Zhang, Tian
https://orcid.org/0000-0001-8914-3531
Mayo Clinic
Harold C. Simmons Comprehensive Cancer Center
Citations 17
Assessment of Regional Variability in COVID-19 Outcomes Among Patients With Cancer in the United States
Hawley, Jessica E. , Sun, Tianyi , Chism, David D. , Duma, Narjust , Fu, Julie , Gatson, Na Tosha , Mishra, Sanjay , Nguyen, Ryan H., Reid, Sonya , Serrano, Oscar K. , Singh, Sunny , Venepalli, Neeta K. , Bakouny, Ziad , Bilen, Mehmet Asım , Choueiri, Toni K. , Dawsey, Scott J. , Fecher, Leslie A. , Flora, Daniel , Friese, Christopher R. , Glover, Michael , Gonzalez, Cyndi J, Goyal, Sharad , Khan, Hina, Lewis, Mark A. , McKay, Rana R. , Messing, Ian , Puc, Matthew , Ravindranathan, Deepak , Rhodes, Terence D., Rivera, Andrea Verghese, Roller, John , Shah, Sumit , Shaya, Justin , Streckfuss, Mitrianna, Wulff‐Burchfield, Elizabeth , Xie, Zhuoer , Shah, Dimpy P. , French, Benjamin , Verma, Amit , Gartrell, Benjamin A. , Ohri, Nitin , Butt, Omar H. , Campian, Jian , Fiala, Mark A. , Monahan, Ryan, Bohachek, Pamela, Mundt, Daniel , Tadesse, Eyob, Lammers, Philip E. , Prete, Salvatore A. Del , Bär, Michael , Gulati, Anthony P., Lo, K. M. Steve, Stratton, Jamie , Weinstein, Paul L., García, Jorge A. , Nakayama, John , Gupta, Shilpa , Ahluwalia, Manmeet S. , Lemmon, Christopher A. , Nizam, Amanda , Hoppenot, Claire , Bouchard, Gabrielle, Busser, Fiona, Connors, Jean M. , Curran, Catherine , Demetri, George D., Kelleher, Kaitlin M. , Shaw, Grace, Allen, Eli Van, Nuzzo, Pier Vitale , Zon, Rebecca L. , Zhang, Tian , Leighton, John, Grivas, Petros , Lynch, Ryan C. , Schweizer, Michael T. , Vinayak, Shaveta , Wagner, Michael J. , Clément, Jessica , Daher, Ahmad , Dailey, Mark, Jayaraj, Asha, Hsu, Emily , Menendez, Alvaro G. , Rathmann, Joerg, Accordino, Melissa , Alexander, Mariam P., Mushtaq, Sarah, Bernicker, Eric , Deeken, John F. , Shafer, Danielle , Gill, David , Low, Clarke A., Mashru, Sandeep H., Mansoor, Abdul-Hai, Zaren, Howard A. , Smith, Stephanie J., Akhtari, Mojtaba, Lau, Eric , Reeves, Mark E. , Elms, Destry, Altman, Jessica K. , Gurley, Michael, Mulcahy, Mary F. , Kulkarni, Amit , Shah, Surbhi , Rosovsky, Rachel , Reynolds, Kerry L. , Bardia, Aditya , Gainor, Justin F. , Zubiri, Leyre , Bonnen, Mark , Mahadevan, Daruka , Salazar, Mary, Faller, Bryan A. , Ajmera, Archana , Brouha, Sharon S. , Cabal, Angelo , Kligerman, Seth , Weissmann, Lisa B., Jani, Chinmay , Thomson, Carey C. , Knoble, Jeanna, Glace, Mary Grace, Stauffer, Karen, Zacks, Rosemary, Blau, Sibel , Menon, Harry, Rovito, Marc A., Elshoury, Amro, Misdary, Christian, Shah, Mansi , Mahmood, Sana , Mico, Vasil, Logan, Barbara, Mandapakala, Chaitanya, Cabebe, Elwyn C., Jha, Alokkumar , Schapira, Lidia , Wu, Julie , Subbiah, Suki , Lopes, Gilberto , Revankar, Sanjay G. , Addison, Daniel , Chen, James L. , Karivedu, Vidhya , Lustberg, Maryam B. , Wall, Sarah , Williams, Nicole , Kasi, Anup , Edwin, Natasha, Smits, Melissa, Owenby, Susie, Doroshow, Deborah B. , Galsky, Matthew D. , Zhu, Huili , Sueyoshi, Mark, Riess, Jonathan W. , Patel, Kanishka G. , Rubinstein, Samuel M. , Ahmad, Syed A. , Grover, Punita , Kharofa, Jordan , Marcum, Michelle, Park, Cathleen, Geiger, Christoper L., Bishnoi, Rohit , Russ, Atlantis Dawn, Rho, Young Soo , Feldman, Lawrence , Hoskins, Kent , Gantt, Gerald, Liu, Li , Khan, Mahir, Nguyen, Ryan H., Schwartz, Candice, Mavromatis, Blanche H., Bijjula, Ragneel R., Cheng, Alex , Duda, Stephany N. , Enriquez, Kyle T. , Gillaspie, Erin A. , Hennessy, Cassandra , Johnson, Douglas B. , Slosky, David, Solórzano, Carmen C. , Vega-Luna, Karen, Kennecke, Hagen F. , Schroeder, Brett A., Carducci, Theresa M., Goldsmith, Karen J., Loon, Susan Van, Topaloĝlu, Ümit , Alimohamed, Saif, Rice, Robert, Cabalona, Wilhelmina D., Pilar, Christine, Peddi, Prakash , Rosen, L, McCollough, Briana Barrow, LoRusso, Patricia , Masters, Tyler, Choueiri, Toni K , Bakouny, Ziad , Hawley, Jessica E , Mishra, Sanjay , Wu, Julie T , Xie, Zhuoer , Zubiri, Leyre , Gatson, Na Tosha N , Fiala, Mark A , Ahluwalia, Manmeet S , Lustberg, Maryam , Nguyen, Ryan H., Bashir, Babar , Caimi, Paolo F. , Hálfdánarson, Þorvarður R. , Hershman, Dawn L. , Labaki, Chris , Pennell, Nathan A , Schwartz, Gary K. , Thompson, Michael A. , Yu, Peter Paul , Warner, Jeremy L. , Hwang, Clara , Halmos, Balázs , Goel, Sanjay , Sica, Roberto Alejandro , Thakkar, Astha , Stockerl‐Goldstein, Keith , Henderson, Jeffrey P. , Zhou, Alice Y. , Panagiotou, Orestis A. , Egan, Pamela , Farmakiotis, Dimitrios , Olszewski, Adam J. , Loaiza‐Bonilla, Arturo , Bar, Michael H., Rose, Suzanne J. , Barnholtz‐Sloan, Jill S. , Li, Ang , Giordano, Antonio , Nohria, Anju , Schmidt, Andrew , Xu, Vincent Eric , Halabi, Susan , Lyman, Gary H , Graber, Jerome J. , Khaki, Ali Raza , Loggers, Elizabeth T , Nakasone, Elizabeth S. , Tachiki, Lisa , Yeh, Albert C. , Huynh‐Le, Minh‐Phuong , Rosenstein, Lori J. , Dailey, Mark, Elias, Rawad , Gadgeel, Shirish M. , Bhutani, Divaya , Reuben, Daniel Y. , Alexander, Mariam, Nagaraj, Gayathri , Berg, Stephanie , Morgans, Alicia K. , Wehbe, Firas , Durbin, Eric B. , Nelson, Heather H. , Sachs, Zohar , Boland, Genevieve M. , Bekaii‐Saab, Tanios , Desai, Aakash , Mesa, Ruben A. , Ramirez, Amelie G , Shah, Pankil , Hsiao, Albert , Rink, Cameron L. , Joshi, Monika , Griffiths, Elizabeth A. , Jabbour, Salma K , McNair, Christopher M. , Kloecker, Goetz Hans , Stover, Daniel G. , Gatti-Mays, Margaret Elena , Jhawar, Sachin R. , Palmer, Joshua D. , Wotman, Michael T. , Fazio, Alyson, Huber, Kathryn E. , Wood, William A. , Jensen, Christopher Edward , Kumar, Vaibhav , Wise-Draper, Trisha Michel , Gulati, Shuchi , Latif, Tahir , Shaikh, Hira , Bowles, Daniel W. , Markham, Merry Jennifer , Shah, Chintan , Acoba, Jared David , Nguyen, Ryan H., Pasquinelli, Mary M. , Vikas, Praveen , Zaman, Qamar U., Davis, Elizabeth J. , Hausrath, Daniel J. , Hsu, Chih–Yuan , Li, Xuanyi , Rini, Brian I. , Shyr, Yu , Tucker, Matthew D. , Wang, Lucy Lu , Aboulafia, David M. , Schroeder, Brett , Hafez, Navid , Herbst, Roy S. , Stratton, Catherine
