Cemiplimab/Peg-Interferon-α in Advanced CSCC

Summary

The primary purpose of this research study is to test the safety and possible harms of cemiplimab/peg-interferon-alpha, when it is given to participants at different dose levels. The researchers want to find out what effects (good and bad) cemiplimab/Peg-Interferon has on participants with advanced cutaneous squamous cell carcinoma (aCSCC) so that they can find the best dose to treat aCSCC and reduce side effects as much as possible.

Timeline

Start

2023-07

Primary completion

2026-07

Completion

2028-07

Publications

• Background Migden MR, Rischin D, Schmults CD, Guminski A, Hauschild A, Lewis KD, Chung CH, Hernandez-Aya L, Lim AM, Chang ALS, Rabinowits G, Thai AA, Dunn LA, Hughes BGM, Khushalani NI, Modi B, Schadendorf D, Gao B, Seebach F, Li S, Li J, Mathias M, Booth J, Mohan K, Stankevich E, Babiker HM, Brana I, Gil-Martin M, Homsi J, Johnson ML, Moreno V, Niu J, Owonikoko TK, Papadopoulos KP, Yancopoulos GD, Lowy I, Fury MG. PD-1 Blockade with Cemiplimab in Advanced Cutaneous Squamous-Cell Carcinoma. N Engl J Med. 2018 Jul 26;379(4):341-351. doi: 10.1056/NEJMoa1805131. Epub 2018 Jun 4.
• Background Regeneron Pharmaceuticals. LIBTAYO® (cemiplimab-rwlc) [Package Insert] Tarrytown. NY: Regeneron Pharmaceuticals; 2018.
• Background Cornell RC, Greenway HT, Tucker SB, Edwards L, Ashworth S, Vance JC, Tanner DJ, Taylor EL, Smiles KA, Peets EA. Intralesional interferon therapy for basal cell carcinoma. J Am Acad Dermatol. 1990 Oct;23(4 Pt 1):694-700. doi: 10.1016/0190-9622(90)70276-n.
• Background Edwards L, Berman B, Rapini RP, Whiting DA, Tyring S, Greenway HT Jr, Eyre SP, Tanner DJ, Taylor EL, Peets E, et al. Treatment of cutaneous squamous cell carcinomas by intralesional interferon alfa-2b therapy. Arch Dermatol. 1992 Nov;128(11):1486-9.
• Background Kim KH, Yavel RM, Gross VL, Brody N. Intralesional interferon alpha-2b in the treatment of basal cell carcinoma and squamous cell carcinoma: revisited. Dermatol Surg. 2004 Jan;30(1):116-20. doi: 10.1111/j.1524-4725.2004.30020.x.
• Background Tucker SB, Polasek JW, Perri AJ, Goldsmith EA. Long-term follow-up of basal cell carcinomas treated with perilesional interferon alfa 2b as monotherapy. J Am Acad Dermatol. 2006 Jun;54(6):1033-8. doi: 10.1016/j.jaad.2006.02.035.

Drugs

Indications