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1. Pembrolizumab plus concurrent chemoradiotherapy versus placebo plus concurrent chemoradiotherapy in patients with locally advanced squamous cell carcinoma of the head and neck (KEYNOTE-412): a randomised, double-blind, phase 3 trial

Author

Rischin, Danny, Hughes, Brett GM, Gao, Bo, McGrath, Margaret, Greil, Richard, Thurnher, Dietmar, Fuereder, Thorsten, Burian, Martin, Rottey, Sylvie, Machiels, Jean-Pascal, Clement, Paul M, Henry, Stéphanie, Deheneffe, Stéphanie, Vasconcelos Alves, Gustavo, Lima, Iane Pinto Figueiredo, Mourão Dias, Josiane, De Marchi, Pedro Rafael Martins, Mak, Milena Perez, Pereira de Santana Gomes, Andrea Juliana, Oliveira de Castro Junior, Dalvaro, Motta, Tatiane Cardoso, Agostinho Padoan, Monica Luciana, Victorina, Ana Paula, de Azevedo, Sergio Jobim, Siu, Lillian L, Brule, Stephanie, Hilton, John, Wang, Chang Shu, Bouganim, Nathaniel, Webster, Marc, Walker, John, Chua, Neil, Zambrano, Angela Regina, Quiroga Echeverri, Alicia, Niño Gomez, Oscar Mauricio, Ortiz, Carlos Alberto, Rojas, Luis, Cardona Zorilla, Andrés, Urrego Meléndez, Olga Marcela, Holečková, Petra Beran, Melichar, Bohuslav, Cvek, Jakub, Prausová, Jana, Vošmik, Milan, Delord, Jean-Pierre, Zasadny, Xavier, Geoffrois, Lionnel, Tao, Yungan, Pointreau, Yoann, Fietkau, Rainer, Haderlein, Marlen, Mueller, Andreas H, Schroeder, Ursula, Wollenberg, Barbara, Laban, Simon, Ivanyi, Philipp, Gruenwald, Viktor, Schafhausen, Philippe, Gutfeld, Orit, Gluck, Iris, Popovtzer, Aron, Meirovitz, Amichay, Billan, Salem, Brenner, Baruch, Limon, Dror, Licitra, Lisa, Perri, Francesco, Caponigro, Francesco, Violati, Martina, Ferrari, Daris, Nole, Franco, Bertolini, Federica, Livi, Lorenzo, Ghi, Maria Grazia, Imarisio, Ilaria, Tahara, Makoto, Homma, Akihiro, Ueda, Tsutomu, Asada, Yukinori, Yamazaki, Tomoko, Matsumoto, Koji, Fujii, Takashi, Ikeda, Sadakatsu, Takahashi, Shunji, Kinoshita, Takashi, Sasaki, Keita, Tsuji, Akihito, Ahn, Myung-Ju, Cho, Byoung Chul, Lee, Keun-Wook, Lee, Ki Hyeong, Choi, Moon Ki, Yun, Hwan Jung, Hendriks, Mathijs P, Oosting, Sjoukje F, Buter, Jan, Van Meerten, Esther, Graham, Jonathan, Kawecki, Andrzej, Debicka, Izabella, Maciejczyk, Adam, Pysz, Maciej, Filarska, Dorota, Hetnał, Marcin, Koralewski, Piotr, Wygoda, Andrzej, Składowski, Krzysztof, Talerczyk, Małgorzata, Berrocal Jaime, Alfonso, Pérez Segura, Pedro, Braña García, Irene, Basté Rotllan, Neus, Mesía Nin, Ricard, Taberna Sanz, Miren, Iglesias Docampo, Lara, Soria Rivas, Ainara, Rueda Domínguez, Antonio, Trigo Pérez, José Manuel, Hong, Ruey-Long, Li, Shau-Hsuan, Wang, Hung-Ming, Yen, Chia-Jui, Yang, Muh-Hwa, Chang, Yi-Fang, Liu, Yi-Chun, Lin, Jin-Ching, Ekenel, Meltem, Harputluoğlu, Hakan, Aksoy, Sercan, Özyilkan, Özgür, Bılıcı, Ahmet, Şendur, Mehmet Alı Nahıt, Arslan, Cagatay, Harrington, Kevin, Ramkumar, Shanmugasundaram, Gujral, Dorothy, Stewart, Simon, Powell, Melanie, Sibtain, Amen, Roques, Tom, Yip, Kent, Mirza, Arafat, Sivaramalingam, Muthiah, Belman, Neil D, Agarwala, Sanjiv, Anderson, Ian, Patel, Arpan, Maggiore, Ronald, Baumgart, Megan, Burtness, Barbara, Fidler, Mary Jo, Kaur, Varinder, Gaughan, Elizabeth, Worden, Francis, Rodriguez, Cristina P, Sukari, Ammar, Wong, Deborah, Yom, Sue, Walsh, William V, Fiorillo, Joseph A, Yorio, Jeffrey T, Obara, Grzegorz S, Alves, Gustavo, Hughes, Brett G M, Mesía, Ricard, Taberna, Miren, Waldron, John N, Simon, Christian, Grégoire, Vincent, Harrington, Kevin J, Swaby, Ramona F, Zhang, Yayan, Gumuscu, Burak, and Bidadi, Behzad

