Search

Your search keyword '"Puduvalli, Vinay K."' showing total 271 results
Start Over Author "Puduvalli, Vinay K." Publication Year Range Last 10 years
271 results on '"Puduvalli, Vinay K."'

3. Oncolytic DNX-2401 virotherapy plus pembrolizumab in recurrent glioblastoma: a phase 1/2 trial

Author

Nassiri, Farshad, Patil, Vikas, Yefet, Leeor S., Singh, Olivia, Liu, Jeff, Dang, Rachel M. A., Yamaguchi, Takafumi N., Daras, Mariza, Cloughesy, Timothy F., Colman, Howard, Kumthekar, Priya U., Chen, Clark C., Aiken, Robert, Groves, Morris D., Ong, Shirley S., Ramakrishna, Rohan, Vogelbaum, Michael A., Khagi, Simon, Kaley, Thomas, Melear, Jason M., Peereboom, David M., Rodriguez, Analiz, Yankelevich, Maxim, Nair, Suresh G., Puduvalli, Vinay K., Aldape, Kenneth, Gao, Andrew, López-Janeiro, Álvaro, de Andrea, Carlos E., Alonso, Marta M., Boutros, Paul, Robbins, Joan, Mason, Warren P., Sonabend, Adam M., Stupp, Roger, Fueyo, Juan, Gomez-Manzano, Candelaria, Lang, Frederick F., and Zadeh, Gelareh

Published
2023
Full Text
View/download PDF

4. Designing Clinical Trials for Combination Immunotherapy: A Framework for GlioblastomaCombining Immunotherapy for Glioblastoma

Author

Singh, Kirit, Batich, Kristen A, Wen, Patrick Y, Tan, Aaron C, Bagley, Stephen J, Lim, Michael, Platten, Michael, Colman, Howard, Ashley, David M, Chang, Susan M, Rahman, Rifaquat, Galanis, Evanthia, Mansouri, Alireza, Puduvalli, Vinay K, Reardon, David A, Sahebjam, Solmaz, Sampson, John H, Simes, John, Berry, Donald A, Zadeh, Gelareh, Cloughesy, Tim F, Mehta, Minesh P, Piantadosi, Steven, Weller, Michael, Heimberger, Amy B, and Khasraw, Mustafa

Subjects
Cancer, Immunization, Clinical Research, Rare Diseases, Brain Disorders, Vaccine Related, Clinical Trials and Supportive Activities, Brain Cancer, 5.1 Pharmaceuticals, Health and social care services research, 8.4 Research design and methodologies (health services), Development of treatments and therapeutic interventions, Brain Neoplasms, Glioblastoma, Humans, Immune Tolerance, Immunosuppression Therapy, Immunotherapy, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

Immunotherapy has revolutionized treatment for many hard-to-treat cancers but has yet to produce significant improvement in outcomes for patients with glioblastoma. This reflects the multiple and unique mechanisms of immune evasion and escape in this highly heterogeneous tumor. Glioblastoma engenders profound local and systemic immunosuppression and is remarkably effective at inducing T-cell dysfunction, posing a challenge to any immunotherapy-based approach. To overcome these mechanisms, multiple disparate modes of immune-oriented therapy will be required. However, designing trials that can evaluate these combinatorial approaches requires careful consideration. In this review, we explore the immunotherapy resistance mechanisms that have been encountered to date and how combinatorial approaches may address these. We also describe the unique aspects of trial design in both preclinical and clinical settings and consider endpoints and markers of response best suited for an intervention involving multiple agents.

Published
2022

5. Systematic review of combinations of targeted or immunotherapy in advanced solid tumors

Author

Tan, Aaron C, Bagley, Stephen J, Wen, Patrick Y, Lim, Michael, Platten, Michael, Colman, Howard, Ashley, David M, Wick, Wolfgang, Chang, Susan M, Galanis, Evanthia, Mansouri, Alireza, Khagi, Simon, Mehta, Minesh P, Heimberger, Amy B, Puduvalli, Vinay K, Reardon, David A, Sahebjam, Solmaz, Simes, John, Antonia, Scott J, Berry, Don, and Khasraw, Mustafa

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Immunology, Clinical Research, Cancer, Clinical Trials and Supportive Activities, Good Health and Well Being, Combined Modality Therapy, Humans, Immunotherapy, Neoplasms, immunotherapy, drug therapy, combination, clinical trials as topic, Oncology and carcinogenesis
Abstract

