anilides, Carcinoma, Non-Small-Cell Lung, Humans, Lung Neoplasms, Neoplasms, Pyridines, Tumor Microenvironment, Sitravatinib, Advanced solid tumors, Pharmacokinetics, Adverse events, Objective response rate, Pharmacology and Pharmaceutical Sciences, Oncology & Carcinogenesis
Abstract

Sitravatinib (MGCD516), a spectrum-selective receptor tyrosine kinase inhibitor targeting TAM (TYRO3, AXL, MERTK) and split kinase family receptors, has demonstrated preclinical anti-tumor activity and modulation of tumor microenvironment. This first-in-human phase 1/1b study included sitravatinib dose exploration and anti-tumor activity evaluation in selected patients with advanced solid tumors. Primary objectives included assessment of safety, pharmacokinetics and clinical activity of sitravatinib. Secondary objectives included identifying doses for further investigation and exploring molecular markers for patient selection. In phase 1, 32 patients received 10-200 mg, while phase 1b dose expansion comprised 161 patients (150 mg n = 99, 120 mg n = 62). Maximum tolerated dose was determined as 150 mg daily. Dose-limiting toxicity was reported in 4/28 evaluable phase 1 patients (three at 200 mg, one at 80 mg). In phase 1b, 120 mg was defined as the recommended dose due to tolerability. Treatment-related adverse events (TRAEs) were experienced by 174/193 patients (90.2%); grade ≥ 3 TRAEs in 103 patients (53.4%). Most common TRAEs were diarrhea, fatigue, hypertension and nausea; TRAEs led to treatment discontinuation in 26 patients (13.5%) and death in one patient. Sitravatinib was steadily absorbed and declined from plasma with a terminal elimination half-life of 42.1-51.5 h following oral administration. Overall objective response rate was 11.8% in phase 1b, 13.2% in patients with non-small cell lung cancer (NSCLC) and 4.2% in patients with NSCLC with prior checkpoint inhibitor experience. Sitravatinib demonstrated manageable safety and modest clinical activity in solid tumors. NCT02219711 (first posted August 14, 2014).

Published
2022

6. Development of an artificial intelligence–based model to predict early recurrence of neuroendocrine liver metastasis after resection

Author

Altaf, Abdullah, Munir, Muhammad Musaab, Endo, Yutaka, Khan, Muhammad Muntazir M., Rashid, Zayed, Khalil, Mujtaba, Guglielmi, Alfredo, Aldrighetti, Luca, Bauer, Todd W., Marques, Hugo P., Martel, Guillaume, Lam, Vincent, Weiss, Mathew J., Fields, Ryan C., Poultsides, George, Maithel, Shishir K., Endo, Itaru, and Pawlik, Timothy M.

Published
2024
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9. Prognostic value of the advanced lung cancer inflammation index in intrahepatic cholangiocarcinoma

Author

Catalano, Giovanni, Alaimo, Laura, Chatzipanagiotou, Odysseas P., Ruzzenente, Andrea, Aucejo, Federico, Marques, Hugo P., Lam, Vincent, Hugh, Tom, Bhimani, Nazim, Maithel, Shishir K., Kitago, Minoru, Endo, Itaru, Martel, Guillaume, Pulitano, Carlo, Shen, Feng, Popescu, Irinel, Koerkamp, Bas Groot, Bauer, Todd W., Cauchy, François, Poultsides, George A., Weiss, Matthew, Gleisner, Ana, and Pawlik, Timothy M.

Published
2024
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10. Avelumab in Combination With Lorlatinib or Crizotinib in Patients With Previously Treated Advanced NSCLC: Phase 1b/2 Results From the JAVELIN Lung 101 Trial

Author

Solomon, Benjamin J., Dagogo-Jack, Ibiayi, Lee, Se-Hoon, Boyer, Michael J., Ramalingam, Suresh S., Carcereny, Enric, Felip, Enriqueta, Han, Ji-Youn, Hida, Toyoaki, Hughes, Brett G.M., Kim, Sang-We, Nishio, Makoto, Seto, Takashi, Okamoto, Tatsuro, Zhang, Xiaoxi, Martini, Jean-Francois, Wang, Erjian, De Beukelaer, Steven, and Bauer, Todd M.

