Intratumoral Injection of LTX-315 in Combination With Pembrolizumab in Advanced Melanoma

Summary

ATLAS-IT-05 was an open-label, single-arm study in patients with advanced melanoma accessible for injections (cutaneous, subcutaneous, lymph node, or intramuscular tumors) and who had either exhausted treatment options or were not eligible for, suitable for, or willing to undergo such treatments.

Timeline

Start

2021-11-05

Primary completion

2025-02-03

Completion

2025-07-01

Publications

• Background Camilio KA, Rekdal O, Sveinbjornsson B. LTX-315 (Oncopore): A short synthetic anticancer peptide and novel immunotherapeutic agent. Oncoimmunology. 2014 Jun 25;3:e29181. doi: 10.4161/onci.29181. eCollection 2014.
• Background Sveinbjornsson B, Camilio KA, Haug BE, Rekdal O. LTX-315: a first-in-class oncolytic peptide that reprograms the tumor microenvironment. Future Med Chem. 2017 Aug;9(12):1339-1344. doi: 10.4155/fmc-2017-0088. Epub 2017 May 11.
• Background Jebsen NL, Apelseth TO, Haugland HK, Rekdal O, Patel H, Gjertsen BT, Jossang DE. Enhanced T-lymphocyte infiltration in a desmoid tumor of the thoracic wall in a young woman treated with intratumoral injections of the oncolytic peptide LTX-315: a case report. J Med Case Rep. 2019 Jun 10;13(1):177. doi: 10.1186/s13256-019-2088-6.
• Background Spicer J, Marabelle A, Baurain JF, Jebsen NL, Jossang DE, Awada A, Kristeleit R, Loirat D, Lazaridis G, Jungels C, Brunsvig P, Nicolaisen B, Saunders A, Patel H, Galon J, Hermitte F, Camilio KA, Mauseth B, Sundvold V, Sveinbjornsson B, Rekdal O. Safety, Antitumor Activity, and T-cell Responses in a Dose-Ranging Phase I Trial of the Oncolytic Peptide LTX-315 in Patients with Solid Tumors. Clin Cancer Res. 2021 May 15;27(10):2755-2763. doi: 10.1158/1078-0432.CCR-20-3435. Epub 2021 Feb 4.
• Results Dalle S, Spicer JF, Diab A, Batten T, Gil M, Sveinbjørnsson B, et al. Safety and efficacy of intratumoral (IT) ruxotemitide (LTX 315) in combination with pembrolizumab in patients with unresectable advanced melanoma or triple-negative breast cancer (TNBC) (Poster 2602). J Clin Oncol. 2026;44:2602(2026).

Drugs

Indications