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

NCT04796194 | Completed Phase 2 Results FDA Drug

• 1 other identifier: C20-315-05 (ATLAS-IT-05)
• Study Type: interventional
• Target: 23
• Locations: 4 countries
• Sites: 10

Brief 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.

Conditions

Advanced Melanoma

Keywords

Oncolytic peptide; LTX-315; Pembrolizumab; Intratumoral; Melanoma; Ruxotemitide

Outcome Measures

Primary Outcomes (3)

• Objective Response Rate (ORR)

  Objective response rate is defined as the proportion of patients who achieved partial response (PR) and/or complete response (CR) per local investigator assessment using RECIST version 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

  Patients were followed throughout the treatment period of up to 24 months and then for an additional 90 days after the end of treatment.

• Clinical Benefit Rate

  Clinical benefit rate was defined as the proportion of patients who respond to treatment, estimated as the proportion of patients who achieve stable disease (SD), PR, or CR per local investigator assessment using RECIST version 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

  Patients were followed throughout the treatment period of up to 24 months and then for an additional 90 days after the end of treatment.

• Overall Survival (OS)

  Overall survival was evaluated as time from baseline until death and was summarized descriptively.

  Patients were followed throughout the treatment period of up to 24 months and then for an additional 90 days after the end of treatment.

Secondary Outcomes (5)

• Number of Participants With Treatment Emergent Adverse Events (TEAEs) Related to LTX-315

  Patients were followed throughout the treatment period of up to 24 months and then for an additional 90 days after the end of treatment.

• Grade ≥3 Treatment Related TEAEs

  Patients were followed throughout the treatment period of up to 24 months and then for an additional 90 days after the end of treatment.

• Pharmacokinetic Results: Cmax

  LTX-315 in plasma was measured at screening and pre-dosing on Days 1, 2, 3, 8, 22, 43, and at post dosing on Day 3 following the last injection at; 1, 5, 10 (±2 mins), 20, 30, 40, 50, 60, 90, 120 and 150 min (±10 mins).

• Pharmacokinetic Results: AUCinf

  LTX-315 in plasma was measured at screening and pre-dosing on Days 1, 2, 3, 8, 22, 43, and at post dosing on Day 3 following the last injection at; 1, 5, 10 (±2 mins), 20, 30, 40, 50, 60, 90, 120 and 150 min (±10 mins).

• Pharmacokinetic Results: t1/2

  LTX-315 in plasma was measured at screening and pre-dosing on Days 1, 2, 3, 8, 22, 43, and at post dosing on Day 3 following the last injection at; 1, 5, 10 (±2 mins), 20, 30, 40, 50, 60, 90, 120 and 150 min (±10 mins).

Study Arms (1)

LTX-315 in combination with pembrolizumab

EXPERIMENTAL

LTX-315 will be injected directly into the selected tumor lesion(s). Pembrolizumab will be dispensed and administered as an IV infusion.

Combination Product: LTX-315 in combination with pembrolizumab

Interventions

LTX-315 in combination with pembrolizumab COMBINATION_PRODUCT

Phase A Pembrolizumab will be given as 200 mg IV infusion over 30 minutes on Days 1 and 22. Phase B Pembrolizumab will be given as 400 mg IV infusion over 30 minutes every 6 weeks starting at Day 43 (3 weeks after the last dose of pembrolizumab in Phase A) until discontinuation from the study or for a maximum of 24 months' total therapy, whichever comes first.