Published
2024
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11. A Phase Ib Study Assessing the Safety, Tolerability, and Efficacy of the First-in-Class Wee1 Inhibitor Adavosertib (AZD1775) as Monotherapy in Patients with Advanced Solid Tumors

Author

Bauer, Todd M., Moore, Kathleen N., Rader, Janet S., Simpkins, Fiona, Mita, Alain C., Beck, J. Thaddeus, Hart, Lowell, Chu, Quincy, Oza, Amit, Tinker, Anna V., Imedio, Esteban Rodrigo, Kumar, Sanjeev, Mugundu, Ganesh, Jenkins, Suzanne, Chmielecki, Juliann, Jones, Suzanne, Spigel, David, and Fu, Siqing

Published
2023
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14. The complication-overall survival (CompOS) risk tool predicts risk of a severe postoperative complications relative to long-term survival among patients with primary liver cancer

Author

Endo, Yutaka, Tsilimigras, Diamantis I., Woldesenbet, Selamawit, Marques, Hugo P., Cauchy, François, Weiss, Matthew, Bauer, Todd W., Poultsides, George A., Maithel, Shishir K., Kitago, Minoru, Alexandrescu, Sorin, Martel, Guillaume, Guglielmi, Alfredo, Pulitano, Carlo, Gleisner, Ana, Hugh, Tom, Aldrighetti, Luca, Shen, Feng, Koerkamp, Bas G., Endo, Itaru, and Pawlik, Timothy M.

Published
2024
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16. Development and Validation of a Machine-Learning Model to Predict Early Recurrence of Intrahepatic Cholangiocarcinoma

Author

Alaimo, Laura, Lima, Henrique A., Moazzam, Zorays, Endo, Yutaka, Yang, Jason, Ruzzenente, Andrea, Guglielmi, Alfredo, Aldrighetti, Luca, Weiss, Matthew, Bauer, Todd W., Alexandrescu, Sorin, Poultsides, George A., Maithel, Shishir K., Marques, Hugo P., Martel, Guillaume, Pulitano, Carlo, Shen, Feng, Cauchy, François, Koerkamp, Bas Groot, Endo, Itaru, Kitago, Minoru, and Pawlik, Timothy M.

Published
2023
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17. Predictors and Prognostic Significance of Postoperative Complications for Patients with Intrahepatic Cholangiocarcinoma

Author

Endo, Yutaka, Moazzam, Zorays, Woldesenbet, Selamawit, Araujo Lima, Henrique, Alaimo, Laura, Munir, Muhammad Musaab, Shaikh, Chanza F., Guglielmi, Alfredo, Aldrighetti, Luca, Weiss, Matthew, Bauer, Todd W., Alexandrescu, Sorin, Poultsides, George A., Kitago, Minoru, Maithel, Shishir K., Marques, Hugo P., Martel, Guillaume, Pulitano, Carlo, Shen, Feng, Cauchy, François, Koerkamp, Bas Groot, Endo, Itaru, and Pawlik, Timothy M.

Published
2023
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18. Higher Tumor Burden Status Dictates the Impact of Surgical Margin Status on Overall Survival in Patients Undergoing Resection of Intrahepatic Cholangiocarcinoma

Author

Endo, Yutaka, Sasaki, Kazunari, Moazzam, Zorays, Lima, Henrique A., Alaimo, Laura, Guglielmi, Alfredo, Aldrighetti, Luca, Weiss, Matthew, Bauer, Todd W., Alexandrescu, Sorin, Poultsides, George A., Kitago, Minoru, Maithel, Shishir K., Marques, Hugo P., Martel, Guillaume, Pulitano, Carlo, Shen, Feng, Cauchy, François, Koerkamp, Bas Groot, Endo, Itaru, and Pawlik, Timothy M.

Published
2023
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19. The Application of Artificial Intelligence to Investigate Long-Term Outcomes and Assess Optimal Margin Width in Hepatectomy for Intrahepatic Cholangiocarcinoma

Author

Alaimo, Laura, Moazzam, Zorays, Endo, Yutaka, Lima, Henrique A., Butey, Swatika P., Ruzzenente, Andrea, Guglielmi, Alfredo, Aldrighetti, Luca, Weiss, Matthew, Bauer, Todd W., Alexandrescu, Sorin, Poultsides, George A., Maithel, Shishir K., Marques, Hugo P., Martel, Guillaume, Pulitano, Carlo, Shen, Feng, Cauchy, François, Koerkamp, Bas Groot, Endo, Itaru, Kitago, Minoru, Kim, Alex, Ejaz, Aslam, Beane, Joal, Cloyd, Jordan, and Pawlik, Timothy M.

