Trial · Interventional
RecruitingPhase 2Registry dataNeoLIPA: Neoadjuvant LTX-315 in Combination with Pembrolizumab in Resectable Stage III/IV Melanoma
Short name NeoLIPA
Overview
- Status
- Recruiting
- Phase
- Phase 2
- Enrollment
- 27 participants (estimated)
- Sponsor
- Oslo University Hospital · Other
- Design
- Allocation not applicable · Open label (no masking)
- Countries
1 country
Norway
- Start
- 1 Nov 2024 (estimated)
- Primary completion
- May 2026 (estimated)
- Completion
- May 2031 (estimated)
- First posted
- 21 Oct 2024
- Last update posted
- 26 Oct 2024
- Conditions
- Melanoma Stage IIIB-IV
Timeline
1 trial · 1 ongoing
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 2
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- LTX-315 + pembrolizumabDrug
Arms1
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 outcomes1
Outcomes the sponsor listed as primary.
Complete Pathologic Response Rate
Time frame · 12 weeks after start of treatment
Registry description
Rate of pathologic complete response (pCR), defined as complete absence of viable tumor in the treated tumor bed.
Secondary outcomes(7)
Safety Evaluation
Time frame · Continously from first dose of treatment to 90 days after last study drug administration
Registry description
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)
Time frame · After 12 weeks of treatment
Registry description
Rate of CR or PR as per RECIST version 1.1 prior to surgery
Pathologic Response Rate
Time frame · After 12 weeks of treatment
Registry description
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)
Time frame · From first dose of treatment to two years
Registry description
Defined as time from start of treatment to progression of disease that precludes surgery, recurrence (local or distant) or death
Recurrence free survival (RFS)
Time frame · Two years after surgery
Registry description
Defined as the time from surgery to recurrence or death.
Overall Survival (OS)
Time frame · Three years after surgery
Registry description
Overall Survival
Quality of Life (QoL)
Time frame · From first dose to end of treatment at approximately 1.5 years
Registry description
Patient reported outcomes (PRO)
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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