With rapid advances in our understanding of cancer, there is an expanding number of potential novel combination therapies, including novel-novel combinations. Identifying which combinations are appropriate and in which subpopulations are among the most difficult questions in medical research. We conducted a Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)-guided systematic review of trials of novel-novel combination therapies involving immunotherapies or molecular targeted therapies in advanced solid tumors. A MEDLINE search was conducted using a modified Cochrane Highly Sensitive Search Strategy for published clinical trials between July 1, 2017, and June 30, 2020, in the top-ranked medical and oncology journals. Trials were evaluated according to a criterion adapted from previously published Food and Drug Administration guidance and other key considerations in designing trials of combinations. This included the presence of a strong biological rationale, the use of a new established or emerging predictive biomarker prospectively incorporated into the clinical trial design, appropriate comparator arms of monotherapy or supportive external data sources and a primary endpoint demonstrating a clinically meaningful benefit. Of 32 identified trials, there were 11 (34%) trials of the novel-novel combination of anti-programmed death 1 (PD-1)/programmed death ligand 1 (PD-L1) and anti-cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) therapy, and 10 (31%) trials of anti-PD-1/PD-L1 and anti-vascular endothelial growth factor (VEGF) combination therapy. 20 (62.5%) trials were phase II trials, while 12 (37.5%) were phase III trials. Most (72%) trials lacked significant preclinical evidence supporting the development of the combination in the given indication. A majority of trials (69%) were conducted in biomarker unselected populations or used pre-existing biomarkers within the given indication for patient selection. Most studies (66%) were considered to have appropriate comparator arms or had supportive external data sources such as prior studies of monotherapy. All studies were evaluated as selecting a clinically meaningful primary endpoint. In conclusion, designing trials to evaluate novel-novel combination therapies presents numerous challenges to demonstrate efficacy in a comprehensive manner. A greater understanding of biological rationale for combinations and incorporating predictive biomarkers may improve effective evaluation of combination therapies. Innovative statistical methods and increasing use of external data to support combination approaches are potential strategies that may improve the efficiency of trial design. Designing trials to evaluate novel-novel combination therapies presents numerous challenges to demonstrate efficacy in a comprehensive manner. A greater understanding of biological rationale for combinations and incorporating predictive biomarkers may improve effective evaluation of combination therapies. Innovative statistical methods and increasing use of external data to support combination approaches are potential strategies that may improve the efficiency of trial design.

Published
2021

8. Phase I clinical trial of peposertib plus radiation in adults with newly diagnosed MGMT-unmethylated glioblastoma.

Author

Majd, Nazanin, primary, Yeboa, Debra, additional, Wang, Shuqi, additional, Weathers, Shiao-Pei S., additional, Yuan, Ying, additional, Al Anssari, Haider, additional, Kamiya-Matsuoka, Carlos, additional, O'Brien, Barbara Jane, additional, Aaroe, Ashley, additional, Patel, Chirag B, additional, Dagher, Samir, additional, Wintermark, Max, additional, Ferguson, Sherise D., additional, Puduvalli, Vinay K., additional, Liu, Siyuan John, additional, Raleigh, David R., additional, and de Groot, John Frederick, additional

Published
2024
Full Text
View/download PDF

9. Accelerated tumor progression after COVID-19 infection in patients with glioblastoma: a retrospective case-control study

Author

Gregory, Timothy A, primary, Knight, Stephanie R, additional, Aaroe, Ashley E, additional, Highsmith, Kaitlin N, additional, Janatpour, Zachary C, additional, O’Brien, Barbara J, additional, Majd, Nazanin K, additional, Loghin, Monica E, additional, Patel, Chirag B, additional, Weathers, Shiao-Pei, additional, Puduvalli, Vinay K, additional, and Kamiya-Matsuoka, Carlos, additional

Published
2024
Full Text
View/download PDF

13. Final report of the phase II NEXT/CNS-GCT-4 trial: GemPOx followed by marrow-ablative chemotherapy for recurrent intracranial germ cell tumors.

