Actively Recruiting
NeoLIPA: Neoadjuvant LTX-315 in Combination with Pembrolizumab in Resectable Stage III/IV Melanoma
Led by Oslo University Hospital · Updated on 2024-10-26
27
Participants Needed
1
Research Sites
338 weeks
Total Duration
On this page
Sponsors
O
Oslo University Hospital
Lead Sponsor
L
Lytix Biopharma AS
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
NeoLIPA: Neoadjuvant LTX-315 in Combination with Pembrolizumab in Resectable Stage III/IV Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of informed consent
- Histologically confirmed, clinically detectable and fully resectable stage III or oligometastatic IV melanoma
- Melanoma of cutaneous (including acral) or mucosal (including conjunctival) origin
- Measurable disease by RECIST 1.1 criteria
- Medically fit for planned surgery
- ECOG performance status 0 or 1
- At least one superficial cutaneous, subcutaneous or lymph node lesion suitable for injection with maximum longest perpendicular diameter of 3.0 cm
- Willing to undergo additional tumor biopsy and submit biopsy and surgical specimens
- Adequate organ function as defined by hemoglobin > 9 g/dL, ANC ≥ 1.0 x 10^9/L, platelet count ≥ 80 x 10^9/L, bilirubin ≤ 1.5 x ULN, AST and ALT ≤ 2.5 x ULN, albumin > 30 g/L, serum creatinine ≤ 1.5 x ULN or creatinine clearance > 30 mL/min
- Female participants willing to use contraception from first study visit to 120 days after last dose and women of childbearing potential with negative pregnancy test within 72 hours prior to first intervention
- Capable of giving signed informed consent and complying with study requirements
You will not qualify if you...
- Uveal melanoma
- History of brain, bone, liver, or leptomeningeal metastases
- Stage IV disease with 4 or more metastatic sites
- Any condition or therapy that might interfere with trial participation or results
- Active autoimmune disease requiring systemic immunomodulatory treatment (replacement therapy allowed)
- History or evidence of interstitial lung disease or non-infectious pneumonitis requiring systemic corticosteroids
- Prior malignancy requiring concurrent therapy
- Allergy or hypersensitivity to pembrolizumab, LTX-315, or their excipients
- Previous treatment with anti-cancer immunotherapy including CTLA-4 or PD-1 inhibitors
- Use of systemic corticosteroids ≥10 mg prednisolone or equivalent or other immunosuppressive drugs within 28 days before study drug administration
- Receipt of live vaccine within 30 days prior to first dose
- Receipt of investigational drug within 4 weeks prior or scheduled during treatment
- Pregnant or breastfeeding
- Any reason deemed by investigator to preclude participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Oslo University Hospital
Oslo, Oslo, Norway, 0491
Actively Recruiting
Research Team
H
Henrik Jespersen, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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