Published
2023
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20. Albumin-Bilirubin Grade and Tumor Burden Score Predict Outcomes Among Patients with Intrahepatic Cholangiocarcinoma After Hepatic Resection: a Multi-Institutional Analysis

Author

Munir, Muhammad Musaab, Endo, Yutaka, Lima, Henrique A., Alaimo, Laura, Moazzam, Zorays, Shaikh, Chanza, Poultsides, George A., Guglielmi, Alfredo, Aldrighetti, Luca, Weiss, Matthew, Bauer, Todd W., Alexandrescu, Sorin, Kitago, Minoru, Maithel, Shishir K., Marques, Hugo P., Martel, Guillaume, Pulitano, Carlo, Shen, Feng, Cauchy, François, Koerkamp, Bas Groot, Endo, Itaru, and Pawlik, Timothy M.

Published
2023
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21. Lymph Node Examination and Patterns of Nodal Metastasis Among Patients with Left- Versus Right-Sided Intrahepatic Cholangiocarcinoma After Major Curative-Intent Resection

Author

Zhang, Xu-Feng, Xue, Feng, Weiss, Matthew, Popescu, Irinel, Marques, Hugo P., Aldrighetti, Luca, Maithel, Shishir K., Pulitano, Carlo, Bauer, Todd W., Shen, Feng, Poultsides, George A., Cauchy, François, Martel, Guillaume, Koerkamp, B. Groot, Itaru, Endo, Lv, Yi, and Pawlik, Timothy M.

Published
2023
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22. Long-Term Recurrence-Free and Overall Survival Differ Based on Common, Proliferative, and Inflammatory Subtypes After Resection of Intrahepatic Cholangiocarcinoma

Author

Alaimo, Laura, Moazzam, Zorays, Endo, Yutaka, Lima, Henrique A., Ruzzenente, Andrea, Guglielmi, Alfredo, Aldrighetti, Luca, Weiss, Matthew, Bauer, Todd W., Alexandrescu, Sorin, Poultsides, George A., Maithel, Shishir K., Marques, Hugo P., Martel, Guillaume, Pulitano, Carlo, Shen, Feng, Cauchy, François, Koerkamp, Bas Groot, Endo, Itaru, and Pawlik, Timothy M.

Published
2023
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23. Application of Hazard Function to Investigate Recurrence of Intrahepatic Cholangiocarcinoma After Curative-Intent Liver Resection: A Novel Approach to Characterize Recurrence

Author

Alaimo, Laura, Moazzam, Zorays, Brown, Zachary J., Endo, Yutaka, Ruzzenente, Andrea, Guglielmi, Alfredo, Aldrighetti, Luca, Weiss, Matthew, Bauer, Todd W., Alexandrescu, Sorin, Poultsides, George A., Maithel, Shishir K., Marques, Hugo P., Martel, Guillaume, Pulitano, Carlo, Shen, Feng, Soubrane, Olivier, Koerkamp, Bas Groot, Endo, Itaru, and Pawlik, Timothy M.

Published
2023
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24. An attempt to establish and apply global benchmarks for liver resection of malignant hepatic tumors

Author

Alaimo, Laura, Moazzam, Zorays, Lima, Henrique A., Endo, Yutaka, Ruzzenente, Andrea, Guglielmi, Alfredo, Ratti, Francesca, Aldrighetti, Luca, Weiss, Matthew, Bauer, Todd W., Alexandrescu, Sorin, Popescu, Irinel, Poultsides, George A., Maithel, Shishir K., Marques, Hugo P., Martel, Guillaume, Pulitano, Carlo, Shen, Feng, Cauchy, François, Koerkamp, Bas Groot, Endo, Itaru, Kitago, Minoru, Aucejo, Federico, Sasaki, Kazunari, Fields, Ryan C., Hugh, Tom, Lam, Vincent, and Pawlik, Timothy M.

