NeoLIPA: Neoadjuvant LTX-315 in Combination with Pembrolizumab in Resectable Stage III/IV Melanoma

Sponsor
Oslo University Hospital
Study ID
NCT06651151
Phase
PHASE2
Status
Recruiting
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Conditions

  • Melanoma Stage IIIB-IV

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • LTX-315 + pembrolizumab — DRUG
    LTX-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

Study Details

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.

Key Dates

Start date
Nov 1, 2024
Status verified
Oct 2024
Primary completion
May 31, 2026
Completion
May 31, 2031

Study Design

Enrollment
27 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental
    LTX-315 will be injected directly into the selected tumor once weekly for a maximum of 5 dosing days. Pembrolizumab will be given as 200 mg IV infusion over 30 minutes every 3 weeks for a maximum of 18 doses of which three doses will be given prior to the planned surgery.

Primary Outcome Measure

Complete Pathologic Response Rate [ Time Frame: 12 weeks after start of treatment ]

Central Contacts

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