Author

Shatara, Margaret, Blue, Megan, Stanek, Joseph, Liu, Yin A, Prevedello, Daniel M, Giglio, Pierre, Puduvalli, Vinay K, Gardner, Sharon L, Allen, Jeffrey C, Wong, Kenneth K, Nelson, Marvin D, Gilles, Floyd H, Adams, Roberta H, Pauly, Jasmine, O'Halloran, Katrina, Margol, Ashley S, Dhall, Girish, and Finlay, Jonathan L

Subjects
GERM cell tumors, ADVERSE health care events, CANCER chemotherapy, TUMOR markers, PROGENITOR cells, DISEASE progression, GERMINOMA
Abstract

Background Patients with relapsed intracranial germinoma can achieve durable remission with standard chemotherapy regimens and/or reirradiation; however, innovative therapies are required for patients with relapsed and/or refractory intracranial nongerminomatous germ cell tumors (NGGCTs) due to their poor prognosis. Improved outcomes have been reported using reinduction chemotherapy to achieve minimal residual disease, followed by marrow-ablative chemotherapy (HDCx) with autologous hematopoietic progenitor cell rescue (AuHPCR). We conducted a phase II trial evaluating the response and toxicity of a 3-drug combination developed for recurrent intracranial germ cell tumors consisting of gemcitabine, paclitaxel, and oxaliplatin (GemPOx). Methods A total of 9 patients with confirmed relapsed or refractory intracranial GCT were enrolled after signing informed consent, and received at least 2 cycles of GemPOx, of which all but 1 had relapsed or refractory NGGCTs. One patient with progressive disease was found to have pathologically confirmed malignant transformation to pure embryonal rhabdomyosarcoma (without GCT elements), hence was ineligible and not included in the analysis. Patients who experienced sufficient responses proceeded to receive HDCx with AuHPCR. Treatment response was determined based on radiographic tumor assessments and tumor markers. Results A total of 7 patients achieved sufficient response and proceeded with HDCx and AuHPCR, and 5 subsequently received additional radiotherapy. A total of 2 patients developed progressive disease while receiving GemPOx. Myelosuppression and transaminitis were the most common treatment-related adverse events. With a mean follow-up of 44 months, 4 patients (3 NGGCTs, 1 germinoma) are alive without evidence of disease. Conclusions GemPOx demonstrates efficacy in facilitating stem cell mobilization, thus facilitating the feasibility of both HDCx and radiotherapy. [ABSTRACT FROM AUTHOR]

Published
2024
Full Text
View/download PDF

14. Final Report of the Phase II NEXT/CNS-GCT-4 Trial: GemPOx followed by Marrow-ablative Chemotherapy for Recurrent Intracranial Germ Cell Tumors

Author

Shatara, Margaret, primary, Blue, Megan, additional, Stanek, Joseph, additional, Liu, Yin A, additional, Prevedello, Daniel M, additional, Giglio, Pierre, additional, Puduvalli, Vinay K, additional, Gardner, Sharon L, additional, Allen, Jeffrey C, additional, Wong, Kenneth K, additional, Nelson, Marvin D, additional, Gilles, Floyd H, additional, Adams, Roberta H, additional, Pauly, Jasmine, additional, O’Halloran, Katrina, additional, Margol, Ashley S, additional, Dhall, Girish, additional, and Finlay, Jonathan L, additional

Published
2023
Full Text
View/download PDF

16. Abstract LB127: VAL-083 in patients with recurrent glioblastoma treated under expanded access program

Author

Kamiya-Matsuoka, Carlos, primary, Weathers, Shiao-Pei, additional, Harrison, Rebecca A., additional, Majd, Nazanin K., additional, Aaroe, Ashley E., additional, Knight, Stephanie, additional, Hanna, Teresa, additional, Gregory, Timothy A., additional, Langlands, John, additional, Brown, Dennis, additional, and Puduvalli, Vinay K., additional

Published
2023
Full Text
View/download PDF

18. Figure S2 from Efficacy of Onalespib, a Long-Acting Second-Generation HSP90 Inhibitor, as a Single Agent and in Combination with Temozolomide against Malignant Gliomas

Author

Canella, Alessandro, primary, Welker, Alessandra M., primary, Yoo, Ji Young, primary, Xu, Jihong, primary, Abas, Fazly S., primary, Kesanakurti, Divya, primary, Nagarajan, Prabakaran, primary, Beattie, Christine E., primary, Sulman, Erik P., primary, Liu, Joseph, primary, Gumin, Joy, primary, Lang, Frederick F., primary, Gurcan, Metin N., primary, Kaur, Balveen, primary, Sampath, Deepa, primary, and Puduvalli, Vinay K., primary

