A phase 2 open-label study of cemiplimab in patients with advanced cutaneous squamous cell carcinoma (EMPOWER-CSCC-1): Final long-term analysis of groups 1, 2, and 3, and primary analysis of fixed-dose treatment group 6

Authors: Hughes, Brett G.M., Guminski, Alexander, Bowyer, Samantha, Migden, Michael R., Schmults, Chrysalyne D., Khushalani, Nikhil I., Chang, Anne Lynn S., Grob, Jean-Jacques, Lewis, Karl D., Ansstas, George, Day, Fiona, Ladwa, Rahul, Stein, Brian N., Muñoz Couselo, Eva, Meier, Friedegund, Hauschild, Axel, Schadendorf, Dirk, Basset-Seguin, Nicole, Modi, Badri, Dalac-Rat, Sophie, Dunn, Lara A., Flatz, Lukas, Mortier, Laurent, Guégan, Sarah, Heinzerling, Lucie M., Mehnert, Janice M., Trabelsi, Sabiha, Soria-Rivas, Ainara, Stratigos, Alexander J., Ulrich, Claas, Wong, Deborah J., Beylot-Barry, Marie, Bossi, Paolo, Bugés Sánchez, Cristina, Chandra, Sunandana, Robert, Caroline, Russell, Jeffery S., Silk, Ann W., Booth, Jocelyn, Yoo, Suk-Young, Seebach, Frank, Lowy, Israel, Fury, Matthew G., Rischin, Danny

Source: In Journal of the American Academy of Dermatology January 2025 92(1):68-77

Breaking the barriers in cancer care: The next generation of herpes simplex virus-based oncolytic immunotherapies for cancer treatment

Authors: Khushalani, Nikhil I., Harrington, Kevin J., Melcher, Alan, Bommareddy, Praveen K., Zamarin, Dmitriy

Source: In Molecular Therapy - Oncolytics 19 December 2023 31

Neoadjuvant cemiplimab and surgery for stage II–IV cutaneous squamous-cell carcinoma: follow-up and survival outcomes of a single-arm, multicentre, phase 2 study

Authors: Gross, Neil D ^*, Miller, David M, Khushalani, Nikhil I, Divi, Vasu, Ruiz, Emily S, Lipson, Evan J, Meier, Friedegund, Su, Yungpo Bernard, Swiecicki, Paul L, Atlas, Jennifer, Geiger, Jessica L, Hauschild, Axel, Choe, Jennifer H, Hughes, Brett G M, Schadendorf, Dirk, Patel, Vishal A, Homsi, Jade, Taube, Janis M, Lim, Annette M, Ferrarotto, Renata, Yoo, Suk-Young, Mathias, Melissa, Han, Hyunsil, Seebach, Frank, Lowy, Israel, Fury, Matthew G, Rischin, Danny

Source: In The Lancet Oncology November 2023 24(11):1196-1205

Stereotactic radiosurgery and anti-PD-1 + CTLA-4 therapy, anti-PD-1 therapy, anti-CTLA-4 therapy, BRAF/MEK inhibitors, BRAF inhibitors, or conventional chemotherapy for the management of melanoma brain metastases

Authors: Dohm, Ammoren E., Nakashima, Justyn Y., Kalagotla, Hruday, Jiang, Shirley X., Tang, Joseph D., Bhandari, Menal, Kim, Youngchul, Graham, Jasmine A., Khushalani, Nikhil I., Forsyth, Peter A., Etame, Arnold B., Liu, James K., Tran, Nam D., Vogelbaum, Michael A., Wuthrick, Evan J., Yu, Hsiang-Hsuan Michael, Oliver, Daniel E., Ahmed, Kamran A.

Source: In European Journal of Cancer October 2023 192

Combined nivolumab and ipilimumab with or without stereotactic body radiation therapy for advanced Merkel cell carcinoma: a randomised, open label, phase 2 trial

Authors: Kim, Sungjune ^*, Wuthrick, Evan, Blakaj, Dukagjin, Eroglu, Zeynep, Verschraegen, Claire, Thapa, Ram, Mills, Matthew, Dibs, Khaled, Liveringhouse, Casey, Russell, Jeffery, Caudell, Jimmy J, Tarhini, Ahmad, Markowitz, Joseph, Kendra, Kari, Wu, Richard, Chen, Dung-Tsa, Berglund, Anders, Michael, Lauren, Aoki, Mia, Wang, Min-Hsuan, Hamaidi, Imene, Cheng, Pingyan, de la Iglesia, Janis, Slebos, Robbert J, Chung, Christine H, Knepper, Todd C, Moran-Segura, Carlos M, Nguyen, Jonathan V, Perez, Bradford A, Rose, Trevor, Harrison, Louis, Messina, Jane L, Sondak, Vernon K, Tsai, Kenneth Y, Khushalani, Nikhil I, Brohl, Andrew S