JAMA Network Open | January 4, 2022 | Volume: 5 | Issue: 1 | Pages: e2142046
Association of Convalescent Plasma Therapy With Survival in Patients With Hematologic Cancers and COVID-19
Shah, Pankil , Rubinstein, Samuel M. , Joyner, Michael J. , Choueiri, Toni K. , Flora, Daniel , Gulati, Anthony P., Koshkin, Vadim S. , Papadopoulos, Esperanza B. , Robilotti, Elizabeth , Su, Christopher , Wulff‐Burchfield, Elizabeth , Xie, Zhuoer , Yu, Peter Paul , Mishra, Sanjay , Senefeld, Jonathon W. , Shah, Dimpy P. , Verma, Amit , Gartrell, Benjamin A. , Ohri, Nitin , Butt, Omar H. , Campian, Jian , Fiala, Mark A. , Monahan, Ryan, Bohachek, Pamela, Mundt, Daniel , Streckfuss, Mitrianna, Tadesse, Eyob, Lammers, Philip E. , Revankar, Sanjay G. , Khan, Hina, Prete, Salvatore A. Del , Angevine, Anne H., Bär, Michael , Lo, KM Steve, Stratton, Jamie , Weinstein, Paul L., García, Jorge A. , Nakayama, John , Gupta, Shilpa , Ahluwalia, Manmeet S. , Dawsey, Scott J. , Nizam, Amanda , Lemmon, Christopher A. , Hoppenot, Claire , Bakouny, Ziad , Bouchard, Gabrielle, Busser, Fiona, Conners, Jean M, Curran, Catherine , Demetri, George D., Kelleher, Kaitlin M. , Shaw, Grace, Nuzzo, Pier Vitale , Zon, Rebecca L. , Zhang, Tian , Grivas, Petros , Lynch, Ryan C. , Schweizer, Michael T. , Tachiki, Lisa ML, Vinayak, Shaveta , Wagner, Michael J. , Yeh, Albert C. , Goyal, Sharad , Clément, Jessica , Daher, Ahmad , Dailey, Mark E., Hsu, Emily , Menendez, Alvaro G. , Rathmann, Joerg, Serrano, Oscar K. , Jayaraj, Asha, Accordino, Melissa , Mushtaq, Sarah, Bernicker, Eric , Deeken, John F. , Shafer, Danielle , Lewis, Mark A. , Rhodes, Terence D., Gill, David , Low, Clarke A., Nagle, Sarah , Hayes‐Lattin, Brandon , Nemecek, Eneida R. , Zaren, Howard A. , Smith, Stephanie J., Akhtari, Mojtaba, Lau, Eric , Reeves, Mark E. , Elms, Destry, Altman, Jessica K. , Gurley, Michael, Mulcahy, Mary F. , Kulkarni, Amit , Shah, Surbhi, Rosovsky, Rachel , Reynolds, Kerry L. , Bardia, Aditya , Gainor, Justin F. , Zubiri, Leyre , Bonnen, Mark , Mahadevan, Daruka , Salazar, Mary, Belenkaya, Rimma , Riely, Gregory J. , Faller, Bryan A. , McKay, Rana R. , Ajmera, Archana , Cabal, Angelo , Shaya, Justin , Weissmann, Lisa B., Jani, Chinmay , Chen, James L. , Jhawar, Sachin R, Lustberg, Maryam B. , Pillainayagam, Clement, Wall, Sarah , Williams, Nicole , Karivedu, Vidhya , Addison, Daniel , Menon, Harry, Rovito, Marc A., Elshoury, Amro, Shah, Mansi , Mahmood, Sana , Mico, Vasil, Rivera, Andrea Verghese, Miller, Chaim , Cabebe, Elwyn C., Glover, Michael , Jha, Alokkumar , Schapira, Lidia , Shah, Sumit , Subbiah, Suki , Logan, Barbara, Lopes, Gilberto , Russell, Karen , Stith, Brittany, Smits, Melissa, Edwin, Natasha, Chism, David D. , Owenby, Susie, Doroshow, Deborah B. , Galsky, Matthew D. , Zhu, Huili , Fu, Julie , Patel, Kanishka G. , Riess, Jonathan W. , Kwon, Daniel H. , Islam, Jessica Y. , Ahmad, Syed A. , Grover, Punita , Kharofa, Jordan , Marcum, Michelle, Park, Cathleen, Geiger, Christopher