Published
2023
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25. 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

27. The impact of tumor location on the value of lymphadenectomy for intrahepatic cholangiocarcinoma

Author

Endo, Yutaka, Moazzam, Zorays, Lima, Henrique A., Alaimo, Laura, Munir, Muhammad M., Shaikh, Chanza F., Guglielmi, Alfredo, Aldrighetti, Luca, Weiss, Matthew, Bauer, Todd W., Alexandrescu, Sorin, Poultsides, George A., Kitago, Minoru, Maithel, Shishir K., Marques, Hugo P., Martel, Guillaume, Pulitano, Carlo, Shen, Feng, Cauchy, François, Koerkamp, Bas G., Endo, Itaru, and Pawlik, Timothy M.

Published
2023
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28. Efficacy of Selpercatinib in RET-Altered Thyroid Cancers.

Author

Wirth, Lori, Sherman, Eric, Robinson, Bruce, Solomon, Benjamin, Kang, Hyunseok, Lorch, Jochen, Worden, Francis, Brose, Marcia, Patel, Jyoti, Leboulleux, Sophie, Godbert, Yann, Barlesi, Fabrice, Morris, John, Owonikoko, Taofeek, Tan, Daniel, Gautschi, Oliver, Weiss, Jared, de la Fouchardière, Christelle, Burkard, Mark, Laskin, Janessa, Taylor, Matthew, Kroiss, Matthias, Medioni, Jacques, Goldman, Jonathan, Bauer, Todd, Levy, Benjamin, Zhu, Viola, Lakhani, Nehal, Moreno, Victor, Ebata, Kevin, Nguyen, Michele, Heirich, Dana, Zhu, Edward, Huang, Xin, Yang, Luxi, Kherani, Jennifer, Rothenberg, S, Drilon, Alexander, Subbiah, Vivek, Shah, Manisha, and Cabanillas, Maria

Subjects
Adolescent, Adult, Aged, Aged, 80 and over, Female, Humans, Hypertension, Intention to Treat Analysis, Kaplan-Meier Estimate, Male, Middle Aged, Mutation, Progression-Free Survival, Protein Kinase Inhibitors, Proto-Oncogene Proteins c-ret, Pyrazoles, Pyridines, Thyroid Neoplasms, Transaminases, Treatment Outcome, Young Adult
Abstract

BACKGROUND: RET mutations occur in 70% of medullary thyroid cancers, and RET fusions occur rarely in other thyroid cancers. In patients with RET-altered thyroid cancers, the efficacy and safety of selective RET inhibition are unknown. METHODS: We enrolled patients with RET-mutant medullary thyroid cancer with or without previous vandetanib or cabozantinib treatment, as well as those with previously treated RET fusion-positive thyroid cancer, in a phase 1-2 trial of selpercatinib. The primary end point was an objective response (a complete or partial response), as determined by an independent review committee. Secondary end points included the duration of response, progression-free survival, and safety. RESULTS: In the first 55 consecutively enrolled patients with RET-mutant medullary thyroid cancer who had previously received vandetanib, cabozantinib, or both, the percentage who had a response was 69% (95% confidence interval [CI], 55 to 81), and 1-year progression-free survival was 82% (95% CI, 69 to 90). In 88 patients with RET-mutant medullary thyroid cancer who had not previously received vandetanib or cabozantinib, the percentage who had a response was 73% (95% CI, 62 to 82), and 1-year progression-free survival was 92% (95% CI, 82 to 97). In 19 patients with previously treated RET fusion-positive thyroid cancer, the percentage who had a response was 79% (95% CI, 54 to 94), and 1-year progression-free survival was 64% (95% CI, 37 to 82). The most common adverse events of grade 3 or higher were hypertension (in 21% of the patients), increased alanine aminotransferase level (in 11%), increased aspartate aminotransferase level (in 9%), hyponatremia (in 8%), and diarrhea (in 6%). Of all 531 patients treated, 12 (2%) discontinued selpercatinib owing to drug-related adverse events. CONCLUSIONS: In this phase 1-2 trial, selpercatinib showed durable efficacy with mainly low-grade toxic effects in patients with medullary thyroid cancer with and without previous vandetanib or cabozantinib treatment. (Funded by Loxo Oncology and others; LIBRETTO-001 ClinicalTrials.gov number, NCT03157128.).