Source: In The Lancet 24-30 September 2022 400(10357):1008-1019

Adjuvant nivolumab versus ipilimumab (CheckMate 238 trial): Reassessment of 4-year efficacy outcomes in patients with stage III melanoma per AJCC-8 staging criteria

Authors: Larkin, James ^{a, ∗}, Weber, Jeffrey ^b, Del Vecchio, Michele ^c, Gogas, Helen ^d, Arance, Ana M. ^e, Dalle, Stephane ^f, Cowey, C. Lance ^g, Schenker, Michael ^h, Grob, Jean-Jacques ⁱ, Chiarion-Sileni, Vanna ^j, Márquez-Rodas, Iván ^k, Butler, Marcus O. ^l, Di Giacomo, Anna Marie ^m, Middleton, Mark R. ⁿ, De la Cruz-Merino, Luis ^o, Arenberger, Petr ^p, Atkinson, Victoria ^q, Hill, Andrew ^r, Fecher, Leslie A. ^s, Millward, Michael ^t, Khushalani, Nikhil I. ^u, Queirolo, Paola ^v, Long, Georgina V. ^w, Lobo, Maurice ^x, Askelson, Margarita ^x, Ascierto, Paolo A. ^{y, 1}, Mandalá, Mario ^{z, 1}

Source: In European Journal of Cancer September 2022 173:285-296

Phase II Trial of Pembrolizumab in Combination With Bevacizumab for Untreated Melanoma Brain Metastases.

Authors: Weiss, Sarah A.¹ (AUTHOR), Djureinovic, Dijana² (AUTHOR), Wei, Wei³ (AUTHOR), Tran, Thuy² (AUTHOR), Austin, Matthew² (AUTHOR), Markowitz, Joseph⁴ (AUTHOR), Eroglu, Zeynep⁴ (AUTHOR), Khushalani, Nikhil I.⁴ (AUTHOR), Hegde, Upendra⁵ (AUTHOR), Cohen, Justine⁶ (AUTHOR), Sznol, Mario² (AUTHOR), Anderson, Gail² (AUTHOR), Johnson, Barbara² (AUTHOR), Piteo, Cecily⁴ (AUTHOR), Mahajan, Amit⁷ (AUTHOR), Adeniran, Adebowale⁸ (AUTHOR), Jilaveanu, Lucia² (AUTHOR), Goldberg, Sarah² (AUTHOR), Chiang, Veronica⁹ (AUTHOR), Forsyth, Peter¹⁰ (AUTHOR)

Source: Journal of Clinical Oncology. 5/10/2025, Vol. 43 Issue 14, p1685-1694. 14p.

Long-term outcomes of patients with active melanoma brain metastases treated with combination nivolumab plus ipilimumab (CheckMate 204): final results of an open-label, multicentre, phase 2 study

Authors: Tawbi, Hussein A ^*, Forsyth, Peter A, Hodi, F Stephen, Algazi, Alain P, Hamid, Omid, Lao, Christopher D, Moschos, Stergios J, Atkins, Michael B, Lewis, Karl, Postow, Michael A, Thomas, Reena P, Glaspy, John, Jang, Sekwon, Khushalani, Nikhil I, Pavlick, Anna C, Ernstoff, Marc S, Reardon, David A, Kudchadkar, Ragini, Tarhini, Ahmad, Chung, Caroline, Ritchings, Corey, Durani, Piyush, Askelson, Margarita, Puzanov, Igor, Margolin, Kim A

Source: In The Lancet Oncology December 2021 22(12):1692-1704

Assessing the Value of Cemiplimab for Adults With Advanced Cutaneous Squamous Cell Carcinoma: A Cost-Effectiveness Analysis

Authors: Konidaris, Gerasimos, Paul, Eleanor, Kuznik, Andreas, Keeping, Sam, Chen, Chieh-I, Sasane, Medha, Xu, Yingxin, Atsou, Kokuvi, Ayers, Dieter, Ruiz, Emily S., Khushalani, Nikhil I., Cope, Shannon

Source: In Value in Health March 2021 24(3):377-387

CASE (CemiplimAb-rwlc Survivorship and Epidemiology): a study in advanced basal cell carcinoma.