L., Bishnoi, Rohit , Feldman, Lawrence , Hoskins, Kent , Gantt, Gerald, Khan, Mahir, Nguyen, Ryan H, Schwartz, Candice, Venepalli, Neeta K. , Kasi, Anup , Fecher, Leslie A. , Mavromatis, Blanche H., Bijjula, Ragneel R., Cheng, Alex , French, Benjamin , Gillaspie, Erin A. , Hennessy, Cassandra , Johnson, Douglas B. , Reid, Sonya , Slosky, David, Solórzano, Carmen C. , Vega-Luna, Karen, Enriquez, Kyle T. , Sun, Tianyi , Carducci, Theresa M., Puc, Matthew , Loon, Susan Van, Goldsmith, Karen J., Rice, Robert, Cabalona, Wilhelmina D., Pilar, Christine, McCollough, Briana Barrow, Peddi, Prakash , Rosen, L, Bilen, Mehmet Asım , Ravindranathan, Deepak , LoRusso, Patricia , Masters, Tyler, Choueiri, Toni K , Bakouny, Ziad , Mishra, Sanjay , Yeh, Albert C , Xie, Zhuoer , Zubiri, Leyre , Su, Christopher , Fiala, Mark A , Joyner, Michael J , Senefeld, Jonathon W , Ahluwalia, Manmeet S , Lustberg, Maryam , Thompson, Michael A. , Henderson, Jeffrey P. , Griffiths, Elizabeth A. , Hwang, Clara , Warner, Jeremy L. , Halmos, Balázs , Goel, Sanjay , Sica, Roberto Alejandro , Thakkar, Astha , Stockerl‐Goldstein, Keith , Zhou, Alice Y. , Tadesse, Eyob, Panagiotou, Orestis A. , Egan, Pamela , Farmakiotis, Dimitrios , Olszewski, Adam J. , Loaiza‐Bonilla, Arturo , Bar, Michael H, Lo, K. M. Steve, Caimi, Paolo F. , Barnholtz‐Sloan, Jill S. , Pennell, Nathan A , Li, Ang , Giordano, Antonio , Nohria, Anju , Schmidt, Andrew , Van Allen, Eliezer M , Xu, Wenxin Vincent , Halabi, Susan , Lyman, Gary H , Graber, Jerome J. , Khaki, Ali Raza , Loggers, Elizabeth T , Nakasone, Elizabeth S. , Tachiki, Lisa M, Gatson, Na Tosha , Huynh‐Le, Minh‐Phuong , Rosenstein, Lori J. , Elias, Rawad , Gadgeel, Shirish M. , Hawley, Jessica E. , Hershman, Dawn L. , Bhutani, Divaya , Schwartz, Gary K. , Reuben, Daniel Y. , McWeeney, Shannon K. , Nagaraj, Gayathri , Berg, Stephanie , Morgans, Alicia K. , Wehbe, Firas , Durbin, Eric B. , Nelson, Heather H. , Boland, Genevieve M. , Hálfdánarson, Þorvarður R. , Bekaii‐Saab, Tanios , Desai, Aakash , Mesa, Ruben A. , Ramirez, Amelie G , Philip, John , Gatti-Mays, Margaret Elena , Jhawar, Sachin R, Palmer, Joshua D. , Stover, Daniel G. , Joshi, Monika , Jabbour, Salma K , Bashir, Babar , McNair, Christopher M. , Wu, Julie , Kloecker, Goetz Hans , Fazio, Alyson, Kumar, Vaibhav , Wood, William A. , Gulati, Shuchi , Wise-Draper, Trisha Michel , Bowles, Daniel W. , Markham, Merry Jennifer , Shah, Chintan , Acoba, Jared David , Rho, Young Soo, Nguyen, Ryan H, Pasquinelli, Mary M. , Vikas, Praveen , Friese, Christopher R. , Zaman, Qamar U, Davis, Elizabeth J. , Hausrath, Daniel J. , Hsu, Chih–Yuan , Li, Xuanyi , Rini, Brian I. , Shyr, Yu , Tucker, Matthew D. , Wang, Lucy Lu , Hafez, Navid , Herbst, Roy S. , Stratton, Catherine
JAMA Oncology | August 19, 2021 | Volume: 7 | Issue: 8 | Pages: 1167
PDIGREE: An adaptive phase III trial of PD-inhibitor nivolumab and ipilimumab (IPI-NIVO) with VEGF TKI cabozantinib (CABO) in metastatic untreated renal cell cancer (Alliance A031704).