Published
2023
Full Text
View/download PDF

19. Supplementary Figure from Infigratinib in Patients with Recurrent Gliomas and FGFR Alterations: A Multicenter Phase II Study

Author

Lassman, Andrew B., primary, Sepúlveda-Sánchez, Juan Manuel, primary, Cloughesy, Timothy F., primary, Gil-Gil, Miguel J., primary, Puduvalli, Vinay K., primary, Raizer, Jeffrey J., primary, De Vos, Filip Y.F., primary, Wen, Patrick Y., primary, Butowski, Nicholas A., primary, Clement, Paul M.J., primary, Groves, Morris D., primary, Belda-Iniesta, Cristóbal, primary, Giglio, Pierre, primary, Soifer, Harris S., primary, Rowsey, Steven, primary, Xu, Cindy, primary, Avogadri, Francesca, primary, Wei, Ge, primary, Moran, Susan, primary, and Roth, Patrick, primary

Published
2023
Full Text
View/download PDF

20. Supplementary Data from Disruption of DNA Repair and Survival Pathways through Heat Shock Protein Inhibition by Onalespib to Sensitize Malignant Gliomas to Chemoradiation Therapy

Author

Xu, Jihong, primary, Wu, Pei-Jung, primary, Lai, Tzung-Huei, primary, Sharma, Pratibha, primary, Canella, Alessandro, primary, Welker, Alessandra M., primary, Beattie, Christine E., primary, Elder, J. Brad, primary, Easley, Michelle, primary, Lonser, Russell, primary, Jacob, Naduparambil K., primary, Pietrzak, Maciej, primary, Timmers, Cynthia M., primary, Lang, Frederick, primary, Sampath, Deepa, primary, and Puduvalli, Vinay K., primary

Published
2023
Full Text
View/download PDF

21. Supplementary Table 2 from Phase I Study of Vorinostat in Combination with Temozolomide in Patients with High-Grade Gliomas: North American Brain Tumor Consortium Study 04-03

Author

Lee, Eudocia Q., primary, Puduvalli, Vinay K., primary, Reid, Joel M., primary, Kuhn, John G., primary, Lamborn, Kathleen R., primary, Cloughesy, Timothy F., primary, Chang, Susan M., primary, Drappatz, Jan, primary, Yung, W. K. Alfred, primary, Gilbert, Mark R., primary, Robins, H. Ian, primary, Lieberman, Frank S., primary, Lassman, Andrew B., primary, McGovern, Renee M., primary, Xu, Jihong, primary, Desideri, Serena, primary, Ye, Xiabu, primary, Ames, Matthew M., primary, Espinoza-Delgado, Igor, primary, Prados, Michael D., primary, and Wen, Patrick Y., primary

Published
2023
Full Text
View/download PDF

22. Supplementary Table from Infigratinib in Patients with Recurrent Gliomas and FGFR Alterations: A Multicenter Phase II Study

Author

Lassman, Andrew B., primary, Sepúlveda-Sánchez, Juan Manuel, primary, Cloughesy, Timothy F., primary, Gil-Gil, Miguel J., primary, Puduvalli, Vinay K., primary, Raizer, Jeffrey J., primary, De Vos, Filip Y.F., primary, Wen, Patrick Y., primary, Butowski, Nicholas A., primary, Clement, Paul M.J., primary, Groves, Morris D., primary, Belda-Iniesta, Cristóbal, primary, Giglio, Pierre, primary, Soifer, Harris S., primary, Rowsey, Steven, primary, Xu, Cindy, primary, Avogadri, Francesca, primary, Wei, Ge, primary, Moran, Susan, primary, and Roth, Patrick, primary

Published
2023
Full Text
View/download PDF

23. Supplementary Table from Disruption of DNA Repair and Survival Pathways through Heat Shock Protein Inhibition by Onalespib to Sensitize Malignant Gliomas to Chemoradiation Therapy

Author

Xu, Jihong, primary, Wu, Pei-Jung, primary, Lai, Tzung-Huei, primary, Sharma, Pratibha, primary, Canella, Alessandro, primary, Welker, Alessandra M., primary, Beattie, Christine E., primary, Elder, J. Brad, primary, Easley, Michelle, primary, Lonser, Russell, primary, Jacob, Naduparambil K., primary, Pietrzak, Maciej, primary, Timmers, Cynthia M., primary, Lang, Frederick, primary, Sampath, Deepa, primary, and Puduvalli, Vinay K., primary