Authors: Park, Soo J., Ellison, David M., Weight, Ryan, Homsi, Jade, Rabinowits, Guilherme, Ruiz, Emily S., Strasswimmer, John, Simmons, Josh, Panella, Timothy, Quek, Ruben GW, Pouliot, Jean-Francois, Khushalani, Nikhil I.

Source: Future Oncology; Feb2025, Vol. 21 Issue 4, p431-436, 6p

Adjuvant nivolumab versus ipilimumab in resected stage IIIB–C and stage IV melanoma (CheckMate 238): 4-year results from a multicentre, double-blind, randomised, controlled, phase 3 trial

Authors: Ascierto, Paolo A ^*, Del Vecchio, Michele, Mandalá, Mario, Gogas, Helen, Arance, Ana M, Dalle, Stephane, Cowey, C Lance, Schenker, Michael, Grob, Jean-Jacques, Chiarion-Sileni, Vanna, Márquez-Rodas, Iván, Butler, Marcus O, Maio, Michele, Middleton, Mark R, de la Cruz-Merino, Luis, Arenberger, Petr, Atkinson, Victoria, Hill, Andrew, Fecher, Leslie A, Millward, Michael, Khushalani, Nikhil I, Queirolo, Paola, Lobo, Maurice, de Pril, Veerle, Loffredo, John, Larkin, James, Weber, Jeffrey

Source: In The Lancet Oncology November 2020 21(11):1465-1477

Cemiplimab in locally advanced cutaneous squamous cell carcinoma: results from an open-label, phase 2, single-arm trial

Authors: Migden, Michael R ^*, Khushalani, Nikhil I, Chang, Anne Lynn S, Lewis, Karl D, Schmults, Chrysalyne D, Hernandez-Aya, Leonel, Meier, Friedegund, Schadendorf, Dirk, Guminski, Alexander, Hauschild, Axel, Wong, Deborah J, Daniels, Gregory A, Berking, Carola, Jankovic, Vladimir, Stankevich, Elizabeth, Booth, Jocelyn, Li, Siyu, Weinreich, David M, Yancopoulos, George D, Lowy, Israel, Fury, Matthew G, Rischin, Danny

Source: In The Lancet Oncology February 2020 21(2):294-305

Principles of Targeted Therapy for Melanoma

Authors: Sun, James, Carr, Michael J., Khushalani, Nikhil I.

Source: In Surgical Clinics of North America February 2020 100(1):175-188

Current Immunotherapy Practices in Melanoma

Authors: Rothermel, Luke D., Sarnaik, Amod A., Khushalani, Nikhil I., Sondak, Vernon K.

Source: In Surgical Oncology Clinics of North America July 2019 28(3):403-418

Outcomes With Postrecurrence Systemic Therapy Following Adjuvant Checkpoint Inhibitor Treatment for Resected Melanoma in CheckMate 238.

Authors: Weber, Jeffrey¹ (AUTHOR) Jeffrey.weber@nyulangone.org, Del Vecchio, Michele² (AUTHOR), Mandalá, Mario³ (AUTHOR), Gogas, Helen⁴ (AUTHOR), Arance, Ana M.⁵ (AUTHOR), Dalle, Stephane⁶ (AUTHOR), Cowey, C. Lance⁷ (AUTHOR), Schenker, Michael⁸ (AUTHOR), Grob, Jean-Jacques⁹ (AUTHOR), Chiarion-Sileni, Vanna¹⁰ (AUTHOR), Márquez-Rodas, Iván¹¹ (AUTHOR), Butler, Marcus O.¹² (AUTHOR), Di Giacomo, Anna Maria¹³ (AUTHOR), de la Cruz-Merino, Luis¹⁴ (AUTHOR), Arenberger, Petr¹⁵ (AUTHOR), Atkinson, Victoria¹⁶ (AUTHOR), Hill, Andrew¹⁷ (AUTHOR), Fecher, Leslie A.¹⁸ (AUTHOR), Millward, Michael¹⁹ (AUTHOR), Khushalani, Nikhil I.²⁰ (AUTHOR)

Source: Journal of Clinical Oncology. 11/1/2024, Vol. 42 Issue 31, p3702-3712. 14p.

Baseline biomarkers of efficacy and on-treatment immune-profile changes associated with bempegaldesleukin plus nivolumab.