Zhang, Tian , Watt, Colleen, Wen, Yujia , Shergill, Ardaman , Vaishampayan, Ulka N. , George, Daniel J. , Vaishampayan, Ulka , Ballman, Karla V. , Choudhury, Atish D. , Chen, Ronald C. , Zemla, Tyler , Emamekhoo, Hamid , Morris, Michael J. , George, Daniel J. , Choueiri, Toni K.
Journal of Clinical Oncology | March 2, 2021 | Volume: 39 | Issue: 6_suppl | Pages: TPS366-TPS366
10.1200/jco.2021.39.6_suppl.tps366
TPS366 Background: First-line treatment of mRCC has rapidly changed to include IPI-NIVO or CABO, with clinical benefit of each based on the Checkmate 214 and CABOSUN (A031203) trials. Combination immunotherapy with VEGF therapies has shown benefit over sunitinib in the JAVELIN 101 and KEYNOTE 426 trials. It is yet unclear which patients (pts) benefit most from combination immunotherapy-VEGF inhibitors, and the optimal sequence of drugs. Methods: In an adaptive, randomized, multicenter phase III trial (Alliance A031704, PDIGREE), pts start treatment with induction IPI 1 mg/kg and NIVO 3 mg/kg intravenously (IV) once every 3 weeks. Key inclusion criteria include clear cell mRCC, International Metastatic RCC Database Consortium (IMDC) intermediate or poor risk, Karnofsky performance status >70, and no prior treatments for mRCC. Based on 3-month radiographic assessment (after completing IPI-NIVO combination), pts with complete responses (CR) undergo maintenance NIVO 480 mg IV every 4 weeks; pts with progression of disease (PD) switch to CABO 60 mg oral daily; pts with non-CR/non-PD are randomized to NIVO 480 mg IV every 4 weeks versus NIVO 480 mg IV every 4 weeks with CABO 40 mg oral daily. Randomization is stratified by IMDC risk criteria and presence of bone metastases. The primary endpoint of the study is overall survival (OS). We hypothesize that 3-year OS will improve to 70% for NIVO-CABO compared to 60% for NIVO alone; to achieve 85% power with a two-sided alpha of 0.05 and exponential distribution, 696 patients will be randomized. Accounting for 30% patients with either CR or PD, and 5% dropout from toxicity, up to 1046 pts will be enrolled. Key secondary endpoints include progression-free survival, 12-month CR rate, overall response rate based on RECIST 1.1 and iRECIST criteria, and toxicity profiles. Quality of life will be assessed based on the FKSI-19, PROMIS-fatigue, and EQ5D-5L questionnaires. Biomarkers associated with CR, tissue-based and plasma-based biomarkers will be assessed. Updated enrollment through January 2021 will be presented. Clinical trial information: NCT03793166 .
PDIGREE: An adaptive phase III trial of PD-inhibitor nivolumab and ipilimumab (IPI-NIVO) with VEGF TKI cabozantinib (CABO) in metastatic untreated renal cell cancer (Alliance A031704).
Zhang, Tian , Watt, Colleen, Wen, Yujia , Shergill, Ardaman , Vaishampayan, Ulka N. , George, Daniel J. , Vaishampayan, Ulka , Ballman, Karla V. , Choudhury, Atish D. , Chen, Ronald C. , Zemla, Tyler , Emamekhoo, Hamid , Morris, Michael J. , George, Daniel J. , Choueiri, Toni K.