Published
2023
Full Text
View/download PDF

24. Supplementary Table 1 from Phase I Study of Vorinostat in Combination with Temozolomide in Patients with High-Grade Gliomas: North American Brain Tumor Consortium Study 04-03

Author

Lee, Eudocia Q., primary, Puduvalli, Vinay K., primary, Reid, Joel M., primary, Kuhn, John G., primary, Lamborn, Kathleen R., primary, Cloughesy, Timothy F., primary, Chang, Susan M., primary, Drappatz, Jan, primary, Yung, W. K. Alfred, primary, Gilbert, Mark R., primary, Robins, H. Ian, primary, Lieberman, Frank S., primary, Lassman, Andrew B., primary, McGovern, Renee M., primary, Xu, Jihong, primary, Desideri, Serena, primary, Ye, Xiabu, primary, Ames, Matthew M., primary, Espinoza-Delgado, Igor, primary, Prados, Michael D., primary, and Wen, Patrick Y., primary

Published
2023
Full Text
View/download PDF

27. A Case Study of Chimeric Antigen Receptor T Cell Function: Donor Therapeutic Differences in Activity and Modulation with Verteporfin

Author

Liang, Jiyong, primary, Fang, Dexing, additional, Gumin, Joy, additional, Najem, Hinda, additional, Sooreshjani, Moloud, additional, Song, Renduo, additional, Sabbagh, Aria, additional, Kong, Ling-Yuan, additional, Duffy, Joseph, additional, Balyasnikova, Irina V., additional, Pollack, Seth M., additional, Puduvalli, Vinay K., additional, and Heimberger, Amy B., additional

Published
2023
Full Text
View/download PDF

28. BXQ-350: Modulating ceramide and sphingosine-1-phosphate for antitumor activity in patients with advanced CRC.

Author

Rixe, Olivier, primary, Curry, Richard Charles, additional, Morris, John Charles, additional, Muller, Carolyn, additional, Noonan, Anne M., additional, Puduvalli, Vinay K., additional, Villano, John L., additional, Wise-Draper, Trisha Michel, additional, Wesolowski, Robert, additional, Yilmaz, Emrullah, additional, Tapolsky, Gilles, additional, and Takigiku, Ray, additional

Published
2023
Full Text
View/download PDF

29. BXQ-350 may alleviate symptoms of chemotherapy- induced peripheral neuropathy via modulation of S1P.

Author

Wesolowski, Robert, primary, Noonan, Anne M., additional, Curry, Richard Charles, additional, Morris, John Charles, additional, Muller, Carolyn, additional, Puduvalli, Vinay K., additional, Rixe, Olivier, additional, Villano, John L., additional, Wise-Draper, Trisha Michel, additional, Yilmaz, Emrullah, additional, Tapolsky, Gilles, additional, and Takigiku, Ray, additional

Published
2023
Full Text
View/download PDF

31. Characterization of recurrence patterns and outcomes of medulloblastoma in adults: The University of Texas MD Anderson Cancer Center experience

Author

Gregory, Timothy A, primary, Mastall, Maximilian, additional, Lin, Heather, additional, Hess, Kenneth R, additional, Yuan, Ying, additional, Martin-Bejarano Garcia, Manuela, additional, Fuller, Gregory N, additional, Alfaro, Kristin D, additional, Gule-Monroe, Maria K, additional, Huse, Jason T, additional, Khatua, Soumen, additional, Rao, Ganesh, additional, Sandberg, David I, additional, Wefel, Jeffrey S, additional, Yeboa, Debra N, additional, Paulino, Arnold C, additional, McGovern, Susan L, additional, Zaky, Wafik, additional, Mahajan, Anita, additional, Suki, Dima, additional, Weathers, Shiao-Pei, additional, Harrison, Rebecca A, additional, de Groot, John F, additional, Puduvalli, Vinay K, additional, Penas-Prado, Marta, additional, and Majd, Nazanin K, additional