Authors: Gogas, Helen, Ravimohan, Shruthi, Datta, Antara, Chhibber, Aparna, Couselo, Eva Muñoz, Diab, Adi, Pereira, Caio, Quéreux, Gaëlle, Sandhu, Shahneen, Curti, Brendan, Khushalani, Nikhil I., Taylor, Matthew H., Daniels, Gregory A., Spreafico, Anna, Meniawy, Tarek, Van Den Eertwegh, Alfons J. M., Sun, Yongliang, Arriaga, Yull, Zhou, Ming, Long, Georgina V.

Source: NPJ Precision Oncology; 7/19/2024, Vol. 8 Issue 1, p1-13, 13p

Subject Terms: REGULATORY T cells, TUMOR markers, NIVOLUMAB, BIOMARKERS, T cells

Quality of life and patient‐reported toxicities in patients with advanced Merkel cell carcinoma treated with combined nivolumab and ipilimumab with or without stereotactic body radiation therapy.

Authors: Hoogland, Aasha I., Brohl, Andrew S., Small, Brent J., Michael, Lauren, Wuthrick, Evan, Eroglu, Zeynep, Blakaj, Dukagjin, Verschraegen, Claire, Khushalani, Nikhil I., Jim, Heather S. L., Kim, Sungjune

Source: Cancer Medicine; Jul2024, Vol. 13 Issue 14, p1-8, 8p

Subject Terms: STEREOTACTIC radiotherapy, MERKEL cell carcinoma, IMMUNE checkpoint inhibitors, SOCIAL skills, NIVOLUMAB

Patient reported outcomes and patient experiences of immune checkpoint modulators for advanced or recurrent melanoma: a mixed methods study.

Authors: Tometich, Danielle B., Geiss, Carley, Maconi, Melinda L., Chavez, Melody, Hoogland, Aasha I., Li, Xiaoyin, Nieves-Lopez, Amarilis, Rodriguez, Yvelise, Bryant, Crystal, Brohl, Andrew S., Eroglu, Zeynep, Markowitz, Joseph, Tarhini, Ahmad A., Hwu, Patrick, Khushalani, Nikhil I., Jim, Heather S. L.

Source: Supportive Care in Cancer; Jun2024, Vol. 32 Issue 6, p1-9, 9p

Ipilimumab alone or in combination with nivolumab after progression on anti-PD-1 therapy in advanced melanoma

Authors: Zimmer, Lisa, Apuri, Susmitha, Eroglu, Zeynep, Kottschade, Lisa A., Forschner, Andrea, Gutzmer, Ralf, Schlaak, Max, Heinzerling, Lucie, Krackhardt, Angela M., Loquai, Carmen, Markovic, Svetomir N., Joseph, Richard W., Markey, Kelly, Utikal, Jochen S., Weishaupt, Carsten, Goldinger, Simone M., Sondak, Vernon K., Zager, Jonathan S., Schadendorf, Dirk, Khushalani, Nikhil I.

Source: In European Journal of Cancer April 2017 75:47-55

Nivolumab + Tacrolimus + Prednisone ± Ipilimumab for Kidney Transplant Recipients With Advanced Cutaneous Cancers.

Authors: Schenk, Kara M.^1,2 (AUTHOR), Deutsch, Julie Stein^3,4 (AUTHOR), Chandra, Sunandana⁵ (AUTHOR), Davar, Diwakar⁶ (AUTHOR), Eroglu, Zeynep⁷ (AUTHOR), Khushalani, Nikhil I.⁷ (AUTHOR), Luke, Jason J.⁸ (AUTHOR), Ott, Patrick A.⁹ (AUTHOR), Sosman, Jeffrey A.⁵ (AUTHOR), Aggarwal, Vikram¹⁰ (AUTHOR), Schollenberger, Megan D.² (AUTHOR), Sharfman, William H.^2,4 (AUTHOR), Bibee, Kristin P.³ (AUTHOR), Scott, Jeffrey F.^3,11 (AUTHOR), Loss, Manisha J.³ (AUTHOR), Wang, Hao^4,12 (AUTHOR), Qi, Hanfei¹² (AUTHOR), Sharon, Elad¹³ (AUTHOR), Streicher, Howard¹³ (AUTHOR), Chen, Helen X.¹³ (AUTHOR)

Source: Journal of Clinical Oncology. 3/20/2024, Vol. 42 Issue 9, p1011-1020. 19p.