Phase II Clinical Trials

• CT236 · PDF Epigenetic immune reprogramming overcomes PD-1 resistance in metastatic melanoma patients: The phase II NIBIT-ML1 study Anna Maria Di Giacomo, Alessia Covre, Maria Fortunata Lofiego, Francesca Pia Caruso, Maura Colucci, Vincenzo D'Alonzo, Raffaella Grifoni, Roberta Depenni, Laura Solmonese, Francesco Marzani, Emma Bello, Antonio De Falco, Monica Valente, Ramiz Rana, Elena Carbonari, Giovanni Amato, Elena Manenti, Ilenia Vizzari, Sandra Coral, Harold Keer, Aram Oganesian, Danna Chan, Roberta Mortarini, Maresa Altomonte, Diana Giannarelli, Andrea Anichini, Teresa Noviello, Michele Ceccarelli, Michele Maio
• CT237 · PDF SCOPE, A phase 2 clinical trial with off-the-shelf DNA plasmid vaccine in first line advanced melanoma combined with check point blockade, shows good T cell responses which correlate with long progression free survival Joseph Chadwick, Samantha Paston, Kate Young, Heather Shaw, Pippa Corrie, Sarah Danson, Miranda Payne, Poulam Patel, Maria Marples, Ioannis Karydis, Satish Kumar, Clare Barlow, Rebecca Lee, Martin Highley, Kellati Prasad, Georgia Goodhew, Olivia Howard, Joe Thornton, Nermeen Varawalla, Lindy Durrant
• CT238 · PDF Intratumoral sotigalimab with pembrolizumab induces rapid activation of antigen presenting cells and drives anti-tumor responses in non-injected tumors in metastatic melanoma: A phase I/II study Salah-Eddine Bentebibel, Daniel J McGrail, Veena Kochat, Emre Arslan, Reham Abdel-Wahab, Sung-Nam Cho, Xiaodong Yang, Daniel H Johnson, Rodabe N Amaria, Isabella C Glitza, Patrick Hwu, Hussein A Tawbi, Jared K Burks, Michael A Davies, Kunal Rai, Suhendan Ekmekcioglu, Adi Diab
• CT240 · PDF IOB-032/PN-E40: A phase 2 study of neoadjuvant/adjuvant IO102-IO103 cancer vaccine plus pembrolizumab in resectable HNSCC Barbara Burtness, Ravindra Uppaluri, Michael J. Dennis, Annette M. Lim, Richard A. Scolyer, Erin Alesi, Ayako Wakatsuki Pedersen, Amy Wesa, Ravi K. Adapala, Ulla Kring Hansen, Marcos Iglesias, Bushi Wang, Cecilie Abildgaard, Qasim Ahmad, Francois Ringeisen, Georgina V. Long, Robert I. Haddad
• CT241 · PDF Phase 2 window of opportunity trial of pyrimethamine in locoregionally advanced head and neck squamous cell carcinoma Paul Zolkind, Emily M. Wilkerson, Harit Panda, Julius Chembo, James Sun, Kate Zhao, Jessica Ley, Michael Atteberry, Nathan Wamsley, Sidra Major, Kynlee Giesie, Luke Chen, Ryan S. Jackson, Jason Rich, Patrik Pipkorn, Alex Harbison, Anthony J. Apicelli, Jennifer De Los Santos, Wade L. Thorstad, Sidharth V. Puram, Peter Oppelt, Douglas Adkins, Michael B. Major
• CT242 · PDF Covalent FAPI imaging-guided precision surgery in medullary thyroid carcinoma Ziren Kong, Yang Liu, Yan-Song Lin, Zhu Li, Xi-Yang Cui, Shengyan Liu, Xin Zhang, Ruochen Li, Ye Yang, Yuning Sun, Yongdu Nie, Zongmin Zhang, Changming An, Song Ni, Yiming Zhu, Zhibo Liu, Jian Wang, Shaoyan Liu
• CT243 · PDF Dirozalkib in patients with advanced ALK-positive non-small cell lung cancer (NSCLC): Results from a phase 2 study Ying Liu, Yan Yu, Zhiye Zhang, Ruiling Ning, Yulan Sun, Meili Sun, Dairong Li, Li Wang, Xianghui Duan, Xuejie Guo, Yan Hu, Weili Liu, Haifeng Liu
• CT244 · PDF Taletrectinib in tyrosine kinase inhibitor (TKI)-pretreated patients with ROS1+ non-small cell lung cancer (NSCLC): Updated data from TRUST-I and TRUST-II Geoffrey Liu, Jorge Nieva, Lyudmila Bazhenova, Chang-Min Choi, Qitao Yu, Shunichi Sugawara, Noriko Yanagitani, Filippo de Braud, Huijie Fan, Enriqueta Felip, Emilio Bria, Maurice Pérol, Feiwu Ran, Wei Wang, Xianyu Zhang, Michael Chen, Caicun Zhou