Published
2020

31. Predictive risk-score model to select patients with intrahepatic cholangiocarcinoma for adjuvant chemotherapy

Author

Endo, Yutaka, Moazzam, Zorays, Alaimo, Laura, Lima, Henrique A., Munir, Muhammad M., Shaikh, Chanza F., Guglielmi, Alfredo, Aldrighetti, Luca, Weiss, Matthew, Bauer, Todd W., Alexandrescu, Sorin, Poultsides, George A., Kitago, Minoru, Maithel, Shishir K., Marques, Hugo P., Martel, Guillaume, Pulitano, Carlo, Shen, Feng, Cauchy, François, Koerkamp, Bas G., Endo, Itaru, and Pawlik, Timothy M.

Published
2023
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32. Lorlatinib vs crizotinib in treatment-naïve patients with advanced ALK+ non-small cell lung cancer: 5-year progression-free survival and safety from the CROWN study.

Author

Solomon, Benjamin J., primary, Liu, Geoffrey, additional, Felip, Enriqueta, additional, Mok, Tony S. K., additional, Soo, Ross Andrew, additional, Mazieres, Julien, additional, Shaw, Alice Tsang, additional, de Marinis, Filippo, additional, Goto, Yasushi, additional, Wu, Yi-Long, additional, Kim, Dong-Wan, additional, Martini, Jean-Francois, additional, Messina, Rossella, additional, Paolini, Jolanda, additional, Polli, Anna, additional, Thomaidou, Despina, additional, Toffalorio, Francesca, additional, and Bauer, Todd Michael, additional

Published
2024
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33. Supplementary Figure S8 from A Histone Methylation–MAPK Signaling Axis Drives Durable Epithelial–Mesenchymal Transition in Hypoxic Pancreatic Cancer

Author

Brown, Brooke A., primary, Myers, Paul J., primary, Adair, Sara J., primary, Pitarresi, Jason R., primary, Sah-Teli, Shiv K., primary, Campbell, Logan A., primary, Hart, William S., primary, Barbeau, Michelle C., primary, Leong, Kelsey, primary, Seyler, Nicholas, primary, Kane, William, primary, Lee, Kyoung Eun, primary, Stelow, Edward, primary, Jones, Marieke, primary, Simon, M. Celeste, primary, Koivunen, Peppi, primary, Bauer, Todd W., primary, Stanger, Ben Z., primary, and Lazzara, Matthew J., primary

Published
2024
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34. Data from A Histone Methylation–MAPK Signaling Axis Drives Durable Epithelial–Mesenchymal Transition in Hypoxic Pancreatic Cancer

Author

Brown, Brooke A., primary, Myers, Paul J., primary, Adair, Sara J., primary, Pitarresi, Jason R., primary, Sah-Teli, Shiv K., primary, Campbell, Logan A., primary, Hart, William S., primary, Barbeau, Michelle C., primary, Leong, Kelsey, primary, Seyler, Nicholas, primary, Kane, William, primary, Lee, Kyoung Eun, primary, Stelow, Edward, primary, Jones, Marieke, primary, Simon, M. Celeste, primary, Koivunen, Peppi, primary, Bauer, Todd W., primary, Stanger, Ben Z., primary, and Lazzara, Matthew J., primary

Published
2024
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35. Supplementary Data from A Histone Methylation–MAPK Signaling Axis Drives Durable Epithelial–Mesenchymal Transition in Hypoxic Pancreatic Cancer

Author

Brown, Brooke A., primary, Myers, Paul J., primary, Adair, Sara J., primary, Pitarresi, Jason R., primary, Sah-Teli, Shiv K., primary, Campbell, Logan A., primary, Hart, William S., primary, Barbeau, Michelle C., primary, Leong, Kelsey, primary, Seyler, Nicholas, primary, Kane, William, primary, Lee, Kyoung Eun, primary, Stelow, Edward, primary, Jones, Marieke, primary, Simon, M. Celeste, primary, Koivunen, Peppi, primary, Bauer, Todd W., primary, Stanger, Ben Z., primary, and Lazzara, Matthew J., primary

Published
2024
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38. ASO Visual Abstract: The Application of Artificial Intelligence to Investigate Long-Term Outcomes and Assess Optimal Margin Width in Hepatectomy for Intrahepatic Cholangiocarcinoma

Author

Alaimo, Laura, Moazzam, Zorays, Endo, Yutaka, Lima, Henrique A., Butey, Swatika P., Ruzzenente, Andrea, Guglielmi, Alfredo, Aldrighetti, Luca, Weiss, Matthew, Bauer, Todd W., Alexandrescu, Sorin, Poultsides, George A., Maithel, Shishir K., Marques, Hugo P., Martel, Guillaume, Pulitano, Carlo, Shen, Feng, Cauchy, François, Koerkamp, Bas Groot, Endo, Itaru, Kitago, Minoru, Kim, Alex, Ejaz, Aslam, Beane, Joal, Cloyd, Jordan, and Pawlik, Timothy M.