LTX-315 in combination with pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Have one of the following confirmed histologically:
• Patients with Stage III B, C, D or Stage IV m1a, m1b unresectable metastatic melanoma who have received an approved anti-PD-1/PD-L1 therapy and have progressed on or after prior anti-PD-1 or anti-PD-L1 therapy, alone or in combination with systemic therapy.
• For patients who have refused prior standard-of-care treatment other than anti-PD-1/PDL-1 therapy, the patient's reason for refusing standard therapy for their disease shall be clearly documented in the study electronic case report form prior to study participation.
• All patients must have received anti-PD-1 or anti-PD-L1 in addition to complying with the relevant criteria below. Melanoma patients with v-raf murine sarcoma viral oncogene homolog B1 (BRAF) mutation who are eligible and suitable for BRAF inhibitor therapy should have received specific BRAF inhibitor therapy before enrolling in this study and must have completed treatments at least 3 weeks prior to starting treatment and have no signs of rapidly progressive disease (PD). Patients who have refused BRAF inhibitor therapy are also eligible for the study.
• The patients should have had radiologically PD after the most recent line of systemic therapy (no more than two prior lines in the metastatic setting). Adjuvant or Neoadjuvant therapy is not considered as a prior line of treatment for eligibility purposes. Anti-PD-1 or anti-PD-L1 does not need to be the most recent line of therapy prior to study entry.
• Disease that is not amenable to further radiotherapy or surgery for cancer treatment.
• Have at least one superficial, non-visceral tumor lesion accessible for injection via cutaneous, subcutaneous, or intramuscular route. Note, lymph nodes with metastatic disease may be selected for injection if they are superficial, but not if deep-seated; visceral lesions must not be selected for injection. The lesion must not be located close to airways, defined as close enough to jeopardize the patient's safety, in the opinion of the Investigator, in the event of a local reaction to LTX-315 injection (for example, if such a reaction has the potential to interfere with swallowing or result in hemorrhaging into the airways). The size of the lesion(s) selected for injection must be ≤2 cm in the mean longest perpendicular diameter. For larger lesions or conglomerate lesions, approval from the sponsor's Medical Monitor is needed prior to enrollment.
• At least one measurable target lesion evaluable according to RECIST version 1.1 that is not planned to be injected with LTX-315 or biopsied. The location of this noninjected tumor may be superficial, deep-seated, or visceral.
• Have a life expectancy ≥3 months.
• Are males or females aged 18 years or older.
• Have an ECOG performance status of 0 or 1.
• Resolution of all disease or prior treatment-related toxicities to Grade ≤1, with the exception of alopecia, \<Grade 2 neuropathy and laboratory abnormalities (parameters below apply). If the patient underwent major surgery or received radiation therapy, they must have fully recovered from the intervention.
• Have a left ventricular ejection fraction (LVEF) that is above the institution's lower limit of normal (by echo scan assessment).
• Meet the following laboratory requirements:
• Absolute neutrophil count ≥1.00 × 109/L,

Sponsors & Collaborators

• Lytix Biopharma AS: lead

Study Sites (10)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Levine Cancer Institute - Atrium Health

Charlotte, North Carolina, 28204, United States

Location

University of Pittsburgh Medical Center (UPMC) Hilman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

MD Anderson Cancer Centre

Houston, Texas, 77030, United States

Location

Centre Hospitalier Regional Universitaire De Lille

Lille, France

Location

Gustave Roussy Cancer Campus

Paris, France

Location

Hospital Lyon Sud

Pierre-Bénite, France

Location

Akershus University Hospital

Lørenskog, Norway

Location

Oslo University Hospital--Radiumhospitalet

Oslo, Norway

Location

Clínica Universidad de Navarra

Pamplona, Spain

Location

Related Publications (5)

• 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.

  PMID: 25083333 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.

  PMID: 28490192 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.

  PMID: 31177991 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.

  PMID: 33542073 BACKGROUND

• 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).

  RESULT

Related Links

• Company webpage

MeSH Terms

Conditions

Melanoma

Interventions

LTX-315; pembrolizumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

The efficacy findings from this study are hypothesis generating and to be interpretated with caution due to the single-arm design, small size, lack of a comparator arm, the descriptive analysis, and heterogeneity in the efficacy population and in prior therapies. Further investigation is planned.

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Lytix AS

info@lytixbiopharma.com

+4797573358

Study Officials

• Oystein Rekdal, PHD

  Lytix Biopharma

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: LTX-315 in Combination With Pembrolizumab

Study Record Dates

• First Submitted: March 2, 2021
• First Posted: March 12, 2021
• Study Start: November 5, 2021
• Primary Completion: February 3, 2025
• Study Completion: July 1, 2025
• Last Updated: September 10, 2026
• Results First Posted: September 10, 2026

Record last verified: 2026-06

Locations

NO (2); ES (1); US (4); FR (3)