This clinical trial aims to evaluate the effectiveness of a new treatment approach for patients with stage III or IV melanoma that has spread to other parts of the body but can still be surgically removed. The study combines two treatments: LTX-315 and pembrolizumab.
Melanoma that has spread to other parts of the body can often be treated with surgery. Despite surgery, there is a high risk of the cancer coming back. Pembrolizumab, an immune checkpoint inhibitor, can reduce this risk when given after surgery. Recent studies have shown that giving pembrolizumab before surgery, along with post-surgery treatment, might be more effective than giving it only after surgery. However, many patients still experience cancer recurrence. Combining pembrolizumab with LTX-315, which triggers a different immune response, might improve the treatment\'s effectiveness and reduce the risk of cancer progression before surgery.
This is an open-label Phase II study, meaning both the researchers and participants will know which treatments are being given. The study will be conducted at a single center and will involve about 27 participants. They will receive LTX-315 and pembrolizumab before their planned surgery to see if this combination could be more effective than pembrolizumab alone.
The primary goal is to assess the tumors response to the neoadjuvant (pre-surgery) treatment, specifically looking at the rate of pathological complete response (pCR), where no cancer is detected in the removed tumor tissue.
Participant must be 18 years of age inclusive, at the time of signing the informed consent.
Histologically confirmed, clinically detectable stage III-IV(M1a) melanoma, judged fully resectable and eligible for neoadjuvant treatment by consensus at a multidisciplinary tumor board. Patients with melanoma of cutaneous (including acral) or mucosal (including conjunctival) origin are eligible. Clinically detectable is defined as being apparent and measurable by radiological assessments or physical examination.
Measurable disease as per RECIST version 1.1 criteria.
Judged medically fit to undergo the planned surgery by the surgical team.
Uveal melanoma. Patients with acral, mucosal or conjunctival melanoma are eligible.
History of brain, bone, liver metastases or leptomeningeal metastases.
Patients with stage IV disease having ≥4 metastatic sites.
A history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating Investigator.
Single group
LTX-315 + pembrolizumab
DrugLTX-315 as intratumoral injection once weekly for a maximum of 5 dosing days, in combination with pembrolizumab as intravenous infusion, 200 mg every 3 weeks for a maximum of 18 doses
Complete Pathologic Response Rate
Rate of pathologic complete response (pCR), defined as complete absence of viable tumor in the treated tumor bed.
Safety Evaluation
Frequency, nature and severity of AE according to NCI CTCAE v 5.0: * All AEs * LTX-315 treatment-related AEs * LTX-315 and/or pembrolizumab treatment-related AEs
Objective response rate (ORR)
Rate of CR or PR as per RECIST version 1.1 prior to surgery
Pathologic Response Rate
Rate of partial (less than 50% of the treated tumor bed is occupied by viable tumor cell) or complete pathologic response. Rate of Major Pathologic Response (MPR) defined as complete or near-complete (less than 10% of viable tumor in the treated tumor bed) pathologic response
Event free survival (EFS)
Defined as time from start of treatment to progression of disease that precludes surgery, recurrence (local or distant) or death
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Oslo University Hospital
Lead sponsor
Lytix Biopharma AS
Collaborator