Published
2023
Full Text
View/download PDF

32. NCCN Guidelines® Insights: Central Nervous System Cancers, Version 2.2022

Author

Horbinski, Craig, primary, Nabors, Louis Burt, additional, Portnow, Jana, additional, Baehring, Joachim, additional, Bhatia, Ankush, additional, Bloch, Orin, additional, Brem, Steven, additional, Butowski, Nicholas, additional, Cannon, Donald M., additional, Chao, Samuel, additional, Chheda, Milan G., additional, Fabiano, Andrew J., additional, Forsyth, Peter, additional, Gigilio, Pierre, additional, Hattangadi-Gluth, Jona, additional, Holdhoff, Matthias, additional, Junck, Larry, additional, Kaley, Thomas, additional, Merrell, Ryan, additional, Mrugala, Maciej M., additional, Nagpal, Seema, additional, Nedzi, Lucien A., additional, Nevel, Kathryn, additional, Nghiemphu, Phioanh L., additional, Parney, Ian, additional, Patel, Toral R., additional, Peters, Katherine, additional, Puduvalli, Vinay K., additional, Rockhill, Jason, additional, Rusthoven, Chad, additional, Shonka, Nicole, additional, Swinnen, Lode J., additional, Weiss, Stephanie, additional, Wen, Patrick Yung, additional, Willmarth, Nicole E., additional, Bergman, Mary Anne, additional, and Darlow, Susan, additional

Published
2023
Full Text
View/download PDF

33. HDAC1 regulates the chromatin landscape to control transcriptional dependencies in chronic lymphocytic leukemia

Author

Lai, Tzung-Huei, primary, Ozer, Hatice Gulcin, additional, Gasparini, Pierluigi, additional, Nigita, Giovanni, additional, Distefano, Rosario, additional, Yu, Lianbo, additional, Ravikrishnan, Janani, additional, Yilmaz, Selen, additional, Gallegos, Juan Jesus, additional, Shukla, Sachet A, additional, Puduvalli, Vinay K, additional, Woyach, Jennifer A., additional, Lapalombella, Rosa, additional, Blachly, James S., additional, Byrd, John C., additional, and Sampath, Deepa, additional

Published
2022
Full Text
View/download PDF

40. Multicenter phase 2 trial of the PARP inhibitor (PARPi) olaparib in recurrent IDH1 and IDH2-mutant contrast-enhancing glioma.

Author

Fanucci, Kristina, primary, Pilat, Mary Josephine Paula, additional, Shah, Ritu, additional, Boerner, Scott Anthony, additional, Li, Jing, additional, Durecki, Diane E., additional, Drappatz, Jan, additional, Collichio, Frances A., additional, Puduvalli, Vinay K., additional, Lieberman, Frank S., additional, Gonzalez, Javier, additional, Giglio, Pierre, additional, Bao, Xun, additional, Ivy, S. Percy, additional, Bindra, Ranjit, additional, Omuro, Antonio Marcilio Padula, additional, and LoRusso, Patricia, additional

Published
2022
Full Text
View/download PDF

42. Bedside to benchtop translational development: Targeting the S1P/ceramide axis may alleviate symptoms of chemical induced peripheral neuropathy.

Author

Takigiku, Ray, primary, Wesolowski, Robert, additional, Rixe, Olivier, additional, Morris, John Charles, additional, Yilmaz, Emrullah, additional, Villano, John L., additional, Muller, Carolyn, additional, Curry, Richard Charles, additional, Puduvalli, Vinay K., additional, Wise-Draper, Trisha Michel, additional, Wolfe, Darren, additional, and Tapolsky, Gilles, additional

Published
2022
Full Text
View/download PDF

43. S1P/ceramides and cytokines as potential biomarkers of response following administration of bxq-350.

Author

Tapolsky, Gilles, primary, Rixe, Olivier, additional, Morris, John Charles, additional, Wesolowski, Robert, additional, Yilmaz, Emrullah, additional, Noonan, Anne M., additional, Villano, John L., additional, Curry, Richard Charles, additional, Muller, Carolyn, additional, Wise-Draper, Trisha Michel, additional, Puduvalli, Vinay K., additional, and Takigiku, Ray, additional

Published
2022
Full Text
View/download PDF

44. A phase 1, safety and dose escalation study of BXQ-350, a nanovesicle formulation of saposin c, a modulator of sphingolipid metabolism, in patients with advanced solid malignancies.