• CT245 · PDF PDR001 in patients with unresectable non-small cell lung cancer (NSCLC) harboring KRAS/NRAS mutation or without actionable genetic abnormalities: Phase II, multicenter, single arm study Yeong Hak Bang, Seong-Eun Kim, Shinkyo Yoon, Dae Ho Lee, Bhumsuk Keam, Dong-Wan Kim, Sang-We Kim
• CT246 · PDF An ensemble multi-omics framework for chemo de-escaltion NSCLC patients with PD-L1-low/negative disease in the PEOPLE phase II trial (NCT03447678) Luca Mauro Invernizzi, Ghazal Farhikhteh, Arianna Rigamonti, Sabrina Pervin Abu, Donato Cosi, Cecilia Silvestri, Luca Agnelli, Tiziana Triulzi, Marta Brambilla, Michela Francesconi, Francesco Sgambelluri, Mario Occhipinti, Maria Chiara Garassino, Roberta Mortarini, Filippo De Braud, Claudia Proto, Francesco Trovò, Monica Ganzinelli, Giuseppe Lo Russo, Arsela Prelaj
• CT247 · PDF Savolitinib combined with Durvalumab in EGFR wild-type advanced NSCLC patients with MET alterations (SOUND): A multicenter, open-label, Phase II trial Yong-Feng Yu, Xiao-Ying Huang, Qian Chu, An-Wen Liu, Li Zhuang, Xiao-Rong Dong, Hong-Cheng Wu, Jian-Ying Zhou, Shun-Dong Cang, Yan Wang, Yi Hu, Zhen-Zhou Yang, Meng-di Wu, Xiao-yuan Wang, Shun Lu
• CT248 · PDF Zidesamtinib in patients with ROS1 + NSCLC previously treated with repotrectinib or taletrectinib Geoffrey Liu, Alexander E. Drilon, Benjamin Besse, Gianluca Spitaleri, Jessica J. Lin, Byoung Chul Cho, Tatsuya Yoshida, Daniel Haggstrom, Steven Kao, Aurelie Swalduz, Misako Nagasaka, Benjamin J. Solomon, Lorenza Landi, Chiara Bennati, Elvire Pons-Tostivint, Christophe Dooms, A. J. van der Wekken, Saiama Waqar, Shirish Gadgeel, Chia-Chi Lin, Tetsuro Kondo, Hidetoshi Hayashi, Daniel Tan, Giulia Pasello, Matteo Duca, Luis G. Paz-Ares, Antonio Calles, Enriqueta Felip, Julien Mazieres, Adrianus Johannes de Langen, Alice T. Shaw, Jonathan W. Riess, Marina Garassino, Elaine Shum, Christina S. Baik, Jessica R. Bauman, D. Ross Camidge, Chien-Chung Lin, Gee-Chen Chang, Dong-Wan Kim, Myung-Ju Ahn, Ji-Youn Han, Kiichiro Ninomiya, Ryo Ariyasu, Ross Andrew Soo, Sanjay Popat, Jürgen Wolf, Maria Rosario García Campelo, Vivek A. Upadhyay, Stephen V. Liu
• CT249 · PDF Detection of EGFR T790M mutation in bronchial washing fluid and therapeutic efficacy of lazertinib in T790M-positive NSCLC patients after first-line EGFR-TKI failure: An open-label, multicenter, single-arm exploratory study Chi Young Kim, Se Hyun Kwak, Eun Hye Lee, Sang Hoon Lee, Eun Young Kim, Yoon Soo Chang
• CT250 · PDF A phase 1b / 2 study of JK06, a 5T4-targeted antibody drug conjugate, in patients with unresectable locally advanced or metastatic cancer Omar Saavedra, Fabricio Racca, Valentina Boni, Emiliano Calvo, Brant Delafontaine, Sylvie Rottey, Bernd Dekeyser, Hans Prenen, Maria deMiguel, Valentina Gambardella, Lionel d'Hondt, Vladimir Galvao, Judit W. Johnson, Jonathan P. McNally, Jennifer Lindelien, Alice Drumheller, Jijun Dong, Samuel P. Murphy, Shalabh Singhal, Naimish Pandya, Nuria Kotecki
• CT252 · PDF Double lung transplantation in patients with metastatic lung-limited non-small cell lung carcinoma (NSCLC): A case series Young Kwang Chae, Liam Il-Young Chung, Ronald Seungjune S. Min, Sanghwa Kim, Ben Ponvilawan, Chan Mi Jung, Yuchan Kim, Brooke Sanson, Rose Dwyer, Tarik Demir, Chitaru Kurihara, Ambalavanan Arunachalam, Ankit Bharat
• CT253 First in India, phase 1/2 study of an indigenously adapted, cost-efficient autologous dual-target BCMA/CD19 CAR T-cell therapy for relapsed or refractory multiple myeloma Uday Kumar Surampudi, Prashant Kashinath Bhavar, Partha Pratim Sarma, Rishi Rahangdale, Guoxiang WU
