Family-wise type I error rate control for an extended 2-in-1 design with graphical approach in oncology drug development

Authors: Li, Wen, Zhou, Heng, Jia, Calvin, Sun, Linda

Source: In Contemporary Clinical Trials August 2022 119

Epacadostat plus pembrolizumab versus placebo plus pembrolizumab for advanced urothelial carcinoma: results from the randomized phase III ECHO-303/KEYNOTE-698 study.

Authors: Cicin, Irfan, Plimack, Elizabeth R., Gurney, Howard, Leibowitz, Raya, Alekseev, Boris Y., Parnis, Francis X., Peer, Avivit, Necchi, Andrea, Bellmunt, Joaquim, Nishiyama, Hiroyuki, Clark, Jason, Munteanu, Mihaela, Kataria, Ritesh, Jia, Calvin, Powles, Thomas, Sternberg, Cora N.

Source: BMC Cancer; 7/25/2024, Vol. 23 Issue 1, p1-11, 11p

Subject Terms: TRANSITIONAL cell carcinoma, PEMBROLIZUMAB, INDOLEAMINE 2,3-dioxygenase, PEMETREXED, IMMUNE checkpoint inhibitors, PLACEBOS

Pembrolizumab plus either epacadostat or placebo for cisplatin-ineligible urothelial carcinoma: results from the ECHO-307/KEYNOTE-672 study.

Authors: Necchi, Andrea, Van der Heijden, Michiel S., Trukhin, Dmytro, Peer, Avivit, Gurney, Howard, Alekseev, Boris Y., Parnis, Francis X., Leibowitz, Raya, De Santis, Maria, Grivas, Petros, Clark, Jason, Munteanu, Mihaela, Kataria, Ritesh, Jia, Calvin, Balar, Arjun V., de Wit, Ronald

Source: BMC Cancer; 7/25/2024, Vol. 23 Issue 1, p1-11, 11p

Subject Terms: TRANSITIONAL cell carcinoma, PEMBROLIZUMAB, IMMUNE checkpoint inhibitors, TERMINATION of treatment, ADVERSE health care events

First-line pembrolizumab (pembro) with or without lenvatinib (lenva) in patients with advanced urothelial carcinoma (LEAP-011): A phase 3, randomized, double-blind study.

Authors: Loriot, Yohann, Grivas, Petros, De Wit, Ronald, Balar, Arjun Vasant, Siefker-Radtke, Arlene O., Zolnierek, Jakub, Csoszi, Tibor, Shin, Sang Joon, Park, Se Hoon, Atduev, Vagif, Gumus, Mahmut, Su, Yu-Li, Karaca, Saziye Burcak, Cutuli, Hernan, Sendur, Mehmet Nahit, Jia, Calvin, O'Hara, Karen, Franco, Sonia, Matsubara, Nobuaki

Source: Journal of clinical oncology. 40(6 suppl):432-432

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100152993413.0x000001&indx=1&recIds=ETOCvdc_100152993413.0x000001

KEYNOTE-905/EV-303: A phase 3 study to evaluate the efficacy and safety of perioperative pembrolizumab or pembrolizumab plus enfortumab vedotin (EV) for muscle-invasive bladder cancer (MIBC).

Authors: Necchi, Andrea, Bedke, Jens, Galsky, Matt D., Shore, Neal D., Xylinas, Evanguelos, Jia, Calvin, Dubrovsky, Leonid, Homet Moreno, Blanca, Witjes, J. Alfred

Source: Journal of Clinical Oncology; 2023 Supplement 16, Vol. 41, pTPS4601-TPS4601, 1p

Phase 3 KEYNOTE-905/EV-303: Perioperative pembrolizumab (pembro) or pembro + enfortumab vedotin (EV) for muscle-invasive bladder cancer (MIBC).

Authors: Necchi, Andrea, Bedke, Jens, Galsky, Matt D., Shore, Neal D., Plimack, Elizabeth R., Xylinas, Evanguelos, Jia, Calvin, Hennika, Tammy, Homet Moreno, Blanca, Witjes, Alfred Alfred

Source: Journal of Clinical Oncology; 2/21/2023 Supplement, Vol. 41, pTPS585-TPS585, 1p