Cemiplimab as Maintenance Treatment for Advanced Adrenocortical Cancer

Summary

This clinical trial is a single-arm, non-randomized, prospective phase II study. The study aims to evaluate if the maintenance immunotherapy with cemiplimab in patients with AdrenoCortical Carcinoma (ACC), who obtained disease response or stabilization after first-line chemotherapy, may delay/prevent disease progression. The study will be conducted at ASST Spedali Civili Hospital, Brescia - Italy.

Timeline

Start

2025-09-18

Primary completion

2028-07

Completion

2028-07

Publications

• Background Powles T, Park SH, Caserta C, Valderrama BP, Gurney H, Ullen A, Loriot Y, Sridhar SS, Sternberg CN, Bellmunt J, Aragon-Ching JB, Wang J, Huang B, Laliberte RJ, di Pietro A, Grivas P. Avelumab First-Line Maintenance for Advanced Urothelial Carcinoma: Results From the JAVELIN Bladder 100 Trial After >/=2 Years of Follow-Up. J Clin Oncol. 2023 Jul 1;41(19):3486-3492. doi: 10.1200/JCO.22.01792. Epub 2023 Apr 18.
• Background Powles T, Park SH, Voog E, Caserta C, Valderrama BP, Gurney H, Kalofonos H, Radulovic S, Demey W, Ullen A, Loriot Y, Sridhar SS, Tsuchiya N, Kopyltsov E, Sternberg CN, Bellmunt J, Aragon-Ching JB, Petrylak DP, Laliberte R, Wang J, Huang B, Davis C, Fowst C, Costa N, Blake-Haskins JA, di Pietro A, Grivas P. Avelumab Maintenance Therapy for Advanced or Metastatic Urothelial Carcinoma. N Engl J Med. 2020 Sep 24;383(13):1218-1230. doi: 10.1056/NEJMoa2002788. Epub 2020 Sep 18.
• Background Cosentini D, Grisanti S, Dalla Volta A, Lagana M, Fiorentini C, Perotti P, Sigala S, Berruti A. Immunotherapy failure in adrenocortical cancer: where next? Endocr Connect. 2018 Dec;7(12):E5-E8. doi: 10.1530/EC-18-0398.
• Background Le Tourneau C, Hoimes C, Zarwan C, Wong DJ, Bauer S, Claus R, Wermke M, Hariharan S, von Heydebreck A, Kasturi V, Chand V, Gulley JL. Avelumab in patients with previously treated metastatic adrenocortical carcinoma: phase 1b results from the JAVELIN solid tumor trial. J Immunother Cancer. 2018 Oct 22;6(1):111. doi: 10.1186/s40425-018-0424-9.
• Background Klein O, Senko C, Carlino MS, Markman B, Jackett L, Gao B, Lum C, Kee D, Behren A, Palmer J, Cebon J. Combination immunotherapy with ipilimumab and nivolumab in patients with advanced adrenocortical carcinoma: a subgroup analysis of CA209-538. Oncoimmunology. 2021 Apr 12;10(1):1908771. doi: 10.1080/2162402X.2021.1908771.
• Background McGregor BA, Campbell MT, Xie W, Farah S, Bilen MA, Schmidt AL, Sonpavde GP, Kilbridge KL, Choudhury AD, Mortazavi A, Shah AY, Venkatesan AM, Bubley GJ, Siefker-Radtke AO, McKay RR, Choueiri TK. Results of a multicenter, phase 2 study of nivolumab and ipilimumab for patients with advanced rare genitourinary malignancies. Cancer. 2021 Mar 15;127(6):840-849. doi: 10.1002/cncr.33328. Epub 2020 Nov 20.
• Background Carneiro BA, Konda B, Costa RB, Costa RLB, Sagar V, Gursel DB, Kirschner LS, Chae YK, Abdulkadir SA, Rademaker A, Mahalingam D, Shah MH, Giles FJ. Nivolumab in Metastatic Adrenocortical Carcinoma: Results of a Phase 2 Trial. J Clin Endocrinol Metab. 2019 Dec 1;104(12):6193-6200. doi: 10.1210/jc.2019-00600.