Published
2024
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2. Adenosine 2A Receptor Blockade as an Immunotherapy for Treatment-Refractory Renal Cell Cancer

Author

Fong, Lawrence, Hotson, Andrew, Powderly, John D, Sznol, Mario, Heist, Rebecca S, Choueiri, Toni K, George, Saby, Hughes, Brett GM, Hellmann, Matthew D, Shepard, Dale R, Rini, Brian I, Kummar, Shivaani, Weise, Amy M, Riese, Matthew J, Markman, Ben, Emens, Leisha A, Mahadevan, Daruka, Luke, Jason J, Laport, Ginna, Brody, Joshua D, Hernandez-Aya, Leonel, Bonomi, Philip, Goldman, Jonathan W, Berim, Lyudmyla, Renouf, Daniel J, Goodwin, Rachel A, Munneke, Brian, Ho, Po Y, Hsieh, Jessica, McCaffery, Ian, Kwei, Long, Willingham, Stephen B, and Miller, Richard A

Subjects
Kidney Disease, Rare Diseases, Immunization, Cancer, Vaccine Related, Biotechnology, Clinical Research, Development of treatments and therapeutic interventions, 5.1 Pharmaceuticals, 2.1 Biological and endogenous factors, Aetiology, Adult, Aged, Antibodies, Monoclonal, Humanized, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Renal Cell, Drug Resistance, Neoplasm, Female, Follow-Up Studies, Furans, Humans, Kidney Neoplasms, Male, Middle Aged, Neoplasm Recurrence, Local, Prognosis, Pyridines, Pyrimidines, Receptor, Adenosine A2A, Salvage Therapy, Survival Rate, Oncology and Carcinogenesis
Abstract

Adenosine mediates immunosuppression within the tumor microenvironment through triggering adenosine 2A receptors (A2AR) on immune cells. To determine whether this pathway could be targeted as an immunotherapy, we performed a phase I clinical trial with a small-molecule A2AR antagonist. We find that this molecule can safely block adenosine signaling in vivo. In a cohort of 68 patients with renal cell cancer (RCC), we also observe clinical responses alone and in combination with an anti-PD-L1 antibody, including subjects who had progressed on PD-1/PD-L1 inhibitors. Durable clinical benefit is associated with increased recruitment of CD8+ T cells into the tumor. Treatment can also broaden the circulating T-cell repertoire. Clinical responses are associated with an adenosine-regulated gene-expression signature in pretreatment tumor biopsies. A2AR signaling, therefore, represents a targetable immune checkpoint distinct from PD-1/PD-L1 that restricts antitumor immunity. SIGNIFICANCE: This first-in-human study of an A2AR antagonist for cancer treatment establishes the safety and feasibility of targeting this pathway by demonstrating antitumor activity with single-agent and anti-PD-L1 combination therapy in patients with refractory RCC. Responding patients possess an adenosine-regulated gene-expression signature in pretreatment tumor biopsies.See related commentary by Sitkovsky, p. 16.This article is highlighted in the In This Issue feature, p. 1.