Published
2023
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39. ASO Visual Abstract: Development and Validation of a Machine Learning Model to Predict Early Recurrence of Intrahepatic Cholangiocarcinoma

Author

Alaimo, Laura, Lima, Henrique A., Moazzam, Zorays, Endo, Yutaka, Yang, Jason, Ruzzenente, Andrea, Guglielmi, Alfredo, Aldrighetti, Luca, Weiss, Matthew, Bauer, Todd W., Alexandrescu, Sorin, Poultsides, George A., Maithel, Shishir K., Marques, Hugo P., Martel, Guillaume, Pulitano, Carlo, Shen, Feng, Cauchy, François, Koerkamp, Bas Groot, Endo, Itaru, Kitago, Minoru, and Pawlik, Timothy M.

Published
2023
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40. 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

44. ASO Visual Abstract: Long-Term Recurrence-Free and Overall Survival Differ Based on Common, Proliferative, and Inflammatory Subtypes After Resection of Intrahepatic Cholangiocarcinoma

Author

Alaimo, Laura, Moazzam, Zorays, Endo, Yutaka, Lima, Henrique A., Ruzzenente, Andrea, Guglielmi, Alfredo, Aldrighetti, Luca, Weiss, Matthew, Bauer, Todd W., Alexandrescu, Sorin, Poultsides, George A., Maithel, Shishir K., Marques, Hugo P., Martel, Guillaume, Pulitano, Carlo, Shen, Feng, Cauchy, François, Koerkamp, Bas Groot, Endo, Itaru, and Pawlik, Timothy M.

Published
2023
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45. ASO Visual Abstract: Application of Hazard Function to Investigate Recurrence of Intrahepatic Cholangiocarcinoma After Curative-Intent Liver Resection: A Novel Approach to Characterize Recurrence

Author

Alaimo, Laura, Moazzam, Zorays, Brown, Zachary J., Endo, Yutaka, Ruzzenente, Andrea, Guglielmi, Alfredo, Aldrighetti, Luca, Weiss, Matthew, Bauer, Todd W., Alexandrescu, Sorin, Poultsides, George A., Maithel, Shishir K., Marques, Hugo P., Martel, Guillaume, Pulitano, Carlo, Shen, Feng, Soubrane, Olivier, Koerkamp, Bas Groot, Endo, Itaru, and Pawlik, Timothy M.

Published
2023
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46. Lorlatinib Versus Crizotinib in Patients With Advanced ALK -Positive Non–Small Cell Lung Cancer: 5-Year Outcomes From the Phase III CROWN Study.

Author

Solomon, Benjamin J., Liu, Geoffrey, Felip, Enriqueta, Mok, Tony S.K., Soo, Ross A., Mazieres, Julien, Shaw, Alice T., de Marinis, Filippo, Goto, Yasushi, Wu, Yi-Long, Kim, Dong-Wan, Martini, Jean-François, Messina, Rossella, Paolini, Jolanda, Polli, Anna, Thomaidou, Despina, Toffalorio, Francesca, and Bauer, Todd M.

Published
2024
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50. Safety and preliminary immunogenicity of JNJ-64041809, a live-attenuated, double-deleted Listeria monocytogenes-based immunotherapy, in metastatic castration-resistant prostate cancer

Author

Drake, Charles G., Pachynski, Russell K., Subudhi, Sumit K., McNeel, Douglas G., Antonarakis, Emmanuel S., Bauer, Todd M., Lauer, Peter, Brockstedt, Dirk, Patricia, Daniel, Wade, Mark, Zudaire, Enrique, Bandyopadhyay, Nibedita, Parasrampuria, Dolly A., Girgis, Suzette, Mason, Gary E., Knoblauch, Roland E., Stone, Nicole, Infante, Jeffrey R., Gottardis, Marco M., and Fong, Lawrence

Published
2022
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