• CT254 · PDF Results of a randomized placebo-controlled phase 2 study of metformin for the prevention of progression of precursor multiple myeloma Catherine R. Marinac, Robert Redd, Adam S. Sperling, Lorenzo Trippa, Victoria A. Kelly, Shonali Midha, Elizabeth K. O'Donnell, Paul G. Richardson, Irene M. Ghobrial, Omar Nadeem
• CT255 · PDF AdAPT-001 in the BETA-PRIME trial: Spatially and temporally coordinated TGF-beta inhibition and oncolytic infection Chris Larson, Vinod Ravi, Jeannie Williams, Erica Burbano, Meaghan Stirn, Scott Caroen, Bryan Oronsky, Anthony P. Conley, Tony Reid
• CT256 · PDF A Phase II chemo/immunotherapy study using metronomic gemcitabine, doxorubicin, docetaxel and nivolumab for advanced angiosarcoma (NCT04535713): An interim analysis Samantha Jeffrey, Piya Mann, Oliver Davidorf, Anmol Dia Agarwal, Sarah Lande, Mihir Chawla, Neal Chawla, Ania Moradkhani, Ted Kim, Victoria Chua-Alcala, Sant Chawla, Erlinda Gordon
• CT257 · PDF Double lung transplantation in patients with recent history of malignancy Young Kwang Chae, Liam IL-Young Chung, Ronald Min, Sanghwa Kim, Ben Ponvilawan, Chan Mi Jung, Yuchan Kim, Brooke Sanson, Rose Dwyer, Carolyn Moloney, Tarik Demir, Chitaru Kurihara, Ambalavanan Arunachalam, Ankit Bharat
• CT258 · PDF Digital survivorship care planning through the eyes of cancer survivors: A qualitative analysis of a phase I/II randomized controlled trial Shalet James, Maria S. Rangwala, Amber S. Kleckner
• CT259 · PDF Rapid analysis and response evaluation of combination anti-neoplastic agents in rare tumors (RARE CANCER) trial (RARE 3): Tiragolumab + Atezolizumab Amanda Walker, Naoko Takebe, Murielle Hogu, Sarah J. Shin, Jared Foster, Andre De Souza, Lamin Juwara, Katherine V. Ferry-Galow, Ralph E. Parchment, Laura Kuhlmann, Helen X. Chen, James H. Doroshow, Alice P. Chen, Jibran Ahmed
• CT260 · PDF Pembrolizumab and epigenetic modification with azacitidine reprogram the tumor microenvironment of platinum-resistant epithelial ovarian cancer: clinical and translational findings from a phase II study Blair V. Landon, Julia L. Boland, Andrea E. Wahner Hendrickson, Deborah K. Armstrong, Boris Winterhoff, Jaime Wehr, Akshaya V. Annapragada, Christopher Cherry, Archana Balan, Guneet Kaleka, Victor E. Velculescu, Stephen B. Baylin, Cynthia A. Zahnow, Dennis J. Slamon, Gottfried E. Konecny, John A. Glaspy, Valsamo (Elsa) Anagnostou
• CT261 · PDF Molecular iodine impairs chemotherapy resistance and adverse effects in breast cancer treatments Jorge V. Gil Leyva, Bruno Estrada-Jimenez, Jessica Vega-Mera, Ximena Ramirez-Morales, Alejandro Ruiz-Diego, Evangelina Delgado-Gonzalez, Guillermo Peralta, Brenda Anguiano, Carmen Aceves
• CT262 · PDF Elacestrant (Ela) in combination with everolimus (Eve) or abemaciclib (Abema) in patients with ER+/HER2- locally advanced or metastatic breast cancer mBC: phase 2 results from ELEVATE, an open-label, umbrella study Hope S. Rugo, Sara M. Tolaney, Nancy Chan, Giuliano Borges, Rinat Yerushalmi, Marina N. Sharifi, Wassim McHayleh, Thaddeus Beck, Neelima Vidula, Erika Hamilton, Kristine J. Rinn, Joyce O’Shaughnessy, Giuseppe Curigliano, Javier Cortés, Paula Muñoz Romero, Giulia Tonini, Alessandro Paoli, Monica Binaschi, Li Cheng, Jennifer A. Crozier, Tomer Wasserman, Virginia Kaklamani
• CT263 · PDF Window of opportunity trial of preoperative low dose azacitidine in high-risk early-stage breast cancer Maria Jose Godoy Calderon, Abhigna Kodali, Manali Patwardhan, Saanvi Sethi, Meredith Russell, Eric Gauchat, Michelle Karan, Zhengjia Chen, Oana Danciu, Kent Hoskins, Abiola Ibraheem, VK Gadi

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