Published
2020

3. Human papillomavirus associated oropharyngeal cancer now the most common mucosal head and neck cancer in Queensland

Author

Porceddu, Sandro V, primary, Negrello, Theresa, additional, Rawson, Neal, additional, Dunn, Nathan, additional, Batstone, Martin, additional, Collins, Michael, additional, Dowthwaite, Sam, additional, Hughes, Brett GM, additional, Kenny, Liz, additional, Ladwa, Rahul, additional, Panizza, Ben, additional, and Cossio, Danica, additional

Published
2024
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4. Pembrolizumab plus concurrent chemoradiotherapy versus placebo plus concurrent chemoradiotherapy in patients with locally advanced squamous cell carcinoma of the head and neck (KEYNOTE-412): a randomised, double-blind, phase 3 trial

Author

Machiels, Jean-Pascal, primary, Tao, Yungan, additional, Licitra, Lisa, additional, Burtness, Barbara, additional, Tahara, Makoto, additional, Rischin, Danny, additional, Alves, Gustavo, additional, Lima, Iane Pinto Figueiredo, additional, Hughes, Brett G M, additional, Pointreau, Yoann, additional, Aksoy, Sercan, additional, Laban, Simon, additional, Greil, Richard, additional, Burian, Martin, additional, Hetnał, Marcin, additional, Delord, Jean-Pierre, additional, Mesía, Ricard, additional, Taberna, Miren, additional, Waldron, John N, additional, Simon, Christian, additional, Grégoire, Vincent, additional, Harrington, Kevin J, additional, Swaby, Ramona F, additional, Zhang, Yayan, additional, Gumuscu, Burak, additional, Bidadi, Behzad, additional, Siu, Lillian L, additional, Hughes, Brett GM, additional, Gao, Bo, additional, McGrath, Margaret, additional, Thurnher, Dietmar, additional, Fuereder, Thorsten, additional, Rottey, Sylvie, additional, Machiels, Jean-Pascal, additional, Clement, Paul M, additional, Henry, Stéphanie, additional, Deheneffe, Stéphanie, additional, Vasconcelos Alves, Gustavo, additional, Mourão Dias, Josiane, additional, De Marchi, Pedro Rafael Martins, additional, Mak, Milena Perez, additional, Pereira de Santana Gomes, Andrea Juliana, additional, Oliveira de Castro Junior, Dalvaro, additional, Motta, Tatiane Cardoso, additional, Agostinho Padoan, Monica Luciana, additional, Victorina, Ana Paula, additional, de Azevedo, Sergio Jobim, additional, Brule, Stephanie, additional, Hilton, John, additional, Wang, Chang Shu, additional, Bouganim, Nathaniel, additional, Webster, Marc, additional, Walker, John, additional, Chua, Neil, additional, Zambrano, Angela Regina, additional, Quiroga Echeverri, Alicia, additional, Niño Gomez, Oscar Mauricio, additional, Ortiz, Carlos Alberto, additional, Rojas, Luis, additional, Cardona Zorilla, Andrés, additional, Urrego Meléndez, Olga Marcela, additional, Holečková, Petra Beran, additional, Melichar, Bohuslav, additional, Cvek, Jakub, additional, Prausová, Jana, additional, Vošmik, Milan, additional, Zasadny, Xavier, additional, Geoffrois, Lionnel, additional, Fietkau, Rainer, additional, Haderlein, Marlen, additional, Mueller, Andreas H, additional, Schroeder, Ursula, additional, Wollenberg, Barbara, additional, Ivanyi, Philipp, additional, Gruenwald, Viktor, additional, Schafhausen, Philippe, additional, Gutfeld, Orit, additional, Gluck, Iris, additional, Popovtzer, Aron, additional, Meirovitz, Amichay, additional, Billan, Salem, additional, Brenner, Baruch, additional, Limon, Dror, additional, Perri, Francesco, additional, Caponigro, Francesco, additional, Violati, Martina, additional, Ferrari, Daris, additional, Nole, Franco, additional, Bertolini, Federica, additional, Livi, Lorenzo, additional, Ghi, Maria Grazia, additional, Imarisio, Ilaria, additional, Homma, Akihiro, additional, Ueda, Tsutomu, additional, Asada, Yukinori, additional, Yamazaki, Tomoko, additional, Matsumoto, Koji, additional, Fujii, Takashi, additional, Ikeda, Sadakatsu, additional, Takahashi, Shunji, additional, Kinoshita, Takashi, additional, Sasaki, Keita, additional, Tsuji, Akihito, additional, Ahn, Myung-Ju, additional, Cho, Byoung Chul, additional, Lee, Keun-Wook, additional, Lee, Ki Hyeong, additional, Choi, Moon Ki, additional, Yun, Hwan Jung, additional, Hendriks, Mathijs P, additional, Oosting, Sjoukje F, additional, Buter, Jan, additional, Van Meerten, Esther, additional, Graham, Jonathan, additional, Kawecki, Andrzej, additional, Debicka, Izabella, additional, Maciejczyk, Adam, additional, Pysz, Maciej, additional, Filarska, Dorota, additional, Koralewski, Piotr, additional, Wygoda, Andrzej, additional, Składowski, Krzysztof, additional, Talerczyk, Małgorzata, additional, Berrocal Jaime, Alfonso, additional, Pérez Segura, Pedro, additional, Braña García, Irene, additional, Basté Rotllan, Neus, additional, Mesía Nin, Ricard, additional, Taberna Sanz, Miren, additional, Iglesias Docampo, Lara, additional, Soria Rivas, Ainara, additional, Rueda Domínguez, Antonio, additional, Trigo Pérez, José Manuel, additional, Hong, Ruey-Long, additional, Li, Shau-Hsuan, additional, Wang, Hung-Ming, additional, Yen, Chia-Jui, additional, Yang, Muh-Hwa, additional, Chang, Yi-Fang, additional, Liu, Yi-Chun, additional, Lin, Jin-Ching, additional, Ekenel, Meltem, additional, Harputluoğlu, Hakan, additional, Özyilkan, Özgür, additional, Bılıcı, Ahmet, additional, Şendur, Mehmet Alı Nahıt, additional, Arslan, Cagatay, additional, Harrington, Kevin, additional, Ramkumar, Shanmugasundaram, additional, Gujral, Dorothy, additional, Stewart, Simon, additional, Powell, Melanie, additional, Sibtain, Amen, additional, Roques, Tom, additional, Yip, Kent, additional, Mirza, Arafat, additional, Sivaramalingam, Muthiah, additional, Belman, Neil D, additional, Agarwala, Sanjiv, additional, Anderson, Ian, additional, Patel, Arpan, additional, Maggiore, Ronald, additional, Baumgart, Megan, additional, Fidler, Mary Jo, additional, Kaur, Varinder, additional, Gaughan, Elizabeth, additional, Worden, Francis, additional, Rodriguez, Cristina P, additional, Sukari, Ammar, additional, Wong, Deborah, additional, Yom, Sue, additional, Walsh, William V, additional, Fiorillo, Joseph A, additional, Yorio, Jeffrey T, additional, and Obara, Grzegorz S, additional