Author

Curry, Richard Charles, primary, Rixe, Olivier, additional, Morris, John Charles, additional, Wesolowski, Robert, additional, Yilmaz, Emrullah, additional, Villano, John L., additional, Muller, Carolyn, additional, Wise-Draper, Trisha Michel, additional, Noonan, Anne M., additional, Puduvalli, Vinay K., additional, Tapolsky, Gilles, additional, and Takigiku, Ray, additional

Published
2022
Full Text
View/download PDF

45. Designing Clinical Trials for Combination Immunotherapy: A Framework for Glioblastoma.

Author

Singh, Kirit, Singh, Kirit, Batich, Kristen A, Wen, Patrick Y, Tan, Aaron C, Bagley, Stephen J, Lim, Michael, Platten, Michael, Colman, Howard, Ashley, David M, Chang, Susan M, Rahman, Rifaquat, Galanis, Evanthia, Mansouri, Alireza, Puduvalli, Vinay K, Reardon, David A, Sahebjam, Solmaz, Sampson, John H, Simes, John, Berry, Donald A, Zadeh, Gelareh, Cloughesy, Tim F, Mehta, Minesh P, Piantadosi, Steven, Weller, Michael, Heimberger, Amy B, Khasraw, Mustafa, Singh, Kirit, Singh, Kirit, Batich, Kristen A, Wen, Patrick Y, Tan, Aaron C, Bagley, Stephen J, Lim, Michael, Platten, Michael, Colman, Howard, Ashley, David M, Chang, Susan M, Rahman, Rifaquat, Galanis, Evanthia, Mansouri, Alireza, Puduvalli, Vinay K, Reardon, David A, Sahebjam, Solmaz, Sampson, John H, Simes, John, Berry, Donald A, Zadeh, Gelareh, Cloughesy, Tim F, Mehta, Minesh P, Piantadosi, Steven, Weller, Michael, Heimberger, Amy B, and Khasraw, Mustafa

Abstract

Immunotherapy has revolutionized treatment for many hard-to-treat cancers but has yet to produce significant improvement in outcomes for patients with glioblastoma. This reflects the multiple and unique mechanisms of immune evasion and escape in this highly heterogeneous tumor. Glioblastoma engenders profound local and systemic immunosuppression and is remarkably effective at inducing T-cell dysfunction, posing a challenge to any immunotherapy-based approach. To overcome these mechanisms, multiple disparate modes of immune-oriented therapy will be required. However, designing trials that can evaluate these combinatorial approaches requires careful consideration. In this review, we explore the immunotherapy resistance mechanisms that have been encountered to date and how combinatorial approaches may address these. We also describe the unique aspects of trial design in both preclinical and clinical settings and consider endpoints and markers of response best suited for an intervention involving multiple agents.

Published
2022

46. Infigratinib in Patients with Recurrent Gliomas and FGFR Alterations: A Multicenter Phase II Study

Author

MS Medische Oncologie, Cancer, Lassman, Andrew B, Sepúlveda-Sánchez, Juan Manuel, Cloughesy, Timothy, Gil-Gil, Miguel J, Puduvalli, Vinay K, Raizer, Jeffrey, De Vos, Filip Y F, Wen, Patrick Y, Butowski, Nicholas, Clement, Paul M J, Groves, Morris D, Belda-Iniesta, Cristobal, Giglio, Pierre, Soifer, Harris S, Rowsey, Steven, Xu, Cindy, Avogadri, Francesca, Wei, Ge, Moran, Susan, Roth, Patrick, MS Medische Oncologie, Cancer, Lassman, Andrew B, Sepúlveda-Sánchez, Juan Manuel, Cloughesy, Timothy, Gil-Gil, Miguel J, Puduvalli, Vinay K, Raizer, Jeffrey, De Vos, Filip Y F, Wen, Patrick Y, Butowski, Nicholas, Clement, Paul M J, Groves, Morris D, Belda-Iniesta, Cristobal, Giglio, Pierre, Soifer, Harris S, Rowsey, Steven, Xu, Cindy, Avogadri, Francesca, Wei, Ge, Moran, Susan, and Roth, Patrick