Journal of Clinical Oncology | May 25, 2020 | Volume: 38 | Issue: 15_suppl | Pages: TPS5100-TPS5100
10.1200/jco.2020.38.15_suppl.tps5100
TPS5100 Background: First-line treatment of mRCC has rapidly changed to include IPI-NIVO or CABO, with clinical benefit of each based on the Checkmate 214 and CABOSUN (A031203) trials. Combination immunotherapy with VEGF therapies has shown benefit over sunitinib in the JAVELIN 101 and KEYNOTE 426 trials. It is yet unclear which patients (pts) benefit most from combination immunotherapy-VEGF inhibitors, and the optimal sequence of drugs. Methods: In an adaptive, randomized, multicenter phase 3 trial (Alliance A031704, PDIGREE), pts start treatment with induction IPI 1 mg/kg and NIVO 3 mg/kg intravenously (IV) once every 3 weeks. Key inclusion criteria include clear cell mRCC, International Metastatic RCC Database Consortium (IMDC) intermediate or poor risk, Karnofsky performance status > 70, and no prior treatments for mRCC. Based on 3-month radiographic assessment (after completing IPI-NIVO combination), pts with complete responses (CR) undergo maintenance NIVO 480 mg IV every 4 weeks; pts with progression of disease (PD) switch to CABO 60 mg oral daily; pts with non-CR/non-PD are randomized to NIVO 480 mg IV every 4 weeks versus NIVO 480 mg IV every 4 weeks with CABO 40 mg oral daily. Randomization is stratified by IMDC risk criteria and presence of bone metastases. The primary endpoint of the study is overall survival (OS). We hypothesize that 3-year OS will improve to 70% for NIVO-CABO compared to 60% for NIVO alone; to achieve 85% power with a two-sided alpha of 0.05 and exponential distribution, 696 patients will be randomized. Accounting for 30% patients with either CR or PD, and 5% dropout from toxicity, up to 1046 pts will be enrolled. Key secondary endpoints include progression-free survival, 12-month CR rate, overall response rate based on RECIST 1.1 and irRECIST criteria, and toxicity profiles. Quality of life will be assessed based on the FKSI-19, PROMIS-fatigue, and EQ5D-5L questionnaires. Biomarkers associated with CR, tissue-based and plasma-based biomarkers will be assessed. Updated enrollment through May 2020 will be presented. Clinical trial information: NCT03793166 .
PDIGREE: An adaptive phase III trial of PD-inhibitor nivolumab and ipilimumab (IPI-NIVO) with VEGF TKI cabozantinib (CABO) in metastatic untreated renal cell cancer (Alliance A031704).
Zhang, Tian , Watt, Colleen, Wen, Yujia , Vaishampayan, Ulka N. , George, Daniel J. , Vaishampayan, Ulka , Ballman, Karla V. , Choudhury, Atish D. , Chen, Ronald C. , Zemla, Tyler , Emamekhoo, Hamid , Morris, Michael J. , George, Daniel J. , Choueiri, Toni K.
Journal of Clinical Oncology | February 19, 2020 | Volume: 38 | Issue: 6_suppl | Pages: TPS760-TPS760
10.1200/jco.2020.38.6_suppl.tps760
TPS760 Background: First-line treatment of mRCC has rapidly changed to include IPI-NIVO or CABO, with clinical benefit of each based on the Checkmate 214 and CABOSUN trials. Combination immunotherapy with VEGF therapies have shown benefit in the JAVELIN 101 and KEYNOTE 426 trials over sunitinib. It is yet unclear which patients (pts) benefit most from combination immunotherapy-VEGF inhibitors, and the optimal sequence of drugs. Methods: In an adaptive, randomized, multicenter, phase 3 trial (Alliance A031704, PDIGREE), pts start treatment with induction IPI 1mg/kg and NIVO 3mg/kg intravenously (IV) once every 3 weeks. Key inclusion criteria include clear cell mRCC, IMDC intermediate or poor risk, Karnofsky performance status >70, and no prior treatments for mRCC. Based on 3-month radiographic assessment (after completing IPI-NIVO combination), pts with complete responses (CR) undergo maintenance NIVO 480mg IV every 4 weeks, pts with progression of disease (PD) switch to CABO 60mg oral daily, and pts with non-CR/non-PD are randomized to NIVO 480mg IV every 4 weeks versus NIVO 480mg IV every 4 weeks with CABO 40mg oral daily. Randomization is stratified by IMDC risk criteria and presence of bone metastases. The primary endpoint of the study is overall survival (OS). We hypothesize that 3-year OS rate will improve to 70% for NIVO-CABO compared to 60% for NIVO alone; to achieve 85% power with a two-sided alpha of 0.05 and exponential distribution, 696 patients will be randomized. Accounting for 30% patients with either CR or PD, and 5% dropout from toxicity, up to 1046 pts will be enrolled. Key secondary endpoints include PFS, 12-month CR rate, ORR based on RECIST 1.1 and irRECIST criteria, and toxicity profiles. Quality of life will be assessed based on the FKSI-19, PROMIS-fatigue, and EQ5D-5L questionnaires. Biomarkers associated with CR and association of IL-6 with treatment benefit will be assessed. Other tissue-based and plasma-based biomarkers are planned. Updated enrollment will be presented. Clinical trial information: NCT03793166.