Published
2024
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5. Durvalumab with first-line chemotherapy in previously untreated malignant pleural mesothelioma (DREAM): a multicentre, single-arm, phase 2 trial with a safety run-in

Author

Nowak, Anna K, Lesterhuis, W Joost, Kok, Peey-Sei, Brown, Chris, Hughes, Brett GM, Karikios, Deme J, John, Thomas, Kao, Steven C-H, Leslie, Connull, Cook, Alistair M, Pavlakis, Nick, Briscoe, Karen, O'Byrne, Kenneth J, Karapetis, Christos S, Lam, Wei-Sen, Langford, Ailsa, Yip, Sonia, and Stockler, Martin R

Published
2020
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8. Durvalumab with first-line chemotherapy in previously untreated malignant pleural mesothelioma (DREAM): a multicentre, single-arm, phase 2 trial with a safety run-in

Author

Nowak, Anna K., Lesterhuis, W. Joost, Kok, Peey Sei, Brown, Chris, Hughes, Brett GM, Karikios, Deme J., John, Thomas, Kao, Steven C-H., Leslie, Connull, Cook, Alistair M., Pavlakis, Nick, Briscoe, Karen, O'Byrne, Kenneth J., Karapetis, Christos S., Lam, Wei Sen, Langford, Ailsa, Yip, Sonia, Stockler, Martin R., Nowak, Anna K., Lesterhuis, W. Joost, Kok, Peey Sei, Brown, Chris, Hughes, Brett GM, Karikios, Deme J., John, Thomas, Kao, Steven C-H., Leslie, Connull, Cook, Alistair M., Pavlakis, Nick, Briscoe, Karen, O'Byrne, Kenneth J., Karapetis, Christos S., Lam, Wei Sen, Langford, Ailsa, Yip, Sonia, and Stockler, Martin R.