• Background Bedrose S, Miller KC, Altameemi L, Ali MS, Nassar S, Garg N, Daher M, Eaton KD, Yorio JT, Daniel DB, Campbell M, Bible KC, Ryder M, Chintakuntlawar AV, Habra MA. Combined lenvatinib and pembrolizumab as salvage therapy in advanced adrenal cortical carcinoma. J Immunother Cancer. 2020 Jul;8(2):e001009. doi: 10.1136/jitc-2020-001009.
• Background Habra MA, Stephen B, Campbell M, Hess K, Tapia C, Xu M, Rodon Ahnert J, Jimenez C, Lee JE, Perrier ND, Boraddus RR, Pant S, Subbiah V, Hong DS, Zarifa A, Fu S, Karp DD, Meric-Bernstam F, Naing A. Phase II clinical trial of pembrolizumab efficacy and safety in advanced adrenocortical carcinoma. J Immunother Cancer. 2019 Sep 18;7(1):253. doi: 10.1186/s40425-019-0722-x.
• Background Naing A, Meric-Bernstam F, Stephen B, Karp DD, Hajjar J, Rodon Ahnert J, Piha-Paul SA, Colen RR, Jimenez C, Raghav KP, Ferrarotto R, Tu SM, Campbell M, Wang L, Sabir SH, Tapia C, Bernatchez C, Frumovitz M, Tannir N, Ravi V, Khan S, Painter JM, Abonofal A, Gong J, Alshawa A, McQuinn LM, Xu M, Ahmed S, Subbiah V, Hong DS, Pant S, Yap TA, Tsimberidou AM, Dumbrava EEI, Janku F, Fu S, Simon RM, Hess KR, Varadhachary GR, Habra MA. Phase 2 study of pembrolizumab in patients with advanced rare cancers. J Immunother Cancer. 2020 Mar;8(1):e000347. doi: 10.1136/jitc-2019-000347.
• Background Grisanti S, Cosentini D, Lagana M, Volta AD, Palumbo C, Massimo Tiberio GA, Sigala S, Berruti A. The long and winding road to effective immunotherapy in patients with adrenocortical carcinoma. Future Oncol. 2020 Dec;16(36):3017-3020. doi: 10.2217/fon-2020-0686. Epub 2020 Aug 28. No abstract available.
• Background Raj N, Zheng Y, Kelly V, Katz SS, Chou J, Do RKG, Capanu M, Zamarin D, Saltz LB, Ariyan CE, Untch BR, O'Reilly EM, Gopalan A, Berger MF, Olino K, Segal NH, Reidy-Lagunes DL. PD-1 Blockade in Advanced Adrenocortical Carcinoma. J Clin Oncol. 2020 Jan 1;38(1):71-80. doi: 10.1200/JCO.19.01586. Epub 2019 Oct 23.
• Background Cremaschi V, Abate A, Cosentini D, Grisanti S, Rossini E, Lagana M, Tamburello M, Turla A, Sigala S, Berruti A. Advances in adrenocortical carcinoma pharmacotherapy: what is the current state of the art? Expert Opin Pharmacother. 2022 Aug;23(12):1413-1424. doi: 10.1080/14656566.2022.2106128. Epub 2022 Aug 3.
• Background Fassnacht M, Assie G, Baudin E, Eisenhofer G, de la Fouchardiere C, Haak HR, de Krijger R, Porpiglia F, Terzolo M, Berruti A; ESMO Guidelines Committee. Electronic address: [email protected]. Adrenocortical carcinomas and malignant phaeochromocytomas: ESMO-EURACAN Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2020 Nov;31(11):1476-1490. doi: 10.1016/j.annonc.2020.08.2099. Epub 2020 Aug 27. No abstract available.
• Background Berruti A, Baudin E, Gelderblom H, Haak HR, Porpiglia F, Fassnacht M, Pentheroudakis G; ESMO Guidelines Working Group. Adrenal cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2012 Oct;23 Suppl 7:vii131-8. doi: 10.1093/annonc/mds231. No abstract available.

Drugs

Indications