WOMENtorship: The #WomenInMedicine perspective
Marshall, Ariela L. , Dversdal, Renee K. , Murphy, Martina, Prill, Donna M., Zhang, Tian , Marshall, Ariela , Jain, Shikha
Medical Teacher | October 10, 2019 | Volume: 42 | Issue: 2 | Pages: 228-230
PDIGREE: An adaptive phase 3 trial of PD-inhibitor nivolumab and ipilimumab (IPI-NIVO) with VEGF TKI cabozantinib (CABO) in metastatic untreated renal cell cancer (Alliance A031704).
Zhang, Tian , Watt, Colleen, Wen, Yujia , Gupta, Shilpa , George, Daniel J. , Ballman, Karla V. , Choudhury, Atish D. , Chen, Ronald C. , Zemla, Tyler , Emamekhoo, Hamid , Morris, Michael J. , George, Daniel J. , Choueiri, Toni K.
Journal of Clinical Oncology | May 27, 2019 | Volume: 37 | Issue: 15_suppl | Pages: TPS4596-TPS4596
10.1200/jco.2019.37.15_suppl.tps4596
TPS4596 Background: First-line treatment of mRCC has rapidly changed to include IPI-NIVO or CABO, with clinical benefit of each based on the Checkmate 214 and CABOSUN trials. Combination immunotherapy with VEGF therapies have shown benefit in the JAVELIN 101 and KEYNOTE 426 trials over sunitinib. It is yet unclear which patients (pts) benefit most from combination immunotherapy-VEGF inhibitors, and the optimal sequence of drugs. Methods: In an adaptive, randomized, multicenter, phase 3 trial (Alliance A031704, PDIGREE), pts will start treatment with induction IPI 1mg/kg and NIVO 3mg/kg intravenously (IV) once every 3 weeks. Key inclusion criteria include clear cell mRCC, IMDC intermediate or poor risk, Karnofsky performance status >70, and no prior treatments for mRCC. Based on 3-month radiographic assessment (after completing IPI-NIVO combination), pts with complete responses (CR) will undergo maintenance NIVO 480mg IV every 4 weeks, pts with progression of disease (PD) will switch to CABO 60mg oral daily, and pts with non-CR/non-PD will be randomized to NIVO 480mg IV every 4 weeks versus NIVO 480mg IV every 4 weeks with CABO 40mg oral daily. Randomization will be stratified by IMDC risk criteria and presence of bone metastases. The primary endpoint of the study is overall survival (OS). We hypothesize that 3-year OS rate will improve to 70% for NIVO-CABO compared to 60% for NIVO alone; to achieve 85% power with a two-sided alpha of 0.05 and exponential distribution, 696 patients will be randomized. Accounting for 30% patients with either CR or PD, and 5% dropout from toxicity, up to 1046 pts will be enrolled. Key secondary endpoints include PFS, 12-month CR rate, ORR based on RECIST 1.1 and irRECIST criteria, and toxicity profiles. Quality of life will be assessed based on the FKSI-19, PROMIS-fatigue, and EQ5D-5L questionnaires. Biomarkers associated with CR and association of IL-6 with treatment benefit will be assessed. Other tissue-based and plasma-based biomarkers are planned. Enrollment will begin this year. Support from UG1CA189823, U24CA196171; https://acknowledgments.alliancefound.org . Clinical trial information: NCT03793166.