Published
2022

47. Infigratinib in Patients with Recurrent Gliomas and FGFR Alterations: A Multicenter Phase II Study

Author

Lassman, Andrew B; https://orcid.org/0000-0001-7386-9928, Sepúlveda-Sánchez, Juan Manuel, Cloughesy, Timothy F, Gil-Gil, Miguel J; https://orcid.org/0000-0003-1380-2718, Puduvalli, Vinay K, Raizer, Jeffrey J, De Vos, Filip Y F; https://orcid.org/0000-0002-9082-5991, Wen, Patrick Y, Butowski, Nicholas A; https://orcid.org/0000-0001-5162-2406, Clement, Paul M J; https://orcid.org/0000-0001-7600-0806, Groves, Morris D, Belda-Iniesta, Cristóbal, Giglio, Pierre, Soifer, Harris S, Rowsey, Steven, Xu, Cindy, Avogadri, Francesca, Wei, Ge, Moran, Susan, Roth, Patrick, Lassman, Andrew B; https://orcid.org/0000-0001-7386-9928, Sepúlveda-Sánchez, Juan Manuel, Cloughesy, Timothy F, Gil-Gil, Miguel J; https://orcid.org/0000-0003-1380-2718, Puduvalli, Vinay K, Raizer, Jeffrey J, De Vos, Filip Y F; https://orcid.org/0000-0002-9082-5991, Wen, Patrick Y, Butowski, Nicholas A; https://orcid.org/0000-0001-5162-2406, Clement, Paul M J; https://orcid.org/0000-0001-7600-0806, Groves, Morris D, Belda-Iniesta, Cristóbal, Giglio, Pierre, Soifer, Harris S, Rowsey, Steven, Xu, Cindy, Avogadri, Francesca, Wei, Ge, Moran, Susan, and Roth, Patrick

Abstract

Purpose: FGFR genomic alterations (amplification, mutations, and/or fusions) occur in ∼8% of gliomas, particularly FGFR1 and FGFR3. We conducted a multicenter open-label, single-arm, phase II study of a selective FGFR1-3 inhibitor, infigratinib (BGJ398), in patients with FGFR-altered recurrent gliomas. Patients and methods: Adults with recurrent/progressive gliomas harboring FGFR alterations received oral infigratinib 125 mg on days 1 to 21 of 28-day cycles. The primary endpoint was investigator-assessed 6-month progression-free survival (PFS) rate by Response Assessment in Neuro-Oncology criteria. Comprehensive genomic profiling was performed on available pretreatment archival tissue to explore additional molecular correlations with efficacy. Results: Among 26 patients, the 6-month PFS rate was 16.0% [95% confidence interval (CI), 5.0-32.5], median PFS was 1.7 months (95% CI, 1.1-2.8), and objective response rate was 3.8%. However, 4 patients had durable disease control lasting longer than 1 year. Among these, 3 had tumors harboring activating point mutations at analogous positions of FGFR1 (K656E; n = 2) or FGFR3 (K650E; n = 1) in pretreatment tissue; an FGFR3-TACC3 fusion was detected in the other. Hyperphosphatemia was the most frequently reported treatment-related adverse event (all-grade, 76.9%; grade 3, 3.8%) and is a known on-target toxicity of FGFR inhibitors. Conclusions: FGFR inhibitor monotherapy with infigratinib had limited efficacy in a population of patients with recurrent gliomas and different FGFR genetic alterations, but durable disease control lasting more than 1 year was observed in patients with tumors harboring FGFR1 or FGFR3 point mutations or FGFR3-TACC3 fusions. A follow-up study with refined biomarker inclusion criteria and centralized FGFR testing is warranted.

Published
2022

50. Infigratinib in Patients with Recurrent Gliomas and FGFR Alterations: A Multicenter Phase II Study

Author

Lassman, Andrew B., primary, Sepúlveda-Sánchez, Juan Manuel, additional, Cloughesy, Timothy F., additional, Gil-Gil, Miguel J., additional, Puduvalli, Vinay K., additional, Raizer, Jeffrey J., additional, De Vos, Filip Y.F., additional, Wen, Patrick Y., additional, Butowski, Nicholas A., additional, Clement, Paul M.J., additional, Groves, Morris D., additional, Belda-Iniesta, Cristóbal, additional, Giglio, Pierre, additional, Soifer, Harris S., additional, Rowsey, Steven, additional, Xu, Cindy, additional, Avogadri, Francesca, additional, Wei, Ge, additional, Moran, Susan, additional, and Roth, Patrick, additional

Published
2022
Full Text
View/download PDF

Catalog

Books, media, physical & digital resources
See catalog results