Abstract

Background: There is a strong unmet need to improve systemic therapy in mesothelioma. Chemotherapy with cisplatin and pemetrexed improves survival in malignant pleural mesothelioma, and immune checkpoint inhibitors are an emerging treatment in this disease. We aimed to evaluate the activity of durvalumab, an anti-PD-L1 antibody, given during and after first-line chemotherapy with cisplatin and pemetrexed in patients with advanced malignant pleural mesothelioma. Methods: DREAM was a multicentre, single-arm, open-label, phase 2 trial done in nine hospitals in Australia. Eligible patients were aged 18 years or older and had histologically confirmed malignant pleural mesothelioma considered unsuitable for cancer-directed surgery, an Eastern Cooperative Oncology Group performance status of 0 or 1, and measurable disease as per the modified Response Evaluation Criteria in Solid Tumors version 1.0 (mRECIST) for mesothelioma that was previously untreated with systemic therapy. All histological subtypes were eligible. The first six participants were treated for two cycles in a safety run-in. All participants received cisplatin 75 mg/m2, pemetrexed 500 mg/m2, and durvalumab 1125 mg intravenously on day 1 of a 3-weekly schedule for a maximum of six cycles. Change from cisplatin to carboplatin with an area under the curve of 5 was permitted. Durvalumab was continued for a maximum of 12 months. The primary endpoint was progression-free survival at 6 months, measured according to mRECIST for malignant pleural mesothelioma and analysed in the intention-to-treat population. Safety analyses included all participants who receive at least one dose of any study drug. This study is registered with the Australia New Zealand Clinical Trials Registry, ACTRN12616001170415. Findings: Between Dec 28, 2016, and Sept 27, 2017, 55 participants were enrolled. 54 patients were eligible and were followed up for a median of 28·2 months (IQR 26·5–30·2)

Published
2020

10. A Prospective Study Investigating the Efficacy and Toxicity of Definitive ChemoRadadiation and ImmunOtherapy (CRIO) in Locally and/or Regionally Advanced Cutaneous Squamous Cell Carcinoma.

Author

Lin, Charles, primary, Ballah, Trishna, additional, Nottage, Michelle, additional, Hay, Karen, additional, Chua, Benjamin, additional, Kenny, Lizbeth, additional, Thomas, Paul, additional, Teng, Michele WL, additional, Keller, Jacqui, additional, Le, Trang, additional, Edmunds, Jennifer, additional, and Hughes, Brett GM, additional

Published
2020
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11. Final Results of the Dream Trial: A Phase 2 Trial of Durvalumab with First-Line Chemotherapy in Mesothelioma with a Safety Run-In

Author

Nowak, Anna K., primary, Lesterhuis, W Joost, additional, Kok, Peey-Sei, additional, Brown, Chris, additional, Hughes, Brett GM, additional, Karikios, Deme J, additional, John, Thomas, additional, Kao, Steven C-H, additional, Leslie, Connull, additional, Cook, Alistair M, additional, Pavlakis, Nick, additional, Briscoe, Karen, additional, O’Byrne, Kenneth J, additional, Karapetis, Christos S, additional, Lam, Wei-Sen, additional, Langford, Ailsa, additional, Yip, Sonia, additional, and Stockler, Martin R, additional

Published
2020
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12. Abstract CT170: KEYNOTE-629: Phase II study of pembrolizumab for recurrent/metastatic or locally advanced unresectable cutaneous squamous cell carcinoma

Author

Grob, Jean-Jacques, primary, Mendoza, Rene Gonzalez, additional, Basset-Seguin, Nicole, additional, Schachter, Jacob, additional, Vornicova, Olga, additional, Bauman, Jessica, additional, Grange, Florent, additional, Meyer, Nicolas, additional, Piulats, Josep, additional, Zhang, Pingye (Eric), additional, Gumuscu, Burak, additional, Swaby, Ramona, additional, and Hughes, Brett GM, additional

Published
2019
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